Defense counsel Andrew See gave the first closing statement in CVN's gavel-to-gavel webcast of the Accutane Trial. "Mr. McCarrell has contracted a very bad disease," said Mr. See, "and he's had a very hard time. No one's arguing about that."
However, the defense argued, information about inflammatory bowel disease was contained in the warning, and the warning identified the disease by name, included the symptoms of IBD, and told the doctor what to do: discontinue use immediately.
Further, according to the defense, the use of the phrase "temporally associated" in the warning was proper because medical journal articles used this language, and in fact this language continues to be used even today.
Mr. See also asserted that Accutane was properly prescribed for Mr. McCarrell, and there was no inflammation during treatment. The symptoms that manifested a year later resulted from a mononucleosis viral infection, and an ulcer, and did not result from any chronic inflammatory condition.
Instead, Mr. McCarrell's IBD developed only after he began double-antiobiotic therapy (Tetracycline and Flagyl). "Dr. Huber testified that you're not supposed to prescribe Accutane unless conventional therapy has failed. And what is 'conventional therapy'? It's antibiotics...And we know from the testimony of every one of these doctors," said Mr. See, "antibiotics can trigger IBD."
Mr. See concluded, "Did Accutane cause this IBD? The answer to that's no...Was there an adequate warning about the risk of IBD? Yes."
Mr. Hook began the plaintiff's closing argument by saying, "Mr. See gave his closing argument. I don't get to put Mr. See in that witness stand, but I do get to respond to him. And several of the things he said to you, if I'd had a seatbelt, I'd probably come out of that seatbelt.
"Let me just show you one thing for example...Let me show you how smart, clever [pointing to the timeline] -- 'No GI Symptoms' -- that's never been a dispute. Andy had symptoms of IBD that you were told were the knee pain, the eye pain, the joint pain, which the doctors admit, those can be manifestations of IBD. So you don't see 'No IBD Symptoms' here; you see 'No GI Symptoms' there...For me to have to sit there and listen, for almost two hours, was extremely, extremely difficult...When I see things going on, it just gets to me. It really does..."
"Accutane is a chemotherapy," said Mr. Hook. "They don't like that term, but they can't run from it. It is a very potent, powerful, toxic drug. It causes birth defects.
"Does it have any effect on the GI tract? Martin Huber came in here, as the head of global drug safety, testified under oath when I took his deposition, he did not know whether it had any effect at all on the GI tract.
"All he had to do was to go to the patent, and we see it right there. Dr. Bollag, the inventor: 'Accutane is so toxic -- so toxic -- not my word, their word -- it should never be given for anything other than severe cystic nodular acne. Accutane, originally submitted to treat cancer, it is then switched by the company and it comes on the market in 1982."
"Their original package insert says nothing about Inflammatory Bowel Disease -- nada. They start getting reports, as soon as it hits the market, they start getting inflammatory bowel disease reports..."
Both sides' closing arguments are now complete, and the jury is ready to be charged. UPDATE: due to bad weather, the jury will not be charged until Tuesday, February 16.
CVN is making the entire Accutane Trial available for purchase on-demand. Free clips from Opening Statements are also available.