Drug companies in California and elsewhere conduct clinical trials to determine the efficacy and safety of new therapies. But what happens when a research company enrolls ineligible patients or doesn’t accurately report results?
Clinical research fraud can harm consumers
In early 2022, a clinical research company project manager received a 30-month prison sentence stemming from his involvement in a conspiracy to falsify clinical drug trial data. Several other employees, including the owner of Tellus Clinical Research, were charged with various counts of pharmaceutical fraud, money laundering and making false statements to the Food and Drug Administration (FDA). Drug companies generally engage contract research organizations (CROs) to perform the clinical trials according to the study protocol and FDA regulations. The clinical trials involved drugs for opioid dependency treatment, irritable bowel syndrome, diabetic nephropathy and kidney disease.
Among the ways the CRO falsified the trail information included:
- Enrolling participants without applicable diagnoses, including friends and family members, to increase participation numbers
- Misappropriating personal information from third parties
- Falsifying clinical notes and medical records
- Claiming to have performed exams and blood draws and making payments to participants
The conspiracy allegedly benefitted research company owners and senior management at the expense of falsified information that could have ultimately affected consumers.
Defending whistleblower fraud claims
The U.S. government offers whistleblowers financial incentives to file fraud claims, which can irreparably damage a company’s reputation even if the claim is proven false. Defendants can face serious multi-count indictments that can lead to lengthy and expensive litigation.
If your company or employees are charged with pharmaceutical fraud, an aggressive defense is necessary to fight the charges and help save your reputation. Additional measures like public relations damage control and thorough record-keeping can help mitigate possible fallout from false allegations.