As I Predicted — Judge Keenan Did Let Mrs. Scheinberg’s $285,000 Fosamax® ONJ Jury Award Stand

I am rather tardy getting to this (busy with other duties) — but it is very much as expected, so no great news value here. [This was my prediction of about 10 days ago.]

Just the same, the very able Judge Keenan has reaffirmed that, under New York law, a drug’s warning label will take a case of injury away from the jury only if there has been no credible evidence about the inadequacy of the label’s warning. Using “mumbo jumbo” magic words (alone) won’t do, under New York law, wrote Judge Keenan. [Compare: In New Jersey, for example, showing that the label warned of the victim’s precise malady might well be enough. Not so here.] Judge Keenan reminded Merck’s lawyers that Mrs. Scheinberg’s experts had clearly suggested that Merck’s label didn’t address ONJ Fosamax® adverse events, with a level of gravamen (at or around 2005) to give the prescribing physician the “unmistakable impression” that the risk involved with the matter was serious.

Here is the operative bit of Judge Keenan’s opinion (as a 10 page PDF file), handed down overnight in Manhattan’s federal District courthouse:

. . . .Finally, the jury was presented with testimony from Dr. Parisian [plaintiff’s expert] about other drugs’ labels that addressed ONJ and oral bisphosphonates. Under New York law, evidence that a manufacturer “diluted” a label or introduced confusion or inconsistencies is relevant to the failure to warn inquiry. The Plaintiff introduced evidence to show that [at or around 2005] the FDA had suggested a label change to include language that most cases of ONJ “have been in patients treated with bisphosphonates intravenously, but some have been in patients treated orally.” The jury learned that Merck rejected this proposed change. Dr. Parisian also spoke to the jury about the labels that were used by Fosamax competitors, namely Actonel and Boniva. These drug labels reflected the FDA’s proposed language almost verbatim. In considering the competitors’ labels and the suggestions made by the FDA, a reasonable juror could have concluded that Merck’s ONJ precaution was inadequate. . . .

Of course, Merck might appeal, but as I’ve said, I think its chances are slim to none here. This was properly a factual question for the jury. The jury carefully weighed the evidence; that makes the jury’s verdict nearly immune from attack. So it goes.


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