Alabama Supreme Court Upholds Generic Drug Decision

On Friday, the Alabama Supreme Court ruled that brand-name drug makers can be held liable for warning labels on the generic versions of the medication, even if the generics were manufactured by another company.

Five of the nine-member court stood by a 2013 ruling on the matter.

A federal lawsuit was filed against five current and former drug makers  by Danny and Vick Weeks for injuries allegedly suffered by the man from long-term use of the prescription drug metoclopramide, a generic version of the brand-name drug Reglan, which is used to treat heartburn and nausea.

The lawsuit alleges that the warning labels on the generic medication failed to adequately describe possible hazards, including the potential for involuntary muscle movements, which should have been disclosed to the Weeks’ physician.

The federal judge initially hearing the case asked the Alabama Supreme Court to clarify state law as to whether the brand-name manufacturers can be legally responsible for fraud or misrepresentation stemming from the warning labels of their generic counterparts.

After the Supreme Court ruled that the Weeks could sue the brand-name manufacturers, the companies asked the court to reconsider. The justices made their ruling this past Friday, revoking the earlier ruling but issuing a second opinion which was similar in comparison to the result of the initial ruling.

In reaffirming its ruling, the majority said the U.S. Food and Drug Administration (FDA) regulations “require a generic manufacturer’s labeling for a prescription drug to 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 ‘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.”

In the majority opinion, the justices clarified that this ruling applies to a specific set of facts which involve a product that is subjected to heavy regulation by the federal government. They said that this legal principle wouldn’t apply to the makers of a hand tool, for example.

Among those who oppose the Alabama Supreme Court’s opinion, the Business Council of Alabama stated that 98 courts across the nation have rejected this legal theory, and that only three other courts have ruled similarly to this decision.

We will continue to keep you up to date on any developments on this ruling. Feel free to stop by our website. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

Related Posts