Hatch-Waxman Amendments Do Not Preempt State Law Claims

PROVIDENCE, R.I. - A New Hampshire federal judge has ruled that state law tort claims brought against a generic drug manufacturer are not preempted by Title I of the Hatch-Waxman Amendments to the Federal Drug and Cosmetic Act. Bartlett v. Mutual Pharmaceutical Company Inc., No. CV-08-358-JL (D. R.I.).

On Sept. 29, Judge Joseph Laplante of the U.S. District Court for the District of New Hampshire denied Mutual Pharmaceutical's motion to dismiss claims that it failed to warn physicians that its anti-inflammatory drug Sulindac. The judge held that nothing in the FDCA prohibits generic manufacturers from post-approval modifications of their warnings, …