EIRs/483s

DoJ Preferring Deferred Prosecution Agreements: Attorneys

Two recent medical product cases could be a harbinger of more Department of Justice (DoJ) deferred prosecution agreements (DPAs) as a vehicle to resolve False Claims Act (FCA) suits, according to lawyers from Troutman Pepper. Earlier this year, Pennsylvania-based Jet Medical agreed to a $745,000 DPA to resolve criminal and civil allegations relating to a medical device migraine headache treatment (see earlier story). Last July, a similar resolution was reached by Solera Specialty Pharmacy that was related to a criminal information for one count of health care fraud, the Troutman Pepper attorneys write.

“These two cases may evidence a new approach to corporate criminal enforcement by DoJ,” the attorneys say. "As previously reported in October 2021, the DoJ announced the creation of the Corporate Crime Advisory Group, which was given ‘a broad mandate’ to review criminal enforcement priorities, ensure prosecutors are adequately resourced, and examine ‘the factors bearing on the determination of whether a corporate case should be resolved through a deferred prosecution agreement … .’”

DoJ has also made “voluntary self-disclosure” a key factor in determining how it investigates and resolves misconduct by companies — “a policy that will likely have implications for companies under investigation for potential FCA violations,” they say. “In a February 2023 memorandum, DoJ announced that under its new mandatory guidance, ‘prosecutors should consider whether the criminal conduct at issue came to light as a result of the company’s timely, voluntary self-disclosure and credit such disclosure appropriately.’”

The attorneys warn that because many FCA actions originate from whistleblower lawsuits, companies may be unable to rely on the safe harbor provided under the voluntary disclosure policy. “In fact, the policy specifically excludes ‘situations where disclosure of a company’s misconduct to the [U.S. Attorney’s Office] USAO was made by whistleblowers, including those who have informed the department of fraud and other misconduct in qui tam actions, the write.’”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome