Posted by: Salvatore J. Zambri, Esquire

Doctors fail to report clinically significant findings to their patients in more than seven percent (7%) of the cases, according to the Associated Press, relying on a new study published Monday in the Archives of Internal Medicine.  Physicians' use of electronic medical records tended to lower instances of failures to inform.  The frequency of errors is higher in practices that used a combination of electronic and paper records, as opposed to practices that relied on only paper or only electronic records, reports Nicholas Bakalar of the New York Times.    

We encourage doctors to utilize the electronic technology now available to better communicate with patients and other physicians regarding a patient's symptoms and conditions.  Reckless record-keeping leads to needless deaths and injuries.  There is a crisis in this country--too many Americans die each year as a result of hospital and doctor errors.  Nearly 100,000 people die every year as a result of hospital mistakes alone.  Safety needs to be a priority as we move forward.

About the author:

Posted by: Salvatore J. Zambri, Esquire

Shannon Pettypiece reports for Bloomberg that Matrixx Initiatives Inc. announced that it failed to turn over to U.S. regulators about 800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.

According to the report, "Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning 'a surprise,' during a conference call with analysts."

The 800 complaints were unearthed only after the FDA performed a routine inspection found 800 reports of consumer concerns this past May.  William Hemelt, acting president and chief operating officer of Matrixx, said that he was informed that  his compnay did not need to report the complaints despite a 2007 regulation requiring companies to turn over reports of serious side effects, arguing that the regulation didn't apply. 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA reported that doctors and consumers have linked a permanent loss of smell to the us of the medications.

When companies withhold critically important information it smacks of putting profits over people.  Safety and public health should always be the paramount concern of drug companies. 

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

Posted by: Salvatore J. Zambri, Esquire 

According to a Reuters article, reported by James Pethkoukis, experts have determined that the FDA's approval process needs to be improved to better protect patients from dangerous risks.

At a congressional hearing, Representative Frank Pallone, who chairs a House Energy and Commerce subcommittee, stated, "There is evidence of an approval system that is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety." The article further comments that "Marcia Crosse, healthcare director for the nonpartisan Government Accountability Office, said various shortcomings 'raise concerns' about the FDA's pre-approval reviews and post-approval monitoring 'that are necessary for ensuring the safety and effectiveness of medical devices.'"

Although Americans benefit greatly from new products, the FDA must do more to protect those who will be using the products in the end--the patients. Without serious oversight, great harm can result.

Our firm has experience pursing cases for patients that involve tragic medication errors, pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability  authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact Mr. Zambri at 202-822-1899.

 By Catherine D. Bertram, Esquire

According to an article by Lisa Rein in the Washington Post,  Doctors Community Hospital, in Lanham, Maryland was recently fined by Maryland Department of Health officials for failing to notify them, as required by state law,  that one patient recently died and at least seven others suffered serious injuries last year as a result of mistakes by the hospital's medical staff.

According to Ms. Rein's article, "Doctors Community Hospital paid the $30,000 fine last month for violating a Maryland law that requires hospitals to report serious medical errors. State officials agreed to reduce a proposed penalty of $95,000 as long as the hospital uses the remaining $65,000 to develop a patient safety program."

"We expect errors to occur," said Wendy Kronmiller, director of the state Office of Health Care Quality. "But we expect systems in place to catch them. What we found at Doctors is that the systems essentially didn't exist."

The Hospital Administration acknowledged their failure to comply with the law and promised to "sharpen the hospital's focus on patient safety."

"Our biggest challenge is making sure that someone is stepping back and saying, 'This isn't acceptable. I'm going to focus on dealing with this issue,' " Scott Gregerson, the hospital's vice president for strategy, said Friday. "Everybody in the institution needs a fundamental understanding of what is an error and what are the state's expectations for reporting."

By Victor E. Long, Esq.

Osteopenia sounds serious -- but is it?  Technically, osteopenia is not in and of itself a disease, as osteoporosis is. Instead, osteopenia is an indication that your bone mineral density is below the statistical norm and that you could eventually develop osteoporosis or be at risk of a future fracture.

On one hand, treating osteopenia sounds logical. Osteoporosis doesn’t develop overnight, out of the blue; surely, a person with the disease was osteopenic at some point along the line. However, just because you have osteopenia doesn’t mean that you’re absolutely guaranteed to develop osteoporosis, nor are you fated to have a serious fracture. Thus, taking bisphosphonates or other bone-building medications for your osteopenia means that you might be treated for a condition you never would have developed even if left untreated.

As a result, many experts argue that most people with osteopenia don’t need treatment, that blanket prescribing of bone-building drugs for osteopenia is more about alleviating anxiety than actually preventing fractures -- and that such a strategy makes no sense when drug costs and potential side effects are taken into account. Instead, the general consensus is in favor of selective, targeted treatment for osteopenia.

Some of Medtronic's pacemakers have been recalled because wires connecting the electronic circuit to other components could separate — potentially leading to serious injury or death.

The class 1 recall, the agency's most serious type, affects more than 21,000 Kappa (600/700/900 Series) and Sigma (100/200/300 Series) pacemakers. Most were implanted at least 5 years ago.

We have reproduced the FDA Press Release in its entirety:
FDA NEWS RELEASE

For Immediate Release: June 11, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Alerts Patients to Medtronic Pacemaker Recall

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

For more information:
Consumer article

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Recently, MedPage Today reported that "The FDA issued an alert regarding the risk of increased mortality in stable liver transplant patients who switch from a calcineurin inhibitor-based (CNI) immunosuppressive regimen to sirolimus (Rapamune)."  It was noted, however, "that a causal relationship has not been established and that" the FDA "is not recommending discontinuation of the drug, which is indicated for prevention of organ rejection in kidney transplant recipients older than 12."

The label for the drug "already carries a boxed warning of excess mortality and graft loss associated with the use of" sirolimus "in combination with tacrolimus (Prograf) in de novo liver and lung transplant recipients."  And it also warns that it is not clear that the drug is safe for liver or lung transplant patients.  Doctors, therefore, should heed those warnings, comments the FDA.  Prescribing medication in a way that is contrary to the labeling may lead to serious permanent injury or death.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

Recent budget cuts have caused many hospitals to reduce infection control measures, according to a recent survey by the Association for Professionals in Infection Control and Epidemiology (APIC).  The "2009 APIC Economic Survey" found that over 40% of the 2,000 infection preventionists who responded reported reductions in budgets for infection prevention during the last 18 months. 

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Medical News Today recently reported that a certain kind of cholesterol--known as lipoprotein (a)--may increase the risk of heart attack (medically referred to as myocardial infarction, or MI).  This type of cholesterol, says the article, has been screened little.  Historically, doctors ahve been screening patients for low-denisty lipoproteins, commonly called "bad protein".  Nevertheless, MI has continued to be a leading cause of death.  As a result, scientists have been looking at other caused of heart disease.

The theory about lipoprotein (a) leading to heart disease stems from a study of people living in Denmark, who had higher levels of lipoprotein (a) due to genetic reasons, and who were at a higher risk of heart attack.  The article comments that the "researchers suggested that although their findings were strong enough to support the idea that higher levels of lipoprotein (a) due to genetic reasons very probably cause higher risk of heart attack, only randomized clinical trials that show fewer heart attacks occur when lipoprotein (a) is reduced through therapy can prove it."  So, expect more studies.

According to the report, representatives of "the National Heart, Lung and Blood Institute's Framingham Heart Study commented that although Kamstrup and colleagues revealed some 'interesting mechanistic insights' into the biological link between lipoprotein (a) and MI, and put forward evidence that there might be potential benefit in reducing lipoprotein (a) early in life, the 'clinical implications are quite limited.'"

Before taking any medication, we encourage you to seek the advice of competent physicians. 

Our firm has experience pursing cases for patients that involvee tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

The World Health Organization today raised its alert level for swine flu (Influenza A - H1N1)to Phase 6, announcing the first influenza pandemic since 1968 as the virus continued to spread around the globe. WHO considers the overall severity to be moderate, according to the announcement by WHO Director General Manager Margaret Chan.  "We have good reason to believe that this pandemic will be of moderate severity, and we know from experience that severity can vary on many factors from one country to another."

Although the current swine flu strain is not considered especially deadly, its ability to spread rapidly to different communities met WHO's criteria for a pandemic.  The alert is related to the geographic spread of the virus, not its severity.

Member countries received notice ahead of its formal announcement of the Phase 6 alert, recommending that nations not close borders or restrict travel and trade. The advance notice indicated the agency remains "in close dialogue with influenza vaccine manufacturers."

By Victor E. Long, Esq.

Research  is changing the way urologists view enlargements of the prostate, known as benign prostate hypertrophy or  BPH. Recent findings suggest that the condition is more complex than originally thought, and these insights are pointing the way to promising new strategies for diagnosis and treatment.  BPH should be distinguished from prostate cancer which has been the subject of a previous blog on this site.
Until recently, BPH was considered to be a single disease responsible for a variety of lower urinary tract symptoms, ranging from discomfort while urinating to the inability to urinate at all. But a new discovery by Johns Hopkins researchers challenges that view. The Hopkins team, lead by Robert Getzenberg, Ph.D.,  suggest that there may be at least two forms of BPH: one type with mild symptoms that are unlikely to cause urinary tract complications and another, more severe form that can lead to irreversible bladder damage. Knowing which form of BPH a man has at diagnosis could help guide treatment choices. The Team also developed a blood test that detects JM-27 protein found in men with severe symptoms. The JM-27 diagnostic test, if eventually approved by the FDA, could be used to identify men with this highly symptomatic form of the disease early, before there is any damage to the bladder or urinary tract.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The AP recently reported that  "The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon." This warning followed a recent inspection which revealed high levels of disease-causing bacteria in the products.  According to the report, the FDA has said that the findings are "particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases."  Yet, according to the report, some of the bacteria found in the products "can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage," the report comments.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

In recent years, the insurance companies in New York have claimed that there was a crisis in medical malpractice claims which was essentially putting doctors and hospitals out of business.  Were the claims of the insurance companies true?   The answer, according to the federal government claims data, is a resounding "no". 

According to a comprehensive report  based on the federal data,  written by Roberto LoBianco and Bill Mahoney of the N.Y. Public Interest Research Group and Arthur Levin of the Center for Medical Consumers.  When you review the actual data from paid medical malpractice claims it is clear that New York's malpractice system has been remarkable consistent and stable.  In fact, the New York medical malpractice settlement figures since 2006 show that the payouts in these cases have declined since 2006.  Despite claims that doctors were fleeing from New York, the data actually shows that the number of active physicians increased by 20% from 1995 to 2008, even though the state's population grew a mere 6%.

The National Practitioner Data Bank (NPDB) was created by federal law and is managed by the U.S. Department of Health and Human Services.  All medical malpractice insurers are required to report their payments to this data base.   The NPDB public use data file is the only publicly-available comprehensive malpractice database in the country since it includes payments from all insurers across the country.   While the NPDB is prohibited from publically releasing the names of the individual doctors who have paid out on malpractice claims,  it does release aggregated information about those payments.  

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Bloomberg News reports that "Merck & Co. and Schering-Plough Corp. were sued by a Pennsylvania fund for active and retired state employees over claims they misled consumers into paying too much for prescriptions of Zetia [ezetimibe] and Vytorin cholesterol pills."  The Pennsylvania Employees Benefit Trust Fund alleges in a complaint that "the companies have known for years -- and failed to make public -- that Zetia doesn't reduce fatty arterial plaques that can cause heart attacks and strokes."  The reports commenst that two studies last year showed that "the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin." Nevertheless, the companies allegedly withheld the the finding and "used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic," according to the report.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Natalie Fullerton's father feels like he is responsible for the death of his child, but he's not.  After a successful lung transplant, Natalie was thriving.  Her loving father tirelessly cared for her post-surgery, administering medication with the use of syringes.  The syringes, however, were manufactured at a factory owned by a Lake Zurich businessman.  And they were contaminated.  Natalie died.  She was 2 1/2 years old.

The tainted syringes from the plant are now "linked to four deaths and 162 illnesses nationwide, including 22 in Illinois", according to ChicagoTribune.com.  The report comments that "an examination of inspection reports and other documents shows that the U.S. Food and Drug Administration missed several chances to stop the tainted syringes from being used by patients."

According to the article, just three months before the contaminated syringes were shipped (in October 2007), "an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust."  Those plans were either faulty or non-existent, and teh FDA did not follow-up sufficiently it is suggested.

"A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or deaths."

The bacteria on the syringes never should have entered the marketplace.  And, unfortunately, there is plenty of blame to go around.  The owner of the plant is now a fugitive of law.  He fled the country and is trying to evade charges that could land him 95 years on prison.

When dispensing medical devices, medical providers must be sure they are sterilized.  Manufacturers and distributors must do the same.  Natalie may not be the last victim of corporate greed and carelessness, but the FDA must do more to protect Americans of all ages.  That's what we pay them to do.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The American Heart Association/American Stroke Association has established a new guideline, based on European studies,  concerning when a clot-busting drug known as tPA can be given intravenously to stroke victims. Previously, the guideline in America was to provide the drug only within three hours of the onset of symptoms,; otherwise, it could do more harm than good.  This posed a problem to patients who, for one reason or another, could not get to a hospital quickly enough following the start of stroke symptoms.  The new guideline extends the time in which the drug can be administered to four and one-half hours after symptoms begin.

