2010

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We covered the topic of product recalls being excludable as subsequent remedial measures in some detail in our Total Recall post, including a list of all the cases we were aware of (whether they involved drugs/devices or not) that had excluded recalls for this reason.  There wasn’t a single federal court of appeals in the

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Just the other day we brought you news that the British medical journal Lancet issued a full retraction of an purported scientific article by a plaintiffs’ expert in autism litigation. The author, who was at the time also serving as a plaintiff-side expert, described parts of his research in a manner that “have been proven to be false.”
Something similar seems to be happening in the Accutane litigation. There’s a new opinion, Palazzolo v. Hoffman-La Roche Inc., No. A-3789-07T3, slip op. (N.J. Super. App. Div. Feb. 3, 2010), in which another plaintiff’s expert has gotten called out for essentially the same thing – publishing an article in a medical journal that failed to accurately describe what was actually done.
Be ready to hold your nose, here’s what went down, and it ain’t pretty:
In Palazzolo the plaintiff’s expert, James Bremner, was hired to offer an opinion that Accutane caused depression and suicide. The sticky situation began when, in the words of the Court, “Plaintiffs paid Bremner to undertake a further study. There is no dispute that the study was commissioned specifically for use in this litigation.” Slip op. at 3. That study – bought and paid for by plaintiffs’ counsel – was nevertheless published at J. Douglas Bremner, M.D., et. al., “Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin,” 162 Am. J. Psychiatry 983 (May 2005). Slip op. at 4.  You can read the whole thing on line here.

According to the opinion, the study protocol (we use the term advisedly) injected some patients with “radioactive glucose” and then “sliced” their brains with something called a “PET scan” – “PET” being short for “positron emission tomography.” Slip op. at 3. However, there didn’t seem to be much dispute that PET scans can’t diagnose depression, therefore, the court held a hearing. Id. at 4 (“the judge questioned how the PET scan study, which all parties agreed did not diagnose depression, nonetheless allowed Bremner to reach the conclusion that Accutane caused depression”).
That hearing was beginning of the end for Dr. Bremner’s study, because the court ordered him deposed, and cross-examination brought out what four judges (the trial judge and the unanimous three-judge panel) all agree happened:

Continue Reading Plaintiffs’ Experts And Peer Review Don’t Mix

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What does a smokeless “electronic cigarette” have to do with drugs and medical devices?  Well, according to the FDA, an electronic cigarette is a “drug-device combination.”  Lately, however, it seems that the Agency’s position has become a strategic misstep. It gave rise to this a recent opinion by Judge Richard Leon, Smoking Everywhere, Inc. v.

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The BBC is reporting that the British Medical Journal Lancet has issued a full retraction of the notorious 1998 article that claimed there was an increased risk of autism associated with use of the MMR vaccine.  Among the grounds for the retraction:  the lead author “was in the pay of solicitors who were acting for

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Once upon a time, quite a few years ago, one of us had the pleasure of a having a case before the (late?) Hon. John Dowling of the Dauphin County (Harrisburg, Pa.) Court of Common Pleas. We still remember winning the case on summary judgment – after finishing our argument, the first words out of

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Have you ever noticed how you notice the same thing everywhere when you’re thinking about it? If you’re contemplating purchase of a station wagon, you see station wagons all over the place (sort of like the parking lot of a 1970’s Bobby Sherman concert).

We’ve been thinking about ex parte interviews with treating doctors. We’re

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Texas, like Michigan, imposes a strong presumption of non-defectiveness on drug labeling approved by the FDA.  As to the Michigan statute (which has been around longer), the Sixth Circuit (where Michigan is located) ruled that an exception to the presumption for fraud on the FDA was preempted by Buckman.  Garcia v. Wyeth-Ayerst Labs., 385