US District Judge Manish S. Shah in the Northern District of Illinois last week denied insurers’ motion to dismiss a pharmaceutical company’s action seeking insurance coverage for the costs associated with responding to a US...more
A recent complaint by the US Department of Justice against private equity firm Riordan, Lewis & Haden signals that such firms could be a new class of defendants in False Claims Act cases. Private equity firms are thus...more
Deputy Attorney General Rod Rosenstein delivered remarks on May 21 at the Mayflower Hotel in Washington, DC, as part of Compliance Week’s 2018 Annual Conference for Risk Professionals. In candid remarks, Mr. Rosenstein...more
The US Department of Justice announced on May 9 a new policy to avoid the imposition of duplicative penalties by multiple authorities in corporate fraud investigations. But, the DOJ’s expectations with respect to compliance...more
Recent statements by top US Department of Justice officials indicate that DOJ may consult the FCPA Corporate Enforcement Policy for guidance outside of the Foreign Corrupt Practices Act context in assessing whether a...more
In a recent memorandum, the US Department of Justice provided guidance to its attorneys on when they should seek dismissal of False Claims Act cases filed by relators. This appears to be the first directive advising DOJ...more
DOJ highlights healthcare, housing and mortgage, and procurement fraud as largest areas of recovery; impending changes under the new tax legislation could limit tax deductions for False Claims Act payments....more
OIG Advisory Opinion paves the way for expanded retailer reward programs.
The US Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion on September 7 that provides important...more
Deputy Attorney General said he anticipates policy changes “in the near future” and suggested emphasis on individual accountability.
The US Department of Justice (DOJ) may soon announce changes to its policies for...more
Acting US Attorney Joel Levin says the new dedicated unit aims to bring “even greater focus, efficiency, and impact to our efforts in this important area.”...more
The Court’s opinion resolves a circuit split concerning the reach of disgorgement orders....more
The US Department of Justice plans to extend its FCPA Pilot Program, an initiative developed to encourage companies to self-report bribery violations and provide extensive cooperation in exchange for reduced penalties,...more
The DOJ Fraud Section’s “Evaluation of Corporate Compliance Programs” puts chief compliance officers on notice about how the adequacy of their companies’ compliance programs is evaluated by prosecutors....more
Government will focus on corruption in sales incentive programs.
Background -
The Chinese government has intensified probes into commercial bribery in the private sector, with a particular focus on sales incentive...more
Supreme Court grants certiorari to clarify whether Section 2462’s five-year limitation period applies to SEC disgorgement claims.
The US Supreme Court granted certiorari to settle a circuit split in the US courts of...more
The Court’s rejection of the condition of payment analysis and adoption of a rigorous materiality standard represents a significant shift in how courts must analyze FCA cases premised on underlying regulatory or contractual...more
6/17/2016
/ Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicare ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
The International Organization for Standardization is developing a certifiable international standard for “anti-bribery management systems” that could influence how the US Department of Justice, US Securities and Exchange...more
The penalties are potentially astronomical for entities with FCA exposure.
In addition to treble damages, the False Claims Act (FCA) provides for mandatory penalties for each false claim submitted “of not less than...more
In qui tam case, Supreme Court oral argument addresses practical implications of limiting the scope of the implied certification theory of liability under the FCA....more
The US Department of Justice has announced the creation of a one-year pilot program intended to encourage companies to self-report bribery violations and provide extensive cooperation in exchange for reduced penalties,...more
The Second Circuit found no proof of material misrepresentations as to some charges, and held that expert testimony was improperly excluded as to others.
On December 8, the US Court of Appeals for the Second Circuit...more
Supreme Court grants certiorari in qui tam case to consider viability and scope of the “implied certification” theory of liability under the False Claims Act.
On December 4, the US Supreme Court granted certiorari in...more
DOJ announces tough new approach to the investigation and prosecution of corporate officers and employees.
On September 9, in a major change to its approach to the investigation of alleged corporate crime, the US...more
9/15/2015
/ Cooperation ,
Corporate Officers ,
Corporate Veil ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Government Investigations ,
Individual Accountability ,
Internal Investigations ,
Investigations ,
Law Enforcement ,
Non-Prosecution Agreements ,
Personal Liability ,
Professional Misconduct ,
Voluntary Disclosure ,
White Collar Crimes
Court rules that the US Department of Justice cannot expand the FCPA’s reach simply by charging non-resident foreign nationals with conspiracy....more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
8/11/2015
/ Amarin ,
Caronia ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs