It is now legal to sue drug manufacturers for personal injuries or wrongful death caused by a dangerous drug or the failure of a pharmaceutical manufacturer to give a proper warning about the use of a product. That is what the Supreme Court decided in a 6-3 vote in a rare pro-consumer decision by upholding a jury verdict and a Vermont Supreme Court decision. A jury in Vermont decided in Wyeth vs. Levine that a woman whose right arm had to be amputated as a result of a drug manufacturer’s failure to warn was entitled to $6.7 million.Wyeth makes Phenergan the drug that caused the amputation. Federal preemption is the legal theory claimed by negligent drug companies. Wyeth argued that FDA approval of a drug gives the manufacturer immunity from liability in state courts for damages caused by the drug, or in this particular case, by the method used to deliver the drug to a patient.
The plaintiff in the case is Diana Levine, a former violinist. She received Phenergan intravenously when a physician’s assistant injected the drug into an artery. That caused gangrene, excruciating pain and the amputation of her arm. The damage occurred because the physician’s assistant used the dangerous IV push method to inject the drug.
The issue in Wyeth vs. Levine was defective labeling of Phenergan. Wyeth’s label did warn against injections close to arteries, but the jury found that the warning was not adequate, and that Wyeth could have done more to prevent such a problem. The Supreme Court subsequently ruled that Wyeth could not hide behind preemption.
The idea of preemption for drugs is so harmful to consumers that some officials inside the FDA have strongly objected to it. And, the dangers from preemption could spread far beyond drugs because, in theory, it could apply to any business that receives government approval for any product that it sells.
In their complaint, those FDA officials stressed that lawsuits brought by consumers injured by drugs had been important complements to the agency’s regulations. They also said that the Bush administration had worked hard in its final months to eliminate many safeguards for consumers.
In Wyeth vs. Levine, Wyeth argued that if a state and the federal government both have a consumer protection law that addresses the same issue, the weaker law should prevail. Wyeth said that it should not be responsible for the damage caused by the company’s failure to strengthen its label, even after other amputations had occurred. The Supreme Court disagreed and ruled in favor of a state’s right to protect its citizens.
The Supreme Court decided this case strictly according to the law, but if the court had taken into account two directly related factors that affect the well-being of consumers, the decision would have been more easily made.
The first consideration is the current state of the FDA. By all accounts, the agency is overworked and underfunded. It has consistently failed to protect American consumers from dangers posed by foods and drugs, and to treat its approvals as the final possible word would subject consumers to needless dangers.
The second factor is that drug makers such as Wyeth have frequently conducted themselves in highly unethical ways. If the FDA were absolutely perfect in its job, and if the drug companies were models of ethical behavior, preemption would still be a bad idea. Put a broken agency and unethical drug companies together, and they make life very dangerous for consumers.
Wyeth vs. Levine is an important step for consumers’ rights, but it creates a glaring contradiction in consumer protection laws. While the Supreme Court has ruled in favor of consumers’ right to sue in state court for damages caused by drugs, medical device makers still enjoy preemption under the Medical Device Amendments (MDA) of 1976.
The Medical Device Amendments grants makers of Class III devices, such as replacement heart valves and balloon catheters, immunity from lawsuits if the FDA has approved the device and the marketing behind it. In a ruling in 2008, the Supreme Court sided with the device makers, but Wyeth vs. Levine is certain to bring new and needed attention to preemption for medical device makers by Congress.
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