- Posted September 6, 2014 by
Merck's Motion to Dismiss Denied in Mumps Whistleblower Suits
A federal judge ruled on September 5, 2014, that two suits against pharmaceutical giant Merck have overcome motions to dismiss and will proceed to trial.
The first suit (1), filed in Pennsylvania in April of 2010 but sealed until June of 2012, was brought under the False Claims Act by two Merck virologists, Joan Wlochowski and Stephen Krahling.
The whistleblowers claimed to have witnessed Merck management instructing staff to withhold information about the high failure rate of the mumps portion of the MMR vaccine before selling it to the U.S. government. The manufacturer claimed the mumps vaccine had a 95% efficacy rate, even during epidemic mumps outbreaks of 2006 and 2009 in highly vaccinated populations. This rate was attained by basing efficacy tests on Merck's own vaccine strain of mumps rather than wild mumps.
After considering the option for two years, the United States Department of Justice declined to join the whistleblower suit when it was unsealed on June 21, 2012, but allowed the suit to proceed in the name of the United States.
Merck based its Motion to Dismiss the suit on the claim that misstating the efficacy rate of the mumps vaccine is a matter for the Food & Drug Administration to investigate, not to be litigated in the court system. The judge disagreed and held up every claim of the suit.
In addition, the Department of Justice filed a May 2013 "Statement of Interest" in opposition to Merck's Motion to Dismiss, claiming that the basis of the motion went against the purpose of the False Claims Act.
The second suit (2), a class action filed 4 days after the June 2012 unsealing of the whistleblower suit, claims Merck violated the Sherman Anti-Trust Act by falsifying the mumps vaccine efficacy rate, which prevented other pharmaceutical companies from bringing another mumps vaccine to market.
In the class action suit, brought by a doctor in New York, a second doctor in New Jersey, and Chatom Primary Care of Alabama, plaintiffs allege to represent a class of doctors and practice groups that were forced to pay more for the MMR vaccine due to Merck’s monopoly of sales to the government.
The judge ruled to allow the Sherman Act claim, along with the claims brought under the laws of each plaintiff’s home state, to proceed. He dismissed the class action's claims under the laws of 22 other states which were filed on behalf of members of the class not yet named.
For more information see The Legal Intelligencer.