U.S. Supreme Court Rules FDA Approval Does Not Bar Pharmaceutical Injury Lawsuits

By March 12, 2009Dangerous Drugs

As a pharmaceutical injury lawyer, I was delighted with the U.S. Supreme Court’s March 4 ruling that drug manufacturers may not escape legal liability simply because their warning labels comply with FDA regulations. Wyeth v. Levine (06-1249). As the New York Times reported, the court ruled 6-3 that there is no implied preemption in federal law that would stop state juries from hearing drug injury lawsuits. The case was closely watched by pharmaceutical companies as well as drug injury lawyers around the country, because it had the potential to stop all drug injury claims, no matter how valid the claim or serious the injury.
The case was brought by Vermont resident Diana Levine, who visited a health clinic for migraine headache treatment. For her nausea, she was given an injection of Phenergan, a drug made by Wyeth. Phenergan is safe when injected into a vein, but causes swift and irreversible gangrene when exposed to blood in arteries. The assistant at the clinic made a mistake, and Levine lost her hand and lower arm — and her livelihood as a musician. She sued and settled with the clinic, but also sued Wyeth, arguing that the manufacturer failed to sufficiently warn users about the risks of administering Phenergan incorrectly.
At trial, Wyeth argued that it should not be held responsible for Levine’s injury because it had followed all of the FDA labeling regulations that applied to the drug. It said the court should find that federal law preempts state claims through implied, not explicit, language. The Supreme Court rejected that argument, saying that Congress had explicitly stated that several federal laws preempt state laws and had the opportunity to include such language in drug regulations — but chose not to. In fact, wrote Justice John Paul Stevens, the FDA welcomed dangerous drug lawsuits as a complement to its own work until 2006, when it underwent “a dramatic change in position” under the Bush Administration. He also criticized the FDA at length for its toothlessness in recent years.
As a dangerous prescription drug lawyer, I am delighted with this ruling, which ensures that people who have suffered permanent injury or lost a loved one to a defective medication can continue to seek justice through state courts. If the court had found that federal law does preempt state claims, it would have eliminated many valid pharmaceutical liability lawsuits brought by seriously hurt people. The painkiller Vioxx, for example, became the subject of thousands of lawsuits after it was revealed to quadruple patients’ chances of serious heart attacks and withdrawn from the market amid allegations that drug maker Merck knew about the problem long before it took action. None of those people would be able to hold Merck responsible for their injuries, or the deaths of their loved ones, if the preemption argument had prevailed.
I can always practice a different kind of law. But for my clients, a ban on dangerous drug litigation leaves them with no recourse if they have been seriously harmed by a drug maker’s irresponsibility — even if, as was alleged with Vioxx, the manufacturer knowingly exposed its customers to serious harm. Thanks to the Supreme Court, patients still have that option. If you or someone you love was seriously hurt by a defective prescription drug, Carey, Danis & Lowe can help. To set up a free consultation about your defective drug claim, please contact us through our Web site or call 1-877-678-3400.