The Cochran Firm Legal Blog

On March 4, 2009, the Supreme Court handed down its landmark decision on the 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. The court decided in Levine v. Wyeth against a general rule of preemption, stating that the Food, Drug, and Cosmetic Act (FDC Act), which gave the FDA its regulatory power over pharmaceutical drugs included no specific preemption clause.

Pharmaceutical injury victims breathed a sigh of relief, because this meant that FDA approval would not serve as a blank check for pharmaceutical companies to profit off a dangerous drug without adequately warning patients or doctors. However, the Supreme Court unfortunately left an open door for drug companies to shield themselves from state-based lawsuits on pharmaceutical injuries.

The Supreme Court stated that because drug companies could unilaterally change labeling to increase warning about dangerous side effects without waiting for the FDA to approve changes, drug companies 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. The only way a drug company could protect itself against lawsuits is by including adequate warning in its labels and submitting adequate warning language to the FDA. Whether the FDA approved the warning or rejected it, the application is important.

At least one major piece of litigation has already been affected by this: the case of McCarrell v. Hoffman-La Roche was remanded by the Superior Court of New Jersey for a new trial, partly because of the altered legal climate created by Levine v. Wyeth. In particular, 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 Andrew McCarrell, a user of Accutane to control acne, who developed inflammatory bowel disease (IBD) while taking the drug. As a result of his IBD, McCarrell had to have his colon removed, and suffered other serious medical complications. Trial court found in favor of McCarrell, granting a products liability lawsuit claim 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. The first sign occurred during pre-approval testing of the drug, when over 20 % of people taking the drug experienced gastrointestinal side effects. Then, after approval in both the United States and Europe, reports came in associating Accutane use with IBD. In response, Hoffman-La Roche added a generic warning about serious side effects that might begin with "severe stomach pain, diarrhea, rectal bleeding" or other symptoms, and telling patients they should talk to their doctors if they experience them. To doctors, they sent a letter saying that Accutane had been "temporally associated" with IBD. Despite internal data suggesting that there might be a stronger association, and a 1988 recognition that more research should be done, Hoffman-La Roche never conducted any clinical trials or epidemiological studies to determine whether a causal relation existed between Accutane and IBD.

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. In following the CBE system, a drug company could "add or strengthen a contraindication, warning, precaution, or adverse reaction," without waiting for FDA approval. The only exception allowed by the Supreme Court is when a drug company could show that it had applied for stronger warnings but had had the warnings rejected by the FDA. Thus, the Superior Court of New Jersey instructed Hoffman-La Roche that, if it wanted to receive preemption protection for its failure to put stronger warnings about IBD on its label, it had to produce evidence that it had applied for stronger warnings, but had them rejected by the FDA.

The outcome of Levine v. Wyeth is actually a win-win situation for those taking potentially dangerous prescription drugs. Either drug companies will see encouragement to report dangerous side effects as soon as these become known, or people injured can pursue lawsuits based on a failure-to-warn argument without having to worry about preemption by weak FDA warnings.

If you have been injured by a dangerous pharmaceutical or any other defective product, you need a firm with nationwide resources to fight the defenses put up by multinational corporations. The lawyers at the New York office of The Cochran Firm are prepared to stand by your side. Schedule a free drug injury lawsuit consultation today.

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