The Alabama Supreme Court recently decided that a brand name drug maker can be held liable for warnings on a generic medication even if it was produced by another company.
Plaintiffs Danny and Vick Weeks filed a federal lawsuit against five current and former drug makers for injuries 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. By the time Mr. Weeks had used the medication, drug maker Wyeth no longer controlled the brand name product, which it sold in 2001.
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.
In a 145 page opinion written by Associate Justice Michael Bolin, the Alabama high court said the maker of a brand name drug can be liable for warnings on a generic medication where the maker of the generic drug copied warnings first issued by the brand name manufacturer, a practice permitted by the U.S. Food and Drug Administration. The Alabama court’s recent decision is in the minority, as courts around the country have consistently refused to find brand name liability for generically produced drugs under state law. Plaintiffs’ attorneys across the country are hopeful that this decision will help serve as guidance for other courts that will be asked to decide this issue.