Insights

Washington – January 4, 2018: Crowell & Moring LLP is pleased to announce that it has elected seven lawyers to the firm’s partnership, effective January 1, 2018. The firm has also promoted 23 associates to the position of counsel. The new partners have been promoted from within the ranks of the firm’s Washington, New York, San Francisco, and Los Angeles offices, and underscore the firm’s commitment to its Government Contracts, Litigation, Corporate, Environment & Natural Resources, International Dispute Resolution, Intellectual Property, and Labor & Employment practices.

Washington, D.C. – February 4, 2016: Crowell & Moring LLP is pleased to announce that clients Corin Group PLC and Corin USA Limited (collectively "Corin") have prevailed in a lawsuit alleging injuries from Corin’s hip resurfacing system, the Cormet, a Class III medical device approved by the U.S. Food and Drug Administration (Swisher v. Stryker Corporation, et al.). After full discovery, Crowell & Moring, on behalf of Corin, filed motions for summary judgment and to exclude the plaintiff’s sole liability expert, metallurgist Mr. Charles Powell. The U.S. District Court for the Western District of Oklahoma excluded the relevant opinions of Mr. Powell and granted summary judgment in favor of Corin on all claims, holding that there was no evidence of the purported defect in the device nor any evidence of medical causation for the plaintiff’s alleged injuries.

The number of medical devices with wireless and network-connected capabilities continues to grow. At the same time, by some reports the number of ransomware attacks on health care facilities has more than doubled in recent years.[1] Recent cyberattacks and/or ransomware attacks on healthcare systems have resulted in stolen patient data, emergency room closures, diversion of ambulances, and cancellation of surgeries and other appointments. Given the potential disruptions in patient care in connection with these incidents, the cybersecurity of medical devices with wireless and network-connected capabilities becomes increasingly important to avoid and mitigate these possible impacts.

Artificial intelligence (AI) and machine learning (ML) have become ubiquitous across industries, and the pharmaceutical industry is no exception. AI and ML are already influencing drug development and manufacturing, but these innovations present unique regulatory challenges. For example, if a ML algorithm can change a CGMP-compliant manufacturing process on its own to increase efficiency, how does the drug manufacturer ensure that the updated, machine-created process is CGMP-compliant? If researchers use AI to identify ideal candidates to participate in a drug trial, how do they account for biases in the data underlying the AI’s decision-making? FDA recently released a discussion paper[1] requesting input from pharmaceutical industry stakeholders on how to tackle such issues. Stakeholders should seize this opportunity to provide input to FDA as the agency develops the applicable regulatory landscape.

Many medical device companies are accustomed to defending product liability litigation, and the applicability of product liability law to traditional medical devices is not usually questioned. But as an increasing number of medical devices are themselves software or include some software-based function – from clinical decision support tools to robotic surgery machines – an important question becomes: is medical device software a “product” within the meaning of product liability law? This threshold issue has the potential to be claim or even case dispositive for defendants facing allegations of defective device software.

Attorneys John Fuson, Hilary Johnson, Robbie Jost, and Andrew McElligott will present a webinar for the Orange County Bar Association Health Care Law Section titled, "3D Printing at the Point of Care: Compliance and Liability Concerns" on Thursday, November 10, 2022. This session will provide (1) a primer on how the FDA regulates medical devices, (2) an outline of how FDA plans to regulate 3D printing of devices at the point of care and legal issues raised by this new model as compared to traditional manufacturing, (3) an examination of the state of product liability litigation when it comes to 3D printed devices and the potential product liability risks when healthcare facilities take on the role of traditional manufacturers, and (4) an analysis of different intellectual property scenarios healthcare facilities must be aware of when 3D printing POC devices.