Andrew D. Kaplan
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.
Career & Education
- Department of Justice: Civil Division
Trial Attorney, Torts Branch, 2003–2008
- Department of Justice: Civil Division
- 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 Third Circuit
- 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. Bankruptcy Court for the District of Columbia
- U.S. District Court for the District of Columbia
- U.S. District Court for the District of Colorado
- U.S. District Court for the Eastern District of Virginia
- U.S. District Court for the Eastern District of Wisconsin
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
Client Alert | 4 min read | 04.07.25
On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.
Publication | 01.15.25
Product Liability: Class Actions Are Increasingly Using Economic Loss To Bring Claims
Publication | 01.14.25
Liability Risk For AI In Medical Devices Demands Greater Care
Event | 12.03.24
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
Client Alert | 4 min read | 04.07.25
On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.
Publication | 01.15.25
Product Liability: Class Actions Are Increasingly Using Economic Loss To Bring Claims
Publication | 01.14.25
Liability Risk For AI In Medical Devices Demands Greater Care
Event | 12.03.24
Recognition
- Lexology Index (formerly Who's Who Legal): Recommended, Healthcare & Life Sciences, 2023–2025
- Thomson Reuters Stand-out Lawyer, 2025
-
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
Andrew's Insights
Client Alert | 4 min read | 04.07.25
On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.
Publication | 01.15.25
Product Liability: Class Actions Are Increasingly Using Economic Loss To Bring Claims
Publication | 01.14.25
Liability Risk For AI In Medical Devices Demands Greater Care
Event | 12.03.24
Insights
Pharmaceutical Products Liability Litigation Impossibility Pre-emption Defence
|06.07.22
International Law Office
Transitioning from the Public Health Emergency into a Post-Pandemic World
|02.25.22
State of the Nation 2022: Product Recall
Post-Pandemic Risks are High for the Pharmaceutical Industry
|02.18.21
Sedgwick US State of the Nation 2021: Product Recall
Torts – Watching the Growing Multi-Plaintiff Challenge
|01.09.19
Crowell & Moring's Litigation Forecast 2019
Food & Beverage — The Belt Gets Tighter
|01.19.16
Crowell & Moring's Regulatory Forecast 2016
Regulatory Forecast 2016: What Corporate Counsel Need to Know for the Coming Year
|01.19.16
a Crowell & Moring LLP publication
"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
|11.05.23
Practices
Andrew's Insights
Client Alert | 4 min read | 04.07.25
On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.
Publication | 01.15.25
Product Liability: Class Actions Are Increasingly Using Economic Loss To Bring Claims
Publication | 01.14.25
Liability Risk For AI In Medical Devices Demands Greater Care
Event | 12.03.24
