Thursday, May 14, 2015

Just To Complete The Record -- On Old Merck's 2004-Era Vioxx® Withdrawal -- And The Attendant Securities Fraud Claims

How to neatly summarize the nearly 25 years, from original R&D -- to withdrawal of this product, in 2004 -- and the now over ten full years of globe-spanning litigation, since?

In a word. . . I won't.

Just search Vioxx® in the search box, here. I've written about 55 posts worth -- just since 2008. I will note that it bothers me that Lexis and Westlaw want to charge people to read the opinion -- so here it is (a 51 page PDF) -- for free.

Our latest development, in this epic litigation? Well, just yesterday, the very able Judge Stanley R. Chesler in the Newark, NJ federal District courthouse released an opinion and order, essentially saying that the Zombie opt out Vioxx securities plaintiffs have survived a motion to dismiss, at least on the assertion that Merck's post-VIGOR opinion -- about the hypothesis supporting the putative safety of Vioxx was so ill-founded as to allow a jury to at least consider, and perhaps decide, whether the conduct reached the level of securities fraud -- from 2001 to 2004. Here is a bit of that:

. . . .In September 17, 2001, the FDA issued its warning letter to Merck, pointedly reprimanding Merck for “selectively present[ing]” the naproxen hypothesis despite the fact that it is “hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties.” (Id., Ex. 466.) A reasonable jury could conclude that, when only weeks after this warning, Merck nevertheless identified the naproxen hypothesis as not only a possible explanation but the favored one over Vioxx’s tendency to increase CV risk, it knowingly deceived investors by, in essence, knowingly misrepresenting that Merck and/or Scolnick were in possession of facts justifying this opinion. . . .

The record contains evidence upon which a reasonable jury could conclude that Defendants not only lacked support for this assertion of belief but, additionally, knew that it did not “fairly align” with other information in their possession. This evidence consists of, for example: Merck’s internal discussions revealing a very different assessment of the VIGOR data than that expressed to the public; its receipt of contrary advice from consultants regarding the naproxen hypothesis as the proper interpretation of VIGOR; Merck’s possession of data discrediting the underlying assumption that naproxen has cardioprotective qualities similar to aspirin; and the FDA’s specific and unequivocal warning regarding Merck’s public espousal of the naproxen hypothesis. . . .

This makes it marginally more likely that Kenilworth will need to settle for some higher figure with these opt out claimants. But I do not foresee a trial on the merits here. That's just my very experienced opinion -- in such (alleged) mass tort cases. We will keep the readership informed. Have a great long weekend, one and all. I certainly will.

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