Join Troutman Pepper White Collar and Government Investigation Partners Callan Stein, Miranda Hooker, and Allison DeLaurentis for a podcast discussion on the DOJ’s updated guidelines regarding corporate criminal enforcement....more
9/27/2022
/ Compliance Monitoring ,
Corporate Crimes ,
Corporate Culture ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement ,
Individual Accountability ,
Internal Controls ,
New Guidance ,
Policies and Procedures ,
Risk Mitigation ,
Self-Disclosure Requirements ,
White Collar Crimes
In the wake of the global pandemic, which forced manufacturers, trade organizations, and all other players in the health care industry to rethink how to provide medical education and communication on new product offerings to...more
On March 18, the Advanced Medical Technology Association (AdvaMed) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code or Code), last revised January 1, 2020. The new version...more
On March 2, Ericsson, the Swedish networking and telecommunications company, reported that the Department of Justice (DOJ) has accused the company of violating its 2019 Deferred Prosecution Agreement (DPA) by failing to...more
The Department of Justice (DOJ) has once again raised the bar for corporations seeking cooperation credit in government investigations. Last Thursday, DOJ issued a department memorandum and announced three significant...more
In a highly watched case relating to the ability of pharmaceutical manufacturers to support patient copay assistance, the Southern District of New York recently denied Pfizer’s request for a declaratory judgment that two...more
The year is 2012, and the biotech you founded has just received FDA approval for a wildly promising product with significant differentiation from other products in its class. You only have 35 employees, but begin to build a...more
Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced revisions to its voluntary “Code on Interactions with Health Care Professionals” (HCPs), which will take effect January 1, 2022. These revisions...more
I. Introduction -
While 2020 was a year like no other in many ways, the challenges posed by the global COVID-19 pandemic do not appear to have stalled the Department of Justice’s (DOJ) health care fraud enforcement...more
2/3/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
OIG ,
Telemedicine
The Department of Justice (DOJ) entered into its first civil settlement for loan fraud involving the Paycheck Protection Program (PPP). On January 12, the U.S. Attorney’s Office for the Eastern District of California...more
Telemedicine providers – whether they are established or new to the space – should examine the type of conduct DOJ has recently focused on and adapt their compliance systems accordingly. Providers should also consider the...more
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
9/17/2020
/ Criminalization ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Free Speech ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Strict Liability ,
White Collar Crimes
Recently, the Department of Justice (DOJ) updated its “Evaluation of Corporate Compliance Programs” guidance — the third iteration of DOJ’s guidance on this topic. The update is intended to offer transparency as to how DOJ...more
Last week, in the In re Plavix decision, the Third Circuit addressed the question of whether relators can be added or substituted in an amended complaint and, in the process, weighed in on whether the first-to-file bar is...more
As scientists around the globe team up to discover and develop treatments and vaccine candidates for COVID-19, we are also seeing unprecedented speed and coordination in the effort to quell a different kind of virus — the...more
8/4/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare Fraud ,
Memorandum of Understanding ,
Securities Fraud ,
SIGPR ,
White Collar Crimes
As the world’s health care facilities grapple with the devastating and unexpected operational struggles brought by COVID-19, nursing homes and long-term care facilities face the added challenge of protecting their residents...more
On June 18, the Third Circuit affirmed a District of Delaware decision dismissing a False Claims Act (FCA) case against Medco Health Solutions, Inc. because the relator was not an original source of the information underlying...more
On April 9, after four days of deliberations, a jury returned guilty verdicts for seven defendants in United States v. Beauchamp, No. 16-cr-00516-D (N.D. Tex. 2016). ...more
The Northern District of Illinois is the latest court to grant a defendant’s motion to dismiss in a False Claims Act (FCA) case, after the relator failed to meet the substantial pleading burden established in the U.S. Supreme...more
3/22/2019
/ False Billing ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Healthcare Fraud ,
Hospira ,
Materiality ,
Medical Devices ,
Medicare ,
Motion to Dismiss ,
Pfizer ,
Relators ,
Universal Health Services Inc v United States ex rel Escobar
Imagine you are representing an individual who has been subpoenaed for testimony as part of the government’s investigation of her employer. ...more
It has been one year since the U.S. Supreme Court’s landmark ruling in Universal Health Services v. United States ex rel. Escobar, which resolved a circuit split as to the validity of the implied false certification theory...more
9/21/2017
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Health Care Providers ,
Healthcare Fraud ,
Implied Certification ,
Materiality ,
Medicaid ,
Motion to Dismiss ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
One year after the Supreme Court changed the False Claims Act landscape, FCA litigants continue to grapple with the “demanding” materiality standard set forth in Universal Health Services v. United States ex rel Escobar. Now...more
A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more