6 Dangers of Pharmacy Compounding: What Patients Need to Know

For millions of Americans, prescription drugs provide the help they need to live healthy, independent, pain-free lives. The Food and Drug Administration (FDA) carefully examines each new drug before allowing pharmaceutical companies to release them onto the market.

However, patients sometimes have special needs that standard prescription medications cannot meet. Compounding pharmacies present solutions to these anomalies, creating customized formulations or delivery methods for patients with allergies or other special considerations. Since a licensed pharmacist must change the ingredients of a medication to meet individual needs, the practice comes with heavy inspections and heightened accountability. Unfortunately, many compounding pharmacies fail to protect public health adequately.

Compound drugs can and do save lives. However, when pharmaceutical companies engage in unapproved compounding practices, the ramifications for patients can include:

•    Contamination. Individual or small batches of medication are more vulnerable to harmful fungi or other particles.

•    Incorrect potency. While FDA-approved formulations have been shown to produce consistent results, custom mixtures may be too weak or strong for patients.

•    Diminished quality. Drugs mixed at independent compounding facilities often lack the quality control of major pharmaceutical manufacturers.

•    Impurities. Outside agents in compound drugs often reduce their efficacy.

•    Exacerbated illness. Patients with serious health issues often receive compound formulations. These can fail to adequately treat conditions, and their side effects can in turn severely impact an individual’s wellbeing.

•    Higher costs. An unfortunate number of compounding pharmacies take advantage of insurance billing policies by loading compound drugs with expensive ingredients. Prescription plans often pass these costs to customers or refuse to cover medications.

When patients receive compound medications from pharmacies, they expect these drugs to perform as indicated without causing unexpected side effects or illnesses. If a compound medication has harmed you or a loved one, a Washington D.C. medical malpractice attorney can help you hold the pharmacy accountable and obtain the compensation you deserve.

Curious about the diverse dangers of the compound pharmacy industry? Read Pharmaceutical Compounds: Investigating and Regulating Their Use (Part 2)

Posted In Medications
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Former Compounding Center Supervisor Arrested Over Meningitis Outbreak

On September 4, authorities detained Glenn Chin at the Logan International Airport in Boston, as he tried to board a flight to Hong Kong with his family. His arrest can be traced back to a 2012 meningitis outbreak caused by tainted drugs from the New England Compounding Center. Chin served as a supervising pharmacist of the now defunct company.

The outbreak, one of the deadliest in recent history, occurred when a batch of the company’s painkilling, injectable drugs was contaminated. Before its recall and the subsequent closure of the plant, the drug devastated families across the U.S. The corruption-created outbreak caused diverse problems, including:

  •  750 cases of meningitis
  •  64 deaths
  •  20 states impacted by contamination-related illness

Of these meningitis cases, “217 infections and 15 deaths” allegedly had been a direct result of Chin’s signing off on a batch of drugs. After an inspection of the New England Compounding facilities, federal and state health investigators reported considerable faults with sterility and maintenance – both areas of Chin’s responsibility as supervisor.

Several pending lawsuits name Chin as a defendant in Boston federal court. The criminal investigation is still in progress, which is why law enforcement officials detained Chin as he attempted to leave the country. Although Chin was not the only individual allegedly responsible for the outbreak, authorities have placed a high priority on holding all former staffers and supervisors from the New England Compounding Center accountable for their actions.

In both traditional pharmacies and compounding facilities, pharmacists assume legal responsibility to keep the medicines they distribute untainted. The recent meningitis outbreak serves as a tragic example of the devastating consequences that can happen when medical professionals fail in their duties.

If you or a loved one became ill due to a pharmaceutical error, you may be entitled to compensation for lost wages, medical bills, pain and suffering and other damages. Contact a Washington D.C. medical malpractice attorney today to discuss your legal options.

Explore more info about these pharmacies (and their dangers) by checking out Pharmaceutical Compounds: What They Are and How They Cost Consumers (Part 1)

Posted In Medications , Patient Safety , Public Health
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Pharmaceutical Compounds: Investigating and Regulating Their Use (Part 2)

In our last post, we discussed how pharmaceutical companies have begun to profit from the proliferation of compound drugs, as reported by the New York Times. Today, we will examine the measures various entities have taken to investigate and regulate these products.

Catamaran, a pharmacy benefits manager, discovered their spending on compounded drugs had increased fourfold over the past two years. The company is now making a concerted effort to examine such claims to determine their validity. Similar companies – including Blue Cross Blue Shield, Harvard Pilgrim, and state workers’ compensation plans – are now doing the same.

Express Scripts, meanwhile, recently decided to stop payments for over 1,000 of the ingredients compounders commonly use. This 95 percent reduction in spending has saved money for consumers, health plans, and employers alike, while cutting into the profit margins of compounding pharmacies.

According to Dr. Sumit Dutta, Catamaran’s chief medical officer, such measures remove the “profit motive” driving these companies to produce more complex and expensive medications.

In Southern California in June, 15 individuals -- including financial brokers, doctors, chiropractors, and pharmacists -- were indicted for participating in a “kickback scheme” targeting workers’ compensation plans. Kareen Ahmed of Landmark Medical Management allegedly helped to purchase accounts receivable from health providers awaiting payment for workers’ compensation related services.

Some states have responded to the compounding pharmacy problem by imposing payment limits (Ohio) and limits on the number of ingredients payable per prescription (Georgia).

However, the compounding industry refuses to go down without a fight. The new Patients and Physicians for Rx Access, founded in June, advocates for compounding pharmacies, claiming that patients need compound drugs -- that standard medications often do not meet their health needs.

Have you or a loved one experienced negative effects as a result of a contaminated or incorrectly formulated compounded drug? Call a D.C. medical malpractice attorney today to discuss your legal options.
 

Want to learn more? Check out: Compounding Pharmacy Report Reveals Limited Regulation

Posted In Medications
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Pharmaceutical Compounds: What They Are and How They Cost Consumers (Part 1)

The rising costs of health care in the United States are no secret to doctors, patients, or pharmacists. Lifesaving drugs, procedures, and equipment continue to place a high cost burden on consumers and their insurers.

Among the fastest-growing and most expensive treatments patients received as of late are compounded drugs, according to a recent article by the New York Times. These formulations consist of custom ingredients to meet the unique needs of patients, from diaper rash to pain and scarring.

Created by compounding pharmacies, these drugs present alternative treatments for individuals unable to take mass-produced drugs due to ingredient intolerances, an inability to take oral doses, or other complications. Pharmaceutical compounds frequently cost exponentially more than their standard counterparts, reaching into hundreds or thousands of dollars.

Compounding companies claim the prices of their products have increased due to rising oversight of their international chemical suppliers. However, a change in 2012 to how pharmacists bill insurers for compound medications likely points to a more compelling reason.

Whereas pharmacists used to submit claims based on the price of the main ingredient in a compound, they now bill based on each ingredient in a compound. Incidentally, the number of ingredients in each compound has begun to increase.

Not only are insurance companies and patients bearing the brunt of these excessive costs – the safety of pharmaceutical compounds has also recently been called into question. A recent high-profile example was a steroid injection that sickened 750 and killed 64 after being tainted with a fungus at the New England Compounding Center.

This troubling news comes as pharmacy benefit managers note compounded drugs often yield no more benefits to patients than their mass-marketed equivalents. In addition, compounds require no FDA approval, putting their safety and efficacy further into question.

In Part 2, we will discuss how the medical and legal communities have reacted to the high costs of compound drugs.

If you or a loved one have experienced injury or illness due to faulty pharmaceuticals, contact a D.C. medical malpractice attorney today.
 

Want to read more? Check out this article: Senate Drafts Bill to Regulate Compounding Pharmacies



Posted In Medications , Patient Safety
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New Research Casts Doubts on Benefits of Niacin for Heart Health

Although many physicians have prescribed niacin, or vitamin B3, to treat high cholesterol levels, a recent study shows the compound may cause more problems than it prevents.

In its July 17 issue, the New England Journal of Medicine details a major clinical trial scientists conducted to explore the benefits of niacin in patients with hardened arteries. Researchers found it did slightly raise HDL (“good”) cholesterol in subjects but presented no apparent cardiovascular benefits.

In the study, researchers at Oxford gave half of the 26,000 study participants a pill composed of niacin and laropiprant, while providing the other half with a placebo.

According to Jane Armitage, senior author of the study and professor of clinical trials and epidemiology at Oxford, niacin intake also heightened the risk of dangerous side effects, such as increased blood sugar in diabetics, higher numbers of new diabetes diagnoses, and a proliferation of skin problems, gout, infections, diarrhea, excess bleeding and liver problems. These side effects led to several hospitalizations.

More notably, 9 percent more patients died when taking niacin compared to the control group. Although researchers note this percentage is not statistically significant, it represents a “deal breaker” to Dr. Donald Lloyd-Jones, who penned the editorial accompanying the study.

Researchers concluded niacin use is unlikely to create the effects for which doctors have prescribed it, such as increasing HDL cholesterol and reducing stroke and heart attack. They recommend any individuals currently taking niacin contact their physicians to discuss switching to statins, which have proven safer and more effective.

Constant discoveries in the medical field often uncover complications and dangers presented by commonly-prescribed medications. Although medical professionals do their best to provide the best care based on the information available to them, they must be held accountable when their recommendations lead to negative effects in their patients.

If you or a loved one have suffered as a result of an inappropriately prescribed medication, contact a DC medical malpractice attorney today to discuss legal options.

Have you talked with your doctor regarding the safety of your medications?


 

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What Does the FDA Say about Sunscreen Labels?

Spending time in the sun represents one of the most enjoyable parts of summer, but the risk of sunburn, early aging and skin cancer do not. To mitigate these risks while keeping individuals more comfortable all season long, numerous sunscreens exist.

In the past, these products have made claims on their packaging that have failed to bear out in regular use. Those believing they were providing themselves with superior sun protection often put stock in misleading claims, leading users to purchase products less effective than advertised and use them less liberally than intended.

To combat widespread misunderstanding about the nature and efficacy regarding sunscreen, the FDA recently released new labeling guidelines to reduce the ambiguity of packaging claims. These new restrictions include:

1.    Cancer risk statements.
On products providing SPF below 15, the FDA now requires companies to provide a disclaimer stating they do not provide sufficient protection from early skin aging or cancer.

2.    Water resistance clarifications.
To reflect the inability of any sun protection product to provide “all day protection” or “sweat-proof” or “waterproof” qualities, sunscreens may now designate themselves only as “Water Resistant (40 Minutes)” or “Water Resistant (80 Minutes).”

3.    Limits on SPF levels. Although sunscreens once designated themselves as high as SPF 100, few products offer more than SPF 50 protection, which blocks close to 100 percent of the sun’s rays. Most highly-rated sunscreens will now advertise as “SPF 50+.”

4.    Tighter restrictions on broad-spectrum.
The term “broad-spectrum” refers to products providing protection from UVA as well as UVB rays. Companies must now pass a wavelength test to ascertain their protection from UVA rays.

5.    Elimination of “sunblock.” This previously used term misled many consumers into believing a product provided full protection from UV rays, leading the FDA to designate all sun protection products as sunscreen.

The FDA’s new regulations have provided additional oversight in an industry prone to ambiguous claims.

When manufacturers use dishonest advertising to sell products, significant injuries and illnesses may result. DC product liability attorneys help those affected by such claims hold companies accountable for their actions.

Are the products you use living up to the claims they make?

Do you need to go to the hospital for a skin condition or sunburn? Read these 10 tips to stay safe.

Posted In Product Liability , U.S. Food and Drug Administration Warnings
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Do Medical Malpractice Lawsuits Impact the Quality and Outcomes of Surgeries? [An Analysis of a Recent Study]

In February, Christina A. Minami and her colleagues published an article in the journal of the American College of Surgeons about the impact of medical malpractice lawsuits and litigation on surgeries in the United States: “Impact of Medical Malpractice Environment on Surgical Quality and Outcomes.” (links to abstract only)

The authors aimed to “perform a systematic review of the literature to examine the association between malpractice environment and outcomes in surgical specialties.”

What did they conclude, and why?

Before we analyze the paper, let's take a look at some interesting assumptions they made at the beginning of the research project. They wrote: “the annual cost of the medical malpractice system has been estimated to be $55 billion. The medical malpractice crisis that began unfolding in the late part of the 20th century continues to be a major concern. The intent of the malpractice system, based on classic tort deterrence theory, assumes that the looming threat of a malpractice suit will deter poor care because providers will be more vigilant and responsible. Proponents of the liability system believe that the threat of malpractice suits will encourage providers to adhere to standards of care, which, in turn, should lead to better patient outcomes.”

They also describe a recent study that “found that one-quarter of American surgeons had been the subject of a malpractice suit over the preceding two years.” They mention that some analysts worry that these lawsuits “may force providers to leave high malpractice risk environments.”

In other words, surgeons might be deterred from engaging in risky, but important medical practices because they don’t want to get sued.

There are several potentially problematic implications here.

First of all, when discussing the medical malpractice “environment,” you cannot leave out the Goliath role played by insurance companies. Many advocates of so-called tort reform want to blame trial lawyers for escalating insurance costs – and thus for indirectly creating stress for medical practitioners. However, a compelling case can be made that trial lawyers are not to blame; rather, insurance companies control the financial dynamics that make circumstances miserable for doctors.

Secondly, there's a troubling subtext in this article: a suggestion that lawsuits against surgeons are out of control. The authors wrote: “One quarter of American surgeons have been the subject of a malpractice suit over the past preceding two years,” thus seeming to imply that lawyers are going crazy and filing spurious suits against surgeons.

Compelling evidence, however, paints a decisively different picture. As recent Harvard University review of medical malpractice cases found, the vast, vast majority of malpractice cases are well-grounded. In fact, it’s likely that the lion's share of medical malpractice incidences go un-litigated and unpunished.

If you or somebody you love believes you’ve been the victim of some kind of malpractice, we invite you to contact the Regan, Zambri & Long team today for a free consultation with our DC medical malpractice lawyers at (202) 463-3030.
 

Posted In Medical Malpractice
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Common Signs of Sports Concussions in Adolescents

As a parent of a child involved in one or more sports activities, would you know how to detect a possible concussion?

Understand the signs and symptoms of this potentially serious head injury to keep your kids safe and healthy.

After a forceful jolt, bump, or blow that causes trauma to his or her head, a child athlete may begin exhibiting changes in their thinking, behavior, or physical functions. Ignoring such signs and symptoms can exacerbate a concussion and put the athlete at risk for further injury.

How to Detect a Potential Athletic Concussion

Several signs may indicate a child has sustained a sports concussion. These symptoms include:

•    Sudden nausea or vomiting

•    Sluggishness or a sense of “haziness” or fogginess

•    Forgetfulness related to instructions or events before or after the trauma

•    Loss of consciousness

•    Clumsy movement

•    Slow, labored speech

Should one or more of these indicators manifest in a child after a head injury, immediately remove him or her from play and seek medical treatment.

How Treatment Guidelines Differ between Children and Adults


Quick and thorough examination following a head injury is the best way to prevent lasting damage. Furthermore, new treatment guidelines from the American Academy of Pediatrics present differences in how adolescents heal from concussions compared to adults.

According to these guidelines, children under 18 years of age require an average of 7 to 10 days to recover fully from a concussion, a longer timeframe than that of the typical adult. As a result, adolescents with signs of concussion should stop engaging in activity immediately and not resume until whatever comes first – 24 hours without symptoms or a doctor’s permission.

Sports injuries may be common in young athletes, but with prompt and careful treatment, children can recover fully and return to their favorite activities.

Have the actions of another individual contributed to your child’s injury while playing sports? To learn whether you have a viable legal case, contact a Washington D.C. child safety lawyer.

Posted In Patient Safety , Pediatrics
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Have Medical Malpractice Lawsuits Caused a Dangerous Rise in C Sections? (Part 2)

In our last post, we discussed the curious implications of a highly cited, provocative medical paper, Yang et. al's "Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section," which obliquely blames medical malpractice attorneys for skyrocketing rates of C-Sections.

The New York Post also recently brazenly asked: “Do Medical Malpractice Threats, Real Or Imagine, Lead to More C-Sections?”

As tantalizing as the thesis that "pressure from medical malpractice attorneys --> more C-Sections" may seem based on superficial analysis, upon deeper inspection, it just doesn't hold up.

There are two compelling problems with the thesis.

Problem #1. The correlation could be spurious.

Just because two trends “go together” does not mean that one causes the other. Correlation, as they say, does not imply causation. Spurious correlations happen all the time, for many different reasons. A popular website, http://www.tylervigen.com/, lists a whole bunch of ridiculous correlations. For instance, the consumption of organic food has been correlated very, very tightly with increasing rates of childhood autism over the past decade. But no one would say that eating more organic food causes babies to be autistic or that autistic children somehow make people more crave organic food. The correlation is just an odd statistical artifact with no meaning.

Problem #2. We could be overlooking other, better explanations for the trend.

In some cases, one unseen driver can cause both trends. In other words, some third force can lead to more malpractice pressure AND more C-Sections at the same time. That would nicely explain any correlation. Tellingly, Yang et al included, as one of their metrics, "increased malpractice insurance premiums."

So maybe the insurance companies' decisions to raise their rates -- which may or may not have been caused by any actual, real changes in lawsuits filed -- caused both the "increase in malpractice pressure" and the spike in C-Sections. By this read, the real "bad guys" would be the insurance companies, not the trial lawyers.

As this blog and many other more objective sources have confirmed, insurance companies have their own agenda and often work very hard to blame malpractice attorneys for problems that they, themselves, either create or exacerbate.

Perhaps the insurance companies raised premiums for their own insurance company reasons, which in turn scared doctors into taking overly-precautionary methods (such as opting for C-Sections instead of VBACs). Meanwhile, the medical malpractice attorneys were innocent. The broader point is that, to understand the cause and effect relationships in complex systems, you need hard science, not just epidemiological observations. (For a more detailed explanation of the problems with many epidemiological studies, see journalist Gary Taubes' fascinating 2007 New York Times piece, "Do We Really Know What Makes Us Healthy?")

For thorough, effective assistance dealing with your potential case, call the medical malpractice attorneys here at Regan, Zambri & Long for a confidential consultation at (202) 463-3030.
 

Posted In Medical Malpractice
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Have Medical Malpractice Lawsuits Caused a Dangerous Rise in C Sections? (Part 1)

Have medical malpractice lawsuits changed how American women give birth?

That thesis, while seemingly far fetched, is growing in popularity among academics and tort reformers alike. Why do people believe this idea? How much good research supports it? In today's post and one to follow, we'll follow this discussion.

In 2009, researchers Yang et al published a provocative paper in the journal Medical Care, entitled “Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section.” The paper tried to answer the question of whether our modern, increasingly litigious environment has caused a spike in the rate of cesarean sections ("C sections").

The authors in the abstract made the following observation: “Since the 1990s, nationwide rates of vaginal birth after cesarean section (VBAC) have decreased sharply and rates of cesarean section have increased sharply. Both trends are consistent with clinical behavior reducing obstetricians' exposure to malpractice litigation.”

The researchers tried to figure out how and whether the malpractice environment impacted VBAC and cesarean section rates. They used “state level longitudinal mixed effects regression models” to take a look at birth statistics in the U.S. from the early 1990s to 2003. They also tried to operationalize “malpractice pressure” by measuring the effect of tort reform and the size of liability insurance premiums.

The researchers DID find an association between increased “malpractice pressure,” as they defined the term, and an increase in a number of cesarean sections and VBACs. The New York Post jumped on this story and published its own interpretation, making it sound like medical malpractice lawyers caused a dismal, dangerous trend in the birthing industry.

Even the Post's headline -- “Do Medical Malpractice Threats, Real Or Imagined, Lead to More C Sections?” -- is a leading question, if there ever was one. The Post quoted an expert, Naomi Riley, who said “there’s universal agreement in the medical community that too many C-sections are taking place, but the fact is that doctors don’t have much choice.”

The implication is clear: malpractice lawyers have made the birthing system more complicated and dangerous for moms and doctors alike.

Or have they?

In fact, this seemingly cut and dry case is anything but. In our next post, we'll explore two huge problems with this thesis.

For now, if you need help with a potential D.C. medical malpractice case, contact the attorneys at Regan, Zambri & Long at (202) 463-3030 for immediate assistance.
 

Posted In Medical Malpractice
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A Look into the VA Waiting List Debacle

The Veterans Health Administration is responsible for the healthcare of 8.76 million veterans and their families every year, representing “America’s largest health care system.” The VA’s crucial role in the life and wellbeing of some of our most honored citizens makes the recent waiting list scandal exponentially more appalling to medical malpractice attorneys as well as the public at large.

The Cover-Up

The VA crisis emerged in April, when a retired clinic director came forward with allegations that the Phoenix VA had falsified their electronic waiting list. Their “secret waiting list” concealed the number of veterans waiting for care, as well as their exorbitant wait times.

Since word of the cover-up has come out, investigators have identified at least 18 veterans that died while waiting for medical care. It is currently unclear whether these individuals’ deaths directly resulted from the delay in care. However, autopsy reports, death certificates, and medical records should provide more conclusive evidence.

The Solution


As the investigation continues, the VA has responded by opening up several mobile medical units throughout Phoenix to give more veterans access to the care they need. In addition, the Senate Veterans Affairs committee is working on a bill that would help veterans by expanding their network of healthcare facilities and providers, eliminating ineffective executives and administrators while increasing facilities and hiring across the country.

Hopefully, these measures will begin to turn around a seriously flawed system whose mismanagement and dishonesty have harmed countless American heroes. However, as more information emerges, we will likely learn that many more veterans have died or suffered needlessly due to the practices of VA facilities across the country.

