FDA Expert Witnesses
What is an FDA expert witness?
FDA expert witness candidates typically have years of experience in healthcare, drug development, food and drug safety, pharmacology, FDA regulations, and/or regulatory affairs. FDA expert witnesses typically hold advanced degrees (MD, PhD, PharmD) and prior experience in FDA compliance. An FDA expert witness should feel comfortable explaining technology, processes, and procedures to a judge and jury. In a high-profile case, or litigation involving a significant financial stake, a law firm may request a subject matter expert with prior expert testimony experience.
What types of cases require an FDA expert witness?
Cases that may require an expert witness with an FDA background will involve drugs, food, medical devices, radiation-emitting products, vaccines, biologics, animal and veterinary products, cosmetics, and/or tobacco products. With FDA compliance and good manufacturing practices (GMP), companies adhere to minimum quality systems requirements to assure that their products are consistently safe and high in quality. The FDA Adverse Event Reporting System Database (AERS or FAERS) tracks drug safety; the database collects adverse effects reports, medication error reports and product quality complaints.
FDA expert witness case examples
Cahn Litigation Services has completed numerous searches for FDA expert witnesses, providing candidates for each case to the specifications provided by the law firm. Exemplary projects include:
- regulatory product labeling and safety information,
- a dietary supplement clinical trial validation,
- hospitalization as a result of a medical device product liability,
- medical device manufacturers’ regulatory submissions,
- cardiovascular implant premarket approval (PMA),
- FAERS data mining,
- drug names and drug labels,
- systematic reviews,
- biologic products,
- clinical trial adverse event incidence,
- enzyme inhibitors,
- cosmetic product development methodology,
- safety signal resulting from healthcare professional spontaneous reports,
- adverse drug reactions reporting rate,
- new drug side effects causation and safety concerns,
- post-marketing commitments (PMCs) data source,
- adverse drug event mitigation case report,
- food manufacturing quality assurance, and
- citations related to a pharmaceutical former FDA approval.
What litigation support work might an FDA expert witness be expected to perform?
Litigation support by an FDA expert witness could include research and authoring expert reports, providing expert opinions, depositions, and trial testimony. In addition, clients may seek an FDA expert for pre-litigation consulting work.
Cahn Litigation Services has the experience required to turn a search for an FDA expert witness around quickly, providing the right balance of expertise and testimony experience.
FDA Expert Witness - Representative Bios
Please Note: All Cahn Litigation expert witness searches are customized to attorneys' precise specifications and preferences. Attorneys are encouraged to discuss search parameters with a Cahn search specialist.
The below expert witness bios represent a small fraction of those FDA experts known by Cahn Litigation Services. These bios are provided to give lawyers a sense of the FDA landscape.