MONTGOMERY, Ala. (Legal Newsline) - The Alabama Supreme Court answered in the affirmative the question of whether a brand-name drug manufacturer, based upon statements made in connection with the manufacture or distribution of the brand-name drug, may be liable to a plaintiff who has claimed injury from a generic version of the brand-name drug.
The U.S. District Court for the Middle District of Alabama certified the following question to the state's high 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?
By an 8-1 margin, the Court answered affirmatively. Justice Michael F. Bolin wrote the 52-page majority opinion, released Jan. 11, while Justice Glenn Murdock dissented with an opinion to follow.
The question arose out of a federal court case in which Plaintiffs Danny and Vicki Weeks filed an action against five current and former drug manufacturers for injuries that Danny Weeks allegedly suffered as a result of his long term use of prescription drug Reglan.
The Weeks claimed that only two companies, Teva Pharmaceuticals USA and Actavis Elizabeth, LLC, manufactured and sold the generic of Reglan that Danny Weeks ingested. Plaintiffs conceded that Danny Weeks did not take Reglan manufactured by the three brand-name defendants Wyeth LLC, Pfizer Inc., and Schwarz Parma, Inc.
"The brand-name defendants moved to dismiss the claims against them, arguing, among other things, (1) that the Weekses' claims, however pled, are in fact product liability claims that are 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 opinion states in regard to the federal district court action.
"On March 31, 2011, [the district court] granted in part and denied in part the brand-name defendants' motion, holding that the Weekses 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 Mr. Weeks's physician about the risks associated with long-term use of brand-name Reglan® and, further, that the Weekses, as third parties, had a right to enforce an alleged breach of that duty."
Resultantly, the district court certified the question to the state Supreme Court.
"As noted in the facts set out in the request for a certified question," Bolin wrote, "other federal courts applying Alabama law have held that Alabama law does not allow a person who consumed a generic version of a brand-name drug to sue the brand-name manufacturer based on fraudulent misrepresentation.
However, Bolin wrote, "The Weekses are not arguing that the Wyeth defendants owed them a duty. Instead, they are arguing that the Wyeth defendants owed a duty to Danny Weeks's physician and that, under the learned-intermediary doctrine, they are entitled to rely on the representations made to their physician.
"A brand-name manufacturer is well aware of the expiration of its patent and well aware that a generic version of the drug will be made when the patent expires ... A brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.
"In the present case, the Weekses have alleged that Danny's physician reasonably relied on the representations made by the Wyeth defendants regarding the long-term use of Reglan in prescribing Reglan to Danny.
"In other words, the Weekses are arguing that 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 and that, here, a misrepresentation to Danny's physician would directly impact the medical care received by Danny," Bolin wrote.
"The principle behind the learned-intermediary doctrine is that prescribing physicians act as learned intermediaries between a manufacturer and the consumer/patient and that, therefore, the physician stands in the best position to evaluate a patient's needs and to assess the risks and benefits of a particular course of treatment for the patient.
"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.
"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.
"We answer 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.
"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.
"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."