Michael A. Walsh
Michael Walsh’s practice is focused on defending toxic exposure, product liability, and commercial matters and counseling clients in FDA-regulated industries on compliance and enforcement matters related to manufacturing, supply, and distribution.
He serves as national coordinating counsel, regional trial counsel, and as local Texas counsel in complex environmental and product liability litigation, and regulatory enforcement matters involving a wide range of industries and products.
He has been published extensively and is an invited speaker on product liability, regulatory compliance, advertising, labeling, marketing, promotion, social media, and the First Amendment issues. He founded the Texas Food and Drug Law Forum, an educational program for lawyers and senior executives and is the author of “The Supply and Distribution of FDA Regulated Products”, a law book published by Thompson Reuters.
Michael has chaired the Products Liability and Food, Drug & Medical Device Industry Teams for more than twenty years, and is the Chair Emeritus of the Federation of Defense and Corporate Counsel’s (FDCC) Drug Device and Biotech Law Section.
- Federation of Defense & Corporate Counsel, Drug Device and Biotechnology Section, Chair
- Defense Research Institute, Drug and Device Committee
- Dallas Bar Association, Member
- New York City Bar Association, Member
- New York State Bar Association, Member, Food and Drug Law Committee
- American Bar Association, Litigation Section
- Association of Food and Drug Officials, Laws and Regulations Committee
State Bar Licenses
- National coordinating counsel and MDL counsel in proceedings mass tort product liability litigation involving toxic exposure, consumer fraud, trespass, nuisance, and property damage.
- National coordinating counsel and defense liaison counsel in consolidated proceedings, state and federal MDL counsel, as well as Texas counsel for pharmaceutical and medical device manufacturers, distributors, and retailers.
- Prior to joining Clark Hill’s Dallas office in 1994, he practiced in New York City as a trial lawyer handling a broad range of matters including securities, commercial, foreclosure, real estate, intellectual property, pharmaceutical mass tort, toxic tort, and environmental contamination matters.
- Texas counsel for the Customs and Tax Administration of the Kingdom of Denmark in a worldwide tax fraud scheme.
- Negotiated and drafted numerous quality, supply, manufacturing, and distribution agreements for raw material and component suppliers, manufacturers, copackers, distributors, and retailers of FDA-regulated products (food, drug, medical device, dietary supplement, cosmetics).
- Resolved disputes between manufacturers and large national retailers over misbranding and labeling compliance issues.
- Coordinated national recalls of misbranded food products and meat products and negotiated enforcement with the FDA.
- Counseling regarding import compliance for toxic element exceedances.
- Responded on behalf of manufacturers to FDA warning letters for food suppliers and medical device manufacturers.
- Review product launch and social media materials for OTC and Class II medical devices.
- Advised cosmetic manufacturers on labeling compliance and product classification issues.
- Created Social Media policies and procedures for online content.
- Counseled device manufacturers on Sunshine Act compliance and the CMS Open Payments program.
- Counsel manufacturers on labeling content for OTC, cosmetic and dietary supplement products.
- Analysis of supply chain agreements and policies and negotiation of terms.
- Counseled on master vendor supply agreement for Contract Research Organization.
- Established Compliance programs, including SOPs for OTC, compounding, and dietary supplement manufacturers.
- Compliance counseling regarding FDA enforcement in connection with laboratory facility.
- Resolved federal enforcement and investigation concerning the use of unapproved foreign manufactured drugs for medical facilities.
- Advise physicians and product developers on the development and marketing of combination products, compounded products, and dietary supplements.
- Advise on acquisition of a clinical trials company and establishment of risk factors for Private Placement.
- Advise on sale of biologics company.
- Food Safety Modernization Act (FSMA) compliance and food safety plan updates for large national food distributors.
- Advised regional restaurant chain on licensing issues and State regulatory enforcement related to Texas Home Rule provisions.
- Advised large regional convenience store chain on federal menu labeling requirements.
- Product launch and labeling review and FDA compliance for sunscreen products and compliance review regarding 510k issues.
- Negotiated with state regulators concerning product adulteration, detention, and corrective action for food manufacturers (dairy).
- Counsel on new dietary ingredients.
- Resolved non-compliance with Prior Notice of Imported food regarding the importation of food products.
- Negotiation California Prop 65 claims regarding alleged elevated levels in food products and other products.
- Advise food packaging manufacturers and importers on food contact substance requirements and regulations.