The outcome of the Phenergan-based case, now before the U.S. Supreme Court, will have a major impact on the concept of drug recalls, the Food and Drug Administration’s (FDA) role, and the ability of healthcare consumers to sue for damages caused by defective or dangerous drugs.
Loss of a Limb after Drug Treatment for Migraines
Musician Diana Levine sued Phenergan’s maker, Wyeth Pharmaceuticals, after she lost her hand and forearm due to gangrene caused by an incorrect administration of the drug for her migraine headaches. A Vermont jury awarded her $6.8 million in compensatory and punitive damages, and Wyeth appealed the decision. The case was recently heard by the Supreme Court, and a decision by the Court is expected in early 2009.
Pre-emption by Federal Law?
The case turns on the question of whether federal law pre-empts (or takes precedence over) state laws such as those of Vermont. Phenergan’s warning label information had been screened and approved by the FDA.
Loss of Opportunities to Be Compensated for Losses
If the Supreme Court agrees with Wyeth — that federal law should take precedence and that the FDA’s approval on a warning label takes precedence — thousands of individuals who have been hurt by dangerous drugs or medical devices will not have legal recourse in American courts. Wyeth’s attorneys argued that Levine cannot sue them for failure to warn about a side effect, because the FDA Okayed the Phenergan labeling that included a relevant warning. Levine’s lawyers noted that she was never told about the warning or the risk.
All drugs approved by the FDA have warning labels, but so many drugs and medical devices that were approved by the FDA have been found to be dangerous and their manufacturers have been held liable for billions of dollars’ worth of damages to consumers. Vioxx, silicone breast implants, Redux, and Avandia are just a few of the more well-known examples; hundreds more are listed on this website.
(Source: Forbes)
If you’ve been harmed by a defective drug, contact us to speak with a defective drug attorney.
