If the pelvic mesh litigation ever ends, the tongue of history will tell a tale of specious plaintiff theories that hoodwinked judges and juries into condemning good products. Plaintiffs extracted millions of dollars and erased product lines by cobbling together irrelevant workplace material handling sheets, counterfactual stories in which the FDA does not exist, and

The complaint in Robinson v. Ethicon Inc., Action No. H-20-3760 (S.D. Tex.) was filed in 2013.  To put that in perspective, Amazon’s first Alexa-enabled device, the Echo, wasn’t on the market.   There’s a good chance you weren’t running your phone on 4G yet.  And, if you were using earbuds with your phone, you were

We’ve used the term one-two punch to refer to a couple different situations – Daubert wins followed by the grant of summary judgment; Mensing preemption for generic manufacturers and no innovator liability for brand manufacturers.  And we’re going to dust it off again today to refer to Couturier v. Bard Peripheral Vascular, Inc., —

A couple of weeks ago we compared New Jersey litigation with New Jersey food and decided we liked the food better. No aspersions were intended. After all, we grew up in New Jersey and still worship at the altars of Seton Hall Prep, Bruce Springsteen, and the New York football Giants. Anyway, we might need

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.”  Taking the alternative design requirement for strict liability as a given, we concentrated in that post on the proposition that an “alternative” design must really constitute a different design for the same product, and not a disguised “stop selling” or “never start selling” claim where the only “alternative” is a different product or, worse, a completely different medical procedure not utilizing that sort of product at all.

Since then, we’ve written about alternative designs several other times, but never comprehensively.

Today, we’re doing something a little different. We’re examining whether an alternative design is also an element of a design-related claim sounding in negligence.  As the rest of this post demonstrates, the overwhelming weight of nationwide precedent established that negligent design claims require the plaintiff to establish the existence of a feasible alternative design the would have prevented the plaintiff’s injuries.

We touched upon the alternative design issue somewhat in our post excoriating the Pennsylvania Supreme Court’s bizarre opinion in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). Lance put the rabbit in the hat and held, for a product allegedly:  (1) “too dangerous to be used by anyone,” and (2) that had been removed from the market by the FDA, a negligent design case could be stated even though the plaintiff didn’t even attempt to prove an alternative design. Id. at 458-60.  What Lance adopted, of course, was a pure “stop selling” claim of the sort preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  “[W]e are convinced that a manufacturer or supplier has a duty to cease further distribution of a product . . . [that] is too dangerous to be used by anyone.” Lance, 85 A.3d at 460.

Generally, in Pennsylvania, negligent design cases have required proof of alternative designs, except in the limited Lance recalled product situation.  “The determination of whether a product was negligently designed turns on whether an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.”  Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38, 64 (3d Cir. 2009) (emphasis original). See, e.g., Kosmack v. Jones, 807 A.2d 927, 931 (Pa. Commw. 2002) (“a plaintiff bears the burden of establishing that there is an alternative design” in negligent design defect cases); Smith v. Yamaha Motor Corp., 5 A.3d 314, 322-23 (Pa. Super. 2010) (requiring proof of alternative design for all-terrain vehicle).

Continue Reading On Alternative Design, Take Two − Negligence