SUPREME COURT RULES AGAINST PHARMACEUTICAL GIANTS
The United States Supreme Court held 6-3 today that FDA regulations do not trump state law to the contrary and that state-law tort claims are not preempted by the FDA’s approval of labeling after being informed of the relevant risk.
As previously blogged about, Diana Levine lost her arm due to complications after being given the anti-nausea medication Phenergan, manufactured by pharmaceutical giant, Wyeth, incorrectly. Levine sued Wyeth in a Vermont state court and was awarded over $6 million in a jury trial. This verdict was upheld by both the state appellate and supreme courts. Wyeth then appealed to the U.S. Supreme Court, contending that the drug’s labeling and warnings were FDA-approved and that FDA regulations trump state laws to the contrary.
The Supreme Court ruled against Wyeth today, holding that the FDA's oversight of drug labeling doesn't prevent the filing of state-level consumer liability lawsuits against drug companies. So what does this mean? This is a victory for American consumers. The Supreme Court has allowed consumers to retain their remedy under the law when drug companies fail to provide adequate warnings for the safe use of their drugs. And as Levine's lawyer noted, this decision "reaffirms the important role state law plays in promoting consumer safety and providing compensation for injuries." To read the full court opinion, please click here.
