The Supreme Court handed down a long-awaited decision in the important dangerous drug lawsuit Levine v. Wyeth. In making its decision, the Court decided against a general rule for preemption of state-based dangerous drug lawsuits by the Food and Drug Administration’s (FDA) regulatory power over the labeling and use of pharmaceutical drugs. This allows lawsuits to go forward against manufacturers of dangerous drugs, even if the drug and its labeling received explicit approval from the FDA for the application responsible for the injury.
However, the Supreme Court unfortunately left an open door for drug companies to shield themselves from state-based lawsuits on pharmaceutical injuries. Drug companies, the Court said, could be held liable for any potential injuries they knew were a risk and either failed to mention or did not adequately communicate in their labeling. But the company could be protected if it could prove it submitted adequate warning language to the FDA, even if the FDA rejected the change.
Accutane lawsuits now hinge on this question. The case of McCarrell v. Hoffman-La Roche was sent back to a trial court by the Superior Court of New Jersey, partly because of the Superior Court of New Jersey established a standard of proof that Hoffman-La Roche must meet to be protected under the Levine v. Wyeth decision.
The case stems from injuries suffered by a user of Accutane to control acne, who developed inflammatory bowel disease (IBD) while taking the drug and had to have his colon removed. Trial court found in favor of McCarrell, granting a products liability lawsuit judgment against Hoffman-La Roche.
The trial court found that Hoffman-La Roche had more than sufficient justification to further investigate the connection between Accutane and IBD and put a strong warning about IBD on the labeling.
In its appeal, Hoffman-La Roche wanted the Superior Court of New Jersey to throw out the verdict because the state-based tort lawsuit was preempted by federal law. Hoffman-La Roche claimed it could not strengthen the label for Accutane without FDA approval of the text. But, as affirmed by the Supreme Court in Levine v. Wyeth the FDA’s “changes being effected” (CBE) system allowed for just such a unilateral action. The Superior Court of New Jersey instructed Hoffman-La Roche that, to receive preemption protection for its inadequate warnings about IBD, it had to produce evidence that it had applied for stronger warnings, but had them rejected by the FDA.
Levine v. Wyeth is a win-win situation for those taking potentially dangerous drugs. Either pharmaceutical companies will see encouragement to report dangerous side effects as soon as these become known, preventing further injuries, or people injured can pursue lawsuits based on a failure-to-warn argument without having to worry about preemption by weak FDA warnings.
Accutane lawsuits are currently going forward. If you are an Ohio resident who suffered inflammatory bowel disease or other digestive condition as a result of Accutane use, your window for filing a lawsuit may be closing. Schedule a free, no-obligation Accutane lawsuit consultation with the drug litigation lawyers at Robert W. Kerpsack Co., L.P.A. today.