by Michael Belkin
TheRefusers.com
This is a legal filing by former Merck virologists who claim they were pressured by Merck management to participate in fraud by falsifying Merck’s mumps vaccine efficacy rate in clinical trials. This filing claims that the mumps vaccine efficacy rate is significantly lower than the 95% that Merck has misrepresented to the government and the public. The mumps vaccine is a component of MMR.
The most disturbing thing about this allegation by company insiders is that Merck would deliberately (not accidentally) enforce a policy of lying about vaccine effectiveness. If they would lie about vaccine efficacy, do you suppose Merck would be truthful about vaccine adverse reactions and safety? Or would they use the same management policy of pressuring company scientists and employees to sugar-coat vaccine safety data?
Keep in mind that Roche (another major drug company) is under investigation by the European Medicines Agency for ignoring 80,000 adverse reactions, including 15,161 deaths. See the pattern? Lie about product efficacy and then ignore adverse reactions. That is business as usual in the pharmaceutical industry. Why do consumers trust their products?
Filed April 27, 2012
UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA
United States of America ex rel.,
Stephen A Krahling and Joan A
Wlochowski,
Plaintiffs,
v,
Merck & Co., Inc.
Defendant
Civil action No. 10-4374 (CDJ)
AMENDED COMPLAINT
VIOLATIONS OF THE FEDERAL FALSE CLAIMS ACT
JURY TRIAL DEMANDED
Stephen Krahling and Joan Wlochowski bring this action as Relators on behalf of the United States against their former employer, Merck & Co., Inc. (“Merck”), under the False Claims Act and allege — upon knowledge with respect to their own acts and those they personally witnessed and upon information and belief with respect to all other matters – as follows:
Introduction
1. This case 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.
2. Specifically, in an effort to maintain its exclusive license to sell the vaccine and its monopoly of the U.S. market for mumps vaccine, Merck has fraudulently represented and continues to falsely represent in its labeling and elsewhere that its mumps vaccine has an efficacy rate of 95 percent or higher. This is the efficacy rate on which Merck’s original government approval for the vaccine was based more than forty years ago, In truth, Merck knows and has taken affirmative steps to conceal – such as by using improper testing techniques, falsifying test data in a clinical trial, and violating multiple duties of government disclosure – that the efficacy rate of Merck’s mumps vaccine is, and has been since at least 1999. significantly lower than this 95 percent rate.
3. Relators Krahling and Wlochowski were employed as virologists in the Merck lab that performed this fraudulent efficacy testing. They witnessed firsthand the improper testing and data falsification in which Merck engaged to conceal what Merck knew about the vaccine’s diminished efficacy. In fact, their Merck superiors and senior management pressured them to participate in the fraud and subsequent coverup when Relators objected to and tried to stop it.
4. As, a result of Merck’s fraudulent scheme, the United States has over the last decade paid Merck hundreds of millions of dollars for a vaccine that does not provide the efficacy Merck claims it provides and does not provide the public with adequate immunization. Had Merck complied with its multiple duties of disclosure and reported what it knew of the vaccine’s diminished efficacy – rather than engage in fraud and concealment — that information would have affected (or surely had the potential to affect, which is all the law requires) the government’s decision to purchase the vaccine. However, since the government was not fully informed, it did not have the opportunity to consider its options, including not purchasing the vaccine from Merck, paying less, requiring a labeling change, requiring additional testing, or prioritizing development and approval of a new vaccine from Merck or another manufacturer.
5, Merck’s failure to disclose what it knew about the diminished efficacy of its mumps vaccine has caused the government to purchase mislabeled, misbranded, adulterated and falsely certified vaccines in violation of Merck’s contract with the Centers for Disease Control(“CDC’”) and in violation of the law.
6. As the single largest 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. 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 against mumps. And while this is a disease the CDC targeted to eradicate by now, the failure in Merck’s vaccine has allowed this disease to linger with significant outbreaks continuing to occur.
7. Relators bring this case on behalf of the United States to recover the funds that the government spent for this fraudulently mislabeled, misbranded, adulterated and falsely certified vaccine, and for all associated penalties. They also bring this case to stop Merck from continuing with its scheme to misrepresent the true efficacy of its mumps vaccine and require Merck to comply with its reporting, labeling and testing obligations under its contract with the CDC and under this country’s vaccine regulatory regime.
PARTIES
8. Relator Stephen A. Krahling is a citizen of the United States and a resident of Pennsylvania. He was employed by Merck from 1999 to 2001 as a virologist in Merck’s vaccine division located in West Point, Pennsylvania. During his employment at Merck, Krahling witnessed firsthand, and was asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck’s mumps vaccine.
9, Relator Joan Wlochowski is a citizen of the United States and a resident of Connecticut. She was employed by Merck from January 2001 to August 2002 as a virologist in Merck’s vaccine division in West Point, Pennsylvania. During her employment there, Wlochowski also witnessed firsthand, and was asked to directly participate in, fraud in a clinical trial relating to the efficacy of Merck’s mumps vaccine.
10, Defendant Merck is headquartered in New Jersey with its vaccine division based in West Point, Pennsylvania. Merck is one of the largest pharmaceutical companies in the world with annual revenues exceeding $20 billion. Merck is also a leading seller of childhood vaccines and currently markets in the U.S. vaccines for 12 of the 17 diseases for which the CDC currently recommends vaccination.
11. Merck is the sole manufacturer licensed by the Food and Drug Administration (“FDA”) to sell mumps vaccine in the United States, Merck’s mumps vaccine, together with Merck’s vaccines against measles and rubella are sold as MMRII Merck annually sells more than 7.6 million doses of the vaccine in the U.S. for which it derives hundreds of millions of dollars of revenue. The US purchases approximately 4 million of these doses annually, Merck also has a license in the U.S. to sell ProQuad, a quadravalent vaccine containing MMRII vaccine and chickenpox vaccine. Under a license from the European Medicines Agency (“EMA”), Merck also sells mumps vaccine in Europe as a part of the trivalent MMRVaxpro and the quadrivalent ProQuad through Sanofi Pasteur MSD, a joint venture with the vaccine division of the Sanofi Aventis Group. ProQuad has been sold intermittently in the U.S. and Europe from its approval in 2005 until 2010.
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