Medical and Diagnostic Devices
Companies planning to develop and commercialize medical devices or diagnostics face a challenging financing, regulatory, reimbursement and liability environment. Saul Ewing Arnstein and Lehr attorneys are experienced in helping medical device and diagnostic companies navigate these challenges.
Many members of our team had careers before law school working as scientists, engineers, bankers and entrepreneurs. We bring a practical, business-oriented approach to advising our clients with respect to protecting and enforcing their intellectual property; developing, manufacturing and commercializing their products; contracting with clinical research organizations or university collaborators; supporting financings, M&A and other business transactions; and defending against product liability claims.
Our medical and diagnostic devices team includes intellectual property attorneys and patent agents who have diverse scientific, engineering, and legal backgrounds that they draw upon to help clients in due diligence, freedom-to-operate/clearance and patent protection. Many have degrees in mechanical, electrical and chemical engineering, computer science, biotechnology, analytical chemistry, genetics and molecular biology. Coupling this technical knowledge with transactional, strategic counseling, litigation experience allows our patent prosecutors to efficiently secure patents that serve our clients’ short- and long-term goals. Additionally, we regularly coordinate design, trademark, copyright, and trade secret strategies to provide a holistic approach to identifying and protecting a client’s intellectual property. When intellectual property disputes escalate, our patent litigators are ready to step in to negotiate or, where necessary, litigate the matter to conclusion.
We have built a national reputation for successfully representing companies in the defense of complex claims made against medical devices, drugs and biologics. Our drug and medical device attorneys have appeared in numerous state and federal courts, with substantial involvement regionally and nationally in mass-tort, multidistrict litigation and “global settlement strategies”. Our representation includes all aspects of litigation, including pre-trial discovery (including e-discovery on both a small and large scale), preparing and arguing dispositive motions, trials before judges and juries, alternative dispute resolution, and appeals. Our experience includes the defense of such products as drug-eluting stents, contact lens solutions, implanted contraceptives, ophthalmologic lasers, orthopedic implants, as well as generic and brand name pharmaceuticals. We utilize our many successes in and out of court to help clients identify, minimize and avoid liability. In this vein, our attorneys advise clients on preventive measures that are designed to reduce the risk of liability yet are in harmony with strategic business objectives. To that end, we also provide counsel concerning regulatory compliance issues.
Our broader team includes health care attorneys who counsel on federally-required disclosure of payments to physicians and teaching hospitals by device companies under the Sunshine Act, as well as white collar and government enforcement attorneys who provide representation in matters ranging from off-label marketing and whistleblower/qui tam complaints under the False Claims Act to exclusion and debarment actions involving allegations of fraud, waste and abuse in federal health care programs.
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