Product Liability
Product liability cases involving medical devices, pharmaceuticals, and health-related products require expert witnesses who can evaluate whether a product was defectively designed, manufactured, or marketed and whether the defect caused the plaintiff's injuries. These cases arise under theories of strict liability, negligence, and failure to warn, and they may involve individual claims or mass tort litigation. Medical expert testimony is essential to establish that the product caused the specific clinical injury alleged, to distinguish product-related harm from the natural course of disease, and to evaluate whether the manufacturer's warnings and instructions for use were adequate to inform prescribing clinicians and patients of material risks.
Medical experts in product liability cases establish the causal link between the product and the patient's injury. For pharmaceutical cases, the expert evaluates whether the drug caused the adverse event based on the temporal relationship, dose-response data, pharmacologic mechanism, and ruling out alternative causes through differential diagnosis methodology. For medical device cases, the expert assesses whether the device malfunctioned, whether the malfunction caused the injury, and whether the device met applicable design and manufacturing standards. The expert reviews the plaintiff's medical records, the product's regulatory history including FDA submissions and adverse event reports, and the relevant scientific literature. In failure-to-warn cases, the expert opines on whether the product's labeling adequately communicated the risk that materialized and whether a different warning would have altered the prescribing decision.
The required specialty depends on the product and injury. Orthopedic surgery experts evaluate failed joint implants, spinal hardware, and orthopedic fixation devices. Cardiology experts assess cardiac device malfunctions including pacemakers, defibrillators, and stents. Pharmacology and toxicology experts evaluate drug causation and dose-response relationships. Gynecology experts address pelvic mesh complications and intrauterine device injuries. Gastroenterology experts evaluate pharmaceutical-induced liver injury and GI bleeding. Hematology experts assess blood product complications and anticoagulant-related bleeding events. Regulatory affairs experts evaluate FDA submission adequacy and post-market surveillance obligations.
Product liability medical experts must demonstrate that their causation opinions satisfy Daubert requirements, which is particularly stringent in pharmaceutical and device litigation. The expert must show that general causation is established through epidemiologic evidence, pharmacologic mechanism, and regulatory data, and that specific causation is supported by the plaintiff's clinical timeline and differential diagnosis. The expert must address alternative explanations for the plaintiff's condition and explain why the product is the most likely cause. Clinical currency and familiarity with the product's use in practice strengthen the expert's credibility.
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