FDA-Regulated Drugs and Devices

WIT represents the most qualified experts for litigation involving the science, manufacturing, and distribution of FDA-regulated drugs, chemical components, and medical devices.

We have been involved in many of the largest product liability cases in recent history, including class action lawsuits involving exposure to toxic chemicals, mass torts involving the distribution and marketing of tobacco products, and dozens of cases in the National Prescription Opiate MDL. Attorneys rely on WIT to provide world-class academics, industry executives, and former government regulators who can assist them in pharmaceutical cases involving:

  • Adverse event monitoring
  • Biosimilar and Hatch-Waxman strategies
  • Clinical trial design
  • CMC and cGMP compliance
  • Distribution and pricing strategies
  • Labeling and advertising matters
  • Manufacturing processes
  • Medical device failures
  • New drug and biologics license applications
  • Product modifications
  • Quality System Regulation issues

Pharmaceutical Expert Team

Our focus on the pharmaceutical industry allows us to bring together independent testifying experts under one virtual roof to address issues in complex legal disputes.

  • Academics: Experts from top universities and institutions with specialized technical knowledge about the science, research, development, and clinical trial protocols of new or generic drugs
  • Industry Executives: Senior-level industry experts with targeted knowledge about pharma industry operations, including the manufacturing and distribution of FDA-regulated drugs, vaccines, and medical devices
  • Regulators: Former government professionals with first-hand knowledge of FDA, USDA, and EPA procedures
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Our Experts

WIT represents world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively. Their expertise covers the following:

  • Small Molecule/Synthesized Drugs
  • Biologic and Biosimilar Drugs
  • Over-the-Counter (OTC) Drugs
  • Research and Development
  • Clinical Trial Design, Monitoring, and Data Analysis
  • Manufacturing Processes, CMC, cGMP, and FDA Compliance
  • Marketing, Labeling, Advertising, and Off-Label Promotion
  • Sales, Distribution, Pricing, and Anti-Kickback Regulations
  • Drug Diversion and Counterfeit Operations

 

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