Colleen M.Heisey

Partner

(T) + 1.202.879.3449

Colleen Heisey's practice focuses on food and drug law with a particular emphasis on product promotion and advertising, compliance counseling, good manufacturing practice requirements, product recalls, FDA inspection, competitor issues, and enforcement actions. She has advised on issues surrounding the regulation of drug, biological, food, dietary supplement, medical device, and cosmetic products by the FDA, USDA, and other federal and state agencies.

Colleen has substantial experience with regulatory oversight and compliance assessment for due diligence audits of drug, medical device, and food companies, including those related to product safety, product labeling, product marketing and advertising, and consumer complaints. She regularly provides legal support for pharmaceutical and device advertising and promotional activities, sales and marketing, and development of practitioner-oriented and direct-to-consumer print and broadcast advertising. Colleen has conducted audits and inspections of pharmaceutical and medical device company policies, procedures, and programs, including drug sampling, adverse event reporting, medical information management, and unsolicited requests. She has advised clients regarding matters related to the False Claims Act and Anti-Kickback Statute, reviewed and commented on strength of clinical trial designs in drug and device development and as potential support of product marketing, and has assessed proposed brand names for drug products in development for potential claims and product confusion, including appraisal of drug name similarity reports by third-party vendors. She has worked with regulated industry to develop and implement comprehensive regulatory compliance programs.

Colleen has written extensively on the food and drug industry.

Experience

  • Shore Capital Partners portfolio company acquires MD Resource CorpJones Day represented Shore Capital Partners LLC in connection with the acquisition by portfolio company Innovia Medical of Medical Device Resource Corporation, a manufacturer and distributor of liposuction and fat transfer systems for the plastic and cosmetic surgery markets.
  • Cortec Group sells WU Holdco to The Carlyle Group and TA AssociatesJones Day advised the Cortec Group in the sale of WU Holdco, Inc., the holding company for Weiman Products, LLC and Urnex Brands, LLC, which are leading developers, manufacturers, and distributors of specialty cleaning products for the consumer and commercial markets, to The Carlyle Group and TA Associates.
  • IZI Medical Products acquires soft tissue biopsy and breast localization needle assets from Cook MedicalJones Day represented Shore Capital Partners, LLC in connection with the acquisition by portfolio company, IZI Medical Products, LLC, of select soft tissue biopsy and breast localization needle assets from Cook Medical.
  • Western Allegheny Capital acquires Oberg IndustriesJones Day advised Western Allegheny Capital in connection with the acquisition and related financing of Oberg Industries, a full-service contract manufacturer of precision machines and stamped components located in Pittsburgh, Pennsylvania.
  • PPC Flexible Packaging acquires Temkin InternationalJones Day represented Morgan Stanley Capital Partners and its portfolio company, PPC Flexible Packaging, LLC (“PPC”), in PPC’s acquisition and related financing of Temkin International, LLC and the assets of Temkin Packaging Colombia S.A.S. (together, “Temkin”).
  • Riverside sells stake in Team Technologies to Clearlake Capital GroupJones Day represented The Riverside Company in connection with the its sale of stake in Team Technologies Inc., a leading custom design and manufacturing partner to many of the world’s leading brands in the dental, cosmetic, and medical industries, to Clearlake Capital Group, L.P.
  • Conagra Brands acquires Pinnacle Foods for $10.9 billion in cash and stockJones Day advised Conagra Brands, Inc. in connection with the acquisition and related financing of Pinnacle Foods Inc. in a $10.9 billion merger.
  • EagleTree Capital acquires majority interest of Gaylord Chemical Company, LLCJones Day advised EagleTree Capital in its acquisition of a majority interest in and related financing of Gaylord Chemical Company, LLC, a specialty chemical producer.
  • Shore Capital Partners acquires Eagle LaboratoriesJones Day represented Shore Capital Partners, LLC in connection with its acquisition of Eagle Laboratories, a manufacturer and distributor of ophthalmic products, focusing on single-use cannula, micro-surgical knives, and blades.
  • Nelson Labs acquires Gibraltar Laboratories, Inc.Jones Day advised Sotera Health's Nelson Labs business in its acquisition of Gibraltar Laboratories, a leading outsourced provider of microbiology and analytical chemistry testing for pharmaceutical and medical device manufacturers.
  • Riverside sells Tate’s Bake Shop to Mondelez International for $500 millionJones Day represented The Riverside Company in connection with the sale of Tate’s Bake Shop to global snacks company Mondelez International, Inc. for approximately $500 million.
  • Gryphon Investors acquires majority interest in Water’s Edge DermatologyJones Day represented Gryphon Investors, Inc. as its regulatory counsel in connection with its acquisition of a majority interest in Water’s Edge Dermatology, a leading provider of comprehensive dermatology services in Florida.
  • DoseLogix joins Riverside’s Team Technologies platformJones Day represented The Riverside Company’s affiliate, Team Technologies, Inc., in connection with the add-on acquisition and related financing of DoseLogix, LLC, a Georgia-based designer of metered dosing dispensers and applicators, which are marketed to compound pharmacies for use with topical medications.
  • Shore Capital Partners acquires Network Medical ProductsJones Day represented Shore Capital Partners, LLC in connection with its acquisition of Network Medical Products Ltd., a designer and manufacturer of sterile single use products for ENT and Ophthalmic procedures.
  • LeBaronBrown Industries acquires American International Chemical, Inc.Jones Day advised LeBaronBrown Industries LLC in connection with the acquisition and related financing of a majority interest in American International Chemical Inc., a leading specialty chemical and ingredients distributor based in Framingham, Massachusetts.
  • Smith & Nephew acquires Rotation Medical Inc. for up to $210 millionJones Day advised Smith & Nephew plc in its acquisition of Rotation Medical Inc., a developer of a novel tissue regeneration technology for shoulder rotator cuff repair, for an initial cash consideration of $125 million and up to $85 million over the next five years, contingent on financial performance.
  • Ambry Genetics sold to joint venture formed by Konica Minolta and Innovation Network for up to $1.0 billionJones Day advised Ambry Genetics Corporation, a leading genetic testing corporation, in its sale to a newly formed joint venture between Konica Minolta, Inc. and Innovation Network Corporation of Japan for up to $1.0 billion (including earnouts).
  • AGIC Capital acquires Fotona from The Gores GroupJones Day advised Asia-Germany Industrial Promotion Limited ("AGIC Capital"), an Asian-European private equity investor focused on industrial technology companies in the European and North American mid-market, in connection with the acquisition and related financing of Fotona, a U.S. and Slovenia based developer of high-tech laser systems and components, primarily used in medicine, aesthetics, surgery, gynecology, and dentistry, from private equity firm, The Gores Group.
  • Pharmaceutical company seeks advice on regulatory reporting obligationsJones Day counsels a major pharmaceutical company in connection with regulatory reporting obligations in more than 40 countries regarding diverted, counterfeited, tampered with, or lost or stolen pharmaceutical product.
  • Shore Capital Partners portfolio company acquires TheraBond® family of products from Alliqua BioMedicalJones Day represented Shore Capital Partners, LLC in connection with the acquisition by portfolio company, Argentum Medical, LLC, a manufacturer of innovative wound care products, of TheraBond® family of products from Alliqua BioMedical, Inc., a regenerative technologies company committed to restoring tissue and rebuilding lives.
  • Speaking Engagements

