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

Posted by Andrew J. Barovick | Mar 03, 2009 | 0 Comments

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.

About the Author

Andrew J. Barovick

Mr. Barovick is a graduate of Columbia College and Cardozo School of Law. He began his legal career at the Queens District Attorney’s Office, where he tried over 20 felonies to verdict, and argued an equal number of appeals before the Appellate Division, Second Department, the New York Court of Appeals and the United States Court of Appeals for the Second Circuit.


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$500,000 wrongful death/medical malpractice settlement on behalf of patient brought to hospital emergency room with serious injuries who suffered complications while unmonitored and died.

$425,000 wrongful death/medical malpractice settlement during trial on behalf of senior hospital patient whose surgeon failed to timely address her worsening symptoms, resulting in her death.

$250,000 to young man whose physician failed to diagnose an impending torsion testicle, causing the loss of the affected testicle.

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