If I’m injured by an FDA-approved prescription drug that has a detailed warning label, may I seek compensation from the drug’s manufacturer?

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Answered by: Scott D. Levensten of The Levensten Law Firm, P.C.

Yes, you may bring a failure-to-warn claim when a pharmaceutical manufacturer’s inadequate warning of a risk results in an injury. On March 4, 2009, in Wyeth v. Levine, the Supreme Court of the United States resoundingly held that FDA approval of a prescription drug’s warning label does not prohibit individuals from seeking compensation from the manufacturer. Even detailed warning labels can inadequately warn of a risk associated with the drug.

In Levine, Dianna Levine, a musician who lost her arm to gangrene following administration of the antihistamine Phenergan, was permitted by the Supreme Court to pursue a claim against Wyeth that Phenergan’s label inadequately warned of the risk of catastrophic consequences associated with intravenous administration of the drug. (Four years earlier, a Vermont jury awarded Levine $7.4 million for her injuries; however the case was appealed by Wyeth until the Supreme Court ruling.) Locally, several decades ago in Incollingo v. Ewing, the Pennsylvania Supreme Court permitted a victim to prove that a manufacturer’s marketing of a drug can negate risks that appear in an FDA-approved label.

If you believe that you are injured by a prescription drug, you should (a) save the remaining medicine in its packaging, (b) document your ingestion of the drug and your injuries, and (c) carefully search for an attorney experienced in pharmaceutical injury cases.


Related Practice Area: Class Action/Mass Torts

Published in Pennsylvania Super Lawyers 2010 — June 2010


Scott D. Levensten

Scott D. Levensten

The Levensten Law Firm, P.C.

1420 Walnut Street, Suite 801

Philadelphia PA, 19102

View Complete Profile for Scott D. Levensten


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