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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

Michael A. Walsh

Member

Michael Walsh devotes most of his practice to defending complex litigation matters. He serves as national coordinating counsel, regional trial counsel and as Texas counsel in a wide variety of tort and product liability litigation matters, including environmental claims and claims involving Food and Drug Administration (FDA) regulated businesses, such as food, dietary supplements, drugs and medical devices.\n\nMike is a frequent writer and speaker on issues related to FDA litigation and compliance issues, and has been published on issues concerning advertising, labeling, marketing, social media, off-label promotion and the First Amendment.

Mike currently serves as chair of Clark Hill Strasburger's Food, Drug & Medical Device and Products Liability Industry Teams. He is the primary contributing author to the firm's Food and Drug Law Blog.

EXPERIENCE

  • Has 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.
  • Negotiated with state regulators concerning product adulteration, detention and corrective action for manufacturers (food, dairy, dietary supplements and medical devices).
  • Negotiated federal enforcement (FDA and USDA) related to product labeling for food (including dietary supplements and meat products), medical devices and compounded drugs.
  • Product recall counselling for major producers of meat products and distributor of specialty foods.
  • Respond to ongoing proposal product detection and seizure.
  • Resolved federal enforcement and investigations concerning use of alleged adulterated and misbranded unapproved foreign manufactured drugs.
  • Advise physicians and product developers on development and marketing of combination products, compounded products and dietary supplements.
  • Review of product labeling, advertising and online content, including social media, for medical device manufacturing products.
  • 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.
  • Advise food packaging manufacturer and importer on food contact substance requirements and regulations.
  • Food and dietary supplement label auditing.
  • Labeling counsel on new dietary ingredients.
  • Created Social Media policies and procedures for online content.
  • Resolved non-compliance with Prior Notice of Imported food regarding importation of food products.
  • 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.
  • Negotiation California Prop 65 claims regarding alleged elevated levels in food products and other products.
  • Address compliance regarding FDA 483 issues in connection with laboratory facility.
  • Lead counsel in Federal Circuit Court of Appeals on issues concerning federal preemption for prescription drug products.

Presentations

  • Employers & Opioids: A Prescription for Risk, Society for Human Resources Management (November 2017)
  • The Marketing Pendulum Has Swung: Civil and Criminal Liability and the New Paradigm, American Conference Institute's FDA Boot Campæ(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 Campæ(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: æSummarizing 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: æSummarizing the Act and Its Effect, ACI FDA Boot Camp (July 2015)
  • Dispensers' DSCSA Compliance, Strasburger Webinar (June 2015)
  • Brand-Threatening RecallsæPresenter: FSMA Updates; Moderator: Industry Panel Preparing for the Unthinkable; Moderator: Panel discussionæTotal 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 (Marchæ2015)
  • The Drug Supply Chain Security Act - Summarizing the Act and Its Effect on FDA Practice, American Conference Institute's FDA Boot Camp (Marchæ2015)
  • 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 (Octoberæ2014)
  • 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 Meetingæ(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

Awards/Achievements
Membership
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
American Bar Association, Litigation Section
Association of Food and Drug Officials, Laws and Regulations Committee
Practice Areas
Food, Drug & Device LawHealthcare Law
Areas of Emphasis
Product Liability
Industries
Healthcare