On September 26, 2022, Biogen Inc. agreed to pay $900 million to the United States and various states to settle a False Claims Act (FCA) lawsuit. This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in …
In a recent JAMA editorial (unfortunately behind a paywall), three authors called for increased use of the Park Responsible Corporate Officer doctrine, under which senior level officials at a company can be held liable under a strict liability theory even if they were not involved …
In a speech last week, Deputy Attorney General Lisa Monaco touched on a number of topics that should interest readers of this blog. First, although the topic of her speech was corporate criminal enforcement, DAG Monaco stressed that DOJ’s “number one priority is individual accountability.” …
Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. That impression was corroborated this week at the GMP by the …
On June 8, 2022, the U.S. Attorney’s Office for the Western District of Virginia, announced that Sovah Health (“Sovah”), a two-campus health system in Danville and Martinsville in southern Virginia, had entered into a non-prosecution agreement (“NPA”) and $4.36 million civil settlement due in large …
Legal doctrines can be like parrots. Sometimes it is hard to know if they are dead or just resting. Under the False Claims Act (FCA), if a company’s fraudulent conduct induces a governmental entity to enter into a contract with the company, then any claims for …
While the Jackson 5 hit “ABC” predates even these rapidly aging bloggers (first performed on Dick Clark’s American Bandstand in 1970, and we challenge you to name all five members of the Jackson 5, we tap out after Michael, Tito, and Jermaine), its basic wisdom …
Things are getting hectic for those of us who advise clients on FDA inspections: FDA is busy addressing its backlog of foreign and domestic inspections. As COVID raged, FDA understandably postponed many GMP (Good Manufacturing Practice) and “Bi-Mo” (Bioresearch Monitoring, usually of sponsors of clinical trials …
With our second OPDP enforcement letter of 2022, FDA is making one thing clear: OPDP will find your promotional content—even when it may not look like promotional content. While it’s not mind-blowing that OPDP would find a series of videos while scrolling Instagram (particularly when …
Well, OPDP is kicking off 2022 in a big way – taking on an Eli Lilly Instagram post with video for Trulicity. This is the second time in a little over a month that Eli Lilly has found itself caught in OPDP’s cross-hairs. On the …
The Justice Department’s Prescription Interdiction and Litigation (PIL) task force strikes again? Not quite yet, but maybe soon, as explained below. The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. …
We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock, it took more than “two” to get this Emgality DTC TV …
“EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s …
Nothing says “happy holidays” quite like the issuance of Federal Trade Commission (FTC) orders – essentially, subpoenas – to large retailers, wholesalers and suppliers of food, cosmetics, personal care and OTC products, among other things, during the supply chain’s busiest time of the year. Antitrust …
Hyman, Phelps & McNamara, P.C.’s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. As we move out of the COVID-19 …
