Drug Company Immunity- Preemption

In a 4-4 vote, the United States Supreme Court today affirmed the 2nd Circuit opinion in Kent v. Warner Lambert, a Rezulin case filed in Michingan. The 2nd Circuit Court of Appeals had reversed the trial courts dimissal of the case. Under Michigan law, a pharmaceutical manufacturer was immune from liability if a drug was approved by the FDA, unless the injured party could bring a claim which would be supported by proof of “fraud on the FDA.” The Kent trial court dismissed the claim, finding that this one available method of proving your claim, required the Plaintiff to bring a “Fraud on the FDA” claim, which the United States Court had held was completely preempted in the Buchman decision. The 2nd Circuit reversed, holding that the Michigan law did not go that far, as such would result in complete preemption of the claims, which was obviously contrary to the Michigan statutes’ plain language. Chief Justice Roberts recused himself from the deliberations, leaving an 8 member court, which split evenly 4-4, in a surprise ruling. Most on the pharmaceutical side believed this Court would reverse the 2nd Circuit, and place another peg on the board for their push to completely immunize pharamceutical companies from liability. The fight is hardly over, as the Supreme Court will be hearing in the fall term another drug case known as Levine v. Wyeth. That case does not involve an FDA approval immunity statute like Kent, but instead focuses on the FDA’a approval of the drug, and the labeling infomation. The justice attorneys of Aylstock, Witkin, Kreis & Overholtz will be fighing hard to preserve our client’s rights to seek redress from pharmaceuttical companies who have sold defective drugs, with defective warnings, and have misled the FDA, patients, and doctors along the way.