Wyeth v. Levine Supreme Court Hearing On Federal Preemption Of Drug Injury Lawsuits

Various Parties Have Filed Briefs With Their Arguments About Whether Or Not An Injured Patient Should Be Able To File A Lawsuit Against The Drug Company

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Drug Injury Lawsuits Are Not Preempted By Federal Law (3/4/09)

On March 4, 2009 the U.S. Supreme Court, in a 6-3 decision, found that FDA approval was not a complete defense to plaintiff Diane Levine’s claim that Wyeth failed to adequately warn against a risk involved with the anti-nausea drug Phenergan. 

As stated by Justice John Paul Stevens: 

Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

Wyeth v. Levine, No. 06-1249 (U.S. Sup. Ct.)

For background information and materials regarding the Wyeth v. Levine case, visit the Federal Preemption of Drug Injury Lawsuits page over at the Drug Injury Law web site.

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As some of you are aware by now, this fall the Supreme Court will hear oral arguments in the case Wyeth v. Levine (No. 06-1294). In the case, Wyeth is appealing a Vermont Supreme Court decision that upheld a $6.8 million jury award to Diana Levine after her use of the drug company's anti-nausea drug Phenergan (promethazine HCl) resulted in serious complications and, ultimately, amputation of her arm.

In essence, Levine's lawsuit against the drug company alleges that the drug had inadequate warnings, whereas the company is arguing that the FDA's authority to approve drug labeling preempts state laws governing product liability.

I have long agreed with the position that the application of the federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation.

Of course, there are various parties with opinions about how the Supreme Court should rule on the federal preemption issue presented by the Wyeth v. Levine case.  Several of those parties have submitted Amicus Curiae (so-called "friend of the court") briefs, some of which are in support of Wyeth (the "Petitioner"), while others are in support of Ms. Levine (the "Respondent"). 

The American Bar Association has compiled a list of hyperlinks for the Amicus briefs filed in connection with the Wyeth v. Levine case for those of your who want to get an in-depth view of both sides to this very important legal and public policy issue.

As always, we welcome your opinion about whether a patient injured by serious side effects of an FDA-approved prescription drug should be able to file a products liability lawsuit against the drug company.  Simply submit a Comment to this post to join the discussion about federal preemption and drug injury product liability lawsuits.

4 responses to “Wyeth v. Levine Supreme Court Hearing On Federal Preemption Of Drug Injury Lawsuits”

  1. Justice in Michigan Avatar
    Justice in Michigan

    Thanks, Tom. Along with discussion here, I would like to invite folks to check in at the Pharmalot site where we have been discussing/debating preemption on an almost daily basis, and now over several months. There’s a lot of relevant info, positions, etc., that might be of interest.
    Thanks and best.

  2. Tom Lamb Avatar

    I fully agree that Ed Silverman’s Pharmalot blog (http://pharmalot.com/) is well-worth visiting for discussions about this federal preemption issue.
    Thanks for the suggestion, and keep up the good work.
    Tom Lamb

  3. Thomas Sharon, R.N., M.P.H Avatar

    I believe that as we contemplate the possibility of drug companies enjoying judicial immunity from product liability (Heaven forbid) we need to look at the level of unscrupulousness and lack of social responsibility that the company executives are exhibiting along with the medical community.
    For example, the research methodologies and results are always suspect when the manufacturer funds the research.
    Moreover, the marketing practices of flying large numbers of doctors to tropical paradise resorts or providing other kinds of incentives to entice the doctors into writing prescriptions is nothing short of bribery.
    Furthermore, the fact that the FDA approves all of the drugs that wind up injuring and killing thousands based on research funded by the manufacturer, leaves me wondering if the FDA officials are also enjoying a few perks.
    Therefore, what possible sense can it make to strip the consumer of all rights to seek justice after being victimized by such corrupt practices?

  4. Tom Lamb Avatar

    Thomas:
    I appreciate you taking the time to weigh in on this important legal and public policy issue of federal preemption in the context of product liability lawsuits concerning prescription drug side effects.
    Hopefully you will continue to advocate your opinion and inform others about what is at stake, here.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

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