Wayne Wolff

Shook Hardy & Bacon LLP

$ $$$

Montgomery Street 1
San Francisco 94104 CA US

Wayne A. Wolff concentrates his practice on the defense of manufacturers of pharmaceutical and medical devices including over-the-counter drugs, orthopedic implants, pain management devices, hospital and emergency care equipment and consumer products.

He has significant experience managing complex litigation involving cutting-edge medical and scientific issues, with an emphasis on developing, presenting and opposing expert witness opinion testimony.

He also has extensive experience defending claims involving FDA approval of pharmaceutical and medical devices, use of the federal preemption defense and compliance with FDA and other federal and state regulatory requirements. Wayne also litigates unfair business practice and healthcare malpractice claims.

Wayne has tried many cases to verdict, including national mass tort litigation involving complex scientific evidence and causation issues. He has worked with leading scientists, physicians and other experts in a variety of fields, including cardiology, neurology, pulmonology, orthopedics, anesthesiology, toxicology, epidemiology, experimental research, regulatory compliance, engineering, accident reconstruction and forensic economics.

He has served on national and regional coordinated litigation defense teams, particularly in the area of scientific and expert witness development, and has successfully challenged admissibility under Daubert and other procedures.

In addition to litigation, Wayne counsels clients on risk prevention, warnings, compliance and document retention issues. Before joining Shook, Wayne was a partner of Sedgwick LLP in San Francisco.

Representative Appellate Matters:

  • In re California Firearm Cases, Nos. A103211, A105309 (Cal App. Ct. 2005). In the first published opinion to directly address the issue of whether a causal nexus between business practices and alleged harm to the public is required under California’s unfair competition law, the court held that such claims cannot be established without a link between a defendant’s conduct and the alleged harm.
  • Kanter v. Warner-Lambert Co., No. A094975 (Cal. App. Ct. 2002). The appellate court held that the federal Food and Drug Administration Modernization Act expressly preempted all claims against manufacturers of over-the-counter head lice treatments.


  • J.D., University of California, Hastings College of the Law (1992)
  • B.A., Ohio Wesleyan University (1983)

Bar Admissions:

  • California
  • U.S. District Court, Central District of California
  • U.S. District Court, Eastern District of California
  • U.S. District Court, Northern District of California


  • Defense Research Institute
  • San Francisco Bar Association


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Montgomery Street 1
San Francisco 94104 CA US
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