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 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
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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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