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Medical Devices and DME

This archive displays posts tagged as relevant to medical devices and durable medical equipment. You may also be interested in our pages:

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October 19, 2020

Utah-based medical device manufacturer, Merit Medical Systems Inc., has agreed to pay $18 million to multiple states to settle allegations of paying illegal kickbacks to healthcare providers and causing false claims to be submitted to Medicaid.  In order to induce sales of its embolotherapeutic devices—which are used to treat arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids—Merit allegedly provided doctors, medical practices, and hospitals with millions of dollars in free advertising, educational grants, and practice support.  NC AG

October 14, 2020

Medical device maker Merit Medical Systems Inc. will pay $18 million to resolve claims first brought by a whistleblower under the False Claims Act that the company paid unlawful kickbacks to doctors and hospitals to induce them to use MMSI’s EmboSphere and QuadraSphere devices for embolization procedures.  MMSI was alleged to have offered hospitals and providers with millions of dollars in free advertising assistance, “educational” grants, and other services based on the providers’ past sales and to induce future sales.  The whistleblower, Charles J. Wolf, M.D., who will receive $2.65 million, was the Chief Compliance Officer for the company; according to DOJ, he repeatedly warned MMSI that its practices violated the Anti-Kickback Statue.  DOJ; USAO NJ

Catch of the Week: 345 Charged in $6 Billion National Health Care Fraud and Opioid Takedown

Posted  10/2/20
Paper Ripped Uncovering Medical Necessity Wording
In the largest health care fraud and opioid enforcement action in the Justice Department’s history, 345 defendants—including more than 100 doctors, nurses, and other medical professionals—face charges for submitting over $6 billion in false or fraudulent claims to federal and private insurers.  Defendants stand accused of submitting $4.5 billion in fraudulent claims linked to telemedicine, $845 million...

September 24, 2020

Transvaginal surgical mesh device manufacturer C.R. Bard, Inc. and its parent company, Becton, Dickinson and Company, have agreed to pay $60 million to 48 states and the District of Columbia to resolve allegations of deceptively marketing the devices.  The company’s surgical mesh—which are permanently implanted to hold up falling organs, and which are extremely difficult or impossible to remove—had life-altering side effects that they failed to disclose, including chronic pain, recurring infections, and shrinking tissue.  Although the devices were taken off the market in 2016, under the terms of the settlement, C.R. Bard and Becton, Dickinson and Company are required to adhere to certain injunctive terms if they choose to reenter the market.  The funds received as part of this settlement will be added to a larger restitution fund that was established after settlement of a similar case with Johnson & Johnson in 2019.  CA AG; FL AG; WA AG

September 10, 2020

Shreveport Prosthetics, Inc. will pay $1.6 million to resolve claims in an action brought by the company’s former office administrator, Kimberly Throgmorton, under the qui tam provisions of the False Claims Act.  The company was alleged to have submitted false bills to Medicare by using the supplier number of a different company after its own supplier number was deactivated, and by routinely waiving patient co-payments.  Ms. Throgmorton will receive over $250,000 as a whistleblower reward.  USAO WD LA

August 21, 2020

A Georgia-based chiropractor and her medical practice have been ordered to pay more than $5 million for violating the False Claims Act.  The government alleged that Dr. Jennifer Heller, D.C. caused Medicare to pay $1.4 million more than it would have had it known that hundreds of Heller’s charges for a surgical neurostimulator procedure were in actuality for acupuncture devices, which are not covered by Medicare, and which do not require surgery.  To resolve the charges, Heller Family Medicine, LLC will have to pay $4.3 million, while Heller herself will have to pay $700,000.  USAO SDGA

April 6, 2020

Following a $7.1 million settlement with seven co-defendants in October 2019, a chiropractor in New Jersey who allegedly concocted the scheme to bill Medicare for medically unnecessary injections and knee braces has agreed to pay $2 million to resolve his liability.  A critical analysis of Medicare claims data revealed that while treating for osteoarthritis, David Podell caused his clinic and seven Osteo Relief Institutes to bill Medicare for viscosupplementation injections—gel-like fluids injected into the knee that act as lubricant—as well as custom knee braces for beneficiaries who did not need them.  Additionally, the claims for the custom knee braces were tainted by illegal kickbacks that Podell solicited and received from the manufacturer.  DOJ; USAO MN

March 4, 2020

The Massachusetts-based marketers of an electrical nerve stimulation device have settled FTC false advertising charges by agreeing to pay at least $4 million.  In marketing materials for Quell, NeuroMetrix, Inc. and CEO Shai Gozani allegedly described the device as "clinically proven" and "FDA cleared" for chronic pain relief all over the body, despite lacking scientific evidence or actual FDA approval to support such claims.  In addition to a cease and desist order and the $4 million judgment, NeuroMetrix has also been ordered to turn over another $4.5 million in future foreign licensing payments.  FTC

Catch of the Week: Colorado Neurosurgeon and His Three Companies Settle Spinal Implant Kickback Claims for $2.35M

Posted  02/14/20
skeleton of a spine
This edition of our Catch of the Week series features the successful resolution of a whistleblower suit against neurosurgeon Dr. William Choi and three companies he owned.  The defendants agreed to pay the United States $2.35 million to resolve allegations that, for over five years, Dr. Choi received illegal kickbacks from spinal implant device distributors for devices he used in surgeries. The kickbacks rendered...

January 30, 2020

Johnson & Johnson has been ordered to pay $344 million to the State of California for misrepresenting the safety of its pelvic mesh implants, which were sold from 2008 to 2014 and have resulted in over 35,000 personal injury lawsuits nationwide.  The State of California brought suit in 2016 after finding the company failed to inform patients and their doctors of possible severe complications, including chronic pain and permanent dysfunctional elimination.  Johnson and Johnson previously settled similar allegations with some 40 other states, for $117 million, in October of last year.  CA AG
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