|U.S. District Judge C. Darnell Jones II|
Merck ($MRK) tried to block two lawsuits claiming it lied about the efficacy of its mumps vaccine--but the pharma giant couldn't stop them. A federal judge in Pennsylvania refused to dismiss the lawsuits, filed by a pair of whistleblowers and a group of doctors and payers. Next stop: Trial.
Thursday, U.S. District Judge C. Darnell Jones II ruled that the whistleblowers--two former Merck virologists--had sufficiently showed the company may have misstated the vaccine's efficacy to the government, Law360 reports. The direct purchasers produced enough evidence to establish that those false statements could have helped give Merck a monopoly.
Merck has been the sole manufacturer with an FDA license to produce mumps vaccine since 1967, the news service points out, and the company has long touted a 95% efficacy rate for the shot. The drugmaker brought in $621 million on mumps vaccine sales last year, between its M-M-R II vaccine and ProQuad, a pediatric combo jab.
If Merck "fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine" in violation of the False Claims Act--as the whistleblowers allege, according to the judge's memorandum--it may have discouraged competition.
"As with the market for any product, a potential competitor's decision to enter a market hinges on whether its product can compete with those products already being sold in the market," the complaint reads, as quoted by Law360. "If an existing vaccine is represented as safe and at least 95% effective, as Merck has falsely represented its vaccine to be, it would be economically irrational for a potential competitor to bring a new mumps vaccine to the relevant market."
It's not the first time Merck has been targeted by whistleblowers. Back in 2008, the company coughed up $671 million to settle complaints that its marketing improperly induced docs to prescribe Vioxx and Zocor, which triggered government overspending. Whistleblower H. Dean Steinke, a Michigan sales manager, took home a $68 million reward for his role in that investigation.
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