Through his practice, James has represented and counseled manufacturers of prescription products on a broad variety of issues, including: prescription product recalls, off-label and product liability issues, preemption, the market and promotion of prescription products, and the reuse of single use medical devices. Additionally, James served as regional counsel for an international medical device company in a product liability action, and was the multi-district litigation liaison counsel in the Gammagard® MDL litigation. James is also the co-author of Prescription Product Recalls – A Proactive Primer, a book that details how to plan and implement the recall process for all regulated products.