Merck’s Expert Opinions, In Upcoming Secrest Fosamax® ONJ Bellwether Trial


Equal time — this is. Here is a complete PDF file (10 pages) of Merck’s expected expert testimony, in the Secrest Fosamax® ONJ Bellwether trial, now slated for March 2011. My coverage of Mrs. Secrest’s experts’ new Federal Rule 26(a)(2)(C) disclosures may be found here, here and here.

From the overnight federal court filing in Secrest, then:

. . . .Dr. Anne de Papp, M.D.

Dr. de Papp’s opinions at trial will be based primarily on her positions, duties, responsibilities, and activities as a Director of Clinical Studies and Global Medical and Scientific Affairs at Merck since 2001, and her testimony will be consistent with and as stated in her previous deposition and trial testimony in the Fosamax MDL proceedings. Dr. de Papp has worked extensively on many aspects of Fosamax and osteoporosis. Testimony that is based upon her first hand experience and observations as a Merck scientist with extensive responsibility for Fosamax. . . .

In addition, Dr. de Papp may testify to matters that are based on her background, training, and experience as an endocrinologist. . . . [though her likely cross-examination, by Mrs. Secrest’s lawyers, will probe, and expose her views on whether so-called “osteopenia” (per the below chart) is an appropriate indication for a Fosamax prescription — in short, for someone like Mrs. Secrest. . . .]

[She will also likely testify as to: (i)] The efficacy and safety profile of Fosamax, including the evidence of the medicine’s benefits on fracture risk, BMD, bone turnover (as measured by bone markers and biopsies), bone quality (as measured by bone biopsies and imaging techniques), and safety, and encompassing the designs and outcomes of Merck’s individual clinical trials, and of the adverse experiences that have been reported in patients taking the medicine. . . .

[(ii)] The effects of the use of Fosamax in the treatment of periodontal disease and symptoms, and the preclinical and clinical trials and other studies in this regard. . . .

[(iii)] That [in her opinion,] the available scientific evidence does not support a causal relationship between Fosamax and ONJ. . . .

As I say, read the whole of the newly-required Federal Rule 26(a)(2)(C) disclosures by Merck, here. As ever, we’ll keep you posted — but we are awaiting a decision from Judge Cavanaugh, the very able federal District Court Judge, presiding in Manhattan over all these trials — on a date for the third Boles jury-trial — Boles III — on damages.

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