Using the False Claims Act to Combat Clinical Trial Fraud
In December 2021, Deputy Assistant Attorney General Arun G. Rao highlighted some of recent enforcement priorities of the Department of Justice (“DOJ”), including COVID fraud, including PPP loan fraud, overprescribing opioids, and clinical trial fraud, all matters which whistleblowers can raise utilizing the False Claims Act and a whistleblower law firm.
A top priority of the DOJ is addressing deceptive practices related to COVID-19. Opportunistic bad actors have taken advantage of the pandemic by selling fake and unapproved treatment and cures. Notably, the DOJ is pursuing injunctive relief and damages against a widespread online marketing scheme peddling Vitamin D-3 and zinc products as COVID treatments. Furthermore, various pharmaceutical companies are under investigation for manufacturing and distributing adulterated or misbranded COVID-related products.
PPP loan fraud still seems to echo throughout the country with the government just starting to catch up on the extent which is tens of billions of dollars. PPP loan fraud occurs in multiple ways but the most common grifts are inflating head count, falsifying total payroll, or just outright fabricating companies. The government relies on whistleblowers invoking the False Claims Act through a qui tam law firm to recoup the taxpayers money incentivizing insiders with up to 30% of what the government recovers as a whistleblower award – with tens of billions of dollars in projected fraud that’s billions of dollars in play for whistleblowers.
The DOJ continues to pursue civil and criminal actions against entities responsible for the opioid epidemic, which has led to over 100,000 overdose deaths in the 12-month period ending April 2021. Targets for investigation and prosecution include manufacturers, distributors, pharmacies, doctors, and pharmacists. Recent prominent defendants include Walmart, Inc., which was accused of violating the Controlled Substances Act, and Purdue Pharma LP, which admitted to violations of laws including the Anti-Kickback Statute.
Clinical trial fraud has also received substantial DOJ attention due to the substantial risks that fabricated studies, and the subsequent release of unsafe drugs, could pose to the public and the cost to the government. Five individuals affiliated with Unlimited Medical Research in Florida were indicted after fabricating data during the safety and efficacy investigations of an asthma medication for children. In another Florida case, eight individuals affiliated with Tellus Clinical Research were charged in connection with creating fictitious clinical trial participants and medical records for studies involving various medical conditions.
The Department of Health and Human Services defines “fraud and research misconduct” as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” Omitting data such that the research is not accurately represented is classified as a form of falsification. Furthermore, the Food and Drug Administration requires those submitting clinical studies to make financial disclosures to eliminate bias and other conflicts of interest.
Whistleblowers with knowledge of fraudulent COVID marketing, unnecessary or kickback-induced opioid prescriptions, or clinical trial fraud can help by retaining whistleblower counsel and filing a lawsuit under the False Claims Act (“FCA”). The DOJ has collected more than $5.6 billion in fiscal year 2021 from FCA lawsuits. Whistleblowers may receive up to 30% of the government’s recovery. If you have information regarding PPP loan fraud, overbilling the federal government, clinical trial fraud, kickbacks or any other systemic fraud against the government, contact some of the best whistleblower attorneys led by a former FBI special agent and legal advisor for a free confidential consultation at 877-561-0000 or by emailing firstname.lastname@example.org
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