Medical Malpractice


Each state creates its own medical malpractice laws, but the National Institutes of Health defines medical malpractice as “any act or omission by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes injury to the patient.” The VA, like any other medical provider, has an obligation to provide its patients with timely and effective healthcare and to abide by the law while doing so.

When healthcare organizations break their trust with those who depend on them for their care, they must be held accountable. Washington D.C. medical malpractice attorneys Regan Zambri & Long work with individuals who have suffered harm at the hands of their medical providers. For a free consultation to explore your legal options, contact us at (202)463-3030.

 

 

Posted In Medical Malpractice
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Virginia Medical Malpractice Suits Against VA Clinics Settle for Over $1 Million

The Center for Investigative Reporting just released a report announcing that the families of four deceased military service members will collect around $1.4 million in settlement money. Caregivers treated the veterans at the Coatesville Veterans Affair Medical Clinic in Virginia.

  • One VA medical malpractice case (which settled for $100,000) concerned accusations that caregivers did not monitor a veteran who later died.
  • Another case, which closed back in February 2008 for nearly $500,000, concerned the VA's failure to manage a psychiatric patient.
  • A third case closed in August 2011: A misdiagnosed VA patient died.
  • A fourth case closed in December 2011 for $500,000: a caregiver failed to monitor a sick veteran.

Amazingly, those four cases constitute just a drop in the bucket. VA facilities around the country currently face over 1,000 wrongful death actions; the government has already settled various matters for over $200 million.

Why is this happening, and what are lawmakers doing about it?

Patrick Mayhem, a Democratic Congressman, lashed out recently against President Obama for allowing the situation at VA facilities to get so bad. Mayhem said “the President spoke of accountability at his press conference today but is showing none… The horrors that have been exposed at the VA facilities across the country are shameful, and addressing them requires less talk and more decisive action.” Among other things, Mayhem had wanted Obama to fire VA Secretary Eric Shinseki.

Obama did meet with Shinseki at the Oval Office, and he exchanged harsh words. The President said: "I told the Secretary I will not stand for [what is happening with the VA facilities] – not as Commander-in-chief but also not as an American.”

Nationwide outrage has been building, following repeated allegations of patients dying at VAs due to misdiagnoses or bad treatment. Patients and their families also complain about costly, nonsensical delays.

There has been a massive influx of soldiers back from campaigns in Iraq and Afghanistan over the past several years. These people often need more than just temporary assistance with medical problems. They also need long term psychiatric help as well as therapy for chronic issues caused by head injuries, PTSD and war-related depression.

Patient rights advocates want to see positive action to fix the VA facilities to make them more functional and make the system fairer. Obama reassured voters last week: “we are going to fix whatever is wrong, and so long as I have the privilege of serving as Commander In-Chief, I am going to keep on fighting to deliver the care and benefits and opportunities that you and your families deserve, now and for decades to come.”

Hopefully, that will be the case.

If someone you love was hurt, misdiagnosed, or otherwise poorly treated at a VA facility or any other medical center, call Regan Zambri & Long today for a free consultation at (202) 463-3030.
 

Posted In Medical Malpractice
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Impassioned Forbes Magazine Piece Shows That Malpractice Lawsuits "Aren't Just About Money"

How widespread is medical malpractice? What are the real costs for patients, for the medical system, for doctors and for insurers? And what can be done to fix the system's fundamental structural problems? A compelling recent piece in Forbes Magazine, “Malpractice Lawsuits Aren’t Just About the Money,” dissects the scope and breath of the problem; it’s truly breathtaking.

The piece begins with the tale of a woman named “Karen,” a Board Certified physician whose mother had been rushed to the hospital, because she had been on the wrong medication. Terrified and enraged, Karen called her mother’s doctor, who proclaimed that he was “on vacation” and could not be bothered to come in and see the sick patient.

Even though Karen was “Board Certified in three specialties,” she felt helpless to navigate the system. Should she file a lawsuit? Perhaps she could complain to the Joint Commission on Safe Accreditation – a watchdog organization that promotes safety and quality care at hospitals. Good idea in theory. Unfortunately, only a third of the 3,000+ hospitals accredited by the Joint Commission have the distinction of being “top performers.” What's more: 2,400 hospitals throughout the country do not even have this accreditation.

The Scope of the Malpractice Debacle

Nearly 100,000 people die and 300,000 people suffer injuries every year at U.S. hospitals due to avoidable errors, per the National Institute of Medicine. This is simply an unacceptable situation.

And reformers are frustrated.

In 2004, reformers created the Institute for Health Care Improvement, which urged hospitals to sign on to evidence-based strategies to protect people from the dangers of malpractice, using objective metrics, and to implement positive changes. 1,000+ hospitals signed on, but these hospitals were notoriously slow to implement key recommendations and often behaved in recalcitrant fashion.

Hospitals have not been the only institutions resistant to change.

The American College of Obstetricians and Gynaecology (ACOG) famously failed to implement powerful changes that helped New York Presbyterian Hospital drop its rate of “sentinel events” (those causing death or serious injury) from 1 out of a 1000 to zero, over a span of just a few years.

Why did ACOG refuse to make these changes? According to the Forbes article, ACOG rejected the reforms “on the grounds they [might] infringe on individual doctor or hospital prerogatives.”

In other words, ACOG made a choice that it's more important to preserve doctor/hospital autonomy than it is to prevent sentinel events in patients.

That's a cynical calculus, if there ever was one.

By contrast, consider what the American Society of Anesthesiologists did back in the early 80s, in the wake of a series of awful patient incidents. That organization did a thorough work over of its processes and, within a decade, dropped the rate of death from anesthesia from 1 in 6,000 to 1 in 200,000.

If you or somebody you love needs legal assistance with a potential case, contact the Washington D.C. malpractice attorneys at Regan Zambri & Long today at (202) 463-3030 for a free consultation.
 

Posted In Medical Malpractice
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Could 12 Million People Be Really Misdiagnosed Every Single Year?

A very alarming new study puts DC medical malpractice cases -- and indeed, the entire issue of malpractice -- in a disturbing new light.

Researchers at Houston Veterans Affairs Medical Center, publishing in BMJ’s Quality and Safety Journal, suggest that one out of 20 Americans every year gets misdiagnosed by a physician. That means that doctors misdiagnose 12 million Americans every year.

Fortunately, most of these misdiagnoses likely do not result in serious injury or death. But that is still a staggering number, and if it’s even remotely accurate, it should set off alarm bells throughout the medical care system and instigate process improvements ASAP.

The researchers concluded that up to 50 percent of the errors in diagnoses could lead to major harm (not that they necessarily DO, fortunately). They wrote that their analysis “should provide a foundation for policyholders, healthcare organization, and researchers to strengthen efforts to measure and reduce diagnostic efforts.”

Traditionally, it has been challenging to identify misdiagnosis statistics outside of hospital and clinical settings. In this study, researchers examined hundreds of patient medical records as well as records of clinical doctor visits, and they then made estimates based on these data and extrapolated their conclusions to the population at large.

Obviously, this study has its limitations. For instance, perhaps the sample that they analyzed was just unlucky; and they endured many more misdiagnoses than typically happen to the patient population. Or perhaps the methodology was somehow flawed or the statistics used to measure and compare patient groups were not accurate or appropriate.

Most Costly Errors?

The researchers noted that “delayed cancer diagnoses is believed to be one of the most harmful and costly types of diagnostic care in the outpatient setting,” especially since early treatment can save lives for patients who develop some cancers and progressive, chronic diseases.

Whether the study accurately gauged the “true” number of misdiagnoses or not, many patients (and families of patients) don’t understand their rights or possible means of recourse after a misdiagnosis-related injury or illness.

The team here at Regan, Zambri & Long can help you understand your legal options. Our Washington D.C. medical malpractice attorneys are standing by to provide a free and confidential case evaluation at (202) 463-3030. Call or email us now for sound insight.
 

Posted In Medical Malpractice
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The Data Are in: National Practitioner Data Bank (NPDB) Publishes Info on Medical Malpractice Payouts

Every year, the National Practitioner Data Bank (NPDB) creates a compilation of data about medical malpractice payouts in the United States. These data can be helpful, because they can help identify trends in medmal, state-to-state, and effectively “take the temperature” of how the country feels about the industry and about tort reform. Surprisingly, the report found that 93% of all payouts in 2013 came from settlements -- only 4% of the money came from verdicts. The survey also illustrated that trial can be quite a risky proposition, from a plaintiff's point of view. Doctors win substantially more cases than they lose in court. Perhaps doctors who feel confident in their positions don't mind going to trial to defend them, while doctors who feel less sure choose to settle.

The NPDB data only focus on medical malpractice cases against practitioners, not hospitals. Some analysts have expressed quibbles with aspects of the NPDB methodology, but these issues are too fine grained and technical to cover here. The data can certainly enlighten us about the key trends, however.

State by State Medical Malpractice Payouts for 2013

In terms of per capita payouts, New York State led the charge -- nearly $40 of per capita. Washington D.C.'s per capita was higher that average at $19.31 per capita. Maryland, meanwhile, had a basically identical rate of $19.27. Virginia fared slightly better at $10.26. North Dakota was on the low end -- just $2.96 per capita was paid out.

For the first in time in over a decade, the total number of payouts went up, as did the amount of payouts. Analysts suggest that this trend may reflect a national push back against the “tort reform” movement. The data do show significant variation from state to state, indicating a volatile industry in transition.

Three years ago, 308 medical malpractice practice cases were settled or decided in court in Maryland for total of $91 million. Meanwhile, in Virginia, 199 cases either settled or got decided in court for $77 million. Even though Virginia settled few cases, the total average payout amount was much higher in VA.

The distribution of medmal payouts roughly follows the Pareto Principle (also known as the “80-20 Rule”), in that just a handful of cases led to the majority of payouts.

Author Michael Krauss analyzed the NPDB data on the Forbes blog and asked penetrating questions about what these numbers might mean: “How much underreporting to the NPDB… goes on? Why is New York so seemingly different from every other state? Do statutes inadvertently skew results?”

When analyzing any data – even carefully controlled surveys that have been vetted and professionally assessed – you need to be careful to avoid jumping to conclusions.

The reality is that survey data like these need to be understood in context and supported by other studies and evidences. If you need a medical malpractice lawyer in Virginia, D.C. or Maryland, please contact Regan, Zambri & Long today for a free consultation at (202) 463-3030.

 

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California Advocates Push to Raise Golden State Medical Malpractice Cap -- Would Be First Increase Since 1975

Under California law, damages in medical malpractice cases are capped at just $250,000.

If that figure sounds anachronistic… well, that's because it is: literally!

The $250,000 cap has been in place for nearly four decades – it became law way back in 1975, when then-Governor Jerry Brown signed the Medical Injury Compensation Reform Act (MICRA). Forty years later, that same cap remains in place. (Curiously, Governor Brown is, once again, Governor of the Golden State).

But that old cap may not last much longer.

Passionate California consumer advocates and attorneys have demanded reform to make the system more fair and modern. Thousands of signatories hope to qualify the "Troy and Alana Pack Patient Safety Act" to go on California’s November ballot later this year. The Act takes its name from a tragic accident: in 2003, two children (Troy and Alana Park) died in a horrific car crash, after their mother felt asleep because her doctors overprescribed her pain killers.

Bob Pack, the father of the two children, wrote the bill. He said the Act would accomplish several things:

•    It would force doctors to undergo random drug testing;
•    It would curb drug abuse related to “doctor shopping” by leveraging the state’s current prescription drug data base;
•    It would increase the cap for pain and suffering in medmal cases, which is still stuck at the 1975 level of $250,000.

Pack told reporters that: “inside these boxes [the ballots for the vote] are the voices of many victims and many Californians who want to see this change." Unsurprisingly, hospitals, doctors, and community clinics have resisted moving the cap. They fear that doing so might spark a wave of lawsuits and increase patient costs. The California Medical Association’s President, Dr. Richard Thorp, did not mince words: “this initiative is bad for patients, bad for taxpayers, and bad for California’s entire system of healthcare delivery.”

Sacramento Democrat, Darrell Steinberg, hopes to ward off a ballot initiative by seeking a legislative solution to get the MICRA cap bumped up to $500,000. This rate, as he noted, would "still be far below the rate of inflation, since MICRA became law 39 years ago."

Steinberg hopes to avoid a political bloodbath: “initiative battles [are] costly and uncertain and will damage the reputation of two fine professions… The issue cries out for a legislative solution, and what I'm offering is a conservative increase that's fair to injured patients as well as the medical and legal communities.”

Steinberg maintains that his compromise number ($500,000) is reasonable and that it would fairly compensate injured patients without significantly increasing medical costs.

But a group called Consumer Watchdog is not so sure. That group's director, Jamie Court, said “legislators have had years to make this change… if there is no popular legislation for patient safety, then the people will make the change.”

The situation in California illustrates the complexity of the medmal cap debate and its divisive tenor. Fortunately, if you or someone you love got hurt due to a doctor or hospital’s negligence or carelessness, you don’t have to fight your legal battle on your own. Call a D.C. medical malpractice attorney here at Regan Zambri & Long today at (202) 463-3030 for a free consultation.
 

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Over 200 Patients Die Daily From Hospital-Associated Infections, Report Shows

Posted by: Salvatore J. Zambri, founding member and partner

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Results from the recently-published Centers for Disease Control and Prevention (CDC) 2011 hospital survey indicate that, despite progress in recent years, the deadly health-care problem of infection continues. According to survey results reported in The New England Journal of Medicine, an estimated 648,000 patients suffered from 721,000 healthcare-associated infections and 75,000 died from them. In his press release, CDC Director Tom Frieden said, "Today and every day, more than 200 Americans with healthcare-associated infections will die during their hospital stay."  The most common infections include:

  • pneumonia  -22%
  • surgical site infections - 22%
  • gastrointestinal infections - 17%
  • urinary tract infections - 13%
  • blood stream infections - 10%

Many antibiotic-resistant bacteria are prevalent in hospitals, including Clostridium difficile (C. diff) and methicillin-resistant staphyloccus aureus (MRSA). As a result, new approaches to controlling bacteria in hospitals have become necessary. Overuse of antibiotics is now discouraged with the hope that some will become more effective again. The proposed federal budget for 2015 includes additional funding for battling antibiotic resistance.

In his statement about the survey results, Mr. Frieden said, "We go to the hospital hoping to become better, and mostly we do, but not always." I hope that hospitals take more aggressive measures to protect their patients from hospital-borne infections. Lives depend on it.

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Medical Malpractice Caps Limits Overturned in Florida

Posted by: Salvatore J. Zambri, founding member and partner

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For years, supporters of so-called tort reform claimed that the costs of medical care would decrease drastically if recoveries in medical malpractice lawsuits were limited. These anti-civil-justice advocates suggest that capping damages in cases would cause doctors to order less tests, reduce their medical malpractice premiums, and make frivolous lawsuits disappear. A number of states bought that theory and enacted laws designed to control medical malpractice lawsuits. Recent rulings and statistics show that "tort-reform" harms Americans. 

As recently reported in the Miami Herald, according to the National Conference of State Legislatures, thirty-five states cap the amount of money that can be awarded in medical malpractice lawsuits. Supporters of medical malpractice caps limits proclaimed that the excessive number of frivolous lawsuits were creating a "malpractice crisis" that drove insurance rates sky-high and forced doctors to leave the state. As a result, caps were enacted.

Florida's Supreme Court recently ruled that those laws were unconstitutional and violated the equal protection guarantee under the state's constitution. Prior to this ruling, Florida limited the amount of recovery for most patient deaths due to medical negligence to $1 million and non-economic damages to $500,000. The ruling did not address the caps limits where the patient didn't die. The court questioned whether the alleged crisis that led to the caps limit ever existed. The court concluded that not only was there no crisis, but that the creation of lawsuit caps enriched insurance companies at the expense of doctors and patients. According to the ruling, during the time that the law was in effect, insurance companies continued to charge excessive premiums to doctors. Any savings that may have resulted from the caps was never passed on to doctors or consumers.

"The most recent records and reports of the Florida Office of Insurance Regulation, and the annual reports of medical malpractice insurers, confirm that not only has the number of insurers providing medical malpractice coverage increased...the profits would probably shock most concerned.

Indeed, between the years of 2003 and 2010, four insurance companies that offered medical malpractice insurance reported an increase in their net income of more than 4300 percent."

The court wrote, "The cap on non-economic damages serves no purpose other than to arbitrarily punish the most grievously injured or their surviving family members." According to the executive director of the Florida Justice Association, "Caps on damages are fundamentally unfair to the victims of medical negligence."

Florida is not the only state where caps on medical malpractice damages hurt Americans. In 2003, Texas passed a malpractice law that capped damages at $250,000.  By 2009, reports indicated that Texas had the highest healthcare costs in the country and Medicare payments rose faster than anywhere else in the country.

As more states realize that artificial caps on medical malpractice claims are unfair to patients and their families who suffer from catastrophic injuries and damages from medical negligence, caps will be eliminated and the evaluation of damages will be returned to juries, as the Constitution of the United States requires.

Do you have any questions about this post?

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3 Counterintuitive Truths about Medical Malpractice Lawsuits


Whether you suffered an injury during a recent hospital stay, or your spouse endured an unnecessary surgery or a prescription drug overdose, you're angry. But you're also cautious. You're somewhat dubious about medical malpractice lawsuits -- you may have concerns about both their ethicality and their utility. To that end, let's explore 3 counterintuitive truths about med mal cases, so that you can make a more informed decision about your next steps.

Truth #1: The vast majority of medical malpractice suits have merit.


Many people sadly buy into the stereotype that medmal cases are often “frivolous” claims brought by greedy or poor claimants -- and that they punish innocent doctors.

Statistics just don’t back up this stereotype.

For instance, the Harvard School of Public Health recently conducted an exhaustive analysis of 1,400 medical negligence claims and found that 97% of them had merit. In fact 80% of the cases studied involved major injury or death. The Harvard researchers said “portraits of a malpractice system that is stricken with frivolous litigation are overblown.”

Likewise, the suits do a good job of zeroing in on the truly dangerous doctors. An analysis conducted from 1991 to 2005 found that fewer than 6% of doctors caused nearly 58% of all malpractice claims payments. Another study of 51 hospitals throughout New York found that the poor patients who lacked insurance were far less likely to sue than other patients.

Truth #2: The actual number of malpractice events likely dwarfs the number of medical malpractice lawsuits.

The Institution of Medicine estimates that 98,000 people, annually, die due to preventable medical errors. Hundreds or thousands of other patients suffer serious, nonfatal, preventable injuries. The number of medical malpractice cases filed is miniscule by comparison, constituting just 3% of all civil tort cases brought annually. In other words, most victims of malpractice do nothing, legally speaking.

Truth #3: Getting fair settlements in medmal cases is quite hard, and “outrageous” jury verdicts are few and far between.


The tort reform lobby convinced many Americans that so-called “runaway juries” enjoy awarding outrageously high settlement amounts. But here's the reality. Per the National Association Insurance Commissioners, payouts for medical negligence claims dropped by 50% between 2003 and 2008. Furthermore, fewer than 0.5% of cases led to verdicts or settlements that exceeded $1 million. The median award for a permanent injury – and remember, this is the total compensation package for someone permanently disabled for life due to someone else's negligence or carelessness – was just $315,000 in 2005.

These counterintuitive truths just scratch the surface. The reality is many myths make life needlessly challenging for injury victims and their families. Fortunately, the team at Regan Zambri & Long can provide thorough, strategic assistance. Call us now at (202) 463-3030 for a free evaluation of your D.C. medical malpractice case.




 

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Study States Hospital-Errors Causing 440,000 Deaths Each Year

Posted by: Salvatore J. Zambri, founding member and partner

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Until recently, data from 1984 has been used to estimate the number of deaths caused by hospital error - 98,000.  A recent report from the Journal of Patient Safety indicates that number was a very low estimate. Updated data reveals that around 440,000 deaths are caused by preventable hospital error. In addition, 10 to 20 times more patients experience serious harm from hospital mistakes.  

Unfortunately for consumers, information for patients is limited. Consumer Reports rates hospitals on safety and quality of care. The Leapfrog Group (representing employer purchasers of health care) rates hospitals on safety measures.  Medicare claims include re-admission within 30 days after discharge statistics. U.S. News' Best Hospital Rankings helps patients who have difficult health problems select hospitals. Other groups create their rankings based on being allowed to use the hospital logo. According to the National Quality Forum, not enough measurable and consistent information exists in a way that consumers can find it.

"The Journal of Patient Safety study found 210,000 'detectable' deaths per year — the number they eventually fixed on of 440,000 reflected the estimate that half or two-thirds of all such deaths are never counted. 'That’s a big range,' said Leah Binder (chief executive of The Leapfrog Group). 'It sounds so high, but what more frightening is that we still don’t know. Nobody’s counting the bodies.' ”

Patients have a right to know about the safety standards and quality of care for hospitals. The needed information is frequently unavailable, inconsistent, or not transparent enough to understand.

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Children and Concussions

Posted by: Salvatore J. Zambri, founding member and partner

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A growing awareness of the dangers of concussions among children has recently become a bigger concern for parents with children involved in sports. Evidence suggests that not only does a concussion affect a child's sports performance, it also has an impact on the daily life of that child.

