Legal News

Wife of Congressman Loses Acne-Drug Suicide Case

By Ashby Jones

The Eleventh Circuit ruled on Wednesday on an interesting and provocative case, albeit one with tragic facts. In an unpublished opinion, the Eleventh Circuit affirmed a trial court’s grant of summary judgment in a case in which the mother of a 17 year-old who committed suicide in 2000 sued Hoffman-La Roche, Inc. The plaintiff alleged that Accutane, an acne drug made by Hoffman-LaRoche caused the suicide. Click here and here for reports from BNET Pharma and the Drug and Device Blog, respectively.

A strange twist to the saga: The 17 year-old was B.J. Stupak, the son of Rep. Bart Stupak (D-Mich). In 2002, Stupak gave the opening remarks at a hearing about the safety of Accutane. Said Stupak:

Two and one half years ago, Laurie, Ken and I lost our son and brother, BJ, who took his own life. Anyone who knew BJ could not understand why a young man with such an outgoing personality and bright future would end his own life. BJ taking his own life, is contrary to everything he believed in!

If Laurie and I had any idea that Accutane could cause depression, suicide ideation or suicide our sons never would have taken the drug. The thought that an acne medication would lead to such devastating side effects never occurred to us. For our family, the risks attributed to Accutane greatly outweigh any of the benefits. . . .

Accutane is a powerful, dangerous drug with devastating consequences for some patients. The birth defects caused by Accutane are horrific. The FDA’s response to the birth defects and psychiatric events has been inadequate, irresponsible and unacceptable. Thousands of babies, teenagers, and young adults have died prematurely. While the FDA has been aware of the birth defects since at least 1982 and the psychiatric injuries since 1985, their responsibility to protect the public has been inconsistent and without direction.

According to the Drug and Device Blog, the trial court granted summary judgment to Hoffman-La Roche on the ground that the warning on the product was adequate and plaintiff could not prove the cause drug caused the suicide. On Wednesday, the Eleventh Circuit affirmed, holding that the package insert mentioned the risk of suicide. Plaintiff had argued that the warning was inadequate because it didn’t mention the possibility of a suicide “without premonitory symptoms.” But the record contained no evidence that Roche knew that Accutane could cause suicide without those symptoms.

Indeed, plaintiffs who suffered bowel problems have had some success collecting in Accutane suits, but much of the suicide litigation is still pending, as a multi-district litigation in Florida.

Full post as published by Law Blog - WSJ.com on June 11, 2009 (boomark / email).