It is important, however, to recognize that the widening of the window does not mean that doctors should act slowly when treating patients with stroke symptoms. The faster the clot in the brain is relieved, thereby restoring normal blood flow, the greater the likelihood of recovery.

The following is the American Stroke Association's list of "warning signs of stroke:

• Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
• Sudden confusion, trouble speaking or understanding
• Sudden trouble seeing in one or both eyes
• Sudden trouble walking, dizziness, loss of balance or coordination
• Sudden, severe headache with no known cause"

If experiencing any of the warning signs of stroke, seek immediate medical attention, as time is of the essence.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to the The Wall Street Journal, staff from the Food and Drug Administration (FDA) indicate that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks." As a result, the FDA is now "considering applications for AstraZeneca PLC's Seroquel [quetiapine] and Eli Lilly and Co.'s Zyprexa [olanzapine] to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer, Inc.'s Geodon [ziprasidone] to treat bipolar disorder in children 10 to 17," comments the report.  In fact, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotic medications, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17."  The report goes on the add that the FDA and the drug-makers announced that "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but also warned that "all had side effects."  These sides effects include "sedation and weight gain."

We encourage our readers to speak with their doctors before taking any medication.  Mixing drugs can be particularly dangerous.  Some drugs pose greater health risks than others.  Relying, too, on what the FDA reports and what the drug-makers themselves state about their own medications may not be sufficient.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An U.S. Department of Health and Human Services (HHS) report confirms that, two days ago, the U.S. Food and Drug Administration (FDA) "warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease."  Citing the FDA, HHS reports that: "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

Graves' disease is an autoimmune disorder which causes the thyroid gland to be overactive. The thyroid gland releases hormones that regulate the rate of the body’s metabolism.  These hormones "are critical for body temperature control, energy, weight, mood, and blood calcium levels."

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Last year on the DC Metro Area Medical Malpractice Law Blog, we reported that there was a 200% increase in the rate of Clostridium difficile (C. Diff.) infections among U.S. hospital patients.

A new study published in this month's American Journal of Infection Control suggests that the problem may be even worse than previously thought.

"The study, which involved a survey conducted by the Association for Professionals in Infection Control and Epidemiology (APIC), concluded that 13 of 1,000 inpatients were either infected or colonized with the C. difficile bug. That rate is 6.5 to 20 times greater than had been previously estimated, APIC reported.

Given this rate, there are at least 7,178 inpatients with C. difficile in American facilities, with an associated cost of $17.7 to $51.5 million, APIC estimates. And the problem is stubborn: 82 percent of APIC respondents said that the rate of C. difficile infections hadn't decreased over the past three years."

For more information:
- read this APIC press release

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

We recently posted a blog informing our readers that a Bloomberg report announced that  researches have determined that certain antidepressants may increase the recurrence  of breast cancer among women who have already survived the disease.  The study reports that drugs including Prozac, Paxil and Zoloft "significantly decrease the effectiveness of a drug [tamoxifen] used to reduce the chances of breast cancer recurrence". 

A new Bloomberg report of yesterday confirms that "US regulators may warn patients taking tamoxifen, a breast cancer medicine...not to use certain types of antidepressants because they block the tumor-fighting drug's effectiveness." Karen Riley, a spokeswoman for the Food and Drug Administration, commented that the agency is considering "'adding new information to the tamoxifen label to advise women taking the cancer drug against using some antidepressants."

Ms. Riley's comments are welcomed, but action is what is needed.  The public must be warned of the harmful effects of mixing these drugs.  It could be a matter of life and death.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to a recent Bloomberg report, researches have determined that certain antidepressants may increase the recurrence  of breast cancer among women who have already survived the disease.  The study reports that drugs including Prozac, Paxil and Zoloft "significantly decrease the effectiveness of a drug [tamoxifen] used to reduce the chances of breast cancer recurrence", states the article. 

Notably, the study revealed that tumors were more than twice as likely to return after two years in women taking the antidepressants cited above while on the anti-cancer drug tamoxifen, as compared with those taking tamoxifen alone. The research was conducted by Medco Health Solutions Inc., and was presented at a meeting of researchers at the American Society of Clinical Oncology in Orlando.

To read the entire article, please click here.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Washington Post reports that Congress plans to question officials with the Department of Veteran Affairs concerning events that have potentially exposed more than 10,000 former VA patients to blood borne illnesses, including HIV.  The purpose of the U.S. House Committee on Veterans' Affairs' investigation is to determine whether the exposure came from improper medical procedures and, if so, what the VA has done to address the problems.  

To read the entire article, please click here.

Our firm has experience pursing cases for patients that involve tragic medical errors.  If you think you have been injured as a result of medical negligence, we encourage you to read an article regarding medical malpractices cases authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

According to a recent study summarized in the Journal of the American Medical Association, use of acid-suppressive medications is associated with increased risk for hospital-acquired pneumonia.  For this study, researchers examined electronic medical data for nearly 64,000 adults hospitalized at one medical center for at least three days over a four-year period.  About half of the patients were prescribed proton-pump inhibitors or histamine-2-receptor antagonists during their hospital stays.  Their conclusion was that "further scrutiny is warranted regarding inpatient prescribing practices" of acid-suppressive drugs.

Below is an abstract of the research, as it appeared in the Journal of the American Medical Association:

"Authors: Shoshana J. Herzig, MD; Michael D. Howell, MD, MPH; Long H. Ngo, PhD; Edward R. Marcantonio, MD, SM

JAMA. 2009;301(20):2120-2128.

Context: The use of acid-suppressive medication has been steadily increasing, particularly in the inpatient setting, despite lack of an accepted indication in the majority of these patients.

Objective: To examine the association between acid-suppressive medication and hospital-acquired pneumonia.

Design, Setting, and Patients: Prospective pharmacoepidemiologic cohort study. All patients who were admitted to a large, urban, academic medical center in Boston, Massachusetts, from January 2004 through December 2007; at least 18 years of age; and hospitalized for 3 or more days were eligible for inclusion. Admissions with time spent in the intensive care unit were excluded. Acid-suppressive medication use was defined as any order for a proton-pump inhibitor or histamine2 receptor antagonist. Traditional and propensity-matched multivariable logistic regression were used to control for confounders.

Main Outcome Measure: Incidence of hospital-acquired pneumonia, defined via codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), in patients exposed and unexposed to acid-suppressive medication.

Results: The final cohort comprised 63 878 admissions. Acid-suppressive medication was ordered in 52% of admissions and hospital-acquired pneumonia occurred in 2219 admissions (3.5%). The unadjusted incidence of hospital-acquired pneumonia was higher in the group exposed to acid-suppressive medication than in the unexposed group (4.9% vs 2.0%; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.3-2.8). Using multivariable logistic regression, the adjusted OR of hospital-acquired pneumonia in the group exposed to acid-suppressive medication was 1.3 (95% CI, 1.1-1.4). The matched propensity-score analyses yielded identical results. The association was significant for proton-pump inhibitors (OR, 1.3; 95% CI, 1.1-1.4) but not for histamine2 receptor antagonists (OR, 1.2; 95% CI, 0.98-1.4).

Conclusions: In this large, hospital-based pharmacoepidemiologic cohort, acid-suppressive medication use was associated with 30% increased odds of hospital-acquired pneumonia. In subset analyses, statistically significant risk was demonstrated only for proton-pump inhibitor use.

Author Affiliations: Divisions of General Medicine and Primary Care (Drs Herzig, Ngo, and Marcantonio), Pulmonary and Critical Care (Dr Howell), and Gerontology (Dr Marcantonio), Beth Israel Deaconess Medical Center, Boston, Massachusetts; and Harvard Medical School, Boston (Drs Herzig, Howell, Ngo, and Marcantonio)."

As reported in The Lancet, a recently concluded CLOTS (Clots in Legs or Stockings After Stroke) study of patients who were admitted to the hospital following a stroke suggests that guidelines for thigh-length graduated compression stockings may need to be revised.  In general, these stockings have been used to reduce the frequency of DVT (deep venous thrombosis) for patients who have suffered from strokes.  Following is The Lancet summary of the study and its results.

Summary
Background
"Deep vein thrombosis (DVT) and pulmonary embolism are common after stroke. In small trials of patients undergoing surgery, graduated compression stockings (GCS) reduce the risk of DVT. National stroke guidelines extrapolating from these trials recommend their use in patients with stroke despite insufficient evidence. We assessed the effectiveness of thigh-length GCS to reduce DVT after stroke.
Methods
In this outcome-blinded, randomised controlled trial, 2518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centres in the UK, Italy, and Australia. Patients were allocated via a central randomisation system to routine care plus thigh-length GCS (n=1256) or to routine care plus avoidance of GCS (n=1262). A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7—10 days and, when practical, again at 25—30 days after enrolment. The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins. Analyses were by intention to treat. This study is registered, number ISRCTN28163533.
Findings
All patients were included in the analyses. The primary outcome occurred in 126 (10·0%) patients allocated to thigh-length GCS and in 133 (10·5%) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0·5% (95% CI −1·9% to 2·9%). Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5%] vs 16 [1%]; odds ratio 4·18, 95% CI 2·40—7·27).
Interpretation
These data do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results."

By Victor E. Long, Esq.

It is estimated that about 15% of colorectal cancers run in families. For that reason, it's important to know the health history of your immediate family and to tell your children.  People with familial adenomatous polyposis (FAP) develop hundreds of polyps in the colon and rectum. Without treatment, FAP usually leads to colorectal cancer by age 40. Less than 1% of all colorectal cancers are due to this rare form of inherited cancer, which is caused by a change in the APC gene.

Surprising data indicates that despite knowing they are at heightened risk for colorectal cancer, some people with or at risk for FAP fail to follow recommendations for endoscopic screening.  Information regarding colonoscopy, woman's screening protocols and  the availability of an alternative, known as virtual colonoscopy, has been provided in this blog.

The major reason respondents gave for not following up with endoscopic screening was that their healthcare provider had not recommended it.

CNN published an interesting article on the hot topic of health insurance for college graduates.  A college graduate's health insurance often expires within six months of graduation and due to the harsh economy, many graduates are having difficulties finding a job.  CNN reports that "34 percent of college graduates will spend some time uninsured in the year after graduation."   Unfortunately, it appears that "two-thirds of young adults ages 19 to 29 who spent time without insurance coverage in the past year had gone without needed medical care because it cost too much."  

Here are some tips discussed in the article:

1. Know your rights;
2. Consider COBRA;
3. Be wary of short-term policies;
4. Shop around for a policy;
5. Consider graduate school.

 For additional information on this topic, please click here. 

By Victor E. Long, Esq. 

The Maryland Court of Appeals upheld the dismissal of  a case which sought to  draw a link between the  Thimerosal and Autism.   The high court affirmed a ruling, the first in the nation, subjecting the thimerosal/autism link to a  difficult evidentiary test.  The defendant's moved to disqualify five potential experts on the grounds that the experts were not qualified in epidemiology, the study of the distribution of diseases in populations.  The motion led to a ten day evidentiary hearing.  The CDC has concluded that the evidence favors rejection of a causal relationship.  Many vaccines contain thimerosal.

Blackwell et al v. Wyeth ,CA No. 112 Sept. Term 2008 Filed May 7, 2008.

"Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008."

Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice.

We have reproduced the FDA Recall Notice in its entirety for our readers below:

"Date Recall Initiated: April 23, 2009
Product: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003 with serial numbers 3000033364 through 3000038740)  This product was manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
Use: This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.
Recalling Firm: 
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall:  This device may fail to sound an alarm.
Public Contact: Customers may contact the company at 1-888-345-4630.
FDA District:
Philadelphia
FDA Comments: On April 23, 2009, the firm sent a letter to their medical supply companies informing them of the potential problem. The firm requested the companies take the following actions:

• return all units in their inventory
• retrieve and return all units already shipped to patients

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
• Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178

Updated May 18, 2009"

Screening for Syphilis Infection in Pregnancy: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

"Screen all pregnant women for syphilis, preferably at their first prenatal visit, the U.S. Preventive Services Task Force reaffirms in Annals of Internal Medicine. According to one study, almost 15% of U.S. obstetricians/gynecologists do not routinely screen pregnant women for syphilis.

The USPSTF engaged researchers to find published evidence updating its 2004 recommendation. No evidence contradicting the recommendation was found, and a study among women in China found a decrease in congenital syphilis after implementation of a screening program."

As reported by the Annals of Family Medicine, cancer screening frequently yields false positives — with resulting invasive procedures.

Researchers studied nearly 68,500 adults, aged 55 to 74, who underwent up to 14 screenings over 3 years in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Tests included digital rectal examination plus prostate-specific antigen measurement; chest x-ray; flexible sigmoidoscopy; and cancer antigen 125 testing plus transvaginal ultrasound.
Among the findings:

• The risk for having one false positive after four tests was 37% among men and 26% among women; after 14 tests, risks rose to 60% and 49%, respectively.
• The risk for undergoing a false-positive–prompted invasive procedure after four tests was 17% among men and 12% among women; after 14 tests, risks were 28% and 22%, respectively.
• Sigmoidoscopy accounted for the most false positives and related procedures.

