Sara Tucker helps clients in the life sciences and cannabis sectors. Sara has a hybrid FDA regulatory and litigation practice. She brings a unique perspective to helping clients solve FDA regulatory challenges. A veteran trial lawyer, Sara has experience defending Fortune 500 pharmaceutical and medical device clients in high-stakes mass tort and multi-district cases in federal and state courts. Sara draws on her litigation background to provide full product life cycle advice and counsel to her clients. 

Sara guides clients in pre- and post-market regulatory and policy issues, such as: 

  • FDA regulatory strategy and compliance;
  • FDA dispute resolution;
  • FDA-regulated products liability risk mitigation;
  • Labeling issues; 
  • FDA submissions and product approvals/clearances;
  • FDA inspections & investigations; and
  • Responding to FDA enforcement actions.

When litigation cannot be avoided, Sara provides her clients zealous advocacy and strategic defense of litigation nationwide. 

Sara is passionate about innovation and technology advancements and provides her clients with up to date advice and counsel related to cutting edge technologies and products spanning many areas, including biotech, digital health, telemedicine, combination products, and cannabis. 

Her clients include global and domestic medical device, biotech, pharmaceutical, biologic, combination products, diagnostics, dietary supplements, cannabis, hemp, and CBD companies, as well as ancillary service providers.  

The American Bar Association’s Young Lawyers Division selected Sara for its “On the Rise – Top 40 Young Lawyers” award, and Georgia Super Lawyers magazine has recognized Sara as a Rising Star for each of the past five years. 

Professional Activities

  • Member, Defense Research Institute (DRI), Young Lawyer’s Division, 2013-Present
    • Steering Committee, 2013–2015; Vice Chair, Substantive Committee Liaison, 2015-2016; Chair, Publications Subcommittee, 2014-2015; Vice Chair, Publications Subcommittee, 2013-2014
    • Drug and Medical Device Steering Committee, 2013-2015; Member, Orientation Subcommittee, 2013-2015; Young Lawyers Liaison, 2013-2015
  • Volunteer Attorney, Atlanta Volunteer Lawyers Foundation, 2008-Present
  • Member, American Bar Association
  • Member, Atlanta Bar Association
  • Member, Georgia Bar Association, Young Lawyer’s Division

Honors and Awards

  • JD Supra Readers’ Choice Awards, Product Liability Litigation, 2021
  • Fellow, American Bar Foundation, 2020 – Present  (A global honorary society of attorneys, judges, law faculty, and legal scholars whose public and private careers have demonstrated outstanding dedication to the highest principles of the legal profession and to the welfare of their communities. Membership is limited to 1% of lawyers licensed to practice in each jurisdiction. Fellows are recommended by their peers and elected by the Board of the American Bar Foundation.)
  • Recipient, American Bar Association Young Lawyers Division “On the Rise – Top 40 Young Lawyers” Award, 2019
  • Team Member, The American Lawyer’s “Regional Litigation Department of the Year - Georgia,” 2018
  • Team Member, The American Lawyer’s “Products Liability Litigation Department of the Year,” 2018
  • Listed, Super Lawyers magazine, Georgia Super Lawyers, "Rising Star," 2015-2019
  • Listed, The Daily Report, "On the Rise," 2017
  • Team Member, The Daily Report’s "Georgia Products Liability & Mass Torts Litigation Department of the Year," 2013 and 2015-2017
  • Team Member, Courtroom View Network’s "Top Defense Verdict of 2016"
  • Team Member, Missouri Lawyer’s Weekly, “Top Defense Wins in 2016”
  • Recipient, "Outstanding Newcomer," Defense Research Institute Young Lawyers' Committee, 2014
  • Team Member, a Law360 "Product Liability Practice Group of the Year," 2011
  • Recipient, "Pro Bono Award," Georgia State University College of Law
  • Litigation Honors, Georgia State University College of Law

