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MONTGOMERY, Ala. —(Mealey’s) A brand-name drug manufacturer may be liable under Alabama law for fraud or misrepresentation in a drug label used by generic drug makers, the Alabama Supreme Court held Aug. 15 after reconsidering its 2013 decision in a Reglan/metoclopramide case (Wyeth, Inc., et al. v. Danny Weeks, et al., No. 1101397, Ala. Sup; 2014 Ala. LEXIS 109 [enhanced opinion available to lexis.com subscribers]).
The state high court withdrew its January 2013 ruling in Wyeth, Inc., et. al. v. Danny Weeks, et al. and substituted a new opinion that arrived at the same conclusion on a new vote of 6-3. The original decision was 8-1.
“In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic 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, as allowed by the FDA [Food and Drug Administration], by the generic manufacturer,” the majority wrote.
Not Creating ‘Innovator Liability’
“In answering the question of law presented to us by the federal court, we emphasize the following: We are not turning products-liability law (or tort law for that matter) on its head, nor are we creating a new tort of ‘innovator liability’ as has been suggested,” the majority continued. “Instead, we are answering a question of law involving a product that, unlike any other product on the market, has unprecedented federal regulation.”
“Nothing in this opinion suggests that a plaintiff can sue Black & Decker for injuries caused by a power tool manufactured by Skil based on labeling or otherwise,” the majority said, responding to an issue raised in one of three dissents. “The unique relationship between brand-name and generic drugs as a result of federal law and FDA regulations, combined with the learned-intermediary doctrine and the fact that representations regarding prescription drugs are made not to the plaintiff but to a third party, create the sui generis context in which we find prescription medication.”
“Again, the fraud or misrepresentation claim that may be brought under Alabama law against a drug manufacturer 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 is premised upon liability not as a result of a defect in the product itself but as a result of statements made by the brand-name manufacturer that Congress, through the FDA, has mandated be the same on the generic version of the brand-name drug,” the majority said.
Justice Michael F. Bolin wrote the majority opinion, as he did in the original opinion. He was joined by Justices Lyn Stuart, James Allen Main, Alisa Kelli Wise and Tommy Bryan.
Concurrence: Narrow Ruling
Justice Greg Shaw wrote to concur specially. He said the question posed to the court by the U.S. District Court for the Middle District of Alabama does not hold one manufacturer liable for injuries cause by another.
Justice Shaw also said the majority’s decision does not create new law but instead applies established law to a factual and legal scenario never before addressed by the state Supreme Court. He said the majority answer is “extremely narrow in scope and cannot conceivably apply outside that context.”
Referring to one of the dissents, he disagreed with the implication that the majority “is trying to ‘correct’ a ‘wrong’ ‘with a second “wrong”’ or to ‘correct’ ‘unfairness’ created by the federal government.”
Justice Shaw also said he rejected the implication that the majority’s decision might chill innovation. “Allowing fraudulent or tortious conduct in the marketplace to go unchecked — if that is what has occurred in this case — would not seem to promote this policy,” he wrote.
Justice Glenn Murdock, Chief Justice Roy S. Moore and Justice Tom Parker dissented in separate opinions.
Danger For Drug Industry
In his 70-page dissent, Justice Murdock said the majority “creates a precedent that poses danger for the prescription-medicine industry and, by extension, for all industry.” Citing the U.S. Supreme Court’s ruling on the preemption of generic drug warning claims, he said the inability of plaintiffs to hold a generic drug maker accountable “is not problem for this or any other state court to correct. And it certainly is not a ‘wrong’ that this or any court should attempt to correct with a second ‘wrong.’”
In his dissent, Chief Justice Moore said the Supreme Court should not have accepted a certified question “when critical facts are not before the Court.” “I would far prefer to address this issue, if necessary, on a complete record following a final judgment in a state trial court that resolved all factual questions,” he said.
“Nothing in federal legislation or regulations at issue here requires this Court to ignore, modify, or override our bedrock legal principles of duty and privity with regard to the originator of a pharmaceutical drug and a consumer who has not consumed a drug manufactured by the originator of the drug,” Chief Justice Moore wrote. He said that the U.S. Supreme Court’s rulings in PLIVA, Inc. v. Mensing (564 U.S. ___, 131 S. Ct. 2567  [enhanced opinion]) and Mutual Pharmaceutical Co. v. Bartlett ( ___ U.S. ___, 133 S. Ct. 2466  [enhanced opinion]) “have made clear that such a consumer is left without a remedy absent a legislative change by Congress.”
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