The researchers conclude that providers "should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening."

Posted by Jacqueline Colclough, Esquire

As the official beginning of summer approaches with Memorial Day Weekend, The Cancer Institute of New Jersey and other health organizations are undertaking efforts to education the public about skin cancer risks and prevention.

According to the American Cancer Society, over one million people across the United States are currently affected by skin cancer. This year alone, more than 68,700 new cases of melanoma, the most serious of skin cancers, are expected nationally. Precautions such as avoiding sun exposure during midday hours (10 a.m. to 4 p.m.), using sunscreen with a sun protection factor (SPF) of 15 or higher, and avoiding tanning beds and sun lamps are all important measures in the prevention of skin cancer.

Posted by Jacqueline Colclough, Esquire

According to Medical News Today, AdvanDx, a leading provider of advanced molecular diagnostic products, announced that it has received FDA clearance for a diagnostic test to detect Streptococcus agalactiae, commonly known as Group B Strep. The 90 minute test enables rapid and highly sensitive detection of Group B Strep to help detect colonization in pregnant women.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Wall Street Journal (WSJ) reports that an "investigation by Walter Reed Army Medical Center in Washington found 'a number of serious questions' about a study by a former surgeon at the hospital evaluating the use of a bone-growth protein in soldiers with leg fractures."  The product at the center of the study, Infuse, is a bone-growth drug that is widely used in hospitals and by physicians to treat broken bones. The report goes on to state that the former Walter Reed surgeon "forged his purported co-authors' signatures on the study and that the number of injured soldiers differs from the Army's records of its wartime casualties. Hospital officials said the study was based on 'falsified information.'"

WSJ was not the only periodical to challenge the study by Timothy R. Kuklo. The St. Louis Post Dispatch reported that  the surgeon "published a study that reported a bone growth drug sold by Medtronic Inc. had a higher success rate than Walter Reed doctors could verify."  Medtronic has confirmed that he "was a paid consultant, but that Medtronic did not review or finance the study."

If the study was indeed falsified, it woul dbe another example of putting profits over people.  Patients rely on drug and device manufacturers conducting ethical and reliable studies.  Pushing drugs and devices into teh marketplace and disseminating promotional materials that are false or misleading can cause serious and potentially deadly consequences.  

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Elizabeth Cohen, of CNN, authored an interesting article on the difficult task of receiving insurance coverage for a pre-existing condition.  This problem often occurs when a child, who has a serious health condition, becomes too old to be covered by her parent's health plan.  Cohen writes: "According to the Kaiser Family Foundation, 21 percent of people who apply for health insurance on their own get turned down, charged a higher price or offered a plan that excludes coverage for their pre-existing condition."  Cohen lists five tips to obtaining coverage for a pre-existing condition:

1. Become a group of one.
2. If you've been laid off, get COBRA.
3. When you lose your employer-related insurance, apply for new insurance within 63 days.
4. Find out whether your state has a high-risk pool.
5. See whether your professional organization offers group insurance.

For more help in finding insurance when you have a pre-existing condition, you can contact the Cover Me Foundation at 877-678-7631 or Coverage For All at 800-234-1317.

"The National Institutes of Health has launched an initiative called "Rethinking Drinking" to help patients reduce their risk for alcohol-related problems, reports the New York Times. The program offers an interactive website that includes quizzes to assess drinking behaviors and calculators to measure the alcoholic and caloric content of drinks. A booklet for patients is also provided.
The program draws on information from a previously published guide for clinicians."

 Several comments from participants in the focus groups summarize the benefits of the program:

• "Sometimes we do things out of habit and we don't really stop to think about it. This made me think about my choices."
• "It emphasized that drinking is not bad in and of itself—it's how much you're doing it and how it's affecting your life."
• "I thought the strategies for cutting down were really good. It gives you tools to help yourself."

Click here for a copy of the free patient booklet
 

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Dow Jones Newswires  reports that the Food and Drug Administration (FDA) has urged Sanofi-Aventis SA, a drug manufacturer, "to stop distributing certain promotional material for its breast cancer drug, Taxotere [docetaxel], saying the material misleadingly claims the medicine is more effective than proven."  According to the report, the FDA has indicated that "binders with reprinted medical studies claim Sanofi's Taxotere is better than other medicines to treat patients with breast cancer after prior chemotherapy treatments failed," yet the "FDA is unaware of substantial evidence to support these claims."

We encourage our readers to be very careful when reading or listening to promotional materials disseminated by drug companies.  All too often these materials are misleading and are driven by the drug companies' desire to maximize its profits.   We believe that people should be above profits and that promotional materials must be accurate and properly informative.  If profits are put above people, public health will be compromised.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

According to a recent article in the Journal of the American Medical Association, a new limited study questions whether aspirin is actually any better than a placebo in preventing cardiovascular events for patients with peripheral arterial disease.

"Despite being recommended in current guidelines, aspirin seems no better than placebo in preventing cardiovascular events in patients with peripheral arterial disease, according to a JAMA meta-analysis. However, editorialists (and the analysts themselves) question the study's power to detect a true difference.

The analysis included nearly 5300 patients in 18 controlled trials examining the effect of aspirin (some used aspirin plus dipyridamole) versus placebo on the occurrence of cardiovascular events. The primary composite endpoint (nonfatal MI, nonfatal stroke, and cardiovascular death) did not occur significantly less often among drug recipients than among controls. However, treatment was associated with a significant decrease in nonfatal stroke alone.
Both the authors and editorialists point to the lack of data underlying evidence-based guidelines, and they argue for the performance of larger, higher-quality trials."

Click here to read the fee abstract fo the JAMA article.

Elizabeth Landau, of CNN, has published a fascinating article concerning new methods of preventing and treating blindness.  Ms. Landau discusses numerous topics, including, stem cell research as well as technological advancements used to assist persons suffering from blindness.

The article states that "a new study in the Journal of Archives of Ophthalmology shows that a single serving of fish per week is associated with a reduced risk of incident early age-related macular degeneration, a disease that is the leading cause of severe vision loss in people older than 60."  

The article then highlights the interesting advancements in technology which have served to assist persons suffering from blindness.  For instance, blind persons are now able to use speech access software to browse the Internet.   Moreover, some movie theaters are now providing special earpieces that have voice commentary describing what's on screen. In addition, visually impaired individuals can choose to use a device that takes a picture of text, such as a menu, and reads it back.

For more information, please review the entire article. 

The American Civil Liberties Union (ACLU) recently filed a lawsuit stating that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.  The patents are owned by Myriad Genetics and the University of Utah Research Foundation.  The ACLU is arguing that patenting the genes limits valuable research on this important health issue. 

More than 192,000 U.S. women receive breast cancer diagnoses every year, and about 5 to 10 percent of those cases are a hereditary form of the disease, according to the National Cancer Institute. Mutations in BRCA1 and BRCA2 -- short for breast cancer 1 and breast cancer 2 -- are involved in many cases of hereditary breast and ovarian cancers, the institute said.  BRCA1 and BRCA2 are the genes patented by Myriad and others. 

The ACLU states that "Myriad's monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford."

For more information on this topic, please review the following articles published by CNN and the ACLU. 

During the Heart Rhythm Society's Annual Meeting, the first comprehensive guidance on implantable cadioverter defibrillators (ICD) lead performance has been released.  The emphasis of the guidance "promotes confidence, trust and transparency in the surveillance, analysis and reporting of lead performance information."

The press release issued by the Heart Rhythm Society includes the following recommendations for clinicians on various issues:

• Informed consent
• Monitoring of device performance
• Clinical presentation of abnormal lead performance
• Clinical management when abnormal lead performance is suspected
• Special considerations for pediatric patients
• Clinician responsibilities for reporting suspected or definite lead related problems

Reuters News details highlights of the meeting in the following report:

"A cardiologists group called for closer monitoring of the performance of wire leads that connect implanted defibrillators and pacemakers to the heart in the wake of malfunctions that led to patient deaths and product recalls in 2007.

The Heart Rhythm Society, which represents doctors who treat cardiac arrhythmias, issued recommendations on Wednesday at its annual meeting in Boston. Among other things, it called for greater visibility of data collected on product performance.

"The measurement and reporting of lead performance are important for clinical decision making, for setting realistic expectations for patients and physicians, for transparency, and for monitoring and improving performance," said Dr. William Maisel, cardiologist at Beth Israel Deaconess Medical Center and co-chair of the group's task force on lead performance.

The guidelines cover pre-market evaluation and post-market monitoring of the devices, the threshold for action and communication after abnormal lead performance is identified, and clinical recommendations for physicians.

Recommendations include use of remote monitoring and a patient registry as surveillance tools.

The group encouraged the U.S. Food and Drug Administration to provide guidance on when and how manufacturers can legally use terms other than "recall" in their product advisory notifications.

"When lead malfunctions are communicated to physicians, patients and the public, the language should be crafted to avoid unnecessary anxiety or inappropriate interventions," said task force co-chair Dr. Robert Hauser, of the Minneapolis Heart Institute. "For example, the term 'recall' should not be used because it falsely implies that the lead should be removed and returned to the manufacturer."

Medtronic halted sales of its Sprint Fidelis lead in 2007 after five patients died, possibly because their leads had fractured. The company is the largest maker of implantable cardioverter defibrillators, or ICDs, that treat abnormally rapid heartbeats.

Besides the guidelines on performance of the devices, the group also set standards to guide physicians who extract leads from patients when the devices wear down.

Among the recommendations are thresholds for the number of lead removal procedures that doctors should perform in training and on an annual basis.

"There were perceptions that things have changed about lead performance," said Dr. Bruce Wilkoff of the Cleveland Clinic.

"Lead performance, if anything, has improved over the years," he said.

But as the volume of procedures has risen into the millions, Wilkoff said, the risk of failure has increased."

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA), along with manufacturers OSI and Genentech, notified healthcare professionals of new safety information that has been added to the " WARNINGS AND PRECAUTIONS" sections of the prescribing information for Tarceva.  The FDA reports that "[g]astrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva." (emphasis added).  Tarceva has been used to treat patients with certain kinds of lung cancer after at least one prior chemotherapy regimen proved to be unsuccessful.  It has also been prescribed to treat patients with pancreatic cancer.

To read the entire FDA report, please click here.

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Stroke is the third leading cause of death in America. It doesn't have to be that way, though.  Recognizing the early signs of stroke and receiving appropriate treatment in a timely manner is essential.

We encourage our readers to learn and share with family and friends the following main symptoms of stroke as defined by the American Stroke Association:

• "Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
• Sudden confusion, trouble speaking or understanding
• Sudden trouble seeing in one or both eyes
• Sudden trouble walking, dizziness, loss of balance or coordination
• Sudden, severe headache with no known cause"

We also encourage you to be aware of the hospitals in your area that have advanced stroke treatment staff and equipment.  These facilities should have a multi-disciplinary team of physicians, including neurosurgeons and endovascular therapists, ready to promptly treat stroke victims.

Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly treat stroke.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Cholesterol can be a confusing topic to many people.  Cholesterol is a type of fat called a lipid.  The body uses it for many things, such as making new cells. Your liver makes the cholesterol that your body needs. You also get cholesterol from the foods you eat. Your body needs some cholesterol. But if you have too much, it starts to build up in your arteries and can lead to a heart attack or stroke.

A recent article on Health.com sheds light on five popular myths, which are:

1. Americans have the highest cholesterol in the world
2. Eggs are evil
3. Kids can't have high cholesterol
4. Food is heart-healthy if it says "0 mg cholesterol"
   
5. Cholesterol is always a bad thing

For more information on this important issue, please click here. 

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA) reports that Biosite and the FDA have notified medical professionals of a Class 1 recall of the Biosite-brand Triage Cardiac Panel.  This particular panel is a test used by healthcare specialists to diagnose a heart attack (myocardial infarction).  However, according to the FDA, the "use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have."

All Biosite customers must stop using all Biosite-brand Triage Cardiac Panels immediately.  Reliance upon these defective tests can lead to mistreatment of people with otherwise treatable heart conditions.

To read the entire recall, please click here.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

The Women's Health Initiative began a fifteen-year research program in 1991 with a goal of addressing "the most common causes of death, disability and poor quality of life for postmenopausal women - cardiovascular disease, cancer, and osteoporosis."  Two studies included in the hormone trial were the estrogen-plus-progestin study of women with a uterus and the estrogen-alone study of women without a uterus.  The estrogen-plus-progestin portion of the program was halted in 2002, after results indicated an increase in susceptibility to heart attack, stroke, breast cancer and blood clots.

Advice given to patients after the WHI trial ended was for those who were taking hormone therapy  to protect their hearts to stop immediately. Both patients and their doctors began receiving and giving confusing and often conflicting advice.

According to a recent article in the Washington Post, "Once again scientists are sharply divided over whether, and to what degree, hormone therapy should be rehabilitated. In the seven years since the WHI dropped its bombshell, the study's results have been endlessly analyzed, with detractors wondering how a single randomized, controlled trial, even one as mammoth as this, could have negated dozens of observational and epidemiological studies that showed estrogen reduced women's heart disease risk by as much as 50 percent.

