Jury Awards $25.16 Million on Claim Acne Drug Caused Bowel Illness

Lawyers suing Roche Laboratories Inc. had reason to be dismayed 14 months ago when a state appeals court threw out a $2.5 million jury verdict they had won for a man who blamed the acne drug Accutane for his bowel disease. But this February the lawyers won 10 times more at the retrial. An Atlantic County jury awarded $25.16 million to Andrew McCarrell of Birmingham, AL, after finding that Roche knew or should have known that Accutane caused inflammatory bowel disease (IBD) and failed to warn prescribing physicians. It's the largest of five victories that Accutane users have won against the drug maker, including a $13 million verdict last November for three plaintiffs.

The Accutane Cases

McCarrell's claim was one of 791 on a list of Accutane cases assigned to a mass tort court in Atlantic City, and dozens more are pending around the country. One of the branches of the Swiss company is in Nutley, NJ. McCarrell, 38, took Accutane 15 years ago and developed chronic ulcerative colitis, which led to removal of his colon, and he has suffered further bowel problems that required further surgeries, according to evidence at the trial before Superior Court Judge Carol Higbee.

As they have in other cases, McCarrell's lawyers presented evidence that Roche never published studies to the scientific and medical community showing that Accutane's byproducts damage the gastrointestinal tract and lead to degeneration and erosion of the intestinal lining ' a trigger for IBD. The lead plaintiffs' counsel, Michael Hook of Hook & Bolton in Pensacola, FL, also presented evidence that physicians prescribing Accutane noticed incidences of IBD in patients and reported them to the company.

The jury answered yes to the questions of whether Roche had failed to provide a warning and was the proximate cause of McCarrell's IBD and awarded $25,159,530 in compensatory damages. No punitive damages were sought. Roche stopped making and selling Accutane last June.

Roche Comments

Defense counsel Michael Imbroscio of Covington & Burling in Washington did not return a call, but a Roche company statement said that “Roche takes any and all information about our products seriously, and our sympathies remain with Andrew McCarrell over his disease.“ The company says it will appeal the verdict, claiming that the jury's findings and the damages awarded were unsupported by the evidence. Roche insisted it had “acted appropriately in providing information about Accutane, including a direct warning about inflammatory bowel disease, to the medical, scientific and regulatory communities.“

“IBD most frequently occurs in patients age 15 to 35 ' generally the same age group as patients who are prescribed Accutane,“ the company said. “According to the Crohn's and Colitis Foundation of America, it is estimated that 1.4 million Americans suffer from inflammatory bowel disease, with approximately 30,000 new cases diagnosed each year.“

Why the First Decision Was Vacated

When it was first tried in May 2007, McCarrell's was the first Accutane case to go to a jury. But an appeals court found that Higbee, in addition to all the rulings she got right, got one wrong: She had restricted the company's ability to show how vast a population of Accutane users existed to demonstrate that the number who complained of ill effects was relatively small.

“It does not matter if the drug is sold to 10 million people or five million people or 1,000 people, because if you have a serious risk, it is significant,“ Higbee said.

As a result, Roche was not permitted to introduce evidence that from 1982 to 1995, five million people had taken Accutane and it could only refer to clinical studies involving 300,000 patients of whom seven or eight had reported symptoms of IDB.

That was unfair, the appeals court ruled, vacating the $2.5 million verdict and ordering a retrial.

David Buchanan of Seeger Weiss in New York, one of the plaintiffs' lawyers, says the reversal disappointed him at the time, but he was buoyed by the affirmance of Higbee's other rulings. As a result, he says, the appeals court “provided a blueprint that will be useful in other trials.“

Excessive Damages?

Buchanan says it is impossible to say for certain why the second jury returned so magnified a verdict after hearing the defense evidence the judge excluded at the first trial.

Two possible explanations: First, the first jury's damage finding was lower than it should have been. “McCarrell's case is one of the most serious,“ he says. Second, the experience of the first trial has improved the plaintiffs' lawyers' presentations. “We're getting better,“ he says.

Buchanan says this recent verdict should send a message to the company that a settlement of pending cases would be wise. “I would hope they would acknowledge what the juries are telling them. I am hoping the message is heard.“

Bloomberg News quoted a juror in the retrial of McCarrell's case, Dorrine Simms of Atlantic City, as saying, “I think it's a fair amount, I really do, considering all he's been through these 15 years.“

Henry Gottlieb is a senior writer for the New Jersey Law Journal, an ALM affiliate publication of this newsletter, in which this article first appeared.

