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Pharma Fraud

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Catch of the Week – Mallinckrodt Pays for Kickbacks on Acthar; Investigation into Copayment Subsidies Continues

Posted  09/6/19
This week, the Department of Justice announced that pharmaceutical company Mallinckrodt ARD LLC had agreed to pay over $15 million to resolve allegations that it paid illegal kickbacks to physicians to induce them to prescribe Acthar.

AKS Allegations

Two whistleblower lawsuits brought under the False Claims Act against Mallinckrodt alleged that from 2009 to 2013, the pharma company, then known as Questcor,...

September 5, 2019

El Paso Integrated Physicians Group, P.A., several physicians in the group, and Accutrack Medical Claims Services, LLC, have agreed to pay $2.93 million to resolve a False Claims Act case filed by whistleblower Sergio Garcia alleging that they double-billed and over-billed government payors for the infusion drug Remicade (Infiximab).  Remicade is sold in single-use vials; defendants were alleged to have pooled Remicade from partially-used vials, diluted Remicade, and illegally imported drugs from Canada and other foreign countries.  USAO WD Tex

September 5, 2019

In yet another enforcement action relating to a nationwide compounding pharmacy fraud scheme involving OK Compounding, Dr. James Womack of Missouri has agreed to pay $471,221 to resolve his liability under the False Claims Act.  Womack allegedly accepting kickbacks disguised as medical director fees in exchange for prescribing medically unnecessary pain creams.  USAO NDOK

September 4, 2019

Pharmaceutical company Mallinckrodt ARD LLC has agreed to pay $15.4 million to settle allegations of violating the Anti-Kickback Statute by “wining and dining” healthcare providers to induce Medicare prescriptions of its drug H.P. Acthar Gel.  The allegations arose from two whistleblowers, who will jointly receive about $2.9 million of the settlement.  DOJ

Question of the Week — Is the use of public nuisance law against J&J for its role in the opioid crisis appropriate?

Posted  08/29/19
The landmark $572M opioid verdict in Oklahoma against Johnson & Johnson stemmed from a single claim: “public nuisance” under state law.  Other cases against opioid manufacturers, including whistleblower cases, involve claims for fraud, unlawful marketing, improper prescriptions, kickbacks, violating the Controlled Substances Act by failing to report suspicious purchases, and even flooding the black market.  But...

Question of the Week — Should Pharmacy Benefit Managers (PBMs) be allowed to deny patients access to essential life-saving drugs prescribed by their doctor?

Posted  08/19/19
pharmacy pills
As described in a recent article in The Fresno Bee, thousands of patients nation-wide have been denied access to essential life-saving medications by pharmacy benefit managers (PBMs) under the guise of ensuring that patients receive the most appropriate and cost-effective treatment. PBMs are the quintessential “middlemen” in the healthcare system, standing between patients and their physicians on one side, and...

Question of the Week — Will Healthcare Settlements Continue to Dominate False Claims Act Recoveries?

Posted  07/24/19
Recent blockbuster settlements continue past trends: healthcare fraud has so far this year dominated FCA recoveries. During the first half of 2019, the Department of Justice (“DOJ”) secured over $750 million in settlements from False Claims Act (“FCA”) cases. And just past the mid-year point, total recoveries have nearly doubled due to a $700 million civil settlement ($1.4 billion total) entered on July 11th...

Question of the Week — Is DOJ’s Blockbuster $1.4 Billion Opioid Settlement Just the Tip of the Iceberg?

Posted  07/12/19
Pill container spilled over with pills fallen out.
On July 11, DOJ announced a record-breaking $1.4 billion settlement with Reckitt Benckiser Group plc (RB Group) over allegations that its former subsidiary Indivior Inc. inflated prescriptions of its opioid-withdrawal drug Suboxone through numerous unestablished representations about the drug’s safety and addictiveness. The settlement resolves RB Group’s potential civil and criminal liability, but Indivior still...

July 11, 2019

Reckitt Benckiser Group plc, which marketed and sold the opioid addiction treatment drug Suboxone until 2014 through its then-subsidiary Indivior Inc., will pay a total of $1.4 billion in a global settlement resolving criminal, civil, and administrative claims.  In marketing Suboxone Film, Indivior allegedly made unsupported claims that the drug was less-divertable and less-abusable than other buprenorphine drugs, and steered patients to doctors known to have a history of over-prescribing Suboxone and other opioids.  In addition, Indivior was alleged to have discontinued its tablet Suboxone for pretextual reasons, claiming a concern for pediatric exposure when, in fact, the company was seeking to delay FDA approval of a generic form of tablet Suboxone.  In a non-prosecution agreement, RB Group will forfeit $647 million in proceeds it received from Indivior, will cooperate with ongoing investigations, and will not manufacture or market controlled substances in the U.S. for three years.  In resolution of civil claims with the U.S. and states, including six lawsuits filed by whistleblowers under the False Claims Act, RB Group will pay $700 million to resolve claims that the marketing of Suboxone caused false claims to be submitted to federal- and state-funded government healthcare programs.  Finally, RB Group has agreed to pay $50 million in a settlement with the Federal Trade Commission to resolve claims that it engaged in unfair competition in seeking to impede generic equivalents of Suboxone.  DOJ; USAO W.D.Va.; FTC; VA; NY; PA
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