Supreme Court Agrees to Rule on Preemption of Generic Drug Labeling

December 16, 2010

The U.S. Supreme Court has agreed to decide whether federal regulations shield generic drug makers from state law claims that they failed to provide adequate warning labels. The decision will obviously impact how class action attorneys will target the pharmaceutical industry. In addition, the ruling, which is expected in June of 2011, should provide more guidance on how the Supreme Court will view future challenges on preemption in other product categories.

The Supreme Court’s decision on this issue will be the third in a series of recent pronouncement on federal preemption of state law claims. The first was Reigel v. Medtronic in 2008, which held that the FDA’s pre-market approval process for Class III medical devices preempted state law claims. Next, the Supreme Court’s decision in Wyeth v. Levine in 2009, addressed preemption in the context of brand name drug makers. In Wyeth, the Supreme Court held that FDA regulations do not protect pharmaceutical manufacturers from state law claims relating to the labeling of brand name drugs.

In the three consolidated appeals recently granted certiorari, generic drug makers Pliva Inc. and Actavis Inc. will try to distinguish Wyeth by arguing that different labeling rules for generics made it impossible for them to change labels to reflect new information on health risks. The generic manufacturers assert that laws requiring their labels to be the same as those of their brand name counterparts, make it impossible for them to update labels if the brand names have not done so first.

The appellate decisions to be reviewed by the Supreme Court were from the U.S. Courts of Appeals for the 5th and 8th Circuits. Both held that the federal regulatory approval processes do not protect manufacturers from lawsuits under state failure-to-warn laws, but for different reasons. The 5th Circuit said labeling laws should not be read to deny generic companies the power to change their labels unilaterally prior to approval from the FDA, a power brand name companies have under the “Changes Being Effected” process. The 8th Circuit did not reach the question of whether the Changes Being Effected process applies to generic companies, but rather focused on its conclusion that the companies should have made some effort to get new information out to doctors and consumers.

The cases the Supreme Court will review are Pliva v. Mensing, 09-993; Actavis Elizabeth v. Mensing, 09-1039; and Actavis v. Demahy, 09-1501.