Medical Devices
We offer a broad range of services specifically suited to the needs of manufacturers, importers and distributors of medical devices. Our medical device practice includes a former Acting General Counsel of HHS, former Acting Chief Counsel to FDA, a former Special Assistant to the Chief Counsel of the FDA, as well as more than 40 lawyers with decades of combined experience in representing and counseling the medical device industry.
Healthcare Regulatory Matters
Our lawyers focusing in healthcare have significant experience advising medical device clients regarding Medicare and Medicaid coverage and reimbursement. We have developed effective strategic plans on behalf of major medical device manufacturers facing denials of coverage and have coordinated advocacy efforts at the local carrier level to ensure comprehensive national coverage of client products. We also counsel clients regarding 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.
We assist in the defense of civil and criminal litigation, including allegations under the False Claims Act. Our lawyers also have experience in developing and implementing corporate compliance programs and in conducting compliance audits and internal investigations.
Our lawyers have assisted a coalition of medical technology manufacturers, medical professional organizations, patient advocates and individuals dedicated to promoting public awareness and targeted screenings for abdominal aortic aneurysms (AAAs). Specifically, our lawyers assisted in drafting legislation to provide a one-time ultrasound screening benefit for Medicare beneficiaries who are at risk of developing AAA; coordinated the promotion of clinical research supporting this initiative; recruited Congressional support of the legislation; and shepherded its introduction. This effort required an intimate familiarity with technological advances in the treatment protocol for AAA, specifically with respect to the use of stents as an alternative to open surgical repair.
Products Liability Litigation
We have defended scores of product liability cases involving a wide variety of implantable, as well as institutionally-based medical devices, including silicone implants, spinal implants, TMJ implants, latex gloves, contraceptive devices, pain pumps, dialysis filters and equipment, drug infusion devices, intravenous tubing and equipment, integrated digital patient monitoring systems, heart valves, anti-reflex implants, intraocular lens implants, contact lenses, surgical equipment and devices and disposables.
We have served as national coordinating counsel in litigation involving different types of silicone implants, managing thousands of individual cases and trying a number of these cases to verdict in state and federal courts around the country. We began briefing the issue of preemption in the 1980s under the express preemption provision of the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act, participated as
amicus curiae in the recent United States Supreme Court case recognizing express preemption for pre-market approved devices, and maintain a vast library of the preemption law that has developed under this statute. We also regularly advise clients with respect to labeling issues and regulatory compliance under FDA’s medical device regulations while remaining sensitive to business concerns in this exciting and frequently challenging sector of the healthcare industry.
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