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Andrew D. Kaplan

Partner

akaplan@crowell.com
Phone: +1 202.624.2699
1001 Pennsylvania Avenue NW
Washington, DC 20004-2595

Andrew D. Kaplan is chair of Crowell & Moring’s Mass Tort, Product, and Consumer Litigation Group. He is also a member of the Product Risk Management Group.

Andrew primarily defends medical device, pharmaceutical, and other U.S. Food and Drug Administration (FDA)-regulated companies in federal and state court litigation. In what are oftentimes nuanced, product-specific cases, Andrew takes a holistic approach to serving his clients. He understands that litigation should be driven by client goals, and a deep understanding of these goals can often lead to spotting and solving larger issues.

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 at the U.S. Department of Justice (DOJ). Andrew frequently represents clients as national, as well as international, coordinating counsel in mass tort litigation, including mass actions, class actions and multidistrict litigation (MDL). He currently represents clients in two of the largest pharmaceutical MDLs in the U.S. and is national counsel for two medical device manufacturers in their multi-state 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. This includes identifying specific areas of need such as regulatory compliance, government reporting, or public disclosures and building a team with tailored expertise. From a global perspective, this includes 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 he has helped his clients avoid or lessen the impact of litigation.

In 2020 and 2021, Andrew was recognized by Who's Who Legal for his work in product liability in the life sciences area. While at the DOJ, he also received multiple Civil Division performance awards for his work in addition to being selected to instruct trial advocacy and tort seminars at the Department's National Advocacy Center.

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

Representative Engagements

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.

Education

  • College of William & Mary, B.A. (1995)
  • Vanderbilt University Law School, J.D. (2000)

Affiliations

Admitted to practice: District of Columbia, Virginia, U.S. Court of Appeals for the Fourth Circuit, the U.S. Court of Appeals for the Ninth Circuit, and the Eastern District of Virginia, U.S. District and Bankruptcy Courts for the District of Columbia.

View More

Florida Judge Narrows Multidistrict Litigation Claims Over Zantac Daily Business Review (July 1, 2021)
Media Mentions
Top Product Liability Cases Of 2021: Midyear Report Law360 (June 25, 2021)
Media Mentions
Big Auto's High Court Jurisdictional Workaround Rebuffed Law360 (March 25, 2021)
Media Mentions
"Post-Pandemic Risks are High for the Pharmaceutical Industry," Sedgwick US State of the Nation 2021: Product Recall (February 18, 2021). Author: Andrew D. Kaplan.
Publication
"Florida’s New Year’s Resolution: A "More Rational, More Fair, and More Consistent" Summary Judgment Standard," Mass Tort, Product, and Consumer Litigation Alert (January 12, 2021). Contacts: Andrew D. Kaplan, Luke Bresnahan
Client Alert / Newsletter
"FDA Postpones DSCSA Provision Enforcement by Three Years," Mass Tort, Product, and Consumer Litigation Alert (November 5, 2020). Contacts: John Fuson, Andrew D. Kaplan, Luke Bresnahan
Client Alert / Newsletter
"Proposed Legislation Would Expand FDA Authority Over Counterfeit Medical Devices," Mass Tort, Product, and Consumer Litigation Alert (October 2, 2020). Contacts: Andrew D. Kaplan, Hilary Johnson, Robbie Rogart
Client Alert / Newsletter
Top Product Liability Cases Of 2020: Midyear Review Law360 (August 3, 2020)
Media Mentions
Product Liability Cases To Watch In 2020: Midyear Review Law360 (July 17, 2020)
Media Mentions
"Agencies, Plaintiffs Target Ethylene Oxide," Mass Tort, Product, and Consumer Litigation Alert (March 19, 2020). Contacts: Peter C. Condron, Andrew D. Kaplan, Byron R. Brown
Client Alert / Newsletter

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Crowell & Moring LLP is an international law firm with offices in the United States, Europe, MENA, and Asia that represents clients in litigation and arbitration, regulatory and policy, and transactional and corporate matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation and government-facing matters, as well as its ongoing commitment to pro bono service and diversity, equity, and inclusion.

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