Saturday, January 30, 2010

Fosamax Judge to Select Replacement "Bellweather" Case, By Tuesday

In addition, Judge Keenan has ruled (full 25 page opinion -- in PDF file format) that Merck may not escape another of the bellweather trials, without having to put on a defense, thus:

. . . .The Court does not agree with Merck’s position that Plaintiff’s claim fails as a matter of law without evidence that she had exposed necrotic bone in her jaw. The BRONJ position paper was updated over one year ago based on new research in the field to include stage zero BRONJ, which does not require exposed necrotic bone. The AAOMS task force is comprised of highly regarded experts in this field, including Dr. Marx, one of Plaintiff’s experts on general causation. Another expert on general causation in this matter, Dr. Hellstein, testified that he regards the AAOMS as the “leading body” in oral surgery (Sept. 16, 2009 Daubert Hr’g Tr. at 357.); that the task force that drafted its position paper on BRONJ was “a panel of careful and experienced researches in the field” (Id. at 361.); and that he has adopted the staging system set forth in paper. (Id. at 352-53.) Merck seemingly ignores that, for those reasons, this Court already has recognized stage zero BRONJ. See In re Fosamax, 645 F. Supp. 2d 164, 171 (S.D.N.Y. 2009) (recognizing “stage zero” as a sub-class of patients with BRONJ); In re Fosamax, 647 F. Supp. 2d at 276 (finding that plaintiff developed ONJ no later than September 2003 because an expert testified that, in his opinion, plaintiff’s symptoms as of that time could have been stage zero BRONJ).

Merck has not presented the Court any authority or expert that disagrees with the AAOMS’s position that stage zero BRONJ should be considered an ONJ injury. Nor does Merck cite any authority that disputes that bisphosphonates can cause this less advanced form of the injury. Rather, Merck attempts to play on an inconsistency within the definition of BRONJ promulgated by the AAOMS and the experts in this matter. Specifically, Merck argues that BRONJ by definition requires exposed necrotic bone, so stage zero, which is not characterized by exposed necrotic bone, cannot be a recognized form of the condition. The AAOMS definition of BRONJ first set forth in 2006 must be read in light of the 2009 amendments. The Court is mindful of the apparent inconsistency of including stage zero into the spectrum of BRONJ injuries while that spectrum remains defined by exposed necrotic bone.

It is important to note, though, that stage zero BRONJ is not merely a sub-clinical injury of those at risk of later developing BRONJ, but rather includes a class of patients — including Plaintiff — who present real symptoms, including aching jaw pain. Although the definitional inconsistency is troubling, it also seems highly dubious to the Court that the AAOMS would include stage zero within the spectrum of BRONJ injuries if it were something other than a less severe form of the injury. . . .

Here is the earlier item I wrote -- on the random selection of the next Bellweather case -- by the very able Judge Keenan, come Tuesday.


Anonymous said...

guess they may may not be able to have it both ways, i.e. osteopenia being a marker for osteoporosis which is a risk for fractures. So treat osteopenia (stage 0) with fosamax.


Condor said...

Ding. Exactly right -- either it is a disease, treatable (and reimbursable!) -- as a code, in the payers'/insurers' databases, or it is not.

But it cannot be that, for liability purposes, Fosamax is in the clear, if the condition for which it was prescribed is now worsening.

Seems simple, right?


condor said...

On February 1, 2010, Judge Keenan selected a new bellwether case — Judith Graves v. Merck — to replace the Flemings bellwether case, which the MDL court dismissed when it granted summary judgment in favor of Old Merck. The MDL court has set the Graves trial to begin on September 13, 2010. A trial in Alabama is currently scheduled to begin on May 3, 2010 and a trial in Florida is currently scheduled to begin on June 21, 2010.

Per Merck just0filed Form 10-K.