CAN A PRESCRIPTION DRUG MANUFACTURER BE LIABLE UNDER STATE LAW FOR INADEQUATE WARNINGS, EVEN IF THE LABEL CONTAINED ALL WARNINGS REQUIRED BY THE FDA?

Sometimes the black letter law passed by the legislature is unclear. The legislature can’t anticipate every possible fact scenario when they pass a law, so it lay to the courts to interpret the law and give guidance to what it means. This interpretation is called case law. When the court decides a certain meeting to the law it essentially answers a legal question. Lawyers and other courts then can rely on that ruling when they have a similar issue in their case. The following case answers the question above.

Wyeth v. Levine, 555 U.S. 555 (2009).

This case addresses the following issue:

Can a prescription drug manufacturer be liable under state law for inadequate warnings, even if the label contained all warnings required by the FDA?

Products, including medications, can be defective in three ways: defective in design, defective in manufacture, and defective because of inadequate warnings. In this case, the Court dealt with whether labeling requirements imposed by the FDA, which a medication manufacturer must follow to release its medications, preempted state-law claims for inadequate warnings. Id. at 558. Finding that the FDA only set a floor as to what was required so far as warnings were concerned, the Court concluded a state-law claim could exist for inadequate warnings in addition to those required by the FDA. Id. at 559.

This case arises from Phenergan, an anti-nausea medication used in hospitals and manufactured by Petitioner. Id. The FDA approved the prescription drug for release and mandated certain warnings be included with the medication. Id. The medication was generally administered via drip IV, where it is mixed with a saline solution. Id. This is because the medication is highly corrosive if it enters an artery, which can occur when the medication is directly injected into an IV. Id. at 560. Respondent had the drug administered in this way, and the medication entered an artery in her right arm, causing the arm to develop gangrene and eventually have to be amputated. Id. A jury found that the drug did not contain adequate warnings about direct injections, despite complying with the FDA’s mandated warnings. Id. at 561. Petitioner argued that the claims for inadequate warnings were preempted by the FDA’s mandated warnings. Id. at 563.

The Court began by noting that its recent decisions had found preemption in many product liability claims arising from medical devices. Id. at 565. However, this case was a bit different. Id. The FDA did require that specific warnings appear on labels for medications as part of its release. Id. at 568. However, the FDA specifically allowed for a drug manufacturer to make additions to these labels when those additions “add or strengthen” warnings or precautions about the medication. Id.

Relying on this ability to modify labels, the Court found that there was no preemption. Id. at 569. The federal law and state law did not impose conflicting or contrary obligations upon Petitioner; in fact, the federal law directly allowed Petitioner to do what the jury found it should have done by adding an additional warning. Id. Thus, a name brand drug manufacturer can be liable for inadequate warnings even if the drug’s label complies with the FDA’s mandated warnings. Id.