MONTGOMERY, Ala. (Legal Newsline) - The Alabama Supreme Court has reaffirmed its ruling in a case questioning whether a brand-name drug maker can be held liable for injuries from a generic version.
The state’s high court issued its 65-page majority opinion Friday. Justice Michael Bolin authored the ruling, joined by justices Lyn Stuart, James Allen Main, Alisa Kelli Wise and Tommy Bryan. Justice Greg Shaw issued a separate concurring opinion, and Chief Justice Roy Moore and justices Tom Parker and Glenn Murdock dissented.
“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 (Food and Drug Administration), by the generic manufacturer,” Bolin wrote.
Last year, the court agreed to reconsider its initial ruling in Wyeth Inc. v. Weeks.
In its January 2013 ruling, the state Supreme Court answered in the affirmative the question of whether a brand-name drug manufacturer, based on 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.
A month later, Pfizer, along with Wyeth LLC and Schwarz Pharma Inc., petitioned for rehearing and asked the court to reject “innovator liability.”
The majority said its decision to reaffirm does not turn products-liability law, or tort law, “on its head.”
“Nor are we creating a new tort of ‘innovator liability,’ as has been suggested,” Bolin wrote of the manufacturers’ arguments.
“Instead, we are answering a question of law involving a product that, unlike any other product on the market, has unprecedented federal regulation.”
He continued, “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.”
Wyeth said it is disappointed in the decision, but noted that the court’s ruling “stands out even more as an outlier” now than it did when it was first decided last year.
“Virtually every court that has considered the issue since the Alabama Supreme Court’s initial decision has rejected the assertion that brand-name drug manufacturers can be liable for injuries caused by a plaintiff's ingestion of a generic drug product,” the company stated. “Twenty-nine other courts have rejected the Alabama Supreme Court’s reasoning since its ruling, including the Iowa Supreme Court and the six federal courts of appeals to have addressed the issue. Overall, 98 courts applying the laws of 30 different states have rejected the so-called ‘innovator liability’ theory.
“Those courts have recognized that subjecting brand-name manufacturers to perpetual liability for injuries resulting from generic products would stifle innovation, including the research and development of new life-saving medicines.”
The U.S. District Court for the Middle District of Alabama certified the following question to the state Supreme 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?”
Plaintiffs Danny and Vicki Weeks sued 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.
Reglan is most often used to treat gastric esophageal reflux disease, or GERD.
Six separate entities filed amicus briefs in support of the manufacturers, fearing the ramifications of the Alabama court’s decision may be felt in other industries in the state and across the country.
They included: the U.S. Chamber of Commerce, the Business Council of Alabama, the Alabama Policy Institute, the Pharmaceutical Research and Manufacturers of America, the Product Liability Advisory Council, and the Alabama Defense Lawyers Association.
“The Court’s [opinion] threatens to unleash the plaintiff bar’s most creative and damaging suits on all businesses in Alabama -- particularly those in Alabama’s burgeoning automotive, aerospace and health-care industries,” the Chamber wrote in its brief.
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