Medical Devices and DME

March 13, 2019

Following an earlier guilty plea, Waveney Blackman, the owner of Washington, D.C. durable medical equipment company WaveCare Health Services, was sentenced to 3.5 years in prison for her role in submitting nearly $10 million in fraudulent claims to Medicaid for would care products that were not actually purchased and provided.  Blackman was also ordered to forfeit $9.4 million and pay restitution in the same amount.  DOJ; USAO DC

March 11, 2019

Medical device manufacturer Covidien LP will pay $20 million to resolve False Claims Act cases initiated by three whistleblowers alleging that Covidien violated the Anti-Kickback Statute by providing remuneration to healthcare providers in California and Florida.  Covidien markets radiofrequency ablation catheters to providers including vein surgery practices for use in procedures for the treatment of varicose veins and underlying conditions, and allegedly provided its customers with substantial assistance in connection with marketing vein screening and related services in order to increase demand for such services and therefore induce purchases of Covidien's vein ablation products.  Covidien will pay $17.5 million to the United States; $1.5 million to California; and $1 million to Florida.  Two whistleblowers who were sales managers for Covidien, Erin Hayes and Richard Ponder, will share a $3.1 million whistleblower reward.  The settlement also resolves claims by whistleblower Shawnea Howerton, a former employee of one of Covidien's customers.  DOJ; USAO NDCal; FL

January 22, 2019

In an investigation lead by Texas and South Carolina, 46 states and the District of Columbia have entered in to a consent judgment with Johnson & Johnson and its DePuy Orthopaedics unit, resolving claims that the company made misleading claims about the lifespan of two of its metal-on-metal hip implant devices, deceptively marketing and unlawfully promoting the medical devices.  The company will pay $120 million and agreed to specific steps to reform how it markets and promotes its hip implants.  Texas; see also, e.g., NY

December 4, 2018

In connection with fraud involving two medical devices, Covidien and ev3 Inc. have agreed to pay a total of $31 million to resolve allegations of violating the False Claims Act. According to whistleblower and former employee of Covidien, Jeffrey Faatz, sister company ev3 Inc.'s Onyx Liquid Embolic System was only FDA approved for use within the brain, but was allegedly being marketed to surgeons for use outside the brain. Furthermore, ev3 reportedly incentivized its sales representatives to sell the device for unapproved purposes by setting up sales quotas and bonuses, and did so even as FDA officials expressed safety concerns to the company's executives. Separately, Covidien was accused of paying kickbacks to hospitals to induce use of its Solitaire mechanical thrombectomy device, causing false claims to be submitted to Medicare and Medicaid. For blowing the whistle on this case, Faatz will receive a relator's share of $2 million. DOJ; USAO CDCA; USAO SDFL; USAO MA

December 4, 2018

Medical device-maker LivaNova USA, Inc. has agreed to pay $1.87 million to resolve claims that it paid improper kickbacks to physicians who were among the largest referrers of patients for LivaNova's implanted epilepsy device.  The payments took the form of "speaking fees" for the doctors, although the doctors who received them were primarily speaking to their own staffs.  Ashley Case, a former employee of LivaNova, initiated the investigation by filing a case under the False Claims Act; she will receive an unspecified share of the settlement.  USAO NDGA

July 18, 2018

AngioDynamics, a New York-based medical device manufacturer, will pay $12.5M to settle allegations that it caused healthcare providers to submit false claims to Medicare and Medicaid. $11.5M of settlement resolves allegations that the aggressively marketed an unapproved drug delivery device, the LC Bead, with false and misleading statements. The remaining $1M resolved allegations that the company sold a device that was approved to collapse malfunctioning superficial veins to collapse malfunctioning perforator veins, also using false and misleading statements. The LC Bead-related fraud was brought to light by a whistleblower who will receive an award of $2.3M. DOJ

July 5, 2018

North Carolina announced it has settled with Rotech Healthcare Inc., a Florida-based respiratory equipment supplier, over civil allegations that Rotech knowingly submitted false claims for portable oxygen contents to Medicaid and Medicare. The settlement is joined by 22 other states and the federal government. The total settlement is $9.95 million, of which North Carolina will receive $43,671.23. Between 2009 and 2012, Rotech automatically billed Medicaid and Medicare for portable oxygen contents regardless of whether the beneficiaries used or needed portable oxygen and without obtaining the required proof of delivery. Rotech continued this practice despite knowing that it was submitting ineligible claims. NC  The settlement is part of previously-reported settlement with the federal government and other states.  April 12 Federal Settlement. The case was initiated by a whistleblower.