Ninth Circuit agrees with other Courts and applies Wyeth v. Levine in holding that failure-to-warn claims are not pre-empted for generic drug manufacturers.

I don't spend too much time on products liability issues, but Wyeth v. Levine was a major ruling in the area of federal preemption, and its reach is still being tested.  In Gaeta v. Perrigo Pharmaceuticals Company (9th Cir. Jan. 24, 2011), the Ninth Circuit agreed with two Courts of Appeals and all of the district courts to consider the issue of whether federal law preempts state law failure-to-warn claims against generic manufacturers.

In Wyeth v. Levine, 129 S. Ct. 1187 (2009), the Supreme Court determined that state law failure-to-warn claims against brand name manufacturers were not preempted by federal law.  However, it was unclear whether the holdilng applied to generic manufacturers.  Applying the Levine analysis, two other Courts of Appeals, and all of the district courts to consider the issue, held that federal law does not preempt state law failure-to-warn claims against generic manufacturers, provided there is no “clear evidence” that the FDA would not have approved the proposed stronger warning. We agree and hold that the district court erred in applying federal preemption. The Ninth Circuit agreed, reversing and remanding.