Walsh mike web

Michael A. Walsh

Member
Office

Dallas

901 Main Street
Suite 6000
Dallas, TX 75202
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Fax: 214.659.4085
Education
J.D., Case Western Reserve University School of Law, Cleveland, Ohio, 1985
B.A., Berklee College, 1980
State Bar Licenses
Texas
New York
Court Admissions
U.S. Court of Appeals, 5th Circuit
U.S. Court of Appeals, 2nd Circuit
U.S. District Ct., E.D. of Texas
U.S. District Ct., N.D. of Texas
U.S. District Ct., S.D. of Texas
U.S. District Ct., W.D. of Texas
U.S. District Ct., S.D. of New York
U.S. District Ct., E.D. of New York
U.S. District Ct., District of Maryland
U.S. District Ct., W.D. of Texas

Michael A. Walsh

Member

Mike devotes his practice to counseling clients in FDA regulated industries on issues related to labeling, compliance and transportation.  He has extensive experience defending clients in complex administrative law and litigation matters, and has served as national coordinating counsel, regional trial counsel and as local Texas counsel. He is the founder of the Texas Food Law Forum, a daylong educational program designed for lawyers and senior executives in the food industry. He is the author of the law book “The Supply and Distribution of FDA Regulated Products” published by Thompson Reuters.  He is a frequent writer and speaker on issues related to compliance and litigation for FDA regulated industry and is regularly published on issues concerning compliance, advertising, labeling, marketing, promotion, social media and the First Amendment.

Mike currently serves as chair of the firm’s Food, Drug & Medical Device Industry Team, and is the Chair of the Federation of Defense and Corporate Counsel’s FDA Law Section.

EXPERIENCE

LITIGATION

  • National coordinating counsel and MDL counsel to large national owner of convenience stores in multiple MDL proceedings in the Southern District of New York.
  • Served as national coordinating counsel, liaison counsel in consolidated proceedings, state and federal MDL counsel, as well as Texas counsel for manufacturers,
  • distributors and retailers in mass tort, toxic exposure, consumer fraud, nuisance, and property damage actions.
  • Prior to joining Strasburger’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.
  • Lead counsel in Federal Circuit Court of Appeals on issues concerning federal preemption for prescription drug products.
  • Lead Texas counsel for the Customs and Tax Administration of the Kingdom of Denmark in a world-wide tax fraud scheme.

COMPLIANCE COUNSELING

  • Resolved dispute between manufacturer and large national retailer over misbranding and labeling compliance issues Negotiated multiple copacking agreements for distributors and major retailer
  • Responded on behalf of manufacturer to FDA warning letter for medical device
  • Review product launch and social media materials or OTC and Class II medical device.
  • Advised cosmetic manufacturer on labeling compliance and product classification issues.
  • Created Social Media policies and procedures for online content.
  • Counseled device manufacturers on Sunshine Act compliance and 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.
  • Negotiated manufacturing agreements for food, dietary supplement, OTC and cosmetic manufacturers and marketers.
  • Counseled on master vendor supply agreement for Contract Research Organization.
  • Established Compliance programs, including SOPs for OTC, compounding and dietary supplement manufacturers.
  • Address compliance regarding FDA 483 issues in connection with laboratory facility.
  • Resolved federal enforcement and investigation concerning use of unapproved foreign manufactured drugs for medical facilities.
  • Advise physicians and product developers on development and marketing of combination products, compounded products and dietary supplements.
  • Advise on acquisition of clinical trials company and establishment of risk factors for Private Placement.
  • Advise on sale of biologics company and negotiation of representations.
  • Food Safety Modernization Act (FSMA) advised client on contract revisions and updates for large national food distributor
  • Advised large national distributor on  new FSMA requirements and compliance issue
  • Coordinated national recall of misbranded food products and negotiated enforcement with FDA
  • Coordinated national recall of misbranded meat products and negotiated terms of recall and enforcement with USDA
  • 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 cosmetic brand and compliance review regarding 510k issues
  • Product launch labeling review and FDA compliance for OTC products, and review of manufacturing and supply agreements
  • Negotiated with state regulators concerning product adulteration, detention and corrective action for food manufacturer (dairy).
  • Food and dietary supplement label auditing.
  • Labeling counsel on new dietary ingredients.
  • Resolved non-compliance with Prior Notice of Imported food regarding importation of food products.
  • Negotiation California Prop 65 claims regarding alleged elevated levels in food products and other products.
  • Advise food packaging manufacturer and importer on food contact substance requirements and regulations.

