On August 9, 2010, the District Court for the Middle District of Tennessee in Smith v. C.R. Bard, Inc., Civil Action Number 3-09-0139, dismissed a claim alleging wrongful discharge in retaliation for actions taken in furtherance of an FCA claim, holding that plaintiff had failed to show that his actions were "sufficiently connected to exposing fraud or false claims against the federal government."
Plaintiff Michael Smith, a former sales representative for pharmaceutical manufacturer C.R. Bard, Inc., brought claims under the FCA alleging that he had been wrongfully discharged in retaliation for his efforts to bring to light his employer’s alleged practice of marketing its product Tegress, a synthetic injectable therapy approved for treatment of incontinence in women, for off-label use. Smith claimed that his employer was engaged in marketing Tegress for use by men, though the FDA had only approved it for use by women. Following a 2008 compliance training where Smith learned for the first time that sales representatives might face individual criminal liability for marketing drugs for off-label use, Smith allegedly raised the issue with his supervisor and with C.R. Bard’s president. Smith specifically explained that the reason for his concern over the off-label promotion was the risk of personal liability and his "concern… as a shareholder" of C.R. Bard.
Under the FCA, an employee who has been fired because of acts taken "in furtherance of" an FCA claim may bring an action for retaliatory discharge. The District Court held that Smith had failed to establish a claim for retaliatory discharge under the FCA because Smith’s reason for raising his concerns regarding off-label marketing of Tegress "was based on his concern over possible personal liability, not exposing fraud." The court also concluded that Smith had failed to establish that he had any objective basis to believe that his employer had defrauded the government because he "failed to identify any doctors who prescribed Tegress off-label because of any promotion by a Bard" sales representative.