When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the Spanish Riding School in Vienna, as we had wished for this since we
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.
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).
We don’t write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem. The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you. We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.
Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices. The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect: “A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.” (emphasis added).
Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design. Or it might not. The point is that the plaintiff has to prove it. Take also the example we discussed in Bexis’ aptly named post “On Alternative Design.” That case involved hernia mesh, not pelvic mesh, and the plaintiffs’ claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer. Consider hormone-based contraceptives. Cholesterol drugs. We could go on and on. All these products bear known and unavoidable risks, and those risks should not be labeled “defects” and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them. And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all. As we observed in the aforementioned post, that would convert strict liability into absolute liability. As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer? You get the point.
We’ve often thought that tort reform should be a major goal of those interested in preserving women’s reproductive choice. Every prescription medicine has risks, which is why the FDA requires a prescription in the first place, and prescription contraceptives are no exception. But ever since the very first birth control pills, back in the 1960s, the other side of the “v.” has consistently attacked every innovation in contraceptive technology and attempted to drive it off the market. It’s happened over and over again – with IUDs, Norplant, OrthoEvra, Yasmin, NuvaRing, Mirena, Essure. Except for the Dalkon Shield IUD forty years ago (and occasional idiosyncratic manufacturing errors), all these products were (or are being) ultimately vindicated, and the FDA continues to consider their designs to be both safe and effective. Unfortunately their users have had to pay a significant tort tax in order to continue exercising their personal choice of contraceptive method.
Niedner v. Ortho-McNeil Pharmaceutical, Inc., ___ N.E.3d ___, 2016 WL 5106479 (Mass. App. Sept. 21, 2016), is both an example of the plaintiff’s bar’s ongoing attempt to deprive women of reproductive choice and an exemplar of how to beat such efforts. Niedner involved a time-release contraceptive patch:
The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.
Id. at *1. The decedent decided to use this product in preference to both condoms and daily birth control pills. Id.
It is a well-known scientific fact that any hormonal contraceptive places its user at an increased risk of stroke, myocardial infarction, and blood clots generally. This product was no exception:
[The prescribing physician] informed [the decedent minor and her mother] of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled by [the] pharmacy, the package included an insert prepared by . . . the manufacturer, as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots.
Id. Unfortunately, after three months use the decedent suffered a fatal “massive bilateral pulmonary embolus.” Id.
Over the Fourth of July weekend, we in the Philadelphia area learned that 120 of the “new, state-of-the-art” trains in our regional commuter rail system were being pulled out of service. Someone noticed that the trains were listing to one side as they traveled down the tracks, and, on inspection, discovered cracks in structural beams in the cars’ undercarriage. So the defective trains are out of service, the rail system’s capacity has been reduced by one-third, and the result is bedlam. Trains packed with standing passengers bypass stations toward the ends of their lines, leaving commuters stranded. Train frequency has been slashed, delays and cancellations are rampant, and everyone is pretty upset. And pretty vocal about it. Oh, and did I mention that the problem won’t be rectified until at least the end of August, cementing this anarchy right through the Democratic National Convention, headed for our fair city in less than three weeks. Two of the three Philadelphia bloggers (McConnell and Weil) commute from the suburbs (Bexis lives a 45-minute walk from the office in West Philly), and the disruption has been substantial. But we suppose we should be grateful that the cracks were discovered before the house of cards tumbled tragically down.
Cracks also plague the foundation of today’s decision. In Crochet v. Bristol-Myers Squibb and Otsuka America Pharmaceuticals, Inc., 2016 U.S. Dist. LEXIS 83685 (M.D. La. June 28, 2016), the plaintiff alleged that the prescription drug Abilify caused him to develop tardive dyskinesia (“TD”), a neurological disorder that resulted in permanent, uncontrollable movements of his mouth and jaw, including lip smacking and jaw clenching. Among the plaintiff’s claims were a design defect claim under the Louisiana Products Liability Act (“LPLA”) and a claim for “redhibition” under Louisiana law. (Our co-blogger, Mr. McConnell, suggested this case for blogging just so we could use the word “redhibition” – but we already had, ) As the court explained, “Under Louisiana law, a buyer has a warranty against redhibitory defects, or vices, in the thing sold. A defect is redhibitory when . . . its use is so inconvenient that it must be presumed that a buyer would not have bought the thing had he known of the defect.” Crochet, 2016 U.S. Dist. LEXIS 83685 at *10 (internal punctuation and citation omitted). Recovery under the theory of redhibition is limited to economic loss, including rescission of purchase price – it does not include recovery for personal injury. The defendants filed a 12(b)(6) motion seeking dismissal of the plaintiff’s design defect and redhibition claims.
Maybe you’ve noticed that many of our recent posts have reported good decisions out of Mississippi. Here, here, and here, for example. It’s as if there has been an outburst of judicial common sense in that fair state. But it has not really been such a sudden thing. Looking back over last year, sound reasoning and clear decision-making seem to be commonplace in Mississippi opinions. You just had to look for these things, and you didn’t have to look all that hard.
Consider Mealer v. 3M Co., 2015 WL 9692735 (Miss. March 28, 2015). That opinion came out ten months ago, and is now available on Westlaw. It isn’t a drug or device case, but its holding on the safer alternative requirement is important for any product liability design defect claim.
The product at issue was a one-use, disposable respirator mask. The plaintiff wore one while wielding a jackhammer in a demolition project. The claim was that the mask did not adequately filter out silica particulates, and that the plaintiff ultimately contracted a fatal lung disease as a result. The plaintiff’s experts opined that there was no design change that could make a disposable respirator mask adequate. Instead, the safer, feasible alternatives included such things as elastomeric respirators with cartridge filters and exhalation and inhalation filters with rubber seals. The court held that those weren’t safer alternatives but were, instead, different products altogether. The disposable mask used by the plaintiff was a simple fiber piece that costs about a dollar. By contrast, the elastomeric respirator costs about $25-30. As the court reasoned, “[t]hey are completely different and their utility is completely different, the variation in longevity of the two products is obvious.”