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...
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...
Question of the Week — Should the CEO Be Held Accountable?: Lessons from the Insys verdict.
Posted 05/10/19
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...
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...
Catch of the Week – Justice Department Sues Tennessee Pharmacies and Pharmacists Illegally Dispensing Opioids
Posted 02/11/19
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...
Catch of the Week – Walgreens Pays Record $273 Million To Settle Three FCA Suits
Posted 01/25/19
Three separate qui tam actions brought by whistleblowers against Walgreens Boots Alliance, Inc. (Walgreens) have resolved in what amounts to the largest settlement payouts for a retail pharmacy.
In the first action, two former Walgreens pharmacists alleged that the company sought reimbursement for insulin pens it dispensed to Medicare and Medicaid beneficiaries who did not need them. Walgreens did so in two ways....
When a Gift is Not a Gift: Pharma Companies Use Charities to Increase Drug Profits
Posted 12/13/18
Imagine if at the end of Charles Dickens’ “A Christmas Carol,” Ebenezer Scrooge announced that he was giving the prize turkey to the Cratchit family for Christmas dinner, but that this “gift” was conditional upon Bob Cratchit agreeing to work even longer hours in the new year, the turkey being cooked in a certain way, and only certain family members eating it. Would we consider Scrooge to have been truly...
This week's Department of Justice "Catch of the Week" goes to Actelion Pharmaceuticals US, Inc., a California pharmaceutical company that sells various pulmonary arterial hypertension drugs, including Tracleer, Ventavis, Veletri, and Opsumit. Yesterday, Actelion agreed to pay $360 million to resolve allegations that it violated the Anti-Kickback Statute by indirectly paying drug copays for thousands of Medicare...
Healthcare Fraud: it’s not just Medicare and Medicaid
Posted 10/17/18
Last year, the U.S. Department of Justice recovered $2.4 billion in settlements and judgments involving fraud in the healthcare industry perpetrated against government payors. But government programs like Medicare and Medicaid aren’t the only targets of massive healthcare fraud schemes. A recent Department of Justice press release announced the unsealing of a 32-count indictment containing charges against four...