Wyeth’s appeal failure could impact US drug labelling

By Gareth Macdonald

- Last updated on GMT

Related tags: Supreme court of the united states, Fda

Yesterday’s US Supreme Court decision upholding a $7m damages award to a Vermont woman who sued Wyeth means that drugmakers are still vulnerable to State consumer liability lawsuits despite FDA approval for a drug and its labelling.

Diana Levine, who lost an arm to gangrene after Wyeth’s nausea treatment Phenergan (promethazine) was given in an IV push, won the original case on the basis that although the drug’s label warned against such administration it did not explicitly advise against the technique.

Wyeth appealed the ruling arguing that not only did Phenergan’s Food and Drug Administration (FDA) approved label provide “clear instructions and warnings​” but that federal law prevented the firm from modifying the administration guidance.

The company’s contention failed to persuade Supreme Court Justice John Stevens who said that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness​.”

Stevens said that the company could have strengthened the warnings prior to the Levine case, citing evidence of more than 20 Phenergan-associated amputations over the last forty years.

He added that: “Wyeth could have analysed the accumulating data and added a stronger warning about IV-push administration of the drug,"​ concluding that "manufacturers, not the FDA, bear primary responsibility for their drug labelling at all times​."

A contrary opinion came from Samuel Alito, one of the three Justices to vote against upholding the award in the split 6-3 decision. He argued that such cases could interfere with the US drug approval system.

Alito said that while state tort suits can coexist with the FDA’s labelling laws it is “[a] far from peaceful coexistence,” ​adding “the FDA told Wyeth that Phenergan’s label renders its use ‘safe.’ But the State of Vermont…said: ‘Not so​.’”

A Wyeth statement presented a similar argument in its response. The company said that: “When lay juries are permitted to second-guess the experts at FDA on the benefits and risks of particular medicines, the result is uncertainty for patients and doctors alike about how and when to use prescription drugs​.”

Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson’s reaction was along the same lines. He said that: “scientists …at the FDA are in the best position to evaluate voluminous information about a medicine’s benefits and risks and to determine which safety information to include in the drug label​.”

Johnson added that: “patients could ultimately suffer if the Supreme Court’s decision forces healthcare providers and patients to second-guess FDA-approved labelling​.”

The FDA declined to comment on the ruling.

Related topics: Markets & Regulations

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