Drugmakers Still on the Hook for Tainted Meds

(CN) - The 8th Circuit revived a potential class action that accuses the makers of a hypertension drug of failing to meet standards set by the Food and Drug Administration.

In the wake of a March 2009 complaint by the FDA against KV Pharmaceutical and its subsidiaries, Ethex and Ther-Rx, for defectively manufacturing the hypertension drug Metoprolol Succinate ER, Rhode Island resident Allen Lefaivre filed suit against the drugmakers for breach of warranty and violations of the Missouri Merchantability Practices Act.

KV moved to dismiss the suit, arguing that Lefaivre's claims were preempted by federal law, and that government agencies have sole authority to enforce those standards.

A Missouri federal judge agreed, but the St. Louis-based federal appeals panel reversed that decision Thursday.

In its settlement agreement with the FDA, KV admitted to selling "adulterated" drugs, acknowledging that it had not used proper quality control procedures when manufacturing Metoprolol Succinate. KV also agreed to destroy the remaining stock of "adulterated" drugs and issued a recall for all stocks of the medication sold to retailers between May 2008 and February 2009.

The appellate court's ruling that this recall notice only affected products "at the retail level."

"A retail-level recall instructs all retailers that had purchased the medication to return all unsold product to KV," Judge Lavenski Smith wrote for the court. "The consent decree did not require KV to distribute its recall notice to individual purchasers of the medication, and it did not do so."

The three-judge panel found that Congress did not intend give the FDA exclusive drug-safety oversight.

"In keeping with Congress' decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation," the opinion states. "The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.

Congress adopted the Federal Food, Drug and Cosmetic Act (FDCA) so that state law could complement FDA regulation, Smith wrote.

"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly," the decision states. "They also serve a distinct compensatory function that may motivate injured persons to come forward with information.

"Failure-to-warn actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times," Smith continued. "Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation."

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