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.
Andrew is ranked in Chambers USA 2022 for Product Liability and Mass Torts. Chambers USA notes that he is “held in high regard for the caliber of his advocacy in product liability litigation” and that “he is smart, communicates effectively and understands business complexity and priorities. He spots issues and avoids hurdles others did not see coming." Who's Who Legal (2020-22) also recognizes Andrew for his work in product liability in the life sciences area. While at the DOJ, he 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 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.
Speeches & Presentations
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"Taking Down the Rising Behemoth: Combatting Plaintiff Tactics That Are Transforming MDLs Into the Machines We See Today"
(December 7, 2021).
Panelist: Andrew D. Kaplan.
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"Combatting Extreme Jury Verdicts: Navigating Extraneous Factors That are Influencing Juror Findings," ACI 24th Annual Conference on Drug & Medical Device Litigation
(December 10, 2019).
Panelist: Andrew D. Kaplan.
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"Hiring the Right Regional Counsel," 23rd Annual Conference on Drug & Medical Device Litigation, New York, NY
(November 30, 2018).
Speaker: Andrew Kaplan.
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"Commercial Contracts, Logistics & Supply Chain: Ways to Create Value and a Sustainable Stream of Affirmative Recovery," RILA’s Retail Law Conference, Atlanta, GA
(October 25, 2016).
Presenters: Beatrice B. Nguyen and Andrew Kaplan.
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"Supply Chain and Commercial Contracts Recovery: Deals Gone Bad," Crowell & Moring's Second Annual In-House Recovery Conference, Dana Point, CA
(March 10-11, 2016).
Presenters: Greg Call, Beatrice B. Nguyen, Andrew Kaplan, and Frank Nuzzi.
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"Food & Beverage Industry: What Will 2016 Bring?" Webinar
(February 10, 2016).
Presenters: John Fuson, Michelle Gillette, Andrew Kaplan, and Chalana N. Williams.
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“Commercial Contracts and Supply Chain,” First Annual In-House Affirmative Recovery Conference, Dana Point, CA
(March 19, 2015).
Presenters: Andrew Kaplan, Beatrice B. Nguyen, Jennifer Romano, William Moore (Hewlett-Packard Company)
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"Food Class Actions," Food and Drug Law Institute (FDLI) Food Week: Advertising, Labeling, and Litigation Conference, Washington, D.C.
(February 24, 2015).
Presenter: Andrew Kaplan.
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"Arbitration Clauses After Concepcion," Blue Cross and Blue Shield Western Operations Conference
(July 9, 2013).
Presenter: Andrew Kaplan.
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"The Class Action Rules Have Changed," Blue Cross and Blue Shield Western Operations Conference
(July 9, 2013).
Presenter: Andrew Kaplan.
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"Navigating High-Profile Litigation and Administrative Enforcement," Crowell & Moring Advertising and Product Risk Management Seminar
(March 19, 2013).
Moderator: Andrew Kaplan; Panelists: Kevin C. Mayer, Keith J. Harrison, and John Fuson.
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"Litigation Risk Mitigation: Getting Inside the Mind of a Plaintiff’s Lawyer," Crowell & Moring Product Risk Management Seminar
(October 19, 2011).
Moderator: Lynn Parseghian. Panelists: Andrew Kaplan, Tracy Roman.
Publications
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"Pharmaceutical Products Liability Litigation Impossibility Pre-emption Defence," International Law Office
(June 7, 2022).
Authors: Andrew D. Kaplan and Lyndsay A. Gorton.
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"Transitioning from the Public Health Emergency into a Post-Pandemic World," State of the Nation 2022: Product Recall
(February 25, 2022).
Authors: John Fuson and Andrew Kaplan.
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"Supply Chain Indemnification Tips For Medical Device Cos." Law360
(December 7, 2021).
Authors: Andrew D. Kaplan, Hilary Johnson, Rachael Padgett, and Ariel Amaru.
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"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.
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"Torts – Watching the Growing Multi-Plaintiff Challenge," Crowell & Moring's Litigation Forecast 2019
(January 9, 2019).
Contributor: Andrew D. Kaplan.
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"Regulatory Forecast 2016: What Corporate Counsel Need to Know for the Coming Year," a Crowell & Moring LLP publication
(January 2016).
Contributor.
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"Food & Beverage — The Belt Gets Tighter," Crowell & Moring's Regulatory Forecast 2016
(January 2016).
Contributors: John Fuson and Andrew Kaplan.
Client Alerts & Newsletters
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"Hospitals Can Be Strictly Liable For Allegedly Defective Drugs, Appellate Court Finds,"
Mass Tort, Product, and Consumer Litigation Alert
(December 23, 2022).
Contacts: Andrew D. Kaplan, Hilary Johnson, Robbie Rogart Jost
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"10 Ways to Reduce Cyberattack Risks on Internet-Connected Medical Devices,"
Mass Tort, Product, and Consumer Litigation Alert
(September 24, 2021).
Contacts: Andrew D. Kaplan, Robbie Rogart Jost, Mimi S. Dennis
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"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
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"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
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"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 Jost
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"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
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"Shifting Liability: AI in Medical Devices,"
Mass Tort, Product, and Consumer Litigation Alert
(February 19, 2020).
Contacts: Andrew D. Kaplan, Hilary Johnson
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"Supreme Court Decision Raises New Questions on Impossibility Preemption in Cases Challenging Sufficiency of Drug Label Warnings,"
Mass Tort, Product, and Consumer Litigation Alert
(June 7, 2019).
Contacts: John Fuson, Andrew D. Kaplan, Robbie Rogart Jost
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"FDA Promotes Evolving Regulation of Medical Device Materials,"
Mass Tort, Product, and Consumer Litigation Alert
(April 8, 2019).
Contact: Andrew D. Kaplan
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"'Natural' Claims: FDA Requests Comments on Use of the Term 'Natural' on Food Labeling,"
Advertising & State AG Alert
(November 13, 2015).
Contacts: Cheryl A. Falvey, John Fuson, Andrew D. Kaplan
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"FDA Loses Battle to Limit Truthful, Non-Misleading Off-Label Promotion of Approved Drugs,"
Advertising & State AG Alert
(August 2015).
Contacts: Andrew D. Kaplan, Robbie Rogart Jost
Press Coverage
Firm News & Announcements