James R. Ravitz

Working with manufacturers and distributors of FDA-regulated products, Jamie brings deep experience on novel drugs, biologics, and cutting-edge products, from concept through post-market and marketing, helping clients reduce enforcement risk. He also assists on healthcare and life sciences transactions, providing FDA-related due diligence to maximize value and minimize roadblocks. 

When compliance or enforcement matters arise, Jamie takes a proactive, business-focused approach. He advises on the regulatory components of internal investigations, enforcement activity, and consumer protection litigation and has handled several responses to Office of Inspector General (OIG) and US Department of Justice (DOJ) subpoenas, as well as the defense and settlement of qui tam False Claims Act suits. 

A recognized thought leader in the health law and medical device spaces, Jamie is a regular speaker at industry conferences and has served on bio-innovation center and trade media editorial boards. Prior to joining McDermott Will & Schulte, he led the FDA, healthcare, and consumer products compliance practice at a large international law firm.

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• Advised a publicly traded healthcare products company in a transaction valued at up to $850 million, providing FDA and life sciences regulatory counsel in connection with the acquisition of a surgical products business.  

• Advised a global medical device manufacturer and private equity sponsor in the acquisition and post-closing integration of an orthopedic products company, including FDA, HIPAA, healthcare compliance, and regulatory diligence matters. 

• Advised private equity sponsors in acquisitions of clinical research organizations, clinical trial sites, medical device companies, healthcare services providers, and other FDA-regulated businesses, including transactions valued at more than $58 million, providing regulatory diligence and transaction risk assessments. 

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