News & Analysis as of

Pharmaceutical Industry Criminal Prosecution

Mintz - Health Care Viewpoints

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the...

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

Lathrop GPM on

The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

Mintz - Health Care Viewpoints

A First-of-its-Kind Telemedicine Criminal Prosecution: Key Takeaways

The indictment, arrest, and arraignment of Ruthia He, the founder, CEO, and clinical president of Done Global (Done), and David Brody, clinical president of Done and the sole shareholder of Done Health, P.C. (PC) in...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Estlund Law, P.A.

Switzerland: INTERPOL’s Operation Pangea XVI- INTERPOL’s Focus on Fraud (Part 3 of 3)

Estlund Law, P.A. on

The last post in this series explored the pattern of erectile dysfunction drugs being the most seized substance by INTERPOL along with the risks of corruption within the operation. Today’s post will explore the ways in which...more

Estlund Law, P.A.

Mozambique, Australia and Qatar: INTERPOL’s Operation Pangea XVI- Pharmaceuticals, Red Notices, and sex (Part 2 of 3)

Estlund Law, P.A. on

The last post in this series described INTERPOL’s Operation Pangea and how law enforcement from varying countries use INTERPOL’s tools to share information and do cross-border investigations.  Today’s post will discuss the...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - October 2023

WilmerHale on

This marks the second issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

Jones Day on

The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

The Volkov Law Group

DOJ Settles Criminal Antitrust Charges with Teva and Glenmark for $305 Million

The Volkov Law Group on

The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed.  Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more

Oberheiden P.C.

SARMs Enforcement and FDA Escalation

Oberheiden P.C. on

Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

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

Bass, Berry & Sims PLC

Lead Generation Prosecution Reminds Pharmacies of Higher Risk Arrangements

Bass, Berry & Sims PLC on

In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more

Sheppard Mullin Richter & Hampton LLP

2023 Top-of-Mind Issues for Life Sciences Companies

Pharma and Life Sciences Investigations and Prosecutions: The First Two Years of the Biden Administration - With the two-year mark of the Biden presidency looming, the administration’s approach to prosecuting and...more

Oberheiden P.C.

U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals

Oberheiden P.C. on

On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more

Burr & Forman

Eleventh Circuit Affirms Convictions Against Florida Physician, Pharmacist for Violating Anti-Kickback Statute

Burr & Forman on

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

Butler Snow LLP

Criminal Liability of Pharmaceutical Executives Under the Controlled Substances Act

Butler Snow LLP on

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

Robinson+Cole Health Law Diagnosis

Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

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

Goodwin

Northern District of Illinois Grants Motion for Partial Reconsideration of Summary Judgment Decision Regarding Whether Former...

Goodwin on

Northern District of Illinois Grants Motion for Partial Reconsideration of Summary Judgment Decision Regarding Whether Former Walgreens CFO’s Statements Were Actionable; Securities Fraud Claims Against Chicken Producer for...more

The Volkov Law Group

Taro, Sandoz and Apotex Pay $447.2 Million to Settle False Claims Act Liability for Price-Fixing of Generic Drugs

The Volkov Law Group on

The healthcare industry faces cascading risks – one risk flows to another with compounding financial results.  Three generic drug companies just experienced this cascading liability. ...more

Knobbe Martens

Affordable Healthcare Solutions Pleads Guilty to Dealing in Non-FDA Approved Devices

Knobbe Martens on

The United States Department of Justice announced that Affordable Healthcare Solutions, LLC has pleaded guilty and was sentenced to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to...more

Goodwin

JHL Biotech Co-Founders Convicted in Genentech Trade Secret Theft

Goodwin on

Recently, JHL Biotech co-founders Racho Jordanov and Rose Lin pled guilty and were convicted of conspiring to steal trade secrets related to Genentech’s cystic fibrosis drug Pulmozyme, and cancer drugs Rituxan, Herceptin, and...more

The Volkov Law Group

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

The Volkov Law Group on

Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more

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