CAN A GENERIC DRUG MANUFACTURER BE LIABLE FOR INADEQUATE WARNINGS EVEN IF IT COMPLIES WITH FDA REQUIREMENTS?

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.

Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).

This case addresses the following issue:

Can a generic drug manufacturer be liable for inadequate warnings even if it complies with FDA requirements?

This case produced quite possibly one of the most controversial and unusual kinks of law in the past twenty years. Id. at 475. Federal law does not preempt an inadequate warnings claim for name brand drugs, meaning that simply using FDA mandates warnings is not sufficient to prevent liability for inadequate warnings. Id. This case determined that state law claims for inadequate warnings are preempted for generic drugs, because generic drugs are required to have the exact warnings name brand drugs carry. Id.

Petitioner manufactured and distributed a generic version of anti-inflammatory pain reliever. Id. at 477. Under FDA regulations and federal law, a generic drug must contain a word-for-word identical label as the name brand version of the medication. Id. In this case, Respondent suffered adverse effects from using Petitioner’s drug. Id. at 478. Respondent filed suit, alleging product liability based on inadequate warnings. Id. at 477. Petitioner argued that federal law preempted any state law claim. Id.

A few years earlier, the Court had determined that state law claims for inadequate warnings were not preempted by federal law in Wyeth v. Levine, 555 U.S. 555 (2009). This decision was made based on the fact federal law allows for additions to labels concerning further warnings about adverse effects. Id. at 493. This decision may make this case seem like an easy win for the injured individual, but the Court took an odd turn in deciding this case. Id. at 478.

Another federal law requires that a generic version of a drug have an identical label as that used by the name brand version. Id. at 489. Thus, where a name brand drug manufacturer is free to add additional warnings—which state law may require to avoid liability—a generic brand drug manufacturer is bound to follow exactly what the name brand manufacturer does. Id. These different obligations were the key in the Court’s decision. Id.

A generic manufacturer cannot obey both federal law and state law simultaneously, as demonstrated here. Id. Because of this conflict, the federal law preempts the state law and there can be no liability. Id. at 490. That was the case here, and judgment for the Petitioner was appropriate. Id.