Thursday, October 28, 2010

Jury Selection In Graves' Fosamax® ONJ Bellwether Trial Begins Tomorrow


As both sides get set to pick the next Fosamax® ONJ jury tomorrow in Manhattan, Judge Keenan handed down a new ruling overnight, setting up specific guardrails, called orders in limine -- about what sorts of questions will be allowed on certain contentious matters.

Merck had sought to block lots of the kind of testimony that was admitted in Boles II, and lawyers for Mrs. Graves have asked that any testimony regarding an "appeal to fear" (that Merck might withdraw Fosamax from the market, if Mrs. Graves recovers damages in this case). The fear-mongering thus involves insinuations that if Merck loses, doctors will have fewer choices to treat osteoporosis. Of course, back in June 2010, Amgen's Prolia® was approved by FDA for osetoporosis, so the argument would be. . . demonstrably false, as well. In fact, a whole new generation of osteoporosis drugs are reaching the market, and showing none of the side effects -- decreased bone turnover -- seen in Fosamax (in at least some patients). But of course, none of that is actually at issue -- in this trial. This trial is about whether Fosamax caused Mrs. Graves' injuries -- injuries which required the removal of her lower mandible, or jaw bone, and the replacement of it with a titanium plate structure.

The problem is, Merck has thus far failed to comply with Judge Keenan's orders to provide the lines of questioning it might use. As a consequence, Judge Keenan will have to decide these matters at side bar, in real time, during the trial, disrupting the flow of the testimony. [Merck must believe this will help it -- by creating a less linear, flowing story-line, on why Fosamax is a good drug that ought to remain on the market.] From the early parts of the able judge's order (full eight page PDf file), then:

. . . .Graves moves to exclude "fear mongering" and argument that a verdict for the plaintiff would take a prescription choice away from doctors.

At oral argument, the Court reserved decision in part on this motion because the Court wished to make rulings based on the specific questions that would be posed to [one of the experts]. Thus, the Court ordered Merck to provide the proposed questions. The Court continues to reserve judgment on this motion until it has received and reviewed Merck’s submission. . . .

In this same order, Merck was granted the right to exclude the same sorts of testimony we mentioned earlier in the week, from additional sources.

Stay tuned.

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