Federal Preemption: Generic Drugs

Posted in Products Liability on December 18, 2008

McKenney v. Purepac Pharmaceutical Company, (5th District, September 25, 2008) 83 Cal.Rptr.3d 810, 08 Cal. Daily Op. Serv. 12,747

A woman who alleged she suffered injuries as a result of using the prescription generic drug metoclopramide filed an action against the manufacturer. The plaintiff alleged that there were false and/or misleading statements in the labeling of the drug which downplayed the risk of tardive dyskinesia, which the plaintiff had contracted while taking the drug.

The trial court sustained the manufacturer’s demurrer to the complaint, finding that because a generic manufacturer of a drug must obtain approval by the FDA before issuing any label which deviates from the labeling previously approved by the FDA, all of the plaintiff’s claims were pre-empted by federal law. However, the court of appeal reversed, holding that the federal requirement that a generic drug have the same labeling as a reference drug does not necessarily pre-empt a state tort action against a generic manufacturer for failure to adequately warn of the dangers of the drug:

“We see no contention from Purepac that all state civil liability for injury caused by mislabeled drugs is pre-empted-such as, for example, injury caused by a manufacturer mislabeling a drug and failing to utilize an FDA-approved label for that drug. The FDA itself has said: “FDA recognizes that FDA’s regulation of drug labeling will not preempt all State law actions. The Supreme Court has held that certain State law requirements that parallel FDA requirements may not be preempted [citation]….”
. . .
The FDA has stated that its mechanism for compelling labeling revisions “applies to both ANDA and NDA drug products” and that “[a]fter approval of an ANDA, if an ANDA holder believes that new safety information should be added, it should provide adequate supporting information to FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised.” (57 Fed.Reg. 17950, 17961.) We therefore see no reason to distinguish between original or “listed” drugs and their generic equivalents for federal preemption purposes. Nor do we see any indication that the FDA itself has ever taken the position that its labeling requirements for generics would invoke federal preemption principles so as to exempt manufacturers of generic drugs from tort liability.
. . .
In the case presently before us, Purepac has not called our attention to anything in the allegations of McKenney’s fourth amended complaint that would demonstrate the necessary applicability of a preemption defense to those allegations. To state this a bit differently, nothing in the McKenney’s fourth amended complaint alleges that Purepac should have given warnings about the use of metoclopramide that the FDA expressly precluded Purepac from giving. The superior court therefore erred in sustaining the demurrer.
Nor has Purepac cited to us any appellate court decision holding that a generic manufacturer of a prescription drug can never be held strictly liable in tort for failure to warn when the generic manufacturer utilizes FDA-approved labeling.”