The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.
The U.S. Department of Justice announced that Keith Berman, formerly the CEO of Los Angeles-based Decision Diagnostics Corp., has received a prison sentence of seven years for misrepresenting the company’s developmental test for the SARS-CoV-2 virus during the height of the COVID-19 pandemic.
With credit card fees taking a sizable bite of their billings, many U.S. health care providers are fighting back by offering patients cash discounts. But when a drug company covers card processing fees for its distributors to pass on to their provider clients so they can pay for so-called “buy-and-bill” Medicare Part B drugs with a credit card at cash prices, it’s fraud if those concessions aren’t figured into the drug’s average sales price – at least that’s what the U.S. Department of Justice is claiming in a complaint it released April 10 against Regeneron Pharmaceuticals Inc.
Kevin Dills, who the U.S. SEC said secretly controlled Oncology Pharma Inc., consented to a final civil judgment in federal district court related to a fraudulent stock-selling scheme.
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences.
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence (AI).
The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory.
The Securities and Exchange Commission (SEC) charged Laura Tyler Perryman, the former CEO and co-founder of Stimwave Technologies Inc., with defrauding investors out of approximately $41 million by making false and misleading statements about one of the company’s products. According to the SEC’s complaint, the Stimwave device comprised several components, one of which was a fake, non-functional component that was implanted into patients’ bodies.
Biotelemetry Inc. and its subsidiary, Lifewatch Services Inc., agreed to pay $14.7 million to settle a whistleblower case alleging overbilling for remote cardiac monitoring. The qui tam case contended that the company’s online portal for its ACT-3L/MCT-3L device and its staff consistently and intentionally forced physicians’ staff to select or themselves selected the most expensive application for the device, despite intent and even written instructions to choose a less expensive service.
Exagen Diagnostics Inc., of Vista, Calif., has agreed to pay slightly more than $653,000 to resolve allegations that it had paid specimen processing fees to physicians to induce those physicians to use Exagen’s lab tests.
