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Whistleblowers behind a lawsuit accusing Merck of fraud hope their case will go before a jury after their attorneys today presented oral arguments to a panel of judges in Philadelphia.
Judges for the U.S. Court of Appeals for the 3rd Circuit today heard oral arguments in United States ex rel. Krahling v. Merck & Co., a lawsuit alleging Merck fraudulently marketed its MMR (measles, mumps and rubella) vaccine.
Lawyers on behalf of the plaintiffs — Stephen Krahling and Joan Wlochowski — argued that the appeals court should overturn a lower court’s dismissal of the suit. Krahling and Wlochowski, both virologists, formerly worked for the Merck lab that conducted what they allege was fraudulent efficacy testing.
“This case,” the complaint said, “is about Merck’s efforts for more than a decade to defraud the United States through Merck’s ongoing scheme to sell the government a mumps vaccine that is mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.”
Krahling and Wlochowksi in August 2010 sued Merck as “relators” on behalf of the U.S. against the pharmaceutical giant.
Today’s hearing — which Children’s Health Defense (CHD) aired on CHD.TV — came after U.S. District Judge Chad Kenney in July 2023 dismissed the case without ruling on whether there was any fraud.
Dorit Rubinstein Reiss — a law professor at the University of California Law San Francisco — wrote in an analysis of that decision, “The court found that even if there were any misrepresentations, they were not ‘material’ — important — to the government’s decision to contract with Merck for its mumps vaccine.”
“So the issue on this appeal,” Gordon Schnell, one of the attorneys for the plaintiffs, told the panel of 3rd Circuit judges, “is whether the relators have provided sufficient evidence of materiality to get it to a jury.”
Schnell argued that he and his colleagues had provided “substantial evidence of materiality…including testimony from former and current CDC” (Centers for Disease Control and Prevention) officials.
Attorney Jessica L. Ellsworth presented arguments on behalf of Merck for why the lower court’s dismissal of the suit should stand.
It is unknown when the judges — Patty Shwartz, Peter J. Phipps and Tamika R. Montgomery-Reeves — will issue their decision.
Case alleges Merck skewed efficacy numbers
The lawsuit claimed that in the 1990s — when Merck was the only company licensed by the U.S. Food and Drug Administration (FDA) to sell a mumps vaccine in the U.S. — Merck skewed tests of its MMR vaccine by adding animal antibodies to blood samples.
In doing so, Merck allegedly was able to produce test results showing that the vaccine was 95% effective — even though more accurate tests would have shown a lower efficacy rate.
The plaintiffs said these false results kept competitors, such as GSK, from trying to produce their own mumps vaccines, as they were unable to match the effectiveness Merck claimed, Reuters reported.
As The Defender previously reported, the plaintiffs argued that Merck defrauded the CDC because the CDC’s Vaccines for Children Program bought the vaccine.
Schnell did not immediately respond to The Defender’s request for comment.
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The heart of this case is about the people who were defrauded
Krahling and Wlochowski’s allegations provided the material for the new narrative film, “Protocol 7: A Whistleblower Story.”
Dr. Andrew Wakefield — who produced the film — said in a recent interview with CHD CEO Mary Holland that U.S. children were particularly affected by Merck’s alleged fraud.
While mumps is a trivial disease in children, Wakefield said, it can have serious consequences for older children. In “post-pubertal males in particular or post-pubertal females in whom it can produce testicular or ovarian inflammation with infertility,” he said.
Wakefield pointed to the outbreaks of mumps in highly vaccinated populations worldwide as evidence of the vaccine’s ineffectiveness.
“I don’t care to a large extent what the FDA … or … CDC knew or didn’t know,” Wakefield said, only about the “people [who] were defrauded” and the harm caused to children who were “no longer protected from mumps in puberty.”
Listen to today’s oral arguments here:
