The U.S. Supreme Court recently ruled that consumers can sue drug makers for defective warnings, though earlier ruled consumers cannot sue medical device manufacturers if the device was FDA approved. This seemingly contradictory ruling claims federal law does not protect drug companies from product liability suits in state courts, though it earlier decided federal law prevents lawsuits against the manufacturers of such medical devices as heart stints and artificial joints. In the drug maker case, the defendant, drug manufacturer Wyeth, argued federal oversight of drug labels by the Food and Drug Administration (FDA) precluded state courts from hearing drug injury lawsuits; the Court ruled, however, that consumers may sue the manufacturer in state court for a defective warning. The Court distinguishes the two cases by pointing out that there are different legal issues involved.
Experts believe that after this decision, there may be an influx in the amount of lawsuits drug makers will face because the FDA approved label will not provide a cover for the industry. Drug maker supporters fear the verdict could make companies more reluctant to produce beneficial drugs if the drugs pose a high risk. The decision could also offer support to some members of Congress who are planning to introduce a bill that would supersede the Court’s medical device ruling, thus allowing injured people or their survivors to sue faulty device makers. Many hope the outcome will lead to more updated labels of possible side effects, though it would require FDA approval every time.
The Wyeth ruling was a victory for consumers – for normal citizens. It was a blow to big business, especially the pharmaceutical industry. If it could, the pharmaceutical industry would have the federal government give it blanket immunity from any law suits, no matter how egregious its conduct. Because the FDA is unable to adequately police the pharmaceutical industry (for a variety of reasons, including funding), one of the most effective checks on that industry is the product liability lawsuit. Wyeth gave this writer hope that that our Court is not turning into the “Corporation Court”, rubber-stamping whatever the industry wants.
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