Two lawsuits accusing Merck & Co. of lying about the efficacy of its mumps vaccines to keep competitors from introducing similar vaccines to the market will be proceed to trial after a federal judge in Pennsylvania refused to dismiss the suits.
U.S. District Judge C. Darnell Jones II ruled that one of the lawsuits, filed by a pair of whistleblowers who worked as virologists for Merck, provided enough evidence that the pharmaceutical giant lied about the vaccine’s efficacy to the federal government. The judge also ruled that the other lawsuit, filed by a group of physicians and direct buyers, could also proceed because it sufficiently demonstrated that Merck’s false statements could have helped it monopolize the market for mumps vaccines.
Merck has been the only manufacturer licensed by the U.S. Food and Drug Administration (FDA) to produce a mumps vaccine since 1967. The company has maintained that the vaccine, which earned Merck $621 million last year, is effective in preventing mumps 95 percent of the time.
However, the whistleblowers allege in their lawsuit that instead of testing the vaccine against a “wild-type” mumps virus, it has tested it against an attenuated strain that the company used to create the vaccine nearly 50 years ago.
The judge found that Merck’s testing methods may have “fraudulently misled the government” when it “omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine,” thereby violating False Claims Act rules and effectively discouraging competition.
“We are pleased that the court has upheld our federal antitrust claim in this important case,” a lawyer representing the direct purchaser plaintiffs said in a statement. “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,” the plaintiffs’ lawyer added.
“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,” Judge Jones said in his ruling.