Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court
Article by: JESSE J. HOLLAND , Associated Press | Updated: March 19, 2013 2:10 PM
WASHINGTON - The Supreme Court seemed skeptical Tuesday of allowing generic drug manufacturers to be sued in state court for a drug's design defects if federal officials approved the brand-name version the generic drug copied.
The justices heard arguments from generic manufacturer Mutual Pharmaceutical Co, Inc., which wants a $21 million judgment dismissed. A New Hampshire jury gave that to Karen L. Bartlett after she took sulindac, the generic form of the drug Clinoril, in 2004. It caused her outer skin layer to deteriorate and burn off, leaving at least 60 percent of her body as an open wound. She is also now legally blind.
The federal appeals courts upheld her verdict, but the company wants the Supreme Court to overturn it.
Justices ruled in 2011 that makers of generic drugs cannot be sued for failing to warn consumers of the possible side effects of their products if they copy the exact warnings on the brand-name equivalents of the medicines as required by federal law. Mutual and the Obama administration want that protection extended to the design of the drug, since the generic is an exact copy of the brand-name drug that has already been approved by the federal government.
To allow Bartlett's verdict to stand would cause a conflict between state liability law and federal law requiring the two drugs to be the same, Mutual lawyer Jay P. Lefkowitz said.
"Federal law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version, but a New Hampshire jury imposed liability because sulindac didn't have a different safety profile, meaning a different ingredient or a different warning," he said.
The Food and Drug Administration approved sulindac in 1978, and Mutual got approval to sell its generic in 1991 after the FDA said it was "safe and effective for use." A warning that the side effects that Bartlett suffered was associated with the drug was added in 2002, and updated in 2006 to specifically refer to toxic epidermal necrolysis, a form of Steven-Johnson Syndrome or SJS/TEN.