"A misunderstanding of the WHI results has turned off so many women and their physicians from hormone therapy," laments Frederick Naftolin, director of reproductive biology research and co-director of menopause medicine at New York University School of Medicine. "And there may be a price to pay. Women may die prematurely from heart disease and suffer unnecessarily from fractures or diabetes because they or their doctors didn't want to consider estrogen."

The newest HRT studies address the timing for initiation of  HRTwo new studies are underway to determine the effect of Hormone Replacement Therapy (HRT) when it begins closer to the onset of menopause.

• The Early Versus Late Intervention Trial With Estradiol study compares the progression of atherosclerosis (hardening of the arteries) when HRT is prescribed for women who recently entered menopause as opposed to those who have been in menopause for more than 10 years.  Findings are expected to be released in 2010.
• The Kronos Early Estrogen Prevention Study focuses on whether a combination of estrogen and progestin prevents or reduces the progression of atherosclerosis.  Results are expected to be released in 2012.

As charming as therapy dogs in hospitals may seem, a new study reveals that they pose risks to patients by carrying and spreading hospital germs, as reported by the New York Times.

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Wall Street Journal reports, "Two Delaware patients died last weekend after taking heparin, a widely used blood thinner made by Baxter International Inc., sparking concerns about a repeat of fatal heparin contamination in 2008." Baxter is quoted in the article as stating that "the heparin involved in the cases of the two patients who died is from North American-derived bulk material supplied by Pfizer Inc. In the heparin deaths last year, the bulk material came from China."  According to the press statements, the FDA has "sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, New York."

According to the Chicago Tribune (5/12, Japsen) the hospital where the incidents occurred, the Beebe Medical Center has suspended the use of heparin. "Adverse reactions were reported in five patients who had problems that included internal bleeding in the brain."  It was reported that the new complications involve premixed intravenous bags of heparin. Last year's problems involved bulk supplies, vials of the medicine and drug-coated medical devices.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Former patients at several Veterans Administration Hospitals have been tested positive for HIV or hepatitis following exposure to dirty medical equipment.  According to a recent report at Chron.com, "[f]ive patients have tested positive for HIV and 33 have tested positive for hepatitis since February, when the VA started notifying more than 11,000 people treated at three VA medical centers to get follow-up blood checks because they could have been exposed to infectious body fluids." The specific VA hospitals involved are located in Miami, Fla., Murfreesboro, Tenn., and Augusta, Ga.

The VA determined last December that its equipment used for colonoscopies and ear, nose and throat procedures "was either not properly cleaned or set up", states the report.  Despite the medical errors, Dr. Jim Bagian, the VA's chief patient safety officer, boldly proclaimed that patients will never be able to prove that they were infected by the tainted equipment, the report comments. Congress is not satisfied with this statement and wants more information.

To read the entire article, please click here.

Senior partner Salvatore Zambri has handled many cases involving patients becoming infected with HIV as a result of medical errors.  There are clear standards that apply to hospitals governing the sterilization of medical devices and products.  If these procedures are not followed, the consequences can be severe.

If you think you have been injured by a defective or unclean device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Subcommittee on Health will hold a hearing tomorrow regarding The Medical Device Safety Act of 2009.   This is an important piece of legislation that should become law.  We encourage our readers to contact their representatives in Congress and urge them to vote in favor of the bill.

The Medical Device Safety Act of 2009 is important for two principal reasons.  First, it will allow every American patient to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products.  It will also prevent the manufacturers of defective devices from receiving total immunity from any claims simply because the devices were previously approved by the Food and Drug Administration (FDA). 

On March 19, 2009, the editors of the New England Journal of Medicine endorsed the Medical Device Safety Act. They stated:

"Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts."

The New York Times has also endorsed the bill.

Medical devices can be extremely dangerous, and the FDA often does a poor job screening defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An editorial from yesterday's New York Times challenges the Food and Drug Administration (FDA) , suggesting that the agency has been too lenient in approving medical devices.  The article notes that a “vaginal sling,” used to control urinary leaks, that was previously sold by the Mentor Corporation,  a company that was acquired by Johnson & Johnson, has caused serious medical problems for many women throughout the country. In one instance, a woman's "surgeon inserted a strip of synthetic mesh — Mentor’s ObTape vaginal sling — under her urethra. It stopped the leakage but soon caused pain and bleeding as pieces of the sling worked their way through her vaginal wall. The woman has had five operations to remove bits of the sling, and another is scheduled."

Last year, the FDA received more than 1,000 reports directly from manufacturers about complications with "vaginal-sling"-like devices, according to the report.  About one-fourth of the complaints concerned "ObTape" specifically.  "The injuries may stem from the fact that far too many medical devices are cleared for sale without undergoing rigorous clinical trials for safety and efficacy."

To read the entire article, please click here.

Medical devices can be extremely dangerous, and the FDA often does a poor job screenign defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. We have reproduced the FDA News Release below in its entirety.

A recent story in the Washington Post highlights the anxiety and insecurity often experienced by families who lose loved ones to eating disorders.  Extreme measures for weight control, serious health problems and sometimes even death may result from untreated or under-treated eating disorders.  Many complex reasons can contribute to eating disorders and many factors contribute to misunderstandings about eating disorders. 

Listed below are several helpful resources for individuals or families dealing with eating disorders. 

• The National Eating Disorder Association information and referral help line: 800-931-2237. Web site: http://www.NationalEatingDisorders.org.
• The Eating Disorder Referral and Information Center: http://www.edreferral.com.
• Something Fishy, a Web site offering information and peer support: http://www.somethingfishy.org.
• The eating disorders program at Johns Hopkins Hospital, Baltimore: 410-955-3863 (outpatient and consultation clinic), 410-501-5467 (inpatient or partial hospitalization programs).

In a recent health blog appearing in the New York Times, seven common sense suggestions are provided.  "Every year, there are 36,000 deaths due to flu, mostly among the elderly, very young children and those with compromised immune systems. In the United States, the new swine flu, officially called A(H1N1), does not appear to be more dangerous than the seasonal flu, but experts are uncertain as to its future course."

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Institute for Safe Medication Practices (ISMP) issued a warning to health care providers that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen.

The warning explains, that "if the vial is accidentally returned to the wrong carton after being used, that sets the stage for a serious insulin mix-up.   That is because the next person looking for a particular insulin product could read the label on the carton, assume that it accurately reflects what is inside, and end up administering the wrong product."

ISMP recommends that the cartons be thrown out, either in the pharmacy before the medication is dispensed, or when at the nursing station. The bottom line? Do not dispense or store insulin vials in their cartons on patient care units.

Medication errors by health care providers and hospital personnel can be life threatening.  In most instances these tragic errors should have been prevented.  If you have questions about a medication error that caused permanent injury or contributed to the death of a patient you speak with an experienced medical malpractice attorney about the circumstances or call us (202 463-3030. 

By Victor E. Long, Esq.

The FDA has issued guidelines on the disposal of prescription drugs.  The Kaiser Family Foundation states that the average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year,

Previously, three federal agencies--the White House Office of National Drug Control Policy, Department of Health and Human Services and Environmental Protection Agency--jointly released new guidelines in February designed to help people safely trash their prescription  drugs.   According to an Enviromental Protection Agency spokesperson  "Flushing medication down the toilet is probably the least desirable of the alternatives," 

In a series of updates, the FDA has now approved updated labeling for antieplietic drugs regarding the suicide risk associated with such drugs. The newest update of May 5, 2009 suggests that all antiepileptic drugs be included in the warning.   We have reproduced the FDA Warnings in their entirety below:

"[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

[December 16, 2008; UPDATED May 05, 2009 - Drug Information Page - FDA]
[January 31, 2008 - Healthcare Professional Information Sheet - FDA]"
 

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA) has found that more than 70 weight-loss products contain prescription drugs, including four illegal drugs that have not approved by the FDA for sale in the United States, according to Public Citizen, citing its Worst Pills, Best Pills News article released last week on WorstPills.org, the organization’s drug safety website.

The FDA has announced what is obvious--that adding active prescription drug ingredients to otherwise ineffective weight-loss supplements is not only illegal, but can be extremely dangerous.  "For instance, sibutramine (brand name Meridia, an appetite suppressant available by prescription only and a controlled substance) and fluoxetine (brand names Prozac and Serafem, an antidepressant available by prescription only) were among the drugs found in the supplements", states Public Citizen. 

Although the FDA is seeking a voluntary recall of the illegal products, some say the FDA is not acting strong enough.  "The FDA’s response has been inadequate,” said Sidney M. Wolfe, M.D., director of Public Citizen’s Health Research Group and acting Public Citizen president. “Some of the drugs found in these supplements are dangerous and are putting people at an unacceptable risk of injury. To protect citizens, the agency needs to go further and seize these products.”

To read the entire article, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by Jacqueline Colclough

Over the years, numerous studies have shown that depression is associated with an increased risk of heart disease, but the nature of this association has never been clear. Researchers at Rush University Medical Center in Chicago have now revealed that depression is linked with the accumulation of visceral fat (fat packed between the waistline and internal organs), which has long been known to increase the risk of cardiovascular disease and diabetes.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have warned the public to be wary of entities selling products through the internet "that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus"--the swine flu.  According to the FDA, many of the products are fraudulently advertised, and officials are going after the perpetrators, who face serious consequences if found guilty of fraud.

“The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies,” said FTC Chairman Jon Leibowitz.  “The FTC will act swiftly against companies that resort to deceptive advertising.”

To read the FDA press release, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

As we draft this post, there has been one death in the US attributed to swine flu. Yet, almost 100,000 patients die from hospital acquired infections in this country every year. The CDC estimates that there are 4.5 hospital infections for every 100 patient admissions.  Deaths from hospital acquired infections in this country are five times higher than deaths from AIDS. 

"About 2 million Americans get hospital-acquired infections every year, says Lisa McGiffert, Austin, Texas-based manager of Consumers Union’s Stop Hospital Infections campaign. Some patients make a full recovery after a simple course of antibiotics and others battle invasive infections for years.  Nationwide, a standard estimate is that hospital infections cost $5 billion to $6 billion a year, she says."

Almost everyone knows someone who has been significantly affected by a hospital infection. You can compare hospitals on the Department of Health and Human Services website and you can also review these data on the Consumer Union's website.

By Victor E. Long, Esq.

Obesity surgery-related complications in the United States declined 21 percent between 2001 and 2006, and payments to hospitals for obesity surgery decreased by as much as 13 percent, partly because there were fewer patient readmissions due to complications, a new study reports.

The findings from a study by the U.S. Agency for Healthcare Research and Quality are based on an analysis of more than 9,500 patients under age 65 who had obesity surgery, also known as bariatric surgery, at 652 hospitals between 2001 and 2002 and between 2005 and 2006.  The study, "Recent Improvements in Bariatric Surgery Outcomes," to be published in the May 2009 Medical Care, found that the complication rate among patients initially hospitalized for bariatric surgery dropped from approximately 24 percent to roughly 15 percent. Much of this was driven by a reduction in the post-surgical infection rate, which plummeted 58 percent. Abdominal hernias, staple leakage, respiratory failure and pneumonia fell by between 50 percent and 29 percent.

A recent article appearing in the Washington Post highlights the struggles faced when medical providers are unable to communicate with their patients.  According to the report, the Washington area has experienced a sharp rise in immigrant population but the addition of language and cultural services has lagged far behind. 

"Many area hospitals have taken steps such as installing phones to connect patients and staff members to interpreters, hiring interpreters or training employees to do the job, and recruiting bilingual staff. But some large physician practices and small primary and specialty care services have not added language or cultural services.

"All providers in this area should . . . have a mechanism to deal with language barriers," said Isabel van Isschot, director of interpretation services at La Clinica del Pueblo in Washington, which supplies interpreters to health facilities. When patients don't have access to an interpreter, she said, "I think that's a form of discrimination."

Hospitals and doctors, however, are wary of the cost of interpretation services, which can run up to $190 an hour; they say the government, not them, should pay these costs.

"Appropriate funding for these services is needed so that patients don't lose access to care," said Joseph M. Heyman, chair of the board of trustees of the American Medical Association, which has asserted in policy statements that "physicians cannot be expected to provide and fund . . . translation services for their patients."

A 45-year-old federal civil rights law requires hospitals and doctors who accept federal funds to offer language services. Some federal funding for interpretation services is available through Medicaid and the Children's Health Insurance Program, state-run programs that serve the poor and children, respectively. But to obtain the money, states have to pitch in some of their own. The District and Virginia have done so; Maryland has not. "

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Approximately 1 in 150 children are diagnosed with autism spectrum disorder (ASD). According to Medical News Today, three studies compared all of the DNA of people with ASD with that of people who do not, and small genetic differences were discovered that impact the manner in which brain cells connect to make the circuitry of a child's brain. The largest of the three studies evaluated the DNA of over 10,000 people, states the report.

These finding suggest that "genetic differences in how cells in the brain link together could influence susceptibility to ASD on a large scale," states the report.  Scientists are now "starting to see genetic pathways in ASD that make sense."

According to the report, scientists plan to do a more extensive genome-wide association study to discover more pieces of the complex ASD genetics puzzle.

