With the retrial of Boles v. Merck about a week away, the filings are a-flyin', today -- in the federal District courthouse in Manhattan where Judge Keenan presides.
At issue, at the moment, is whether the plaintiff, Shirley Boles -- who alleges her ONJ was made worse by long-term use of Fosamax® -- will be allowed to introduce any evidence that Merck's non-standard, overly-inclusive purported defintion of the disease "osteoporosis" was challenged by FDA, during a time-frame relevant to Mrs. Boles' claims. If FDA objected to the definition, the argument goes, Merck should be allowed less protection from the imprimatur of safety an FDA approval would otherwise hold.
Lawyers for Mrs. Boles want to call a Merck witness to establish that by 2007, Merck had been clearly told by FDA to revise the Fosamax labeling, to bring it into line with the widely-accepted (WHO and FDA) definitions of what constitutes osteoporosis. [Here is a rundown on the difference, from last weekend.]
Merck's lawyers claim that since FDA first complained about the definition, in writing, after Mrs. Boles' injuries, such a showing ought not be admissable.
Presumably, Mrs. Boles' lawyers would reply that they want to call the Merck label copy witness primarily to find out whether she is aware of any earlier non-written complaints (in oral, face to face meetings, or telephonic conversations) from any FDA staffer, that might even go back to 2004 or earlier.
. . . .Merck can only assume that Plaintiff has subpoenaed Ms. Birzin to establish that in April 2007. . . the FDA proposed that Merck change the definition of osteoporosis in the Fosamax Plus D label to include a T score of -2.5 and below. This assumption is based on Plaintiff’s motion in limine papers, which cite an April 2007 email from Ms. Birzin to Dr. Santora attaching the proposed label change. . . .
I'll let you know what Judge Keenan decides.
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