Saturday, December 11, 2010

The Next Fosamax® ONJ Trial: Secrest -- And What Her Doctors Will Likely Say Happened To Her

As we wait for an early 2011 date on Judge Keenan's trial calendar for the third Boles jury trial -- on the issue of damages -- I'll run down what Mrs. Secrest's lawyers expect to prove by way of expert testimony, from Mrs. Secrest's treating physicians. [Mrs. Secrest's lawyers will will begin picking jury-panel members, on March 14, 2011 -- under Judge Keenan's previous orders.]

Note especially (from this overnight filing in Manhattan's federal District courthouse) that her doctors will testify that when she started Fosamax®, she only had the pseudo-condition called osteopenia -- not the full-on FDA and WHO-recognized disease called "osteoporosis":

. . . .Dr. [Lawrence A.] Epstein is anticipated to testify that, beginning in 1998, he prescribed Fosamax for Linda Secrest because he thought the benefits outweighed the risks for Linda Secrest, an osteopenic patient.

This was based upon what was told to him in the label and what Merck's sales representatives told him, that the use of Fosamax by osteopenic women would prevent fracture. Dr. Epstein is anticipated to testify that, in light of the information disclosed in the MDL deposition of Dr. Arthur Santora of Merck, and the review by Dr. Anthony Mucci, (Plaintiffs Exhibit 1. 0097), he no longer would prescribe it to a patient who was not osteoporotic and for no period of time exceeding three years. Based upon his familiarity with the half-life of Fosamax in bone, Dr. Epstein will testify that he is of the opinion that Fosamax stays in bone too long and that can result in undesired adverse effects. Further, he will testify regarding his own clinical experience with prescribing Fosamax to hundreds of patients and that, based upon that clinical experience, the clinical efficacy of the bisphosphonate drugs for osteopenia/osteoporosis, including Fosamax is lacking when compared to other available osteoporosis treatments and when compared to the claims stated for Fosamax.

He is further anticipated to testify that Linda Secrest took Fosamax beginning in 1998 and that her prescription records establish that she took it for more than three years before the year 2004 and, based upon his review of prescribers subsequent to him, Linda Secrest continued to take Fosamax through early 2005.

Based upon his own personal observations, Dr. Epstein is also anticipated to testify regarding the damages to Linda Secresf's jaw during the time of his care and treatment of Linda Secrest.

Dr. Epstein will also testify that Linda Secrest's condition renal tubular acidosis does not constitute renal failure and is not a serious condition. Dr. Epstein will testify that Linda Secrest had Sjogren's syndrome (dry eyes, dry mouth), that he treated her for that condition, and that while it may have caused dental (teeth problems) it did not cause the jaw problems for Linda Secrest.

Dr. Epstein will also testify regarding his familiarity with the Fosamax labels, and that there was no warning concerning osteonecrosis ofthe jaw or the risk of injury to the jaw bones before the Summer of 2005 and that had he know of any such warning, he would have shared that information with Linda Secrest, he would not have prescribed Fosamax to Linda Secrest or would have placed her on a drug holiday before having any invasive dental procedures. Further, Dr. Epstein will also testify that from 1998 to 2005, no Merck sales representative advised him of the risks of osteonecrosis ofthe jaw or jaw bone damage from Fosamax. . . .

Dr. Epstein will also testify that, as a prescriber of Fosamax, he is familiar with much of the medical and dental literature relating to the risk of osteonecrosis of the jaw from Fosamax use including but not limited to the American Dental Association's Expert Panel Recommendations. He will testify that Linda Secrest developed osteonecrosis of the jaw and that Fosamax was the most likely cause ofher osteonecrosis ofthe jaw.

Dr. Epstein will also testify that Linda Secrest was prescribed hormone replacement therapy while she was on Fosamax. He will testify that he has reviewed the FDA Statistical Review by Dr. Bruce Schneider (Plaintiffs Exh. 1. 6005B), as well as the team leader's memo relating to the same by Dr. Gloria Troendle (Plaintiff's Exh. 1. 6005C), and that no information about the danger of oversuppression of bone turnover was ever disclosed to him by Merck and that had such information been disclosed he would not have prescribed concomitant Fosamax and hormone replacement therapy.

In addition to the foregoing, the bases for Dr. Epstein's opinions include the MDL deposition of Dr. Arthur Santora, the FDA Biostatistical Review by Dr. Anthony Mucci (Exh. 1.0097), the exhibits to the deposition of Dr. Epstein, and Dr. Epstein's medical records and chart for Linda Secrest. . . .

We'll keep you posted, as the March 2011 trial date nears -- and as Merck undoubtedly files objections to parts of this testimony.

I'll cover the expected testimony of Mrs. Secrest's other physicians on subsequent Saturdays and Sundays, in this space.


Anonymous said...

Merck certainly deserves to 'take a few to the jaw' on the appalling Fosamax redefinition of osteoporosis leading to jaw osteonecrosis. Crime deserves punshment...

condor said...

It is indeed deeply unfortunate when (as here, it seems) an excessively activated profit motive causes a violation of the very first principle of good pharma, and good science:

. . . first, do no harm. . .

Namaste -- do stop back!

condor said...

A new installment in this series -- of Secrest v. Merck Fosamax® ONJ bellwether expert witness previews -- is now up as a separate post.