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Pharma Fraud

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New York Introduces Bills to Expand Whistleblower Protections

Posted  06/21/19
statute of liberty New York symbol
Under current law, whistleblowers who reported fraudulent activity in the government or other settings in the State of New York are typically barred from bringing other legal actions. Maybe not anymore. Last week, both the New York State Senate and Assembly signed off on a series of amendments aimed at providing greater protection for employees who notice and report illegal activity, and expanding the definition of a...

June 5, 2019

Opioid manufacturer Insys Therapeutics will pay $225 million to resolve federal criminal and civil claims against it regarding the unlawful marketing of its drug Subsys, including the payment of kickbacks to providers through sham "speaker programs" that rewarded practitioners who increased their Subsys prescribing, as well as jobs for prescribers' relatives and friends, and lavish meals and entertainment.  $195 million of the settlement will be paid to resolve False Claim Act allegations in five separate whistleblower lawsuits in which the government intervened in 2018; the whistleblower reward shares have not yet been determined.  To resolve the criminal claims, Insys will pay $2 million and forfeit $28 million; its operating subsidiary will plead guilty to wire fraud and related charges.  In addition, Insys entered into a five-year Corporate Integrity Agreement and a five-year deferred prosecution agreement. Previously, five former Insys executives were convicted of racketeering in connection with Subsys marketing.  DOJ; USAO Mass

May 31, 2019

Generic drug maker Heritage Pharmaceuticals, Inc. has entered into a deferred prosecution agreement for criminal antitrust charges, admitting that it conspired to fix prices, rig bids, and allocate customers for the diabetes drug glyburide.  Heritage will pay a $225,000 criminal penalty and has agreed to cooperate in ongoing antitrust investigations.  In addition, Heritage will pay $7.1 million to resolve allegations under the False Claims Act that the company paid and received unlawful remuneration under the Anti-Kickback Statute through its arrangements with other generic drug makers regarding prices, supply, and allocation of customers for drugs including glyburide, hydralazine, and theophylline.  DOJ; USAO ED Pa

May 29, 2019

Almirall, LLC, f/k/a Aqua Pharmaceuticals, LLC , will pay $3.5 million to settle kickback allegations exposed by a former Aqua sales representative.  According to the whistleblower, the pharmaceutical company paid kickbacks in the form of free meals, trips, gift cards, and gifts, to dermatology providers in exchange for prescriptions of their drugs to Medicare and TRICARE patients.  It also paid kickbacks by compensating healthcare providers for speaking engagements and consulting services. For coming forward with details of the fraud, the unnamed whistleblower will receive a $735,000 share of the recovery.  USAO EDPA

May 29, 2019

A doctor in South Carolina has agreed to pay $92,506.30 to settle allegations of accepting illegal payments from OK Compounding, LLC, in exchange for prescribing their pain creams to TRICARE patients.  The False Claims Act violations allegedly occurred between February and May 2013, and involved “medical director fees” paid to Dr. Jerry Back that were in reality, kickbacks.  This was the eighth kickback settlement in the Northern District of Oklahoma since the beginning of the year.  USAO NDOK

Question of the Week — Should institutions return past donations from Big Pharma executives and their family members implicated in the opioid crisis?

Posted  05/23/19
Money with Pills Spilled Over
The New York Times recently reported that the Metropolitan Museum of Art has decided to stop accepting gifts from members of the Sackler family linked to Purdue Pharma, the maker of OxyContin, one of the drugs at the center of the opioid epidemic that has killed more than 200,000 Americans in the past two decades. The Met’s decision follows that of other museums and universities, including the Tate Modern, the...

Question of the Week — Should the CEO Be Held Accountable?: Lessons from the Insys verdict.

Posted  05/10/19
By Jessica T. Moore
Handcuffed business-leader walking through jail.
In a shocking first, a federal jury has convicted an opioid-company CEO and other top executives of a criminal racketeering conspiracy. Insys founder and chairman John Kapoor and four other executives bribed doctors to overprescribe a highly addictive fentanyl painkiller, and ran a phony call-center to defraud insurance companies into paying for the expensive drug. Although the company itself had already paid over...

May 2, 2019

Insys Therapeutics executives were convicted for their part in a racketeering conspiracy where they defrauded Medicare and private insurance carriers. From May 2012 to December 2015, the defendants bribed medical practitioners to prescribe Subsys, an extremely addictive sublingual fentayl spray intended for use by cancer patients. In furtherance of these efforts, the defendants provided kickbacks to practitioners who increased their Subsys prescriptions. The defendants also defrauded health insurance providers who were hesitant to approve payment for the drug when it was prescribed for non-cancer patients. DOJ

April 30, 2019

Pharma company US WorldMeds LLC has agreed to pay $17.5 million and enter into a corporate integrity agreement to resolve allegations that it improperly induced the use of its drugs Apokyn, used to treat Parkinson's, and Myobloc.  The company was alleged to have improperly used a foundation to pay Apokyn copayments for Medicare beneficiaries, knowing that it was the only donor to the foundation’s Parkinson’s Disease fund and that virtually all of the fund’s donations were spent on Medicare Apokyn patients.  In addition, the company was alleged to have paid kickbacks to physicians, including excessive speaking and consulting fees, to induce them to prescribe Apokyn and Myobloc. The litigation was initiated under the False Claims Act by whistleblowers, who will receive $3.15 million of the settlement.  DOJ; USAO Conn

April 25, 2019

Pharma company Amgen Inc. has agreed to pay $24.75 million and enter into a corporate integrity agreement to resolve allegations that its use of purportedly independent foundations to pay copayments on its drugs Sensipar and Kyprolis for Medicare beneficiaries violated the False Claims Act.  Amgen's "donations" were not bona fide, but were, by design, intended to benefit only patients of its own drugs, thereby constituting an unlawful kickback designed to generate revenue for Amgen.  With respect to Kyprolis, Amgen's donation to the fund was expressly tied to the anticipated amount required to fund Kyprolis copayments.    DOJ; USAO Mass
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