INTERPOL Red Notices - do they expire?
The Legal Tightrope: Surviving Parallel Investigations
The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
Should you try to remove an INTERPOL Red Notice yourself?
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'
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
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
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more
I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
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
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
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more
Key Takeaways: ..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012. ..Individuals face criminal liability for misrepresentations made to FDA. ...more
The U.S. Department of Justice’s (DOJ) Consumer Protection Branch works with other branches and federal law enforcement agencies to investigate and prosecute civil and criminal violations of the nation’s consumer protection...more
In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more
DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more
Denver jury acquits DaVita, former CEO, of all charges in antitrust trial - After two days of deliberations, a Denver jury found DaVita and former CEO Kent Thiry not guilty of all charges relating to charges they...more
What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more
Report on Research Compliance 19, no. 4 (April, 2022) - A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more
21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more
The U.S. Food and Drug Administration (FDA) is investigating companies that produce and sell poppy seeds due to growing concerns over contamination with a controlled substance. In doing so, it is collaborating with the Drug...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more
In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...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
In what may be the beginning of a wave of enforcement actions, the Justice Department charged an organization and its leadership with dual healthcare and securities fraud charges. The prosecution underscores the risks facing...more
J.Crew filed for bankruptcy protection; the company’s lenders have agreed to “convert $1.65 billion . . . into equity.” Neiman Marcus Group Inc. and J.C. Penney are also on the bankruptcy path, already entering talks with...more