Merck has known for a decade that its mumps vaccine is "far less effective" than it tells the government, and it falsified test results and sold millions of doses of "questionable efficacy," flooding and monopolizing the market, a primary caregiver claims in a federal antitrust class action.
Alabama-based Chatom Primary Care sued Merck on Monday, the week after the unsealing of a False Claims Act complaint two relators filed in 2010.
Those relators, Stephen Krahling and Joan Wlochowski, were Merck virologists who claim in their unsealed complaint that they "witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine's efficacy findings."
Krahling and Wlochowski claimed Merck's scheme caused the United States to pay "hundreds of millions of dollars for a vaccine that does not provide adequate immunization."
"As the largest single purchaser of childhood vaccines (accounting for more than 50 percent of all vaccine purchases), the United States is by far the largest financial victim of Merck's fraud," according to the 2010 False Claims Act complaint. "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. 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."
The United States told a federal judge in April that it did not want to intervenein the False Claims case, but reserved the right to do so later.
Chatom says in its antitrust complaint that Merck falsely claims its mumps vaccine is 95 percent effective.
That claim "deterred and excluded competing manufacturers," who would enter the risky and expensive vaccine market only if they believed they could craft a better product, Chatom says in its complaint.
Merck is the only manufacturer licensed by the FDA to sell the mumps vaccine in United States, and if it could not show that the vaccine was 95 percent effective, it risked losing its lucrative monopoly, according to the complaint.
That's why Merck found it critically important to keep claiming such a high efficacy rate, the complaint states.
And, Chatom claims, that's why Merck went to great lengths, including "manipulating its test procedures and falsifying the test results," to prop up the bogus figure, though it knew that the attenuated virus from which it created the vaccine had been altered over the years during the manufacturing process, and that the quality of the vaccine had degraded as a result.
Starting in the late 1990s, Merck set out on its sham testing program with the objective of "report[ing] efficacy of 95 percent or higher regardless of the vaccine's true efficacy," the complaint states.
Chatom says Merck initially called its testing program Protocol 007.
Under Protocol 007, Merck did not test the vaccine's ability to protect children against a "wild-type" mumps virus, which is "the type of real-life virus against which vaccines are generally tested," the complaint states.
Instead, Chatom says, Merck tested children's blood using its own attenuated strain of the virus.
"This was the same mumps strain with which the children were vaccinated," the complaint states.
That "subverted" the purpose of the testing regime, "which was to measure the vaccine's ability to provide protection against a disease-causing mumps virus that a child would actually face in real life. The end result of this deviation ... was that Merck's test overstated the vaccine's effectiveness," Chatom claims.
Merck also added animal antibodies to blood samples to achieve more favorable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that "did not in any way correspond to, correlate with, or represent real life ... virus neutralization in vaccinated people," according to the complaint.
Chatom claims that the falsification of test results occurred "with the knowledge, authority and approval of Merck's senior management."
And as Merck's vaccine is the only game in town, the vaccine's "significantly degraded" quality means "there has remained a significant risk of a resurgence of mumps outbreaks," Chatom says in its complaint.
It claims that the degraded quality of the Merck vaccine played a role in a 2006 mumps outbreak in the Midwest, and in another outbreak in 2009.
Those outbreaks caused the Centers for Disease Control to push back its target date for eradicating the disease from 2010 to no earlier than 2020, the complaint states.
"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," the complaint states. "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."
Merck spokesman Ron Rogers told Courthouse News in a statement that the False Claims lawsuit "is completely without merit," and that Chatom's lawsuit is merely derivative of that case.
"Merck has presented information that demonstrated to the United States Department of Justice that these allegations are factually false, and after the Department conducted its own two-year investigation, it decided not to pursue this lawsuit," Rogers said.
In addition, he said, the U.S. Food and Drug Administration "previously examined the issues raised in the lawsuit, and they were resolved to the agency's satisfaction."
Chatom seeks to represent the class of all those who bought Merck's mumps vaccine from Jan. 1, 1999 to today.
It seeks damages for monopolization under the Sherman Act, violation of state consumer protection laws, unjust enrichment and breach of warranty.
Chatom is represented by Richard Golomb of Golomb & Honik, in Philadelphia.