False Claims Act Suit Accusing Merck of Falsifying Information regarding its Mumps Vaccine will Proceed
The United States District Court for the Eastern District of Pennsylvania has denied Merck’s attempt to obtain dismissal of a lawsuit accusing the drug company of violating the False Claims Act by providing the government with false information regarding the effectiveness of its mumps vaccine.
In United States of America, ex. rel. Krahling v. Merck & Co, Inc., former employees claimed that Merck falsified and manipulated test data to make its mumps vaccine appear to be more effective than it actually was. According to the relators, the company failed to provide the government with accurate test results in order to mislead the government into purchasing the vaccine and that because the vaccine was not as effective as claimed, the government received something other than what it paid for. Merck argued that the relators were actually challenging the accuracy of the information contained on the product’s label and that this issue should be addressed by the Food and Drug Administration rather than through a suit under the FCA. The court disagreed, indicating that it would be inconsistent with the purpose of the FCA to hold that only the government can charge a defendant with committing fraud on the FDA or violating its regulations. The court then concluded that the relators had set forth sufficient facts in their complaint to support their contentions that Merck 1) submitted claims for payment to the government for the purchase of the vaccine after the allegedly fraudulent testing had taken place; 2) failed to provide the government with information regarding the effectiveness of the vaccine and this omission was material to the government continuing to purchase this product; 3) had a duty to provide the government with accurate information regarding the safety and effectiveness of the medication; 4) knew its claims were false and 5) deliberately concealed or provided incomplete information to the FDA. As a result, Merck’s motion to dismiss was denied and this issue will now proceed through the discovery process.