The US Supreme Court has upheld the right of a woman injured after an accident while she was being injected with Wyeth’s antinausea drug Phenergan to sue the company, even though the drug carried federally-approved warnings.

In a 6-3 verdict handed down yesterday, the judges upheld a ruling by the Vermont Supreme Court awarding musician Diana Levene $6.8 million in damages after she developed gangrene as a result of Phenergan (promethazine) accidentally being injected into one of her arteries. Ms Levene, a guitarist who lost her hand and forearm as a result of the accident, was being treated with the drug for migraine.

Ms Levene’s suit, brought under Vermont law, argued that Phenergan’s Food and Drug Administration-approved labelling did not warn sufficiently against the potential dangers of injecting the drug rather than administering it through an intravenous drip. A state jury agreed and awarded her damages, and the Vermont Supreme Court then affirmed that FDA-approved labelling did not protect a drugmaker from being sued under state law.

Wyeth’s case was that the FDA had determined Phenergan to be safe and effective, and it called on the national Supreme Court to rule that federal law pre-empts product liability cases brought under state laws which challenge the adequacy of FDA-approved label warnings.

Wyeth was supported by an amicus curiae (friend of the court) brief filed by the Bush Administration through the Justice Department, which argued that Ms Levine’s claims would be pre-empted by federal law because they challenge labeling which had been approved by the FDA after it was informed of the relevant risk.

Another amicus brief, filed jointly by the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO), also pointed out that “state law cannot require what federal law prohibits.” Moreover, it warned the Court that allowing the Vermont judgement to stand would “encourage pharmaceutical companies to inundate FDA with requests for labelling changes to ensure that federal regulators have been presented with every potential labeling permutation. These requests, driven by the need to create a record for future litigation rather than science, will distract agency scientists from their core mission of reviewing the safety and effectiveness of prescription medications.”

However, the highest US court ruled yesterday that it had not been persuaded by these arguments that “failure-to-warn claims like Levine’s obstruct the federal regulation of drug labelling.”

Wyeth could have chosen to add a stronger warning about the way the drug was given to Ms Levene, said the judges, adding that there was no evidence that the FDA would have turned down such a move and concluding that the manufacturer is responsible, at all times, for the labelling of its product.

However, one of the three dissenting judges, Justice Samuel Alito, said the case showed that “tragic facts make bad law,” in that the court had found a state tort jury rather than the FDA to be “ultimately responsible for regulating warning labels for prescription drugs."