Andrew D. Kaplan

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.

• Chambers USA, Product Liability & Mass Torts – Nationwide, 2022 – present
• Legal 500 United States: Product Liability, Mass Tort and Class action - Defense: Consumer Products (including tobacco) 2024 
• Who's Who Legal: Life Sciences 2023 – 2024