Roche Wins 2 of 3 Accutane Cases

Posted by msch on Apr 8, 2011 8:10:00 PM

Mike Hook and Orlando Richmond in James Marshall Accutane TrialGreenblatt v. Hoffman-La Roche (Atlantic City, New Jersey)

After hearing evidence for more than six weeks, a 7-member jury awarded $2M in damages to one Accutane plaintiff, but two other plaintiffs, including actor James Marshall, received nothing.

In his closing argument on behalf of Roche, Butler Snow's Orlando Richmond told the jury that they would have to decide whether the plaintiffs' illness was caused by Accutane (isotretinoin), and whether a different warning would have convinced the plaintiffs not to have taken Accutane.

According to Mr. Richmond, the evidence showed that Roche appropriately warned the plaintiffs' treating physicans of the risks associated with Accutane.  The evidence also showed, according to Mr. Richmond, that none of the three plaintiffs developed IBD as a result of their using Accutane. 

"And finally," said Mr. Richmond, "This evidence has established that Roche took patient safety seriously in dealing with the issues regarding Accutane." Each of three prescribing physicians was warned, said Mr. Richmond, "When it comes to decision points in this case, what they say they understood, what they say they appreciated, what they say they considered, and what they say they would have done if the world were different, is where this case ought to be decided, when it comes to the label."

In his closing argument on behalf of the three plaintiffs, Hook & Bolton's Mike Hook told the jury that Roche had overwhelming internal evidence of Accutane's severe risk of inflammatory bowel disease (IBD); that Roche internally concluded that Accutane induces, triggers, or causes IBD; and that Roche failed to properly warn Accutane patients of the nature of the risk.

Plaintiff Kelley Andrews took Accutane and developed Crohn's disease, a form of IBD. She was hospitalized over 25 times, and suffered seven major gastrointestinal surgeries, including colon removal. 

Plaintiff Gillian Gaghan took Accutane and developed ulcerative colitis. She endured multiple hospitalizations and lupus-like symptoms, and suffered ongoing symptoms, including nighttime loss of bowel control.

Plaintiff James Marshall took Accutane and suffered ulcerative colitis in 1993, with symptoms including rectal bleeding, the hallmark of ulcerative colitis. A prior reported intestinal problem when Mr. Marshall was eighteen years old was not a pre-existing IBD, said Mr. Hook, because ulcerative colitis always presents with rectal bleeding, and Mr. Marshall suffered none before 1993.

Roche's warning of a temporally related association of IBD and Accutane was inadequate, said Mr. Hook, because IBD symptoms were not only temporally related but could extend long after Accutane use ended and were not reversible; because Roche had evidence of causation but only reported an association; because Roche understated the extent of the risk; because Roche understated and the amount of evidence demonstrating the risk; and because Roche failed to specially warn at-risk patients who had a greater risk of developing IBD. 

"If you know what the real risks are and you decide to take the drug then you have assumed that risk. That's the way our country operates. But you know, in order to take take the risk you have got to know what it is. You've got to know what the full risk is. You can't tell people just a little bit. It's not whether you mention that it's temporally associated. It's tell them what you know. So they can make that decision. That's what this is about. They'd like to say because we say temporally associated our obligation ends, and that is not the law. That is not the law. And that is not the obligation of a pharmaceutical company, nor any corporation for that matter."

Mr. Hook reviewed testimony from all of the plaintiffs' treating physicians that when they prescribed Accutane they did not understand from the label that Accutane caused IBD, and that they would have discussed the risk of permanent injury with the plaintiffs if they had known.

For plaintiff Kelley Andrews, the jury found that Accutane was a substantial factor in her developing IBD, Roche failed to provide an adequate warning of the risks, but Roche's failure to warn was not a substantial factor in her taking Accutane. 

For plaintiff Gillian Gaghan, the jury found that Accutane was a substantial factor in her developing IBD, and Roche failed to provide an adequate warning, and that the failure to warn was a substantial factor in her taking Accutane. The jury found that an award of $2M would reasonably compensate Ms. Gaghan.

For plaintiff James Marshall, the jury found that Accutane was not a substantial factor in his developing IBD.

Because James Marshall presented evidence that his IBD cost him a very substantial film career, this trial risked a much higher damages award than even the $25M award to Andrew McCarrell last year. Because this jury was willing to find against Roche on all of the key issues -- that Accutane can cause IBD, that the warning was inadequate, and that the failure to properly warn could have had a decisive effect -- that Roche escaped with a total damage award of only $2M may be seen as a significant victory in this case.

However, for future plaintiffs today's result is consistent with the result in all prior Accutane trials: every jury considering the issue has concluded that Accutane can cause IBD and that Roche's warning was inadequate.

The next Accutane trial is expected to be Kamie Kendall v. Roche, which will retry a case that resulted in a $10.5M verdict in 2008, but was reversed on appeal.

Accutane Warning Label

CVN webcast the James Marshall Accutane trial live and gavel-to-gavel.

Topics: Toxic Torts, accutane, Greenblatt v. Roche, Pharmaceutical