An Alabama health care provider filed a lawsuit against Merck Monday, June 25, a week after a 2010 whistleblower lawsuit against the drug manufacturer was unsealed, revealing allegations that for a decade, Merck may have knowingly made and marketed a mumps vaccine that was “far less effective” than it told federal regulators.
According to the Courthouse News, Chathom Primary Care in Chathom, Alabama, filed a federal antitrust class action against Merck after learning about a False Claims Act complaint brought against the drug maker by two former Merck virologists familiar with the company’s vaccine development. In that complaint, Stephen Krahling and Joan Wlochowski allege that Merck “knowingly falsified its mumps vaccine test data, spiked blood samples with animal antibodies, and sold a vaccine that actually promoted mumps and measles outbreaks.”
Merck’s fraudulent manufacture and promotion of the mumps vaccine, they charge, caused the U.S. government to spend “hundreds of millions of dollars for a vaccine that does not provide adequate immunization.”
According to the 2010 complaint, the United States was “by far” the largest financial victim of Merck’s fraud because it is the largest single buyer of childhood vaccines in the country.
“But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection,” the lawsuit states. “And while this is a disease that, according to the Centers for Disease Control (‘CDC’), was supposed to be eradicated by now, the failure in Merck’s vaccine has allowed this disease to linger, with significant outbreaks continuing to occur.”
Chathom’s lawsuit alleges that Merck falsely claimed a 95 percent efficacy rate for its mumps vaccine, manipulated test procedures, and falsified test results in an effort to stave off potential competition and maintain its monopoly on the vaccine. Because vaccine development is an especially long, risky, and costly endeavor for pharmaceutical companies, Merck’s overstatement of the vaccine’s efficacy, the lawsuit charges, was enough to discourage other drug makers from developing potentially more effective mumps vaccines.
According to Courthouse News, Chathom Primary Care “claims the degraded quality of the Merck vaccine played a role in a 2006 mumps outbreak in the Midwest and in another outbreak in 2009.” The outbreaks prompted the CDC to push back its target date for eradicating the disease from 2010 to 2020 at the absolute earliest.
“But no amount of extra time or dosages will be enough to eliminate the disease when the vaccine does not work as represented in the labeling,” Chathom’s complaint alleges. “It will merely allow Merck to continue to misrepresent the vaccine’s efficacy and thereby maintain its exclusive hold on the relevant market with an inadequate vaccine.”