ALLENTOWN, Pa.—In an issue of the mumps portion of Merck’s MMR vaccine being “good” but not “good enough”—or, more specifically, perhaps not being nearly as good as the company has maintained over the years—the pharma giant now faces a threat to its control of the mumps vaccination market after a federal court ruling Sept. 5.
Issuing a single opinion in two related suits—United States v. Merck & Co. and Chatom Primary Care v. Merck & Co.—a judge in the U.S. District Court for the Eastern District of Pennsylvania has upheld antitrust claims brought against Merck in a qui tam suit and related class action over the company's testing and government sales of its mumps vaccine. The Friday ruling overcomes Merck’s motions to dismiss and will allow claims against it to proceed to trial.
The first suit, a whistleblower case, was filed in Pennsylvania in 2010 but sealed until 2012, and had been brought under the False Claims Act by two Merck virologists, Joan Wlochowski and Stephen Krahling. The second suit is a class action filed mere days after the unsealing of the whistleblower case and maintains that Merck violated the Sherman Anti-Trust Act by falsifying the efficacy of its mumps vaccine, one of the claims of that case being that such actions discouraged or prevented other companies from bringing rival mumps vaccines to market.
U.S. District Judge C. Darnell Jones II found with regard to the first case, the qui tam action, that a fraud-on-the-FDA theory through a False Claims Act suit can proceed, noting, “Plaintiffs have argued sufficient facts to sustain a claim for proximate causation, detailing the significant barriers that other companies would face to enter the mumps vaccine market.”
His opinion on the second case, the class action suit, was more favorable to Merck, though, in that he dismissed the class action's claims under the laws of 22 states which were filed, except for some of involving New York and New Jersey law.
A spokesperson for law firm Robins, Kaplan, Miller & Ciresi L.L.P.—one of the firms involved with suing Merck—contacted DDNews via email on the day of Jones’ ruling to point out that “there have been two historic mumps outbreaks in the U.S. among vaccinated populations in just the last decade. With a third mumps outbreak currently underway in the U.S. … Robins, Kaplan, Miller & Ciresi L.L.P. today achieved a significant victory against pharmaceutical stalwart Merck. The U.S. District Court for the Eastern District of Pennsylvania upheld the firm’s federal antitrust claims, and state consumer protection claims, against Merck for falsifying test data and misrepresenting the efficacy of its mumps vaccine, ultimately discouraging other providers from entering the market with competing products and breaking up Merck’s monopoly.
“Plaintiffs in the case allege that Merck fraudulently represented that its mumps vaccine has an efficacy rate of 95 percent or higher, when in truth, Merck has taken affirmative steps to conceal—by using improper testing techniques and falsifying test data—that the efficacy rate of its mumps vaccine is significantly lower than 95 percent.”
Kellie Lerner, a partner at Robins, Kaplan, Miller & Ciresi, who serves as co-lead counsel on behalf of direct purchasers of the mumps vaccine, added in an email statement, “We are pleased that the court has upheld our federal antitrust claim in this important case. While Merck has enjoyed an exclusive monopoly on the sale of mumps vaccine in the United States, mumps outbreaks continue to occur because, as we allege in our lawsuit, Merck has misled the public about the vaccine’s efficacy. This decision brings us one step closer to shining a light on Merck’s deceptive business practices so that new and more effective vaccines will ultimately be developed in the future.”
So far, Merck has been quiet on the latest ruling, though presumably it still maintains its innocence, and in 2012, the company said the qui tam lawsuit was “without merit and the company intends to vigorously defend itself in court.” Merck has claimed that the vaccine’s ability to prevent disease remains the same, and said that “MMR-II continues to be recommended for routine administration to childen by public health authorities around the world … Nothing is more important to Merck than the safety and effectiveness of our vaccines and medicines and the people who use them. It’s important to understand that none of the allegations in the complaint relate to the safety of MMR-II, and we remain confident that MMR-II helps protect against measles, mumps and rubella as described in the labeling for the vaccine.”
The whistleblowers who gave rise to the antitrust case claim to have witnessed Merck management give instructions to staff to withhold information about failure rates regarding the mumps portion of the MMR vaccine before selling it to the U.S. government. Merck maintained that the mumps vaccine had a 95-percent efficacy rate, even during epidemic mumps outbreaks of 2006 and 2009 in highly vaccinated populations—a rate reportedly attained by basing efficacy tests not on wild mumps but rather on Merck's own vaccine strain of the disease.
On its website page outlining its history and legacy with regard to vaccines, Merck quotes Dr. Julie Gerberding, president of Merck Vaccines and former director of the U.S. Centers for Disease Control and Prevention as saying, “Vaccines are a powerful force of health and health development, and their globalization is not just a business necessity but a public health obligation. Merck is on a mission to ensure that more people can access our vaccines, regardless of where they live or their financial circumstances."