Tag Archives: Amgen Prolia FDA EMEA Merck Fosamax Bone Density Osteonecrosis Claims Femur and Jaw Jury Trial US Dist Ct NY Bellweather Case Boles Graves Secrest Hester 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 ofFosamax, 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.

EXCLUSIVE: Massachusetts Files For $191 Million In Proventil® (Albuterol) Pricing Fraud Punitives

UDATED commentary — 12.11.10 @ 11 AM EST (originally posted 12.10.10 @ 5:14 PM EST).

The Attorney General for the Commonwealth of Massachusetts just filed his memorandum of law, and request for miscellaneous relief this afternoon, in the Proventil® (Albuterol) price fraud litigation. Recall that last month, the federal trial court jury awarded $4.6 million in actuals, and the very-able federal District Court Judge Patti Saris reserved the right to calculate — and then impose — civil punitive damages, at a later time. [Legacy Schering-Plough acquired Warrick; then in late 2009, Merck acquired Schering-Plough.] Tonight, Massachusetts has sworn to what it thinks (and I concur) ought to be the penalty: $191 million. Do see it all, as a 32 page PDF file, but here is a bit of it:

. . . .The Commonwealth moves, pursuant to Fed. R. Civ. P. 58(b) (2) (A) and (d), for entry of judgment in its favor, based on the jury’s verdict of $4.6 million in damages in this case (plus prejudgment interest and costs), which must be trebled, and asks for an award of over $191 million in civil penalties. While substantial, penalties in this amount are needed to punish the Defendants for their misconduct in this case, which the jury found to be willful, and to deter them and others from engaging in similar acts to defraud the Massachusetts Medicaid program (MassHealth), a vital government program serving the Commonwealth’s poorest and most vulnerable citizens. As set forth below, penalties in this amount, which are less than 4 percent of the minimum penalties mandated by the Massachusetts False Claims Act (MFCA), do not violate the Excessive Fines or Due Process clauses of the federal and state Constitutions. The Commonwealth also requests that the Court enter judgment in its favor for Defendants’ breach of the implied covenant of good faith and fair dealing in the Medicaid Rebate Agreement. . . .

Although Defendants may have accurately reported AMPs for purposes of the rebate agreement, they “sabotaged” the intended benefit of the agreement by simultaneously reporting, and failing to correct, falsely inflated published prices, thereby inflating reimbursement and diminishing the value of the rebates. Defendants’ extra-contractual conduct (violating the MFCA, the MMFCA and committing common law fraud) interfered with the reasonable expectations of the parties and destroyed the value of the agreement to the Commonwealth. Accordingly, the Court should rule as a matter of law that Defendants breached the implied covenant of good faith and fair dealing implicit in the Medicaid Rebate Agreement. . . .

The jury found Defendants liable under both Section 1 and Section 2 of the MFCA.
Under Section 1, the jury found Defendants caused 989,103 false claims to be presented. Section 1 of the MFCA provides:

Any person who (1) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval. . . shall be liable to the commonwealth or political subdivision for a civil penalty of not less than $5,000 and not more than $10,000 per violation, plus three times the amount of damages, including consequential damages, that the commonwealth or political subdivision sustains because of the act of that person.

M.G.L. c. 12 § 5B.

The plain language of the statute indicates that (1) each false claim that a person “causes to be presented” to the Commonwealth is a violation and (2) a civil penalty is to be assessed “per violation.” By the plain terms of the statute, a person commits a violation (and is subject to a civil penalty) each time he causes a false claim to be presented. “The Supreme Court has repeatedly emphasized the importance of the plain meaning rule, stating that if the language of a statute or regulation has a plain and ordinary meaning, courts need look no further and should apply the regulation as it is written.” In re Pharmaceutical Indus. Average Wholesale Price Litig., 582 F.3d 156 (1st Cir. 2009)(quoting Textron, Inc. v. Comm’r, 336 F.3d 26, 31 (1st Cir. 2003)). . . .

And so, $191 million is at the very low end of what Massachusetts could assert, under a plain reading of the relevant statutes — as the jury found 989,103 separate violations, times $5,000 each is nearly $5 billion; that number times $10,000 is nearly $10 billion. Ouch. $191 million looks waifish — by comparison. We’ll keep you informed when Merck answers this motion.