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Brand name drugmakers liable for generics: Alabama high court rules again

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Brand name drugmakers liable for generics: Alabama high court rules again

The Alabama Supreme Court has reaffirmed its controversial ruling that brand-name drugmakers can be held liable for injuries caused by drugs produced by generic manufacturers.

The court issued its original ruling in Wyeth Inc. et al v. Danny Weeks and Vicki Weeks in January 2013. Six months later, it agreed to reconsider the ruling at the request of New York-based Pfizer Inc., which acquired Wyeth Inc. after the original litigation was filed.

But the Alabama high court reaffirmed its position Friday in a 5-3 ruling.

Pfizer said in a statement it is disappointed in the ruling, which it described as an “outlier” contrary to other courts' rulings.

The case involved a patient who developed tardive dyskinesia, a condition that causes involuntary movements, after long-term use of the prescription heartburn drug metoclopramide, a generic form of the brand name drug Reglan that Wyeth produced.

In reaffirming its ruling, the majority said Food and Drug Administration regulations “require a generic manufacturer's labeling for a prescription drug be exactly the same as the brand-name manufacturer's labeling.”

“It is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce ... when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated, as allowed by the FDA, by the generic manufacturer,” the court ruled.

“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,” said the ruling. “Instead, we are answering a question of law involving a product that, unlike any other product on the market, has unprecedented federal regulation.”

“While we are disappointed that the Alabama Supreme Court declined to reverse its earlier decision in this case, the court's ruling stands out even more as an outlier now than it did when it was initially decided,” Pfizer said in its statement.

Citing the rulings of 98 other courts, Pfizer said, “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.”

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