The Committee of Sports-Related Concussions, a project by The Institute of Medicine and the National Research Council, part of the non-profit, private National Academy of Sciences, jointly issued a report urging "more research on younger athletes and establishment of a national system to monitor how often they are getting concussed." The report indicates that even with limited data available regarding children's sports injuries, sports-related concussions are a significant public-health issue. In addition, the culture of resistance among athletes prevents many children from even reporting an injury. Although helmets are used for football, protecting against skull fractures, there is limited evidence that current helmet designs reduce concussion risks.

The concussion report was sponsored by the Centers for Disease Control and Prevention, the U.S. Department of Defense, U.S. Department of Education, Health and Human Services Administration, the National Athletic Trainers Association Research and Education Foundation, the National Institutes of Health, and the CDC Foundation (via a grant from the National Football League).

Recommendations by the committee include:

  • "The CDC should set a national surveillance system to determine the rate sports-related concussions among youth, and include data on protective equipment, causes and extent of the injuries.
  • The National Institutes of Health and the Department of Defense should support research to improve concussion diagnosis and create age-specific guidelines for managing concussions.
  • National Institutes of Health and the Department of Defense should conduct studies on effects of concussion and repetitive head impacts over a life span. To aid this research, the National Institutes of Health should maintain a national brain tissue bank.
  • The NCAA and the National Federation of State High School Associations 'should undertake a rigorous scientific evaluation of the effectiveness of age-appropriate techniques, rules and playing and practice standards in reducing sports-related concussions.'
  • The National Institutes of Health and the Department of Defense should fund research on age- and sex-related variants in risk for concussions.
  • The NCAA and the National Federation of State High School Associations, in conjunction with other groups, should develop 'large-scale efforts to increase knowledge about concussions and change the culture (social norms, attitudes, and behaviors) surrounding concussions among elementary through college-aged youth and their parent, coaches, sports officials, educators, trainers, and health care professionals.' "

A recent issue of Pediatrics, the Official Journal of the American Academy of Pediatrics, outlines some guidelines for physicians in assisting students who have experienced concussions return to the classroom successfully:

  • "In the short term, students who have a concussion may need to have their academic workload adjusted so that the brain is not overtaxed and symptoms do not worsen. Cognitive rest could include a break from electronic devices as well.
  • Since most concussion symptoms improve within 3 weeks, academic adjustments can often be made without a formal written plan. If symptoms persist beyond that time, students could benefit from a more detailed medical assessment and a formal education strategy (such as an Americans with Disabilities Act "Section 504" plan).
  • Ideally, students would be assisted in their return to the classroom by a multidisciplinary team that includes people from the medical community, school, and family.
  • Students should be performing at their baseline academic level before they return to extracurricular activities, including sports."

Neither the report issued by the Committee of Sports-Related Concussions nor the guidelines offered by the American Academy of Pediatricians will answer all parent questions regarding choosing a sport or equipment for their child. Parents, make the best decision possible based on the knowledge available at the time and follow medical advice in determining if or when your child should return to sports activities following a concussion.

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Senate Drafts Bill to Regulate Compounding Pharmacies

Posted by Salvatore J. Zambri, founding member and partner

 

Following the recent debates over how to regulate the compounding pharmacy business, the Health, Education, Labor and Pensions Committee of the U.S. Senate has drafted a bill aimed to "make clear oversight responsibilities for pharmaceutical compounding and ensure safety for consumers." According to the news as posted on the Committee's Senate.gov website:

 "Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders."

As I have noted in earlier posts, the most challenging problem with compounding pharmacies has been determining who is in charge of regulating them. FDA Commissioner Margaret Hamburg indicated that the conflicting patchwork of state and federal laws regarding pharmacies has resulted in a lack of aggressive policing by the FDA.  The new bipartisan Senate bill requires compounding manufacturers to register with the FDA, report the drugs they make, and meet standards similar to those of drug manufacturers.

The International Academy of Compounding Pharmacists has criticized the bill for creating "more confusion and blurring the jurisdiction authority of regulators."  Its position continues to be that states should license and oversee compounding pharmacies and that the FDA should oversee and regulate pharmaceutical manufacturers.

Public Citizen, a consumer advocate and nonprofit organization has also weighed in on the proposed Senate bill to regulate compounding pharmacies. In its press room release on May 1, 2013, "Public Citizen to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety", Public Citizen criticizes the bill for actually weakening  existing FDA control and creating more ambiguity defining compounding pharmacies. An alternative suggested by Public Citizen proposes legislation that would:

"- Draw a single, clear line between traditional compounding and drug manufacturing, with no newly created category of second-tier, substandard drug manufacturers, called “compounding manufactures”;

- Provide adequate funding to the FDA to aggressively enforce existing laws against “compounding pharmacies” that cross the line into manufacturing;

- Strengthen the FDA’s authority to police the line between traditional compounding and drug manufacturing by requiring registration and granting the FDA authority to inspect for traditional compounding pharmacies, regardless of whether they engage in drug manufacturing activities; and

- Require clear, standardized warning labels to communicate to providers and patients who purchase traditional compounded products that the safety, efficacy and the accuracy of the product’s labeling have not been assessed by the FDA."

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Analysis of 25 Years of Paid Malpractice Claims

Posted by Salvatore J. Zambri, founding member and partner

 

A recent article published by BMJ Quality and Safety studied the diagnosis-related claims from the National Practitioner Data Bank maintained by the federal government for a 25 year period from 1986-2010. This study reviewed and cataloged the error type, outcome severity and payments of malpractice claims, comparing diagnostic error to other malpractice claims.  Of the 350,706 paid claims studied during this 25 year period, diagnostic errors accounted for 28.6% of the errors as well as the highest proportion of total payments (35.2%). "Diagnostic errors more often resulted in death than other allegation groups (40.9%) and were the leading cause of of claims-associated death and disability."

 Researchers contributing to this study concluded, "Among malpractice claims, diagnostic errors appear to be the most common, most costly and most dangerous of medical mistakes. We found roughly equal numbers of lethal and non-lethal errors in our analysis, suggesting that the public health burden of diagnostic errors could be twice that previously estimated. Healthcare stakeholders should consider diagnostic safety a critical health policy issue."

According to Johns Hopkins University School of Medicine neurologist David E. Neuman-Toker, one of the lead researchers in this study, "Diagnostic errors are the most common, the most costly and the most deadly of all medical errors.”  He also indicated that, “there are no public reporting requirements for measuring diagnostic accuracy or error,” because diagnostic errors are not always evident immediately, as contrasted to medication and surgical errors.

Hopefully, the medical community will use the information from the study to make changes that will lead to greater patient safety.

Continue Reading Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Women's Health Issues
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Compounding Pharmacy Report Reveals Limited Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

The push to regulate compounding pharmacies is beginning to gain more attention on the national front. According to a congressional report released on April 15, 2013, the state-by-state examination last fall into the safety issues surrounding the common practices among compounding pharmacies demonstrates that states do not adequately track, regulate or inspect these pharmacies, exposing patients to unsafe drugs, disease and death.

 

The Markey Report, "State of Disarray," findings and conclusions:

  • "State boards of pharmacy generally do not know which pharmacies engage in compounding, do not know whether pharmacies ship compounded drugs across state
    lines, and do not know which pharmacies manufacture large quantities of compounded
    drugs.
  • Only thirteen state boards of pharmacy know which pharmacies are providing sterile compounding services and only five of these states have inspectors that are trained to identify problems with sterile compounding.
  • States typically do not maintain pharmacy inspection records that enable them to identify systemic and repeated compounding pharmacy safety problems that originate either in-state or out-of-state.
  • States are unable to effectively police compounding pharmacy activities in other states. Moreover, when issues arise with out-of-state pharmacies, states do not consistently inform the origination state or the FDA.
  • Despite general increases in state board of pharmacy budgets, the number of pharmacy inspectors has remained consistently low. Furthermore, states usually do not distinguish between inspections of traditional and compounding pharmacies."

Congressman Markey is among those who support legislation to give the Food and Drug Administration more authority over compounding pharmacies.  A scheduled hearing of a House Energy and Commerce subcommittee will be held on Tuesday, April 16, 2013 to focus on this issue.

I will continue to update our readers on this critical consumer issue as more attention is given to the safety problems of compounding pharmacies. 

Do you have any questions about this post?

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Inspector General of HHS Issues Special Fraud Alert

Posted by Salvatore J. Zambri, founding member and partner

 

The Office of the Inspector General of the Department of Health and Human Services recently released a special fraud alert regarding physician-owned entities. "This Special Fraud Alert addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs)." 

"To report suspected fraud involving physician-owned entities, contact the OIG Hotline at
http://oig.hhs.gov/fraud/report-fraud/index.aspor by phone at 1-800-447-8477 (1-800-HHS-TIPS)."

Do  you have any questions about this post?

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Clinical Specialties Compounding Pharmacy Recalls All Sterile Products

Posted by Salvatore J. Zambri, founding member and partner

 

The FDA has announced that Clinical Specialties Compounding Pharmacy is recalling all sterile products due to lack of sterility assurance.  We have reproduced the FDA notice in its entirity for our readers.

 "Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance

 [Posted 03/21/2013]

AUDIENCE: Health Professional, Pharmacy, Patient

ISSUE: Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.

BACKGROUND: This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.

RECOMMENDATION: Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday through Friday between the hours of 10 am to 5 pm EST, or e-mail at clinicalrx@bellsouth.net. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/21/2013 - News Release - FDA]

[03/20/2013 - Press Release - Clinical Specialties ]

Related MedWatch Alert

[03/18/2013 - Press Release - Clinical Specialties ]"

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

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Another Compounding Pharmacy Recalls All Products

 Posted by Salvatore J. Zambri, founding member and partner

 

 A recent U.S. Food and Drug Administration (FDA) press release announced the voluntary recall of all compounded products by Medprep Consulting, Inc. due to potential mold contamination.  We are including the complete FDA press release along with a listing of all the products in the recall.

 "Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

Contact
Consumer:
732-493-3390

Media:
Angelo J. Cifaldi, Esq., R.Ph.
Satish V. Poondi, Esq., R.Ph.
Counsel for Med Prep Consulting Inc.
(732)855-6096

FOR IMMEDIATE RELEASE – March 17, 2013 – Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.

Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.

The products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these products were distributed to the described users through March 13, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.

Included in the recall are the following product list:

  • Acetylcystiene vials
  • Adenosine Bags
  • Alteplase syringe
  • Atropine syringe
  • Avastin syringe
  • Aztreonam syringe
  • Bacitracin vials
  • Bupivacaine Bag
  • Bupivacaine
  • Epinephrine Bag
  • Bupivacaine Syringe
  • Bupivacaine OnQ Pump
  • Calcium Gluconate Bag
  • Calcium Gluconate syringe
  • Cefazolin syringe
  • Cefazolin Bag
  • Cefepime syringe
  • Cefepime Bag
  • Cefotaxime syringe
  • Cefotetan syringe
  • Cefoxitin syringe
  • Ceftazidime syringe
  • Ceftazidime Bag
  • Ceftriaxone syringe
  • Ceftriaxone Bag
  • Cefuroxime syringe
  • Cefuroxime Bag
  • Clindamycin syringe
  • Darboepoetin (Aranesp) syringe
  • Denusumab Syringe
  • Dexamethasone Bag
  • Diltiazem Bag
  • Diphenhydramine Bags
  • Dobutamine Bag
  • Dobutamine syringe
  • Ephedrine syringes
  • Epinephrine Bag
  • Epinephrine Bag
  • Epinephrine syringe
  • Epoetin Alfa syringe
  • Esmolol syringes
  • Famotidine syringe
  • Fentanyl Citrate Bag
  • Fentanyl Citrate with Bupivacaine HCL Bag
  • Gentamicin syringe
  • Gentamicin Bag
  • Glycopyrrolate syringes
  • Granisetron syringe
  • Hectoral syringe
  • Heparin syringe
  • Heparin bag
  • Hydromorphone syringe
  • Hydromorphone Bag
  • Hydromorphone PCA syringe
  • LET Gel syringe
  • LET Soln syringe
  • Leukine syringe
  • Magnesium Sulfate bag
  • Meperidine Bag
  • Methadone Syringe
  • Midazolam Bag
  • Midazolam syringe
  • Morphine Sulfate Bag
  • Morphine Sulfate syringe
  • Norepinephrine bag
  • Norepinephrine Syringe
  • Ondansetron Bag
  • Ondansetron – Dexamethasone Bag
  • Ondansetron syringe
  • Oxacillin syringe
  • Oxacillin Bag
  • Oxytocin bag
  • Palanosetron (Aloxi) syringe
  • Penicillin syringe
  • Penicillin Bag
  • Phenylephrine Bags
  • Phenylephrine syringes
  • Potassium Chloride Bag
  • Potassium Phosphate l bag
  • Ranitidine syringe
  • Rituxan syringe
  • Ropivacaine Bag
  • Ropivacaine OnQ Pump
  • Sodium Citrate syringe
  • Sodium Phosphate bag
  • Succinylcholine syringes
  • Sufentanil with Bupivacaine Bag
  • Timentin syringe
  • Tobramycin syringe
  • Vancomycin Bags
  • Zometa syringe

All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Product complaints related to this recall should be reported to 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.

Do you have any questions about this post?

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Controversy Continues Regarding Compounding Pharmacy Regulation

Posted by Salvatore J. Zambri, founding member and partner

 

In a move prompted by pressure from Congress and health-care watchdogs, the FDA launched a series of aggressive surprise inspections of large compounding pharmacies last week. Among their findings so far: contaminated drugs, medications without expiration dates, and drug containers "not clean and sterilized." The inspections of about 30 facilities are expected to continue for the next two months and could result in fines and possible suspensions of their licenses. This new program of aggressive inspections is aimed at regulating the multibillion-dollar industry that custom mixes medications for individual patients, hospitals and clinics. As I have posted previously, the compounding pharmacy industry has fallen between the regulatory cracks.

According to Howard Sklamberg, director of compliance for the FDA's Center for Drug Evaluation and Research, inspectors do not know exactly what they may find during these inspections, since compounding pharmacies currently do not have to register with the FDA, nor tell them what medications they produce. "A lot of these firms are behaving like manufacturers and producing like manufacturers, yet they are trying to operate under the law as if they were a small pharmacy."  According to the Washington Post's investigative series, "The FDA is seeking authority from Congress to require registration, which would allow the agency to demand that firms release detailed information about operations and give it greater authority to require that safety problems be fixed."

Patient safety should be the ultimate goal for compounding pharmacies instead of making as much profit as possible and resisting oversight by the FDA or other regulatory agencies.  Profit should never be put ahead of patient safety.

Do you have any questions about this post? 

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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FDA Recall: DePuy Orthopaedics Class I Recall for LPS Diaphyseal Sleeve

Posted by Salvatore J. Zambri, founding member and partner

 

The FDA recently announced a Class 1 Recall for DePuy Orthopedics.  We are reproducing the recall notice below for our readers in its entirety.  If you anticipate or have recently had knee replacement surgery, please consult with your surgeon regarding the type of implant and possible symptoms or issues related to it.

"DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May  Not Accommodate Physiologic Loads

[Posted 02/22/2013]

AUDIENCE: Orthopedics, Surgery, Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I recall of the LPS Diaphyseal Sleeve. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.

The FDA has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.

The affected devices were manufactured from 2008 to July 20, 2012. See the Recall notice for a list of affected product codes and lot numbers.

BACKGROUND: The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

RECOMMENDATION: On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to DePuy.

DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[02/22/2013 - Recall Notice - FDA]"

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Should Compounding Pharmacies Be Required to Follow FDA Safety Regulations?

Posted by Salvatore J. Zambri, founding member and partner

 

The International Academy of Compounding Pharmacies has traditionally fought against FDA oversight for compounding pharmacies and has argued that state pharmacy board registration and control was sufficient. Under the current laws, pharmacies must register with and are licensed by the state boards of pharmacy, not the FDA.  For drug manufacturers, FDA registration is required and their products must have FDA approval.  

Following a recent investigative research article by the Washington Post about the lack of safety regulation for compounding pharmacies, the executive vice president of the organization now endorses, "FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."  As the FDA commissioner argued before Congress several months ago, "non-traditional" compounders need a special category for stepped-up enforcements, but left open recommending whether the FDA or state pharmacy boards should be responsible for the enforcement. 

This new position by the International Academy of Compounding Pharmacies seems to acknowledge the need for more control by the FDA. Creation of a way to regulate "non-traditional" drug manufacturing is currently being debated on Capitol Hill. Compounding firms frequently use non-FDA-approved drugs as key ingredients and many of their drugs are not dispensed in pill form, creating a difficult regulation scenario. According to Sarah Sellers, executive director of the Center for Pharmaceutical Safety, her concern is that a new enforcement system would be set up for compounders that assumes they are using FDA-approved ingredients. “When people use FDA-approved ingredients, built into that are good manufacturing practices. But there is an entire group of compounding pharmacies that are not using FDA-approved drugs. I’m concerned they will end up creating a ‘good manufacturing practices light.' ”

As I posted previously, the safety problems with compounding pharmacies have been known for years. Finding a way to police the industry effectively is important for patient safety.

Continue Reading Posted In Medications , Patient Safety , Product Liability , Public Health
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Why Are Compounding Pharmacies So Dangerous?

Posted by Salvatore J. Zambri, founding member and partner

 

After so many cases and deaths related to the New England Compounding Center's tainted steroid shots, new inspections have resulted in a report about conditions and practices that violated federal law aimed at maintaining sterile environments.  Sarah Sellers, a former FDA official who is now a consultant on quality and sterility issues, also reviewed the report. “The entire pharmacy was an incubator for bacteria and fungus,” she said. “The pharmacy knew about the contamination and did nothing.”

However, a more recent review of compounding pharmacy practices shows that these organizations have been tied to deaths and illnesses over the past decade and that those pharmacies have experienced safety problems for years. According to a recent Washington Post article, compounding pharmacies "mass-produce medications and ship them across state lines, often without individual patient prescriptions." Compound pharmacies supply about 40% of all intravenous medications used in hospitals and are not required to follow the safety rules that apply to commercial drugmakers. With such a lightly-regulated industry, neither state nor federal authorities did much to "systematically inspect and correct hazards posed by specialty pharmacies," resulting in practically no punishment for the pharmacies, even when their mistakes caused deaths. 

As further indication that this problem has been known for some time: "In 2007, a team of investigators from the Centers for Disease Control and Prevention issued an unusually blunt warning to hospitals and doctors: Compounded drugs had a higher risk of contamination than commercially manufactured drugs, and compounding pharmacies had 'generally lower quality-control standards than pharmaceutical manufacturers.' ”

The FDA has pressed Congress for more authority to regulate compounding pharmacies. FDA Commissioner Margaret Hamburg said, "Legislation is needed that would allow the FDA to routinely inspect 'non-traditional' compounding pharmacies, hold them to higher production standards and see records about the volume of drugs being made, as well as require compounders to report adverse events associated with their products."  State pharmacy boards have the primary responsibility for policing the compounding pharmacies, but they have an uneven record of enforcement. In addition, the regulatory standards that do exist for the compounding pharmacy industry has not kept pace with the rapid expansion pace of that business. By relying on gaps in laws and conflicting court rulings, these companies have fought enforcement orders and kept the FDA out of their facilities.

Do you have any questions about this post?

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Anticlotting Drug Pradaxa Allegedly Causing Deaths

Posted by: Salvatore J. Zambri, founding member and partner

 

Please read the front-page of the Business Day section of the New York Times (11/3, B1, Thomas, Subscription Publication, 1.23M), which reported that blockbuster anticlotting drug Pradaxa is producing deaths from unstoppable bleeding, and critics are taking aim at the FDA "because it allowed a potentially dangerous drug to be sold without an option for reversing its effects." Unlike warfarin, Pradaxa - or dabigatran - has no antidote to stop its blood-thinning ability. The Times adds, "Pradaxa is an example, some critics say, of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine. Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin."

Please consult with your doctor before taking any medication.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Merck to Settle Rofecoxib Class-Action Suit

Posted by: Salvatore J. Zambri, founding member and partner


The AP (11/2) reported Merck & Co. Inc. announced Nov. 1 that it has "agreed to settle a class action lawsuit filed on behalf of Missouri consumers" over its prescription painkiller Vioxx (rofecoxib). The FDA "approved Vioxx as a painkiller in May 1999," but the Justice Department "said Merck began marketing it almost immediately" off-label as a rheumatoid arthritis treatment, an indication for which the FDA did not grant approval "until 2002." The proposed agreement would settle "claims that New Jersey-based Merck violated the Missouri Merchandising Practices Act by promoting and selling Vioxx, which Merck pulled from the shelves eight years ago because of evidence that it doubled users' chances of suffering a heart attack or stroke."

According to the Philadelphia Inquirer (11/4, Sell, 346K), the agreement "calls for Merck to pay $39 million to $220 million, depending on how many members of the class are certified." Notably, the proposed settlement offers consumers the choice of two options: Based on a "one-month drug cost of $90," they could obtain a "onetime payment of $180 if they submit a claim with a declaration under oath, but provide no proof." Or, by "declaring under oath and providing proof of payment," consumers could claim "$90 for each month" they purchased Vioxx.

The St. Louis Business Journal (11/2, Weiderman, Subscription Publication) noted that the "case, which has been pending since 2004, was moved to federal court before the 8th US Circuit Court of Appeals moved it to plaintiff-friendly Jackson County." The proposed settlement "must be approved by the Jackson County Circuit Court before it becomes final."
 

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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A Family Impacted by Compounding Pharmacy's Tainted Medications Seeks to Transfer all Related Cases to A Minnesota Court

By Catherine Bertram, partner

                                                                                                             

A family that filed a contaminated steroid case against New England Compounding Pharmacy asked the the Judicial Panel on Multidistrict Litigation to transfer all federal compounding pharmacy cases to the U.S. District of Minnesota for consolidated pretrial proceedings.

