Merck (NYSE:MRK) and other large brand-name pharmaceutical manufacturers could be legally liable for injuries resulting not from the use of their brand name products, but from generic versions of those drugs made by other companies, according to a new ruling from the Massachusetts Supreme Judicial Court.
The court ruling could set the precedent that such brand-name pharma companies could be found liable for reckless behavior if they fail to update labeling for their products which are also used for generic versions, according to court documents.
In the case, plaintiff Brian Rafferty claimed labeling on a generic version of Merck’s Provacar failed to indicate that sexual side affects he experienced could last even after he had stopped taking the drug.
Rafferty was forced to level the suit against Merck due to a ruling in 2011 from the US Supreme Court that set a precedent that generic drug companies couldn’t be sued for label warning issues related to side effects, as the generic producers are required to use the name-brand producer’s label on their products.
Rafferty’s case was dismissed by a lower court, but a higher court reversed the decision and allowed for a recklessness suit in place of negligence, according to a Reuters report.
“Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product. Consequently, this is the rare (perhaps the only) type of case involving a manufactured product where the requirements of general negligence may be satisfied even where the requirements of products liability are not,” Massachusetts Supreme Court Chief Justice Ralph Gants wrote.
Merck said that it was disappointed by the decision but stands by its Proscar product, according to the Reuters report.