It is easy to lose sight of the overall effort Merck undertook to bring Fosamax® to the widest market it possibly could, when looking at the injuries of individual plaintiffs, like Mrs. Graves. But it is critical to keep that larger narrative in mind, when evaluating her claim, as in cases where a drug is aggressively marketed to women who may not need it at all, the emerging common law suggests that there should be some additional responsibility to "first, do no harm." So, I'll let Mrs. Graves' lawyers offer you some of that narrative [click the image at right, to enlarge to reading size], here (from a full 25 page PDF file). [UPDATED: Merck's presser -- in reaction to these stories -- is here. No surprise, here -- Merck predicts the evidence will show that there is no basis for liability.]
As a refresher, then, here is essentially the same information, in a graph (from the Boles I and II trials):
And the below is from Boles II, reciting Merck's own expert's view (Dr. Santora -- as above, now in Graves):
. . . .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. . . with a T-score of [better than] -2.4. . . .In the [Boles II] 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 [better than] -2.5 or for patients who had been on Fosamax for more than three years. . . .
No comments:
Post a Comment