Presentations

  • When Business as Usual Becomes a Crisis (grass is GRAS and Crisco is not), Global Food Law Current Issues Conference, Michigan State University School of Law, East Lansing, Michigan (June 2018)
  • Prescription Opioids: Controlled Substances, Uncontrolled Litigation, program topic and papaer), Defense Research Institute, DRI Drug and Device Litigation, New York, New York. (May 2018)
  • The Opioid Crisis: A Prescription for Intense Oversight, Investigations and Litigation Webinar, American Health Lawyers Association (April 2018)
  • Employers & Opioids: A Prescription for Risk, Society for Human Resources Management (November 2017)
  • Program Chair. The Opioid Dilemma - Pain and Punishment, Federation of Defense and Corporate Epedemic: Where We Are  & Where We Go From Here, Defense Perspective, Product Promotion and Distribution, Dallas, Texas (February 2017)
  • Compliance, Labeling, Enforcement & Penalities - 2017 Annual Conference & Trade Show: FDA &TTB Related Businesses, San Marcos, Texas (February 2017)
  • Food Law: What Every Texas Lawyer Needs to  Know: An Overview of Food Law in Texas, SBOT Website (January 2017)
  • The Food Safety Modernization Act, SBOT Webinar (January 2017)
  • FDA Law: Off-Label Use of Drugs and Medical Devices, SBOT Website (December 2016)
  • The Marketing Pendulum Has Swung: Civil and Criminal Liability and the New Paradigm, American Conference Institute's FDA Boot Camp (September 2016)
  • Program Chair. Food Law Forum, Strasburger & Price LLP (September 2016)
  • Moderator. Managing the Response, Strasburger's Food Law Forum (September 2016)
  • Panelist. Defending the Aftermath: Civil and Criminal Liability and the New Paradigm, Strasburger's Food Law Forum (September 2016)
  • Moderator. Analytical Ingredient and Product Testing and The Rise of Litigation, ABA Section of Litigation Food & Supplements Annual Workshop (June 2016)
  • Regulatory Changes and the Cost of Compliance/Enforcement Actions, Strasburger's Business & Law Forum (May 2016)
  • Start-to-Finish Handling: Food License, Permit and Certification Issues, National Business Institute Food Business Law Forum (May 2016)
  • Food Contracts - Drafting and Negotiating, National Business Institute Food Business Law Forum (May 2016)
  • Inspections, Detentions and Enforcement, National Business Institute Food Business Law Forum (May 2016)
  • FDA Enforcement and Litigation: Food and Drug Law, Dallas Bar Association (March 2016)
  • Managing the Crisis Before it Happens - Labeling Advertising and Promotion, American Conference Institute's FDA Boot Camp (March 2016)
  • Program Chair. Food Law Forum, Strasburger & Price LLP (November 2015)
  • Moderator. FDA Labeling, Strasburger's Food Law Forum (November 2015)
  • The Drug Supply Chain Security Act:  Summarizing the Act and Its Effect, ACI FDA Boot Camp (September 2015)
  • Food Drugs and Rock and Roll: The Evolution of Deference and the First Amendment, Tsai Talk @ SMU Law School (September 2015)
  • Moderator. The Changing Landscape of GRAS: PHO, GMO and More, Strasburger's Food Law Roundtable (September 2015)
  • The Drug Supply Chain Security Act: Summarizing the Act and Its Effect, ACI FDA Boot Camp (July 2015)
  • Dispensers' DSCSA Compliance, Strasburger Webinar (June 2015)
  • Brand-Threatening Recalls Presenter: FSMA Updates; Moderator: Industry Panel Preparing for the Unthinkable; Moderator: Panel discussion Total Recall or Not, Houston Food Law Forum (June 2015)
