Thursday, September 10, 2009

Judge Keenan May Declare a Fosamax® ONJ Mistrial on Friday Evening: Analysis Of "What's Next?"


With the overnight news that Juror No. 5 alleges she is being intimidated, and the plaintiffs lawyer reporting very loud shouting matches -- ones plainly audible from inside the courtroom -- perhaps a hundred feet away from the closed doors behind which the jury deliberates. . . it is time to take stock of what a mistrial might here mean.

First, Merck must believe that the majorityof the jurors are leaning toward an ultimate finding of "not proved" -- either on causation, or on the alleged inadequacy of the labeling. This is true, because Merck has opposed the plaintiff's motion for a mistrial.

But there is more here -- Merck opposes a mistrial in part because that doubles the cost of this defense. This case will be retried, and retried quickly. There is no reason to delay, other than conflicts on Judge Keenan's trial calendar. In addition, in this new trial, presumably, the testimony of the two additional plaintiffs' medical experts will be admissable, as Judge Keenan ruled yesterday, in 24 other Fosamax cases, finding Merck's own internal documents (on duration of Fosamax® use, and progression of the disease) highly relevant:

. . . .Dr. Marx [one of the two doctors seeking to testify] was persuaded by internal Merck emails produced in discovery analyzing spontaneous ONJ reports Merck has received, which he reviewed in early or mid-2008 (07/09/2009 Hrg. Tr. at 100-01, 136; Marx Report ¶ 45.) A June 2005 email from the director of Merck’s Clinical Risk Management and Safety Surveillance noted that there was “a range of durations reported,” with a median of four years and a minimum of eight months. (Pl.’s Mem. in Opp’n to Summ. J. (“Pl.’s Mem.”) Ex. 1.0136.) The email concluded, “If their implication is that very long treatment makes for more likely occurrence, our data do not currently support that hypothesis.” (Id.) A November 2006 email revealed that 31 of the 71 reports adjudicated by Merck to be highly likely cases of ONJ involved less than or equal to three years of Fosamax use (Pl.’s Mem. Ex. 1.0185). . . .

[Moreover, an] Australian study, a survey of oral maxillofacial surgeons sponsored by Australia’s health authority, found a two-year median duration of Fosamax use prior to ONJ onset in 30 cases. (Pl.’s Mem. Ex. 2.0348 at 419). The USC study found that two of nine reported ONJ cases occurred within one year of Fosamax use. (Id. Ex. 2.0805.) It concluded that these findings “indicate that even short-term oral use of alendronate led to ONJ in a subset of patients after certain dental procedures were performed” (Id.). . . .

So, as the jury takes a "cool-off" day today, Merck should be assessing how it will handle a second trial of Shirley Boles' claims, with this sort of testimony being admissable. And it should be preparing for the next two bellweather cases -- in December 2009 and January 2010, along these very same lines.

We may still see a verdict from this jury -- but it is not likely to be an exoneration of Fosamax, in my estimation. We should know something more by Friday night. Stay tuned.

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