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?
Hook: Does Accutane cause Inflammatory Bowel Disease?
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…