Iowa Federal District Court Establishes Standard for Alternative Design Testimony Which Expert Could Not Satisfy Without Either Industry Experience or Testing.
In a case challenging the design of a polypropylene mesh used to treat female pelvic organ prolapse, an Iowa federal court hit on a vital but infrequently articulated point: that for a design to qualify as a safer alternative design in a medical product liability case, it is not enough to offer testimony that an alternative treatment would be safer. Rather, the alternative design must be for the same product and the design must be shown by either experience or testing to be not only safer, but also effective.
In Willet v. Johnson & Johnson, 2020 WL 2988299 (S.D. Iowa June 3, 2020), the court held that the plaintiffs’ expert failed to meet these tests and granted summary judgment. The expert’s testimony that the surgeon could have used native tissue or donor tissue flunked the first test because those are different treatments that present different advantages and disadvantages even though they treat the same condition. Id. at *8-9. The choice among them is for the surgeon to make. And the expert’s opinion that a larger-pore polypropylene mesh would have caused less inflammation and been safer could not carry the day because there was no scientific testing or medical experience to show “what the potential rate of error or failure” of such an alternative would be. Id at *9. The expert’s reliance on discussion of proposed alternatives in internal company documents was not good enough.
The principle that a safer alternative design must be for the same product, and not a different one, is well-established. See Restatement (Third) of Torts: Product Liability (§2, cmt f, illus 9,10); Barnes v. Medtronic PLC, 2019 WL 1353990 (E.D. Mich. March 26, 2019) (rejecting alternatives to polypropylene mesh).
On the other hand, the requirement that a proposed alternative must not only be safer, but also equally effective, has received less attention. However, there are examples such as Ackely v. Wyeth Laboratories, Inc., 919 F.2d 397, 403 (6th Cir. 1990) where the court ruled that to establish defect in a vaccine, the plaintiff must show an alternative that is “paretosuperior,” i.e. a product “that is at least as effective and also provides less risk.” There is also the example of Conklin v. Novartis Pharmaceuticals Corp., 2012 WL 412795, at *10 (E.D. Tex. Sept. 18, 2012). There the court ruled that the expert lacked sufficient data to show that a lower dose of the medication in question would be equally effective.
Willet approached the problem by finding the expert’s testimony insufficient under Daubert where there was no testing or medical experience to show what the “error rate” of a proposed alternative device would be when used in treatment. This is a more universal approach which should disqualify any similarly defective testimony about alternatives whether or not the jurisdiction requires proof of a safer alternative design in every case. See Ackley, supra (liability would have to be based on something other than inadequate alternative). See also Rachel B. Weil, Expert Excluded and Summary Judgment Granted In Pelvic Mesh Remand Case, Drug and Device Law Blog, June 3, 2020).
Johnson & Johnson and Ethicon were represented in Willet by Robert D. Houghton and Nancy J. Pepper of Shuttleworth & Ingersoll. Butler Snow is national counsel in the Ethicon pelvic mesh litigation, and Butler Snow motions team members involved in the Willet decision include Amy M. Pepke and Richelle W. Kidder.