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Reaction To Levine Case

Posted by Jane Akre
Wednesday, March 04, 2009 2:14 PM EST
Category: Major Medical, Protecting Your Family
Tags: Diana Levine, Wyeth, Phenergan, Federal Preemption, Tort Reform

Reaction to Diana Levine case decision today by the Supreme Court.

Diana Levine Speaks 

Injuryboard, along with Alliance for Justice feature the Diana Levine story in a video on page one of Injuryboard.com.  Hear Diana Levine tell her own story in her own words. 

Levine had received Demerol for treatment of a migraine headache in 2000. Phenergan (Wyeth) was delivered to stop the nausea created by the Demerol by IV push which punctuated her artery causing gangrene and the amputation of her arm. 

The U.S. Supreme Court today in a 6-3 decision upheld Levine's victory in a lower court that the warning label was not clear on the Phenergan drug. Levine had won $6.7 million in that jury trial.

Alliance For Justice- A Victory For Consumers

    The nonprofit Washington D.C-based group, Alliance for Justice issued this statement:

Today’s victory for Diana Levine is really a victory for all American consumers,” said Alliance for Justice President Nan Aron.  The Supreme Court, in a 6-3 decision, rejected the premise that drug manufacturers who fail to warn consumers of the dangers associated with their products can evade responsibility for the harm they do to Americans.  “The six justices who stood up for accountability sent a clear message that FDA approval does not necessarily grant a corporation a license to hit and run,” Aron noted.

“The dangers posed to consumers do not end with the happy outcome in Wyeth v. Levine, however. Millions of other Americans who use medical devices are still left without recourse if they are injured.  This is why Congress must act swiftly to pass the Medical Device Safety Act.  The proposed bill would make clear that FDA approval to market does not preempt victims from having unsafe product lawsuits heard by juries in state courts.” 

"Congress must make clear that big corporations do not have a right to 'hit and run' by causing serious health damage and then walking away from legal responsibility," concluded Aron. "Passage of the Medical Device Safety Act will protect the victims of unsafe products and ensure that manufacturers have a strong incentive to make safe products in the first place.”


Online Community

Online, many consumers, the very people who could be hurt by drugs if they are not properly labeled, express some cynicism and misunderstanding about the right they have to access the courts in America. 

The primary misunderstanding is that this is a failure-to-warn case, and the label for Phenergan did not warn against the aggressive delivery of the drug through the IV push method.  

“Under no circumstances should be given by interarterial injection,” says the label insert for Phenergan. Levine had argued if the IV push method was specified in the drug label, the clinician would not have delivered it into her right arm by that method. 

Levine did sue the clinic which delivered the drug by IV push.  

In the video on Injuryboard.com, Levine returns to the clinic for the first time, to discuss how the injury happened.


Wyeth- Patients Best Served by a national standard

Doug Petkus, a spokesman for Wyeth sent an e-mailed press release:    

  “Madison, N.J., March 4, 2009 – The U.S. Supreme Court’s ruling in Wyeth v. Levine is disappointing, not only for Wyeth, but for patients and public health in general.  Patients are best served by a national standard for the labeling of prescription medications – set by the medical and scientific experts at the U.S. Food and Drug Administration (FDA).  When lay juries are permitted to second guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs.

            “Wyeth’s labeling of Phenergan provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case,” says Bert Rein, an attorney from Wiley Rein, a Washington D.C. law firm representing Wyeth in this matter.  “The medical and scientific experts at FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product’s label.”  

            In the dissenting opinion, Justice Alito stated, “This case illustrates that tragic facts make bad law.  The Court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs…To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades.  But this case is far from peaceful coexistence.  The FDA told Wyeth that Phenergan’s label renders its use ‘safe.’  But the State of Vermont, through its tort law, said: ‘Not so.’” #


Anonymous User
Posted by Jackie Wellbaum
Wednesday, March 04, 2009 3:27 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 Jodi B
Wednesday, March 04, 2009 5:40 PM EST

For those who like or need to research, there was an article in USA Today about an FDA whistle blower some years back. Of course whistle blower would not be a key word since the Bush Administration maintained a lock jaw on our 1st Amendment. Yet, there was an official who had worked at the FDA and he did make a public statement regarding the FDA not following its own guidelines-safety tests and such if I am recalling correct. It seemed to be on the front page but maybe not. Good luck!

Anonymous User
Posted by Jane Akre
Wednesday, March 04, 2009 5:54 PM EST

Hello All-

What's so interesting is the opinion of MD's who publish the New England Journal of Medicine who state flat out that the agency does not have the resources to police drug safety.

Interesting read :

And visit the Diana Levine story on right hand side of Injuryboard.com Web site.

Anonymous User
Posted by Joan Petty
Friday, March 06, 2009 11:27 PM EST

Thanks to the product liability for Devises and the Levin Case that the US Supreme Court has now ruled for, also gives me hope for my Case that is now in the United States Supreme Court for Distribution for Rehearing on preemption of the product liability for prescription drugs.The other half of the FDCA ACT that Congress omitted.
Also brings up a Civil RICO Complaint and a Constitutional Question? Why is the Drug Companies not held responsible for the killing and damages they do when it comes to criminal acts.? It appears that drug companies are above the law.

Comments for this article are closed.

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