Orrick Grows Life Sciences & HealthTech Platform with 7-Lawyer FDA and Healthcare Regulatory Team
6 minute read | July.11.2024
Senior Counsel
Washington, D.C.
A substantial part of Shari’s practice involves aiding life sciences (pharma, medical device, and biologic) and healthcare companies with internal investigations and working with clients on compliance with government investigations, subpoenas, and investigative demands, as well as the defense of whistleblower qui tam suits involving the False Claims Act and the Anti-Kickback Statute. Shari has also managed litigations and helped lead trial teams involving diverse fields of science and technology including pharmaceuticals, various medical fields, and seals used in the semiconductor industry. She specializes in mastering complicated science and technologies and explaining them to judges and juries.
Shari regularly represents companies with FDA-regulated products and healthcare companies on strategic regulatory counseling matters. She also regularly conducts regulatory due diligence for private equity funds, acquirers, sellers, and underwriters in corporate transactions.
Shari also has substantial experience advising clients on complex advertising/promotion issues, including claim substantiation, disputes before the National Advertising Division of the BBB National Programs (NAD), and advertising lawsuits under Section 43(a) of the Lanham Act. She also regularly advises consumer product companies on Consumer Product Safety Commission related compliance.
Upon graduation from Harvard Law School, Shari clerked for the Honorable Frank A. Kaufman, United States District Court for the District of Maryland, who sat by designation on the U.S. Courts of Appeals for the Federal Circuit, the Fourth Circuit, the Seventh Circuit, and the Eleventh Circuit.
6 minute read | July.11.2024