Merck’s Measles-Mumps-Rubella (MMR) vaccine is under fire following allegations of wrongdoing from several parties, namely two former Merck scientists-turned-whistleblowers. A third whistleblower is a senior scientist at the Centers for Disease Control (CDC), who has confessed to misconduct involving the same MMR vaccine.
A U.S. judge rejected Merck’s attempt at a dismissal after determining there was plausible grounds for the claims. Therefore the medical giant is being forced to defend themselves and their vaccine in at least two federal cases. Merck could also be forced to defend itself in Congress. Representative Bill Posey (R-FL) – a known critic of the CDC whom is investigating the link between autism and vaccines – is reviewing hundreds of documents turned over by the CDC whistleblower.
According to the whistleblowers’ court documents, Merck’s misconduct was far-ranging: It “failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing.”
The fraudulent activities, say the whistleblowers, were designed to produce test results that would meet the FDA’s requirement that the mumps vaccine was 95 percent effective.
Outstanding Merck Cases
The first, United States v. Merck & Co., was brought by former Merck scientists alleging, “Merck fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act].”
The second, a class action suit, Chatom Primary Care v. Merck & Co., leans heavily on evidence provided by whistleblowers. The suit contends Merck fraudulently monopolized the mumps market. Those that are involved in the suit – medical practices and doctors – would be able to recover compensation for having been sold an overpriced, monopolized product and a defective one at that, in that the vaccine wasn’t effective. That suit alleged that, “Merck expected outbreaks to occur and, as predicted, that was the case — mumps epidemics occurred in 2006 in a highly vaccinated population and again in 2009-2010).”
The third, a senior CDC scientist, indirectly blew the whistle on Merck as it was really directed at his own actions as well as his CDC colleagues that were part of a 2004 study that involved the MMR vaccine. In this case the claims involve a cover-up of data that showed higher rates of autism in African-American boys after receiving the MMR vaccine.
If the courts side with the whistleblowers, it would represent a moral victory as they repeatedly attempted to stop Merck while still in its employ. Under the False Claims Act, the whistleblowers would receive a share – an estimated 25 percent to 30 percent – of the amount recovered by the government. Previous settlements of this kind have ended in hundreds of millions of dollars and have gone into the billions.