Greenblatt 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.

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

Greenblatt v. Roche (Atlantic City, New Jersey).

Actor James Marshall testifies, describing the symptoms and effects of Inflammatory Bowel Disease, and how it impacted his acting career.  Mr. Marshall also described the start and development of his acting career, as well as the effect of the IBD on his career.

Mr. Marshall also narrated for the jury clips from several of his movies and television shows, including the motion picture Gladiator, below, with Brian Dennehy. Mr. Marshall described the physically demanding set conditions for filming Gladiator, during which he had no symptoms of IBD.

In the lawsuit, Mr. Marshall and his co-plaintiffs, Kelley Andrews and Gillian Gaghan, claim that the use of Accutane (Isotretinoin) caused their illnesses.

CVN is webcasting the James Marshall Accutane Trial live.

Gaghan, Andrews, and Greenblatt v. Roche (Atlantic City, New Jersey).

Butler Snow’s Orlando R. Richmond, Sr., told the jury that Roche appropriately warned each of the three plaintiffs’ dermatologists about the risks of severe recalcitrant nodular acne medication Accutane (isotretinoin) by stating that”Accutane has been temporally associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders.” The warning was present, prominent, and accurate.

In addition, said Mr. Richmond, none of the three plaintiffs developed Inflammatory Bowel Disease (IBD) as a result of using Accutane. Mr. Marshall, for example, had inflammatory bowel disease at least seven years before the ever took Accutane, according to Mr. Richmond.

Ms. Andrews had an extensive history of antibiotic use, which, Mr. Richmond told the jury, was “something Mr. Hook didn’t talk to you a whole lot about yesterday, but literally from infancy forward — extensive antibiotic use.” 

As for Ms. Gaghan, said Mr. Richmond, “we’re going to present expert testimony to talk about [ulcerative colitis and Crohn's Disease] and the very recent scientific evidence regarding them. And you will learn that the type of inflammatory bowel disease that she had does not have scientific support with respect to being caused by Accutane.”

Finally, said Mr. Richmond, Roche took patient safety seriously. Accutane was not developed as a chemotherapy, said Mr. Richmond, but as a cancer preventive.

CVN is webcasting the Gaghan Accutane trial live.

Greenblatt v. Roche (Atlantic City, New Jersey).

Representing three plaintiffs allegedly injured by a Hoffman-La Roche acne medication, Michael Hook, of Hook & Bolton, explained to the jury in his opening statement that isotretinoin or “Accutane” had originally been developed as a chemotherapy for the skin and GI tract, and only subsequently was considered as a treatment for severe cystic nodular acne.

Animal studies showed, as early as the 1970s, said Mr. Hook, that isotretinoin posed a severe risk to the gastrointestinal tract. Nonetheless, despite reports of Crohn’s disease or Inflammatory Bowel Disease (IBD), and intestinal bleeding, supported by very strong evidence, Roche did not adequately warn of the risk prior to the plaintiff’s use of Accutane, according to Mr. Hook.

Plaintiff Kelley Andrews took Accutane at age 17, from 1997-1998, said Mr. Hook, and she was diagnosed with Crohn’s Colitis within a few months of completing her Accutane treatment. Ms. Andrews has been hospitalized over 25 times and endured seven major gastrointestinal  surgeries, including the removal of her colon and small bowel resection.

Plaintiff Gillian Gaghan took Accutane when she was 22 years old, in 1998, said Mr. Hook, and within a few months she began to experience the symptoms of Inflammatory Bowel Disease, and was diagnosed with Crohn’s Colitis. Ms. Gaghan suffered multiple hospitalizations and ongoing severe symptoms that would require continuous and lifetime medical care and treatment.

Plaintiff James Marshall took Accutane when he was 25 years old, in 1992 and 1993, said Mr. Hook, and he was subsequently diagnosed with Ulcerative Colitis. Mr. Marshall then was prescribed another round of Accutane, said Mr. Hook, even though Roche’s internal documents showed that Accutane was contraindicated for patients with colitis, because Roche did not put the warning on the label. Mr. Marshall had his entire colon removed, endured major surgeries, and was left permanent and severe symptoms.

The trial continues Wednesday morning with the defense opening statement.

CVN is webcasting the Andrews-Gaghan-Greenblatt Accutane trial live.

UPDATE: Because of the Appellate Division’s decision in Kendall v. Roche, The Greenblatt case has been continued with no new date. However, the case is expected to come back on calendar.

UPDATE 2: The Greenblatt trial is now scheduled to begin February 14, 2011. Watch it on live CVN.

Martin Sheen, Brian Dennehy, and Rob Reiner are expected to testify in Greenblatt v. Hoffman-La Roche. Bloomberg reports that Esai Morales, of the show NYPD Blue, and Rick Nicita, chairman of Morgan Creek Productions, will also testify.  Other plaintiffs in the trial are Gillian Gaghan and Kelley Andrews.

According to IMDB, James Marshall, born James Greenblatt got his first break when he was cast in television series Twin Peaks.  “The buzz on Marshall was so great that director Rob Reiner cast James and co-star Cuba Gooding Jr. in his upcoming film A Few Good Men. The movie was an excellent springboard towards a busy acting career.”

According to plaintiff attorney Mike Hook, the evidence at trial will show that Marshall would have had a stellar career, but for an inflammatory bowel disease the resulted in the removal of Marshall’s colon. The IBD, Marshall will contend, was caused by Accutane, an acne treatment medicine that Hoffman-La Roche allegedly should have warned could cause IBD.

According to Hoffman-La Roche, (1) Accutane has had IBD warnings for 20 years, and (2) the link between Accutane and IBD has not been scientifically proven.

CVN has covered four prior Accutane trials in which plaintiff attorney Mike Hook represented clients allegedly harmed by Accutane: McCarrell v. Hoffman-La Roche (2007), Kendall v. Hoffman-La Roche, (2008), In re: Accutane (2009), and McCarrell v. Hoffman La-Roche (2010 – retrial after appeal).

CVN will webcast Greenblatt v. Roche live, gavel-to-gavel.