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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...

Tagged in: Defendants, Healthcare Fraud, Importance of Whistleblowers, Lack of Medical Necessity, Off-Label and Unapproved Use, Pharma Fraud, Question of the Week, Whistleblower Case,

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

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...

Tagged in: Pharma Fraud, Question of the Week,

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...

Tagged in: FCA Federal, Government Programs Fraud, Healthcare Fraud, Housing and Mortgage Fraud, Pharma Fraud,

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...

Tagged in: Anti-Kickback and Stark, FDA Fraud, Healthcare Fraud, Medicaid, Medicare, Other Government Health Programs, Pharma Fraud, Provider Fraud,

New York Introduces Bills to Expand Whistleblower Protections

Posted 06/21/19

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...

Tagged in: FCA State, Healthcare Fraud, Importance of Whistleblowers, Pharma Fraud, Retaliation, Whistleblower Eligibility, Whistleblower Protection Laws,

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

Posted 06/14/19

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...

Tagged in: Catch of the Week, FCA Federal, FDA Fraud, Medical Devices and DME, Whistleblower Case,

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

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...

Tagged in: Healthcare Fraud, Pharma Fraud, Question of the Week,

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

Posted 05/10/19

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...

Tagged in: Anti-Kickback and Stark, Criminal Proceedings, Defendants, Dosage Fraud, Healthcare Fraud, Lack of Medical Necessity, Off-Label and Unapproved Use, Pharma Fraud, Question of the Week,

Ohio Seeks to Recover Overcharges from OptumRx

Posted 02/21/19

After a 2018 investigation by the Ohio Bureau of Workers Compensation (BWC) of its prescription drug spending, the BWC pharmacy program manager, John Hanna, concluded that "we were being hosed." The BWC had contracted with OptumRx to act as a pharmacy benefits manager (PBM). PBMs act as middlemen between drugmakers, pharmacies, and payors such as worker's compensation programs, Medicaid, Medicare, and other...

Tagged in: FCA State, Medicaid, Other Government Health Programs, Pharma Fraud,

Catch of the Week – Justice Department Sues Tennessee Pharmacies and Pharmacists Illegally Dispensing Opioids

Posted 02/11/19

Stethoscope with computer tablet saying "Opiod epidemic"

On Friday, the Justice Department announced that it has sued several pharmacies and pharmacists in Tennessee to stop them from illegally dispensing opioids. According to the complaint, both defendants have “fueled and profited from” the opioid epidemic by “repeatedly dispensing opioids and other controlled substances prone to abuse without a legitimate medical purpose and outside the usual course of professional...

Tagged in: Catch of the Week, FCA Federal, Healthcare Fraud, Pharma Fraud,

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

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

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

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

New York Introduces Bills to Expand Whistleblower Protections

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

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

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

Ohio Seeks to Recover Overcharges from OptumRx

Catch of the Week – Justice Department Sues Tennessee Pharmacies and Pharmacists Illegally Dispensing Opioids

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