Most recently, Roche lost several Accutane lawsuits brought by people who claimed the Accutane drug caused them to develop inflammatory bowel disease (IBD). In November 2008, a New Jersey jury ordered the company to pay $13 million to three such plaintiffs. The previous April, another New Jersey jury awarded $10.5 million to a woman who blamed the drug for her ulcerative colitis. In May 2007, another New Jersey trial resulted in an Accutane award of $2.62 million to a patient who needed to have his colon and most of his rectum removed after taking the drug. In October that same year, a Florida jury awarded $7 million in damages to another Accutane user who developed the IBD.
In announcing its decision to pull Accutane, Roche did cite the high cost of product liability Accutane suits - it currently faces 5000 such Accutane lawsuits - involving the Accutane drug. But according to Bloomberg.com, the company also said a reevaluation of its Accutane product line had shown Accutane faced serious competition from generics.
Harvard Suicide Victim's Father Sues School Over Prescriptions
By Thom Weidlich
Dec. 5 (Bloomberg) -- The father of a Harvard College sophomore who killed himself in 2007 sued the school's president and fellows for wrongful death, alleging the institution's health service prescribed drugs known to increase suicide risk.
John B. Edwards II of Wellesley, Massachusetts, sued on behalf of the estate of his son, known as Johnny, in state court in Middlesex County on Dec. 2. A doctor and nurse employed by Harvard simultaneously prescribed skin, antidepressant and attention-deficit disorder drugs linked to suicide and other side effects, according to the complaint.
"Three of these drugs have risks associated with heightened suicidality," the father's lawyer alleged in the complaint. ;All four drugs have significant side effects."
Harvard College in Cambridge, Massachusetts is the undergraduate school of Harvard University, whose $26-billion endowment is the world's largest academic fund.
"The care he received at Harvard University Health Services was thorough and appropriate and he was monitored closely by its physicians and allied health specialists," Harvard said yesterday in an e-mailed statement. "Similar complaints previously have been filed with the Board of Registration in Medicine, the Board of Registration in Nursing and the Board of Registration in Pharmacy, and in all three instances the complaints were dismissed upon review."
Suicide Warnings
Johnny Edwards was valedictorian of his high school class, according to the complaint. Arrowood alleged he was prescribed Swiss-based Roche Holding AG's Accutane for cystic acne; Dublin- based Shire Plc's Adderall for attention deficit hyperactive disorder diagnosed by the school nurse; Indianapolis-based Eli Lilly Co.'s Prozac for an anxiety disorder she also diagnosed; and London-based Glaxosmithkline Plc's Wellbutrin, which contains a warning about suicide for patients under 25, according to the complaint.
Roche said in June that it would pull Accutane from the U.S. market. The product carries cautions about reports of depression and suicide in patients. U.S. Representative Bart Stupak, a Michigan Democrat, said in 2000 that his son's suicide at age 17 was linked to depression caused by Accutane.
A 2004 report from the Food and Drug Administration suggested that antidepressants such as Prozac and Wellbutrin might double the risk of suicidal thoughts and actions in children and teens who take them. The FDA study, which led to a 20 percent decrease in antidepressant prescriptions for children between March, 2004, and June, 2004, examined data from 24 human studies involving 4,582 young patients.
Psychological Effects
Shire strengthened warnings on Adderall XR in 2006 to include psychological side effects.
The nurse signed the prescriptions for the drugs as a doctor, the lawyer alleged.
"As a result of the acts of both commission and omission by all defendants, Johnny's young life, full of unbridled promise, came to an abrupt and horrific end on Nov. 29, 2007," Arrowood wrote in the complaint. She is seeking unspecified damages.
The case is Edwards v. President and Fellows of Harvard College, 09-4695, Massachusetts Superior Court (Middlesex County).
