Access To Justice

Anesthesia given intravenously to patients could potentially lead to infection with hepatitis B and hepatitis C, according to researchers at the Centers for Disease Control (CDC). The CDC researchers traced an outbreak of the disease to an anesthesiologist who did not follow procedure and used a single-use vial of the anesthesia drug propofol to dose multiple patients.
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Pharma giant Pfizer has received a warning letter from the Food and Drug Administration (FDA) saying it has 15 business days to correct testing procedures that resulted in several children receiving overdoses during a company drug trial in 2007.  The Associated Press reports that the medication under study was Geodon, an antipsychotic which Pfizer investigated to treat bipolar disorder in pediatric patients.

It’s been another tough week for Toyota Motor Co. The embattled Japanese carmaker agreed to pay a record $16.4 million fine issued against it by the National Highway Traffic Safety Administration (NHTSA) for being slow to report sudden acceleration problems to regulators. In a statement, Toyota denied the NHTSA’s allegations that it violated safety regulations or hid defects.

Toyota also said it would recall all 9,400 of its 2010 Lexus GX 460 sport utility vehicles to update software in the Vehicle Stability Control system. The company temporarily suspended sales of the vehicle after it was slapped with a rare “Don’t Buy” warning from Consumer Reports magazine, which called out the SUV’s potential risk of rollover when making a sharp turn.

Finally, The National Law Journal (subscription required) reports that the federal judge overseeing the Toyota litigation named four lawyers as temporary lead counsel and set the first scheduling hearing for May 13.

The U.S. Food and Drug Administration (FDA) is teaming up with private agencies to make things a lot more clear for expecting mothers, with a brand new program called the Medication Exposure in Pregnancy Risk Evaluation Program or MEPREP.

A Dec. 30, 2009 FDA news release reveals that the federal agency is going to work with several other groups including Kaiser Permanente, Vanderbilt University, and the HMO Research Network Center for Education and Research in Therapeutics (CERT).

The result? More about the risks of using specific drugs during pregnancy.

Margaret Hamburg, M.D., Commissioner of Food and Drugs, has stated that MEPREP will “guide regulatory policy and influence medical practice.”

Prior to this new program, the FDA relied on a “grade” system for determining the risks of various pharmaceuticals for pregnant women. This grading system often left many questions about whether a medication represented an acceptable risk for any given patient.

Grassroots pregnancy advocacy groups are duly positive about the FDA decision.

“It needs to be done,” posted jeannesager on Jan. 4, on the parent advocate blog StrollerDerby, dubbed ‘The Mother of All Parenting Blogs.’

Other big advocacy blogs are looking forward to the change, as are some of the main participants.

Vanderbilt online sources show that William Cooper, M.D., M.P.H., professor of Pediatrics, has been selected as the principal investigator representing the school’s involvement in the program.

“This [MEPREP] will allow us to look at exposures we would never have been able to study before,” said Cooper in December, according to the internal news release.

Reports also quote Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research, saying that MEPREP will “provide valuable information for physicians and patients” about using various drugs during pregnancy.

The MEPREP program is a valuable New Year’s present to American families. The hope is that this new initiative will make talking to doctors about drug regimens for expecting and new mothers more concrete, and help to prevent some of the range of birth injuries and birth defects that can be caused by side effects of some pharmaceuticals.

Learn more about birth-related  injuries at our ChildRC Blog.

News developments that we’ll be watching at Sokolove Law:

The U.S Food and Drug Administration (FDA) plans to study how medications taken in pregnancy affect mothers and their unborn children, according to a report from Reuters. The new study will be called the Medication Exposure in Pregnancy Risk Evaluation Program. Two-thirds of mothers-to-be have used at least one prescription drug during pregnancy, according to the FDA. There are few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.

A class-action lawsuit filed in Manhattan’s Federal District Court last week alleges that some New York debt collectors are using “fraudulent documents to surreptitiously win court judgments – all without the debtors’ knowledge,” writes The New York Times. The paper reports that use of the practice has been spurred by the recession and the rise in consumer debt actions.

Recent Recalls

General Motors announced a January recall of 22,000 Chevrolet Corvettes after finding problems with their removable roof system, writes The Burlington County Times. The recall applies to 2005-07 model year Corvettes and Corvette Z06 models. According to the article, GM told the National Highway Traffic Safety Administration (NHTSA) that the adhesive between the roof panel and the frame may separate, allowing the roof to come off while driving and posing an accident risk. GM will install a redesigned roof panel as a result. The automaker issued a similar recall in 2006.

Make personal safety one of your resolutions in the New Year. As always, Sokolove Law is here to help.

Stevens Johnson Syndrome (SJS) is a rare but serious, disorder affecting the skin and mucous membranes.  SJS may be the result of a severe allergic reaction to a medication, particularly anti-inflammatory medications (NSAIDs), anticonvulsants such as Dilantin and Tegretol, and antibiotic drugs like Levaquin. Click here to see a list of drugs that have been associated with SJS.

SJS is characterized by a red or purple skin rash that spreads and blisters, accompanied by extremely painful blistering sores on the mucous membranes lining the mouth, throat, eyes, nose and genitals.  As it advances, SJS eventually causes peeling and shedding of the skin. Toxic Epidermal Necrolysis (TEN) is an even more severe, life-threatening form of SJS affecting a larger portion of the body.

Patients with TEN may experience peeling over 30% or more of their body surface, similar to a severe burn. Like SJS, TEN is also commonly the result of a drug-related reaction.  In extreme cases, SJS and TEN can lead to permanent skin damage, loss of hair, loss of finger and toenails, damage to internal organs and blindness.  It’s not pleasant!!

If you or a loved one thinks you might be suffering from SJS or TEN, consult your physician immediately, and if you believe that your illness was caused by medical malpractice, contact us because you may be entitled to compensation.