Manufacturers in the pharmaceutical/life sciences and medical device sectors face growing pressures stemming from regulation, pricing, competition and potential product liability.

Montgomery McCracken’s attorneys offer a depth of experience in related legal and business disciplines, ranging from compliance, intellectual property, manufacturing, labeling and distribution issues, to environmental, employment, labor and immigration, to the defense of governmental and complex product liability or consumer protection claims.

In addition to the above services, our attorneys provide legal guidance on general business counseling, licensing, manufacturing arrangements, distribution arrangements, administration of employee benefit programs, compensation packages, immigration issues, preventive practical advice on workplace problems, including arbitration and other alternative dispute programs and a variety of broader human resource matters, and preventive risk management.

Recent engagements

  • Represented pharmaceutical companies in criminal and civil investigations relating to False Claims Act claims, anti-kickback allegations, challenges to nominal pricing and “best price” issues, and AWP challenges.
  • Represented a drug wholesaler in a national price-fixing case.
  • Designed and helped implement compliance programs for a major pharmaceutical company to detect sales and distribution issues and problems before they result in regulatory violations or litigation.
  • Advised a major drug wholesaler on anti-trust concerns, including price restrictions and price discrimination, related to the client’s distribution network and contracts.
  • Represented a drug manufacturer in an antitrust case involving FDA approval of generic substitutes for a branded drug.
  • Represented a manufacturer of products for drug delivery systems with respect to environmental and worker safety issues.
  • Represented pharmaceutical and medical device companies in significant product liability cases.
  • Structured consulting agreements between medical device and pharmaceutical companies and physicians and medical researchers.
  • Assisted a major pharmaceutical company with all immigration issues related to the hiring and movement of its multi-national work force.