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CATCH OF THE WEEK – Avanir Pharmaceuticals

Posted  09/27/19
Our Catch of the Week goes to Avanir Pharmaceuticals, manufacturer of Nuedexta, for allegedly paying kickbacks to physicians and engaging in false and misleading marketing tactics.  Avanir allegedly marketed Nuedexta in long-term care facilities and targeted their sales tactics to encourage doctors to prescribe the drug to dementia patients for off-label uses. The pharma company agreed to pay over $108 million in...

Florida Pharma Whistleblower Case Results in FCA Settlement by Private Equity Firm

Posted  09/27/19
Last week, the government announced that compounding pharmacy Diabetic Care Rx LLC, known as Patient Care America (“PCA”), its executives, and the private equity firm managing the pharmacy Riordan, Lewis & Haden Inc., had agreed to pay over $21 million to settle allegations they violated the False Claims Act (“FCA”) by executing a kickback scheme to generate referrals of TRICARE patients. The allegations...

Question of the Week — Should Drug Companies that Defraud the Government Lose Their Patents?

Posted  09/18/19
Settlements between drug companies and the government are commonplace these days. Just last week the DOJ announced another settlement with a pharmaceutical company, Mallinckrodt, for allegedly paying kickbacks to doctors to induce them to prescribe more of the company’s drug. The company was accused of violating the Anti-Kickback Statute, which generally prohibits medical providers from paying or receiving...

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,...

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...

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...

Catch of the Week — Wound Care Device Manufacturer ACell Inc.

Posted  06/14/19
Nurse Wrapping a Wound on Mans Wrist
Our Catch of the Week goes to ACell Inc., a Maryland-based medical device manufacturer that pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to report that it had partially removed its wound-care product, MicroMatrix, from the market because it was contaminated with endotoxins, placing treated patients in danger of serious infection, even death, without informing the FDA that it...
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