Cosmetic Industry Class Actions: Navigating New Risks Under Modernization of Cosmetics Regulation Act
Unapproved Drug Claims, Product Performance, False and Misleading Advertising, Mislabeling
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will examine consumer class actions targeting the cosmetics industry under the increased scrutiny by the FDA as it continues implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The panel will consider the possible impact of Loper Bright and how new FDA requirements already have and are expected to fuel class litigation. The panel will discuss theories of liability and strategies for defending and settling claims. The panel will also discuss proactive steps clients should take to minimize their exposure to class claims in light of increased FDA scrutiny and regulation.
Outline
- History of cosmetics regulation in the U.S.
- New requirements and FDA enforcement powers
- Regulation of good manufacturing practices
- Claims
- Defenses
- Strategies for plaintitff and defense
Benefits
The panel will review these and other important issues:
- How does adverse incident reporting (or failure to report) create risk of class litigation?
- What is the difference between asserting that conduct violates the FDCA and attempting to enforce the FDCA?
- What defenses may be available under MoCRA?
Faculty
Christopher E. Gottfried
Of Counsel
Greenberg Traurig
Mr. Gottfried focuses his practice on health care, as well as administrative and regulatory matters. He represents... | Read More
Mr. Gottfried focuses his practice on health care, as well as administrative and regulatory matters. He represents clients such as executives at large physician practice groups and hospital chains, compounding pharmacies, managed care organizations, ambulatory surgical centers, and home health agencies. Mr. Gottfried has experience working with numerous federal and state governmental agencies, and handles matters concerning the federal and Florida Anti-Kickback Statutes, the federal Stark Law, the federal and Florida False Claims Act, the federal Food, Drug, and Cosmetics Act, Florida’s Patient Brokering Act, and various hospital and physician billing laws and regulations.
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Eleanor A. (Miki) Kolton
Of Counsel
Greenberg Traurig
Ms. Kolton has wide-ranging legal, administrative and management experience in medical practice law; HIPAA, Stark,... | Read More
Ms. Kolton has wide-ranging legal, administrative and management experience in medical practice law; HIPAA, Stark, Medicare and CMS regulations; with the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); and other civil and administrative law areas. She possesses executive corporate experience and broad clinical background in a variety of health care settings, including the ability to understand scientific and medical community cultures, business challenges and concerns.
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Gretchen N. Miller
Shareholder
Greenberg Traurig
Ms. Miller is the Co-Chair of the Products Liability & Mass Torts Practice and focuses her practice in toxic... | Read More
Ms. Miller is the Co-Chair of the Products Liability & Mass Torts Practice and focuses her practice in toxic tort, product liability, and class action litigation in state and federal courts. She is a trial lawyer with experience, both as first and second chair trial counsel, defending manufacturers against claims of product defect for industrial, automotive, and medical products on a national basis. As national counsel, Ms. Miller oversees products liability, toxic tort, and commercial litigation nationwide and counsels clients on risk management strategies. She also has wide-ranging experience litigating complex and mass tort litigation, both in the products liability and toxic tort context. In addition to her litigation practice, Ms. Miller counsels manufacturers, distributors and retailers regarding product safety issues and regulatory compliance. Her practice includes counseling clients on compliance with federal and state regulations, including regulations enforced by the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, and providing guidance with recalls and recall procedures.
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Ginger Heyman Pigott
Shareholder
Greenberg Traurig
Ms. Pigott provides critical product liability advice and litigation defense to emerging and established businesses. As... | Read More
Ms. Pigott provides critical product liability advice and litigation defense to emerging and established businesses. As a shareholder in the Pharmaceutical, Medical Device & Health Care Litigation Practice, she manages products liability litigation matters with an emphasis on the defense of complex medical device and pharmaceutical products. Ms. Pigott handles high-stakes, single-plaintiff cases (including through trial) and complex litigation, including MDLs, coordinated state actions and class actions working as both national and regional counsel. She also works with companies to reduce and eliminate litigation risk through essential assessment and review of potential product liability exposure, including helping to organize and establish more effective claims handling in pre-litigation as well as in identifying and reducing risk producing activities and providing information to allow companies to understand triggers for potential exposure and manage such risks. In addition, Ms. Pigott has worked on a wide variety of other product liability matters, including welding products and consumables, automobiles, buses and private shuttles, airplanes, helicopters, rocket propelled parachute systems, soft drinks, and video games.
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