I now wonder if these below (alleged) problems were part of why the solo mumps vaccine program with the government was moth-balled -- in favor of a more economical (in terms of overall cost to immunize) and efficacious three way vaccine. We will never know, but on Friday Merck learned that it will have to put on a defense against claims it falsely inflated its efficacy claims for the mumps vaccine -- in order to secure a more fullsome federal reimbursement -- of the jab. On its face,that makes out a False Claims Act violation, and possibly a qui tam one, as well -- for the people who blew the whistle on it all. I suppose Whitehouse Station could settle, by paying money -- but I'd not hold my breath, there.
From the Friday article in Law 360o, then a bit [followed by my own edits and a bit of the opinions, from the pen of the very-able federal District Court Judge Jones]:
. . . .Two lawsuits accusing Merck & Co. Inc. of lying about the efficacy of its mumps inoculation in order to keep competitors from bringing their own versions of the vaccine to market will move forward, after a Pennsylvania federal judge ruled in favor of whistleblowers and direct purchasers Thursday. U.S. District Judge C. Darnell Jones II ruled that the whistleblowers had sufficiently pled that Merck might have provided false statements to the government and that the direct purchasers had shown enough evidence to establish that these falsehoods may have caused the government to overpay for the vaccine. . . .
[Specifically, as the order and opinion (42 page PDF file) of Judge Jones relates:] Defendant [Merck] allegedly told Relators that the “objective”of this new methodology was to “[i]dentify a mumps neutralization assay format. . . that permits measurement of a ≥ 95% seroconversion rate in MMR®II vaccines.” Defendant continued to test the vaccine against the virus strain that originated the vaccine. In addition, Defendant added animal antibodies to pre and post vaccinated blood samples. Relators allege that this addition was “for the singular purpose of altering the outcome of the test by boosting the amount of virus neutralization counted in the lab.” Relators claim that the use of animal antibodies created a high number of pre-vaccinated positive results, which Defendant systemically destroyed or falsified in order to legitimize the use of animal antibodies. Relators also allege that senior management was aware, complicit, and in charge of this testing. . . .
Relators reported these alleged infractions to the FDA, leading to an FDA visit. After the FDA visit, Relators were barred from participating in the mumps vaccine testing. Relators assert that Defendant continued to make the false representations of its inflated 95 percent efficacy rate to the government, while deliberately covering up the results of the tests showing a diminished efficacy. . . .
[Plaintiffs based their Complaint on the qui tam action filed by the Relators.] Plaintiffs’ theory is that because the vaccine’s efficacy was diminished, the vaccine was mislabeled and was not the product for which the government paid. As such, Plaintiffs allege that Defendant knowingly presented a fraudulent claim for payment to the U.S. government in violation of 31 U.S.C. § 3729(a)(1)(A).
Second, Plaintiffs allege that Defendant falsified, abandoned, and manipulated testing data that should have been shared with the government in order to fraudulently mislead the government into purchasing the mumps vaccine. (Dkt. No. 12 ¶ 155.) As such, Plaintiffs allege that Defendant knowingly incorporated falsified records material to their fraudulent claims for payment for the vaccine. 31 U.S.C. § 3729(a)(1)(B). . . .
Given that this Court must construe the Complaint in the light most favorable to the plaintiff, construe the CFA liberally, and approach motions to dismiss “with hesitation,” this Court finds that Plaintiffs have adequately pleaded a claim under the CFA. . . .
The court rejects Defendant’s argument that Plaintiffs’ surviving state claims are preempted by Federal law, and finds that Plaintiffs have adequately stated claims under the consumer protection statutes of New York and New Jersey. However, the Court finds that Plaintiffs have failed to state claims for breach of contract and unjust enrichment. Thus, the Court dismisses Count II, except for claims brought under the NYDAPA and the NJCFA; and, dismisses Count III, Count IV, Count V, and Count VI in their entireties. . . .
So this means that the very capable Judge Jones has ruled that Merck cannot dismiss these allegations summarily. Merck must now move forward -- to articulate legal defenses -- against these allegations. If the relators and plaintiffs prove at trial what they've alleged above, that would be enough to make it past a motion for summary judgment, and ultimately get to the jury. We will watch these suits, for the readership, going forward. Have a wonder-filled sunny late summer Sunday, one and all! I know I will.
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