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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Supreme Court To Decide Generic Drug Preemption Issue After All

Posted in Generic Drugs

I’ve been engrossed in a mesothelioma trial and have fallen behind in blogging. Frequent readers will snarkily note that this is not an uncommon occurrence. However, there has been a major development in generic pharmaceutical litigation. The Supreme Court has granted certiorari (that means accepted) in three Reglan lawsuits. If the Supreme Court rules in favor of the Reglan manufacturers, Reglan litigation will basically disappear. More importantly, so will most litigation regarding failure-to-warn claims against manufacturers of generic drugs.

In the Mensing case, the question the Court will answer is: “Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the labeling approved by the Food and Drug Administration for the listed (or branded) drug.” (The Mensing case is actually two of the three cases.)

The third case, Actavis v. Demahy, asks this question: “Whether the states are preempted under the Supremacy Clause of the Constitution from requiring additional safety information n a generic product label when the brand has not changed its label.”

My gut feeling is that the Supreme Court is going to kill litigation against generic drug manufacturers. Of course, I also thought it was going to go the other way in Wyeth v. Levine. So maybe I’m wrong.

I hope so, because otherwise the American taxpayers will become the insurers for generic drug manufacturers. (If you can’t sue the manufacturer, Uncle Sam through Medicare and Medicaid will likely foot the bill for any injuries.)

  • dad disgusted with bad med care for autism

    Please see video on youtube called, “Autistic Patient in Crisis Goes Unnoticed”
    Mom caught autistic son’s adverse reaction to Haldol (drug listed he was allergic to by the way in his med chart) on film. She confronts nurses why they left him in crisis and demands treatment. What a mess. medical mismanagement at it’s finest. Good thing she got it on tape.