Sunday, June 7, 2015

Merck's Mumps Vaccine Efficacy Suits -- A Stormy Sunday Morning Update

I have a nice quiet block of time, here -- until my niece's plane arrives -- on a terrifically stormy Sunday morning. . . and so I thought I'd catch the readership up on these developments.

Last September, Merck failed to have the case dismissed, without full discovery. We covered that, in detail. Since then, there have been numerous discovery disputes -- the most pressing one of which has just led to a motion to compel being filed against Merck, with the Magistrate Judge. In sum, the complaint is that Merck will not admit that it does not know (and cannot ascertain, without unreasonable expense and effort) what the present day efficacy rate of its monopoly mumps vaccine really is.

And this is important because, it is claimed, Merck was able to artificially create a monopoly in the vaccine, by overstating the actual efficacy rate, thus discouraging all other vaccine makers from producing a competitor -- (again allegedly falsely) figuring that theirs would be less effective. That's the gist of the Qui Tam complaint, here. All discovery is supposed to be complete by September of 2015 -- and trial could be as early as this time next year. We shall see. In any event, here is a bit of the latest back and forth -- and the full six page PDF letter to the Magistrate Judge. It makes a pretty compelling argument, in my estimation:

. . . .From the outset of this case, Merck has . . . argu[ed that] its mumps vaccine works "phenomenally" and "enormously" well, with "tremendous efficacy." Merck did so in its unsuccessful motion to dismiss where Merck argued it "remains indisputably true" its vaccine "confer[s] a high degree of protective efficacy against the mumps." Merck did so again in its Answer to the operative complaint where it denied "the efficacy of the vaccine is falsely represented" on the product's labeling. And Merck did so again in the Joint Rule 26(f) Report where in the summary of its defenses to this action Merck argued it "has full confidence" in the efficacy of the vaccine and that the product labeling "accurately reflects" that efficacy. . . .

Merck has likewise repeatedly argued how the efficacy of its vaccine is a critical issue in this case. In fact, at oral argument on the motion to dismiss, Merck at least a half-dozen times protested (unsuccessfully) to the Court that the complaint fails to allege "what the actual efficacy of the vaccine is." See Transcript of MTD Hearing at 6-10. And in its Rule 26(a) Initial Disclosures, Merck identified as among the limited categories of documents "likely to support Merck's claims and/or defenses," those relating to the efficacy of the vaccine.

But now, when asked to confirm what Merck believes that efficacy to be, Merck refuses to answer or acknowledge it does not know. This is readily apparent in Merck's refusal to answer Interrogatory No. 1 (First Set) which asks Merck to "[s]tate, as a percentage, the current Efficacy of the mumps component of Merck’s MMRII vaccine . . . ."1 Rather than answer this interrogatory, however, Merck merely identifies the vaccine's efficacy as Merck measured it roughly 50 years ago when the vaccine was originally licensed. Merck refuses to identify the current efficacy, arguing "there are no 'current' efficacy' clinical trials involving Merck's mumps vaccine and [] it is not now possible to conduct such double-blind controlled studies." . . .

We will keep you apprised.

[The above all happened at the beginning of June, but I was far too. . . lost, to get it out, in real time. . . . Ah, well. . . so it goes. . . Onward.]

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