Black box warning for antidepressants spelled the death of litigation

There used to be a legal specialty built by plaintiff attorneys around filing lawsuits against antidepressant makers and then settling them. But the black box warning put on antidepressants in 2004 has turned out to be a shroud for the once lucrative legal business.

The debate over whether the warning was a good thing ultimately has yet to be settled, however. A study in the June issue of British Medical Journal found that there has been an increase in suicides among teens and young adults in the U.S. since the black box warnings were added and antidepressant use in those groups has fallen off.

U.S. courts once brimmed with hundreds of lawsuits against Paxil producer GlaxoSmithKline ($GSK), Cymbalta maker Eli Lilly ($LLY) and others. Now only a few remain, according to the Indianapolis Star. Houston lawyer Andy Vickery was one of those attorneys who flourished in the days when the media was full of reports of people on antidepressants who committed suicide, or murder, or both. But Vickery, the only trial lawyer to win an antidepressant suicide case before a jury, said that business has all but vanished.

He won a $6.5 million judgment against GlaxoSmithKline in a 2001 case tied to a Wyoming man who three years earlier shot and killed his wife, daughter and granddaughter, before turning the gun on himself. The case settled after GSK appealed. In fact, most of the cases were settled. But the Wyoming case is believed by Vickery and others to have been a turning point, leading the FDA to more closely examine the tie between antidepressant use and suicidal actions. The suicide warning, added for adolescents in 2004, was extended to include young adults in 2007.

Even after the warnings, sales of antidepressants remained strong. Cymbalta was Lilly's best-selling drug, churning out about $5 billion a year in sales until going off patent late last year. But after the black box precaution was added people couldn't claim they had not been warned and the lawsuits petered out. While it changed his career, Vickery believes there are people alive today because of the warning that drugmakers resisted.

Not everyone agrees. Some think it has kept some people from taking drugs that might have prevented them from taking their own lives and the BMJ study by Harvard researchers supports that. While the study has its critics, Dr. Ken Duckworth, the medical director of the National Alliance on Mental Illness, said it seems pretty clear. "I was afraid it would have a chilling effect on antidepressant use," Duckworth, who testified to the FDA advisory panel that recommended the warning, tells the Indianapolis Star. "That appears to be what happened."

- read the Indy Star story