It is reported that attorneys for Brenda and Robert Bansale made this request in a filing earlier this week.  They argue all the compounding pharmacy cases should be combined for motion practice, discovery and damage issues because it  will involve the same evidence and arguments and therefore consolidation is appropriate under the federal code.

We are investigating several cases of tainted medication for families and our firm participates in these class actions, commonly referred to as MDLs (multi-district litigation)  across the country for clients from various states.  If you have questions about this litigation feel free to call me.  202-822-1875.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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10 Tips Patients Can Do to Make Your Hospital Stay Safer

By Catherine Bertram

According to the Centers for Disease Control and the Agency for Healthcare Research and Quality, these ten tips are actions patients and their families can do during hospital stays to try to make their hospital stay safer:

  1. "SPEAK UP"
    Talk to your doctor about any worries you have about your safety and ask them what they are doing to protect you.
  2. "KEEP YOUR HANDS CLEAN"
    If you do not see your healthcare providers wash their hands, please ask them to do so. Also remind your loved ones and visitors. Washing hands can prevent the spread of germs.
  3. Ask if you still need a central line Adobe PDF file [PDF - 191KB] catheter or urinary Adobe PDF file [PDF - 226KB] catheter. Leaving a catheter in place too long increases the chances of getting an infection. Let your doctor or nurse know if the area around the central line becomes sore or red, or if the bandage falls off or looks wet or dirty.
  4. ASK YOUR HEALTH CARE PROVIDER "Will there be a new needle, new syringe, and a new vial for this procedure or injection?" Healthcare providers should never reuse a needle or syringe on more than one patient.
  5. BE CAREFUL WITH MEDICATIONS
    Avoid taking too much medicine by following package directions. Also, to avoid harmful drug interactions, tell your doctor about all the medicines you are taking.
  6. Photo: A healthcare professional preparing to vaccinate a patient.GET SMART WITH ANTIBIOTICS
    Help prevent antibiotic resistance by taking all your antibiotics as prescribed, and not sharing your antibiotics with other people. Remember that antibiotics don't work against viruses like the ones that cause the common cold.
  7. Prepare for surgery Adobe PDF file [PDF - 207KB].
    There are things you can do to reduce your risk of getting a surgical site infection. Talk to your doctor to learn what you should do to prepare for surgery. Let your doctor know about other medical problems you have.
  8. Watch out for C. diff. Adobe PDF file [PDF - 179KB] (aka Clostridium difficile)
    Tell your doctor if you have severe diarrhea, especially if you are also taking an antibiotic.
  9. Know the signs and symptoms of infection.
    Some skin infections, such as MRSA, appear as redness, pain, or drainage at an IV catheter site or surgical incision site. Often these symptoms come with a fever. Tell your doctor if you have these symptoms.
  10. GET YOUR FLU SHOT
    Protect yourself against the flu and other complications by getting vaccinated."

By following these 10 steps, you can help make healthcare safer and help prevent healthcare-associated infections.

Continue Reading Posted In Cancer Misdiagnosis , Medical Malpractice , Medications , Men's Health Issues , Obstetrics , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Doctor Contends 15 Dead in NECC Medication Contamination was Preventible and Predictable

By Catherine Bertram

                                                                                                            

According to Dr. Michael Carome, of Public Citizen, the fungal meningitis outbreak associated with 15 recent deaths and over 200 serious illnesses was completely preventable.  In an article released by CNN, Dr. Carome contends that,  "(T)he injectable steroid medication produced at the center was never approved by the FDA and was not manufactured in accordance with the FDA's rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

As a result, as many as 14,000 patients in 23 states were exposed to potentially contaminated steroids and need to be monitored for signs of fungal meningitis or other infections."

Dr. Carome contends that many entities are responsible for this preventable deadly outbreak, "(W)hile numerous probes and investigations are just getting under way and litigation targeting the producer of the tainted drug and health care providers who used it will certainly take years to resolve, blame for this disaster will undoubtedly rest with many parties. Among them are the compounding pharmacy that produced the contaminated steroid drugs, health care facilities and providers who chose to use a dangerous drug lacking approval by the FDA and evidence that the products were sterile, trade associations and professional groups representing compounding pharmacies that have vigorously resisted federal regulatory oversight of their members, state and federal regulators, and Congress."

On October 4, the Federal Drug Administration (FDA) advised health care providers not to use any New England Compounding Center (NECC) products after a patient was diagnosed with meningitis that was possibly associated with an epidural injection of a steroid medication.   On October 6, NECC announced a recall of all of its products.  Click here for a complete list of the  products subject to this recall.  

The FDA is advising healthcare professionals to follow up with patients who were administered any injectible medication from or produced by NECC after May 12, 2012.  

We are currently investigating cases involving tainted medication such as this. If you or a family member has questions about this please call me for a free consultation.  202-822-1875.

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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So You Think Your Medical Device Was Safety Tested? Think Again.

Posted by: Salvatore J. Zambri, founding member and partner

Medical devices such as artificial joints, heart defibrillators and surgical mesh have become an integral part of the healthcare industry.  As consumers, we would naturally expect that those devices have been tested for safety and effectiveness. In reality, many implants and other high-risk devices on the market have not undergone any safety testing.  Rather, the manufacturers have frequently only  filed paperwork and paid the mandatory FDA user fee to market those items. 

In 2011, the Institute of Medicine of the National Academies, an independent, non-profit organization that works outside of the government to provide unbiased and authoritative advice to decision-makers and the public, released a consensus report concluding that "the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." In summary, they recommended that the FDA completely overhaul its system that regulates medical devices because presently it doesn't ensure patient safety either before or after products are on the market.  Surprisingly, Congress is currently working on a new law that neither addresses the failures of the current FDA process nor forces manufacturers to sufficiently safety test devices. Rather, its goal is to allow them to market devices even faster.  That's a shame.

Continue Reading Posted In Medical Malpractice , Men's Health Issues , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Sedona Labs Recalls iFlora Children's Supplements

Posted by: Salvatore J. Zambri, founding member and senior partner


Reuters (7/11, Simpson) reports that Atrium Innovations Inc.'s Sedona Labs unit is recalling its iFlora 4-Kids Powder, sold by healthcare professionals, and its iFlora Kids Multi-Probiotic, sold online and in US health food stores, due to possible contamination of a galactooligosaccharide component with salmonella. To date, no salmonella-related incidents have been reported. According to a company statement, the products involved have a distribution date range from March 16 through May 3. The recall affects the following lot numbers: 1074711, 1479611, 1640811 and 1734411.

Please do not consume this potentially contaminated product or provide it to your children.  I advise you to speak to a physician about what alternatives can be provided.

Be safe.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Medications , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings
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Rogue Doctors Go Undisciplined By States

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

State Medical Boards are utterly failing to discipline physicians who have been sanctioned by hospitals for a variety of reasons, including committing medical errors.  A report shows that "63 percent of the doctors whose hospital privileges were restricted or revoked were not disciplined by the state's Board of Medicine."  This should be unacceptable.

The best way to reduce medical costs is to reduce medical errors.  To reduce medical errors, there needs to be greater oversight by the states' medical boards.

I hope this study compels the boards to do a better of job going forward.  Otherwise, patient safety is at risk. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.

Posted In Men's Health Issues , Patient Safety , Public Health , Tort Reform , Women's Health Issues
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Stryker Recalls Modular Neck-Stem Devices Attaching to Artificial Hips

Posted by: Salvatore J. Zambri, founding member and senior partner


The Boston Business Journal (7/10, Donnelly, Subscription Publication) reported, "Stryker Orthopaedics has voluntarily recalled two brands of devices used in conjunction with artificial hips in hip replacement surgeries, according to the US Food and Drug Administration website." To date, "there have been at least 45 adverse event reports from patients who say the devices caused pain and/or tissue swelling." This week, Stryker said that "it would remove Rejuvenate and ABG II modular-neck stems, which attach to artificial hips, from the market and cease global distribution."

The modular neck-stem devices were recalled "because of postmarketing data showing fretting and corrosion at the modular neck junction, according to an alert from the US Food and Drug Administration (FDA)," Medscape (7/11, Hitt) reports. "The FDA posted the company's press release, dated July 6." Stryker "states that patients who already have the implanted modular-neck stems should contact their surgeon only if they experience pain and/or swelling of the hip and should undergo revision surgery only if symptoms of pain and swelling at the local joint site are not attributable to other conditions such as aseptic loosening and periprosthetic sepsis."

If you have had a hip replacement, or if you are thinking of getting one, please speak with your doctor about product safety.  I have many clients who have been victims of faulty hip replacements, and they are left with a lifetime of pain and suffering.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Article Suggests Merck Hid Evidence of Vioxx's Harmful Effects

Posted by: Salvatore J. Zambri, founding member and senior partner

Our health is so important.  For some, it's the most important thing in life.  So we need companies to manufacture medicines to maintain health and cure illness.  It is never acceptable, however, for a company to put profits over people.

Pharmalot (7/11, Silverman) reports that almost eight years after Merck removed Vioxx from the market "over links to heart attacks and strokes," a new paper suggests that "the drugmaker hid evidence that Vioxx tripled the risk of cardiovascular death for more than three years before taking the pill off the market in 2004." The authors of the paper say that instead of using an "intent-to-treat analysis" of the control studies, Merck instead relied on an "on-treatment analysis," which is "not the preferred method for ferreting out potentially harmful side effects that may occur in a clinical trial." Jerry Avorn, one of the co-authors, says "Intention-to-treat is the gold standard for evaluating clinical trial results" and "the information was never presented publicly and there was no oversight because none of the three Alzheimer's trials had a Data Safety Monitoring Board that have might persuaded the drug-maker to include this information." Merck has declined to respond specifically to the paper.

Do you have questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2012)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Women's Health Issues
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How Important Is Physician Honesty to You, the Patient?

Posted by: Salvatore J. Zambri, founding member and partner

Health Affairs, which touts itself as the leading journal of health policy and research, recently published results of a survey indicating that at least some physicians are not always open or honest with patients.  Health Affairs is a multidisciplinary journal that covers a wide range of health care topics. It was founded in 1981as part of Project Hope, a nonprofit international health education organization. According to the survey of physicians, varying attitudes exist regarding how much information should be relayed to patients.  The excerpt below summarizes the survey results as well as the opinion of Health Affairs authors.

"The Charter on Medical Professionalism, endorsed by more than 100 professional groups worldwide and the US Accreditation Council for Graduate Medical Education, requires openness and honesty in physicians’ communication with patients. We present data from a 2009 survey of 1,891 practicing physicians nationwide assessing how widely physicians endorse and follow these principles in communicating with patients. The vast majority of physicians completely agreed that physicians should fully inform patients about the risks and benefits of interventions and should never disclose confidential information to unauthorized persons. Overall, approximately one-third of physicians did not completely agree with disclosing serious medical errors to patients, almost one-fifth did not completely agree that physicians should never tell a patient something untrue, and nearly two-fifths did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had told patients something untrue in the previous year. Our findings raise concerns that some patients might not receive complete and accurate information from their physicians, and doubts about whether patient-centered care is broadly possible without more widespread physician endorsement of the core communication principles of openness and honesty with patients."

If knowing the complete information about your health is important to you, discuss your concerns with your physician.  Do you want all news, even when it's bad?  Would you rather not know?  The decision is very personal and individual, but making certain that you and your physician are in agreement should be important to everyone.  At a minimum, you should be informed of all information necessary to make fully-informed decisions about your health.

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Medical Malpractice Claims - From Investigation to Litigation

By Catherine Bertram, partner
     cbertram@reganfirm.com



Medical malpractice cases are often some of the most complex civil claims that trial attorneys handle.  In almost all states, and certainly in Maryland, D.C. and Virginia, there are special statutes and regulations that apply to these types of cases.  Attorneys who practice in this area must be familiar with these rules in order to represent their clients and the families of their clients.  Experienced attorneys know how to efficiently review and investigate these cases.  At our firm, we have established working relationships with medical experts on a national basis in almost all specialties so we can obtain independent reviews of the events and obtain answers for our clients to determine if the care rendered met the applicable standards or not.  

Step One

In most cases after we conduct an initial interview we ask the patient, or the family member with legal power to sign for the patient, to sign a medical authorization that allows us to obtain the key medical records and images.   Our staff is very experienced in this part of the case and they know how to process these requests and get us the records and images we need in a timely fashion.  

Step Two

Once the records are obtained they are reviewed and organized in a coherent manner for the reviewing expert or experts.  In some cases the records need to be reviewed by several types of experts in order to determine if there is a case of medical malpractice.  In some cases have records reviewed by both physician and nursing experts, depending on the circumstances.

Step Three    

We will then speak with the reviewing expert in order to determine if the case has merit in their opinion and whether it is a case that can be pursued.   We also try to answer any questions the patient or family may have about the outcome.  During those calls we have to ask certain questions to determine whether the elements of a medical malpractice claim exist.  The first issue is generally whether the doctor or nurse’s care fell below the standard expected of that individual in the same or similar circumstances.  The second question, which is equally important and must be proven by the patient in a civil malpractice case, is whether the doctor or nurse’s failure was a proximate cause of the patient’s injuries and harms.  In other words, is there a direct link between the doctor or nurse’s wrongful act,  or failure to act, and the injury the patient sustained.  This is commonly referred to by attorneys and judges as “proximate cause”.   If the case has failures by the doctor or nurse but those failures are not a cause of the patient’s injury then there is no case.     Sometimes the questions the patient has can be answered and sometimes the expert has more question and needs additional records or images or other information before they can reach a conclusion.   We continue to work with the expert to obtain that information.  Sometimes, a final conclusion cannot be reached because the records are not clear, the information is missing or there is contradictory information in the records. These issues are all then discussed with the patient and/or the family.  Sometimes,  final answers to certain questions are not obtained until you take the sworn testimony of various doctors and nurses in the lawsuit.  

Step Four

The attorneys from our firm then have a conversation with the patient and/or the family about what the expert’s conclusions were and what the next steps will be. There is no cost associated with this meeting or phone call.   Sometimes this conversation is done by phone, especially in circumstances where the patient is too hurt to travel or lives out of town.   In other cases,  the meeting is held in person at the law firm.  If circumstances are such that the patient cannot travel, and we need to meet, then our attorneys travel to the patient’s home, rehabilitation center or the hospital.

Step Five

If the family and the law firm decide the case has merit, and we want to pursue it together,  then a legal document called a retainer is signed. This document explains how the fee will be paid and how expenses from the case will be handled.

Step Six

Depending on whether the case is in DC, Maryland or Virginia, we work with our experts to develop the case.  We have working relationships with many local hospitals and insurance companies who insure the local doctors and hospitals.  We can often contact those claims directors or the risk managers for the hospital or nursing home and talk to them directly about the claim before the lawsuit is filed.  They know we mean business and they know we have qualified experts who have thoroughly reviewed the case so they are often willing to explore early resolution of cases through private mediation with a retired local judge.  This works quite well for our clients.   

If early resolution is not possible, we have the resources and the experience to file the necessary paperwork and provide the required statutory notices in DC, Maryland and Virginia to pursue the claims.  

If you have any questions about a potential case, feel free to call. 

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a Top Lawyer for Washingtonian Magazine. Ms. Bertram has over 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes a majority of her practice to the representation of patients and families who have been injured or lost due to medical errors.  Ms. Bertram lives in DC and lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Birth Injury , Cancer Misdiagnosis , Legal Info , Legal Services , Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Women's Health Issues
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FDA Links Cholesterol-Reducing Medications to Other Medical Issues

Posted by: Salvatore J. Zambri, founding member and partner

The Food and Drug Administration (FDA) has now officially linked cholesterol-reducing drugs to cognitive problems, diabetes and muscle pain.  Some important safety labeling changes are now to be included on these drugs, generally known as statins, including Lipitor, Lescol, Mevacor, Altoprev, Livalo, Pravachol, Crestor, and Zocor, as well as several combination products.

According to the director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research, “We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol." 

Currently, more than 20 million Americans take some form of statin medication.  While the benefits of these drugs are certainly not disputed, the FDA's ongoing review of medical literature, clinical trial data and reports of adverse events prompted the new cautions. 

Listed below are the specific labeling changes that will be required:

  • "The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
  • Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
  • Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
  • Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections."

If you or a member of your family are currently taking any of the listed statin medications for the reduction of cholesterol, please consult with your personal physician to determine the potential risks of these drugs. Patients should report any side-effects to their physician. As with any medications, do not attempt to quit taking your prescriptions without consulting a medical professional first.  Doing so often causes unintended medical complications.    

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DECODING MEDICAL RECORDS IN MALPRACTICE CASES


By Catherine Bertram, partner (cbertram@reganfirm.com)


One of the key tasks we initially perform when investigating a case involving malpractice or abuse at a health care facility is a thorough review of the medical records.  At our firm we have two attorney who have both worked in hospital settings so we are quite familiar with medical records.  Catherine(“Katie”) Bertram is a partner at the firm and was previously the Director of Risk Management at Georgetown Hospital.  Jackie Colclough is a nurse-attorney with the firm who has a wealth of experience including work as labor and delivery nurse in a local hospital.

Here are a few basic tips to keep in mind when looking at records:

COMPLETE  CHART

The first task is to review the records and try to make sure you have a complete set.  Often, the records are incomplete.  We check to make sure we have an initial History & Physical, Orders, Physician Progress Notes, Nursing Notes, Laboratory Data, Radiology Reports, Operative Notes, Operative Records/Consent Forms, Pathology, and a Discharge Summary.

Medical Records for pregnant patients are quite different.  We have extensive experience with these types of cases as well.  In childbirth cases you will also have to review the prenatal records from the mother’s office visits before the delivery. It is key to obtain the Fetal Monitor Strips (FMS) or Fetal Heartrate Strips (FHR) which demonstrate the baby’s heart rate relative to the mother’s contractions.  This is often critical in determining if the doctor acted promptly to deliver the child and avoid injury to the child.  You will also need the child’s chart and the operative delivery records.

INITIAL HISTORY & PHYSICAL


Doctors are required to write a detailed note within 24 hours of a patient’s admission. This note is often referred to as the “H&P.”  This is a good place to start in your review since it usually provides a history of the patient’s present condition and symptoms, past medical and surgical history and any significant labs or imaging results.  The note also usually includes a detailed plan for the patient.

ORDERS

Physicians have the responsibility and authority to order medication, labs, imaging and other services that the patient or nursing home residents need.  We check these orders to see what medication or services or consults have been ordered for the patient.  The orders should have a time and date and should be legible.  It should also have some indication that the R.N. acknowledged receipt and review of the order and that it has been carried out.  Some special order sheets may also be included like a patient controlled analgesia record (“PCA”) which is utilized if the patient has a pain pump which allows medication to be self-administered at regular intervals.

PROGRESS NOTES


There is another section of the medical record that includes entries by doctors and nurses, and sometimes others like consultants, physical therapists, pharmacists and medical residents.  This section often looks like a diary or a log.  Most doctors were trained to write their notes in a SOAP format. The first section should detail the “subjective” concerns of the patient.  The “objective” section follows and this  is where the physician performs a physical examination of the patient and records the findings.  The doctor usually goes through each system of the body and records the important findings or any changes.   The third section is “assessment” - which is the where the doctor records his or her thoughts about what is going on with the patient after considering the subjective complaints and the findings on physical examination along with any test results or images.  The final section is the “plan.”   Here, the doctor writes out the plan of action which should address the concerning findings and include a plan consultations by other specialists, medication changes, labs or imaging that is necessary and other follow up.

NURSING NOTES

In some facilities the nurses also write in the progress notes along with the doctors, but in many hospitals the nurses have their own checklists and flow sheets where they record their nursing assessments and interventions from their shift.  There may also be other specialized forms for medication administration (MAR) and for treatment (TAR).    

In long term care facilities (nursing homes) we check the skin sheet to verify if the patient is being turned and the skin integrity is being checked.  *Families are reminded that you must also check your loved one’s skin yourself.  It is key not to let any concerning new “hot spots” progress.  If you see a red spot or a pressure point that is concerning you need to ask questions and get the staff to act on it right away.

If a patient has a fall or any other abnormal event, the facts and circumstances should be clearly documented in the progress notes along with a plan.   In most cases, a fall requires prompt physician assessment.  

LABORATORY REPORTS

The laboratory report can also give you clues about what is happening with the patient and what needs to be addressed.  A high white blood cell count (WBC) can be a sign of an infection.  The lab usually provides the normal range for each value on the report so that you can compare the patient’s value to the normal population.   In most labs the patient’s value will be followed by an “H” or an “L” if the value is abnormally HIGH or LOW.   For lab values that are critical, or an emergency, the lab also usually includes documentation that the result was called into either the physician or the nurse assigned to the patient and the time of that conversation.   It is often the case that you can have the facility print out a laboratory summary report for the patient  that shows the results of the lab data over many days, an entire hospital stay or over the course of many hospital stays. This can be quite helpful in terms of tracking trends.  

RADIOLOGY REPORTS

Many patients also have x-rays, CT scans, MRIs, mammograms, sonograms or other diagnostic imaging performed as a part of their hospital stay. The written reports from these tests should also be included in the hospital chart.  You can often determine the date and time the image was obtained, which physician read the image and also if the image is very concerning, the radiologist often documents that the results were called into the patient’s doctor or nurse directly and the time of such a call.   The written reports may also suggest additional follow up testing or imaging that may be required for the patient given the clinical circumstances.  You also need to be careful because occasionally there are initial preliminary reports of the results and then final reports. If this is the case, you want to carefully compare the two for any significant differences.  

