Medical Devices and Prescription Drug Policy

Supreme Court weighs limits on lawsuits over dangerous drugs

{mosads}Oral arguments are an imperfect guide to how the justices are likely to rule, and the justices peppered lawyers on both sides of the case with skeptical questions. 

The case deals with a woman who was badly injured by a generic painkiller. Most of her skin burned off and turned into an open wound, causing permanent disabilities. 

She sued the drug maker, arguing that its product was too dangerous — even though the drug was approved by the Food and Drug Administration (FDA), and its label warned about the disease she developed.

Attorneys for the drug company and the Justice Department argued that her suit should be “preempted” by federal laws that require the FDA to balance risks and benefits when it decides whether to approve a new drug. Juries shouldn’t be able to second-guess those expert determinations, they argued.

“What we’re trying to do is protect the FDA’s role here,” said Anthony Yang, who represented the federal government.

State laws are generally preempted by federal laws when it’s impossible to comply with both. But Justice Elena Kagan, along with other traditionally liberal members of the court, questioned whether there’s actually a conflict between FDA approval of a drug and a court ruling that says the drug shouldn’t have been sold.

The FDA doesn’t require companies to sell a drug, it only allows them to, Kagan argued.

The Supreme Court ruled in a 5-4 decision in 2011 that patients can’t sue over the warning labels on generic drugs — a far more common type of lawsuit. The claim in this case isn’t just that the drug’s label is insufficient, but that it was too dangerous to sell in the first place — at least without making hefty payments to the patients who suffer severe injuries.

“Here, no words would have made any difference,” said David Frederick, who argued on behalf of the patient.

A ruling is expected this summer.


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