(CN) – The U.S. Supreme Court on Wednesday ruled 6-3 that the federal law does not prevent a patient from filing a state-law tort claim against drug maker Wyeth, after insufficient warning labels on the anti-nausea drug Phenergan led to the amputation of her right forearm.
When a clinician injected Phenergan directly into Diana Levine’s vein, known as the “IV-push” method, the corrosive drug entered her artery and caused her to develop gangrene. Because the damage was irreversible, doctors had to amputate first her right hand and then her entire forearm.
Levine settled claims against the health center and clinician, but brought a state-law claim for damages against Wyeth, alleging negligence and strict liability.
Phenergan’s labeling warned of the danger of gangrene and amputation if the drug is accidentally injected into a nearby artery, but Levine said the label should have instructed clinicians to use the safer IV-drip method of administration.
“More broadly, she alleged that Phenergan is not reasonably safe for intravenous administration because the foreseeable risks of gangrene and loss of limb are great in relation to the drug’s therapeutic benefits,” Justice Stevens summarized.
Wyeth moved to dismiss, claiming the failure-to-warn claims were pre-empted by Food and Drug Administration regulations. The FDA had approved Phenergan’s label in 1998.
After a five-day trial, a jury found Wyeth negligent and awarded Levine $7.4 million, which the court reduced to take into account her earlier settlement.
Both the trial court and the Vermont Supreme Court concluded that the verdict didn’t conflict with the FDA’s labeling requirements, because Wyeth could have included a stronger warning without the agency’s approval.
The trial court added that the amputation would not have occurred had there been an adequate warning label.
Wyeth argued that it would have been impossible to comply with the state-law labeling requirements without violating federal law. It also claimed that the state tort action impermissibly substitute’s a jury’s decision about drug labeling for the FDA’s expert judgment.
The high court rejected those arguments, saying Congress “took care to preserve state law” when it expanded the FDA’s powers.
Moreover, Congress did not require the FDA to pre-approve all changes to drug labels when new safety information surfaces, the court noted.
“Instead, it adopted a rule of construction to make it clear that manufacturers remain responsible for updating their labels,” Stevens wrote.
“[The FDA] cast federal labeling standards as a floor upon which States could build and repeatedly disclaimed any attempt to pre-empt failure-to-warn claims,” the court concluded.
Justice Alito wrote the dissenting opinion, joined by Justice Scalia and Chief Justice Roberts.
“This case illustrates that tragic facts make bad law,” Alito wrote. “The Court holds that a state tort injury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs.”