Saturday, June 19, 2010

Shirley Boles Has Rested Her Fosamax® ONJ "Bellweather" Case-In-Chief

Facing new issues, but following a familiar, now well-worn path, Merck's counsel will likely begin its Fosamax® defense case on Monday in the Manhattan's federal District Courts. This time, in Boles II, a central issue at trial is what actually defines the disease "osteoporosis". The W.H.O. and FDA adhere to a statistical evidence definition: "osteoporosis" is a T-score of -2.5 standard deviations or more, below peak bone mass in healthy women . This should be compared to simple osteo-penia (at -2.0 or worse) -- as I've detailed in several posts -- here (1), here (2), here (3) and here (4). See this, for a graphic depiction of the dispute:

And so -- just as it did in the earlier Maley Fosamax bellweather trial -- on Friday afternoon, Merck's trial counsel filed a Rule 50(a) motion to decide the case without having to put on a defense. Such a motion, if made at all, is properly made at the close of the plaintiff's case in chief. That point must have come Friday. From here, three things can happen: Judge Keenan may (i) decide to delay a decision on Merck's motion, and listen to some or all of Merck's defense case (and decide the motion later); (ii) promptly deny Merck's motion, and let the case continue; or (iii) grant Merck's motion, and effectively end the trial in a loss for Shirley Boles.

I'd put the order of probabilty of occurence in the same order as I laid out the options: (i), (ii) and finally (iii). Here is some of the memo of law supporting Merck's motion -- it sets out the issues to be decided:

. . . .Dr. Santora’s deposition testimony that there is “no evidence that any drug reduces the risk of fracture in people who don’t have osteoporosis” means that Dr. Santora does not believe that Fosamax provides fracture reduction efficacy in people with a T score above [worse than] -2.5. . . . As the Court has recognized, there “have been several definitions of osteoporosis promulgated over time by different medical organizations,” and some such definitions have included patients with a T-score below -2.0. . . .

[When Dr. Santora] refers to patients who do not have osteoporosis, he is. . . referring to patients, like Plaintiff [Shirley Boles], with a T-score of -2.1. . . .

In the present case, according to Plaintiff, Dr. Mucci issued a final statistical analysis showing that Fosamax had no fracture reduction benefit for patients with a T score above [worse than] -2.5 or for patients who had been on Fosamax for more than three years. . . .

Thus, one clearly central issue -- should the case be allowed to reach the jury -- is whether Merck was negligent in seeking, and obtaining, FDA approval for a condition not defined as osteoporosis by most worldwide health authorities -- without any data to suggest that (i) the actual-osteoporosic patients would see benefits from the drug, and/or (ii) people taking Fosamax for three years or more (without a holiday) would see any benefit. In fact, as to this second group, there is now some credible evidence that longer-term Fosamax use does affirmative harm to otherwise healthy women. We'll now have to wait to see whether the very-able Judge Keenan allows the case to continue, and requires Merck to put on a defense. I'll keep you posted.

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