McKenney v. Purepac Pharmaceutical Company
In the Court of Appeals of the State of California
25 September 2008
F052606 (Super. Ct. No. 343927)

Drug manufacturer Held Liable for a Generic Drug

This case answers the questions of whether or not drug manufacturers may be sued for its failure to warn potential dangers albeit the product had a federally approved label.

It appears that Carlyne McKenney, the petitioner herein, filed a suit against respondent Purepac Pharmaceutical Company and other defendants. She alleges that she was injured as a result of using the prescription drug metoclopramide made by Purepac.

Purepac moved for a demurrer to McKenney’s fourth amended complaint, which demurrer was granted by the superior court and entered judgment in its favor.

The amended complaint alleges that metoclopramide is the active ingredient of the brand name Reglan, and that Purepac “distributed the generic drug metoclopramide.” It also alleges that there were “false and/or misleading statements contained in” Purepac’s labeling of the drug, and that the labeling “substantially understated and downplayed the risk of tartive dyskinesia,” which causes involuntary muscle movements suffered by McKenney.

In granting the demurrer in favor of the pharmaceutical company, the superior court concluded that “All of the Plaintiff’s causes against Purepac are pre-empted by federal law… Defendant Purepac is not the original manufacturer of Reglan. It is a generic manufacturer of metoclopramide which deviates from the labeling previously approved by the FDA.”

Carlyne McKenney appealed the superior court’s judgment.

In a 3-0 decision, the Court of Appeal disagreed with the superior court judgment. The Court ruled that the generic manufacturer could have brought the additional label changes for consideration.

The appeals court held that an FDA-approved label isn’t necessarily the last word on the risks, thereby dismissing Purepac’s contention. Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling.

Said the Court, “The FDA has stated that its mechanism for compelling labeling revisions applies to both ANDA and NDA drug products and that after 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.”

“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,” ruled the Court.

“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.”