National Product Liability, Toxic Tort & Health Care Litigation
Kelly has a national litigation practice focusing on complex litigation of all types including product liability, toxic tort and health care litigation with significant experience in FDA and EPA regulated products. She regularly serves as national and regional counsel in New York and New Jersey defending clients in a variety of matters including class actions, multidistrict litigation (MDLs) and state coordinated litigation. She has represented numerous pharmaceutical, medical device, nutritional supplement, agricultural and chemical manufacturers and health care organizations in mass torts and single plaintiff cases throughout the country involving complex scientific, medical and regulatory issues.
Her practice has given her a keen understanding of regulated industries. Representative clients include: manufacturers and distributors of brand-name and generic pharmaceuticals, medical devices, over-the-counter drugs, biologics, vaccines, dietary supplements, homeopathic products, cosmetics and food; as well as manufacturers of consumer products, hair dyes, pesticides, laboratory chemicals, industrial equipment and building materials. Kelly also defends health care and long term care companies in a variety of litigation matters.
In addition to her extensive experience defending product liability litigation, Kelly advises life science companies concerning pre-litigation risk assessments; recalls and market withdrawals; company submissions to FDA, including package inserts and other labeling; direct-to-consumer advertising; website and social media content; sales and training materials and pharmacovigilance.
Kelly has represented a number of large corporations in complex consumer products class actions and false advertising matters involving FDA-regulated products, such as cosmetics and dietary supplements. She regularly defends businesses in high-stakes cases involving consumer protection laws, warranty claims and false advertising related to nutrition and health claims. Kelly also has experience defending companies facing class actions who have been alleged of violating the Telephone Consumer Protection Act and other federal and state laws related to website content and accessibility.
Kelly applies her vast litigation and negotiation skills to many other types of cases. She regularly handles general liability/negligence cases and business and commercial litigation, from simple breach of contract disputes to complex litigation involving extensively detailed agreements.
RECENT PUBLICATIONS + SPEAKING ENGAGEMENTS
A nationally recognized lawyer, Kelly has authored key articles in leading life-science journals and presented on numerous topics at national seminars addressing issues such as defense of products liability claims, as well as topics such as adverse event reporting, product recall management, preemption, social media use for FDA-regulated companies, bellwether selections and e-discovery. Some of her more recent examples include:
- "Unanimous Approval Received for Amendments to Federal Rule of Evidence 702: Testimony of Expert Witnesses," Harris Beach Legal Alert (June 2022).
- "Harris Beach Victory in Criminal Pro Bono Case – Violation of Temporary Restraining Order Dismissed by New Jersey Court," Harris Beach In The News, October 2021.
- "PFAS: Navigating a New Frontier in Environmental Regulation," Harris Beach Legal Alert, October 2021.
- "Regulatory and Legal Risks on the Rise in the Post-Pandemic Era," Sedgwick US Recall Index 2021 Edition 1 (pages 31 and 32).
- "New York High Court Recognizes 'American Pipe' Cross-jurisdictional Class Action Tolling but Dismissal Restarts the Clock," Harris Beach Legal Alert (December 2020).
- “Buckman Implied Preemption Wipes Out Misbranding Claims that a Product is Not a Cosmetic but a Drug,” DRI For the Defense – newsletter of the DRI Drug and Medical Device Committee, (October 2020).
- "New Jersey Reinforces the Trial Judge’s Gatekeeper Function in Expert Admissibility," Harris Beach Legal Alert (September 2020).
- “And Now a Word from the Panel - Current Trends and Hot Topics Emerging in Products Liability MDLs and State Coordinated Litigation,” Speaker, DRI Annual Meeting (October 2018).
- “Discussion with John O. Brennan, Former Director of CIA,” Speaker, DRI Annual Meeting (October 2017).
- “A Changed Ireland, a Changed World, a Changed Diaspora—Panel including Enda Kenny, TD and former Taoiseach (Prime Minister) of Ireland,” Speaker, The Ireland Funds Conference (June 2017).
