In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions.  Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim.  Even where an alternative product design is not mandatory, plaintiffs frequently offer such evidence. In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.”

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed.  Thus, as a matter of logic and semantics, “feasibility” would seem to demand that any proposed “alternative” to the existing design of a product subject to FDA scrutiny must likewise have passed the same level of FDA scrutiny.  For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims.Continue Reading The FDA and Feasible Alternative Designs