DC Metro Area Medical Malpractice Law Blog

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.

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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800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.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.

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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."