Mar 4 2009

U.S. Supreme Court Decides Wyeth v. Levine, Holding There Is No Federal Pre-emption

The U. S. Supreme Court has issued its long-awaited decision in Wyeth v. Levine, according to Bloomberg News,   And the news is not good for Wyeth.

The Court held that: “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV push method of administration.”  That’s a summary.  The decision runs some 80 pages. (Thanks to colleague Tom Valet for emailing it to me.)

Bloomberg reporter Greg Stohr’s lead in to his story sums up the decision’s impact nicely.  “The U.S. Supreme Court said patients can sue drugmakers for failing to provide adequate safety warnings, upholding a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.”

Speaking stricly to my fellow lawyers, the true impact of this case is, of course, that similarly situated victims of inadequate drug warnings will now be able to initiate actions against the drug maker in state court.  They are not pre-empted from suing simply because a drug’s labeling has been approved by the FDA.

This is good news for medical consumers, who have come to see that FDA “approval” of anything does not mean very much anymore.

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  1. throckmorton said:

    This case was originally about an inter-arterial injection of phenergan. Interarterial injections are contraindicated for all medications that are IV (intervenous push). In the case, a physicians assistant gave the medication incorrectly. Rather than a lawsuit against him, this was a deep pockets case and so the plaintiff went after the company with the biggest pockets. Even though this medication is now generic. Interestingly, phenergan does have a warning about potential gangreen with IV injections. So, a PA gives a medication in a way that is true negligence and the response is to sue the company that made it.

    March 5th, 2009 at 7:35 pm
  2. throckmorton said:

    What timing. I just got an email from our childrens hospital. They are taking phenergan off the formulary so the only antiemetic we now have is Zofran which is bost costly and secondly doesn’t seem to work for our kids on chemo.

    March 5th, 2009 at 7:38 pm

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