Archive

March 23, 2021

Medical device manufacturer Boston Scientific Corporation has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve allegations concerning its transvaginal surgical mesh, which were found to be deceptively marketed in violation of consumer protection laws and allegedly caused serious complications for thousands of women nationwide.  As part of the settlement, Boston Scientific also agreed to implement various marketing, training, and clinical trial reforms.  Similar settlements were previously reached with other medical device manufacturers, including Johnson & Johnson, which paid $116.9 million in 2019, and C.R. Bard, which paid $60 million in 2020.  CA AG; FL AG; NY AG

March 16, 2021

Jack Lee Stapleton and Jack Hunter Stapleton, the former owners of a Florida-based telemarketing company known as CV McDowell LLC or J&J Tel Marketing LLC (the Stapleton Entities), have agreed to pay at least $4 million to resolve a qui tam case by a former employee alleging violations of the False Claims Act.  According to whistleblower Dwayne Thornton, the Stapletons solicited prospective patients through telemarketing calls, convinced them to accept compounded drugs regardless of need, and then procured prescriptions and sent them to compounding pharmacies that agreed to pay the Stapletons half of all TRICARE reimbursements.  USAO MDFL

March 2, 2021

Medical practice Allergy and Asthma Associates Inc., in Roanoke, Virginia, will pay $2.1 million to resolve allegations that it fraudulently billed Medicare and Medicaid for asthma treatments.  AAA treated patients with Xolair, an asthma treatment sold in single-use vials, and billed government healthcare programs for the entire vial when, in fact, they were splitting vials between different patients.  USAO WDVA

February 9, 2021

India-based cancer drug manufacturer Fresenius Kabi Oncology Limited (FKOL) has agreed to pay $50 million in fines and forfeiture for failing to provide certain records to FDA investigators.  In violation of the Federal Food, Drug and Cosmetic Act, which helps ensure the purity and potency of drugs sold in the United States, FKOL actively obstructed a 2013 FDA inspection of one of its plants by removing and deleting manufacturing records.  As part of the settlement, FKOL has also agreed to implement a compliance and ethics program to prevent, detect, and correct any further violations of U.S. laws.  DOJ; USAO NV

February 2, 2021

The owner of Mississippi-based Medworx Compounding and Custom Care Pharmacy, Marco Bisa Hawkins Moran, has been sentenced to ten years in prison and ordered to pay $34.3 million in fines and restitution following his guilty plea on charges related to a conspiracy to defraud TRICARE and other healthcare programs.  As part of the scheme, which resulted in the submission of $22.1 million in fraudulent claims, Moran and his co-conspirators adjusted prescription formulas to ensure the highest reimbursement, paid marketers and physicians kickbacks and bribes to obtain prescriptions for high-yield compounded medications without regard to medical necessity, and routinely waived and/or reduced the collection of copayments. USAO SD MS

January 15, 2021

The co-owner of multiple compounding pharmacies and pharmaceutical distributors in Mississippi has been sentenced to 18 years in prison and ordered to pay over $287 million in restitution and over $56 million in forfeiture after pleading guilty to healthcare fraud and money laundering.  As part of his guilty plea, Wade Ashley Walters admitted to being the mastermind behind a four-year scheme that defrauded TRICARE and private health benefit programs of over $287 million.  To perpetuate the fraud, Walters and his co-conspirators solicited and paid recruiters to procure prescriptions for highly reimbursed compounded medications, solicited and paid physicians to authorize prescriptions for same, adjusted prescription formulas to ensure the highest reimbursement possible, and improperly waived or reduced mandatory beneficiary copayments.  USAO SDMS

December 17, 2020

Pharmaceutical company Biogen Inc. agreed to pay $22 million, and specialty pharmacy Advanced Care Scripts agreed to pay $1.4 million, to resolve claims that they conspired to use two foundations, the Chronic Disease Fund and The Assistance Fund, as conduits to pay Medicare co-payments for patients taking Biogen’s MS drugs, Avonex and Tysabri, in violation of the Anti-Kickback Statute.  The government alleged that Biogen coordinated with ACS to time its payments to the foundations and direct its money to cover co-pay costs for patients using its drugs.  DOJ; USAO MA

November 2, 2020

Hospital system Memorial Health Services will pay a total of $31.5 million after self-disclosing that it overcharged California’s Medicaid program, Medi-Cal, for outpatient prescription drug reimbursements under the 340B Drug Pricing Program.  Memorial Health billed Medi-Cal for outpatient drugs at its usual and customary rate, rather than the lower “actual acquisition costs,” as required under the 340B Drug Pricing Program. California will receive $18.9 million of the settlement, and the federal government will receive $12.6 million.  Cal; CD Cal

October 21, 2020

Purdue Pharma LP agreed to criminal fines and forfeitures totaling $5.544 billion following its guilty plea on charges arising from its manufacture and sale of opioid products.  Purdue falsely represented to the DEA that they maintained an effective anti-diversion program while continuing to market opioid products to healthcare providers that it had reason to believe were diverting opioids, aided and abetted the dispensing of opioids without a legitimate medical purpose, paid doctors to induce them to prescribe Purdue’s products, and paid an EHR company to boost the presence of Purdue’s products on the EHR system.  Purdue will receive a credit of up to $1.775 billion based on its prior settlements with state and local entities.  In addition to the criminal fines and forfeitures, a civil settlement provides the U.S. with an allowed claim of $2.8 billion to resolve claims that the company caused the submission of false claims to federal healthcare programs.  Individual members of the Sackler family, which owns Purdue, separately agreed to pay $225  million to resolve claims arising from their approval of a marketing program aimed at extreme high-volume prescribers and their transfer of assets into Sackler family holding companies and trusts.   DOJ

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