Roche Must Pay $7M In Accutane Trial
2 CommentsBy Ed Silverman // October 11th, 2007 // 6:08 pm
The drugmaker was handed its second defeat in as many trials over charges the acne med caused inflammatory bowel disease. The latest case occurred in Florida, where a jury decided Roche failed to adequately warn of Accutane’s risks and helped cause Crohn’s disease in an unemployed, 31-year-old welder, who took the drug for nine years.
“It will help me with medical expenses and everything,” Adam Mason, who suffers from diarrhea, fatigue, and depression, tells Bloomberg News. “I’m glad it’s all over with. It’s been a long ride. Seven years.”
Roche faces 400 lawsuits blaming Accutane for causing inflammatory bowel disease. A New Jersey jury in May awarded $2.62 million to an Alabama man in the first such case to reach trial, the wire service reminds us. Roche lawyers claimed the disease’s cause is unknown and drug-label warnings were adequate. Roche spokeswoman Shelley Rosenstock says the drugmaker is disappointed and would appeal, according to Bloomberg.
About 13 million people have taken Accutane since it was introduced in 1982. Roche lost patent protection on the drug in 2002 and continues to sell it, with generic competition. Accutane, used to treat the worst cases of acne, also has been associated with birth defects and depression. The drugmaker also faces lawsuits over charges the med can cause suicidal thoughts and behavior.
Roche lawyer Edward Moss said in closing arguments that Roche adequately studied the drug before its launch and warned doctors in 1984 that it was “temporally associated” with bowel disease. “Roche is not responsible to Adam Mason in this case,” Moss told jurors. He noted the former welder’s testimony that he hadn’t read Accutane’s label during his nine years of using the medicine.
A plaintiff’s expert on gastroenterology, David Sachar, testified that Roche hasn’t done any clinical studies to determine whether Accutane causes inflammatory bowel disease. He said the drug was the cause of Mason’s illness. A Roche expert on gastroenterology, Richard Blumberg, testified that Accutane had “no effect” on Mason’s disease.
The FDA warned in March that buying Accutane over the Internet raises the risk that patients will have babies with birth defects. Women are supposed to agree to use two forms of birth control and take a pregnancy test to get a prescription from a doctor.
The FDA imposed tougher restrictions on Accutane in March 2006 based on reports of deformities and low intelligence in children whose mothers took the drug during pregnancy. Internet pharmacies may bypass these rules and distribute products with counterfeit and potentially dangerous ingredients, the FDA said.
On Oct. 9, Roche announced the FDA loosened restrictions in the program designed to prevent women taking Accutane from becoming pregnant. The FDA approved changes to the iPledge program to make it less cumbersome for doctors to prescribe the drug and its generic equivalents, Roche said. The revisions extend the number of days patients have to fill their prescriptions and eliminate a 23-day waiting period when prescriptions aren’t filled on time.
Simon Passanante - Roche loses another Accutane case
[...] known as Crohn’s Disease has won a $7 million verdict against the drugmaker Roche. According to Pharmalot, this was the second case to go to trial against Roche over the acne drug and it was the second [...]
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