Capabilities
Life Sciences and Healthcare Regulatory

Healthcare and Life Sciences Product Investigations and Enforcement

Corporations or individuals who face civil or criminal healthcare, pharmaceutical or medical device crises, investigations and enforcement turn to us for our unparalleled depth of experience. In some of the most complex and challenging matters across the life sciences and healthcare sectors, we have established a record of developing comprehensive and effective strategies to counsel and defend clients through all stages of internal investigations, recalls, inspections, audits, civil, criminal and congressional investigations, and trials. Our team includes a former head of criminal healthcare fraud for the US Department of Justice, former head of civil healthcare fraud enforcement for the Eastern District of Pennsylvania, two former heads of the Major Crimes Unit for the Southern District of New York, the former Assistant Solicitor General responsible for healthcare issues for the US government, and an array of accomplished former Assistant United States Attorneys and FDA litigation counsel. Our litigators are complemented by a team of sophisticated regulatory attorneys who focus on FDA, HHS-OIG, and CMS matters. This collaboration delivers sophisticated and integrated legal counseling and a comprehensive commitment to achieving a successful outcome. Our focus remains addressing our client's needs, always conscious that the ultimate goal is to avoid indictment, civil liability, exclusion, and adverse publicity. Based on this deep experience, we also routinely work with clients to develop proactive crisis plans and procedures, and help them avoid future problems by conducting continuous improvement reviews to identify important gaps in controls relative to regulatory and compliance risks.

Perspectives

Pharmaceutical and Medical Device Compliance Update: Management of Critical and Emerging Legal Challenges (html)
Arnold & Porter Seminar/Conference
FDA Releases New Guidance Proposing Further Limitations on Regulatory Oversight of Low Risk Medical Devices
Arnold & Porter Advisory
The Evolving Role of Drug and Medical Device Company Field-Based Medical and Scientific Employees: New Risks or The Same Old Traps?

FDLI Update Magazine

Update
Arnold & Porter Advisory
Persistent technical issues heighten concern over Sunshine's data accuracy (pdf)

Healio.com

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