Wyeth v. Levine!

Wyeth v .Levine!!!! Plaintiffs’ lawyers have seen drug (and medical device) injury victims take punch after punch. But in a huge win for patient safety, the Supreme Court upheld in a 6-3 ruling today that in a Vermont woman’s verdict against Wyeth for injuries she suffered after taking one of the drug maker’s medicines. Justice John Paul Stevens, writing for the majority, said FDA oversight of drug labeling doesn’t prevent the filing of state tort claims.

It is a little bit pathetic that this is a huge win. Gee, the law for the last 90 years is not going to be completely uprooted. Yippy! But the Drug and Device Law Blog predicted victory and those guys have been on the winning side of most everything lately. (A guest Drug and Device Law blogger also broke down the justices individually and predicted victory but I cannot find the post to link to it.) So I’ll admit I was more than a little scared. Now, I’m thrilled that even this conservative Supreme Court found decisively in favor of the Plaintiff.

The one downside: a loss may have mobilized Congress to act. This win in Wyeth v. Levine could ironically slow progress on a bill to overturn Medtronic v. Riegel.

You can find an article on the verdict here. You can find the Supreme Court opinion in Wyeth v. Levine here.

  • laura schmitz

    Mr Miller,
    Like you, I celebrate the Supreme Court’s wise decision to uphold Diane Levin’s verdict against Wyeth.

    Unlike you, however, I am hopeful that this decision will serve as a catalyst for Congress to pass a law that clarifies that, like drugs, medical devices manufacturers are not preempted from lawsuits because the FDA has approved them. I have to believe that this will be a wake-up call to Congress that they must act immediately to make clear that the wording in the Medical Device Amendment of 1976 was not meant to remove all accountability from medical device manufactures.

    My family and I stand as victims of a medical device manufacturer whose product killed our mother. Our lawsuit against the manufacturer has basically been put on hold until Congress clarifies their intent. While I’m thrilled that accountability has not been removed from drug manufacturers, I stand in wonder, hoping that Congress will move quickly to remove the preemption that was handed to medical device companies last February by the Supreme Court.

    Like drugs, Class 3 medical devices are approved and overseen by the FDA.

    Like drugs, clinical trials are conducted, not by the FDA, but by the manufacturers.

    Like drugs, adverse events are reported to the manufacturers who, in turn, report them to the FDA.

    Like drugs, medical device companies pay the FDA huge amounts of money to review and approve their products.

    Like drugs, medical device manufacturers sometimes fudge data and under report adverse events in order to get and keep their products on the market.

    Congress must correct the inequity that now exists and reintroduce and pass the Medical Device Safety Act. They must,once again, return accountability to medical device companies for the products that they place on the market.

    I am confident that Congress will act quickly to correct this mistake.

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