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From Products Liability Law Daily, June 18, 2013

Alabama high court to reconsider ruling on brand-name drug makers’ liability for generic drugs made by other companies

By Pamela C. Maloney, J.D.

The Alabama Supreme Court on June 13, 2013, set for oral argument its decision that manufacturers of brand-name drugs could be liable for fraud or misrepresentation for injuries caused by generic versions of their drugs manufactured by other companies (Wyeth, Inc. v. Weeks, June 13, 2013). The Alabama high court’s decision was issued in response to a question certified to it by the U.S. District Court for the Middle District of Alabama (Wyeth, Inc. v. Weeks, January 11, 2013, Bolin, M.).

Background. In the underlying action, the Weeks alleged that three brand-name manufacturers—Wyeth, Pfizer, Inc., and Schwarz Pharma, Inc.—of Reglan®, a metoclopramide drug, were liable for injuries Mr. Weeks sustained as a result of his long-term use of a generic version of the drug based on theories of fraud and misrepresentation. Mr. Weeks developed a movement disorder called tardive dyskinesia and other movement disorders. Conceding that Mr. Weeks did not ingest any drugs manufactured by the three brand-name drug companies, the Weeks alleged that the brand-name manufacturers were liable nonetheless because they manufactured or sold the brand-name version of the drug and either misrepresented or failed to adequately warn Mr. Weeks or his physician about the risks of using the drug long-term. Citing the disagreement among the federal district courts in Alabama as to the liability of a brand-name manufacturer for injuries allegedly caused by ingestion of another manufacturer’s generic drug, the district court certified the following question to the Alabama Supreme Court:

Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?

State products liability rule. In its response to the district court’s certification, the Alabama high court first addressed Wyeth’s argument that the state’s Extended Product Liability rule subsumed Weeks’ claim because the rule made manufacturers liable only to the consumers of their products, not to consumers of products made by others. The court rejected that argument, holding that the rule did not eliminate tort claims involving injuries caused by fraud, negligence or wantonness. The court noted that every state had a law permitting substitution of generic drugs, and many insurance plans commonly require substitution of generics where available, so that brand-name drug makers reasonably could expect that their failures to warn physicians could result in injuries to the consumers of generics.

Effects of FDA regulation. The court next addressed Wyeth’s claim that the comprehensive regulation of prescription drugs by the Food and Drug Administration (FDA) preempted the state tort action. Reviewing the process for approval of new drugs, including the abbreviated process for approval of generics, the court noted that the detailed review of safety and effectiveness occurs with the application for approval of brand-name drugs. The generic manufacturers must show that their drug is bioequivalent and therapeutically equivalent to the brand-name drug. FDA regulations require the brand-name manufacturer to report adverse events even after market approval and to report annually any information that might affect the safety, effectiveness or labeling of the drug. Only the brand-name manufacturer could modify its labeling or issue a “Dear Doctor” warning letter to account for new information, subject to FDA approval.

The state high court recognized that unlike other consumer products, prescription drugs were highly regulated by the FDA but cited the U.S. Supreme Court’s decision in Wyeth v. Levine for the proposition that Congress did not preempt common-law tort claims and that the FDA “traditionally regarded state law as a complementary form of drug regulation.” The court in Wyeth also stated that “manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge; state-law tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly and serve a distinct compensatory function that may motivate injured persons to come forward with information.”

The Alabama high court further noted that FDA regulations require generic drug makers to use exactly the same labeling as that used by the brand-name makers, making it impossible for the generic drug maker to change the warning labels on the products without violating those requirements. Therefore, in the context of inadequate warnings by the brand-name manufacturer on a prescription drug manufactured by a generic drug manufacturer, the Alabama high court concluded that, fundamentally, it was not unfair to hold the brand-name manufacturer liable for warnings on a product that it did not produce because the manufacturing process was irrelevant to misrepresentation theories which were based on information and warning deficiencies, given that those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic maker.

Oral argument has been scheduled for September.

The case number is: 1101397.

Attorneys: Anna Manasco (Bradley Arant Boult LLP), Bryan A. Vines (Hare, Wynn, Newell and Newton, LLP), Leslie A. Benitez (Clark, Thomas & Winters) for Wyeth, Inc. Christopher B. Hood,.(Heninger Garrison Davis LLC) for the Weeks.

Companies: Wyeth, Inc.; Pfizer, Inc.; and Schwarz Pharma, Inc.

MainStory: TopStory SCLIssuesNews WarningsNews DrugsNews AlabamaNews

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