Phenergen Dangerous Drug Lawsuit Paves Way for Liability
The U.S. Supreme Court took a significant step forward in personal injury law on March 4, 2009 when deciding the case Wyeth v. Levine. In Wyeth v. Levine, a Vermont musician, Levine, brought action against Wyeth, the makers of Phenergen, because Levine developed gangrene after receiving an injection of the drug into her artery. The delivery technique used, known as an “IV push,” is not supposed to inject medication into patients’ arteries, although there is a known risk of such an outcome. In this case, an arterial injection led to Levine developing gangrene, which resulted in amputating her arm and ending her music career.
Both Wyeth and the FDA were aware of the risks associated with the “IV push” injection method, but did not prohibit this type of medication delivery. In fact, the FDA approved labeling for Phenergen, and simply warned against the IV push delivery technique. Levine claimed that the Phenergen label was inadequate, thus posing marketing misrepresentation, because it did not prohibit a harmful type of drug administration, but Wyeth countered that its use of the warning label complied with FDA regulations.
Basically in this case, Levine could use Vermont tort (injury) law to win her claim, but Wyeth was claiming that federal law, based on the FDA regulations, preempted the product liability claim. Meaning, because the federal and state law differed on the issue of warning label adequacy, Wyeth said federal law should be used over state law, and therefore, Levine did not have a claim against the drug manufacturers of Phenergen. However, the Supreme Court did not agree with this argument and upheld the Vermont verdict for the nearly $6.8 million dollars awarded to Levine.
The court found that state tort law can always add more protection for the benefit of its citizens- it simply cannot offer less protection than federal law. The court said, “state law offers an additional, and important, layer of consumer protection that complements FDA regulation.” This means that even if a drug has been given approval by the FDA, patients who are injured by medications can still sue the drug’s manufacturer for damages based on state law. This is a tremendous victory in the realm of personal injury law because it means that an FDA warning is no longer the “end all” in terms of drug manufacturer liability with harmful drugs.
If you or a loved one has been injured by any medication, please contact me for a free consultation. I am happy to discuss your case and legal options with you. As founding partner of Page//Cagle, a top Missouri Personal Injury Law Firm, I represent injured clients every day. Call me at 314.322.8515 or toll free at 1.800.500.INJURY (4658). You can also email me at john@pagecagle.com or visit www.injuredclient.com for more information. You pay nothing unless you recover.