In a highly anticipated decision, the U.S. Supreme Court has ruled that federal law does not preempt state law claims alleging that drugs were not adequately labeled. It is a major victory for those who have been injured by dangerous or defective drugs – and a huge setback for drug companies.

What the ruling means

The Supreme Court, the highest court in the nation, ruled 6-3 that those injured by an inadequately labeled drug can bring a lawsuit against a manufacturer in state court. In the past, drug companies claimed that they were shielded from those lawsuits because the U.S. Food & Drug Administration (FDA) is responsible for approving drugs. The term is known as preemption, but the high court disagreed with drug industry’s argument.

Writing for the Court, Justice John Paul Stevens said that the drug industry’s argument, "relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to preempt state law.” In other words, the industry’s argument simply goes too far. In its reasoning, the Court explained:

Wyeth* suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the Federal Drug and Cosmetics Act and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its labels at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.

*Wyeth Laboratories vs. Levine, No. 06-1249, March 4, 2009

Consumers win – big

Consumers who have been injured due to dangerous or defective drugs will definitely consider the Court’s ruling a victory – a big victory. Thousands of lawsuits brought by those who have been injured by dangerous or defective drugs have been dismissed against manufacturers in the past simply because manufacturers played their preemption card. However, injured victims can now get their day in state court.

If you’ve been injured due to a dangerous or defective drug and would like to find out how this important ruling affects you, contact an experienced drug litigation attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.