Background - Practices (Details)

Medical Devices

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Representative Engagements

Regulatory Counseling and Compliance

  • Supported internal investigations and advised on responses to related FDA inquiries following reports of serious adverse events related to use of a medical device.
  • Guided evaluations of appropriate FDA pre-market review pathways for new product proposals and counseled on and prepared communications to FDA in support of those determinations.
  • Provide business counseling and regulatory advice to support a leading technology company with its larger, strategic commercial partnerships with health systems for the development of artificial intelligence (AI) and machine learning in health care.
  • Reviewed and counseled on promotional practices, including evaluation of off-label claims.
  • Reviewed and counseled on evolving regulatory requirements applicable to in vitro diagnostic tests.

Litigation

  • U.S. national counsel for products liability litigation for international medical device company. Successfully defended company in dozens of hip implant lawsuits and claims over past eight years without a single adverse judgment or settlement.
  • National counsel for one of the largest U.S. health care and medical device companies in IVC filter litigation involving thousands of claims in more than ten U.S. jurisdictions and in Canada.
  • National counsel for medical device manufacturer in product liability litigation over vascular closure device.
  • National counsel for medical equipment distributor in all product liability litigation.
  • Representation of a major medical device manufacturer in responding to a whistleblower complaint alleging that the company paid kickbacks to certain "group purchasing organizations" (GPOs) in order to qualify its medical devices for eligibility for purchase by the GPO's hospital members.
  • Served as expert to review and evaluate U.S. litigation strategy for national docket of high-risk medical device litigation.

Diligence and Related Counseling

  • Served as due diligence counsel for fortune 50 U.S. company in acquisition of medical device technology.
  • Served as due diligence counsel for top 10 U.S. medical device company in distribution agreement with Israeli medical device company.
  • Provided diligence counseling for top medical device manufacturer in potential product acquisition and distribution agreements.
  • Acted as product liability due diligence counsel international medical device company in acquisition of domestic medical device company.
  • In the acquisition by managed care plan Centene Corporation of various physician practices, our team performed the health care strategic and regulatory due diligence in connection with its purchase of a majority interest in a medical management services organization and provider of in-home health services for high acuity populations.

Corporate & Transactional

  • Advised major U.S. medical device company in distribution agreement.
  • Represented a California surgery center in connection with the sale of its business to a leading surgical services provider.
  • Represented a software company in its acquisition of assets and the formation of a joint venture to develop software for the public health sector.
  • Represented hospital operator and other health care facilities in asset sale and joint venture transactions involving hospitals and ambulatory surgery centers.
  • Represented an international food supplement and drug development company in the outsourcing of certain development and distribution services and clinical trial services with respect to new drugs and food supplements.

Domestic and International Government-Related Matters

  • Spearheaded the world’s largest public-private partnership – encompassing over 1,500 collaborating organizations, spanning government, industry, and patient organizations – to strengthen ethical business practices for the medical device industry, by delivering high-standard codes of ethics to 10 countries, including China, where they previously did not exist.
  • Advised a foreign government in developing a national digital health strategy.
  • Reviewed and counseled on evolving regulatory requirements applicable to in vitro diagnostic tests and digital health software, including clinical decision support and artificial intelligence products.
  • Executed a government affairs strategy before relevant health & trade ministries in Thailand for a U.S.-based, global medical device company facing a regulatory change which threatened their supply chain.
  • Engaged by a major medical device company to help strengthen health systems and the business environment in emerging economies by promoting value-based healthcare within the Association of Southeast Asian Nations (ASEAN), along with complimentary bilateral government affairs engagement.
  • Worked with regulators and industry to create a Regulatory Harmonization Steering Committee within the 21 member Asia Pacific Economic Cooperation (APEC) forum tasked with achieving convergence on regulatory approval procedures for medical products, including on medical devices.
  • Lobbied the U.S. Congress for a delay in the implementation of the Affordable Care Act Medical Device Tax and sought permanent repeal of the tax.