Wyeth Not Responsible For Plaintiff Injury In Pre-Emption Case, Company Official Writes

Main Category: Pharma Industry / Biotech Industry
Also Included In: Litigation / Medical Malpractice;  Regulatory Affairs / Drug Approvals
Article Date: 07 Nov 2008 - 8:00 PDT

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The injury sustained by Diana Levine -- the plaintiff in Wyeth v. Levine, a U.S. Supreme Court case that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts -- "was undeniably tragic, but it was strictly a case of human error," William Ruane, vice president and general counsel for Wyeth, writes in a Wall Street Journal letter to the editor (Ruane, Wall Street Journal, 11/6). Levine lost her hand and forearm to gangrene after she received the nausea medication Phenergan through a push IV injection, which is more potent and takes less time to act than a traditional injection but has increased risks (Kaiser Daily Health Policy Report, 11/4).

Ruane writes, "At the time, the Phenergan labeling had no less than four separate warnings against the risks" of push IV injection. According to Ruane, the "essential facts of this case are very clear and weren't challenged: There is no evidence, argument, or even suggestion that Wyeth concealed or failed to provide" FDA with "any relevant information about Phenergan," and FDA was "fully aware of the risks posed by IV-push administration of the drug (as was the treating physician) when making its labeling decision." He adds, "Despite claims to the contrary, because there was no new information regarding the risk or benefit of Phenergan, Wyeth couldn't unilaterally change the product's labeling without being in violation of federal law and contradicting FDA's expert judgment on how Phenergan could best serve the public."

A decision in favor of Wyeth in the case would not "close the courthouse doors to all pharmaceutical product liability claims" and would "only affect those cases in which a jury's verdict will conflict with a considered, scientific judgment by the FDA," Ruane concludes (Wall Street Journal, 11/6).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation.  All rights reserved.

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