Andrew Kaplan

Partner

Overview

When products face high-stakes challenges from consumers and regulators, companies trust Andrew Kaplan for his business-grounded advice and effective litigation advocacy. Andrew has devoted more than 20 years to helping clients primarily in the medical device, pharmaceutical, and other U.S. Food and Drug Administration-regulated arenas avoid risk and defend themselves from aggressive legal challenges.

Andrew is a first-chair trial attorney who has led multiple jury and bench trials both in private practice and while serving in the Civil Division, Torts Branch, of the U.S. Department of Justice. He frequently represents clients as national, as well as international, coordinating counsel in mass tort litigation, including mass actions, class actions, and multidistrict litigation. Andrew currently represents clients in two of the largest pharmaceutical MDLs in the United States and is national counsel for two medical device manufacturers in their multistate dockets of product liability litigation. In this centralized role, Andrew helps clients develop and implement their litigation strategy while minimizing risk and maximizing consistency and efficiency, including identifying specific areas of need, such as regulatory compliance, government reporting, or public disclosures, and building a team with tailored experience. From a global perspective, these include anticipating the impacts of litigation and regulatory actions in individual countries on a company’s broader strategy.

Informed by his litigation experience, Andrew also counsels clients on risk mitigation and compliance programs. His practice focuses on product risk management issues and responding to related government civil enforcement actions. Through proactive risk management, Andrew has helped his clients avoid or lessen the impact of litigation.

Andrew is ranked by Chambers USA for Product Liability & Mass Torts-USA-Nationwide ranking. Chambers USA notes that Andrew is held in high regard for the caliber of his advocacy in product liability litigation. He also serves as co-chair of the firm’s Mass Tort, Product, and Consumer Litigation Group.

Andrew maintains an active pro bono practice focused on representing victims of domestic violence in obtaining and enforcing civil protection orders. 

Career & Education

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    • Department of Justice
      Civil Division
      Trial Attorney, Torts Branch, 2003 — 2008
    • Department of Justice
      Civil Division
      Trial Attorney, Torts Branch, 2003 — 2008
    • College of William & Mary, B.A., 1995
    • Vanderbilt University Law School, J.D., 2000
    • College of William & Mary, B.A., 1995
    • Vanderbilt University Law School, J.D., 2000
    • District of Columbia
    • Virginia
    • U.S. Court of Appeals for the Fourth Circuit
    • U.S. Court of Appeals for the Ninth Circuit
    • U.S. Court of Appeals for the Eleventh Circuit
    • U.S. Court of Appeals for the Eastern District of Virginia
    • U.S. District Court for the District of Columbia
    • U.S. Bankruptcy Court for the District of Columbia
    • U.S. District Court for the District of Colorado
    • District of Columbia
    • Virginia
    • U.S. Court of Appeals for the Fourth Circuit
    • U.S. Court of Appeals for the Ninth Circuit
    • U.S. Court of Appeals for the Eleventh Circuit
    • U.S. Court of Appeals for the Eastern District of Virginia
    • U.S. District Court for the District of Columbia
    • U.S. Bankruptcy Court for the District of Columbia
    • U.S. District Court for the District of Colorado
Andrew Kaplan is held in high regard for the caliber of his advocacy in product liability litigation … He is smart, communicates effectively, and understands business complexity and priorities. He spots issues and avoids hurdles others did not see coming.

Chambers USA, 2022

Andrew's Insights

Representative Matters

Medical Device and Pharmaceutical Litigation

  • Serving as national counsel for an international medical device manufacturer in all U.S. product liability litigation. Over the past decade in this role, the company has never paid a settlement or judgment. 
  • Representing a large U.S. medical device manufacturer as national counsel in mass tort litigation. Leading the defense of the product liability lawsuits across numerous state, federal and international courts. 
  • Serving as lead counsel for a Fortune 20 company in two of the largest pharmaceutical MDLs in the country, including serving in a defense group leadership position in the largest of the MDLs.
  • Serving as national and international counsel for a global company in its entire docket of medical device and pharmaceutical product liability litigation. This engagement has allowed the company to harmonize strategy across jurisdictions, lessen exposure, and lower legal spend. 
  • Litigated dozens of individual medical device product liability actions involving issues related to the Federal Food, Drug and Cosmetic Act (FDCA) and the Premarket Approval (PMA) and Premarket Notification (510(k)) regulatory approval processes.
  • Provided expert testimony on U.S. product liability law in international arbitration between a U.S. medical device manufacturer and an international insurance company. 

Food Industry Litigation

  • Defended a food manufacturer in a consumer protection lawsuit under the D.C. Consumer Protection Procedures Act (DCPPA) involving product labeling.
  • Defended a food manufacturer in a putative national class action involving product labeling and advertising.
  • Represented a food trade association in responding to non-party subpoenas in multiple putative class actions involving food labeling.

Risk Management Counseling

  • Represented a pharmaceutical manufacturer in response to a Federal Food and Drug Administration enforcement action under the Federal Food, Drug, and Cosmetic Act (FDCA), including negotiation of a novel consent decree.
  • Counseled a food manufacturer on litigation risks for product labeling and advertising.
  • Represented a dietary supplement manufacturer in response to an FDA enforcement action.
  • Conducted a product liability risk analysis for a large corporation acquiring a medical device manufacturer.
  • Conducted a product liability/regulatory risk assessment for a medical device and pharmaceutical company.
  • Conducted a risk analysis for an international standards institute regarding its involvement in the review of U.S. medical devices.

Andrew's Insights

Recognition

  • Chambers USA, Product Liability & Mass Torts – Nationwide, 2022 – present
  • Who's Who Legal: Life Sciences 2024

Andrew's Insights

Insights

Speaking Engagement | 11.05.23

"Key Takeaways from this Year’s Top MDLs: Impactful Rulings and Hot Opinions from the Tylenol, Zantac and Exactech MDLs,” ACI’s 28th Annual Drug & Medical Device Litigation Conference
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Andrew's Insights