Medical Devices

We harness the breadth of knowledge possessed by our multidisciplinary team to assist clients in matters involving a range of premarket approval and 510(k) cleared medical devices, including:

Our healthcare lawyers regularly advise medical device clients on Medicare and Medicaid coverage, reimbursement, and fraud and abuse issues. We develop strategic plans for major medical device manufacturers facing denials of coverage and coordinate advocacy efforts at the local carrier level to obtain national coverage of client products. We also counsel clients on fraud and abuse issues in connection with marketing activities and the distribution of devices, including HIPAA, state and federal self-referral prohibitions, and state and federal anti-kickback limitations. In addition to defending clients in civil and criminal litigation, including allegations under the False Claims Act, we assist in developing and implementing corporate compliance programs and conducting compliance audits and internal investigations.

For more than four decades, major medical device clients have turned to Sidley for creative and efficient representation in products liability litigation. Often serving in lead roles as national counsel, we have successfully defended claims in thousands of individual cases and tried many of these cases to verdict in state and federal courts across the U.S. Our lawyers have also developed strategies for handling multidistrict litigation and coordinated proceedings across many jurisdictions. 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.

We are well-versed in the preemption law that has developed under the express preemption provision of the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act, having been involved in briefing these issues since the 1980s. In addition, we provide advice with respect to labeling issues and regulatory compliance under the U.S. Food and Drug Administration’s medical device regulations.