医療機器

Medtech is transforming the world at a rapid pace. Medical device companies must constantly evaluate whether and to what extent their pioneering technologies are regulated, secure necessary approvals around the world to bring their products to market, and ensure reimbursement where appropriate. At the same time, they must take steps to protect and defend their products from a host of competitors and from product liability lawsuits that threaten innovation. Established and emerging medical device companies seek the advice of our lawyers in navigating the ever-evolving challenges and opportunities inherent in this industry. Our FDA regulatory, healthcare, patent litigation, and product liability lawyers have a nuanced understanding of the multifaceted issues confronting medical device companies in their day-to-day operations. Members of our team have deep knowledge of regulatory pathways, and have counseled many clients on matters raising a variety of medical device regulatory issues. Sidley’s global platform and multidisciplinary practice offerings allow us to seamlessly counsel multinational medical device companies as they navigate the varying regulatory regimes across the U.S., Europe, and Asia.

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:

Our healthcare lawyers leverage their decades of industry experience to advise medical device companies on business-defining matters at every step of the product lifecycle. From prelaunch to proven products, we help our clients develop effective strategies to secure coding, coverage, and reimbursement for their products; structure complex arrangements with physicians, hospitals, distributors, and other customers; determine federal and state transparency reporting obligations; vet innovative pricing and value-based proposals; and engage with government agencies when needed to solve difficult regulatory problems. We provide sophisticated fraud and abuse analysis and counseling on matters of particular concern to medical device manufacturers — such as novel business arrangements, marketing programs, and patient support offerings — in a way that balances the potential risks with business demands. Our healthcare lawyers also advise on regulatory due diligence related to device manufacturer acquisitions and post-acquisition integrations.

“Sidley provides excellent written work product married with savvy business-friendly solutions."
Chambers USA 2022 Nationwide Healthcare: The Elite

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.

Our veteran lawyers are at the forefront of IP litigation for the medical device and medtech industry, having successfully conducted numerous trials in this area in the past decade. With a deep bench of first-chair trial lawyers, we have led significant patent litigation victories in district courts, at the PTAB and on appeal, representing medtech and medical devices clients, as well as pharmaceutical, biotech, electronics, and software companies. Our work includes numerous recent trial wins on behalf of industry leaders, as well as handling over 300 PTAB proceedings in parallel with litigation.

“Inter-Partes Review Firm of the Year”
LMG Life Sciences Awards 2021

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.

For more than four decades, major medical device clients have turned to Sidley for creative and efficient representation in product liability litigation. Often serving as national counsel in complex matters spanning multiple jurisdictions, we have successfully defended claims in thousands of individual cases and tried cases to verdict in state and federal courts across the U.S. We have particular strength in understanding the scientific issues that are central to these matters, and have long been at the forefront of litigating the complex federal preemption defenses that play a key role in adjudicating these claims, an area where we have seen significant success in obtaining both complete dismissals of claims and significant narrowing. In addition, we provide advice with respect to labeling issues and regulatory compliance under the FDA’s medical device regulations.

“A deep bench noted for its expertise in the life sciences sector, having obtained a number of high-profile defense verdicts in this field.”
Chambers USA 2023, Nationwide Product Liability & Mass Torts – The Elite

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.