Roche Must Pay Accutane User $7 Million for Illness

By David Voreacos and Mari Krueger

Oct. 11 (Bloomberg) -- Roche Holding AG must pay $7 million to a Pensacola man who blamed the company's Accutane acne drug for his inflammatory bowel disease, a Florida jury said, handing the company its second defeat in as many trials.

Roche failed to adequately warn of Accutane's risks and helped cause Crohn's disease in unemployed welder Adam Mason, 31, the jury said today after a state court trial in Pensacola. Mason, who took the drug for nine years until his diagnosis in 2000, suffers from diarrhea, fatigue, and depression. He testified he hasn't been able to work full-time in five years.

"We're obviously pleased," Mason's attorney Michael Hook said after the six-member jury gave its verdict. "It won't bring Adam's health back to him, but it will help him live with what he's got to face for the rest of his life."

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. Roche lawyers claimed the disease's cause is unknown and drug-label warnings were adequate.

The Pensacola jury's award to Mason, whose Crohn's disease is a form of inflammatory bowel disease, includes $5,146,500 for future pain and suffering, $766,500 for past pain and suffering, $617,599 for lost earning capacity, $387,561 for future medical expenses and $110,134 for lost earnings.

'Medical Expenses'

"It will help me with medical expenses and everything," Mason said. "I'm glad it's all over with. It's been a long ride. Seven years."

Accutane is made by Roche unit Hoffmann-LaRoche Inc. of Nutley, New Jersey.

Roche spokeswoman Shelley Rosenstock said the company was disappointed in the verdict and would appeal, according to an e- mailed statement.

About 13 million people have taken Accutane since it was introduced in 1982. Basel, Switzerland-based 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.

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.

Clinical Studies

A plaintiff's expert on gastroenterology, Dr. 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, Dr. Richard Blumberg, testified that Accutane had "no effect" on Mason's disease.

The U.S. Food and Drug Administration 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.

Tougher Restrictions

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 that U.S. regulators had 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.

The case is Mason v. Hoffmann-LaRoche Inc. and Roche Laboratories Inc., 2001-CA-2416, Circuit Court in Escambia County, Florida (Pensacola).

To contact the reporters on this story: David Voreacos in Newark, New Jersey, at dvoreacos [at] bloomberg [dot] net; Mari Krueger in Pensacola, Florida, state court at mari [dot] saugier [at] gmail [dot] com.