To read the entire article, please click here.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

By Victor E. Long, Esq.

Studies show that practices such as meditation or guided imagery and visualization can be calming. Yoga and tai chi also may be helpful. Acupuncture has been shown to provide relief for some kinds of pain. Herbs, such as peppermint and ginger, may help ease the nausea and vomiting associated with chemotherapy. 

 According to a recent study reported in the Journal of Pain and Symptom Management , massage and acupuncture relieved pain and depression in surgery patients more than traditional postoperative care alone.  In the study, both massage and acupuncture were given for 10-30 minutes at the bedsides of 138 people who underwent surgery for intestinal and other cancers. Swedish massage was used along with an acupressure foot massage. Acupuncture was given at points related to the patients' symptoms, which included pain and nausea.

New FTC Staff Report Offers Guidance on Online ‘Negative Option’ Marketing

According to a recent press release by the Federal Trade Commission, two diet supplement marketers violated federal law by offering "free" samples of their products, then debiting consumer credit cards with "negative option" offers.  Below is the FTC report regarding this issue:

"Two dietary supplement marketers that lured consumers on the Internet with allegedly deceptive weight-loss claims and bogus “free” sample offers, and then debited their bank accounts or charged their credit cards for continuing shipments without their consent, have agreed to settle Federal Trade Commission charges that they violated federal law. With the increase in Internet marketing, the FTC staff has issued a report providing guidance for marketers to help them avoid deception in making online “negative option” offers. (With negative option marketing, a company takes a consumer’s silence or failure to cancel as acceptance of the offer and permission to bill them.)

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

For nearly thirty years, in-vitro fertilization (IVF) has been consider relatively safe.  A recent report in the New York Times, however, reports that new epidemiological studies and scientific techniques have revealed findings that suggest that "there may be some abnormal patterns of gene expression associated with IVF and a possible increase in rare but devastating genetic disorders that appear to be directly linked to those unusual gene expression patterns."  The report also states that, with IVF, there "appears to be an increased risk of premature birth and of babies with low birth weight for their gestational age."

To read the entire article, please click here.

If you are considering an IVF procedure, we encourage you to speak with your doctors about all potential risks and benefits, so that you can make fully informed decisions.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The economy is forcing twenty percent (20%) of Americans to delay or avoid needed medical care, according to a recent Thomson Reuters survey. The survey also reports that more than 20% of Americans believe they will have difficulty paying for health insurance or health services over the next three months.

"We are seeing a positive correlation between Americans losing their access to employer-sponsored health insurance and deferral of healthcare," said Gary Pickens, of Reuters' health-care division, who led the study.  "if this trend continues, it will ultimately have an impact on our collective well-being."

To read the entire article, please click here.

If you are having difficulty affording health coverage, we urge you to contact local and state agencies to see if you qualify for Medicaid or other benefits.  Certain private companies, like Walgreens, provide programs for the unemployed and uninsured, as well.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

"The U.S. Food and Drug Administration (FDA) has issued a public health advisory recommending that individuals who use transdermal drug patches that contain aluminum or other metal backing remove these patches before undergoing MRI (magnetic resonance imaging) scans. These patches may cause skin burns during the scan.

Transdermal patches, which contain a time-release dose of medication that is absorbed through the skin and into the blood stream, are used for delivery of several types of drugs; these include nicotine for smoking cessation, estrogen for management of menopausal symptoms, nitroglycerin for angina (chest pain), and several forms of pain medication. Some of these patches contain aluminum and other metals, which are used as backing.

Even though this metal backing is not in contact with the skin, it can overheat during an MRI and cause a painful burn on the patient’s skin. In an effort to avoid such injury, the FDA advises that patches containing metal are removed prior to an MRI and individuals who use transdermal patches look for warning labels about risk of burns. And, because not all patches containing metal currently have warning labels, it’s recommended that any patch containing metal is removed before an MRI scan.

In order to avoid a burn during an MRI scan due to metal backing on a transdermal patch, patients are advised to talk to their physician about removing and discarding the patch before undergoing the scan. Physicians will also advise patients about replacing the patch after the scan. As well, when an MRI is scheduled, patients should notify the facility performing the scan that they use a patch. This will help ensure that the correct procedures are followed to remove the patch before the scan and replace it with a new one following the MRI.

The risk of burning associated with transdermal patches during an MRI is avoidable. By consulting with physicians, being aware of this potential complication, and following correct safety procedures, patients can get the most benefit from transdermal medications and MRIs, safely and comfortably."

Reference: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings [FDA Public Health Advisory]. US Food and Drug Administration Web site.

April 16, 2009.

Recent local outbreaks of measles have prompted health officials to issue immunization and prevention reminders: 

"The virus usually causes a red skin rash, high fever and watery eyes, symptoms that last for about a week. The first symptoms can appear as long as 21 days after exposure. Although most people recover within a week, measles can lead to pneumonia and, in rare cases, can be fatal. Those who suspect that they might have measles are encouraged to call ahead before going to doctors' offices or hospitals to avoid spreading the virus.

Measles cases are uncommon in the United States because vaccinations are required of most schoolchildren and foreign-born individuals who become U.S. citizens. Outbreaks often begin when an unimmunized person visits a country where the disease is still prevalent and then returns with the infection. The virus is usually spread through sneezing and coughing and can remain in the air or on surfaces for two hours. "

Outbreaks continue to occur in high schools (one or two per year) and on college campuses (less than one per year). These educational institutions are potential high-risk areas for measles transmission because of large concentrations of susceptible people.

As the incidence rate of measles declines in the United States, aggressive surveillance becomes increasingly important. Known or suspected measles cases should be reported immediately to local health departments.

Speed in implementing control programs is essential in preventing the spread of measles. Control activities should not be delayed until laboratory results on suspected cases are received. All persons who cannot readily provide 1) a physician-documented history of measles, 2) laboratory evidence of measles immunity or 3) a documented history of vaccination with live measles virus vaccine on or after the first birthday should be vaccinated or excluded from school. Documentation of vaccination should be considered adequate only if the date of vaccination is provided. If a person's measles immunity is in doubt, he/she should be vaccinated."

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to MercuryNews.com, technologists monitoring the threat have determined that hundreds of medical devices used at hospitals throughout the country are infected by the computer worm known as "Conficker".  The infected devices include MRI machines and hundreds, if not thousands, of other medical devices.  Manufacturer of the devices told investigators that "none of the machines were supposed to be connected to the Internet — and yet they were. And because the machines were running an unpatched version of Microsoft's operating system used in embedded devices they were vulnerable," states the report.

The report explains that "Conficker spreads by copying itself onto machines running Microsoft's Windows operating system that lack the security patch from October. Conficker installs itself and periodically reaches out for directions from its maker that cause it to rewrite its code, increasing its capabilities for malicious action and decreasing its chance of detection."  Apparently, patients have not yet been harmed, but it is clear that these infected devices place patients at risk.

To read the entire article, please click here.

Many Americans are injured or killed each year due to defective products.  For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

By Victor E. Long, Esq.

According to Washington Post  the American Cancer Society, finds Virtual Colonoscopy  to be effective at finding large polyps.  Virtual colonoscopy is a procedure used to look for signs of pre-cancerous growths, called polyps; cancer; and other diseases of the large intestine. Images of the large intestine are taken using computerized tomography (CT) or, less often, magnetic resonance imaging (MRI). A computer puts the images together to create an animated, three-dimensional view of the inside of the large intestine.

Invented 16 years ago by a radiologist who got the idea while playing video games on a flight simulator during advanced training at Johns Hopkins, virtual colonoscopy has become an increasingly popular.  However, Medicare has tentatively decided not to pay for virtual colonoscopies.

Posted by Victor E. Long, Esq.

According to a recent study published in the April 2009,  New England Journal of Medicine, although uncontrolled asthma may increase the risk of adverse perinatal outcomes, women with well-controlled asthma in pregnancy generally have good outcomes.  The recommendations in the article are consistent with the guidelines published by the American College of Obstetrics and Gynecology in 2008.

Avoiding allergens and irritants, such as tobacco smoke, that exacerbate asthma can improve maternal well-being and lessen the need for medication. Additional information is available thourh American College.

According to a recent investigation by the Associated Press, "U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water - contamination the federal government has consistently overlooked."

As recently reported in American Medical News, Washington Hospital Center began a pilot program for residents working in the intensive care unit - an ethics checklist.  The program was implemented after a realization that checklists seemed to have helped in surgery and infection control.  "Hospitals implementing the WHO checklist cut deaths after surgery by 46% and surgical complications by 36%.   Director of WHO Safe Surgery Saves Lives initiative recommends integrating ethics issues."  We have reproduced the ethical checklist in its entirety:

Clinical Ethics Patient Assessment

Add relevant ethical issues to progress notes and report on rounds

• Patient's wishes unclear/refusal of treatment
• Questionable capacity to consent to, or refuse, treatment
• Disagreement involving relatives/surrogates/caregivers
• End-of-life (advance directive/power of attorney, do not resuscitate/allow natural death, withdraw/withhold Rx)
• Confidentiality/disclosure issue
• Resource or fairness issue
• Other (please note)
• No notable ethical issues

"FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

Read the complete MedWatch Safety summary including links to the FDA news release, Q&A's and a listing of all products included in this alert."

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Doctors are increasingly practicing medicine in DC, Md, and Va.  This fact flatly rejects the myth that physicians are fleeing because of medical liability concerns.  The new figures from the American Medical Association (AMA) show the number of doctors has risen over the last five years and also outpaced the metropolitan area's population growth.

“The AMA’s own figures show that tort reform is clearly unnecessary, and may actually be detrimental to patient safety," states Salvatore J. Zambri, senior partner at Regan Zambri & Long and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C.  According to a comprehensive study by the American Association for Justice, nationwide, all states saw an increase in doctors; however, the number of physicians per capita (100,000 population) is 13 percent higher in states without caps. In the four states that doctor growth did not outpace population (Georgia, Alaska, Utah and Montana), caps have been passed.  Additionally, a study released in December 2008 from the American College of  Emergency Physicians showed that states with tort reform scored far worse in patient safety.

“Safety improves when patients can hold negligent hospitals or doctors accountable,” said Zambri.  “Tort reform will only help insurance companies that want to hoard more profits while leaving patients less safe.”

Posted by Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The U.S. Agency for Healthcare Research and Quality supported a study of 122 closed malpractice claims by Allen Kachalia, M.D., J.D., Tejal K. Gandhi, M.D., M.P.H., Ann Louise Puopolo, B.S.N., R.N., and others, the results were published in the February 2007 Annals of Emergency Medicine 49(2).  That study has been available for more than two years.   Unfortunately, we continue to see these sames types of errors in the cases we have at Regan Zambri & Long.  As set forth below in the AHRQ summary,  a majority of the ER malpractice cases that were reviewed involve  failure to order appropriate test and consults or failure to perform an adequate examination of the patient. 

According to the government study, "65% of the cases involved missed emergency department (ED) diagnoses that harmed patients. Nearly half (48% ) of these missed diagnoses were associated with serious harm, and 39 percent resulted in death. The leading breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (58 percent of errors), failure to perform an adequate medical history or physical examination (42 percent), incorrect interpretation of a diagnostic test (37 percent), and failure to order an appropriate consultation (33 percent).  The cause of malpractice was complex.  A majority of cases involved multiple breakdowns in the diagnostic process, several contributing factors, and more than one provider. The most common contributing factors were mistakes in judgment (87 percent of missed diagnoses), lack of technical competence or knowledge (58 percent), and lapses in vigilance or memory (41 percent).

These cognitive factors operated alone in one-third of missed diagnoses; in two-thirds of cases other factors also contributed to the missed diagnoses. Other leading contributing factors to missed diagnoses included patient-related factors (34 percent), lack of appropriate ED staff supervision (30 percent), inadequate handoffs of patients to new staffers (24 percent), and excessive workload (23 percent)."

Posted by Jacqueline Colclough

On April 27, 2009, the American Urological Association (AUA) issued new guidelines on prostate cancer screening for men. Contrary to recent advice of other groups, AHA recommends that well informed men aged 40 and over who have a life expectancy of at least 10 years should be offered the prostate-specific antigen (PSA) test in order to establish a baseline reading and that PSA testing should be individualized rather than a blanket annual test for any man aged 50 and over. These guidelines have been issued amid growing recent controversy regarding when men should start regular PSA screening, how often, and at what point a biopsy is indicated.

According to a recent editorial in the NY Times, an alarming one-fifth of all Medicare patients discharged from the hospital end up back in the hospital within 30 days, and fully a third return within 90 days. If this yo-yoing could be greatly reduced, Medicare could save billions of dollars. Many patients would certainly benefit from the better care.

High rates of rehospitalization are partly the fault of the hospitals. The more fundamental problem is the fragmented nature of the American medical system: too often, health-care providers fail to communicate with one another, patients fall between the cracks and no one seems clearly in charge of a patient’s welfare.

A new analysis by three researchers, published in The New England Journal of Medicine, estimated that unplanned rehospitalizations among fee-for-service beneficiaries cost Medicare $17.4 billion in fiscal year 2004, which is a big chunk of the $102.6 billion that Medicare paid hospitals that year.

