Federal Judge Permits False Claims Act Case to Continue Against Vaccine Manufacturer Merck

Medical corporation Merck & Co. will decidedly face the music in the ongoing class action and related anti-trust lawsuit involving its mumps vaccine – a product routinely given to babies and children for generations. The issue, which involves allegations of false compliance with FDA standards for vaccines, prompted a False Claims Act lawsuit: United States v. Merck & Co.

This case was commenced by two virologists once employed with Merck, alleges a systematic and long-standing commitment by the company to lying about the efficacy of its mumps vaccination, thereby prompting possible exposure to liability under the federal False Claims Act. The government has not yet opted to intervene, but has reserved its right to join in the case in the future.

Details of Case Against Merck

The False Claims Act lawsuit against Merck began after two employees revealed that the company may have been lying about the efficacy rate of its mumps vaccine – touting it as having a 95 percent rate of success when its actual success rate may be much lower. The relators claim that Merck inflated its rates despite findings in clinical testing and research showing that the vaccine is not as combative against the mumps virus as previously thought.

The United States is the largest single purchaser of childhood vaccines and is therefore “the largest financial victim of Merck’s fraud” according to the relator’s 2010 complaint. The complaint continues to allege that the true victims of this type of fraud are the children having received the vaccinations that are possibly ineffective against the onset of the mumps virus. The relators further contend that, despite the contentions by the Centers for Disease Control that mumps has been eradicated in the United States, outbreaks continue to linger.

Details of Fraudulent Scheme

Relators assert that they witnessed firsthand both improper testing procedures of mumps vaccines, as well as a subsequent falsification of documents for submission to the FDA. According to allegations, Merck engaged in an elaborate cover-up scheme in order to keep its mumps vaccines on the market. Allegedly, beginning in the 1990’s, Merck devised “Protocol 007” as its sham testing regime in order to “report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy.” Specifically, Merck developed its own attenuated strain of the mumps virus – which was unlike the “wild type” mumps virus to which actual children would be exposed – and testing the vaccine against the weaker version of the virus.

The company also allegedly added animal antibodies to tests in order to boost efficacy ratings, despite knowing that the human immune system would never actually produce similar antibodies. In sum, the complaint alleges that the testing protocol for Merck’s mumps vaccine “did not in any way correspond to, correlate with, or represent real life.”

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