Sometimes imaging is obtained before, during or after surgery while the patient remains in the operating room so it is important to  make sure you obtain all of that imaging and those reports as well.  

OPERATIVE RECORDS

If the patient has had a surgical procedure, as an in-patient or in a same day setting, there are certain required records that will be present.  First, the pre-operative assessments, including anesthesia assessment and the consent form for the procedure. In some circumstances the patient will have had an x-ray, a cardiac clearance or certain blood work performed to make sure it is safe for the surgery.  The anesthesia provider will meet with the patient and obtain a history and assess the patient for anesthesia risks.   Also, the surgeon will talk to the patient about the surgery and obtain a written consent from the patient.

During the surgery, the healthcare team documents many things.  The nursing staff  document on records often called “perioperative” records that include safety checklists performed prior to surgery, including patient placement, verification of the surgery to be performed including which side and which surgery and other safety factors.  The nursing team keeps track of which surgical instruments are used during the surgery and must account for all instruments at the end of the surgery before the patient is closed to make sure no instruments or sponges are left in the patient.   The nurse also documents which nurses are in the operating room and when they leave. At some hospitals the doctor’s entrance and exit are also noted.

The anesthesia providers keep a very detailed log of the patient’s vital signs during surgery, the medication that are given and any response the patient has to medications.

The surgeon does not take notes during the surgery but is required to dictate a detailed operative note following the surgery.

The patient is moved to the post anesthesia care unit (PACU) following most surgeries. This used to be called the recovery room.  In most hospitals the patient is monitored by nurses and the anesthesia team in this area for a certain amount of time until the anesthetic wears off and the patient is either ready to leave based on certain discharge criteria or the patient is transferred to the hospital floor if it is a more involved surgery.   

PATHOLOGY

If a patient has cultures take, a biopsy or a surgery that involves removal of tissue, the patient should have a pathology report.   If the report involves growth results of a culture it can take a few days or several weeks for the final report to be issued.  Oftentimes we have to call and obtain those final reports as they may not make it to the final paper version of the hospital record.

DISCHARGE SUMMARY/AUTOPSY RESULTS

Once a patient leaves the hospital, the attending physician is required to dictate a discharge summary. Most hospitals require the discharge summary be completed and signed within 30 days of the date the patient leaves the hospital. This is also true if a patient dies in the hospital. In that case, you will also want to request any autopsy report or findings.   There are certain circumstances involving patient deaths where the facility is required to conduct an autopsy based on state law.  In other circumstances a physician may ask for an autopsy or a family may request one.  Again, certain testing may be done as part of an autopsy and the results may take a few days or have to be sent to a separate lab so make sure you obtain all of the results that accompany the autopsy.   In a medical case, we often request the entire autopsy file which may include photographs, tissue blocks and/or pathology slides with special staining.  


About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a Top Lawyer for Washingtonian Magazine. Ms. Bertram has over 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes a majority of her practice to the representation of patients and families who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted In Cancer Misdiagnosis , Cerebral Palsy , Medical Malpractice , Medications , Men's Health Issues , Nursing Home Negligence , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Brain Damage/Cerebral Palsy Can Be Caused By Malpractice

       By Catherine Bertram, Partner & Senior Trial Attorney 

                       

"Some people come into our lives, leave footprints on our hearts, and we are never the same." -Franz Peter Schubert

The medical staff at the Mayo Clinic define "Cerebral palsy" (CP) is a general term for a group of disorders that appear during the first few years of life and affect a child's ability to coordinate body movements. Cerebral palsy can cause muscles to be weak and floppy, or rigid and stiff.

In the United States, cerebral palsy occurs in about two to four out of every 1,000 births. The disorder is usually caused by brain injuries, including lack of oxygen, also called hypoxia or anoxia. Cerebral palsy isn't curable.  Medical evidence supports theories that infections, birth injuries, and poor oxygen supply to the brain before, during, and immediately after birth result in up to 15% of cases.

Between 35% and 50% of all children with CP will have an accompanying seizure disorder and some level of mental retardation. They also may have learning disabilities and vision, speech, hearing, or language problems.  Often parents are overwhelmed when their child is given this diagnosis and rightly so.  There are many questions and no clear answers.  As a parent of a child with special needs, you may be asking:

  • Why did this happen to my child?
  • How am I going to pay for what my child needs now and in the future?

Every circumstance is unique, just like very child and every family.   If you have questions about that care you received or the birth experience or the care your child received after birth and you think it may be a factor in your child's condition, you can get answers.   We have significant experience handling these types of cases and have many nationally known experts who are willing to review your child's case and determine what happened.  I was Director of Risk Management at a major teaching hospital in DC and have experience reviewing these cases from both the patient's side and the hospital's side.   We also have a nurse-attorney on staff at my firm who worked in a local hospital on the labor and delivery unit so she has special expertise in reviewing the records and determining what happened. 

As a parent, and as a patient advocate,  I urge you to get answers if you have these questions.  You owe it to yourself and your child.  Click here for some great quotes for families with special needs children and pass this on to other parents you know who have children with special challenges for those days when a few words may lighten our hearts.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Birth Injury , Cerebral Palsy , Medical Malpractice , Obstetrics , Patient Safety , Women's Health Issues
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Stevens-Johnson Syndrome Can Be Deadly if Not Diagnosed Promptly

 

By Catherine Bertram

Stevens-Johnson Syndrome (SJS) is a serious disorder in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed. It  is important that physicians keep this diagnosis in their differential so that it can be diagnosed and treated promptly and properly.

SJS usually begins with fever, sore throat, and fatigue, which can be initially misdiagnosed. Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips but also in the genital and anal regions. Those in the mouth are usually extremely painful and reduce the patient's ability to eat or drink.

SJS is most often caused by  of medication. The leading cause appears to be use of antibiotics and sulfa drugs.    Although SJS can be caused by viral infections.

Medication causes

Drugs commonly associated with Stevens-Johnson syndrome include:

  • Anti-gout medications, such as allopurinol
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Sulfonamides and penicillins, which are used to treat infections
  • Anticonvulsants, which are used to treat seizures

Allopurinol currently has warnings about the potential risk of severe skin side effects, and prescribing physicians should be on the lookout for the possible development of SJS. A multinational study published in the Journal of the American Academy of Dermatology in January 2008 indicated that Allopurinol was the most common cause of SJS and TEN in Europe and Israel, constituting about 18% of all cases.   Allopurinol is the generic name for Zyloprim, made by Prometheus Laboratories, Inc. There are also several generic manufacturers. 

RESOURCES

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2012 Washingtonian Best Lawyers. She lives and practices in Washington, D.C.  Ms. Bertram was formerly Director of Risk Management at Georgetown Hospital.  She lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Medical Malpractice , Medications
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Chiropractic Cervical Manipulation, If Done Wrong, Can Be Deadly

By Catherine Bertram, partner

Each year in the U.S., 22 million patients are treated by Doctors of Chiropractic,more commonly called chiropractors, or "chiropractic physicians" in some states. It is estimated that there are 52,000 chiropractors currently performing such treatment.  The average chiropractor in private practice performs as many as 50-100 manual vertebral manipulations a day, at a cost of $25 to $40 each.

The goal of chiropractic is the diagnosis and correction by manual spinal manipulation or adjustment of a chiropractic condition called "vertebral subluxation."  Although most chiropractors claim they perform thousands of cervical manipulations annually without any serious complications, malpractice suits have been successfully brought against chiropractors for injuries sustained as a result of improper manipulative technique and/or performance of spinal manipulation where it is contraindicated.  Patient injuries can range from headaches and post-treatment soreness to permanent complications of stroke, including left or right side paralysis, loss of bowel and bladder function,  vertebral fracture; disc herniation; rib fracture; and other serious neurologic syndromes.

According to chiropractic experts, neurologists and emergency medicine experts, inexperienced, or poorly trained chiropractors have performed the cervical manipulation in a disproportionate number of cases where serious injuries have occurred.   As an experienced malpractice attorney, and Co-Chair of the National Chiropractic Litigation Group, I have experience with these tragic cases and have access to national experts for review of these cases.  If you would like to talk to me about your situation you can call me (202) 822-1875 or email me directly.

About the author:

Catherine Bertram is board certified in civil trials, she is a 2012 Best Lawyer and Super Lawyer for Washington, D.C.  Ms. Bertram has over 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes a majority of her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  She lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

 

Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Women's Health Issues
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Adverse Event Report: Why It Matters to Patients

Posted by: Salvatore J. Zambri, founding member and partner

In its 2011 Annual Report, the District of Columbia Patient Safety Reporting Program summarized the process by which adverse event reporting and patient safety is reported as well as the results of the District of Columbia's most recent reporting period. The purpose of the annual reporting is to comply with the District of Columbia Medial Malpractice Amendment Act of 2006. "The Act requires that any licensed healthcare provider or medical facility must report adverse events, which includes the 28 Serious Reportable Events defined by the National Quality Forum (NQF) as events that are unambiguous (identifiable and measurable), serious (resulting in death or significant disability), and usually preventable.  In 2009, the Act was amended to require that adverse events reports must be reported within 60 days of their occurrence.  In January, 2010, a web-based adverse event reporting system was implemented in the ongoing effort to improve healthcare delivery."

For the 2011 report, the following highlights are noted:

  • "There was an increase in the number of NQF (National Quality Forum) and other events reports, not including HAI (healthcare-associated infections) events.  In 2010, 66 NQF and other events were reported and there were 90 in FY 2011.
  • A total of 112 adverse event reports were received.  Seven (6%) involved a patient death.
  • The majority of reports, 88 (78%), were submitted by acute care hospitals.
  • During the current reporting period there was an increase in the total number of event types reported, from 9 event types in FY 2010 up to 14 event types this past year."

The report states, "Medical errors and adverse events are a significant killer in the United States, and most are preventable."  Major categories of  medical errors listed were pressure ulcers, HAIs, falls, device related events, and surgical events.  The most frequently reported issue in almost every event was communication failure within a facility.  Other contributing factors include failure to follow protocol and failure to assess patients. Collecting and analyzing information about each incident is a first step in improving patient safety.  Using the information as an opportunity to improve the quality of medical care and education is the critical step to actually improve patient care.

"The District Patient Safety Reporting Program's main goals include:

  • Promoting patient safety
  • Improving the culture of safety
  • Learning from and preventing adverse events
  • Providing feedback to District facilities."

Listed below are some of the previous posts that I have written about patient safety:

As a practicing attorney for over twenty years, I have seen the results of preventable medical errors and the devastating effects they inflict on patients and their families.  Having an effective system in place that requires healthcare facilities to report on adverse events is a beginning to prevention of those types of errors and improving patient safety.  Much more needs to be done beyond the reporting of events to actually impact patient safety, namely, action. 

Do you have any questions about this post?

Continue Reading Posted In Medical Malpractice , Men's Health Issues , Nursing Home Negligence , Patient Safety , Public Health , Women's Health Issues
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Dirty Surgical Instruments Compromise Patient Safety

Posted by: Salvatore J. Zambri, founding member and partner

According to a recent investigative study by the Center for Public Integrity, a nonprofit organization that focuses on ethics and public service, contaminated surgical instruments are creating additional worries for surgeons and their patients.  Surgical tools are supposed to be cleaned and sterilized between operations, and manufacturers of those tools are supposed to provide detailed instructions for the cleaning process.  A big part of the problem is that cleaning technicians are not required to obtain any certification at all to clean and sterilize instruments.  By comparison, manicurists and dog groomers are required to take infection control courses for licensing.  Another part of the problem is that manufacturers are not required to design devices that can be easily cleaned in real world environments. The end result is that instruments frequently come into the operating room carrying bits of blood, bone and tissue from a previous operation, as well as potentially dangerous and sometimes deadly bacteria.  Earlier instruments were primarily made of metal or glass, both of which can withstand high temperatures required for sterilization.  Newer high-tech devices cannot withstand that level of heat and must be cleaned.  

Hospital-acquired infections continue to be problematic because of the difficulty in tracking them and the challenges of thoroughly cleaning reusable medical devices.  During a workshop held last summer by the FDA, representatives from manufacturers, hospitals, CDC and FDA, a presentation by Jahan Aziz, a major hospital's risk management clinical engineer, demonstrated how prevalent the problem is.  After showing the group 350 surgery-ready suction tips, which were cleaned by the recommended method, he revealed that 343 of them contained debris from earlier procedures. According to Charles Hancock, an independent medical device sterilization consultant, the supply of dirty devices in hospitals is potentially massive due to the design of the instruments, the lack of training for cleaning technicians, and the frantic pace of the instrument sterilization process. 

The FDA is working on creating a draft recommendation for reprocessing of medical devices as well as suggestions for manufacturers' development of more robust instructions for reprocessing for the real world hospital market. In addition, the draft is intended to serve as a guide for device manufacturers as they seek FDA clearance for new devices.

As this story develops and more information is available from the FDA reviews and recommendations, we will revisit the topic and post another blog entry.

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Continue Reading Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Unclear Surgery Rules Lead to Multiple Operations for Breast Cancer

Posted by: Salvatore J. Zambri, founding member and partner

According to a recent article in the New York Times, inconsistent guidelines are prevalent among radiology oncologists and breast cancer surgeons. "Nearly half of women who had lumpectomies for breast cancer had second operations they may not have needed because surgeons have been unable to agree on guidelines for the most common operation for breast cancer, a new study finds. It also hints that some women who might benefit from further surgery may be missing out on it." 

Dr. Laurence Cahill, author of the study, surgeon and assistant director of the Lacks Cancer Center in Grand Rapids, Michigan and Dr. Monica Morrow, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York, concluded that a consensus statement needs to be made by the leaders in oncology radiation and surgery.  Close to half of the repeat operations were performed on women whose pathology reports indicated that no cancer cells were left behind after the first surgery while 14% of the patients who did have cancer left behind did not have a second operation.  Repeat surgery rates range from 0% to 70% and can vary widely by doctor.  However, a doctor's repeat rate is not necessarily the best indicator of whether the original operation was done correctly, as the surgeon may have performed more mastectomies than lumpectomies or could have neglected to operate a second time, even when it was needed. 

After a lumpectomy, the most common operation for breast cancer, nearly all patients receive additional radiation and systemic treatment with chemotherapy or hormones to decrease the recurrence rate and margin size concerns.  Questions remain as to the margin necessary between cancer cells and healthy tissue.  Until those questions can be answered and surgeons come to a consensus, many women will continue to either have a potentially unnecessary second surgery or miss one when it is needed.  Both of these unsatisfactory options add more physical and mental stress for patients.

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Continue Reading Posted In Patient Safety , Women's Health Issues
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Some NSAIDS May Increase Risk of Birth Defects

Posted by: Salvatore J. Zambri, founding member and partner


Reuters (12/13, Thrasybule) reported a study in the American Journal of Obstetrics and Gynecology suggesting that some over-the-counter painkillers, when taken during early pregnancy, may slightly increase the risk of rare birth defects. For instance, aspirin and naproxen have been linked to babies with either anophthalmia or microphthalmia. Other conditions that saw a rise in risk with painkiller use included amniotic band syndrome, cleft palate, and spina bifida. However, the researchers noted that the majority of NSAIDs were not tied to birth defects, and emphasized that the study does not prove that the painkillers caused the increased risk. An expert not involved with the study suggested avoiding ibuprofen, aspirin or naproxen altogether and using acetaminophen for pain relief instead.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Breast Cancer Awareness and Mammography Importance

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

As you've probably noticed during the month of October, the pink ribbon representing breast cancer awareness has been on prominent display in a number of  advertisements, sporting events, websites, and other public places.  In addition, October 21 was designated as National Mammography Day, when many locations provided free or drastically reduced mammograms for patients.

According to the Centers for Disease Control and Prevention (CDC), regular screening mammograms are recognized as the best way to find breast cancer early.  "In 2007 (the latest year for which statistics are available), 202,964 women were diagnosed with breast cancer, and 40,598 women died from the disease."  Because early breast cancer does not cause signs and symptoms, many experts have determined that a mammogram is the most effective way to detect breast cancer early, sometimes up to three years before a lump can be felt through a self-exam.  After breast cancer grows, the following symptoms become more evident:

  • "New lump in the breast or underarm (armpit).
  • Thickening or swelling of part of the breast.
  • Irritation or dimpling of breast skin.
  • Redness or flaky skin in the nipple area or the breast.
  • Pulling in of the nipple or pain in the nipple area.
  • Nipple discharge other than breast milk, including blood.
  • Any change in the size or the shape of the breast.
  • Pain in any area of the breast."

The National Breast and Cervical Cancer Early Detection Program  is part of the CDC and works with health departments and other groups to provide low-cost or free mammograms to women who qualify.  The CDC website also features a section explaining mammograms in terms that assist women in understanding the value of mammograms.

I encourage all women, as well as men, to speak with their physician about the most effective ways to prevent ill consequences of breast cancer.

Continue Reading Posted In Patient Safety , Public Health , Women's Health Issues
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Brain Stents: Not Quite Ready for Patient Use

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

In 2005, the Food and Drug Administration (FDA) approved a humanitarian exemption for use of tiny brain stents for patients who were at high risk of suffering a second stroke. The wire mesh brain stents were inserted into the brain arteries of high-risk patients in an attempt to remove blockages and prevent strokes.  The original trial involved 45 patients, but did not include a control group for comparing how well the stents worked.  Encouraged by those results, surgeons inserted thousands of wire stents into patients. 

The subsequent trial included 450 patients in a rigorously controlled study.  As recently reported in the New England Journal of Medicine (NEJM), after conducting a multi-center clinical trial, the following statistics became evident:

  • "For stent patients:
    • 15% had a second stroke or died within 30 days of starting treatment.
    • 20.5% had a stroke or died within a nearly one-year follow-up period.
  • For non-stent patients:
    • Under 6% had a second stroke or died within 30 days of starting treatment.
    • 11.5% had a stroke or died within a nearly one-year follow up period."

Co-principal investigator Colin P. Deredeyn, MD, of the Washington University School of Medicine in St. Louis, said:

"The complications on the stent side of the trial were higher than we expected.  Further research may identify specific groups of patients who may benefit from these stents, but for now we seem to be able to save more lives by aggressively working to lower blood pressure and cholesterol."

Dr. Derereyn went on to say:

"An earlier study found that high blood pressure and cholesterol levels in this group of patients was strongly associated with increased stroke risk.  We developed 'aggressive medical management' protocols that asked treating physicians to work hard to bring patient blood pressure and cholesterol into safe ranges.  We also regularly monitored patients to see if these goals were being met."

"We only accepted patients whose stenoses blocked 70% or more of an artery, so this was a very high-risk group.  While we were selective in that regard, we did not investigate the nature of the blockages - for example, how much of the blockage was plaque only and how much of it was blot clot on a plaque.  These patients may have different risk of stroke with stenting."

As summarized in an editorial by the New York Times, "This case raises the question of whether the FDA should demand more rigorous trials before a device is granted a humanitarian exemption. It clearly shows the value of conducting rigorous controlled studies with enough patients to provide meaningful results." 

Continue Reading Posted In Patient Safety
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FDA Alert Issued Regarding Avastin

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

According to a recent alert issued by the U.S. Food and Drug Administration (FDA), health care professionals are being cautioned as a result of recent serious eye infections resulting from Avastin injections.  Several recent incidents of patients losing all remaining vision after Avastin injections prompted the FDA alert.  Although Avastin is approved for treatment of some cancers, it has not been approved, but is frequently-prescribed treatment for wet age-related macular degeneration (AMD). Regulators and manufacturers warn against unapproved use of Avastin, citing infection and loss of vision as examples of the risks associated with doing so. It is believed that the tainted injections were from a pharmacy that repackaged the preservative-free vials into smaller single-use syringes.  The investigation continues.

The FDA alert states: "Health care professionals should be aware that repacking sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.  Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.  Avastin solution for intravenous infusion is approved for the treatment of various types of cancers.  Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication."

Genentech, the division of Roche that manufactures Avastin, maintains that caution against unapproved use was always advised.  According to a Genentech spokesman, "Avastin is not manufactured or approved and to date has not been proven safe for use in the eye."  Many ophthalmologists argue that Avastin is a much cheaper alternative treatment of wet AMD and that the infection and vision-loss incidents are due to carelessness instead.  The safety debate regarding off-label use continues.

Please check with your doctor if you have been prescribed any off-label medications.  Although some off-label prescribing of medication has existed for an extended period of time, the fact that serious infections and even blindness can occur when a cancer medication to treat eye disease reveals that it is a risky practice. 

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Continue Reading Posted In Medications , Patient Safety , U.S. Food and Drug Administration Warnings
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Hip Replacement: Safety Problems and Questions Continue

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

Hip replacement is one of the most common surgical procedures in the United States. It is estimated that 250,000 replacements are performed each year. Since the beginning of 2011, the Food and Drug Administration (FDA) has received over 5,000 complaints about metal-on-metal hips, more than the previous four years combined.  Some experts believe that this rise in complaints is an indication of  the "biggest and most costly medical implant since Medtronic recalled a widely used heart device component in 2007."  In May, the FDA ordered producers of metal hips to submit proposals to the FDA with plans for studying how frequently the devices were failing and to examine the threat to patients.  The agency is expected to determine the adequacy of those plans by  November, 2011.   Even the chief scientist at the FDA who oversees medical devices acknowledges that finding answers to the complaints could take several years.

