Archive

March 23, 2018

Massachusetts-based medical device manufacturer Alere Inc. agreed to pay $33.2 million to resolve allegations that Alere violated the False Claims Act by causing hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling unreliable point-of-care diagnostic testing devices marketed under the trade name Triage. According to the government, Alere received customer complaints that put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making. Nonetheless, the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Amanda Wu, who formerly worked for Alere as a senior quality control analyst. She will receive a whistleblower award of roughly $5.6 million from the proceeds of the government's recovery. DOJ

March 8, 2018

Massachusett’s-based Abiomed, Inc. agreed to pay $3.1 million to settle claims of violating the False Claims Act and Anti-Kickback Statute by purchasing lavish meals for physicians in order to induce them to use Abiomed’s Impella line of heart pumps. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by a former Abiomed employee. The whistleblower will receive an award of $542,500 from the proceeds of the government’s recovery. DOJ (MA)

January 23, 2018

California medical device company DJO Global Inc. agreed to pay $7.62 million to resolve allegations that its Minnesota subsidiary Empi Inc. submitted false claims to TRICARE for excessive, unnecessary transcutaneous electrical nerve stimulation electrodes that TRICARE beneficiaries did not need or use. TENS is a therapy that uses low-voltage electrical current for pain relief. DOJ

September 20, 2017

New Jersey-based durable medical equipment supplier R&V Medical Supplies LLC and its former owner Victor Saul agreed to pay $220,000 to settle charges of violating the False Claims Act by engaging in a scheme to defraud Medicare by billing for equipment not properly authorized by a physician or not actually provided. DOJ (EDPA)

June 29, 2017

Innovative Therapies, Inc. and its parent company Cardinal Health, Inc. agreed to pay roughly $2.7 million to settle charges they violated the False Claims Act by submitting false claims to Medicare through their marketing of certain negative pressure wound treatment devices as durable medical equipment when they knew these devices did not have the expected life of a durable device.  The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by a former ITI employee.  The whistleblower will receive an award of $488,700 from the proceeds of the government's recovery.  DOJ (MDTN)

June 15, 2017

Magdiel Garcia and the durable medical equipment company he owned, MAK Healthcare PC (d/b/a Multicare Plus), agreed to pay $225,000 to settle claims they violated the False Claims Act and The Stark Law by improperly self-referring Medicare beneficiaries for services and equipment to MAK. DOJ (EDPA)

May 8, 2017

Kansas medical equipment supplier Pos-T-Vac, Inc. agreed to pay $1 million to settle allegations it violated the False Claims Act by charging Medicare for vacuum supplies not medically necessary, lacking documentation of medical necessity, and/or not properly ordered by a physician. DOJ (DKS)

April 25, 2017

Braden Partners, L.P. (d/b/a Pacific Pulmonary Services) agreed to pay $11.4 million to resolve allegations against it and its general partner, Teijin Pharma USA LLC, for violating the False Claims Act by submitting claims for reimbursement to Medicare and other federal healthcare programs for oxygen and related equipment supplied in violation of program rules, and for sleep therapy equipment supplied as part of a cross-referral kickback scheme with sleep clinics. According to the government, Pacific Pulmonary submitted claims to the Medicare, TRICARE and Federal Employee Health Benefits programs for home oxygen and oxygen equipment without obtaining the required physician authorization. The government further charged that certain of the company’s patient care coordinators agreed to make patient referrals to sleep testing clinics in exchange for those clinics’ agreement to refer patients to Pacific Pulmonary for sleep therapy equipment in violation of the Anti-Kickback Act. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Manuel Alcaine, a former sales representative of Pacific Pulmonary. Mr. Alcaine will receive a whistleblower award of roughly $1.8 million from the proceeds of the government's recovery. DOJ

January 12, 2017

Indiana-based manufacturer of orthopedic and dental implant devices Zimmer Biomet Holdings Inc. agreed to pay a $17.4 million criminal penalty in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act involving the company’s operations in Mexico and Brazil. By failing to require appropriate due diligence and documentation and contracts for payments to third parties, Biomet allowed its Mexican subsidiary Biomet 3i Mexico S.A. de C.V. to pay bribes to Mexican customs officials through customs brokers and sub-agents so 3i Mexico could import contraband dental implants into Mexico. Importing those products into Mexico violated Mexican law because they lacked proper registration or labeling. In related proceedings, the company also agreed to pay the SEC disgorgement of $6.5 million including pre-judgment interest and $6.5 million as a civil penalty. DOJ

January 11, 2017

Ireland-based Shire Pharmaceuticals LLC and certain subsidiaries agreed to pay $350 million to settle charges that Shire and the company it acquired in 2011, Advanced BioHealing violated the False Claims Act and Anti-Kickback Statute by using kickbacks and other unlawful methods to induce clinics and physicians to use or overuse their “Dermagraft” skin product. It is the largest False Claims Act recovery in a kickback case involving a medical device, and resolves claims brought by the federal government along with 37 states and the District of Columbia. The States will receive $6,104,000 for the State share of the Medicaid program. According to the government, Dermagraft salespersons unlawfully induced clinics and physicians with lavish dinners, drinks, entertainment and travel; medical equipment and supplies; unwarranted payments for purported speaking engagements and bogus case studies; and cash, credits and rebates. The allegations originated in six lawsuits filed brought by whistleblowers in, or transferred to, the United States District Court for the Middle District of Florida. Two of the qui tam actions named New York and other states and included allegations that Shire submitted or caused to be submitted false claims to the Medicaid program under federal and state False Claims Acts. The whistleblowers will receive a yet-to-be-determined whistleblower award from the proceeds of the government recovery. Whistleblower Insider, NY, FL