Expert Commentary
Practical insights on FDA regulation, medical devices, diagnostics, pharmaceuticals, biologics, product liability, and the evaluation of complex medical product cases.
Sometimes the Wrong Questions Cost More Than the Wrong Answers
The strongest cases rarely begin with the right answers. They begin with the right questions. Experience provides the insight to recognize what’s missing, where to find it, and how those missing pieces can change the entire picture.
Published on LinkedIn July 2026
How I Evaluate a Medical Device Case: A Systematic Framework
Every medical device case is unique, but the analytical process should be systematic. This article describes the framework I use to evaluate complex medical device litigation by integrating engineering, medical science, FDA regulations, manufacturing practices, and clinical evidence into a disciplined, objective analysis.
Published on LinkedIn June 2026
The Three Questions I Ask When Evaluating a Medical Device Failure
Medical device cases often require analysis across FDA regulatory requirements, engineering performance, and patient outcomes. This article discusses the three fundamental questions that help frame many product liability and failure investigations.
Published on LinkedIn June 2026
What Did the Manufacturer Know—and When Did They Know It?
One of the most important questions in product liability litigation is not simply whether a product failed, but what information was available before the event occurred. This article examines how complaint files, MDRs, CAPAs, investigations, risk assessments, and recalls can help reconstruct what manufacturers knew and how they responded to potential product performance issues.
Published on LinkedIn June 2026
What MAUDE Data Can—and Cannot—Prove in Medical Device Litigation
The FDA’s MAUDE database can provide valuable insight into device performance and recurring failure modes, but adverse event reports must be interpreted carefully. This article discusses the strengths, limitations, and common misconceptions surrounding MAUDE data in litigation.
Published on LinkedIn June 2026
FDA Approved? FDA Cleared? Does That Mean a Medical Device Is Risk-Free?
FDA approval and FDA clearance are frequently misunderstood in medical device litigation. This article discusses what FDA review actually means, why no regulatory pathway eliminates risk, and how these concepts are often misinterpreted in product liability cases.
Published on LinkedIn June 2026