- “E-Discovery in Mass Tort Litigation," Panel Speaker (with Hon. Shira A. Scheindlin), Mass Tort Judicial Forum (March 2017).
- “Best Practices: Is your care facility subject to New York Public Health Law § 2801-d?” DRI, MedLaw Update (March 2017).
- "Significant Choice of Law and Statute of Limitations Decision from New Jersey Supreme Court," Harris Beach Legal Alert (January 2017).
- “To Report, or Not to Report- That is a Dietary Supplement Company’s Question: How to Counsel Clients in the (Adverse) Event of a Post-Market Incident,” DRI, Rx For The Defense (October 2016).
- “ADR for Complex Claims and Multi-District Litigation: Choosing and Using the Most Effective Resolution Instruments for Drug & Medical Device Claims,” Panel Speaker (with Hon. Marina Corodemus), LexisNexis (August 2016).
- "Hot Off the 3-D Press: Additive Manufacturing's Effect on Medical Device Companies," DRI, The Voice (March 2016).
- "The Road to Partnership--Strategy and Perseverance," chapter in Young Lawyer’s Guide to Defense Practice, DRI (June 2015).
- “An Ounce of Prevention – Six Tips for Nutritional Supplement Companies,” DRI, In-House Defense Quarterly (Summer 2015).
- "Drawing the Line between Liquid Dietary Supplements and Beverages: What Every Dietary Supplement Manufacturer Needs to Know," DRI, Strictly Speaking (August 2014).
- "FDA Approval – Modification & Off Label Use," Panel Speaker (with Hon. Faith S. Hochberg and Hon. Richard A. Kramer), Mass Tort Judicial Forum (April 2014).
- “Negligent Sale Liability: A Troubling Attempt to Create an Unrecognized Duty for Medical Device Manufacturers,” DRI, Rx for the Defense (March 2014).
- “Innovator Liability for Brand-Name Pharmaceutical Makers Rejected,” New York Law Journal (January 15, 2014).
- “TED Talk: Welcome to Virtual Reality – Productivity in the Aftermath of Hurricane Sandy,” Speaker, DRI Annual Meeting (October 2013).
- "Fitting a Square Peg in a Round Hole: Harmonizing Current FDA Promotion Rules in the World of Social Media," Speaker, DRI Drug & Medical Device Seminar (May 2013).
- "Federal State Coordination: Coordination, Cooperation, Coercion," Panel Speaker (with Hon. Cynthia M. Rufe and Hon. Richard A. Kramer), Mass Tort Judicial Forum (March 2013).
- “FDA Off-Label Promotion Rules in the World of Social Media,” DRI, For the Defense (November 2012).
- “Mensing Changes Landscape for Generic Drug Manufacturers,” New York Law Journal (April 23, 2012).
- "PCBs from A to Z: A Re-Emerging Toxic Tort Concern," DRI, For the Defense, (January 2012).
- “The Importance of Hazard Analysis and Document Management under the FDA’s Food Safety Modernization Act,” DRI, In-House Defense Quarterly (July 2011).
- “The Un-Generic Problems with Generic Pharmaceuticals: Supreme Court Decisions, Preemption & More,” Panel Speaker (with Hon. Carol A. Higbee and Hon. Jessica R. Mayer), Mass Tort Judicial Forum (June 2011).
- “Staying in the Game: E-Discovery with a Live Pharmaceutical Product ”DRI, For The Defense (October 2010).
- “AER’ing on the Side of Caution - Complying with the FDA’s Adverse Event Report System for Dietary Supplements and Nonprescription Drugs,” DRI, For The Defense (February 2008); reprinted in San Diego Defense Lawyer’s The Update (April 2008).
- “Navigating the FDA's RiskMAP Guidance,” Products Liability Law & Strategy (January 2006).