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Diana Levine Case Concludes Before Supreme Court In Ruling For Consumers

Posted by Jane Akre
Wednesday, March 04, 2009 1:30 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Preemption, Diana Levine, NEJM, Alliance For Justice, Wyeth

Diana Levine case before the high court concludes in a victory for consumers injured by drugs.


IMAGE SOURCE:  Courtesy Charles Eller Studios, Diana Levine under a rainbow


A ruling for consumers today by the U.S. Supreme Court means patients can sue drugmakers for failing to warn about a drug’s safety.

The case stems around Diana Levine. She’s the musician from Marshfield, Vermont who went into a local clinic for treatment of a migraine headache. 

Her story is available in video form, produced by the Alliance for Justice and on Injuryboard.

In the past she had received medication, but this time she also got a dose of phenergen, made by Wyeth, for nausea, which was delivered through an IV push, a more aggressive way of delivering drugs immediately into the bloodstream.

The drug was delivered in such a way that it penetrated her artery, destroying it and causing her right arm to become gangrenous. It had to be amputated up to her elbow.

The package insert or label, did not specifically warn against using phenergan in an IV push method.

While Levine had won a $7 million judgment in the lower court, Wyeth took the issue to the highest court arguing that the drug's approval by the federal government meant state court decisions could be preempted.

The justices voted 6-3 that drug companies are not shielded from lawsuits by the Food and Drug Administration’s approval of a treatment and the included label.  

“Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” wrong Justice John Paul Stevens for the court. 

Thousands of lawsuits against pharmaceutical companies had been waiting for the outcome of this case to clarify the muddy issue of federal preemption.  AstraZeneca's Seroquel, Wyeth’s Prempro and Premarin drugs are facing litigation which drug makers claimed was preempted by federal immunity.

Diana Levine’s lawyer, David Frederick sasys this is a, “broad victory for consumers”.

A broad decision

But it may not be.  The justices left open the possibility that lawsuits might still be barred by injured persons if the FDA had considered a requirement for a stronger warning, but researched the change and then rejected the necessity for change.  That would mean a tougher label received extra consideration by the FDA.  

Justices John Roberts, Antonin Scalia and Samuel Alito were the disssenting votes.  Alito believes that state filed lawsuits will interfere with the federal drug approval system. 

The Bush administration had also backed federal preemption arguing that a jury can interfere with the FDA’s work approving drug. 

FDA commissioners write along with medical experts in the New England Journal of Medine (NEJM) in a brief to the U.S. Supreme Court, (as friends of Levine) that the FDA does not have the ability to carefully regulate and monitor the safety of all drugs before they are approved.  #


Anonymous User
Posted by Jackie Wellbaum
Wednesday, March 04, 2009 3:03 PM EST

Drug companies like Pfizer and Wyeth can run but cannot hide. It is simply untrue that, as Wyeth attorney Rein asserts in a written statement:

"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label."

Drug companies 'negotiate' vigorously with the U.S. Food and Drug Administration (FDA) over the text of the warning label which accompanies each drug to the marketplace. Drug companies such as Pfizer and Wyeth hold the results of their clinical trials close, keeping from the public AND the FDA analysis of clinical data which link the use of their drugs to serious adverse events and deaths. Is it still true that potential tragedies for a 'few' American consumers become the 'cost of doing business' for Pfizer and others as they have practiced a strategy of lobbying to dilute FDA enforcement while also hiding behind it's 'expertise' as an insulation against litigation? Answer before today's supreme court ruling: Yes! Today's supreme court decision upholding a cash award for Ms. Levine may be an early warning signal to pharmaceutical companies such as Pfizer and Wyeth to take far more responsibility for what is contained in AND omitted from their warning labels. These drug companies have failed in their attempt to lead the public into believing that a chronically hog-tied Food and Drug Administration maintains ultimate legal and moral responsibility for the safety of the American public from harmful and deadly side-effects. How long did Pfizer think it could succeed with this strategy knowing how many deaths and other serious side-effects are suffered by its 'customers?' To pharmaceutical companies everywhere: If your product maims and kills people, you will be exposed and will pay either in negative publicity or cash or both. And when will either Bush or Cheney, leaders of an failed and embarrassed American administration, finally suffer a drug-company-induced serious adverse event? Sooner rather than later is my fervent hope.

Anonymous User
Posted by Carol Foe
Wednesday, March 25, 2009 9:52 PM EST

I am so proud of our US Supreme Court in their ruling that will help keep the giant drug houses in line. It is bad enough that myself and hundreds of other women had to suffer breast cancer from Prempro, but the truth of the matter is that Wyeth needs to look at itself, the way it does business and be a lot more careful in its research and clinical trials. It should also endeavor to keep its executives at their desks working rather than allowing their supervisors to travel and party of the beachs of Cuba! What an outrage! Especially as it came about 3 weeks prior to the release by the NIH of their data that indicated Prempro was a causitive factor in the development of breast cancer, July 2002.

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