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.

The first day of plaintiff attorney Mike Hook’s presentation of evidence in the Accutane trial featured four Hoffman-La Roche employees testifying by video deposition.  

 Former Roche Research Scientist John McLane and Roche’s Global Head of Drug Safety Dr. Martin Huber testified in the morning session on January 14th.  

The afternoon session saw the completion of Dr. Huber’s testimony, as well as the video depositions by Eileen Leach, Roche’s Medical Director of Dermatology, and Heather Mayer, Roche’s Product Knowledge Manager for Accutane.

Hook asked, “Mr. McLane, isn’t it true that Roche knew inflammatory bowel disease was an irreversible condition, yet while you were there, had a label in effect that implied or inferred that the condition was irreversible?”  

McLane was unwilling to speak toward Roche’s knowledge, so Hook asked, “Do you know whether inflammatory bowel disease in some people is irreversible?”  McLane’s response was, “No, I don’t know that.”

Dr. Huber testified to the importance of challenge/de-challenge/re-challenge data in establishing causation. According to Dr. Huber, Roche would be interested and would follow-up on even one report of challenge/de-challenge/re-challenge.  This exchange followed:

Hook: Can you give us any estimate of the number of reports that your company has internally in which it is reported to be a de-challenge, re-challenge situation?

Huber: I don’t know the exact number, but my last knowledge there was one case I think that was considered with a positive rechallenge.

Hook: Just one case?

Huber: To the best of my knowledge.

Hook then reviewed with Dr. Huber more than ten internal reports indicating that various intestinal ailments, including Crohn’s disease, had been associated with Accutane, had ceased after Accutane had been discontinued, and had reappeared after Accutane treatment was re-commenced, including several from before 1995, when Andrew McCarrell began his treatment.

Eileen Leach, Medical Director of Dermatology, testified next.

Leach: Roche told prescribing physicians that Isotretinoin [Accutane] causes birth defects when you take the medication.  They were very explicit, they were very straight forward about it, they put it everywhere.

Hook: Did Roche convey to the prescribing physicians or tot he public that Accutane caused any other injury?

Leach: No.

Hook: Does Accutane cause Inflammatory Bowel Disease?

Leach: No.

Hook showed Heather Mayer, Roche’s Product Manager for Accutane, a product label that warned of symptoms that, “if left untreated, could possibly result in permanent effects.” Hook then asked whether if those symptoms were indicative of Inflammatory Bowel Disease, the condition would abate or be temporary?

Mayer: My understanding of Inflammatory Bowel Disease is that it waxes and wanes.

Hook: Yeah, the disease waxes and wanes.  Sometimes it’s controlled, other times it’s uncontrolled, but you always have it.

Mayer: That’s my understanding of it.

Hook: My question is, If the symptoms listed are symptoms of Inflammatory Bowel Disease, why would Roche then tell consumers that if they get those symptoms they can get treatment and the condition will be non-permanent — because that’s what it’s saying, isn’t it?

Mayer: I cannot address why this verbiage was put in here.

Hook: Are you surprised when I show you documents like this, as the Product Knowledge Officer Manager — Professional Product Knowledge Manager for Roche — when I show you documents like this, that your company has disseminated to the public, that convey this type of information, or lack of information, regarding its product Accutane?

Mayer: You’re asking if I’m surprised what we’re reading here, is that what you are saying?  I don’t know that ‘surprised’ is the right terminology.

Hook: Are you disturbed by it?

Mayer: I don’t think ‘disturbed’ is the right terminology either.  I think they are trying to make a warning…and you’re pointing out some problems with the warning, which could be construed as being valid, but I think the warning is there…it’s probably a balanced piece…

CVN is providing free clips from each side’s opening statements. Or purchase individual days or the entire Accutane trial, live or on demand. 

Defense attorney Andrew See, from the Kansas City office of Shook, Hardy & Bacon, completed his opening statement on behalf of pharmaceutical defendant Hoffman-LaRoche (Roche) this afternoon as the McCarrell Accutane trial continued.

See hammered hard and repeatedly on his theme that although Andy McCarrell may have suffered mightily from Crohn’s Disease, this Inflammatory Bowel Disease (IBD) was not caused by Accutane.

See said that the evidence would show McCarrell took Accutane briefly in 1995, and that McCarrell showed no symptoms of IBD until long after any remnant of Accutane had left his body. Instead, McCarrell’s IBD appeared a year later, approximately two weeks after McCarrell began a double-antibiotics treatment regime.

Opening statements are now complete.  The McCarrell v. Hoffman-LaRoche Accutane trial will continue on Thursday at 9:30am Eastern.  CVN is webcasting the trial live, gavel-to-gavel. 

