CGMP Violation Claims are 'Parallel,' Not Preempted, Judge Rules

NEW YORK - A defective manufacturing claim which accuses the manufacturers of the Trident hip replacement system of violating current good manufacturing practices requirements parallels a violation of the Food Drug and Cosmetic Act and is therefore not federally preempted, a New York federal judge has ruled. Gelber v. Stryker Corp., No. 09-1322 (S.D. N.Y.).

On April 18, Judge P. Kevin Castel of the U.S. District Court for the Southern District of New York ruled that plaintiff's claim that the device was defective because it was manufactured with excess manufacturing residue "would not impose any additional burdens on the defendants …