Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
On May 3, 2023, the Seventh Circuit Court of Appeals, in Astellas US Holding Inc. v. Federal Insurance Co., held that a liability insurer was required to contribute its limits toward its insured’s payment to settle potential...more
The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases. The Justice Department is executing on that promise and doing so with great success. Week after week, we read about...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
In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
The 1Malaysia Development Berhad scandal (“1MDB scandal”) has been making headlines for the past few years. The turning point for US prosecutors was the cooperation of Malaysian law enforcement and the corruption allegations...more
Well, add another pharmaceutical company to the FCPA healthcare “sweep.” Frankly, the term “sweep” makes it sound like a coordinated enforcement effort – instead, it is more accurate to think of it as multiple prosecutions...more
The Justice Department added to its roster of criminal FCPA defendants. Going back to 2017, it is clear that the Yates Memorandum requirements have resulted in an increase in criminal FCPA prosecutions....more
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more
The D.C. Circuit held oral arguments on April 12, 2016 in the case PHH Corp v. Consumer Financial Protection Bureau (CFPB), a case challenging the CFPB’s constitutionality as well as its interpretations of the Real Estate...more
Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more
The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more
Can the sleaze get any worse with the maker of a dirty medical device that investigators say sickened dozens and played a role in killing 21? Sadly, it can. Federal prosecutors say that the maker of a flexible scope used in...more
On Aug. 12, 2015, Vincente Garcia (former head of Latin American sales for SAP International Inc.) pled guilty in federal court in San Francisco to violations of the Foreign Corrupt Practices Act. In addition to pleading...more
On August 5, 2015, PHH Corp. (“PHH”) won a stay of the $109M penalty handed down by Consumer Financial Protection Bureau (“CFPB”) director Rich Cordray. Cordray’s aggressive legal reasoning and the harsh penalties he imposed,...more
In a decision asserting broad authority for the CFPB and which is certain to set the tone for future CFPB appellate rulings, Bureau director Richard Cordray recently issued the Bureau’s first decision from an appeal of a...more
In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments in the past month with links to primary...more
The Brazilian corruption scandal took a new turn last week, when the Brazilian government announced that it was investigating the country’s health ministry and the state-owned bank Caixa Econômica Federal (Caixa). As reported...more
Earlier this month, a federal judge in New Jersey held that a secretly recorded conversation between a former chief executive officer and his general counsel may be used by prosecutors as evidence against the former executive...more