ATLANTIC CITY, NJ – A state court jury has determined Roche Holding AG, manufacturer of the popular acne medication Accutane, must pay $18 million in damages to two former users who developed inflammatory bowel disease because of the drug.

The trial, which concluded last Friday after nearly two-months of testimony, involved the combined claims of four individual plaintiffs treated with Accutane who also developed inflammatory bowel disease, or IBD. The two prevailing plaintiffs, Kathleen Rossitto and Riley Wilkinson, received $9 million each, however the jury found in favor of Roche in the two other cases and awarded no damages, according to a Courtroom View Network video webcast of the verdicts being read in court.

In all four cases, attorneys for the plaintiffs argued Roche knew of the risks associated with Accutane but failed to properly warn doctors and patients. During closing arguments, David Buchanan of Seeger Weiss repeatedly told the jury Roche purposely ignored studies suggesting Accutane caused bowel problems. “Roche had internally concluded Accutane has been causally associated with inflammatory bowel disease,” he said. “They want to focus on what is outside of Roche’s walls and not inside their internal conclusions.”

Buchanan referenced expert witness testimony from Dr. David Sachar, a former adviser to the Food and Drug Administration, stating Roche had access to studies suggesting out of 100 patients with IBD who also take Accutane, 80% of those IBD cases were caused by the Accutane itself. “There’s a reason why Roche does not want to talk about the numbers from the study,” said Buchanan, who also noted Roche’s attorneys declined to cross-examine Dr. Sachar on those claims, instead relying on testimony from their own expert witness.

Representing Roche, Orlando Richmond of Butler Snow argued strongly to the jury against the connection alleged between Accutane and IBD, citing that similar bowel conditions have been known to the medical community since the 19th century. “The vast majority of these (IBD) cases are idiopathic, meaning the cause is unknown,” said Richmond. “It’s always been the case. It was the case during the 90′s, and it’s the case now.”

Richmond also referred to one of Roche’s expert witnesses, a pediatrician who testified individuals from the same young adult age range are the most likely to both take Accutane and to independently develop IBD, which would explain the apparent overlap in some cases without also suggesting Accutane caused the disease. The jury seemed to accept this argument for two of the four plaintiffs by determining Accutane did not cause their health problems.

Accutane was first manufactured in 1982, and Roche claims to have treated over 13 million acne patients since then. In 2009 Roche stopped manufacturing Accutane after patents on the drug expired, but the generic version known as isotretinoin is still widely produced and prescribed for acne treatment throughout the United States.

Nine of the 13 Accutane lawsuits to reach a jury to date resulted in verdicts against Roche, though a number have been reversed on appeal. The first case went to trial in New Jersey in 2007, and since then Judge Carol Higbee has had responsibility for thousands of similar Accutane lawsuits consolidated at the state court level in Atlantic City with federal claims consolidated in Florida before United States District Judge James Moody.

All of the New Jersey Accutane trials have been video recorded in full and archived by Courtroom View Network. New Jersey, along with many other states, allows for video coverage of civil trials, though news media cameras are generally not permitted in federal court.

The lead case caption is Kathleen Rossitto v. Hoffmann-La Roche Inc., ATL-l-7481-10-MT, New Jersey Superior Court, Atlantic County (Atlantic City).

David Buchanan explains to the jury what Roche knew internally about the risks associated with Accutane.

New Jersey is home to another Accutane toxic tort trial, as plaintiff Priya Tanna sues Roche to recover for her permanent injuries. Tanna started using the prescription Accutane as a 15 year old and has since developed Inflammatory Bowel Disease (IBD). 

During his opening statements, plaintiff’s counsel Paul Smith asserted that Accutane’s brochure was misleading because it never mentioned IBD, latency or the permanency of resulting conditions. Further, he shared images of Roche’s internal documents that show Accutane knew about such toxicity effects like IBD.

Defense counsel, Marie Woodbury of Shook, Hardy & Bacon, LLP stated that this trial is actually about Tanna’s medical history and the conversations she had with her two dermatologist, Doctors Vierra and Barber.

“The warning information that was communicated to Priya Tanna’s doctors was adequate, appropriate, accurate and acknowledged by these doctors,” Woodbury said. “Roche has a 7-step warning system to make sure that doctors understand the importance of communicating risks to patients.”

