Happy family

Find a legal form in minutes

Browse US Legal Forms’ largest database of 85k state and industry-specific legal forms.

Rejection of Limits on Litigation Against Drug Companies

The US Supreme Court rejected limits on litigation against drug companies on Wednesday in Wyeth v. Levine, when it held that drug companies must comply with state product liability laws, not just labeling approval requirements of the Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act. The court upheld a $6.7 million verdict awarded to Diane Levine in a negligence and failure to warn product liability suit. Levine ultimately lost her arm after an intravenous injection of the migrane and anti-nausea drug, Phenergan, caused gangrene.

Wyeth contended any additional warnings based on state recommendations would have violated the FDA’s requirements as the FDA alone can approve drug safety and it had already done so based on the drug’s label, which did not include such warnings. Justice Stevens noted that Wyeth had become aware of at least 20 previous cases of a Phenergan injection resulting in gangrene and amputation and stated:

‘If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA’s 70-year history. … Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.’

Source: http://jurist.law.pitt.edu/paperchase/2009/03/supreme-court-rules-state-law-not.php
http://news.findlaw.com/ap/other/1110/03-05-2009/20090305015009_01.html