Saturday, September 4, 2010

One Pharma "Premption Defense" Ruling Reversed -- Implications For Fosamax® ONJ Cases

Merck has made motions to overturn the jury's $8 million Fosamax® ONJ verdict in Boles II, in part by arguing that the concept of premption (most recently curtailed in the United States Supreme Court (PDF file) decision in Wyeth v. Levine) prevents Mrs. Boles from recovering for any FDA-approved product.

One of the cases Merck relies upon for this notion was just reversed on appeal. So Mrs. Boles' lawyers just informed the very able Manhattan based federal District Court Judge John Keenan of this fact, thus:

For their part, Merck's lawyers had argued, in footnote 14 of their latest brief that this reversal didn't change their view of the law of the case. Plainly the above is intended to suggest that Merck's lawyers are at best mistaken, and at worst, have misrepresented Judge Keenan's earlier rulings in Boles I, and/or the actual Longs reversal opinion -- see Merck's Footnote 14:

. . . .In its opening memorandum, Merck cited Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) as supporting Merck’s preemption argument. On August 18, the Sixth Circuit reversed the district court’s preemption decision in Longs. See Wimbush v. Wyeth, __ F. 3d. __, No. 09-3380, 2010 WL 3256029 (6th Cir. Aug. 18, 2010). That case, however, did not involve a situation where the FDA clearly rejected an analysis that, according to plaintiff, warranted a contraindication.. . .

We'll keep you apprised, but it would seem that (apart from the allegations of lawyer misconduct), Merck will have a hard time getting this verdict set aside, as more and more lower courts take the teachings of Wyeth v. Levine to heart.

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