CVN is also offering free clips of both the plaintiff and defense opening statements.  As you can see in the images below, CVN also streams the digital evidence as it is presented to the jury.

The McCarrell v. Roche Accutane trial started with a scathing opening statement from plaintiff attorney Mike Hook. Hook said, “This is what the company knew. This is what was going on…The evidence will show that not only did the company know this, but they developed a plan” to keep the information private.

CVN is providing a live webcast of this important Accutane trial in New Jersey, as well as Free Clips of both sides’ opening statements.

As you can see in the images below, CVN also streams the digital evidence as it is presented to the jury. 

According to the clerk of court, opening statements are expected to begin on Wednesday, January 13.  

CVN anticipated jury selection on Monday and the trial to begin Tuesday, but according to the clerk, pretrial motions were delayed due to a longer than expected voir dire.

CVN Offer:  Free Accutane Trial Opening Statement Video Clips 

With the McCarrell-Roche Accutane trial imminent, the New York Times reported last week that,

“The gold standard of treatment for severe acne has been Accutane, a powerful prescription drug also used in chemotherapy for brain and other cancers. It is associated with serious side effects, including birth defects and bowel inflammation.”

In May 2007, a jury awarded $2.6M to Andrew McCarrell, who suffered more than mere bowel inflammation after taking the drug Accutane, and ended up having his colon removed.

At the time McCarrell began his treatment, 5 million patients had taken Roche’s Accutane.  The May 2007 verdict was reversed on appeal because Roche was precluded from getting this fact before the jury.  By 2009, over 13 million patients had been treated with Accutane since it was released in 1982, and even more have taken Accutane’s generic equivalent, Isotretinoin, after Roche’s Accutane patent expired in February, 2002.

 Isotretinoin, which was originally developed for chemotherapy, causes birth defects.  Some studies indicate a connection between Isotretinoin and depression, bowel inflammation, Crohn’s Disease, and Ulcerative Colinitis.

CVN is webcasting the Accutane trial live, and also providing free video clips of each side’s opening statements.  The trial is expected to begin January 11.

In the trial of McCarrell v. LaRoche, judge Carol Higbee did almost everything right.  According to the appeals court, her “overall studious and even-handed management of [the] complex case was exemplary.”

But…   

But she should have allowed defendant pharmaceutical manufacturer Roche to present statistical evidence, such as the fact that Roche’s acne treatment drug Accutane had five million users when the plaintiff began his treatment.

As a result, a $2.6M plaintiff verdict was reversed, and the parties will do it again before Judge Higbee in New Jersey Superior Court, starting Monday January 11, 2010.

Andrew McCarrell sued Hoffman-LaRoche and Roche Laboratories, which manufactured and distributed the prescription drug Accutane. McCarrell alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease (IBD), which led to the surgical removal of his colon.

The defense proffered testimony from Dr. Martin Huber, Roche’s Global Head of Drug Safety, that five million people had been treated with Accutane when the plaintiff began his treatment, thus purporting to show that the defendant might reasonably have interpreted the user complaints as a weak signal of risk.  But Judge Higbee concluded that “[t]o suggest that a reasonable company doesn’t explore a rare risk is an unfair suggestion to the jury…it does not matter if the drug is sold to 10 million people or 5 million people or 1,000 people, because if you have a serious risk, it is significant.”

In an unpublished opinion, the Appellate Division summarized the factual record regarding the drug Accutane:

Accutane is a prescription medication developed by Roche. It was approved by the Food and Drug Administration (FDA) in 1982 to treat recalcitrant nodular acne, a severe and disfiguring skin disease characterized by large, inflamed cystic lesions on the patient’s face and back.

Although the exact mechanism of action for how Accutane works is unknown, Roche discovered that the drug was effective in suppressing the production of oil and waxy material produced in the sebaceous glands. Nodular acne is caused by the accumulation of sebumunder the skin, which ultimately ruptures the follicle wall, forming an inflamed nodule. Accutane was found to be highly effective in treating nodular acne that has been recalcitrant to standard treatments.

Accutane is a teratogen, meaning that there is a high risk that if a woman takes the drug while pregnant, her child will be born with life-threatening birth defects. Additionally, common adverse effectsfrom Accutane include dry skin, lips, and eyes, conjunctivitis, decreased night vision, muscle and joint aches, and elevated triglycerides.

Prior to receiving FDA approval for Accutane, Roche conducted several pre-clinical studies of the drug, using dogs.Those studies revealed instances of gastrointestinal bleeding in the treated dogs. 

 CVN will webcast the Accutane trial live from New Jersey.  CVN is also offering Free Clips of the first five minutes of each side’s opening arguments.