As more problems are uncovered, some surgeons have abandoned installing all-metal hips, and they are looking for safer alternatives, usually those which combine metal and plastic components.  Many surgeons are also dealing with questions related to replacing the all-metal hips in their patients who don't seem to to have obvious problems.  For some patients, crippling injuries have resulted from the tiny particles of cobalt and chromium that shed into the patient's body.  Debris-caused tissue damage is very extensive in those cases.  Some researchers believe that many all-metal hip implants have an inherent flaw.  Numerous unanswered questions remain about their safety, whether from the the device itself, or its interactions with human tissue.

According to the FDA, "Many all-metal devices were sold without testing in patients or without a requirement that producers track their performance."  According to a recent report in the New York Times, the FDA is now intervening and ordering producers to study how frequently the devices were failing and to examine the threat to patients.  There are currently "no standard protocols for a uniform procedure to measure metallic ions in a patient's blood or how to calibrate diagnostic equipment to best detect tissue damage."

To date, almost 75% of the hip implant device complaints received by the FDA have been regarding the Articular Surface Replacement (A.S.R.), which was recalled by the DePuy Division of Johnson & Johnson in 2010.  Another Johnson and Johnson product receiving complaints was the Pinnacle.  Still another model receiving complaints is the Durom Cup, manufactured by Zimmer Holdings.  Along with DePuy and Zimmer, other companies submitting study proposals to the FDA include Wright Medical and Biomet.

If you have received a hip replacement, please consult with your surgeon to determine whether the model you received is subject to recall.  As the safety of hip replacement devices is further investigated, other models and brands of all-metal implants may be recalled in the future.

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Continue Reading Posted In Medical Malpractice , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Securing The Best Resolution Possible For Clients

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

I was invited to give a presentation to the Connecticut Trial Lawyers Association on the day of their annual gala.  I had a wonderful time meeting members of the Association.  As a past-president of the Trial Lawyers Association of Metropolitan Washington, DC, I always enjoy  meeting leaders of other associations and collaborating about hot-topic issues in the law.

My presentation was about how to maximize the potential to resolve cases favorably for clients through the use of settlement videos.  Settlement videos can be expensive, but they are powerful settlement tools when dealing with significant cases.

I was told by several members that they learned a lot from the presentation, which was very gratifying.  I strongly believe that lawyers should help lawyers become better at what they do.  We are in a fellowship together, working to bring justice to those who need it the most.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Patient Safety
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$58.6 Million Awarded in Malpractice Suit

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

A Connecticut jury has awarded a local couple $58.6 million in a medical malpractice lawsuit, a record for a single incident of medical malpractice in the state of Connecticut. The lawsuit was against a physician and his practice, and it was shown that the doctor waited too long to perform a cesarean section during the wife's labor, which caused the child to be born with permanent brain damage. The boy suffers from cerebral palsy and is unable to eat, walk or talk. 

The recovery will allow the boy and his family to cover medical expenses and other losses the boy will endure for the rest of his life.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Cerebral Palsy , Obstetrics , Patient Safety , Pediatrics , Women's Health Issues
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Experts Say Cell Phones Are "Possibly Carcinogenic"

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             


ABC World News (5/31, lead story, 3:10, Sawyer) reported, "An important new alert about the safety of cell phones and the possible risk of cancer, brain cancer in particular...comes from the World Health Organization." NBC Nightly News (5/31, lead story, 3:10, Williams) reported, the WHO "statement labeling cell phones as a possible carcinogenic hazard comes from a panel of 31 scientists."      

According to the AP (6/1, Cheng), the statement was "issued in Lyon, France, on Tuesday by the International Agency for Research on Cancer" (IARC) after a "weeklong meeting" during which experts reviewed "possible links between cancer and the type of electromagnetic radiation found in cellphones, microwaves and radar." The IARC classified cellphones in "category 2B, meaning they are possibly carcinogenic" to humans. The assessment now "goes to WHO and national health agencies for possible guidance on cellphone use."

The Wall Street Journal (6/1, Martin, Hobson, Subscription Publication) reports that the IARC working group did not conduct new research. Instead, the panel reviewed existing literature that focused on the health effects of radio frequency magnetic fields. Its findings are slated to be published July 1 in Lancet Oncology.

The New York Times (5/31, Parker-Pope, Barringer, Subscription Publication) "Well" blog noted that the panel's decision to "classify cellphones as 'possibly carcinogenic' was based largely on epidemiological data showing an increased risk among heavy cellphone users of a rare type of brain tumor called a glioma." Most "major medical groups," including the National Cancer Institute, have "said the existing data on cellphones and health has been reassuring." Earlier this year, the Journal of the American Medical Association "reported on research from the National Institutes of Health, which found that less than an hour of cellphone use can speed up brain activity in the area closest to the phone antenna."

The lesson here is simple:  Don't blindly believe what the cell-phone companies are saying. their products may in fact cause cancer, according to international experts.  Consequently, be safe.  Use a cell phone only when necessary, and use an earpiece if possible. 

Let's hope the cell phone companies do the right thing by both testing their products sufficiently and revealing the true results of the tests, so customers can make proper decisions to protect their health.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective products, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Pfizer Under-Reported Side Effects of Smoking-Cessation Drug, Says Report

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             


ABC News reports that a new analysis by the Institute for Safe Medication Practices "says that there were 150 instances" where users of the smoking-cessation drug Chantix committed suicide "out of the nearly 600 delayed reports of severe issues noted in the study."  As a result, the FDA "wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts."

I applaud the FDA in demanding Pfizer to release its records.  Decisions to market drugs should be based principally on patient safety and health, not on profits.  It would be a shame if people lost their lives as a result of using a drug after side-effects were concealed.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Study Shows Poor Infection Control in Nursing Homes Linked to Lower Staffing Levels

By Catherine Bertram

Infections in nursing homes kill 400,000 residents a year according to a recent study published in the American Journal of Infection Control.   The authors contend that nearly one-sixth of the US nursing homes have significant deficiencies in infection control.  Over 100,000 patient encounters were reviewed.  The University of Pittsburgh Public Health program researchers analyzed records from 2000 through 2007 and found that infection control citations in 96% of US nursing homes were linked to lower nursing staff levels. 

Infections are leading cause of morbidity and mortality in U.S. nursing homes.  This study reminds us of the direct link between professional staffing levels and safe care for our most vulnerable citizens.  Those are are family members and advocates for seniors need to keep speaking up and asking questions about the infection rates and infection control requirements at long term care facilities.

Continue Reading Posted In Men's Health Issues , Nursing Home Negligence , Public Health , Women's Health Issues
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100,000 Lives Lost Each Year Due to Dirty Hospitals and Nursing Homes

By Catherine Bertram

Each year 100,000 patients in hospitals and nursing homes in this country die from infection they acquired after being in a health care facility.  This is the most common complication of hospital care and also one of the deadliest risks for patients according to government officials.

In addition the loss of lives, the cost for our health care system is enormous. The estimated annual cost for hospital acquired infections is between $28 and $33 billion. 

What is even more shocking and tragic is that the consensus in the US medical community is that most of these infections are preventable.  How you ask?  This is really where it should make us all angry - by washing your hands in between patients.  It is not expensive or dangerous to implement.  What will it take to make hospitals and nursing homes clean up their act? Unfortunately, it has to hit them where it hurts - in their pocket book.   In 2008, the Centers for Medicare and Medicaid (CMS) began denying payments to hospitals for the costs of patient's care and patient days related to these infections.   

If you want more information about hospital acquired infections you can look at the Centers for Disease Control (CDC)  website which provides  links to infection prevention materials, statistics on infection rates and other materials.

Continue Reading Posted In Men's Health Issues , Nursing Home Negligence , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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MSRA Bacteria Found in Meat Samples In Detroit

By Catherine Bertram


Kim Kozlowski of the Detroit News reports, "For the first time in the United States, scientists have shown that the antibiotic-resistant bacteria MRSA is sometimes found in meat and poultry available at the neighborhood grocery store," according to the US Centers for Disease Control. (CDC) in a recent study in the journal Emerging Infectious Diseases. The study included 289 meat samples from 30 grocery stores in Detroit, Michigan.   They reported  "six samples -- three chicken, two beef, and one turkey -- tested positive for MRSA, methicillin-resistant Staphylococcus aureus."  It is believed that the germs may be introduced by human food handlers. This is community acquired MSRA.    The method of transmission, however,  is similar to how patients get infected with MSRA in hospitals when members of the health care team fail to wash their hands before they care for patients or touch their medicine or IV lines without taking proper precautions.  While cooking the meat may decrease the risk of infection significantly, the risk of infection is reported to be high for individuals who handle infected meat who have open cuts or sores on their hands or skin, according to the study's author. The reason this is so dangerous is because this super bug has become resistant to most antibiotics so it can be extremely difficult to treat. 

Continue Reading Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Medical Malpractice "Reform" Increases US Deficit

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             


Writing for the Huffington Post, Joanne Doroshow of the Center for Justice and Democracy remarked on a March analysis from the Congressional Budget Office tat found that savings from malpractice "reforms" would be minimal. Doroshow pointed out that "reforms" imposed by HR 5, which includes a $250,000 non-economic damage cap, will actually increase the US deficit.  Doroshow explained that malpractice victims who are arbitrarily barred from obtaining compensation through litigation will turn to avenues like Medicare and Medicaid. The CBO's prediction that reform will reduce health spending by 0.4 percent does not account for this deficit increase.  The CBO also fails to consider "that these kinds of extreme 'tort reforms' would weaken the deterrent potential of the tort system, with accompanying increases in cost and physician utilization inherent in caring for newly maimed patients," says Doroshow.

Ms. Doroshow's big-picture understanding of this important issue helps Americans understand that the real driving force behind reducing citizens' rights in court is not about decreasing healthcare spending at all.  It's about Big Business trying to pad their profits at the expense of patient safety.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com. 

Posted In Men's Health Issues , Patient Safety , Public Health , Tort Reform , Women's Health Issues
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CMS Reports On Prevelance Of Medical Errors

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

The St. Louis Post-Dispatch reports that on Thursday, March 31, the Centers for Medicare and Medicaid Services (CMS) "released data...that for the first time show how often patients are injured by certain medical errors in hospitals." However, "the government did not explain why only eight types of serious, preventable errors were included in the comparison," while other such errors, like as medication errors, were not included in the study.  Th e report does include the following types of medical errors: "air in the bloodstream, falls, bedsores, infusions with the wrong blood type, urinary tract infections, blood infections, uncontrolled blood-sugar levels, and foreign objects left in the body after surgery."

A review of the study reveals that the medical industry needs to focus on error prevention.  Too many people are needlessly injured or killed as a result of preventable medical errors.  As the report makes clear, "the Office of Inspector General for the U.S. Department of Health and Human Services said 180,000 Medicare recipients die each year from hospital mistakes. That's more people than are killed every year in car crashes, or from diabetes or pneumonia."  This trend cannot continue.

We applaud the institutions and doctors who are taking steps to analyze past errors and eliminate preventable medical errors.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com. 

Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Malpractice Cap Rejected As Senseless In New York

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             


The New York Times (3/16, Kaplan) reports that the two "houses of the State Legislature passed budgets on Tuesday that rejected  crucial provisions of Gov. Andrew M. Cuomo's overhaul of Medicaid ... drawing sharp battle lines with the governor two weeks before the deadline to pass a spending plan." The Assembly's plan "rejects a cap on damages for pain and suffering in medical malpractice lawsuits, which was a key provision sought by hospitals to offset a sharp reduction in Medicaid financing from the state." The plan from the Senate includes a damages cap.  Cuomo "did not comment after the budget votes."

We congratulate the New York State legislature for recognizing that an artificial cap has no place in American society.  The civil justice system, by the power of the Constitution, allows a patient who has been injured by a medical error to receive full and fair compensation for the patient's harms and losses.  Governments should not arbitrarily set values of claims.  The extent of a patients harms and losses are rightfully assigned by citizens after they hear and view all of the relevant evidence.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.

Posted In Men's Health Issues , Patient Safety , Public Health , Tort Reform , Women's Health Issues
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Tort Reform Is Civil Justice Deform

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

An editorial in the Des Moines Register points out that proponents of medical malpractice reform "don't acknowledge many doctors order tests because they're trying to do a thorough job with patients. They rarely mention too much testing is a result of this country's "fee for service" system of paying doctors." Moreover, "current tort reform efforts aimed at reducing malpractice risk would be relatively ineffective in alleviating physicians' concern about lawsuits and therefore may not alter defensive medicine practices," a University of Iowa study concluded. Des Moines neurosurgeon and tort reform proponent Dr. Thomas Carlstrom echoed this point, saying lawsuit damage caps wouldn't curb what the called his practice of "Cover You're A-" medicine.

Even doctors admit that capping damages and promulgating so-called tort reform won't meaningfully reduce medical costs and insurance premiums.  Insurance reform is what is needed.  Victims of negligence--those that suffer greatly as a result of medical errors--are all-to-often forced to live with significant pain, physical impairments, and loss of enjoyment o f life.  Their rights and legal protections should not be taken from them too.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.

 

Posted In Men's Health Issues , Patient Safety , Public Health , Tort Reform , Women's Health Issues
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Measles Exposure in DC Area

By Catherine Bertram

 

According to reports in the Washington Post, a woman infected with measles, a contagious disease which can be dangerous to some patients, was present in the District and Maryland after flying into Dulles International Airport. The 27-year-old woman from New Mexico arrived at Dulles reportedly on  February 20th  and left our area on February 22nd, from Baltimore-Washington International Airport.

In between, she spent time in Georgetown and Columbia Heights.  The D.C. Department of Health advises individuals exposed to measles should figure out whether they have they received two doses of measles vaccine. Those who cannot confirm that, and anyone showing symptoms should contact their health care providers. People with measles should stay home as long as advised by their doctor which is usually until after the characteristic rash appears because they can contaminate others. Other symptoms include fever, redness of the eye, and a cough. The woman was exposed to measles while in Europe.  For more info, click: Health Alert: Measles Exposure in the District of Columbia, DC Department of Health, News Release,

Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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AMA Predicts Errors With Electronic Medical Records

Posted by: Salvatore J. Zambri, founding member and senior trial attorney     

American Medical News (1/3, Dolan) reports, "Medical liability insurers once said electronic medical records would let physicians earn discounts on their premiums, because the potential benefits of the technology included improving patient safety." But "those discounts haven't materialized" and "the reason, a study says, is that liability insurers are betting that claims will rise during a so-called adjustment period, when practices new to the technology are working out the kinks in their systems." The study found that "in the short term, 'as systems are tested, errors with coding data input and software-interoperability failures may occur."

The movement to electronic medical records is a very positive change. So long as information is inputted correctly and timely, errors should not occur.  If they do occur, patients could be seriously injured.  Sometimes change is difficult for people, but failing to make appropriate entries in electronic medical records should not be excused.  Too much--the health of patients--is at risk.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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FDA Issues New Guidelines for CT Scanning

Posted by: Salvatore J. Zambri, founding member and senior trial attorney     

As reported in a recent article by the New York Times, "the Food and Drug Administration has concluded that manufacturers of CT scanners should do a better job of training and educating those who use their equipment, and that the machines themselves could be made safer by warning operators that a dangerously high radiation dose is about to be administered.

These two conclusions . . . are the result of a yearlong investigation by the F.D.A. into hundreds of radiation overdoses in 2008 and 2009 that occurred during a specific diagnostic test for a stroke, called a CT brain perfusion scan."

Over-radiation can be very dangerous.  Manufacturers of scanners and physicians must work together to maximize patient safety.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

 

 

 

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Litigation Over DePuy Hip Replacements Rising

Posted by: Salvatore J. Zambri, founding member and senior attorney     

An August recall of DePuy ASR hip implants had led to lawsuits.  The suits claim that the manufacturer knew its product was failing, but nevertheless continued to sell it for profit without informing consumers.

The problem seems to be with the metal-on-metal design of the device, which does not appear to adhere well in the hip joint.  Consequently, the failed replacements have to be re-done, often at a terrible cost both financially and physically. Some patients have suffered metal poisoning, and others are having a hard time ambulating.

My firm regularly represents victims of product defects.  It is a shame when you see companies put profits over people.  Bad things--tragic things--happen when that business model is used.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Nurses Union States Understaffing At DC Hospital Jeopardizes Patient Care

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The nation's largest nurses union has asked the D.C. Health Department on Monday to investigate nurse under-staffing at Washington Hospital Center.  According to the union, under-staffing is jeopardizing patient care.

The National Nurses United union filed a 19-page report with the D.C. Health Department, which documents 50 separate instances of what it describes as unsafe patient care across all departments in the hospital this year.

As the Washington Post reported, the union filing describes "instances of patients not receiving medication on time, newborn infants not being fed promptly and a patient who was rushed back to the operating room after the patient had stopped breathing and suffered cardiac arrest. The union did not know whether the patient survived."  The full Post article can be read by clicking here.

Under-staffing is a major issue that plagued hospitals across the country.  It is important for hospitals to put safety above profits and staff their facilities appropriately.  If they don't, patients will be seriously injured and killed.  I represent victims of medical malpractice and their families every day.  All too often the harms caused to patients could have been easily avoided if sufficient competent staff was in place to monitor and treat patients. 

I hope the union report spurs positive change.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medical Malpractice , Medications , Men's Health Issues , Patient Safety , Pediatrics , Public Health , U.S. Food and Drug Administration Warnings
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Is The Chamber of Commerce Hypocritical Regarding Lawsuits?

Posted by: Salvatore J. Zambri, founding member and senior attorney     

For years now, the Chamber of Commerce has been spending millions upon millions of dollars trying to limit peoples' right to seek justice through the court system when they have been victimized by corporate greed and wrongdoing.   Yet, the Chamber itself utilizes the court system to advance its own selfish agenda multiple times every single week.

This hypocrisy was noted in a recent publication by the Association for Justice.  Here is a reproduction of some of that report:

Washington, D.C.--Earlier this month, U.S. Chamber of Commerce President and CEO Tom Donohue called litigation "one of our most powerful tools for making sure that federal agencies follow the law and are held accountable." 

Yet ironically, the Chamber today holds its annual Legal Reform Summit – an event underwritten by its multinational corporate members that promotes undermining the civil justice system to weaken the basic legal protections of American workers and consumers.

The Chamber's hypocrisy – blocking justice for everyday Americans while using the courts liberally for its own pro-corporate agenda – is the subject of a new report released today by the American Association for Justice (AAJ) that exposes the Chamber as one of the most aggressive litigators in Washington, entering lawsuits at a rate of over twice weekly.

"The Chamber's 'one rule for corporations, another rule for everybody else' motto has come at the expense of ill-treated workers, defrauded investors and injured consumers," said AAJ President Gibson Vance. "It readily spends millions of dollars to prevent Americans from holding wrongdoers accountable in the courtroom, and then aggressively uses the very same legal system to advance the agenda of its multinational corporate membership."

In almost every case, the Chamber's litigation on behalf of corporations has come at the expense of Americans' health or financial security. The Chamber has:

  • justified the actions of Wall Street banks that drove the country's economy into turmoil; • defended the most conceited and worst behaved CEOs and their most extravagant excesses;
  • tried to force workers, instead of employers, to pay for their own safety equipment; • filed numerous actions opposing any move to combat climate change;
  • sought to shield pharmaceutical executives who skirted safety procedures that ultimately killed 11 children;
  • opposed measures allowing workers to receive a rest period during a full work day;
  • fought on behalf of lead paint manufacturers found to have poisoned thousands of children;
  • defended corporations that discriminated on the basis of race and disability; and
  • spent years defending big tobacco, asbestos companies and chemical companies found to have contaminated water and air.

"The Chamber has every right to seek what it believes to be justice in a court of law, even if representing the most deplorable corporate interests," said Vance. "But it must learn that this right to justice belongs not just to their organization, or big business generally, but to all Americans."

The report, titled "The Chamber Litigation Machine: How the Chamber Uses Lawsuits to Keep Americans out of Court," can be found by clicking here.

Don't let the Chamber or other special interests fool you.  Contact your local and federal legislators and fight for your rights.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Public Health , Tort Reform , Women's Health Issues
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Candy and Candy-like Tablet Recalled

Posted by: Salvatore J. Zambri, founding member and senior attorney     

With Halloween approaching, it is appropriate to consider which candies children should and should not eat.  CQ HealthBeat (10/26) reports, "The Food and Drug Administration on Monday put out a warning that Hyland's Teething Tablets may pose a risk to children and the company has agreed to a voluntary recall. The agency also passed along recall information about two candy products in this week before Halloween." Notably, the "teething relief product, manufactured by the Standard Homeopathic Company, contains a small amount of belladonna, a substance that can cause serious harm at larger doses."

In addition, "Nestlé USA's Confections & Snacks Division has voluntarily recalled its Raisinets Fun Size Bags, which the company says may contain peanuts even though there is nothing on the label to indicate that" peanuts are included in the snacks.  Also, "Colombina, S.A., which manufacturers Mega Pops brand lollipops, is recalling specific lots of the candy" since "certain packages may contain 'traces of foreign particles.'"

Enjoy Halloween, but please put safety first.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Age-Related Macular Degeneration

Posted by: Salvatore J. Zambri, founding member and senior attorney     

A recent article in the Washington Post personalizes the daily fears and worries of individuals who have macular degeneration.  As the population ages, age-related macular degeneration becomes a prevalent health issue for many.  Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people over 60.  Although there is no cure for AMD, individuals with it need to monitor their eyesight carefully and visit their eye doctor on a regular basis. Treatments are available that can delay or reduce the severity of the disease.  Early diagnosis is a key factor in slowing the progression.

The major risk factors for macular degeneration are aging, heredity and smoking. Early stages of macular degeneration have few symptoms, other than a subtle change in vision. The first real sign is usually a distortion of straight lines, followed by a gradual loss of central vision and diminished color perception. 

