Cigarette makers and drug companies could be shielded from many product liability lawsuits if the US Supreme Court decides to uphold two lower court rulings. Cigarette maker Philip Morris, which faces 30 lawsuits around the country stemming from so-called “light” cigarettes, and drug maker Wyeth have argued in separate cases that their products should be shielded from suits if they have been approved for use by a federal agency — such as the Food and Drug Administration — and a warning label is included. If the Supreme Court rules in favor of these companies, thousands of people suing over injuries caused by defective drugs and other products will lose the right to have their cases heard in court.
In the drug case, the Supreme Court agreed to hear Wyeth’s appeal of a $6.8-million verdict in favor of a Vermont woman whose arm had to be amputated after she was injected with Phenergan, a nausea medication. In April 2000, the woman went to a health clinic complaining of a migraine and nausea. The injection she was given punctured an artery in her arm, which led to gangrene. A Vermont jury agreed that Wyeth should have warned nurses and doctors against injecting the drug. But Wyeth said the suit should be thrown out because the FDA had approved the use of injections to administer its anti-nausea drugs and because the label warned against injecting the drug into an artery.
In the second case, the court agreed to hear an appeal from cigarette maker Philip Morris, which is being sued by smokers who say they were deceived by the company’s marketing into thinking that “light” cigarettes were less dangerous. Philip Morris attorneys say all these claims should be thrown out because the federally approved labels warned consumers of the dangers of smoking.
These two cases are similar to another appeal filed by medical device maker Medtronic the Supreme Court agreed to hear earlier this month. Medtronic claims that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. When it wrote the law, Congress didn’t specify that those federal standards preempted state common law claims. But Medtronic believes that the amendments do just that. Before the Supreme Court, the company argued that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.
Over the years, Congress has had several opportunities to enact the type of shield laws Medtronic and the other companies want, but has declined to do so. Clearly, if Congress had intended such shields, they would be present in the Food, Drug and Cosmetic Act, or other laws. Unsuccessful in their attempts to get Congress to do their bidding, Wyeth, Medtronic and Philip Morris are trying to get the Supreme Court to take on an active role in rewriting the law to suit their needs.
One legal expert told the LA Times that rulings in favor of Medtronic and the other companies could do great harm to consumers. If the FDA’s approval is enough to shield a drug maker from being sued, “this could give drug makers an immunity from litigation they have long coveted,” Georgetown law professor David Vladeck said. “It also sends exactly the wrong message to drug companies. We know the names of drugs like Vioxx and Rezulin because of the failures of FDA regulation.”
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