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BRAND-NAME DRUG MAKERS LIABLE FOR INADEQUATE WARNINGS ON DRUGS MANUFACTURED BY GENERIC COMPETITORS

An unprecedented decision made by the State of Alabama's highest court in January 2013 held that a brand-name drug maker could be liable for injuries resulting from a consumer's use of a generic version of its drug manufactured by another company.

Plaintiff, Danny Weeks, sued several drug manufacturers for injuries related to his use of the generic version of a brand-name drug, Reglan, claiming that several brand-name companies, including Pfizer, Inc., misrepresented or failed to adequately warn him or his doctor about the long-term risks of using its generic counterpart. Wyeth, Inc. v. Weeks, __ So.3d __ (2013 WL 135753 ("Pfizer").

Brand-name and generic pharmaceutical companies supplying competing products in the prescription drug market must strictly adhere to a diet of regulations administered by the Federal Drug Administration (FDA), including rules pertaining to a product's warning labels. A generic drug-maker's product label must be identical to the label of its brand-name counterpart "because the brand-name drug is the basis for approval of the drug by the FDA." 21 U.S.C. §355 (j)(2)(A)(v); PLIVA, Inc. v. Mensing (2011) 131 S.Ct. 2567, 2574-2575. In addition, a generic drug-maker cannot unilaterally change the safety label on their products. Pfizer at *8, 17. In turn, a brand-name drug-maker has a continual obligation to report to the FDA any serious and unexpected adverse reactions suffered by a user of a drug, as well as significant information, including information that might affect the safety, effectiveness, or labeling of the product. Pfizer at *5, 17.

The Alabama Supreme Court favored Mr. Week's theories and held that a brand-name manufacturer could be held liable for fraud or misrepresentation based on statements made in its warning labels in connection with another company's manufacture of the generic version of a drug.

The court explained, "[a] prescription-drug manufacturer fulfills its duty to warn the ultimate users of the risks of its product by providing adequate warnings to the learned intermediaries who prescribe the drug. Once that duty is fulfilled, the manufacturer has no further duty to warn the patient directly. However, if the warning to the learned intermediary is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by the patient. The patient must show that the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient's injury." Pfizer, at *19. (Emphasis Added).

Courts, however, have historically recognized that brand-name manufacturers do not owe a duty to consumers who use generic versions of their product because the brand-name manufacturer did not make the product. Thus, manufacturers like Pfizer have traditionally enjoyed immunity from liability for injuries sustained by such consumers.

Recognizing the seemingly juxtaposed ruling to well-settled legal authority, the Alabama Supreme Court explained that the question was not based on manufacturer liability traditionally recognized in product liability cases. "Because a warning label is not a part of the manufacturing process, we do not agree that the fact that a brand-name manufacturer did not produce the version of the drug ingested by the plaintiff bars the plaintiff's tort action when the plaintiff is arguing that he or she was injured by a failure to warn." Pfizer at *15.

Rather, the court distinguished that the question was about a brand-name manufacturer's duty to warn based on the foreseeability of harm from a doctor relying on false or inadequate representations in a warning label drafted by a brand-name manufacturer that a generic manufacturer is required to duplicate pursuant to federal law. This novel decision puts Pfizer and similarly situated companies in a difficult position of owing a duty to a consumer of a competing product, yet having little to no means to satisfy this duty because these companies have no relationship or platform to communicate product information to these consumers.

The discord surely heard by large pharmaceutical companies after the decision in Pfizer is the sound of increased exposure for liability in product liability cases to end-users and non-end-users alike. Pfizer filed a motion for re-hearing in February. There are also pending regulatory changes at the FDA that may negate a prior Supreme Court decision PLIVA v. Mensing, 131 S. Ct. 2567 (2011), on which the Alabama Supreme Court relied in rendering their decision in Wyeth.

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