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.
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.
“They are always prepared, and anticipate what questions a client might have, which is very valuable … they are always available and have gone the extra mile.”
Chambers USA 2021, Nationwide: Healthcare: The Elite
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
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 2021, Nationwide: Product Liability & Mass Torts