Boles v. Merck: Fosamax® Retrial Starts Monday In Manhattan Federal Court

After a week's delay, this sensational "Runaway Jury"-style retrial will get underway, in earnest.

The very able Judge Keenan has not ruled on Mrs. Boles' request to offer evidence that Merck "moved the goalposts" when it -- and it alone, in all the world -- defined "osteoporosis" to include a more robust group of post-menopausal women than either the World Health Organization, or the FDA.

Merck decided, on its own, that even women with relatively strong bones had "osteoporosis". That way, a much larger, and healthier patient population could be ultimately treated, and for many more years, with Fosamax^®, or so Merck hoped. See below -- click to enlarge:



The above chart seems decidely relevant to me, in deciding whether Merck should be at least partially responsible for the osteonecrosis of Mrs. Boles' jaw bone (or jaw bone "death"), which she claims was caused (at least in part) by her very long term use of Merck's Fosamax.

Here is how I framed this issue, about two weeks ago:

In fact, then -- not only did Merck likely double its US market, it also set up a "stacked deck" legal defense, as problems began to appear in longer term users of Fosamax. So that is why this bit of package insert will be an important part of the Boles v. Merck retrial, beginning June 7 2, 2010:

. . . .Effect on bone mineral density

The efficacy of Fosamax 10 mg once daily in postmenopausal women, 44 to 84 years of age, with osteoporosis (lumbar spine bone mineral density [BMD] of at least 2 standard deviations [NOT 2.5 standard deviations] below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration. . . .

As irony would have it, it may ultimately turn out (five or ten years from now) that Merck's "creative" definition has, all these years later, greatly increased the number of claims for injuries it will face. This is likely so, because these "healthier" women will have been on Fosamax longer (at every age -- and there will be more of them), than would have obtained -- had only women with real osteoporosis been targeted for prescriptions by Merck. Odd. And sad.