Supreme Court says “Let them sue!”

A long-awaited Supreme Court ruling that denies Wyeth’s appeal in a product liability case probably has the entire pharmaceuticals industry sighing, and NOT with relief.

The decision dashes the hopes of drugmakers that were hoping to pin responsibility for inaccurate or misleading drug labels entirely on the FDA. The court ruling implies that FDA approval is not a roadblock that can keep patients from filing state lawsuits against pharmaceutical manufacturers over such labels.

The drug industry already experiences a high level of government, patient, and cross-company litigation over issues ranging from manufacturing and marketing practices to patent loss and generic competition. This ruling will keep the line of patient lawsuits claiming “failure to warn” coming, and it may increase their frequency now that the Supreme Court has backed their legitimacy.

The decision, which seems contrary to last year’s ruling protecting medical device makers against certain patient lawsuits but agrees with a recent cigarette manufacturing judgment, could also impact consumer cases against other types of manufacturers.

The decision will certainly keep pharma label-writers on their toes, and it also showcases the fact that while the FDA should be able to fully regulate drugmakers and their labeling practices, the agency does not presently have the resources to do so.