On October 14, 2020, the DOJ announced that it had finalized settlement negotiations with Merit Medical over allegations that Merit provided illegal payments to physicians in order to induce those providers to use Merit products. Under the guise of an internal program known as the “Local Advertising Program,” Merit allegedly provided remuneration to healthcare providers in the form of millions of dollars in free advertising assistance, practice development, practice support, and unrestricted “educational” grants to induce healthcare providers to purchase a wide variety of Merit products.

Despite publicly claiming that its financial assistance was designed to “increase the awareness” of medical treatments, Merit allegedly provided assistance only to select healthcare providers as a reward for past sales, to induce future sales, and to steer business to Merit and away from competitors. As part of the settlement agreement, Merit was required to enter into a 5-year CIA.  The CIA requires Merit to hire a compliance expert and an independent review organization (at Merit’s expense) to analyze the company’s compliance systems and transactions.

Related links are available at: DOJ Press Release; Press Coverage; CIA Agreement.

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Photo of Josh Levy Josh Levy

Joshua Levy is co-chair of the global Litigation and Enforcement practice group at Ropes & Gray LLP. He focuses on white collar defense and related complex civil litigation, particularly in the health care, pharmaceutical, medical device and Health IT industries. In 2019, Joshua…

Joshua Levy is co-chair of the global Litigation and Enforcement practice group at Ropes & Gray LLP. He focuses on white collar defense and related complex civil litigation, particularly in the health care, pharmaceutical, medical device and Health IT industries. In 2019, Joshua was lead counsel for one of the parents charged in the college admissions scandal. In 2018 and 2019, Joshua represented both Pfizer and Alexion in securing favorable False Claims Act settlements involving novel kickback theories relating to Patient Assistance Programs. In 2017, Joshua led a team that secured a $40 million criminal and civil global resolution with DOJ, FDA, OIG and the SEC, which included criminal misbranding and HIPAA charges. In 2016, Mr. Levy secured a complete acquittal after a three-week trial in federal court of a real estate developer and he was named as one of the Lawyers of the Year by Massachusetts Lawyers Weekly. In 2016, Joshua also led teams that secured the first DOJ declination under the FCPA Pilot Program and won a significant False Claims Act case dismissal in the First Circuit Court of Appeals.