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Greenberg Traurig Adds Former FDA Associate Chief Counsel for Litigation James Fraser in Firm’s Washington D.C. Office

WASHINGTON, D.C. Sept. 2, 2021 – Global law firm Greenberg Traurig, LLP has expanded its Washington, D.C. Litigation and Health Care & FDA practices with the addition of James C. Fraser, a former Associate Chief Counsel for Litigation at the U.S. Food and Drug Administration (FDA). Fraser will also focus on litigation matters within the firm’s Products Liability & Mass Torts and Pharmaceutical, Medical Device & Health Care Litigation practices.

Fraser, who has more than 16 years of experience in life sciences litigation, most recently worked in conjunction with the Department of Justice representing the FDA in civil litigation throughout the United States. This included defending the FDA against Administrative Procedure Act challenges to the agency’s decisions regarding pharmaceuticals, medical devices, and other FDA-regulated products; bringing civil enforcement actions against manufacturers of pharmaceuticals and other products for violations of the Food, Drug, and Cosmetic Act; and drafting amicus curiae and other filings advocating the FDA’s positions on federal preemption and preclusion.

Prior to joining the FDA, Fraser was a partner at an AmLaw 100 firm, where he spent more than 11 years representing pharmaceutical and medical device manufacturers in mass tort and other products liability litigation. In this capacity, he worked in tandem with Greenberg Traurig attorneys on matters involving the defense of prominent life sciences companies in products liability cases.

Greenberg Traurig recently welcomed Robert P. Charrow back to the firm as senior chairman of the firm’s Health Care & FDA Practice. Charrow, with whom Fraser worked while at the FDA, most recently was general counsel of the U.S. Department of Health and Human Services (HHS), where he led an office of more than 600 lawyers and oversaw the chief counsel for the various agencies within the department, including the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the various Public Health Service agencies such as the National Institutes of Health and the Centers for Disease Control and Prevention.

“Having worked with Jim for several years, I am certain that his significant ability to successfully litigate complex matters concerning pharmaceuticals, medical devices, and other FDA-regulated products is of tremendous value to our clients,” said Charrow, who helped lead the U.S. government’s response to the coronavirus pandemic prior to his re-joining the firm in 2021. “Jim has the rare blend of government and private practice experience that enables him to effectively represent life sciences companies in both FDA issues and consumer litigation matters. I look forward to again working with him, especially as part of a team that includes Health Care & FDA Practice Co-Chairs David C. Peck and Nancy E. Taylor.”

“I have been fortunate to have worked with Jim in the past on pharmaceutical product liability litigation and am beyond thrilled to welcome him as part of our firm and part of multiple practice areas at Greenberg Traurig. Having Jim join us fresh out of the FDA will yield tremendous benefits for our life sciences clients, as he brings all of his direct knowledge and in the trenches experience,” said Lori Cohen, vice chair of Greenberg Traurig and co-chair of the firm’s Global Litigation Practice and Trial Practice. “Specifically, Jim has been at the crossroads of FDA litigation and regulatory issues and will bring that unique knowledge to Greenberg Traurig and our clients.”

“Greenberg Traurig’s stellar reputation in pharmaceutical and medical device litigation was a tremendous draw for me to join the firm, particularly having worked with Lori Cohen – who is truly a superstar in the sector – when I was in private practice,” said Fraser, who also served as a U.S. Air Force JAG Corps Judge Advocate within the Air Force’s Appellate Counsel Division in Washington, D.C. “I also look forward to again working with Bob Charrow and collaborating across Greenberg Traurig’s platform of legal talent to further grow practices as we provide unparalleled client service.”

Fraser earned his J.D., with distinction, from the University of Iowa College of Law and a B.A. from Michigan State University. He has served as an adjunct professor at the University of Maryland Francis King Carey School of Law.

“With client demand now stronger than ever for exceptionally talented litigators – particularly within the health care sector, it is a pleasure to welcome Jim to our growing Washington, D.C. office,” said Ernest Lamont Greer, co-president of Greenberg Traurig and chairman of the firm’s Washington, D.C. office.

Fraser is the third of three shareholders who joined Greenberg Traurig’s Litigation, Products Liability & Mass Torts, and Pharmaceutical, Medical Device & Health Care Litigation practices in August 2021: Nicole E. Narotzky and Thomas R. Pack are based in the firm’s Minneapolis office.

About Greenberg Traurig’s Litigation Practice: Greenberg Traurig’s Litigation Practice includes a team of more than 600 attorneys. The firm’s trial lawyers regularly appear in state and federal courts throughout the country, as well as in appellate courts and before international arbitration panels. They work closely with in-house counsel to develop a strategy that best fits a litigation cost and proficiency model appropriate to the client’s unique needs and goals.

About Greenberg Traurig’s Health Care & FDA Practice: Greenberg Traurig’s HealthCare & FDA Practice is recognized for handling transactional, litigation, regulatory, product approval, enforcement, and compliance matters for organizations across many diverse industries. The team offers clients practical know-how that comes from firsthand experience working in their industries and in their regulatory circles. Our interdisciplinary team has the experience and scope of knowledge needed to steer our clients ahead in an ever-evolving, dynamic health care space.

About Greenberg Traurig’s Pharmaceutical, Medical Device, & Health Care Practice: Greenberg Traurig’s Pharmaceutical, Medical Device & Health Care Practice includes more than 90 trial attorneys representing clients in complex litigation in courts across the country. The team regularly serves as national, regional, special trial, or science counsel – in both mass torts and individual cases – to leading global companies that produce innovative, life-saving products.

About Greenberg Traurig’s Products Liability and Mass Torts Practice: Greenberg Traurig's Products Liability & Mass Torts Practice is an integral part of the firm’s 600-plus member global Litigation Practice. The team brings a sophisticated and coordinated approach to trying complex cases in diverse industries such as chemicals, pharmaceuticals, telecommunications, energy, toxic mold, and tobacco.

About Greenberg Traurig: Greenberg Traurig, LLP (GT) has approximately 2200 attorneys in 40 locations in the United States, Latin America, Europe, Asia, and the Middle East. GT has been recognized for its philanthropic giving, diversity, and innovation, and is consistently among the largest firms in the U.S. on the Law360 400 and among the Top 20 on the Am Law Global 100. The firm is net carbon neutral with respect to its office energy usage and Mansfield Rule 3.0 Certified. Web: www.gtlaw.com