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Preemption – How it Affects Your Safety

Tort laws are some of consumers’ best defenses against dangerous products and their manufacturers. When a pharmaceutical company endangers the health and safety of the public by putting faulty or mislabeled drugs on the market, tort law gives consumers the right to hold the manufacturer responsible by filing a lawsuit.

Now, a case set to be heard by the Supreme Court may take that right away. In Wyeth v. Levine, the Supreme Court will rule on the doctrine of preemption – essentially deciding whether Food and Drug Administration (FDA) approval of a drug prevents injured consumers from suing the drug’s manufacturer.

What is Preemption?

The doctrine of preemption holds that federal rules, such as those set by the FDA, “preempt,” or override, tort laws set by individual states. This means that an injured consumer would not be able to sue a drug’s manufacturer if that drug had previously gained FDA approval. In other words, preemption would give pharmaceutical corporations virtual immunity from lawsuits.

Wyeth v. Levine

In 2000, Diana Levine went to the hospital to get treatment for a severe migraine and nausea. She received Wyeth’s anti-nausea drug, Phenergan, via IV push. Unfortunately, when the drug came into contact with her arterial blood, Levine developed gangrene in her right arm, forcing doctors to amputate it.

Levine later sued Wyeth, pointing out that the drug’s labeling did not warn of the dangers associated with administration via IV push, even though Wyeth clearly knew about the strong possibility of gangrene.

The issue before the Supreme Court – whether Wyeth can shirk responsibility for Levine’s injuries simply because the FDA approved the labeling for Phenergan, or whether Wyeth should pay for failing to warn consumers and medical personnel of Phenergan’s risks. The Court heard arguments in early November and is expected to rule shortly.

Why is Preemption a Bad Idea?

If the Supreme Court upholds the doctrine of preemption, American citizens will lose a vital layer of protection against careless, negligent, or greedy corporations. Consumers’ only shield against dangerous products would be government regulatory agencies like the FDA.

Unfortunately, history shows that agencies like the FDA are far from foolproof. Dangerous medications, such as dexfenfluramine and rofecoxib, were initially granted FDA approval but were removed from the market years later after being linked to serious, often life-threatening side effects. Numerous advocacy groups have also criticized the FDA in recent years for allegedly being influenced by the very pharmaceutical companies they should be regulating.

Furthermore, because only Congress has the authority to preempt state law, the new language adopted by the FDA and other agencies may be unconstitutional in the first place. Read the American Association for Justice’s report on the dangers of preemption here.

In short, allowing federal agencies to unilaterally preempt state tort laws and give drug companies immunity from tort litigation would put countless American consumers at risk and bar them from seeking compensation in case of serious injury. Williams Hart believes that corporations should not be allowed to hide behind the doctrine of preemption; we hope that you will join us in opposing the efforts of big business to take advantage of the American consumer.

About Williams Hart

For 25 years, Williams Hart has fought for the rights of injured consumers, often against large, wealthy corporations. For more information on our firm, please contact us at (800) 220-9341.

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