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
Emphasizing its commitment to enforcing the False Claims Act (FCA) and combating health care fraud, the Trump Administration recently instituted a DOJ-HHS False Claims Act Working Group dedicated to “combating health care...more
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
President Trump Puts a “Pause” on FCPA Enforcement - On Monday, President Donald Trump signed an executive order (EO) pausing the enforcement of the Foreign Corrupt Practices Act (FCPA). According to the EO, the pause will...more
On August 1, 2024, the Department of Justice (DOJ) released a 14-page memorandum outlining the Corporate Whistleblower Awards Pilot Program announced earlier this year. Deputy Attorney General Lisa Monaco explained in her...more
On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more
For years, Department of Justice officials have stressed how important chief compliance officers are as the first line of defense in fighting corporate crimes. While that’s true, compliance programs now have a competitor in...more
Introduction: On April 15, 2024, the Department of Justice’s (DOJ) Criminal Division announced a new Pilot Program on Voluntary Self-Disclosure for Individuals. Under this program, individuals who voluntarily disclose certain...more
Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more
The U.S. Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act 2010, along with dozens of trade treaties and conventions, forbid consummated (and attempted) improper or unethical payments to government officials or...more
On July 20, 2022, the Department of Justice announced charges against 36 criminal defendants across 13 different federal districts for healthcare fraud violations resulting in Government losses in excess of $1.2 billion. The...more
Last Monday, the Eleventh Circuit ruled that the Middle District of Florida’s sentence of probation for former physician Nicole Bramwell in a $4.4 million Tricare fraud case was substantively unreasonable. The district...more
Little problems can become big ones. A failure to respond to a risk – whether it is a conflict of interest violation or a weakness in internal controls – can become even more significant depending on the size and scope of...more
On November 24, 2020, the 11th Circuit issued a notable decision in United States v. Shah, 981 F.3d 920 (11th. Cir. 2020), which clarifies whether, in order to obtain a conviction under the federal Anti-Kickback Statute...more
The UK Serious Fraud Office (the “SFO”) has reached a £1.2 million civil recovery settlement with Julio Faerman, a Brazilian national linked to the sprawling “Operation Car Wash” investigation involving the Brazilian...more
I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more
To our bad guys, 2019 was a year flush with hope and opportunity; it ended with recidivism, more misery from Venezuela, a charlatan, an Okie who pulled a multi-million dollar fast-one on Chesapeake and, as in years past, a...more
Last Friday, the Department of Justice (DOJ) secured another trial court conviction in a Foreign Corrupt Practices Act (FCPA) prosecution involving an individual. Following on the heels of the Hoskins guilty verdict, it...more
This week I have been considering the guilty pleas of the former Unaoil Chief Executive Officer (CEO), Cyrus Ahsani, and former Chief Operations Officer (COO), Saman Ahsani, as was laid out in their Information. Most...more
Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million. The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2...more
This week I am mining the guilty pleas of the former Unaoil Chief Executive Officer (CEO), Cyrus Ahsani, and former Chief Operations Officer (COO), Saman Ahsani, for what they might mean for Foreign Corrupt Practices Act...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
Details are trickling in on the tentative Brexit agreement reached between UK and EU negotiators this week, just 14 days ahead of the Halloween departure deadline. A massive sticking point here remains the British...more
Telemedicine permits two-way, real time interactive communication between health professionals and patients. Its recent expansion has dramatically improved patient health by providing new access to health care for rural...more
Precedential Opinions of Note - Court Overturns Narcotics Conviction for Lack of Evidence of Drug Quantity - United States v. Rowe (April 2, 2019), No. 18-1192 - Unanimous decision: Fisher (writing), Smith, and McKee - ...more
Last week, a grand jury in the Southern District of Florida indicted two former Venezuelan officials, charging them with seven counts of money laundering and one count of money-laundering conspiracy. The charges relate to...more