Presentations

  • Panelist, “How to Navigate the FDA Approval Process and Other Regulatory Issues”, SCBIO, December 1, 2020
  • Panelist, “Stem Cell Therapy – Regulatory Developments and Claim Considerations,” Professional Liability Underwriting Society, November 9, 2020
  • Panelist, “Cybersecurity and Privacy - FDA Regulated Medical Devices,” Food and Drug Law Institute (FDLI), October 8, 2020
  • Panelist, “Personal Branding for Lawyers,” National LGBT Bar Association Lavender Law Conference, August 12, 2020
  • Panelist, “COVID 19: Planning for the Return and the Restart,” CFO Leadership Council, May 19, 2020
  • Speaker, “General Liability Considerations for Reopening from COVID-19 Shutdown,” Wealth Counsel, May 19, 2020
  • Speaker, “Return to Work Webinar Series: General Liability Considerations,” Womble Bond Dickinson, April 28, 2020
  • Speaker, “Getting it Right When It All Goes Wrong: Successful Compliance Programs and Crisis Management,” Association of Corporate Counsel CLE, January 15, 2020

Experience

Any result the lawyer or law firm may have achieved on behalf of clients in other matters does not necessarily indicate similar results can be obtained for other clients.

  • Counsel for digital health platform providing diagnostic tests and telemedicine services regarding strategic development of business model and platform and FDA regulatory issues;
  • Counsel for leading cannabis manufacturing and consulting company on general product liability risk and compliance issues related to designing, licensing, and operating cannabis extraction facilities;
  • Counsel for face mask manufacturers in seeking FDA Emergency Use Authorizations and/or 510(k) clearance for the sales of face masks in United States; 
  • Counsel for foreign face shield manufacturer in getting Emergency Use Authorization to sell and distribute face shields in the U.S. Market, including FDA regulatory advice; 
  • Counsel for textile manufacturer in commercializing hospital gowns for sale during pandemic, including FDA regulatory advice; 
  • Counsel for medical device start-up regarding commercialization issues and FDA regulatory advice;
  • Counsel for pharmaceutical companies and medical device companies to analyze FDA regulatory issues in manufacturing supply and distribution agreements; 
  • Obtained numerous dismissals of product liability lawsuits against Fortune 500 pharmaceutical and medical device companies on the basis of federal preemption due to FDA approval;
  • Counsel for pharmaceutical and medical device clients regarding “off-label” promotion issues related to FDA-regulated products;
  • Counsel for disinfectant manufacturers regarding FDA and EPA regulatory pre-market issues during COVID-19; 
  • Counsel for pharmaceutical company in multidistrict litigation (MDL) involving proton-pump inhibitor (PPI) medications;
  • Counsel for global medical technology company in cases alleging bacterial contamination of sterile syringes;
  • National trial team member for global medical device company related to inferior vena cava (IVC) filters;
  • National trial team member for global medical device company in both MDL as well as state court litigation involving hernia mesh products;
  • Counsel for medical device company in cases alleging death and /or paralysis related to surgically implanted medical devices;
  • Counsel for pharmaceutical company in MDL litigation relating to chemotherapy medications;
  • Trial team member for one of the world’s largest medical device companies involving allegations of negligence in the design of a laser-resistant endotracheal tube. The client was assessed zero liability despite jury verdict of $18 million awarded against co-defendant health care providers;
  • Trial team member for multinational developer, manufacturer, and marketer of medical devices in MDL bellwether cases involving vaginal mesh products as well as consolidated state court litigation;
  • Counsel to major pharmaceutical company in multidistrict and associated state court litigation involving an antipsychotic medication with more than 15,000 cases;
  • Counsel for pharmaceutical company in cases alleging death caused by narcotic medication;
  • Counsel to an international mining corporation in silica litigation in multiple jurisdictions around the country;
  • Counsel to leading national restaurant chain in several putative class actions involving the sodium content of its meals;
  • Counsel to international automobile manufacturer in multidistrict litigation involving thousands of plaintiffs, as well as associated state court cases;
  • National trial team member for one of the world’s largest chemical companies in asbestos litigation in numerous jurisdictions;
  • Counsel to health care professionals in malpractice lawsuits; and
  • Counsel to international beverage manufacturer in pre-litigation advisory role.