Practice Tip: Pliva, Inc. v. Mensing

An Open Door?

While Levine shut the door on the argument that FDA regulation constitutes a per se bar to state tort law prescription drug product liability claims, the opinion appeared to leave the door open for some more targeted preemption arguments:

• The Court's focus on the CBE regulations governing brand-name prescription drugs, see Id. at 1199, suggested that a different preemption ruling might apply to generic drug manufacturers that do not have CBE authority but, rather, are required to use labeling identical to that in the corresponding brand-name drugs.
• The Court suggested that preemption might be appropriate if there were evidence that the FDA would have rejected stronger label warnings with respect to the alleged health risk at issue. See Id. at 1988 (“absent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements”).
• The Court expressly refused to address the question whether negligent marketing claims ' i.e., claims that a drug manufacturer should not have marketed a drug at all ' were preempted by FDA approval of the drug as safe and effective. See Id. at 1194 (we “need not decide whether a state rule proscribing intravenous administration would be pre-empted”).
• The Court distinguished, and therefore indicated its continued adherence to, the holding in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), that claims alleging fraud on the FDA were preempted. Id. at 1195 n.3.

The Courts and Levine