Dr. Sam W. Lee, formerly a Principal Investigator at Harvard Medical School and Massachusetts General Hospital (MGH), has agreed to pay $215,000 to resolve allegations that he submitted false information to get a grant from the National Institutes of Health (NIH) to do research involving “DNA damage response and carcinogenesis.” According to a settlement agreement finalized on August 6, 2021, Dr. Lee “knowingly included inauthentic data” and “falsified the results of experiments” in his NIH grant application. In its press release announcing the settlement, the U.S. Attorney’s Office for the District of Massachusetts noted that MGH disclosed Dr. Lee’s conduct and “separately repaid NIH the full amount of funds it drew from the grant.”
Importantly, unlike many DOJ settlement agreements, this settlement agreement does not contain a provision where the defendant denies the government’s allegations. To the contrary, Paragraph F of the agreement bars Dr. Lee from making “any public statement denying, directly or indirectly, any of the Covered Conduct or creating the impression that the Covered Conduct is without factual basis.” This language recently has become standard in District of Massachusetts False Claims Act settlement agreements and should put an end to the practice by some defendants (e.g., Biogen) of paying large settlements and then claiming that the government’s allegations lack basis. As Jacob Elberg, a professor at Seton Hall Law School noted in a recent law review article, such post-settlement denials undermine the deterrent effect of DOJ’s enforcement actions, “threaten the perceived legitimacy of the FCA enforcement system,” and “fuel a cost-of-doing-business narrative in which health care entities are required periodically to pay inconsequential settlements to the government regardless of their conduct.” Settlements like the one with Dr. Lee send a message that, at least in the District of Massachusetts, a defendant cannot agree to pay a large sum to the government and then claim that, notwithstanding the magnitude of the settlement and the severity of the alleged misconduct, the enforcement action lacked legitimacy.