  • FDA's Regulation of Off Label Promotion and Emerging Issues, Webinar Q1 Productions (March 2015)
  • Co-Presenter. The Regulation and Dissemination of Off-Label Information, American Conference Institute's FDA Boot Camp (March 2015)
  • The Drug Supply Chain Security Act - Summarizing the Act and Its Effect on FDA Practice, American Conference Institute's FDA Boot Camp (March 2015)
  • Product Safety and Quality Global Compliance Emergency Action Planning Food Safety Modernization Act, Strasburger's Food Law Forum (February 2015)
  • The Drug Supply Chain Overview of Developments, PCSC/ASIS/NBSC Educational Conference (February 2015)
  • FDA and Social Media - A New Paradigm for FDA, Compliance OnLine (October 2014)
  • What You Need to Know about the Drug Supply Chain Security Act, FX Conference (October 2014)
  • The Drug Supply Chain Security Act - Summarizing the Act and Its Effect on FDA Practice, American Conference Institute's FDA Boot Camp (September 2014)
  • Use of Statistics in the Courtroom - Views of Two Lawyers and a Scientist, FDCC Annual Meeting (July 2014)
  • Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance (June 2014)
  • Emerging Issues: Surveying the Regulatory and Litigation Horizon 2014 Section of Litigation Food & Supplements Fourth Annual Workshop, Cargill, Inc. (June 2014)
  • Social Media: Using It to Your Advantage and Avoiding Liability, The Food and Drug Law Institute, Food Week(February 2014)
  • Regulation and Dissemination of Off-Label Information, Post-Approval Marketing Guidance and Preemption Protocols, American Conference Institute's FDA Boot Camp (March 2014)
  • Federal Oversight and Enforcement? The Food Modernization Act and the $5,000 Egg, Texas Assisted Living Association Conference (April 2014)
  • Speaker. Off-Label Promotion: A Case Study Civil Penalties, Criminal Enforcement and Tort Claims, American Conference Institute (September 2013)
  • Labeling, Social Media, and the First Amendment, Product Liability Conference (April 2013)
  • Panelist. Post-Approval Marketing Guidance and Preemption Protocols Master Class, American Conference Institute's FDA Boot Camp (March 2013)
  • Speaker. Basic Training in Core Regulatory Concepts for Life Sciences Lawyers, Business executives and Policy Analysts, American Conference Institute's FDA Boot Camp (September 2012)
  • Speaker. The FDA and Medical Products: Practices and Proposals for Internet and Social Media (July 2012)
  • Speaker. Food and Supplements Seminar, ABA Section of Litigation, Sara Lee Corporation (2012)
  • Speaker. Off-Label Promotion - Regulation and Dissemination, American Conference Institute's FDA Boot Camp (March 2012)
  • Speaker. Off-Label Promotion - Regulation and Dissemination, American Conference Institute's FDA Boot Camp (September 2011)

PUBLICATIONS

MEDIA

  • Four Key Takeaways From FDA's 2017 Enforcement Stats, Law360. Subscription required. (January 2018)
  • FDA, Industry Face Hurdles with Trump Reg. Overhaul, Law 360. Subscription required. (January 2017)
  • Product Liability Cases to Watch: Midyear Report, Law360. Subscription required. (June 2017)
  • FDA, Industry Face Hurdles With Trump Regulatory Overhaul, Law360. Subscription required. (January 2017)
Memberships
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