AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
To quote CMS, “The Open Payments program is a national disclosure program that promotes a more transparent and accountable health care system. Open Payments houses a publicly accessible database of payments that reporting...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
Our Virtual Regional Compliance Conferences provide updates on the latest news in regulatory requirements, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask questions from...more
Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more
Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more
A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal...more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...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
After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...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
Over this two-part blog post series, I have been considering the Stryker Corporation 2018 Foreign Corrupt Practices Act (FCPA) enforcement action brought by the Securities and Exchange Commission (SEC)....more
Last month, Stryker Corporation joined a rather ignominious list of recidivists under Foreign Corrupt Practices Act (FCPA) enforcement annuls....more
On September 28, 2018, the Securities and Exchange Commission (“SEC”) announced a settlement with a Michigan-based manufacturer and distributor of medical devices, over allegations that the company had violated the books and...more
Stryker Corporation has suffered a second FCPA enforcement action, and will now bear the stigma of FCPA “recidivist.” In reaching a settlement with the SEC and agreeing to pay a $7.8 million civil penalty, Stryker will now...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
For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more
In its continuing quest to push the message of aggressive FCPA enforcement, the SEC resolved FCPA charges against Orthofix, a medical device company, for $6 million in penalties and disgorgement. In a related action, the SEC...more
The drug and medical device industries have been taking it on the FCPA chin for years. The risk factors in the international marketplace are significant – healthcare professionals are normally government employees; government...more
Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more
It is hard to imagine how prosecutors were able to bring cases before there was email communications. When I was a prosecutor, we looked for evidence in a lot of other sources, internal memos, calendars and other places where...more
In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more
Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more