Eli Lilly ($LLY) has battled to protect its best-selling drug, the antidepressant Cymbalta, against generic competition but has decided not to stand and fight a lawsuit tying it to the suicide of a 16-year-old boy. The company agreed to settle the litigation in advance of a trial set to begin next month.
The amount of the settlement was kept confidential but the Indianapolis Star says a provision calls for a trust fund to be set up in the name of Peter Schilf, who shot himself on Christmas eve in 2004. The drug was approved in 2004 and Schilf was given samples by a doctor in November of that year. The suit said that Schilf and his mother were not told that some Cymbalta users were inclined toward suicide and doctors were not informed that a participant during a trial of the drug had hanged himself. Schilf shot himself a month later. An FDA recommended black box warning about suicide was added to Cymbalta in 2005. Lilly's marketing partner, Quintiles Transnational, is a co-defendant in the suit.
Lilly has had to deal with similar accusations of playing down health risks for the schizophrenia drug Zyprexa, a former multi-billion dollar seller for the company. In 2009 it also paid $1.4 billion to settle Justice Department litigation for marketing that drug too aggressively, promoting it for off-label conditions.
Cymbalta remains Lilly's best-selling drug, but not for long. It brought in just shy of $5 billion last year, $4 billion of that in the U.S., but it will lose patent protection at the end of 2013. It was slated to go off patent June 30, but Lilly last year won a 6-month extension after testing the drug for treating depression in adolescents through the FDA pediatric-exclusivity program. It is estimated the drugmaker will reap an additional $1.5 billion in sales from the extra 6 months of exclusivity.
- read the Indianapolis Star story
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