    • January 2019
      Blockchain in Healthcare, New York State Bar Association Annual Meeting
    • May 4, 2016
      Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
    • December 9-10, 2015
      Enforcement, Litigation, & Compliance The Food and Drug Law Institute (FDLI)
    • October 15-16, 2015
      ABA/MDMA/FDLI Medical Device Law 2015
    • October 1-2, 2015
      Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries, The Food and Drug Law Institute
    • July 16, 2015
      ABA's FDA Drug Law Fundamentals, Webinar
    • November 12, 2014
      ABA's Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion webinar
    • September 10, 2014
      Presentation to Mansfield-PhRMA Fellows: How U.S. Law Firms Help Their Clients Bring Pharmaceuticals and Biologics to Market
    • May 18, 2014
      ATA Telemedicine Venture Summit 2014
    • May 6, 2014
      Executive Roundtable Series: New Frontiers in Health Care and Life Sciences; A Look at the Legal Implication
    • February 20, 2014
      The Digital Health Revolution: How Law is Shaping the Next Frontier in Health Care Delivery, Health Law and Justice Society
    • November 13, 2013
      2013-2014 Life Sciences Webinar Series: Intellectual Property, Regulatory, and Antitrust Issues in Life Sciences M&A and Capital Markets Transactions
    • October 24, 2013
      FDA Fundamentals: FDA Drug Approval and Oversight, American Bar Association
    • September 11, 2013
      Healthcare Technology Approvals, Clearances and Commercialization, Angel Venture Forum’s Cyber Security & Healthcare Investment Conference
    • August 1, 2013
      Successfully Navigating FDA Citizen Petitions and Responses
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