Lance L. Shea M.S., J.D.

Partner

Washington, D.C.
T +1.202.861.1648
F +1.202.861.1783

Overview

Using legal and scientific methods that he has developed over 25 years, Lance Shea handles legal matters that require development, interpretation or advocacy of scientific evidence – primarily evidence of product efficacy, safety or bioequivalence. The differentiating feature of Lance’s practice is that he develops an in-depth understanding of the relevant scientific evidence and governing law before crafting legal strategies and positions. 

Lance represents clients such as drug, medical device and biotechnology companies. Matters span regulatory (e.g., FDA, FTC, EPA) and litigation forums (e.g., federal and state courts, other tribunals). Additionally, he advises clients on the development of evidence needed to maximize marketing exclusivity and market share for medical products – a process that spans entire product life cycles. For an overview of Lance’s methods for developing and evaluating health science evidence, see his white paper “Causal Leverage Analysis: Obtaining Product Approval and Winning Approval Litigation.”

Select Experience

  • Represented a pharmaceutical company in the development of a 74-page, science-driven citizen petition to the FDA requesting that certain criteria be met before a generic version of the client’s top-selling drug could be approved. Represented the same client in the development of comments on FDA draft bioequivalence guidance for the same drug.
  • Represented a pharmaceutical company in the development of a citizen petition to the FDA requesting that a competitor’s product be ordered withdrawn from the market because it was never appropriately approved for marketing.
  • Represented an executive of a pharmaceutical company in a securities fraud case, in which evidence of product risk was a key issue.
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Experience

  • Represented a pharmaceutical company in the development of a 74-page, science-driven citizen petition to the FDA requesting that certain criteria be met before a generic version of the client’s top-selling drug could be approved. Represented the same client in the development of comments on FDA draft bioequivalence guidance for the same drug.
  • Represented a pharmaceutical company in the development of a citizen petition to the FDA requesting that a competitor’s product be ordered withdrawn from the market because it was never appropriately approved for marketing.
  • Represented an executive of a pharmaceutical company in a securities fraud case, in which evidence of product risk was a key issue.
  • Represented an international pharmaceutical company that had received reports of potentially fatal adverse drug events and advised on empaneling a safety advisory committee, assessing a future life cycle strategy based on evidence of the possible drug-event relationships, amending product labeling and preparing litigation defense. 
  • Represented a cosmetic device manufacturer in the development of an impactful advertising claims strategy by identifying potential strengths and weaknesses in an existing clinical trial, suggesting potential alternative claims and recommending additional studies. 
  • Represented a pharmaceutical company required to conduct a post-marketing safety study for a rare adverse event and recommended a novel trial designed to test the role of risk factors that appeared related to the adverse event rather than a study of standard design.
  • Represented academic medical centers in evaluating and managing conflicts of interest in clinical trials research.
  • Represented pharmaceutical companies in long-running, nationwide mass torts alleging injury from OTC cough and cold products, prescription analgesic products, and prescription colonoscopy preparation products. Often serves in the role of lead science counsel.

Recognitions and Memberships

Recognitions

  • Chambers USA: Recognized Practitioner: Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia (2016, 2017)
  • Martindale-Hubbell: AV Preeminent
  • Washington, D.C. "Super Lawyer" (2014 to 2016)

Memberships

  • Food and Drug Law Institute
    • Monograph Committee
      • Past Chair: 2011
      • Chair: 2010
    • Primer Committee
  • University of Maryland Francis King Carey School of Law: Adjunct Professor, Scientific Evidence
  • University of Maryland School of Pharmacy: Affiliate Assistant Professor, Regulatory Science graduate curriculum

Admissions

  • District of Columbia
  • Arizona
  • Texas [Inactive]

Education

  • J.D., University of San Diego School of Law, 1989, magna cum laude; San Diego Law Review, Editor-in-Chief
  • M.S., Health Science, Arizona State University, 1986
  • B.S., Health Sciences, The University of Arizona, 1982, with distinction