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Medical Device Company CEO Indicted on Securities Fraud Charges

By Josh Levy on December 17, 2020
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On December 15, 2020, the CEO of Decision Diagnostics, Inc. (“DECN”) was indicted by a federal grand jury in connection with an alleged scheme to defraud investors by making false and misleading statements about the purported development of a new COVID-19 test, allegedly leading to millions of dollars in investor losses.

The indictment alleges that Keith Berman falsely claimed to investors that DECN had developed a 15-second test to detect COVID-19 in a finger prick sample of blood, and that the test would be ready by the summer of 2020.  In truth, Berman knew his test was merely an idea and not a validated method of accurately detecting COVID-19, much less an actual product ready for manufacture and sale.   Allegedly, Berman and DECN were in precarious financial condition in the lead up to the pandemic, and Berman wrote in internal emails that he needed a “new story” to “raise millions.”

The indictment further alleges that Berman falsely told investors that the FDA was on the verge of approving DECN’s request for emergency use authorization of its new COVID-19 test.  In truth, Berman knew that the company lacked the financial resources and insurance necessary to conduct the clinical testing required by the FDA to complete the application process.

Related links available at: DOJ Press Release; Indictment; Press Coverage

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.

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  • Posted in:
    Banking, Finance and Securities
  • Blog:
    Life Sciences Securities Litigation
  • Organization:
    Ropes & Gray

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