Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court
Robert Barnes | The Washington Post | March 19, 2013
Karen Bartlett’s burn surgeon called her life “hell on Earth,” and there is no reason to believe that is an exaggeration.
In 2004, after she took the anti-inflammatory drug sulindac at her doctor’s direction to relieve shoulder pain, she developed a rare but known side effect: a form of Stevens-Johnson Syndrome, or SJS/TEN.
It caused the outer layer of her skin to deteriorate until it became an open wound over more than 60 percent of her body. She spent months in a medically induced coma. She underwent 12 eye surgeries, with more to come. She has lung damage and esophageal damage and is now legally blind.
She sued Mutual Pharmaceutical, which manufactured the drug, and a New Hampshire jury awarded her $21 million.
But Mutual’s attorney told the Supreme Court on Tuesday that because sulindac is the generic version of the brand-name drug Clinoril, the company could not take the precautionary actions the New Hampshire jury said it should have.
“Federal law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version,” attorney Jay P. Lefkowitz told the court. But the jury found the company liable “because sulindac didn’t have a different safety profile, meaning a different ingredient or a different warning.”
It is impossible for the company to comply with both, he said, and federal law takes precedence.
The case presents issues that have divided the court before. In 2009, it ruled that the Federal Drug and Cosmetics Act did not shield a brand-name drug manufacturer from a state suit that its warning label was inadequate, despite federal regulators’ involvement in writing the label.
But in 2011, it did protect a generic-drug company against a state tort because it said the warning label was dictated by requirements imposed by the U.S. Food and Drug Administration on its brand-name counterpart.
Lefkowitz and David Frederick, representing Bartlett, received tough questioning.
