Drug Lawsuit Preemption Case. The Supreme Court finally heard arguments today in a case involving drug personal injury lawsuits. Reports indicate that the Justices had tough questions for parties on both side of the argument, and right now, no one is predicting which way the High Court will rule.
At issue is whether or not Food & Drug Administration (FDA) approval of a drug bars state product liability lawsuits against a manufacturer.
The case being heard, Wyeth vs. Levine, involves a Vermont woman who alleged she lost her arm from adverse events tied to Wyeth’s nausea and motion sickness drug Phenergan. Levine, who was awarded more than $6 million in her state court claim against Wyeth, said she was administered Phenergan at her local hospital emergency room.
The product normally is administered intramuscularly, but hospital staff used a method called I.V. push of injecting the drug into her vein, which resulted in an inadvertent arterial injection.
Inadvertent arterial injection of Phenergan is known to be dangerous. Levine, a guitar player, developed gangrene in her arm, which resulted in it being amputated.
Levine has contended that Phenergan’s labeling failed to adequately warn
Levine has contended that Phenergan’s labeling failed to adequately warn about the dangers of using the I.V. push method. In 2000, the same year Levine sustained her injury, Wyeth changed the label of Phenergan to warn that the drug should not be given by intra-arterial injection because of the risk of gangrene.
Wyeth claimed that the FDA had weighed the risks and benefits of Phenergan in approving the drug’s prescribing literature, or label, as a guide for doctors.
The FDA was aware of risks associated with injecting some forms of Phenergan, but did not require the label to specifically warn about the technique used with Levine. Wyeth claims that the FDA’s judgment in such matters cannot be overruled by a state court.
During oral arguments today, the Justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval.
“Wyeth could have gone back to the FDA anytime” to update the label, said Justice David Souter. “And it simply didn’t do it.”
The drug’s label carried warnings about that
The attorney for Wyeth argued the FDA already knew that improperly administering Phenergan through an IV-push method, which happened to Levine, could result in problems and said the drug’s label carried warnings about that. But the lawyer for Levine argued that the warning was weak.
But Justice Antonin Scalia, called Phenergan’s label “muscular” and questioned whether the burden was on the FDA, not Wyeth, to ensure the label properly reflected the risks associated with the drug.
Both the FDA and the Bush Administration back Wyeth’s position. Consumer groups, on the other hand, argue that it is vital that a consumer’s right to sue over a defective drug are fully upheld.
They point out that the FDA approval process does not always catch safety problems, and in some instances, drug makers purposely withhold vital information from the agency. As a recent editorial in the New England Journal of Medicine pointed out, often litigation is the only way such wrongdoing is ever made public.
While the FDA’s public stance is in favor of lawsuit pre-emption, documents released last week by a congressional investigation show that officials within the agency were concerned about that stance, saying it isn’t consistent with the agency’s role to protect the public health.