Diagnosis of macular degeneration is usually detected during a routine eye exam by the presence of drusen (yellow deposits under the retina). Additional testing determines the degree and severity of the macular degeneration.  Several treatment options available include:

  • vitamin supplements,
  • laser therapy,
  • photodynamic laser therapy,
  • anti-angiogenesis drugs, and
  • low vision aids.

Although a couple of experimental surgical treatments are being researched, individuals with age-related macular degeneration (AMD) must be realistic in their expectations for a "miracle cure" and continue to test their vision regularly and follow up with ophthalmologist to help slow vision loss.

Johns Hopkins Medicine publishes a free guide to the causes, prevention strategies, warning signs and symptoms, as well as treatment options for macular degeneration.  Other sources for information about AMD include:

It is important for physicians to diagnosis the condition early on and prescribe appropriate treatment so the patient's eye-sight can best be preserved.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Patient Safety
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Follow-Up Treatment for Children's Concussions Frequently Lacking

As summarized in a recent Reuters Health article, over 100,000 children are treated each year in emergency rooms for concussions, many returning home afterwards without instructions for follow-up care. This new study (originally published in the Journal of Pediatrics) of ER records and outpatient visits from 2002-2006 by Dr. William P. Meehan III, director of the sports concussion clinic at Children’s Hospital Boston, and colleague Dr. Rebekah Mannix, revealed that 28 percent of patients younger than 19 are discharged from the emergency room with no further instructions for follow-up treatment. Their research highlighted that ER treatment is not sufficient to determine how serious an injury is. According to Dr. Meehan, “It’s only in the days following the concussion that the course of the injury can be assessed, and parents can be advised on when their kids can safely return to sports or other activities. None of that can be done in the ER.” He emphasized the message for parents, “Go to the ER, make sure there is no emergency, then follow up with your pediatrician.”

Continue Reading Posted In Pediatrics
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Sulindac Caused Blindness, Scarring

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The AP (9/9, Tuohy) reports, "A federal jury in New Hampshire has awarded $21 million to a woman blinded and scarred by a prescription drug she took for shoulder pain. Karen Bartlett, 51, of Plaistow suffered extreme burns to her skin, mucus membranes and eyes after taking the anti-inflammatory drug Sulindac." After taking the medication for two weeks, Bartlett "was admitted to the hospital" and "was diagnosed as having Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN)." The jury concluded "that Philadelphia-based Mutual Pharmaceutical Co. was liable for her injuries and should have known the drug was unreasonably dangerous to consumers."

If you have been taking the drug, please stop ingesting it and speak to your doctor. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Maryland Hospital Wrongly Denies Stent Problem

Posted by: Salvatore J. Zambri, founding member and senior attorney     


In a column in the Baltimore Sun (8/31), Jay Hancock writes that St. Joseph Medical Center in Towson, MD, "deserves credit for shutting down Dr. Mark Midei last year when an internal review showed that he was implanting stents in numerous coronary arteries with 'insignificant' blockage." Now St. Joseph "needs to continue to do the right thing and negotiate in good faith with patients who got stents that a state inquiry and the hospital's own probe suggest were unneeded." They should drop the "stonewalling" and "the legal bluster" that is being used to deny justice to those who have been harmed.

Every day I represent patients who have been harmed, and sometimes killed, as a result of medical negligence.  Medical providers should indeed be credited when changes take place to avoid future errors.  Making changes is not enough, though.  The providers should also take responsibility for their wrongdoing and fairly compensate the victims of the medical mistakes.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Cosmetic Surgery Death Leads to $1.95 Million Jury Verdict

Posted by Salvatore J. Zambri, founding partner

A Virginia Beach jury recently awarded a $1.95 million verdict to the family of a woman who died of aspiration pneumonia following a cosmetic surgery known as the "mommy makeover" operation.  According to the family's lawyer, the surgeon in this case allowed the patient to go home an hour after completion of a breast lift and augmentation, liposuction and a tummy tuck, although she was having trouble breathing at the time.  After leaving the surgery center, she later experienced dizziness and fever, as well as problems moving and concentrating.  A call from the woman's sister to the surgeon's office the day after the surgery was not returned. 

As more cosmetic procedures for any number of perceived or real deficiencies are being done in surgery centers instead of traditional hospital settings, more risks may become evident because patients are frequently sent home prematurely. Some steps available to patients that may help in minimizing risks of surgery at a surgery center:

  • check the cleanliness and professional appearance of the surgery center;
  • verify that the facility is accredited by a national agency, the state where the facility is located, or Medicare; (Not all states even require surgery centers to be accredited.)
  • confirm that the doctor is board certified in the specialty for your surgery;
  • ensure that the doctor is credentialed by a hospital. If local hospitals would not allow that surgeon to perform the procedure in their facility, the surgery center may be a haven for a non-credentialed surgeon.

I have handled botched cosmetic surgery claims for many years.  Without a good doctor performing the procedure in a sanitary environment with the appropriate equipment and staff, the patient will be at great risk.  Don't be afraid to ask questions before undegong any procedure.  It is, after all, your health that is at stake.

Continue Reading Posted In Medical Malpractice , Patient Safety
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Are Doctors Ordering Risky C-Sections Too Frequently?

Posted by: Salvatore J. Zambri, founding member and senior attorney     


The CBS Evening News (8/30, story 9, 0:40, Smith) reported that a recently released study reveals that "one in three first-time mothers" in America "has a c-section these days," a trend that's not likely to "reverse in the near future, because once a woman has a c-section she's more likely to have future babies delivered the same way."   The study claims that the rate of c-section is worrisome because "Caesareans pose a risk of surgical complications and research has found that they are more likely than normal births to cause problems that can put the mother back in the hospital and the infant in intensive care," the New York Times (8/31, D7, Grady) reports. "Caesareans also increase the risk of dangerous abnormalities in the placenta during later pregnancies, which can cause hemorrhaging and lead to a hysterectomy." What's more, "costs for a Caesarean are nearly twice those for a vaginal delivery."

Indeed, "C-sections are necessary sometimes to save the baby or the mother or both," according to the Washington Post's "The Checkup" blog. "But experts think they're being done far too frequently." The current study authors "stress that the study can't determine exactly how many of the C-sections were really unnecessary and could have been avoided," but it "does provide new evidence that more could be done to avoid women getting C-sections the first time around, and more could at least try a regular birth even if they have had a previous C-section."

Before reaching those conclusions, researchers at the Eunice Kennedy Shriver National Institute of Child Health & Human Development looked at data on "230,000 deliveries at 19 hospitals across the country," according to the Los Angeles Times' (8/30, Roan) "Booster Shots" blog.  The paper in the American Journal of Obstetrics & Gynecology revealed, "not surprisingly, that the major reason for undergoing a cesarean was due to the woman having a prior C-section.  Still, almost half of the cesareans that took place after labor had started were due to 'failure to progress,' and the study suggests that doctors aren't acknowledging that labor takes time and doesn't follow a predictable pattern in women, especially first-time mothers."

In preparing for child delivery, it is important for women to speak with their physicians to best understand the safest available options.  Natural delivery may be the healthiest method for a mom.  However, it should always be remembered, that during natural delivery, the baby or the mother may suffer distress, which will require a c-section under the applicable standards of care. Doctors, nurses, and hospitals must be prepared to take whatever action is necessary and appropriate to protect the mother and child. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Obstetrics , Patient Safety , Public Health , Women's Health Issues
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Hospitals Failing To Protect Patients From Drug-Induced Bacteria

Posted by: Salvatore J. Zambri, founding member and senior attorney     

It is commonly acknowledged that hospitals should do all they can to protect patients from drug-resistant bacteria.  But far too many hospitals are not, leading to serious injuries, and even death of patients.

The Las Vegas Sun (8/8) editorialized that recently published articles detailing patients' experiences with "lethal drug-resistant bacteria during" their hospital stays "should serve as a wake-up call to those medical facilities that more needs to be done to improve patient safety." Between 2008 and 2009, the "rate of patients who contracted the contagious bacteria known in shorthand as MRSA rose by 34 percent in area hospitals," even though some hospitals have "said they adhere to national standards intended to prevent the spread of bacteria among patients." But, "this is troubling, because it tells us either that the national standards are deficient or that hospitals have not been as careful as they say they have been."

Hospital-induced MRSA infections are all-too-common and can be prevented by creating a sanitary environment by washing hands, wearing clean clothing, and by taking other steps to protect patients. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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AstraZeneca Pays $198Mill To Settle 17,500 Lawsuits

Posted by: Salvatore J. Zambri, founding member and senior attorney     

Bloomberg News (8/9, Feeley, Kelley) reports, "AstraZeneca Plc will pay about $198 million to settle 17,500 lawsuits, or about two-thirds of the total, alleging its antipsychotic drug Seroquel causes diabetes in some users." As I mentioned in an earlier blog, AstraZeneca "previously agreed to pay at least $55 million to resolve more than 5,500 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, people familiar with those settlements said. These earlier agreements are part of the 17,500 settlements, the company said." The Financial Times (8/9, Jacobs) reports that the settlement stems from court-ordered mediation, a process where the parties meet together, discuss the issues, and work to come to a fair resolution. The Wall Street Journal (8/9, Zekaria) reported that analysts called the settlement figure relatively small, given the alleged defect of the product at issue. The AP (8/9) also covered the story.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Protect Yourself From Lab Errors

Posted by: Salvatore J. Zambri, founding member and senior attorney     

I recently published a couple blogs about the closing of Georgetown University Hospital's Lab and the rise in laboratory errors nationwide, which has caused patients tremendous physical and emotional anguish nationwide.  I thought you might like to know about an article I read in Good Housekeeping that included some good advice about how to protect yourself from lab errors.  Here are some suggestions taken from the article:

  • "Ask your doctor about the lab she uses. It should be accredited and approved by the College of American Pathologists (a sign that it meets high standards).
  • If you can see the test tube or slide, double-check that your name is on it; if you're in the hospital, make sure your wristband is accurate.
  • If the result of the test is a surprise, ask your doctor: "Did you expect this? Do you think this is what I have?" If the answers are no, consider repeating the test.
  • Get a copy of all lab results and reports, suggests Susan Sheridan, president of Consumers Advancing Patient Safety. "Patients may not realize they have the right to these," she says.
  • Have a specialist read your slides. With a skin sample, for instance, you'll improve odds of the right diagnosis if it's viewed by a dermatopathologist, says Mark Lebwohl, M.D., chairman of dermatology at the Mount Sinai School of Medicine in New York City. Your insurer may not cover a specialist, so you'll have to decide whether to pay for it yourself."

Obviously, you have every right to rely on your doctor and the labs used for testing.  They should know what they are doing and take all steps necessary to ensure that your lab results are timely, accurate, and properly communicated to your physician and, if necessary, to you as well.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Dietary Supplements Have Unsafe Ingredients, Says Consumer Reports

Posted by: Salvatore J. Zambri, founding member and senior attorney     

ABC World News (8/3, story 8, 1:50, Sawyer) reported, "Dietary supplements are a $27 billion a year business in this country, but Consumer Reports has an alert" on "supplements the magazine says can be dangerous to your health." Consumer Reports' Nancy Metcalf said, "With the dozen supplements that we've identified, we think it's all risk and no benefit."

The Los Angeles Times (8/4, Stein) notes that the list of those that are unsafe include "aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe." The report also "argues that the FDA has not fully used its limited authority granted by the Dietary Supplement Health and Education Act to ban supplement ingredients that may be dangerous."

The Washington Post (8/4) adds that supplement manufacturers "routinely, and legally, sell their products without first having to demonstrate that they are safe and effective."

Before taking any dietary supplement, or any medication for that matter, please consult with your doctor.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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FDA Wants Tougher Medical Device Regulation

Posted by: Salvatore J. Zambri, founding member     

The AP (8/4, Perrone) reports that "makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year." The FDA "released recommendations Monday night designed to improve oversight of the US device industry, including the government's ability to recall products that prove unsafe or ineffective." At "the center of the overhaul" is the so-called 510(k) system the FDA "uses to grant speedy approval to devices that are deemed similar to products already on the market." FDA critics "say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny."

The Minneapolis Star Tribune (8/4, Moore) reports among the recommendations released is the creation of "a new class of devices that would require clinical evidence before gaining 510K approval." The designation "would streamline the process for a 'small subset' of devices by telling applicants up-front what will be required to gain marketing clearance, thus avoiding delays." As it stands, "only 8 to 10 percent of the devices approved under the 510(k) moniker require clinical studies," said Jeffrey Shuren, director of the FDA's device center.

Increased oversight is needed, so that patients' health and lives are not put at risk.  Safety must be put above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Senate Bill Introduced To Increase FDA Safety Oversight

Posted by: Salvatore J. Zambri, founding partner     

The Hill 's (8/4, Lillis) "Healthwatch" blog reports, "citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation's drug supply." The "Colorado Democrat says his proposal," which would "greatly expand the FDA enforcement powers while holding drug companies more accountable for the products they sell," is "vital in a globalized age when more and more drug ingredients originate overseas."

I applaud this introduction of this important legislation.  The lack of oversight has allowed drug and other product manufacturers to push products into the market for profit without proper safety considerations.  Let's hope Congress will do the right thing and make this bill law.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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AstraZeneca To Pay $55Mill To Resolve Seroquel Lawsuits

Posted by: Salvatore J. Zambri, founding partner     

As Bloomberg News (8/5, Feeley, Milford) reports, "AstraZeneca Plc, the UK's second-biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel [quetiapine]." AstraZeneca's "5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing." The company "is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium [esomeprazole] in the next four years."

We hope that these settlements effect how drug companies decide to do business.  They must put patient safety above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Are Drug Studies Reliable or Tainted?

Posted by: Salvatore J. Zambri, founding partner     

A recent analysis of the outcomes of pre-market drug-trials raised some great concerns.  The Los Angeles Times (8/2, Roan) "Booster Shots" blog reported, "According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry." A review of 546 drug trials "found that industry-funded trials reported positive outcomes 85% of the time, compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations." But, among "the nonprofit or non-federal studies, those that received industry contributions were more likely to be positive (85%), compared with those that did not have any industry support (61%)."

I'm concerned that drug companies are not sufficiently testing their drugs before pushing them on the market for a profit.  The vast difference in the trial outcomes conducted by teh drug companies and the federal government suggests that the pharmaceutical industry needs to do more to protect consumers.  Safety must be put above profits.

And the non-profit and non-federal organizations involved in performing drug studies need to be careful not to take a blind eye to negative effects of drugs just because drug companies make financial contributions to the entities. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Lab Errors: These Mistakes Can Be Deadly

By Catherine Bertram

An article in the Boston Globe last week, by Jonathan Salzman,  reports that a lawsuit has been filed by a patient who had surgery to remove his prostate after being told that he had prostate cancer.   Our blog mentioned this case last week.  The surgery left him incontinent.  Tragically, he did not have prostate cancer. It was a lab error.  The lab technician mistakenly mixed up his results with that of another patient.  As a result, this patient had a surgery he did not need and must now wear adult diapers and live with the consequences.  Another patient reportedly had an eight month delay in the treatment of his prostate cancer due to a lab mix up. He was told he was cancer free but that was incorrect.  He actually had cancer and was not treated for eight month.  The article reports that by the time he was informed of the mix up the cancer had spread to his lymph node.

Lab errors can be devastating to patients and can negatively impact the patient's chances of survival and require additional treatment.  We have this type of cases pending right now and we have the experience to understand how hospitals should label and track these types of results and what safety measures should be put in place to avoid these tragic occurrences.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital.  Ms. Bertram is a member of the bar for the U.S. Supreme Court.  She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 

Posted In Cancer Misdiagnosis , Medical Malpractice , Men's Health Issues , Patient Safety , Pediatrics , Women's Health Issues
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Georgetown University Hospital Lab Problems Prompt Closing

Posted by: Salvatore J. Zambri, founding partner     

Georgetown University Hospital's lab for genetic analysis for breast cancer has closed and is being investigated by federal health officials, according to a Washington Post article (8/5/2010). In addition, tissue samples have been sent to an independent  lab for retesting.  "Federal officials are continuing to investigate the employee's allegations, according to an official with the Centers for Medicare and Medicaid Services, the federal agency in charge of overseeing the quality of testing in medical laboratories." According to the formal complaint filed with the Centers for Medicare and Medicaid Services, there was concern that retesting was taking too long and that the hospital was not sharing the problem with patients. The eleven-month testing period in question began in May, 2009 and involved quality-control testing for HER2, a gene that causes breast tumors more likely to spread or return.

I urge anyone who was tested at Georgetown's lab during the past year to contact their personal physician to determine whether she should be retested.  Experts indicate that treatment should begin within twelve months of diagnosis.

If you have any questions about your legal rights, feel free to contact me at 202-822-1899.

Do you have any questions about this post?

Continue Reading Posted In Cancer Misdiagnosis , Medical Malpractice , Patient Safety , Women's Health Issues
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More Hospitals Found To Overdose Patients With Brain Scan Radiation

Posted by: Salvatore J. Zambri, founding partner     

The Los Angeles Times (8/3, Zarembo) reports, "Los Angeles County-USC Medical Center and Bakersfield Memorial Hospital are the latest additions to a list of California hospitals where [radiation] overdoses occurred during CT brain perfusion scans." According to officials at both facilities, the scanners had been "programmed...according to the manufacturer's specifications." The hospitals, however, "are unlikely to be absolved of responsibility," as "LA County health officials who investigated the County-USC overdoses concluded that the technologists were not paying attention to dose levels during the scans." Meanwhile, "Toshiba issued a statement Monday saying it 'cannot comment on specific cases' because of an investigation underway by the US Food and Drug Administration," adding, "We continue to work with all of our customers to educate them on the dose reduction technologies that we provide on our CT systems."

As more and more hospitals are found to overdose patients with radiation, doctors and health-care providers must be even more diligent to ensure patients are not put at risk.  The consequences of over-radiation can be horrific, even life-threatening.

I represent patients who have been injured as a result of medical errors every day.  The medical mistakes should never happen if reasonable standards are followed.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.
 


 

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Studies Prove Poor Supervision of Resident Doctors Leads To Medical Errors

Posted by: Salvatore J. Zambri, founding partner     

The Dallas Morning News (8/1, Dunklin, Ambrose) reported that "national medical research increasingly supports the long-held concern that poor supervision of doctors-in-training at teaching hospitals contributes to patient harm, even death." Two months ago, a study led by University of California-San Diego researchers "reported a 10 percent increase nationally in medication errors that killed patients during the month of July, the traditional start date for new residents." A 2008 report by the Institute of Medicine "urged that residency programs have 'measurable standards,' such as when and how residents consult faculty doctors." This summer, the Accreditation Council for Graduate Medical Education proposed "updated guidelines that are to be refined before adoption next year."

I hope meaningful changes are made soon regarding the manner in which residents are supervised.  I recognize the importance of training residents, but giving them too much independence too soon threatens patient safety, leading to terrible medical problems.  I represent many people who were severely injured as a result of unsupervised medical care.  Proper supervision would likely have lead to appropriate medical care.  Instead, the people I represent will have to endure a lifetime of physical and emotional anguish.

 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Pediatrics , Public Health , Women's Health Issues
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Lab Errors May Lead to Tragic Consequences

Posted by: Salvatore J. Zambri, founding partner     

The Boston Globe (8/2, Saltzman) reports that a law suit was filed last week against Beth Israel Deaconess Medical Center on behalf of a patient who underwent "unwarranted" prostate surgery after a hospital pathologist "had mistaken his [biopsy] slides for those of another patient who did have prostate cancer." A separate lawsuit was filed against a private laboratory in Lexington on behalf of another patient "whose situation was the reverse." That specimen, which was analyzed by Strata Pathology Services, came back negative, but eight months later "a second biopsy, examined at a different lab, revealed that he had cancer." These errors show that confusing biopsies can have devastating consequences.

I have represented victims of medical errors for nearly twenty years.  I am still amazed as to how many times laboratories mix biopsies and make other medical errors.  I see first-hand the emotional and physical harm such errors cause.  Labs need to do more to protect against these mistakes--errors that should never happen.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.
 

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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IMA INC To Pay $1.25 Mill Due To Medical Privacy Rights Violations

Posted by: Salvatore J. Zambri, founding partner     

A jury has determined that IMA Inc. violated the privacy rights of a man when it negligently disclosed to credit companies that the man is HIV positive.  The facility filed a suit against the man for non-payment of a bill totaling merely $326.  In doing so, the company revealed to the public that the man suffers from HIV.

It is against the law for medical providers to disclose patient's private health issue without prior consent.  This reckless conduct happens all across this country, causing a great deal of embarrassment and shame.  It needs to stop.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Radiation Overdoses More Common, Dangerous Than Previously Believed

 

Posted by: Salvatore J. Zambri, founding partner     

On its front page, the New York Times (7/31, A1, Bogdanich) reports that cases of radiation overdoses during CT brain perfusion scans, which "began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation." But, "after 10 months, the agency has yet to provide a final report on what it found." Now, "an examination by the New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage," as well as eye damage. The "review also offers insight into the way many of the overdoses occurred."

Before undergoing a CT scan or any radiological procedure, you should speak to your doctor about the pros and cons of the procedure, and I encourage you to question the facility giving the test to be sure the doses of radiation are not excessive.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.


