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 teams of experts comprised of former FDA officers, skilled medical professionals, and highly credentialed academics 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

FDA-Regulated Drugs and Devices Expert Team

WIT represents academics, scientists, industry veterans, and former regulators with years of consulting and testifying experience in the subjects most relevant to drug and medical device litigation. Many of our experts are former pharmaceutical executives whose experience spans everything from product development to corporate transactions.

  • Industry executives on the pharmaceutical industry, corporate M&A/due diligence, research and development, and drug distribution process
  • Former FDA officers who understand or oversaw drug approvals for many drugs
  • Epidemiologists who study and analyze collected data regarding the efficacy of prescription and OTC drugs
  • Toxicologists who research and analyze chemical compounds and other substances to identify harmful components
  • Medical doctors on health issues associated with exposure to chemicals and drugs
  • Biostatisticians who monitor and track demographic data surrounding drugs and potential environmental or industrial toxins
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Our Experts

WIT’s experts can assist in developing and advancing the strongest litigation posture in defense of major pharmaceutical and life sciences companies. Their expertise covers the following:

  • Chemistry and Manufacturing Controls
  • Clinical Trial Design
  • Current Good Manufacturing Protocols
  • Conjugation
  • Corporate M&A/Due Diligence
  • Epidemiology
  • FDA Compliance
  • Good Clinical Practice
  • Medical Causation
  • Microbiology
  • Multivalence
  • Proteomics
  • Research & Development
  • Toxicology
  • Vector Development

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