The U.S. Supreme Court says pharmaceutical companies can be sued in state court over alleged drug effects, even if the Food and Drug Administration has approved the medication and its warning label.
In what some are describing as a landmark decision Wednesday in Wyeth v. Levine, No. 06-1249, justices voted 6-3 against the drug giant and issued a major defeat to the pharmaceutical industry. The majority determined that the federal regulation and warning label approval doesn't preempt state laws and shield companies from damages as part of liability claims.
The decision is a blow to companies such as Indianapolis-based Eli Lilly, which have long sought to establish federal oversight as a single standard for preempting state law and had support from the Bush administration that pushed to shield pharmaceutical industries from negligence suits.
Critics say this Wyeth ruling could lead to a flood of litigation in state courts, while others contend it simply reinforces what should already be happening.
Indianapolis attorney Irwin Levine, who has no connection to this case but represents multiple plaintiffs against Wyeth in other cases nationally, said the SCOTUS decision makes a lot of sense.
"The FDA, which we all know is overburdened, underfunded, and can't even keep our food supply safe, is not the end all, be all for consumer safety," he said. "Drug companies wanted a free pass, but the court determined that the FDA approval is not a get-out-of-jail-free card."
Justices found in favor of Diana Levine, a once-professional musician who received a $6.8 million jury award in Vermont after she developed gangrene and lost her right forearm because of how Wyeth's anti-nausea drug, Phenergan, was administered. The trial court concluded that Levine's injury would not have occurred if the drug's label had included an adequate warning about the significant risks of delivering it by means of the IV-push method.
The court rejected the drug maker's arguments that the FDA had approved warning labels for the drug and that trumped state law under which the suit was filed.
"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly," authoring Justice John Paul Stevens wrote. "They also serve a distinct compensatory function that may motivate injured persons to come forward with information."
Justice Stevens wrote a footnote that conceded the FDA has "limited resources to monitor the 11,000 drugs on the market," and he mentioned a series of studies lamenting the federal agency's inability to use its drug-approval authority to ensure that pharmaceutical companies are doing all that they must do to warn doctors and patients about the risks of new drugs and of the methods of administering them to patients.
Writing for the minority, Justice Samuel Alito called the ruling a "frontal assault" on the FDA's regulatory regime for drug labeling and that the warnings in this case sufficiently warned of the possible dangers.
"This case illustrates that tragic facts make bad law," he wrote.
"The unfortunate fact that respondent's healthcare providers ignored Phenergan's labeling may make this an ideal medical malpractice case," he later wrote.
Indianapolis attorney Scott Montross said he finds it refreshing that the court refused to accept the attempts to further extend the preemption limitation, which had come from a ruling last year denying plaintiffs the right to sue medical-device makers because of express language.
Justice Stevens' recognition that Wyeth received notice about 20 similar incidents but didn't attempt to strengthen the warning label shows the dangers of what could have happened in this case had the decision been different.
"(That) demonstrates how dangerous it is to cloak a manufacturer with any immunity, be it for prescription drugs or medical devices," Montross said. "The pre-emption doctrine removes the incentive to the manufacturer to monitor the use of its products and to take reasonable steps to protect innocent patients."