Most patients were readmitted for problems other than those that led to their original hospitalizations. Surgical patients, for example, were typically readmitted for such medical conditions as pneumonia, heart failure or bacterial infections. Some of these readmissions may have been unavoidable in an elderly, sick population. But many could surely have been prevented through better planning and coordination.

The most disturbing finding was that half of the medical (nonsurgical) patients readmitted within 30 days had not seen a physician for follow-up care after they were discharged. They were apparently left on their own, perhaps with poorly understood instructions from the hospital on how to take care of themselves.

There was also wide variation in readmission rates between hospitals and between states: only 13 percent of patients were readmitted within 30 days in Idaho, compared with 22 percent in Maryland. That suggests that there is plenty of room for improvement. The rates were adjusted to compensate for the severity of patients’ illnesses, so hospitals and states with high readmission rates can’t easily blame caring for sicker patients.

Proposed solutions include better discharge planning by hospitals, more effective education of patients and closer cooperation between hospitals and physicians to ensure follow-up care.

The Obama administration, as part of its ambitious health care reform, has proposed that Medicare use incentives and penalties to encourage hospitals and doctors to cooperate in overseeing care from hospitalization through the first 30 days after discharge. The administration estimates the approach could save $26 billion over 10 years. It is a sound idea that should also improve the lives of patients.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Washington Post reported moments ago that Maryland Governor Martin O'Malley has stated that there are now six "probable" cases of the swine flu in the state.  According to the report, of the six cases, three live in Anne Arundel and three reside in Baltimore County.  Each case is linked to individuals who have traveled out of the country to areas where swine flu has been present, including Mexico and the Caribbean, states the report.

"Maryland officials said they expect there will be additional cases in the state,"  according to the report.  "O'Malley (D) said the state will maintain close contact with local health departments and is working to build a stockpile of anti-viral medication."  So far, there are no reported cases of swine flu in either the District of Columbia or Virginia.

To read the entire article, please click here.

Previously on the DC Medical Malpractice Law Blog, we have posted the following articles:

• Swine Flu Raising More Questions Than Answers While the U.S. Sees Its First Fatality;
• World Health Organization Raises Swine Flu Pandemic Alert to Phase 4
• CDC Provides Swine Flu Questions and Answers.

If you have been in contact with anyone who has traveled to parts of the world where swine flu has been detected, we encourage you to seek a medical evaluation.  Obviously, if you suffer any symptoms associated with swine flu, please seek medical attention immediately.

For information, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Amy S. Gurgle, Esq.

While it is not surprising that language barriers can create problems for doctors communicating with patients, a new study published by the Journal of General Internal Medicine found that "doctors' assumptions about communication -- what they deem important in communication -- may also have a role," according to this article from the New York Times. Also, the study found that resident physicians may underutilize interpreters in the interest of saving time, according to the article.

"The medical profession must take steps to "identify, limit, and manage conflicts of interest," the Institute of Medicine advises in a report issued online.

Among the recommendations:

• Medical institutions should create conflict-of-interest policies that mandate "disclosure and management" of personal and institutional financial ties to industry.
• Investigators should not conduct human trials if they have financial interests in the results.
• Academic medical centers and teaching hospitals should ban faculty from accepting gifts or making presentations managed by industry.
• Physicians should provide free drug samples only to patients without the means to pay for them.
• CME programs should be funded without industry support.

The report concludes: "The public needs to be able to trust that physicians' decisions are not inappropriately influenced by their financial relationships with industry."

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The New York Times reported recently that the Food and Drug Administration (FDA) will conduct a rare meeting to discuss its device division, which is responsible for, among other things, evaluating, monitoring, and regulating medical devices.  According to the report, Dr. Donna-Bea Tillman, the agency's director of device evaluation, called an "all-hands" meeting.  This comes in response to a letter from nine scientists who have written President Obama, charging that some in the agency have acted illegally, exposing the public to harmful, even deadly, products.  

In the letter to President Obama, the scientists claimed that the device center inappropriately approved imaging studies designed to detect breast cancer and also allowed hospitals to wash and reuse device that were designed as single-use products, among other things.  Congress instituted an investigation into the charges. In January, the Government Accountability Office released a report that criticized the device center.

To read the entire Times article, please click here.

We hope that the FDA will seriously evaluate its deficiencies and make the changes that are necessary to protect the public from dangerous devices.

For information about defective devices and your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by Victor E. Long, Esq.

More than 10,000 veterans who were exposed to the endoscopic equipment--which wasn't sterilized properly--are all being tested. The problem would be unpleasant, enough no matter how the three got infected, but what arguably makes it worse is that each were infected at different hospitals, one at a VA facility in Murfreesboro, TN, one at a facility in Augusta, GA, and a third in Miami. Not only that, there have been six positive hepatitis B tests and 19 positive hepatitis C results at the three facilities.

An orthopaedist  who worked in two different hospitals during 25 years in practice before retiring was confronted with three different spikes in acute infections of Total Joint Reconstruction over a 25 year career. In all three episodes, the hospital's response always was that it was a surgeon problem related to my technique (you must be doing something different that is causing your patients' infections, as the hospital has not changed any of its techniques or personnel).

Based on his experience, there are common problems that need to be addressed.

Posted by Jacqueline Colclough

Although often considered a benign disease, acute gastroenteritis remains a major cause of morbidity and mortality in children around the world, accounting for 1.8 million deaths annually in children younger than 5 years, or roughly 17% of all child deaths. Because the severity of the disease can widely vary depending on hydration status, which is greatly impacted by diarrhea and vomiting, accurately assessing and treating dehydration in children presenting with acute gastroenteritis remain a critical skill for every physician. Fortunately, most cases of dehydration in children can be accurately diagnosed by a careful clinical examination and treated with simple, non-invasive measures.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Each year in America there are approximately 16,000 new diagnoses of esphogeal cancer, reports an article in Medical New Today.  Unfortunately, according to the report, only 10% of those diagnosed survive the disease.  The principal reason for this alarming statistic is the lack of early detection.

It is widely recognized that smokers are predisposed to esophageal cancer.  However, as the article points out, there are several other contributing factors, including:

• Excessive alcohol consumption;
• Obesity;
• Lye ingestion; and,
• Gastroesophageal reflux disease (GERD), also known as acid reflux or heartburn.

To read the entire article, please click here.

We encourage our readers to speak with their doctors about their health risks.  Physicians should know to check for illnesses when their patients manifest certain health risks. 

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

 By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

A recent article in the New England Journal of Medicine, reports that despite “a consensus that the use of health information technology should lead to more efficient, safer, and higher-quality care” , less than 2% of U.S. Hospitals have invested in a comprehensive electronic medical record system. The research was funded by the Department of Health and Human Services and the Robert Wood Johnson Foundation.  This study did not include Veterans Affairs (“VA”) Hospitals, which have been using computerized medical records for more than a decade. 

Posted by Patrick M. Regan

The CBS Evening News (4/22, story 8, 0:20, Couric) reported "an update...on the so-called morning-after birth control pill." On its website, the Food and Drug Administration (FDA) announced on Apr. 22 that "it will obey a judge's order and allow 17-year-olds to buy it without a prescription. The contraceptive, also called Plan B, is taken after unprotected sex and before an egg is fertilized." The FDA's decision, "which overturns one of the most controversial health rulings of the Bush administration, was scorned by abortion opponents and hailed by their abortion rights counterparts."

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Food and Drug Administration ("FDA ") notified consumers and health care professionals of a recall of 34 dietary supplement products. The FDA lab identified undeclared sibutramine, which is more commonly known as "Meridia",  an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that the products listed below pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Posted by Amy S. Gurgle, Esq.

A new study has determined that women whose healthy ovaries are removed during hysterectomy have a higher likelihood of developing a condition leading to death, including lung cancer and heart disease, as reported by the Los Angeles Times.

Posted by Jacqueline Colclough, Esquire, R.N.

Researchers at Duke University Medical Center and Arkansas Children's Hospital have recently reported that a carefully administered daily dose of peanuts has been found to be effective therapy for peanut allergies in children. In fact, the therapy has been so successful that a select group of children involved in the research study is now completely off treatment and eating peanuts daily. The studies were funded by the National Institutes of Health, The Food Allergy and Anaphylaxis Network, Food Allergy Project, Gerber Foundation and the Robins Family Foundation.

Posted by:  Salvatore J. Zambri and Catherine Bertram

Not even the inventors of Botox could have anticipated how widely used the drug has become.  Once thought to be the answer to wrinkles, Botox is now being administered to treat all kinds of  ailments, including,  migraines, speech impediments, skin disorders, muscle and gland problems, and much more, according to a recent publication in the New York Times. 

The Times report quotes Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker, who stated, “We see it as a molecule that keeps on giving.  As we understand it more, it gives us new ideas of how to use it." But not everyone agrees.  “It’s trial and error with a nerve poison,” says Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group. 

To read the entire Times article, please click here.

Botox is a nerve poison produced by the bacteria that cause botulism, a disease that paralyzes muscles and can be fatal. Before taking any medication, please be sure you are evaluated by your physician.  The wrongful administration of medication can cause serious permanent injury or death. 

For information about defective medications and your rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Thyroid problems can go easily undiagnosed, especially because pregnant women are understandably thinking of lots of others things besides the health of their thyroid.  The thyroid gland produced hormones that regulate many body functions, including metabolism, heart-rate, and body weight.  The development of hyperthyroidism (the production of too many hormones) and hypothyroidism (too little hormones) can lead to premature birth, pre-eclampsia, and diminished intelligence in newborns. 

In a recent New Your Times article, it is reported that 20% (1out of every 5) of women of child-bearing age suffer from hypothyroidism, the more worrisome of the two illnesses. 19% of children born of mothers with hypothyroidism obtain IQ levels of 85 or lower, states the report.

To read the full article, click here.

If you suffer from fatigue, overly-dry skin, anxiety, inability to sleep, or unexplainable weight loss, you may want to get a thyroid test, especially if you are pregnant or desire to become pregnant.

We encourage our readers to be active and follow your doctor's instructions on fitness.  Be safe and healthy.

For information, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to the New York Times, a new study found that pregnant women who took a popular epilepsy drug-- valproate, sold generically and under the brand name Depakote-- to treat migraines, pain and psychiatric disorders had children whose I.Q. scores were significantly lower than similar children who were not exposed to the drug.  Valporate remains the second-most-popular antiseizure medication used for epilepsy, says the report, but users must fully appreciate  its risks.

“My thought is that if I make a mistake and the patient has a breakthrough seizure, I can change the medication and switch the patient to valproate,” said Dr. Kimford J. Meador, professor of neurology at Emory University School of Medicine in Atlanta, and the first author of the new study. “If I put the patient on valproate as a first choice and the baby has cognitive impairment or a malformation, I can’t repair that.”

To read the full Times report, please click here.

Before taking any medication, please be sure you are evaluated by your physician.  The consequences of mixing medications and taking them while pregnant can be devastating. 

For information about defective medications and your rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

The American Association for Justice is following a developing story involving FDA approval of uses of the anti-psychotic drug Seroquel.  The FDA has approved the drug for schizophrenia and bipolar disorder, but AstraZeneca has been marketing the drug to patients suffering from depression and anxiety.  AstraZeneca is currently under review by the FDA to have the drug’s use expanded to include patients of depression and anxiety.  However, many believe that sealed documents with the court could shed some light on the side effects of Seroquel.   

Ted Baker, 60, of Bastrop, La., a Vietnam veteran who suffers from post-traumatic stress disorder and major depressive disorder, was prescribed Seroquel in 2001 as an antidepressant and continued to take it until 2006.  Due to his Seroquel use, he was diagnosed with Type II diabetes in March 2004.

Many people fear that the expanded use of this drug could expose others to diabetes.   Please review AAJ's press release for more details concerning this story. 

Public Citizen, a national non-profit public interest organization, has published its annual rankings of state medical boards. Using an analysis of data just released by the Federation of State Medical Boards (FSMB) on all disciplinary actions taken against doctors in 2008, Public Citizen calculated the rate of serious disciplinary actions (revocations, surrenders, suspensions and probation/restrictions) taken by state medical boards in 2008.  

For the first time since Public Citizen has been publishing the rankings, California, the largest state in the country, and Florida, one of the largest, are among the 10 states with the lowest rates of serious disciplinary actions. Minnesota was the worst state when it came to disciplining doctors and, along with Maryland, South Carolina and Wisconsin, has consistently been among the worst 10 states for each of the last six rankings.  Unfortunately, there is considerable evidence that most boards are under-disciplining physicians.    

Posted by Catherine D. Bertram and Salvatore J. Zambri

The Food and Drug Administration (FDA) issued a Class 1 Recall in April 2009 involving defective Defibrillators that may fail.  This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death.  According to the FDA's recall notice, Zoll Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest.”

In the New York Times advertising column, Stephanie Clifford writes that "the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, "warning them that their "search advertisements...had to start including risk information about each drug or else be rewritten or removed."

The companies, however, argued that "there was no way to include all the required information" within the "95 characters...allowed for search ads." According to Arnie Friede, counsel at McDermott, Will & Emery, "Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule" under which they would be "in compliance" if they "provided risk information within one click of their search ads." In changing the ads, industry executives now claim they "are even more confusing and misleading" and that "the agency is ignoring the realities of Internet marketing." Furthermore, the drug industry argues that the FDA "is not issuing clear rules about compliance."

