We have some good news and some bad news.
Okay, if you insist.
First, the good news: It’s Judge Moody’s decision granting the defendants’ Daubert motion to exclude plaintiffs’ general causation expert in the Accutane MDL.
You gotta love America. Just last week, the big news was that a New Jersey state court jury had socked Hoffman LaRoche with a $2.62 million verdict because Accutane caused a plaintiff’s inflammatory bowel disease. Now, a federal judge looks at the science, and it turns out — who’d a thunk it? — that there’s no evidence that Accutane causes IBD. “One can live greatly in the law.”
But we digress.
Yesterday afternoon, Judge Moody granted defendants’ motion to exclude the general causation testimony of Dr. Ronald Fogel. In re Accutane Prods. Liab. Litig., MDL 1626 (M.D. Fla. June 15, 2007). (We can’t find the decision on-line, and we can’t upload a copy from where we’re blogging. But, as of bright and early Monday morning, you’ll be able to click here for a link to the opinion.)
On paper, Dr. Fogel appears to be a real expert. He’s the Head of the Division of Gastroenterology at Henry Ford Hospital in Detroit, and he’s been a practicing board certified gastroenterologist for 25 years. Dr. Fogel had four bases for his expert opinion that Accutane is capable of causing IBD: (1) animal and cell culture studies, (2) biologically plausible mechanisms of action, (3) defendants’ own internal documents, and (4) case reports.
The doctor went 0 for 4.
First, the animal and cell culture studies. The beagle study showed only temporary intestinal irritation at high doses of drug. Dr. Fogel didn’t account for the temporary nature of the condition or the possible existence of a dosage below which no response would occur.
The rat studies were done in an animal that may not correlate to humans, used vitamin A rather than Accutane as the test substance, and administered drugs at a very high does (ignoring the possibility of a threshold dose below which there would be no response).
And the cell culture studies were done in laboratory conditions; the results may not apply to live human beings.
0 for 1.
Second, the biologically plausible mechanisms of action. Although Dr. Fogel hypothesized three possible biologically plausible mechanisms of action, none had been tested or proven.
0 for 2.
Third, the defendants’ own internal documents. Internal documents that supposedly contain “causality assessments” (about which Judge Moody has ruled and we have posted before) in fact reflect only the reporter’s own opinion whether ingesting the drug caused the injury. They cannot support a finding of causation.
0 for 3, but he’s not out yet.
Finally, adverse event reports and case reports in the medical literature. These descriptions must be viewed with “great caution . . . . [M]erely because symptoms occur a short time after a person takes a drug does not mean the drug caused the symptoms.” Slip op. at 21.
0 for 4, and he’s out.
The Accutane decision also shows one of the (few) advantages to a defendant of having cases coordinated in a multidistrict litigation. In individual litigation, a “flexible” plaintiff’s expert may reveal his willingness to opine that a drug caused everyone’s problems only slowly over time, and the testimony will be taken in cases pending in multiple courtrooms. In an MDL, that process may be accelerated, and a judge may be offended when many increasingly preposterous expert opinions are offered in his or her own courtroom.
In the Accutane MDL, Dr. Fogel opined that Accutane caused Mary Farr’s symptoms even though she had not taken the drug for nearly three years before their onset. And Dr. Fogel thought the drug caused Andrew Messick’s problems even though he had been off Accutane for over seven years before his symptoms appeared. The defendants’ ability to point to those opinions may have helped the judge to realize that the good doctor did not actually have science on his side.
Congratulations to Paul Schmidt and Michael Imbroscio of Covington & Burling for the result in that case (and a hat tip for having sent us the opinion so promptly).
Sadly, we must now go on to the bad news for the week, in a post titled:
“The Week That Was — To Z (Zyprexa Preemption Decision).”
That post will probably be up in a couple of hours.
We know, we know: You can hardly wait.