Woodbury asserts that Roche followed the 7-step process and it was the shortfall of Tanna’s doctors that led to her lack of information or misinformation. Woodbury stated that the aim of the 7 step warning process is to make sure “that no one makes a casual decision to prescribe Accutane.”

Watch this Priya Tanna Accutane Trial live on CVN.

Paul Smith breaks his case down into three parts.

Marie Woodbury shows the jury the blister pack for Accutane as the last step in the 7-step process.

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.

Greenblatt v. Hoffman-La Roche (Atlantic City, New Jersey).

Watch the stars testify in this week’s Accutane trial, Greenblatt v. Roche.

According to IMDB, James Marshall, born James Greenblatt, got his first break when he was cast in the 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.”

Mr. Marshall’s attorey says that Marshall would have had a stellar career, but for an inflammatory bowel disease that resulted in the removal of Mr. Marshall’s colon. The IBD, Mr. Marshall will contend, was caused by Accutane, an acne treatment medicine that Hoffman-La Roche allegedly should have warned could cause IBD.

CVN expects to see live or video deposition testimony from Martin Sheen, Brian Dennehy, Rob Reiner, Esai Morales, and Rick Nicita, describing the career that Mr. Marshall might have had.

In addition to James Greenblatt, there are two other plaintiffs in the trial: Gillian Gaghan and Kelley Andrews.

This Accutane trial was originally scheduled for last summer, but a New Jersey Appellate Division ruling reversing a prior Accutane Award — Kamie Kendall v. Hoffman-La Roche — delayed the Greenblatt trial until now. CVN expects the Kendall retrial to be held in May.

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).

Watch a FREE 5-MINUTE CLIP of Mike Hook’s opening statement in the second McCarrell Accutane trial.

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

The $10.5M Accutane verdict in Kendall v. Roche has been reversed, and remanded for retrial, for reasons similar to last year’s reversal of McCarrell v. Roche. 

Kamie Kendall’s colon was removed as a result of inflammatory bowel disease allegedly resulting from the use of the acne medication Accutane (Isotretinoin).  Plaintiff attorney Mike Hook told the jury that Ms. Kendall’s condition caused her “to go to the bathroom, with diarrhea and blood, anywhere from 5-20 times per day, and will for the rest of her life.” 

Mr. Hook argued that Accutane was a highly toxic drug developed as a chemotherapy, not an acne treatment, but that Roche did not adequately warn of known gastrointestinal risks, and that Ms. Kendall’s treating dermatologist in fact did not know of the risks.

Butler Snow’s Lee Thames, on behalf of Roche, argued that Accutane was one of the most effective acne treatments, and the warnings were adequate.  Mr. Thames suggested that Mr. Hook had quoted the Accutane warnings without enough context, and advised the jury, “Look at the whole bloomin’ document, before you decide something.”

On April 22, 2008, the jury found in favor of the plaintiff, and awarded compensatory damages of $10.5M.

On August 5, 2010, the Appellate Division of the New Jersey Superior Court published an unpublished opinion vacating the judgment and remanding for a new trial so that Roche could provide quantitative information to the jury relating to the number of Accutane users and the background rate of IBD, to cast light on Roche’s efforts to monitor the risk of harm.

CVN webcast the original Kendall Accutane trial, as well as both the original 2007 McCarrell trial, and the 2010 McCarrell retrial.

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.

The jury returned a $25 million verdict in favor of the plaintiff in the re-trial of McCarrell v. Hoffman-La Roche, after approximately 3 hours of deliberating. 

Judge Carol Higbee polled the jury. The nine jurors voted 7-2 that Roche failed to adequately warn of the dangers of Accutane. The jurors voted 7-2 again (although not the same two dissenting jurors) that Accutane was the proximate cause of Andy McCarrell’s Inflammatory Bowel Disease (IBD).

The jury ruled 9-0 that McCarrell’s compensatory damages would be $25M.

In the original May 2007 Accutane Trial, the jury returned a $2.7M verdict. However, that verdict was overturned on appeal because the defense was prevented from telling the jury that there were 5M Accutane users.

CVN covered the both the original May 2007 Accutane trial and the 2010 re-trial live.  On-demand coverage of the entire Accutane Trial is available, as well as free clips from opening statements.