The Legal Tightrope: Surviving Parallel Investigations
The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
Navigating Civil Standing Requirements for Defense Success — RICO Report Podcast
INTERPOL Red Notices and Immigration. Can You Obtain Immigration Relief in the U.S. Even with a Red Notice?
INTERPOL and Politically Motivated Red Notices - What We Can Learn from INTERPOL’s Annual Reports.
Episode 333 -- The Boeing Proposed Plea Agreement
The Presumption of Innocence Podcast: Episode 42 - AI in Criminal Justice: Opportunity or Opportunity for Misuse?
The Presumption of Innocence Podcast: Episode 41 - The Dynamics of Decision-Making: Psychology and the Criminal Justice System
INTERPOL and Child Kidnapping Cases. What are INTERPOL’s Abilities and Limitations?
What to do when finding that you are the subject of a RedNotice?
Episode 324 -- Third-Party Risks and Sanctions Compliance
Episode 323 - Carlos Villagran Discusses Rebuilding a Corporate Culture After a Crisis
AGG Talks: Antitrust and White-Collar Crime Roundup Podcast - Episode 9: Exploring the DA’s Proof, Michael Cohen’s Cross-Examination, and Jury Scenarios in Trump’s Election Interference Trial
False Claims Act Insights - Railroaded! How to Approach the Twin Tracks of Parallel Proceedings
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
Three things the CCF won’t do and why.
The Presumption of Innocence Podcast: Episode 35 - A Double-Edged Sword? The DOJ Confronts AI
The Presumption of Innocence Podcast: Episode 34 - A Conversation With Jesse Eisinger, Author of 'The Chickenshit Club: Why the Justice Department Fails to Prosecute Executives'
The Justice Insiders Podcast - Demystifying Sentences for White Collar Crimes: What's Next for SBF
The Presumption of Innocence Podcast: Episode 33 - Framing the Narrative: Journalism's Influence on the Presumption of Innocence
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more
Civil lawsuits are an unavoidable and expected consequence of operating in a heavily regulated industry. While CEOs and other pharmaceutical executives may lose sleep over the outcome of civil trials and the potential...more
On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more
On May 2, 2019, a jury sitting in the District of Massachusetts convicted five senior executives of Insys Therapeutics, Inc. (Insys) with racketeering conspiracy in violation of Title 18, United States Code, Section 1962(d)....more
Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more
Opioid manufacturers, distributors, pharmacies and prescribers are facing a deluge of lawsuits that involve criminal and civil claims in both federal and state courts. On May 2, 2019, a federal jury in Boston, Massachusetts,...more
Congress has activated a new Anti-Kickback law known as Eliminating Kickbacks in Recovery Act of 2018 (commonly referred to as EKRA). The new Anti-Kickback law applies to arrangements involving recovery homes, clinical...more
A recent headline revealed that over 30 doctors, and multiple pharmacists and nurse practitioners in six different states were charged with federal crimes based on allegations of unlawful distribution of controlled substances...more
The national opioid epidemic is almost unprecedented in every conceivable way—its catastrophic death toll, its broad effect on a wide swath of this country’s population, its rapid escalation (which is alleged to have been...more
An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths....more
With the passage of the Eliminating Kickbacks and Recovery Act in October 2018, Congress took aim at the ongoing opioid crisis threatening communities across the U.S. This new criminal statute targets healthcare providers...more
It’s Time to Review Your Compliance, Data and Auditing Plans - As we near the end of 2018, healthcare providers and companies are understandably focused on 2019 and the trends ahead. In planning for next year, however,...more
The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more
Recently, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced its largest ever national health care fraud takedown, resulting in charges against 601 diverse defendants including...more
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel...more
As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more
On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more
On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more
On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more
The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more