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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; NC AG

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,

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

Tagged in: Defective Products, Medical Devices and DME,

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

Tagged in: FCA Federal, Medical Billing Fraud, Medical Devices and DME, Whistleblower Case, Whistleblower Rewards,

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

Tagged in: Chiropractic, FCA Federal, Healthcare Fraud, Medical Billing Fraud, Medical Devices and DME, Medicare, Provider Fraud,

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

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Lack of Medical Necessity, Medical Devices and DME, Medicare,

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

Tagged in: Medical Devices and DME, Misrepresentations,

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

Tagged in: Defective Products, Healthcare Fraud, Medical Devices and DME,

January 15, 2020

ResMed Corp. has agreed to pay $37.5 million to resolve five whistleblower-brought lawsuits alleging that the durable medical equipment (DME) manufacturer paid illegal kickbacks to suppliers, sleep labs, and other health providers, in violation of the Anti-Kickback Statute and False Claims Act.  $6.2 million of the settlement will be split amongst the whistleblowers, who had revealed that ResMed improperly provided or helped provide free or below cost call center services, patient outreach services, medical equipment and installation, and interest-free loans, in exchange for business.  DOJ; USAO EDNY; USAO NC; USAO NDIA; USAO SC; USAO SDCA

Tagged in: Anti-Kickback and Stark, FCA Federal, Healthcare Fraud, Medicaid, Medical Devices and DME, Medicare, Other Government Health Programs, Whistleblower Case, Whistleblower Rewards,

January 15, 2020

TMJ & Orofacial Pain Treatment Centers of Wisconsin has agreed to pay $1 million to settle a qui tam suit alleging submissions of false claims to Medicare and TRICARE.  According to the anonymous whistleblower, who will receive an undisclosed share of the settlement, TMJ billed the government health programs for prosthetic devices as if they had been fabricated by in-house surgeons, when in fact they had been fabricated by an outside laboratory.  USAO EDWI

Tagged in: FCA Federal, Healthcare Fraud, Medical Billing Fraud, Medical Devices and DME, Medicare, Other Government Health Programs, Provider Fraud, Upcoding, Whistleblower Case,

November 7, 2019

Medical device manufacturer Life Spine Inc. has agreed to pay $5.5 million to settle fraud allegations stemming from a qui tam suit, with founder and CEO Michael Butler agreeing pay another $375,000, and VP of business development Richard Greiber agreeing to pay another $115,000.  As part of the settlement, the defendants admitted to paying kickbacks to surgeons and entities between 2012 and 2018 in exchange for their use of Life Spine’s spinal implants, devices, and equipment.  USAO SDNY

Tagged in: Anti-Kickback and Stark, Healthcare Fraud, Medicaid, Medical Devices and DME, Medicare, Whistleblower Case,

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