Partner Frederick Stearns Quoted in Article on Generic Drug Warnings

Date: Jun 01, 2012

Keller and Heckman Partner Frederick Stearns was quoted in an article on proposed legislation that would permit companies to update warnings on generic drugs, which appeared in the June 2012 issue of General Surgery News. The article explained that H.R. 4384 and S. 2295, introduced in the U.S. House of Representatives and the Senate in April, would permit generic drug manufacturers to update warning information for their products in the same way that brand manufacturers currently can.

The article noted that the bills are intended to address a 2011 Supreme Court ruling, Pliva v. Mensing, which held that generic drug companies cannot be held liable for failure to warn because they are legally required to use the same label as their brand-name counterparts.

Mr. Stearns cautioned that while the statutory language of the legislation doesn't directly address Pliva v. Mensing, it potentially opens the door to lawsuits against generics drug manufacturers. Although, he suggested that the prospects for the bills may be doubtful, adding, "I seriously doubt we will see action in the foreseeable future."