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Wyeth, Inc. v. Weeks - 159 So. 3d 649 (Ala. 2014)

Rule:

Under Alabama law, a brand-name-drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company. Prescription drugs, unlike other consumer products, are highly regulated by the Food and Drug Administration ("FDA"). Before a prescription drug may be sold to a consumer, a physician or other qualified health-care provider must write a prescription. The Supreme Court of the United States has recognized that Congress did not preempt common-law tort suits, and it appears that the FDA has traditionally regarded state law as a complementary form of drug regulation: The FDA has limited resources to monitor the approximately 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; 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.

Facts:

Plaintiffs Danny and Vicki Weeks filed a lawsuit in federal district court against defendants Wyeth, Inc. and four other drug manufacturers for injuries that Mr. Weeks allegedly suffered as a result of his long-term use of the prescription drug product "metoclopramide," which was the generic form of the brand-name drug "Reglan." The Weeks' claim that defendants Teva Pharmaceuticals USA and Actavis Elizabeth, LLC manufactured and sold the generic form that Mr. Weeks ingested. The Weeks' conceded that Mr. Weeks did not ingest any Reglan manufactured by the three brand-name defendants—Wyeth, Pfizer Inc., and Schwarz Pharma, Inc. The Weeks' asserted, nonetheless, that the brand-name defendants were liable under theories of fraud, misrepresentation, and/or suppression because they at different times manufactured or sold brand-name Reglan and purportedly either misrepresented or failed adequately to warn Mr. Weeks or his physician about the risks of long-term use of Reglan. The brand-name defendants field a motion to dismiss the claims against them, arguing, among other things, that: (1) the Weeks' claims, however pleaded, were in fact product liability claims that were barred for failure of "product identification," and; (2) they had no duty to warn about the risks associated with ingestion of their competitors' generic products. The district court certified a question of state law to the Supreme Court of Alabama.

Issue:

Under Alabama law, could the brand-name defendants be held liable for fraud or misrepresentation (by misstatement or omission), based on statements they made in connection with the manufacture of a brand-name drug, by a plaintiff, such as Mr. Weeks, claiming physical injury from a generic drug manufactured and distributed by different companies?

Answer:

Yes.

Conclusion:

The Supreme Court of Alabama answered the certified question in the affirmative. The court held that Congress did not preempt common-law tort suits. The court noted that prescription drugs, unlike other consumer products, were highly regulated by the Food and Drug Administration ("FDA"), and the FDA regarded state law as a complementary form of drug regulation. In the context of inadequate warnings by the brand-name manufacturers placed on the drug manufactured by generic manufacturers, it was not fundamentally unfair to hold the brand-name manufacturers liable for warnings on a product it did not produce because the manufacturing process was irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturers and merely repeated by the generic manufacturers as mandated by Congress, through the FDA.

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