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.

The Los Angeles Times says that the anticipated webcast of today’s Proposition 8 trial has been delayed by the U.S. Supreme Court. The trial was to be webcast live to virtual overflow rooms in other courthouses, and later posted on YouTube.

“Any additional order permitting broadcast of the proceedings is also stayed pending further order of this court,” the justices said. They added that the temporary order “will remain in effect until Wednesday, Jan. 13.”

The high court did not explain its reasoning.

Only Justice Stephen G. Breyer, a San Francisco native, dissented. “In my view, the court’s standard for granting a stay is not met” in this case, he wrote. “In particular, the papers filed, in my view, do not show a likelihood of ‘irreparable harm.’ “

Under the court’s rules, lawyers can seek an emergency order only if they can show their clients will suffer “irreparable harm” if the justices fail to act. In this case, the defenders of Prop. 8 said their witnesses could be subjected to harassment and intimidation if they testified in favor of the ban on marriage for gay and lesbian couples.  

It is surprising to see the U.S. Supreme Court make an extraordinary move against cameras, disagreeing with both the trial judge and the Court of Appeals, based on the speculative arguments posed.

It has long been argued that the presence of cameras in court will somehow taint the proceedings, even though the trial is a completely public proceeding in all other respects open to the public.  [For a complete history of the controversy, review White Papers by Boies Schiller and by Jim Lyons].

However, the time for such speculation is long past.  CVN has captured hundreds of civil trials, with no adverse impacts noted.

CVN’s experience with cameras is exceptionally broad, involving over a hundred judges in 30 different states, and more than 1,000 attorneys, in all kinds of proceedings, including hearings, bench trials, and jury trials.

Plus, the nation’s experience with courtroom cameras is not limited to CVN’s activity.  Florida allows cameras into virtually all courtroom proceedings, and recently celebrated the 30th anniversary of their successful experiment with public access to the judicial process.  In fact, some states, including Kentucky and Arizona, have permanent cameras in their courtrooms.

Last year the First Circuit reversed a federal court order allowing cameras because, according to the Court, the local rule did not give the trial judge discretion to allow a webcast.  However, the First Circuit conceded that there were good reasons to allow a webcast, and that “emerging technologies may eventually change the way” the public learns about information from court cases.  A concurring opinion went even further, stating:

“Indeed, in my view, there are no sound policy reasons to prohibit the webcasting authorized by the district court.  Therefore, this case calls into question the continued relevance and vitality of a rule that requires such a disagreeable outcome.”

That is why it was so surprising to see extraordinary relief by the Supreme Court in an instance where there was no rule prohibiting cameras, and not even a jury to be potentially impacted.

Of course the Proposition 8 trial is high profile, and perhaps some witnesses are uncomfortable stating their views in a public forum. However, federal courts are exceptionally public forums.  Cameras do not create the public nature of the event, nor will their absence prevent detailed reporting of who said what and when.  

Indeed, the absence of cameras will not make this public event even slightly private.  But suppose it be true that some witnesses who were otherwise comfortable testifying in a high-profile federal trial would prefer that cameras not be present; it is not at all clear why that preference should outweigh the public’s interest in having access to its own judicial process.

The argument seems to come down to just that, because the real-world experience with cameras in court has provided voluminous evidence quite in conflict with the speculation that the judicial process suffers “irreparable harm” from exposure to light. 

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.