Lawyers suing Roche Laboratories Inc. had reason to be dismayed 14 months ago when a state appeals court threw out a $2.5 million jury verdict they had won for a man who blamed the acne drug Accutane for his bowel disease. But this February the lawyers won 10 times more at the retrial. An Atlantic County jury awarded $25.16 million to Andrew McCarrell of Birmingham, AL, after finding that Roche knew or should have known that Accutane caused inflammatory bowel disease (IBD) and failed to warn prescribing physicians. It's the largest of five victories that Accutane users have won against the drug maker, including a $13 million verdict last November for three plaintiffs.

The Accutane Cases

McCarrell's claim was one of 791 on a list of Accutane cases assigned to a mass tort court in Atlantic City, and dozens more are pending around the country. One of the branches of the Swiss company is in Nutley, NJ. McCarrell, 38, took Accutane 15 years ago and developed chronic ulcerative colitis, which led to removal of his colon, and he has suffered further bowel problems that required further surgeries, according to evidence at the trial before Superior Court Judge Carol Higbee.

As they have in other cases, McCarrell's lawyers presented evidence that Roche never published studies to the scientific and medical community showing that Accutane's byproducts damage the gastrointestinal tract and lead to degeneration and erosion of the intestinal lining ' a trigger for IBD. The lead plaintiffs' counsel, Michael Hook of Hook & Bolton in Pensacola, FL, also presented evidence that physicians prescribing Accutane noticed incidences of IBD in patients and reported them to the company.

The jury answered yes to the questions of whether Roche had failed to provide a warning and was the proximate cause of McCarrell's IBD and awarded $25,159,530 in compensatory damages. No punitive damages were sought. Roche stopped making and selling Accutane last June.

Roche Comments

Defense counsel Michael Imbroscio of Covington & Burling in Washington did not return a call, but a Roche company statement said that “Roche takes any and all information about our products seriously, and our sympathies remain with Andrew McCarrell over his disease.“ The company says it will appeal the verdict, claiming that the jury's findings and the damages awarded were unsupported by the evidence. Roche insisted it had “acted appropriately in providing information about Accutane, including a direct warning about inflammatory bowel disease, to the medical, scientific and regulatory communities.“

“IBD most frequently occurs in patients age 15 to 35 ' generally the same age group as patients who are prescribed Accutane,“ the company said. “According to the Crohn's and Colitis Foundation of America, it is estimated that 1.4 million Americans suffer from inflammatory bowel disease, with approximately 30,000 new cases diagnosed each year.“

Why the First Decision Was Vacated

When it was first tried in May 2007, McCarrell's was the first Accutane case to go to a jury. But an appeals court found that Higbee, in addition to all the rulings she got right, got one wrong: She had restricted the company's ability to show how vast a population of Accutane users existed to demonstrate that the number who complained of ill effects was relatively small.

“It does not matter if the drug is sold to 10 million people or five million people or 1,000 people, because if you have a serious risk, it is significant,“ Higbee said.

As a result, Roche was not permitted to introduce evidence that from 1982 to 1995, five million people had taken Accutane and it could only refer to clinical studies involving 300,000 patients of whom seven or eight had reported symptoms of IDB.

That was unfair, the appeals court ruled, vacating the $2.5 million verdict and ordering a retrial.

David Buchanan of Seeger Weiss in New York, one of the plaintiffs' lawyers, says the reversal disappointed him at the time, but he was buoyed by the affirmance of Higbee's other rulings. As a result, he says, the appeals court “provided a blueprint that will be useful in other trials.“

Excessive Damages?

Buchanan says it is impossible to say for certain why the second jury returned so magnified a verdict after hearing the defense evidence the judge excluded at the first trial.

Two possible explanations: First, the first jury's damage finding was lower than it should have been. “McCarrell's case is one of the most serious,“ he says. Second, the experience of the first trial has improved the plaintiffs' lawyers' presentations. “We're getting better,“ he says.

Buchanan says this recent verdict should send a message to the company that a settlement of pending cases would be wise. “I would hope they would acknowledge what the juries are telling them. I am hoping the message is heard.“

Bloomberg News quoted a juror in the retrial of McCarrell's case, Dorrine Simms of Atlantic City, as saying, “I think it's a fair amount, I really do, considering all he's been through these 15 years.“

Henry Gottlieb is a senior writer for the New Jersey Law Journal, an ALM affiliate publication of this newsletter, in which this article first appeared.