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The U.S. Food and Drug Administration announced that it had obtained,  "a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs."

Posted by Jacqueline Colclough, Esquire, R.N.

Autism is the most common condition in a group of developmental disorders known as the autism spectrum disorders and is characterized by impaired social interaction, problems with verbal and nonverbal communication, and unusual, repetitive, or severely limited activities and interests. The National Institute of Neurological Disorders and Stroke estimates that three to six children out of every 1,000 will have autism.

April is National Autism Awareness Month in the United States, and it been celebrated by the Autism Society of America (ASA) since the 1970s in order to highlight the growing need for concern and awareness about autism. The month presents a unique opportunity for everyone to educate the public about autism and issues within the autism community, and the ASA suggests eight ways you can celebrate National Autism Awareness Month this year. Continue Reading Posted In Pediatrics , Public Health
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A new study by the advocacy group Donate Life America found that people harbor misconceptions about organ donation preventing them from electing to be an organ donor, as reported by the New York Times.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire 

For decades women have been advised to undergo mammograms to screen for breast cancer.  Routine exams, especially after age 50,  are highly recommended.  It was recently reported in a New York Times article, however, that British medical experts came to the conclusion that mammographies may do more harm than good.  The so-called experts suggest that for every life saved by the procedure at least one other person is forced to endure unnecessary and invasive procedures to treat slow-growing cancers that would otherwise cause no harm if left untreated.

Many experts, including the American Cancer Society, dispute the British claim, and urge women with usual risks (ie, family history of cancer, over age 50) to utilize mammograms as part of their routine screening for breast cancer.  On balance, the benefits of earl detection outweigh the risks associated with under-treatment.

To view the Times article, click here.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Nearly forty million prescriptions were written in 2008 in an effort to treat Attention Deficit Hyperactivity Disorder (ADHD). A recent study, however, warns that many of these widely prescribed drugs may cause more harm than good, especially if taken for more than two years. According to the study, prolonged use of ADHD medications can lead to significantly stunted growth.

To read the study, which was published in the Washington Post, please click here.

One lesson to take from the study is that it is critically important for parents to communicate well and often with their children's physicians and to question any prolonged prescription plan recommended by a physician. The more informed you are as parents, they better you are able to make decisions in your children's best interest.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

On April 8, 2009, Genetech and the US Food & Drug Administration (FDA) announced a voluntary phased withdrawal of Raptiva (efalizumab) from the U.S. market.  We have reproduced the FDA  statement for our readers in its entirety.

FDA Statement

 FOR IMMEDIATE RELEASE
Statement
April 8, 2009

Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.

Additional Information
Efalizumab (marketed as Raptiva) Information

For information about your legal rights, please click here or call
the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

During the past several years, researchers have discovered that Avandia, used to treat Type 2 diabetes, increases patient risks for a variety of problems, including, but not limited to:

• 43% increase for heart attack risk
• 64% increased risk of death from heart disease
• double risk for bone fractures
• increased risk of anemia
• increased risk of vision loss from macular edema

Recent research conclusions published in the America Diabetes Association's (ADA) Diabetes Care advises against use of Avandia because of an increase in life-threatening liver toxicity.  Both the American Diabetes Association and the European Association for the Study of Diabetes released a consensus statement concluding  "given that other [treatment] options are now recommended, the consensus group members unanimously advised against using rosiglitazone (generic name for Avandia)."

Public Citizen, a national non-profit public interest organization requested that FDA ban Avandia in its petition.  Earlier, the FDA included black-box warnings for Avandia, which later were strengthened as more dangers were documented.  The DC Metro Area Medical Malpractice Blog provided summaries and links for earlier FDA notices:  

• FDA to Require Black Box Warning on Avandia, Actos
• FDA Adds [New] Black Box Warning to Actos, Avandia
• Older Diabetes Drugs Rival New, More Advanced Ones: New Study

Although Avandia prescriptions have decreased sharply since the first warnings were revealed, there are still approximately 10,000 prescriptions being filled every day for it.  If you have been prescribed Avandia, consult your physician to determine whether you are a candidate for an alternative medication. 

If you or a family member believe that you have a case involving a medication or medical care please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

The FDA has issued a Class 1 Recall for electronic infusion pumps that deliver IV medications and fluids to patients.   Class 1 recalls, the most serious category, are made when there is a reasonable probability that use of the product will cause injury or death.  We have reproduced the FDA Warning Notice in its entirety for our readers. 

Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Date Recall Initiated: January 23, 2009
Product:  Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163

These products were manufactured and distributed from February, 1997 through December, 2008.

Use:  Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

Recalling Firm:
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd.
Round Lake, Illinois 60073

Reason for Recall:

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death.

Public Contact:
Customers may call Baxter Healthcare Corp. at 1-800-843-7867

FDA District:
Chicago

FDA Comment:

On January 23, 2009, the company sent a correction letter to all of its customers about failures that could lead to:

* interruption of therapy
* damaged battery messages
* smoke and fire hazards
* serious injury and/or death

The letter also:

* advised institutions to have contingency plans to verify that back-up pumps are available
* provided new steps for addressing an interruption of therapy with any failure code
* provided instructions for addressing damaged battery messages
* provided instructions for proper device cleaning

For more information about this recall, please see the company’s press release at: http://www.baxter.com/about_baxter/news_room/ news_releases/2009/03_11_09_colleague.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* FAX: 1-800-FDA-0178

Updated March 11, 2009

The Supreme Court of the United States recently announced its ruling in the Wyeth v. Levine case. The principal question before the Court was whether FDA approval of a drug's label overrides (or preempts) state-law claims of inadequate warning. The argument made by the drug company was that it would be impossible to comply with both state and federal laws if the state's law provides for a stronger warning label than the FDA labeling regulation. The Supreme Court rightly rejected that argument, finding that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." By issuing this ruling, the Court will allow consumers more protection from drug injuries that could have been prevented if the drug label had included proper warnings.

In this case, Diane Levine, a professional musician being treated for migraine headaches was injected with Phenergan, a drug manufactured by Wyeth. Because of the direct IV administration (IV push) of the drug, Ms. Levine's artery in her arm died, ultimately resulting in amputation of that arm. Wyeth was aware of the dangers of the IV push method for administering Phenergan, but never included any warnings to prohibit IV push administration on the label. The FDA had not determined whether the label should have included the warning. However, the FDA's labeling rules require that a prescription drug manufacturer change warning labels as soon as there is reasonable evidence that the drug causes adverse reactions without waiting for FDA approval of the label change.

Government regulations are intended to set minimum safety standards, but cannot guarantee safety. The preamble of regulations was intended to define the agency's interpretation. Beginning in 2005, Federal agencies started adding to the preamble of regulations without Congressional approval. With these additions, the agencies claimed that federal standards overrule any state safety standards and that state tort claims should be discarded. By adding preemption language to the agency preamble, the agencies bypassed Congress in determining if or when state law should be overruled. In 2007, however, Congress passed the Food and Drug Administration Act of 2007 (FDAAA), forcing the FDA to require drug manufacturers to update their labels when the manufacturers become aware of potential hazards.

If you or a family member has been injured as a result of a drug error or other product defect, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

According to recent research by the Mayo Clinic, both risks and benefits may exist for individuals considering aspirin therapy for heart attack and stroke prevention.  Every case must be evaluated individually and discussed with your doctor. 

Issues to consider before daily aspirin therapy include the following risk factors:

• "Smoking tobacco;
• High blood pressure — a systolic pressure of 140 millimeters of mercury (mm Hg) or higher or a diastolic pressure of 90 mm Hg or higher;
• Total cholesterol level of 240 mg/dL (6.22 mmol/L) or higher;
• Low-density lipoprotein ("bad") cholesterol level of 130 mg/dL (3.68 mmol/L) or higher;
• Lack of exercise
• Diabetes
• Stress
• Having more than two alcoholic drinks a day for men, one drink a day for women
• Family history of a stroke or heart attack"

Some conditions may prevent daily aspirin therapy:

• "A bleeding or clotting disorder (bleeding easily)
• Asthma
• Stomach ulcers
• Heart failure
• Other medications or supplements"

Daily aspirin therapy may also have some serious side effects:

• "Hemorrhagic stroke. While daily aspirin can help prevent a clot-related stroke, it may increase your risk of a bleeding stroke (hemorrhagic stroke).
• Gastrointestinal bleeding. Daily aspirin use increases your risk of developing a stomach ulcer. And, if you have a bleeding ulcer, taking aspirin will cause it to bleed more, perhaps to a life-threatening extent.
• Allergic reaction. If you're allergic to aspirin, taking any amount of aspirin can trigger a serious allergic reaction.
• Ringing in the ears (tinnitus) and hearing loss. Too much aspirin (overdosing) can cause tinnitus and eventual hearing loss in some people.
• Excessive bleeding during surgery or dental procedures."

The Food and Drug Administration also warns that regularly taking aspirin means that individuals should limit the amount of alcohol they drink because of its additional blood-thinning effects and potential to upset your stomach. No more than one drink a day if you're a woman or two drinks a day if you're a man. "Aspirin and all other over-the-counter pain relievers and fever reducers for adults will soon carry a warning to people who drink three or more alcoholic beverages a day: Talk with your doctor before using these drugs. Heavy drinkers may have an increased risk of liver damage and stomach bleeding from these medicines, which contain aspirin, other salicylates, acetaminophen, ibuprofen, naproxen sodium, or ketoprofen."

According to the FDA Consumer Magazine, "most health professionals agree that long-term aspirin use to prevent a heart attack or stroke in healthy people is unnecessary. If you are using aspirin to lower the risk of heart attack and stroke and you haven't talked with a health professional about it, you may be putting your health at risk."

New FDA-regulated modifications to over the counter cold and cough medicines should be observed by parents of young children. The following is the FDA statement regarding the new regulations applied to over-the-counter cough and cold medicine. Links have been added to the original statement for the readers' convenience.

  According to a report on medicalnewstoday.com, consumer complaints and Internet searches conducted by members of the Mexico-US-Canada Fraud working group lead the Federal Drug Administration (FDA) to find that 125 products sold online, that are boasting prevention, treatment, and/or cures for cancer, are fraudulent. Government officials are concerned that these products will interfere with legitimate cancer treatment and/or be independently harmful to individuals. Furthermore, it is worrisome that cancer patients may rely on these false claims and not seek appropriate medical care.

 Medicare, the largest insurance provider in the country, announced on October 1, 2008,  that it will no longer be financially responsible for the costs of hospital’s medical errors, nor will these costs be pinned on patients themselves.

Infections of the bacteria Staphylococcus aureus may be an overlooked cause of sudden infant death syndrome (SIDS), according to research published in a recent edition of the medical journal Archives of Disease in Childhood.

Common ultrasound imaging may be able to reveal which patients face a particularly high risk for heart attack or other heart-related illnesses, according to research recently published in the journal Radiology -- official journal of the Radiological Society of North America.

The FDA has issued a warning to consumers regarding expired and suspected counterfeit drugs for two Baltimore pharmacies.   The FDA News Release is reproduced below in its entirety.  

                            FDA News

              FDA Warns Consumers About Potential Problems

                                at Two Baltimore Pharmacies

Expired and suspected counterfeit prescription drugs

found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include: 

• Lisinopril (20 milligrams)
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
• Gabapentin (100 mg, 300 mg and 400 mg)
• Metoprolol (50 mg)
• Nifedipine (30 mg)
• Diclofenac Sodium (30 mg)
• Glucophage (500 mg Extended Release)
• Glucovance (125 mg and 500 mg)
• Glipizide/Metformin (2.50 mg/250 mg)
• Furosemide (20 mg)
• Tamoxifen Citrate (10 mg)
• Metformin HCl ER (500 mg)
• Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Whether the drug names are Celexa and Celebrex, Losec and Lasix, or even Prilosec and Prozac, sound-alike drug names pose dangers to patients.  Those dangers are compounded by the multi-ethnic and geographic diversity of the U.S. healthcare system, where strong accents combined with ordinary mispronunciation of complex pharmaceutical terms can lead to catastrophic outcomes if the wrong medication is accidentally dispensed.  Medication errors and sound-alike drug names are the topics of a recent article featured on HealthDay News.

Making certain that young children receive their recommended vaccinations is particularly important for their long-term health ― as well as for the health of their friends and classmates. Vaccines protect children against common seasonal diseases like the flu, but they also help prevent much rarer, more serious diseases.

All parents can determine what vaccines their children need and when the doses should be administered by consulting the nationally recommended Childhood Immunization Schedules, available on the web site of the U.S. Centers for Disease Control and Prevention (CDC).

If a child falls behind schedule on his or her vaccinations, it can sometimes be difficult to determine the best way to catch up. To help, the CDC has developed a Catch-Up Immunization Scheduler -- an online tool that shows parents and healthcare providers the best options for getting children six years of age and younger back on schedule.

The number of fatal medication errors occuring in people's homes has risen dramatically in recent years, particularly in those situations where alcohol or street drugs are also involved.  The finding is the result of research published in a recent edition of the Archives of Internal Medicine.  Authors of the study note that the number of years of potential life lost due to these home-based medication errors is likely greater than the number of years of life lost from all other accidents combined -- including falls and automobile accidents.

