Sharon M. Bradley

Associate

Contact

  • Washington, DC
    p202.955.1978
    f202.828.3777
  • Washington, DC
    p202.955.1978
    f202.828.3777

Sharon's practice focuses on issues relating to the regulation of drugs, biologics, medical devices and other products regulated by the FDA and other federal and state agencies.

Sharon works with FDA-regulated companies on compliance-related investigations, development of regulatory compliance programs, evaluation of advertising and promotional materials, due diligence in product acquisitions, and litigation.

Sharon also has represented a variety of clients in products liability and mass tort litigation in federal and state court. Sharon participated regularly in hearings and court conferences, engaged in motion practice, conducted all facets of discovery, and recruited and prepared scientific and medical expert witnesses.

Sharon also has demonstrated a commitment to pro bono. She has served as first chair in an evidentiary hearing before the Southern District of New York in an international child abduction case, achieved a favorable settlement on behalf of an inmate bringing prisoner abuse claims, and, as lead associate, secured political asylum for a woman who was persecuted and tortured in her home country.

Sharon is admitted to practice before the US District Court for the Southern District of New York and the US Court of Federal Claims.

Relevant Experience

  • Counseled pharmaceutical company on advertising and promotion issues related to FDA-regulated products. Assisted pharmaceutical and medical device companies in revising regulatory and healthcare fraud and abuse compliance programs, including the development of standard operating procedures.
  • Provided training to FDA employees regarding enforcement of FDA regulations.
  • Advised specialty pharmaceutical company in connection with investigation by OPDP.
  • Assisted pharmaceutical company with preparation of report related to a Corporate Integrity Agreement.
  • Developed strategy regarding general and specific causation in pharmaceutical product liability litigation.
  • Member of team that conducted internal investigation on behalf of major consumer product company in association with international healthcare cost recovery claims.
  • Conducted mock jury research of product liability claims on behalf of Fortune 20 company.
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