 

Posted In Cancer Misdiagnosis , Men's Health Issues , Patient Safety , Public Health , U.S. Food and Drug Administration Warnings
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DC Nursing Homes: How to Report Abuse or Neglect

Posted by: Catherine Bertram

The District of Columbia Department of Health licenses and certifies health care facilities for compliance with state and federal health and safety standards. Facilities include nursing homes, hospitals, home health agencies, dialysis centers, ambulatory surgical centers, intermediate care facilities for the mentally retarded, and laboratories. The Health Care Facilities Division ("HCFD") is charged with conducting regular on-site surveys to ensure health, safety, sanitation, fire, and quality of care requirements. HCFD identifies deficiencies that may affect state licensure.

The D.C. government publishes a list of nursing home facilities in DC and also has a list of home health agencies in DC.  A family member, friend or even the resident can  file a complaint on line  or can call the DC Hotline 202-442-5833.

Continue Reading Posted In Men's Health Issues , Nursing Home Negligence , Patient Safety , Women's Health Issues
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Exposure To Evamist Dangerous For Children And Pets

Posted by: Salvatore J. Zambri, founding partner     

The FDA has warned that "inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product."

According to the announcement, the FDA has received several post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years during the period July 2007 through June 2010. "Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling."

Please keep your children and pets away from the drug. If you have experienced any adverse side effects from the use of Evamist, please contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Glaxo to Pay $1 Billion to Children with Birth Defects from Mothers who took Paxil

                                                                       

By Catherine Bertram

Bloomberg News reported that GlaxoSmithKline P.L.C.  has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil.  The medication has been in use in the U.S. since 1992.   Paxil generated about $793 million in sales in 2009 alone which was about 1.8 percent of Glaxo’s total revenue.  Glaxo reported U.S. sales exceeding $11 billion since 1997. 

Not all of the pending birth defect cases are resolved, according to the report, about  100 Paxil claims are not included in this settlement.   Glaxo confirmed that it settled some Paxil cases citing the reason as avoiding costs and uncertainties of litigation, but would not comment on the terms of the settlement.  A Philadelphia jury awarded a 3 year old boy $2.5 million finding that Paxil caused severe heart defects in a trial in October of last year.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital.  Ms. Bertram is a member of the bar for the U.S. Supreme Court.  She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted In Medications , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Drinking Miracle Mineral Solution (MMS) Can Cause Serious Harm

Posted by: Salvatore J. Zambri, founding partner     

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

According to the FDA's website, "The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away."

MMS claims to treat many illnesses and disease, including HIV,  the H1N1 flu virus, common colds, hepatitis, acne, cancer, and other conditions. However, the FDA is not aware of any studies that prove that MMS effectivey treats any of these conditions.

If you have experienced any negative side effects from MMS, please contact your doctor or visit an emergency room as soon as possible.  Do not use the product any longer, and keep it away from others, especially children. Adverse events can be reported to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Bad Doctors - Who is Minding the Store?

 

                                                                                              By Catherine Bertram

An updated annual ranking of state medical boards by the consumer advocacy group Public Citizen reveals widespread discrepancies in both the numbers of disciplinary actions taken against physicians' licenses, and the rates of those disciplinary actions from state to state.  Though the specific numbers have changed again, a pronounced trend of significant discrepancies between individual states has held constant for years.  Unless geography influences a physician's competence, these state-by-state discrepancies point to a dangerously inadequate national system of physician oversight -- one that could conceivably allow dangerous, incompetent physicians to continue to practice medicine by moving from state to state.

The data raises questions about patient safety -- particularly the safety of patients who reside in states with the lowest records of physician discipline.   The same physician would likely be barred from practice in many states with effective systems of physician oversight and accountability, yet that same physician is allowed to continue to practice in some states due to lack of proper oversight.

The data also suggests that many states continue to failure their obligations to protect patients from incompetent or reckless doctors -- doctors who have a pattern of failing to practice safe and responsible medicine -- endangering the lives and health of those who trust them to provide life-saving, quality care.

According to the survey results, the total number of serious disciplinary actions against physicians dropped 17% from 2004, resulting in 553 fewer serious actions overall in 2007 than in 2004.  Given the increasing number of U.S. physicians since 2004, the rate of serious actions actually fell 22%, from 3.72 serious disciplinary actions per 1,000 physicians to 2.92.

South Carolina was the worst state, but out of the 10 lowest-ranking states, 4 have been at the bottom for each of the past five years:  Maryland, Minnesota, South Carolina and Wisconsin.

Ten states have accomplished at least a 10-place improvement in ranking between the 2001-2003 ranking and the 2005- 2007 ranking:  Arkansas, Delaware, Hawaii, Illinois, Maine, Nebraska, Rhode Island,  Tennessee, Vermont and the District of Columbia (DC improved from 42nd to 22nd). 

Annual rankings are based on data gleaned from the Federation of State Medical Boards (FSMB), specifically regarding the number of disciplinary actions taken against doctors in 2007.  Public Citizen calculated the rate of serious disciplinary actions (revocations, surrenders, suspensions and probation/restrictions) per 1,000 doctors in each state.

Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

Continue Reading Posted In Patient Safety
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St. Louis Hospital Investigated For Safety Lapses

Posted by: Salvatore J. Zambri, founding partner     

According to the St. Louis Post-Dispatch (7/30, Wagman), US Rep. Russ Carnahan (D-MO) "has announced two fresh investigations into the use of improperly sterilized medical equipment" at the Cochran Veterans Affairs "hospital in midtown St. Louis." The article also states that "the General Accounting Office -- a watchdog agency that takes its orders from Capitol Hill -- will include Cochran into an existing investigation focused the processing of reusable medical equipment at several VA hospitals around the country."

The use of unsanitary medical devices and equipment can cause patients to suffer a host of serious medical conditions, including hepatitis and MRSA infections.  There is simply no excuse for failing to utilize sterile equipment while treating patients. 

I have represented many people over the past two decades who has been seriously injured and killed due to the misuse of unsanitary equipment and medical products at hospitals.  Let's hope these nationwide investigations compel, if not force, medical providers to safely treat patients as we go forward.

 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Public Health , Women's Health Issues
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Shoulder Pain Pumps Destroy Shoulder Joints

Posted by Catherine Bertram   

   
Recognized medical studies show that pain pumps that inject pain medicine right into shoulder joints after surgical procedures are a very likely cause of severe cartilage damage.  The FDA, in November 2009 and again in February 2010 issued a warning about this device.  At the heart of the shoulder pain pump litigation is the fact that continuous infusion pumps were not approved by the FDA for this use.   The pain medication essentially eats away the cartilage in the shoulder joint which is critical to allowing the shoulder to move smoothly without pain and grinding.   The research shows that this permanent injury occurs when an intra-articular pain pump catheter is inserted into the shoulder joint by the surgeon in an effort to reduce the patient's pain, usually after a shoulder surgery.  The catheter then pumps pain medication right into that key joint for several days.    The medical studies show the damage can be inflicted in 2-3 days.  This is a permanent injury and is extremely painful and limiting for the patient. Symptoms include increased pain and stiffness, a clicking or popping or grinding in the shoulder and less motion and loss of strength.  The condition is known as Postarthroscopic Glenohumeral Chrondrolysis (PAGCL).

If you or a family member has this condition and a pain pump was used you may want to consider having the records reviewed and the matter investigated. 
                                                                                       

Continue Reading Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Whistleblower Suits Likely To Increase Given Healthcare Reform

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Bass) reported, "Federal fraud cases begun by private citizens against drugmakers, insurers and hospitals will probably surge . . .driven by incentives in the new health law." The "health overhaul makes it easier for citizens to be rewarded for uncovering swindles" and reduces the time "before medical providers can be accused of withholding overpayments from Medicare and Medicaid."

Whistleblower actions empower private citizens to come forward and stop companies from breaking the law.  These courageous citizens are protected by the law and may be entitled to compensation for their efforts that, in end, make our communities safer.

My firm accepts whistleblower cases, and if you have any questions about these cases, please do not hesitate to contact me.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , Women's Health Issues
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Families of Nearly 3,500 Deceased Vioxx Users Receive Payments From Merck

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Voreacos, Johnson) reports "Merck & Co. paid claims to the families of 3,468 users of its Vioxx painkiller who died of heart attacks or strokes," a court-appointed administrator told a judge Tuesday. "A $4.85 billion settlement fund made payments to the families of 2,878 Vioxx users who died of heart attacks and 590 who died of strokes," according to the report. Merck "pulled Vioxx from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes."

Well, it is nice to see families of victims obtain justice, but it is nevertheless a shame that so many lives had to have been lost before the dangerous drug was pulled from the market.  Hopefully, the tragic results regarding Vioxx will compel drug companies to focus on safety above profits in the future.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Columbia University brain lab injected impure drugs into study patients

                                                                                 

By Catherine D. Bertram

The New York Times reported that Columbia University has closed the research arm of its Kreitchman PET Center, a prominent brain-imaging clinic, after the U.S. Food & Drug Administration found in 2008 and January 2010 that the Center had injected patients with drugs containing high impurity levels.  Lab staffers are accused of falsifying records to hide the improper injections from auditors. 

A positron emission tomography, or PET, scan requires the patient to be injected with radioactive drugs, which move through the brain and allow the PET scan to build a three-dimensional model of the brain.  But the drugs have a short shelf life, and the FDA regulates them to keep patients safe.  The impurities could have been especially damaging to the Center's patients, many of whom were schizophrenic or depressed.  Columbia's own investigation apparently did not find evidence of harm to any patients.

Continue Reading Posted In Patient Safety
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Our tax dollars to study "tort reform" - What about patient safety?

                                                                                      

                                                                                                 By Catherine D. Bertram

Massachusetts obtained a $3 million grant to study "alternatives" to a consumer's 7th Amendment right to a jury trial when it comes medical malpractice claims.  The grant is part of a U.S. Department of Health and Human Services program to investigate ways to improve compensation for people injured by medical errors and has a secondarily identified goal of  lowering malpractice insurance premiums.

One of the grant's goals is to "ensure that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits."    We can save significant tax payer funds and save many lives by doing what the Institute of Medicine suggested more than 10 years ago, in the 1999 report called "To Err Is Human" -- focus on patient safety and preventing patient injuries during the delivery of health care.   Please leave consumers' constitutional rights alone.  For  more than 10 years it has been common knowledge that 98,000 patients die year year from preventable errors during the delivery of health care.  This study does nothing to reduce that shocking statistic.   That is the correct goal and the only goal that will result in less harm and less need to compensate consumers who have been injured due to the fault of others. 

It sounds great to talk about reducing frivolous lawsuits, but as tax payers and patients what we need to ask is where is the data that demonstrates there are "frivolous" medical malpractice claims being filed and more importantly, where is the evidence that such meritless cases result in significant awards that are paid?  

There are procedural requirements in place that safeguard against consumers filing cases without expert support.   In Maryland and Virginia, consumers and their lawyers have to have written reports from qualified medical experts in hand before pursuing a medical malpractice claim.  In the District of Columbia, the injured consumer is required by law to send a detailed notice letter to the heath care provider outlining the claim before the lawsuit can even be filed.  

Putting laws in place to limit damages simply shifts the burden of paying for a lifetime of care away from the wrongdoer and back onto the U.S. tax payer.  It does nothing to try to make health care safer.  What it does is protect insurance companies from paying out legitimate claims after a jury has determined that the patient was entitled to compensation to balance the harms done.   That patient is still permanently injured and in most circumstances cannot work.  That patient still needs a lifetime of care.  Who pays for that care?  We do and we have still done nothing to reduce these claims and make health care safer.   How tragic.

Continue Reading Posted In Men's Health Issues , Patient Safety , Pediatrics , Tort Reform , Women's Health Issues
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Are Hospitals Safe?

Posted by: Salvatore J. Zambri, founding partner     

Carol Diemert, a nursing practice specialist, and Carrie Mortrud, a governmental affairs and public policy specialist with the Minnesota Nurses Association, write in a Minneapolis Star Tribune (7/27) commentary, "Inside the walls of Twin Cities acute care hospitals, all is not as healthy as the public relations flacks would have you believe," and "their own consultants have issued a report that substantiates the internal turmoil nurses describe." They argue that "hospitals aren't as safe as they claim because they collect incomplete data, allowing them to be opaque about the realities nurses witness." Diemert and Mortrud say that "hospitals...need to be regulated regarding appropriate staffing," and conclude that the current system "operates on the backs of nurses' professional ethics, valuing profit over care, seriously challenging every nurse's core value of caring for patients in a safe environment."

These sentiments are shared by nurses and health-care providers throughout the country.  Until our medical system puts patients over profits, medical errors will continue to kill and severely injure hundreds of thousands of people each year.  The deaths, alone, caused by medical errors amount to nearly 100,000, according to the Institute of Medicine.  This trend must end.

 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Pediatrics , Public Health , Tort Reform , Women's Health Issues
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Zinc nasal gels could cause some patients to lose sense of smell.

Posted by: Salvatore J. Zambri, founding partner     

The New York Times (7/26, D6, Rabin) reports "a new analysis has concluded that controversial zinc nasal gel products can cause some patients to lose their sense of smell," according to a study in the Archives of Otolaryngology - Head & Neck Surgery. There is no danger "from taking zinc gluconate orally" but that "when sniffed through the nose it can burn olfactory tissue." The FDA "last year warned consumers to stop using Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs," popular "homeopathic remedies that contain zinc." Arizona-based Matrixx Initiatives, which markets them, "has denied the zinc gels cause anosmia and called the conclusions 'scientifically unfounded and misleading.'"

It seems to me that we all should heed the FDA warning.  As with any drug, do not take the zinc gels without first speaking with your doctor.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Medications , Men's Health Issues , Patient Safety , Pediatrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Attorney says civil remedies drive product safety improvements.

Posted by: Salvatore J. Zambri, founding partner     

In a column in the Asian Journal (7/24), Atty. C. Joe Sayas, Jr. wrote, "Legal remedies protect the lowly consumer against big companies who put profits over the public good. The factual history of the American civil justice system shows how the courage of these consumers and their attorneys who waged these legal fights...advanced the cause of product safety." Sayas presents several product safety "cases compiled by the American Association for Justice," commenting "it is difficult to imagine how these safety changes could have been made if the manufacturers of these products were not held accountable in our civil courts."

Thomas Jefferson said to Thomas Paine in 1789, "I consider trial by jury the only anchor ever yet imagined by man, by which a government can be held to the principles of its constitution."  He recognized that access to the court system was needed, too, in order to hold private entities accountable for the harms they commit to people.  I am very lucky to be part of a profession that  gives a voice to people who otherwise could not be heard.

 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted In Men's Health Issues , Patient Safety , Public Health , Tort Reform , Women's Health Issues
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DUI for Prescription Drugs

A recent report from the New York Times reveals that some patients are being arrested for driving under the influence (DUI) after taking medications that have been prescribed to them. What has been surprising to most is that a DUI can be issued to a driver who is impaired from any substance while operating any vehicle such as a car, boat, or bicycle.

Statistics relating to impaired driving don't breakout the causes, so it is not known how many drivers, arrested for DUI, are actually impaired from prescription drugs or from alcohol. To avoid this potential problem, it is recommended that patients talk to their doctor, follow the directions on their prescription, and inquire about any possible interaction between medications.

 

Posted In Medications
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AAJ Fights Back Against Chamber's Mission to Limit Access To Justice

Posted by: Salvatore J. Zambri, founding partner     


The BLT: Blog of Legal Times (7/23, Levine) reported, "Legal groups have been in the thick of legislative fights to overhaul the financial regulatory system and change liability laws in the wake of the oil spill, though their lobbying spending varies widely. Disclosure reports filed this week show the US Chamber's Institute for Legal Reform spent $3.75 million and the trial lawyers' group, the American Association for Justice, spent $1 million, lobbying on dozens of proposals in the second quarter of the year." Linda Lipsen, "the chief executive officer and lead lobbyist for AAJ, said the group is now focused on legislation related to the oil spill. 'I think that right now, our attention is on what's going on in the Gulf Coast, and making sure that victims of the disaster emanating from the oil spill are fully compensated,' she said.

The Chamber has a history of spending a tremendous amount of money in an effort to limit people's access to justice to pad the profits of corporate executives.  The good, decent, honest corporate executives deserve the salaries they earn, but no laws should be made to augment those profits to the detriment of community safety and justice.

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About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 
 

Posted In Men's Health Issues , Patient Safety , Public Health , Tort Reform , Women's Health Issues
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Defective Circumcision Equipment Permanently Impairs Young Man

                                                                                                   

By Catherine D. Bertram

A jury in Florida issued a decision last week that, L.G., a Florida infant, was entitled to judgment against Mogen Circumcision Instruments, manufacturer of the popular Mogen clamp.  The device severed the glans of the infant's penis during a routine circumcision causing permanent and severe medical complications for this young child.

The company had previously stated that such an injury was impossible, but the journal Pediatrics, published by the American Academy of Pediatrics, published a 1996 case study detailing a similar injury.  Fortunately, in that case, a skilled urologist was able to reattach the approximately 2mm of glans.  In 2000, the FDA issued a warning about Mogen clamps causing similar injuries under certain circumstances.

Tragically, Mogen appears to be going out of business, and these severely injured young patients and their families may have no way to collect the funds they are owed for a lifetime of future care needs.

We have experience with similar cases at RZL, sometimes the injury is a result of defective equipment and other times it is a result of mistakes by the surgeon or physician performing the circumcisions.  These preventable errors cause a lifetime of hardship for these young boys.

Continue Reading Posted In Medical Malpractice
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FDA Recall: CONSTELLATION Vision System

CONSTELLATION Vision System is a microsurgical system used to perform various eye surgeries.  This system was recently recalled by the Food and Drug Administration (FDA) due to software and hardware problems associated with:

  • unplanned shutdowns
  • error messages
  • touchscreen malfunctions
  • system setting and infusion performance problems

The FDA warns that these issues may cause eye injuries, including blindness.

The devices recalled were manufactured from September 1, 2008 through April 30, 2010.  The FDA's recall notice includes specific model numbers affected by the recall.

It is recommended that any adverse events or side effects related to this product be reported to the FDA's reporting program.

Posted In U.S. Food and Drug Administration Warnings
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Is Patient Safety Really ACOG's Priority? ACOG relaxes guidelines for VBAC

By Catherine Bertram

                                                                                                             

The American Congress of Obstetricians and Gynecologists has issued revised guidelines regarding when to offer a woman a vaginal birth when she had previously delivered a baby via cesarean section, or VBAC.  Nationally, less than one in ten women undergo VBAC; the rest undergo an elective c-section.  While the revised guidelines require the physician to discuss each procedure's risks and benefits with the patient, there are subtle changes in the wording of the guidelines that patients will not notice that could impact the safety of the mother and baby.

The ACOG guideline states as follows in part:  "Women and their physicians may still make a plan for a TOLAC in situations where there may not be "immediately available" staff to handle emergencies, but it requires a thorough discussion of the local health care system, the available resources, and the potential for incremental risk. 'It is absolutely critical that a woman and her physician discuss VBAC early in the prenatal care period so that logistical plans can be made well in advance,' said Dr. Grobman. And those hospitals that lack "immediately available" staff should develop a clear process for gathering them quickly..."

VBAC carries a recognized but rare risk of uterine rupture which is a serious complication for the mother and the child.   Uterine rupture requires emergency surgery and can  threaten the life of the mother and the child.  ACOG previously recommended that VBAC only occur in hospitals with emergency anesthesiologists and surgeons immediately available to deal with uterine rupture.  In this revised guideline the language has changed, but what about the risks for the mother and the baby?  Have those changed or is this relaxed new guideline a result of pressure on hospital and physicians to allow this procedure to be performed in hospitals where trained anesthesiologists and surgeons are not physically present in the hospital.   Are parents being told about this subtle but important change? How soon can the anesthesiologist get to the hospital?  Minutes matter for both baby and mother in these rare but extremely serious circumstances.

ACOG attributes this to "the onerous medical liability climate for ob-gyns".   There is only a claim for liability when a mother or baby are injured due to the negligence of the physician or hospital staff.   In fact, if a physician adequately explains the risk of uterine rupture in VBAC including the alternatives and her delivery is appropriately managed then the physician is not liable for any uterine rupture that is beyond his or her control. What this new relaxed guideline does is tries to allow hospitals without anesthesiologists and surgeons in the hospital at all times to perform VBAC.  The question is whether families understand the risk that this provides and whether they are being allowed to choose to go where surgeons and anesthesia teams are readily available in the hospital.  The goal of ACOG should be to educate physicians about when VBAC is clinically appropriate and also teach them how to counsel patients about their options.  Of course parents should be completely informed of their options and the risks associated with those options, including whether the anesthesiologist and surgeon are immediately available.  All of the risks need to be discussed with the patient or they have not been provided a fair chance to make the best choice for their family.  Even if that means the safest choice for baby and mom is to deliver at another hospital. 

Continue Reading Posted In Obstetrics , Tort Reform , Women's Health Issues
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FDA to Conduct Formal Safety Review of ARBs

Posted by: Salvatore J. Zambri, founding partner     


The New Jersey Star-Ledger (7/16, Todd) reports that spurred by a "recently published study," the "Food and Drug Administration is investigating whether some of the most commonly used blood pressure medicines may increase the risks of cancer."

According to the report, the "agency said it began a review of a class of drugs known as angiotensin receptor blockers after a recently published study suggested the medicines could be associated with a slight increased risk of cancer, according to a notice posted on the FDA’s website."

The group of drugs under concern include some of the top-selling blood pressure drugs, such as  Cozaar, which is manufactured by Merck, and Avapro, a Bristol-Myers Squibb drug.

Before taking any medication, please speak with your doctor, who is obligated to inform you of all risks and benefits of the drug prescribes so you can make the best--most informed--decision about your health.

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