Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
In its first update in a decade and effective January 1, 2020, the revised Advanced Medical Technology Association (AdvaMed) Code of Ethics in Interactions with Health Care Professionals (Code) in the United States contains...more
The False Claims Act (“FCA”) permits a person, known as a “qui tam relator” (or more commonly, a “whistleblower”), to bring a lawsuit on behalf of the federal government when that person has information that a healthcare...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more
On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more
The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more
Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more
We are pleased to present Bradley’s annual review of significant False Claims Act (FCA) cases, developments, and trends. From a relatively short article several years ago, the Review has grown to a significant publication...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more
I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more
The False Claims Act (FCA) imposes liability on individuals and companies who defraud or submit false claims to the federal government. The FCA allows the federal government to seek treble damages, civil penalties and...more
Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more
Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more
I always like to make predictions at the beginning of each year. My track record is plus and minus – sometimes on target, sometimes off-target. The biggest story in the last five years has been the rise of FCPA...more