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 Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more
Neurotechnology, like wearable EEG headbands and invasive brain implants, collects information from electrical nerve impulses and brain waves derived from your brain, spinal cord, or nervous system. This information, or...more
On February 7, the Department of Justice (DOJ) issued a press release indicating that settlements and judgments under the False Claims Act (FCA) exceeded $2.2 billion in the fiscal year ending September 30, 2022. Of this...more
McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more
On February 27, 2023, a jury in Minnesota federal court rendered a verdict in favor of the United States and against a surgical product distributor following a False Claims Act jury trial that lasted six weeks. The jury...more
Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...more
The Federal Trade Commission's (FTC's) in-house administrative law judge (ALJ) has handed the FTC a loss in its suit to reverse the completed acquisition of GRAIL, Inc. by Illumina, Inc. This is the FTC's second high-profile...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
The European General Court (GC) has affirmed a EUR 28 million (USD 32 million) fine against Canon for gun-jumping in connection with Canon's 2019 acquisition of Toshiba's medical device business (TMSC). The GC's decision...more
On 29 July 2021, the Federal Court of Australia (the “Court”) handed down its largest ever pecuniary penalty for serious, sustained and knowing contravention of the Therapeutic Goods Act 1989 (Cth) (“TG Act”). The decision...more
On June 29, 2021, the Supreme Court published its divisive opinion in Minerva Surgical, Inc. v. Hologic, Inc., Et. Al. The 5-4 decision penned by Justice Kagan upheld the centuries-old doctrine of Assignor Estoppel, while...more
Assignor estoppel survived the Supreme Court’s decision in Minerva Surgical Inc. v. Hologic Inc., but the Court’s clarification requires diligence and presents opportunities. Review patent assignment and employee agreements...more
On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...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
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
The FTC announced a settlement with NeuroMetrix, Inc., and its CEO, Shai Gozani, relative to allegations that the marketers made deceptive pain relief claims on a medical device called Quell....more
Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more
In a unanimous Opinion and Final Order issued on November 1, 2019, the Federal Trade Commission (“FTC”) upheld an administrative law judge’s determination that the acquisition by one leading US supplier of lower-limb...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
Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more
In the context of the practice of medicine, we are all very familiar with the Latin phrase primum est non nocere. It means “first, do no harm” and is the ethical guiding principle in the medical profession. Inherent in this...more
Addressing pre-America Invents Act (AIA) 35 USC § 102(b), the US Court of Appeals for the Federal Circuit held that the public-use and on-sale bars did not apply to the claimed surgical method because pre-critical-date...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 1, the U.S. Court of Appeals for the Third Circuit, in Shuker et al. v. Smith & Nephew PLC, affirmed a District Court’s ruling that claims against a medical device manufacturer are expressly preempted by federal law....more