医疗器械

We harness our lawyers’ breadth of knowledge to assist clients in high-profile matters involving a range of premarket approval and 510(k) cleared medical devices, including:

Working hand-in-hand with our clients’ in-house compliance departments, our healthcare lawyers develop and implement best-in-class compliance programs that are tailored to our clients’ needs. Our team also conducts compliance audits and internal investigations on both discrete and enterprise-level concerns and counsels boards of directors of multinational medical device companies on U.S. healthcare compliance matters.

We have long represented medical device companies in all types of major litigation and enforcement actions. Our healthcare lawyers have experience at all levels of civil and criminal litigation, from pretrial investigation through trial to appeals before state and federal courts, including the U.S. Supreme Court. This includes False Claims Act, antitrust, class action, and health policy litigation.

We have a strong understanding of the technical issues that are central to medtech litigation, including software, source code, and other innovative features. Our lawyers frequently delve into the software and code of high-tech medical devices to identify the distinction between innovation and infringement. Working closely with our colleagues on Sidley’s Global Life Sciences and Food, Drug, and Medical Device teams, we provide scientific and business counsel to help clients navigate complex FDA compliance requirements and clearance filings.

We also advise innovative medical device companies that have not historically been considered medtech companies but are now defining themselves as such. Our lawyers provide tailored advice to these companies as they seek to swiftly invest in, acquire, or deploy new digital solutions, helping them to leverage technology to grow their businesses. Our work covers many types of medical devices, including representing multinational corporations who create remote cardiac monitoring devices, spinal cord stimulation systems, surgical robotics, and smartwatches and other wearable fitness trackers.

Our product liability lawyers represent medical equipment manufacturing and distribution companies as well as medical device sterilization companies in matters involving products ranging from hip implants and contraceptive devices to duodenoscopes and cardiac leads. Examples include:

• Defending a multinational medical equipment manufacturing company in a high-stakes product liability MDL regarding the company’s hip resurfacing prosthesis, a Class III medical device.
• Defending a multinational medical device, pharmaceutical, and life sciences company as lead national counsel and coordinating counsel in product liability litigation concerning a Class III medical device for female contraception.
• Defending a global industrial sterilization services company on multiple fronts as it confronts litigation, regulatory, and legislative threats arising from the use of ethylene oxide as a sterilizing agent for millions of critical medical devices and surgical kits worldwide.
• Successfully represented a major medical device company on a number of fronts, including the defense of multiple product liability cases in connection with CRE infections following duodenoscope procedures.
• Served as national counsel to a major medical device company and its subsidiary in the successful defense of product liability and other challenges facing the company’s ICD Leads, which were the subject of a Class I recall based on alleged product failures.