A recent FDA report to health care providers, warned of potential "adverse events" due to computerized tomography (CT) scans of patients with electronic devices implanted. Though few incidents have been reported thus far, the FDA is taking all reports seriously. Possible adverse events include medical devices shocking patients, sending inaccurate signals due to the CT scans, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.

The Chicago Tribune noted this announcement came as a surprise to physicians, many of whom were aware of these dangers with MRI scans. Dr. Leonard Berlin, chairman of the radiology department at Rush North Shore Medical Center in Skokie says he was not aware of this. "We haven't seen any of these problems and I'm not aware of any of my colleagues having seen them either. But, of course, we'll abide by what the FDA is recommending," Dr. Berlin says.

So what devices are possibly affected?

Rotavirus cases in the current 2007-2008 season showed up much later than usual and have been less severe, overall, than during any previous season on record, according to an interim report issued by the U.S. Centers for Disease Control and Prevention (CDC).

Electronic medical record systems have been touted as the wave of the future in healthcare and research has demonstrated their value in preventing medical errors.  According to new data published in the New England Journal of Medicine, however, only 4% of physicians have extensive, fully-functioning electronic systems, and only 13% have even a basic system.

A six-fold increase in the number of liver cancer patients receiving transplants has been linked to a method of donor organ allocation which was initiated in early 2002.  The research finding was recently published in Gastroenterology, official journal of the American Gastroenterological Association.

Whole milk is as effective as diluted barium when used as an oral contrast agent for patients undergoing a gastrointestinal CT scan.  It's cheaper and safer for patients, according to a new study published in a recent edition of the American Journal of Roentgenology.

The reliability of mammography results varies significantly between medical facilities, according to new research published in a recent edition of the Journal of the National Cancer Institute (JNCI).  Even more importantly, certain organizational characteristics tend to predict which facilities will return a more accurate reading.

The National Center for Complementary and Alternative Medicine (NCCAM) -- a division of the National Institutes of Health (NIH), recently launched an educational campaign to encourage patients (particularly those 50 years of age or older) to speak openly with their primary care providers about complementary and alternative medicines.  The campaign, known as Time to Talk, focuses on medical practices and products that aren't presently considered to be conventional medicine -- items such as herbal supplements, meditation and acupuncture.

Bacterial infections such as E. coli and Staphylococcus aureus -- sometimes acquired in medical facilities -- may be responsible for many cases of sudden infant death syndrome (SIDS).  The finding is the result of new research published in a recent edition of the British medical journal The Lancet.

The New York Times reported on the Food and Drug Administration's announcement last week of a new system to track already-released drugs' effectiveness. Called the Sentinel Initiative, many bodies such as the Institute of Medicine have recommended such a system for years. Additionally, the Sentinel Initiative is supported by recently-released research showing fast-tracked approval of new drugs leads to problems down the road. However, there are also many criticisms regarding the system's method of collecting data and its accuracy.

Patients who suffer a heart attack often subsequently develop acute kidney injury, a complication significantly increases a patient's risk of death.  The finding is the result of new research published in a recent edition of the Archives of Internal Medicine.

According to statistics reported by the U.S. Centers for Disease Control and Prevention (CDC), almost one in three Americans will develop shingles (herpes zoster) during their lifetime.  The disease is particularly dangerous to people over age 60 and those who are immunocompromised.  Fortunately, there is a way to reduce the risk of developing shingles and the long-term pain that often follows an outbreak of the disease.

Women who quit smoking lower their risk of dying from coronary heart disease by 47% within five years of smoking their last cigarette.  The risks associated with dying from other smoking-related diseases also decreases, but after different lengths of time, depending on the disease.  The findings are the result of new research recently published in the Journal of the American Medical Association (JAMA).

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

The 2008 edition of the schedule of recommended immunizations for people 18 years of age and younger has been posted by the Advisory Committee on Immunization Practices (ACIP) -- a division of the U.S. Centers for Disease Control and Prevention (CDC).  The advisory committee releases new recommendations annually to reflect changes in vaccine formulations and current recommendations for the use of licensed vaccines. 

This summer, don't wait until the last few busy weeks before fall school registration begins to make your child's vaccination appointment -- schedule an appointment now, and enjoy a safer summer. 

Changes from the 2007 immunization schedule are as follows:

Elevated levels of allergens in the home are associated with asthma symptoms in allergic individuals, and asthmatics who experience allergies may improve their health by reducing allergen exposures.  The findings are the result of new research published in The Journal of Allergy and Clinical Immunology, and reported in a recent press release by the U.S. National Institutes of Health.

A newly updated annual ranking of state medical boards by the consumer advocacy group Public Citizen has revealed 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 this year, 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.

Despite the rising costs of fuel this year, millions of Americans will be hitting the nation's roads and airports for a summer vacation -- and for those who suffer from seasonal allergies, summer traveling can pose some unique challenges.  The American Academy of Allergy, Asthma & Immunology (AAAAI), reminds travelers that the climate of your destination, rather than your home, determines the pollens and molds to which you'll be exposed on vacation, and that all seasonal allergy sufferers should take time to plan their clothing and needed medications appropriately. 

The academy offers the following additional allergy management tips for summer vacationers:

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

Laser eye surgeries such as LASIK (Laser-Assisted In Situ Keratomileusis) are quickly becoming some of the most common and technologically sophisticated procedures available for correcting relatively minor vision problems.  Generally performed on an out-patient basis with the aid of only anesthetic eye drops, LASIK procedures are usually quick and easy, and the results are often remarkable.  Unfortunately, however, the results can be underwhelming, too -- and occasionally even catastrophic. 

To help clear up some misconceptions and misinformation regarding LASIK procedures, and to help consumers better understand the risks of laser eye surgeries, the U.S. Food and Drug Administration (FDA) has established a web page devoted specifically to patient education.  According to the agency, there are a few categories of people who should think twice before they attempt to resolve their vision problems with LASIK surgery.

Melanoma is one of the deadliest skin cancers, but new research demonstrates that melanomas located on the scalp or neck are even twice as deadly as those found on other parts of the body.  The finding is the result of a study published in a recent edition of the medical journal Archives of Dermatology. 

New figures released by the federal government have revealed a steep and potentially deadly spike of a serious, hospital-based infection that gives patients blood poisoning and sometimes incurable diarrhea.  This latest public health research data, released by the U.S.Agency for Healthcare Research and Quality (AHRQ) shows an increase of 200% in the prevalence of Clostridium difficile (C. Diff.) infections among U.S. hospital patients between the years of 2000 and 2005.

A Mumps comeback in the U.S. in 2006 was alarming in its severity, and the disease may now take several years to completely eradicate, according to federal public health experts.  Interestingly, the viral outbreak occurred despite the routine administration of a second dose of a mumps vaccine throughout the early 1990s.  These findings were reported in a recent edition of the New England Journal of Medicine (NEJM).  Among other data presented in the article is the fact that 84% of people between 18 and 24 years of age who contracted Mumps during the outbreak had already been given the second recommended dose of MMR vaccine -- a dose that should have protected them from Mumps.

New U.S. Food and Drug Administration (FDA) guidelines for oversight of "off-label" drug use -- still in draft form and unfinalized -- could allow pharmaceutical companies to market more drugs for unapproved uses.  The proposed guidelines are a step in the wrong direction according to Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center.  His concern for patient safety was articulated in a recent edition of the New England Journal of Medicine.

The U.S. Food and Drug Administration (FDA) has announced that it is working with Merck, Inc., the pharmaceutical company, to explore a possible link between the popular asthma and allergy drug Singulair (known generically as montelukast) and behavioral changes, mood changes, and increased rates of suicide among users.  The investigation could take nine months, and although the agency is not yet recommending that anyone stop taking the drug, it is asking health care professionals to monitor Singulair patients for changes in condition that may indicate a suicide risk.

Physicians treating chest pain in patients who are young, or in those who have no obvious risk factors for heart disease, should ask those patients about their potential cocaine use.  The advice is a key recommendation by the American Heart Association (AHA), recently published in the medical journal Circulation. 

If you see someone suffer a heart attack and go unconscious, immediately dial 9-1-1 and begin pushing on his or her chest as hard and as often as you can -- don't stop until someone else can take over, or until paramedics arrive.  Those are the latest instructions from the American Heart Association (AHA), which is now confident that hands-only cardiopulmonary resuscitation (CPR) can be done in an emergency, even by people who have no CPR training.  Throat sweeping and mouth-to-mouth emergency breathing are still recommended, but not for bystanders -- those components are only encouraged for trained medical personnel.  The organization's new position appears in the March 29 issue of the medical journal Circulation.

Adverse drug events affect about 7% of U.S. children in hospitals -- adverse events such as getting the wrong medication, the wrong doses of medication, and dangerous, preventable reactions.  The percentage is much higher than previous estimates, too, underscoring growing concerns about medical errors involving hospitalized children, according to new research published in the journal Pediatrics.

Breathing muscles which go unused during ventilator-assisted respiration weaken more rapidly than previously understood, according to a new study published in a recent edition of the New England Journal of Medicine. 

A complex assortment of pharmaceutical drugs has been found in the drinking water supplies of tens of millions of Americans, according to a recent Associated Press investigation.  The contamination affects the drinking water supplies of at least 24 major metropolitan areas across the U.S., including the DC Metro area.

Emergency Room patients treated for severe asthma often continue to have poorly controlled symptoms as much as one month afterward, according to new research published in a recent issue of  Annals of Allergy, Asthma and Immunology.

West Nile virus infections can lead to significant long-term health problems, including mental and functional impairment and depression, according to data from an ongoing National Institutes of Health study recently presented at the International Conference on Emerging Infectious Diseases in Atlanta, Georgia.  The research data collected thus far, as reported by Reuters Health, suggests that the most common long-term symptoms include fatigue, weakness, depression, personality changes, difficulty walking, memory loss and blurry vision.

It has previously been documented that humans and dogs can infect one another with methicillin-resistant Staphylococcus aureus (MRSA), but it now appears that humans and cats can spread the virulent bacteria back and forth between one another, as well.  What may be the first documented instance of such transmission has been reported in a recent edition of the New England Journal of Medicine. 

An American woman's risk of developing particular skin cancers is influenced by where she lives, according to a new study published in a recent edition of Archives of Internal Medicine.

National survey findings released this month demonstrate that although most adults are aware of serious eye diseases commonly associated with visual impairment, they lack critical knowledge concerning how and when to seek timely detection and treatment of those diseases.  The Survey of Public Knowledge, Attitudes, and Practices Related to Eye Health and Disease, was jointly sponsored by the National Eye Institute (NEI), the National Institutes of Health (NIH), and Lions Clubs International Foundation (LCIF).  Conducted in 2005, the survey data was made available just this month. 

A simple new lab test can reliably predict which patients will suffer acute kidney failure following surgery, giving physicians as many as three additional days in which to initiate treatment.  The development could lead to significantly improved patient outcomes, according to researchers whose findings appear in the latest edition of the Clinical Journal of the American Society of Nephrology.

Reducing the television and computer time of obese children by half can subsequently reduce the amount of food they eat and help them lose weight -- even if those children don't increase their physical activity at all.  The finding is the result of a new study published in a recent edition of the Archives of Pediatrics & Adolescent Medicine.

Though patients and even dentists are often unaware, crowns, bridges and other dental devices produced by foreign manufacturers contain dangerous levels of lead in many instances, according to an investigative report by WBNS-10 TV  -- an Ohio television station that has captured the attention of the American Dental Association (ADA) and millions of concerned patients.

Unnecessary appendectomies have become drastically less common since 1996, thanks to the increased use of CT scanning in the diagnosis of acute appendicitis.  The finding was announced by a research team led by Dr. Steven Raman of the University of California - Los Angeles, and appears in a recent letter to the New England Journal of Medicine (NEJM).

According to the U.S. Food and Drug Administration (FDA), Baxter Healthcare Corp. has announced that it is recalling all remaining multi-dose vials of their heparin, as well as single-dose vials and Hep-Lock heparin flush products, which prevent blood clots in intravenous (IV) lines.  Baxter widened its initial recall after another manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the FDA that it could meet the demand for the entire supply of the blood thinner in the United States.  Several U.S. manufacturers produce items similar to Baxter's Hep-Lock.

Endometriosis is an illness that affects women during their reproductive years, but frequently goes undiagnosed.  In women who suffer from the condition, endometrium-like tissue grows outside of the uterus, often throughout the abdominal cavity, leading to a variety of symptoms that aren't routinely seen together.

A diet rich in fresh vegetables, fruits and whole grains is an excellent defense against many chronic diseases -- even some cancers -- but routinely including them in your diet can seem challenging.  University of Michigan dietary experts advise this approach:  Include them for just one day.  One day of healthy lifestyle choices, they reason, can give you the perspective and direction needed to stay the course.  Erica Wald, registered dietitian for the University of Michigan's health promotion division, provides the following suggestions for eating healthier and removing many processed foods from your diet:

As a hospital patient, you're significantly less likely to survive a heart attack on night and weekend shifts, according to a new study published in a recent edition of the Journal of the American Medical Association (JAMA).