Merck Scores A Partial Win In Fosamax Litigation
3 CommentsBy Ed Silverman // August 31st, 2011 // 7:12 am
No, Merck has not won another Fosamax trial. But a federal judge has tossed part of a so-called bellwether lawsuit against the drugmaker over its osteoporosis drug, which has been blamed for causing a type of jaw damage known as osteonecrosis in which tissue is severely damaged.
In his ruling, US District Court Judge John Keenan decided to allow Linda Secrest to pursue a claim that Fosamax suffered from a design defect that caused her jawbone tissue to die. But the former United Airlines flight attendant, who lives in Florida and used the drug from 1998 to 2005, cannot pursue punitive damages or a claim that Merck failed to warn of possible problems with its drug.
Why? In his 42-page decision, Keenan wrote there was no evidence that her doctor would have told her to stop using Fosamax at the time she developed osteonecrosis, which was in 2004, if Merck had included a warning on the labeling. As for punitive damages, Keenan wrote Secrest, who suffered other jaw and mouth injuries, did not offer any evidence suggesting Merck “engaged in intentionally wrongful or grossly negligent conduct” by delaying a label change until after osteonecrosis emerged.
“To recover punitive damages in the context of a products liability action, a plaintiff must show not only that the manufacturer breached a legal duty, but also that the manufacturer did so intentionally or out of a ‘conscious disregard or indifference’ to the well-being of its customers. On the evidence presented by plaintiff, no reasonable jury could conclude” Secrest was entitled to such damages (read the ruling here).
[UPDATE: A loyal reader points out that this is not the first time that a judge has ruled a Fosamax plaintiff cannot pursue a claim that Merck failed to warn of potential problems or win punitive damages. In the second bellwether case, the same judge decided a reasonable jury could not find that Merck intentionally misrepresented or concealed the risk before the plaintiff sustained an injury (see here and here). Nonetheless, the plaintiff, Shirley Boles, won the case based on a design defect and was awarded $8 million].
This is the fourth bellwether case over Fosamax. Such cases are chosen to proceed to trial and used to gauge where the litigation may be headed. Earlier this year, a New Jersey state court jury decided that the drug not cause a 67-year-old woman to develop jaw damage; this was the first state court trial to reach a verdict and only the fourth to go to trial.
The three previous trials were held in federal court in Manhattan, and Merck won the first case. The second lawsuit, which is known as the Boles case and is noted above, ended in a mistrial in September 2009 and Merck lost a retrial last year, although an $8 million award was subsequently reduced (see here) and Merck is appealing. Merck won the third case last November.
original industry insider
Merck victory notwithstanding, this osteonecrosis thing with Fosamax has spurred business for the oral and maxillofacial surgeons. An OMF surgeon friend of mine says he says it is somewhat of a diversion from treating car accident victims, but he also says that full blown osteonecrosis of the jaw from bisphosphonates is worse than many things that he’s seen, comparable in some cases to injuries suffered in a head on collision.
Condor
Good stuff, Ed — and true enough, many outlets are reporting that the very able Judge Keenan, in Manhattan’s US District Court, has limited the theories Mrs. Secrest may present to the jury at her bellwether Fosamax® ONJ trial, in a few weeks — as to her claims of injury from long-term, uninterrupted use of Merck’s Fosamax. True, this is good news for Merck. But it may not be enough to avoid liability, to be sure. Why? Well, read it all here, but. . .
What is lost in these current reports is that the same limits were present in the first bellwether case — called Boles — and that resulted in an $8 million verdict for Mrs. Boles (subsequently reduced to $1.5 million by Judge Keenan).
In short, a Fosamax design defect claim — without a possibility of punitive damages — was enough, for Mrs. Boles. See pages 14 to 15 of the Judge’s order, from October of 2010 in Boles II:
. . . .Following the mistrial, Merck again moved for judgment as a matter of law under Rule 50(b). On March 26, 2010, the Court granted the motion in part, finding that Plaintiff had failed to establish proximate causation in that she did not introduce evidence from which a reasonable jury could conclude that Plaintiff’s treating physician would not have prescribed her Fosamax even if he had been warned of the risk of ONJ. See In re Fosamax Prods. Liab. Litig., No. 06 Civ. 9455, 2010 WL 1257299, at *4-5 (S.D.N.Y. Mar. 26, 2010). The Court found, however, that Plaintiff had introduced sufficient evidence at trial to support her negligent design and strict liability design defect claims and thus denied Merck’s motion with respect to those claims. . . . .
Namaste, one and all.
Condor
So. . . it may well turn out to be a rather hollow interim victory, for Merck.
Namaste