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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:

Page 1 of 13

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,

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...

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

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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,

Catch of the Week – ResMed Pays $37.5 Million to Settle Five Qui Tam Cases Alleging Kickbacks

Posted  01/16/20
Pizza cut into wedges
Sleep apnea equipment manufacturer ResMed agreed to pay $37.5 million to resolve allegations that it violated the False Claims Act and Anti-Kickback Statute by providing unlawful remuneration to durable medical equipment distributors, sleep labs, doctors, and other healthcare providers.  It seems that ResMed’s kickback schemes struck many people as wrong: the settlement resolves five separate cases brought by...

Tagged in: Anti-Kickback and Stark, Catch of the Week, FCA Federal, Healthcare Fraud, Medical Devices and DME, Multiple Whistleblowers and First-to-File, Whistleblower Case,

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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,

Sharp HealthCare — Medicare Fraud/Kickbacks (undisclosed settlement amount)

Three of our whistleblower attorneys represented a whistleblower in a qui tam action under the False Claims Act against Sharp HealthCare, a regional hospital system in San Diego.  Our client alleged that the Sharp Healthcare Center for Research, Sharp’s clinical-trial research arm, fraudulently billed government payers in violation of “secondary payer” rules that prohibit billing the government when other payers will pay for a patient’s care. Our whistleblower client also alleged that Sharp cultivated an illegal kickback scheme to entice prospective trial sponsors to host clinical trials at Sharp by regularly undervaluing Sharp’s costs involved in managing clinical trials.  By offering below-market value incentives and billing government and commercial insurers for injuries, the lawsuit alleged that Sharp sought to increase its attractiveness to trial sponsors. Sharp’s alleged purpose was to burnish the organization’s reputation and offer a lucrative stream of income for Sharp-affiliated physicians involved in clinical trials. Sharp settled the whistleblower’s case for an undisclosed amount.  Read more here.

Tagged in: Anti-Kickback and Stark, FCA Federal, FCA State, Healthcare Fraud, Hospital Fraud, Medicaid, Medical Billing Fraud, Medical Devices and DME, Medicare, Other Government Health Programs, Pharma Fraud, Private Insurance Whistleblower Reward Programs, Provider Fraud, Whistleblower Rewards,

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,

October 28, 2019

Sanford Health, Sanford Medical Center, and Sanford Clinic have agreed to pay $20.25 million and enter into a Corporate Integrity Agreement in order to resolve alleged violations of the Anti-Kickback Statute and False Claims Act.  Despite warnings by several physicians that a top neurosurgeon was illegally profiting off his use of implantable medical devices as well as performing medically unnecessary surgeries involving the devices, Sanford did nothing to stop the offender, allowing Medicare and Medicaid to continue being defrauded.  The allegations were raised by Sanford surgeons Drs. Carl Dustin Bechtold and Bryan Wellman, who will share in a $3.4 million cut of the settlement proceeds.  DOJ; USAO SD

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

October 17, 2019

Johnson & Johnson and its subsidiary, Ethicon, Inc., have agreed to pay $116.9 million to 41 states and the District of Columbia for endangering the health of women nationwide by deceptively marketing transvaginal surgical mesh devices and failing to adequately disclose possible serious complications.  A multistate investigation found that both Johnson & Johnson and Ethicon knew of the risks—including chronic pain and inflammation, fistula formation, incontinence, and mesh extrusion and erosion into the body—yet failed to warn consumers or their physicians.  As part of the settlement, the companies must refrain from falsely describing the mesh as “FDA approved,” as well as provide full disclosure of the device’s risks.  DE AG; PA AG; MI AG; NY AG; SC AG; TX AG

Tagged in: Defective Products, Medical Devices and DME,

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