The Supreme Court of Alabama recently held that a brand-name drug manufacturer can be held liable for fraud or misrepresentation based on statements it made in connection with the manufacture of the drug in an action brought by consumer who was allegedly injured by a generic version of drug.
Danny and Vicki Weeks filed a lawsuit in federal court against drug manufacturers for injuries that Mr. Weeks allegedly suffered as a result of his long-term use of the prescription drug product metoclopramide, which is the generic form of the brand-name drug Reglan.® The Weekses claim that two companies—Teva Pharmaceuticals USA and Actavis Elizabeth, LLC—manufactured and sold the generic metoclopramide that Mr. Weeks ingested.
The Weekses concede that Mr. Weeks did not ingest any Reglan® manufactured by the three brand-name defendants, Wyeth LLC, Pfizer Inc., and Schwarz Pharma, Inc. The Weekses nonetheless assert that the brand-name defendants should be liable for Mr. Weeks’s harm on fraud, misrepresentation, and/or suppression theories 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 using Reglan® long-term.
The brand-name defendants moved to dismiss the claims against them, arguing they had no duty to warn about the risks associated with ingestion of their competitors’ generic products. Because the lawsuit was governed by Alabama law, the federal court decided to ask the Alabama Supreme Court whether the Weekses could sue the brand-name defendants even though they admitted to only taking generic versions.
The question presented to the Alabama Supreme Court was:
“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?”
In Wyeth, Inc. v. Weeks, No. 1101397 (Ala. January 11, 2013), the court answered the question as follows:
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.
The Alabama Supreme Court explained that:
Unlike other consumer products, prescription drugs are highly regulated by the FDA. Before a prescription drug may be sold to a consumer, a physician or other qualified health-care provider must write a prescription. The United States Supreme Court in Wyeth v. Levine recognized that Congress did not preempt common-law tort suits, and it appears that the FDA traditionally regarded state law as a complementary form of drug regulation: 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; 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. Wyeth v. Levine, 555 U.S. at 578–79.
FDA regulations provide that a generic-drug manufacturer’s labeling for a prescription drug must be exactly the same as the brand-name-drug manufacturer’s labeling. The Supreme Court in PLIVA held that it would have been impossible for the generic-drug manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug must match the warning on the brand-name version, preempting failure-to-warn claims against generic manufacturers.
In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is 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 manufacturer and merely repeated by the generic manufacturer.
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If you or a loved one has experienced the tragedy of losing a family member as a result of prescription narcotics usage, you and your family deserve answers to your questions. If your loss was as a result of a defective drug or perhaps a physician’s negligence, you have the right to demand that the drug company or negligent physician be held responsible.
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