Kelsey Tavares

Products Liability and Mass Tort Actions

• Defended medical device companies in multi-district and mass tort coordinated actions involving allegedly defective implantable products;
• Represented multinational pharmaceutical and biotechnology companies in connection with individual product liability actions initiated after a voluntary recall of a combination pharmaceutical and medical device product;
• Defended a multinational healthcare and industrial conglomerate in lawsuits alleging their actions contributed to PFAS groundwater contamination;
• Defended a multinational medical device company in a product liability action filed in the District of Massachusetts which sought to require the company to make certain label changes;
• Monitored incidence of litigation involving ethylene oxide and advised on risk of liability to company on an ongoing basis; and
• Advised leading wireless network operator on product liability risks associated with new ventures involving emerging technologies.

Regulatory Representation

• Conducted legal review of promotional activities, including labeling and marketing claims for various life sciences, food, beverage, cosmetic, alcohol, and consumer products companies (including FDA, TTB, FTC, USDA, CPSC, and state and local agencies);
• Advised companies on product recall management, Warning Letter and 483 responses, risk mitigation, and regulatory compliance;
• Counseled clients on risks associated with implementation of innovative business strategies;
• Advised clients on agreements involving contract manufacturers and raw material suppliers (cGMP/ISO);
• Coordinated regulatory advice from counsel in Canada, Europe, Asia, and Latin America for clients with regulated products in multiple ex-U.S. jurisdictions;
• Counseled companies on state and federal permit and registration issues (FDA, USDA, TTB, CPSC, and state and local agencies); and
• Conducted regulatory due diligence on behalf of clients in corporate transactions involving regulated products.

Class Actions and Complex Commercial Disputes

• Represented multinational companies in connection with class action suits involving deceptive product labeling and advertising claims;
• Defended a multinational consumer technology company specialized in consumer electronics, software and online services in connection with consumer class actions;
• Represented a performing arts center facing claims of discrimination based on imposition of face mask mandate during the height of the COVID-19 pandemic; and
• Represented pro bono clients bringing a class action lawsuit challenging deficiencies in administration of SNAP Act entitlements.

• Co-author, "FDA’s Recent Guidance on Real-World Evidence and the Potential Impact for Mass Tort Litigation," American Bar Association, April 2022
• Co-author, "Compliance Tips For Marketing Health Benefits In Alcohol," Law360, October 2021
• Co-author, "EU Medical Device Regulation May Spur Litigation Uptick," Law360, May 2021