Brand-Name Drug Company May be Liable for Labeling Fraud/Misrepresentation in Action by Consumer Claiming Injury Caused by Generic Drug Manufacturer

A man allegedly suffered injuries 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 man and his wife sued two generic manufacturers of the drug and three brand-name manufacturers of the drug. The plaintiffs conceded that the man did not ingest any metoclopramide manufactured by the brand-name manufacturers.


The plaintiffs sued the brand-name manufacturers for fraud, misrepresentation, and suppression because they at different times manufactured or sold brand-name Reglan and allegedly misrepresented or failed to adequately warn the man or his physician about the risks of long-term Reglan use. The plaintiffs argued that the brand-name manufacturers owed a duty to the man’s physician and that, under the learned-intermediary doctrine, they were entitled to rely on the representations made to their physician. If a defendant's misrepresentation to a third party causes the third party to take actions resulting in the plaintiff's injuries, then the factual causation link is satisfied. A misrepresentation to the man's physician would directly impact the medical care he received.


The brand-name manufacturers filed a motion to dismiss arguing (1) that the claims were product liability claims that were barred for failure of product identification and (2) that they had no duty to warn about the risks associated with ingestion of their competitors' generic products. The Southern Division of the United States District Court for the Middle District of Alabama granted in part and denied in part the brand-name defendants' motion, holding that the plaintiffs might be able to state a claim for relief under Alabama law if they could prove that the brand-name manufacturers had a duty to warn the man's physician about the risks associated with long-term use of brand-name Reglan and, further, that the plaintiffs, as third parties, had a right to enforce an alleged breach of that duty.


The Alabama Supreme Court answered in the affirmative a question certified from the District Court. Specifically, 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 court first concluded that the plaintiffs’ claims were not product liability claims. Fraudulent suppression and misrepresentation are separate causes of action from product liability claims. Under Alabama law, fraudulent misrepresentation consists of (1) a false representation (2) concerning a material fact (3) relied upon by the plaintiff (4) who was damaged as a proximate result. A key aspect of a fraudulent misrepresentation claim is a duty to disclose.


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. In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.


The court reasoned it is not fundamentally unfair to hold a 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.


See: Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala., January 11, 2013) (not designated for publication).