A divided Alabama Supreme Court has ruled that brand-name drug manufacturers can be held liable harm to patients who take generic versions of their drugs.
The 6-3 ruling places Alabama in a minority of jurisdictions.
“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,” Justice Michael Bolin wrote for the majority Friday.
The court reheard the case but reaffirmed a ruling it handed down in 2013.
The majority did not say that brand-name manufacturers can be held liable for manufacturing defects in drugs made by generic drugmakers—only for “fraudulent statements on the warning label related to that medication” or for omitting warning on the label.
The court rejected an argument that the court was creating a new tort of innovator liability. Brand-name manufacturers have a duty not to make false representations about their warning labels when they continue to control the labels, Bolin said, and they have a duty to update those labels when side effects become apparent after their drugs have been on the market.
Plaintiffs Danny Weeks and his wife, Vicki Weeks, allege that he suffered a neurological movement disorder after taking the generic version of Reglan. But the plaintiffs allege that the brand-name manufacturers, Wyeth LLC, Pfizer Inc. and Schwarz Pharma Inc. were liable to Weeks for allegedly misrepresenting the long-term risks of using Reglan and failing to warn his physician about those risks.
The legal issue in the case of Wyeth Inc. v. Weeks was certified to the Supreme Court by the U.S. District Court for the Middle District of Alabama.
In dissent, Chief Justice Roy Moore said the court should not have accepted the question.
The U.S. Supreme Court has ruled that generic drugmakers aren’t liable for failing to warn of the risks of their products because brand-name manufacturers have the exclusive authority to control the labels for their products and generic pharmaceutical companies must match the brand-name labels exactly.
In dissent, Justice Tom Parker said the U.S. Supreme Court’s rulings in Pliva Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett “have made clear that such a consumer is left without a remedy absent a legislative change by Congress.”
In dissent, Justice Glenn Murdock said that the Weeks ruling leaves the Alabama Supreme Court standing “alone as the only appellate court in the country to hold that a brand-name manufacturer may be responsible for injuries caused to a party who ingests a generic drug that the brand-name manufacturer did not manufacture or sell.”
The Iowa Supreme Court recently ruled that brand-name manufacturers cannot be held liable for versions of their drugs made by generic drugmakers.
Amaris Elliott-Engel is a contributor to law.com.