Generic Drug Decision Upheld in Alabama

Brand-name drug makers can be held liable for warnings on a generic medication even if it was produced by another company, the Alabama Supreme Court ruled Friday, standing by an earlier decision that business leaders viewed as a defeat.

The all-Republican court was divided, with Chief Justice Roy Moore and two other members issuing dissents.

But a majority of five justices on the nine-member court stuck by a 2013 ruling in a case that was watched closely by both business groups and plaintiff lawyers.

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

The couple claimed 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 Weeks’ physician.

A federal judge hearing the case asked the Alabama Supreme Court to clarify state law on the question of whether the brand-name manufacturers could be held responsible for fraud or misrepresentation.

Last year, the Supreme Court said the couple could sue brand-name makers. The companies asked the court to reconsider, and the justices issued a second opinion withdrawing the first but closely paralleling its result.

In an opinion written by Associate Justice Michael Bolin, the court said it’s not unfair to hold the maker of a brand-name drug liable for warnings on a generic medication if the maker of the generic drug only copied warnings first issued by the brand-name manufacturer, a practice permitted by the U.S. Food and Drug Administration.

The justices, who have been criticized for the 2013 decision by business groups, said the ruling applied only to a specific set of facts involving a product subject to heavy regulation by the federal government. The same legal principles wouldn’t apply to the maker of a hand tool, for example, said the majority opinion.

“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 …,” Bolin wrote.

Wyeth, which made Reglan for a time, and the Business Council of Alabama both expressed disappointment in the decision and cited a dissent by Associate Justice Glenn Murdock, who wrote: “This court creates a precedent that poses danger for the prescription-medicine industry and, by extension, for all industry.”

The Business Council said 98 different courts nationwide had rejected the legal theory adopted by the Supreme Court’s ruling. Only three other courts ruled similarly to the Alabama Supreme Court, the business group said.

Moore wrote that the state court should have never agreed to answer the federal court’s question because “critical facts” weren’t before the Supreme Court.