Today’s guest post is by Courtland Chillingworth, here at Reed Smith. His timely post concerns an excellent decision by the Connecticut Supreme Court from December, 2021 – a decision that we, frankly, missed initially. As readers can tell from what follows, this decision was good enough that, had we not been asleep at the switch, it would likely have made our top ten list for last year. As always, our guest posters deserve all the credit (and any blame) for what they write.
How are you doing on your New Year’s resolutions? Are you still “exercising more” or “eating better?” How many times have you called Mom since January 1? Well, if you instead resolved to “read more,” then you are in luck. Thanks to the Connecticut Supreme Court, blog readers can stop staring with guilt and/or determination at that copy of Moby Dick on the bookshelf and instead print a sprawling copy of Fajardo v. Boston Scientific Corp., SC 20455, — A.3d —-, 2021 WL 5989909 (Conn. Dec. 16, 2021). The first two parts of Fajardo pose questions that should appeal to the legal nerd in all of us, and stay tuned to the end for brief notes on those plotlines. It is the third part of Fajardo, however, that really provides the pay-off for sitting yourself down for a nice long read; it will enlighten and may just warm your defense-minded hearts. How often can you say that about a safer reasonable alternative design decision (one of this blog’s frequently revisited genres), particularly if you practice in the problematic world of surgical mesh?
At issue in Fajardo was the defendant’s vaginal implant for the treatment of stress urinary incontinence, a mesh sling designed to be placed using a transobturator approach. The jury returned a defense verdict. The question on appeal was whether the trial court properly declined to give the jury an instruction on safer reasonable alternative design, one of the two ways under Connecticut law that a plaintiff can prove design defect. The trial court determined that there was insufficient evidence of a safer reasonable alternative design to warrant the instruction. A five-to-one majority of the Connecticut Supreme Court affirmed the judgment. That part of the decision, in particular, is chock full of legal nuggets for those who represent the right side of the “v.” to mine.
What makes Fajardo such a compelling decision is not just the good outcome, but also its thoughtful and detailed explanation of the type and quality of evidence that a plaintiff needs to make a prima facie case for a reasonable alternative design. The key takeaways include:
- the existence of an alternative design or designs alone is insufficient;
- a reasonable alternative design cannot be found in a class of products, but must be identifiable in a specific product;
- the scientific data must show that the alternative design is on the whole safer, not just equally safe (or unsafe) and not without consideration of the alternative design’s own unique risks;
- the alternative design would have addressed the plaintiff’s needs and avoided the plaintiff’s injuries without unreasonably increasing costs;
- these alternative design requirements must all be tied together with expert testimony; and
- (newsflash!) the plaintiff’s design expert better not call the plaintiff’s own proposed alternative design defective.
The legal framework for Fajardo was straightforward. In product liability cases, Connecticut applies a “risk-utility test,” and, under that test, a product is defective if one of two prongs is satisfied (the “Bifolk” prongs, after Bifolk v. Philip Morris, Inc., 152 A.3d 1183 (Conn. 2016)): Bifolk 1 – “A reasonable alternative design was available that would have avoided or reduced the risk of harm and the absence of that alternative design renders the product unreasonably dangerous. In considering whether there is a reasonable alternative design, the jury must consider the feasibility of the alternative[.];” and Bifolk 2 – “The product is a manifestly unreasonable design in that the risk of harm so clearly exceeds the product’s utility that a reasonable consumer, informed of those risks and utility, would not purchase the product.” Fajardo, 2021 WL 5989909, at *12-*13 (citations omitted).
The trial court instructed the jury on Bifolk 2, but declined to do so for Bifolk 1, and the question before the Connecticut Supreme Court was “whether the trial court correctly concluded that the evidence did not support an instruction under the reasonable alternative design prong of the risk utility test[.]” Id. at *13.
What Plaintiffs claimed as their reasonable alternative design was not as straightforward, at least insofar as the majority and the dissent disagreed on what it was Plaintiffs claimed (more on that below). As far as the majority was concerned, Plaintiffs asserted that a different class of stress urinary continence implant—retropubic tension free transvaginal tape or “TVT”—represented a reasonable alternative design. Fajardo, 2021 WL 5989909, at *11, *18. The term “TVT” was important, because “TVT” was the brand name for the original tension free transvaginal tape, made by a different manufacturer, yet “TVT” had also come to be used as a generic term for all such devices. Id. at *11 n.9; see also id. at *26 (Ecker, J., dissenting). Per the majority’s view of the record, Plaintiffs were referring to the generic TVT—i.e., tension free transvaginal mesh as a whole—and, crucially, not the other manufacturer’s branded product. Id. at *11 n.9, *18. Not only that, Plaintiffs’ reference at trial to “TVT” was actually to the exclusion of that branded product, as none of the literature Plaintiffs relied on compared this defendant’s product to that other product, and Plaintiffs’ one and only design expert, the ubiquitous Dr. Bruce Rosenzweig, did not do so either. Id. at *18.
Dr. Rosenzweig’s role as Plaintiffs’ one and only design expert was an important point, because, at the outset, the Court established that “expert testimony is required in a reasonable alternative design case when the evidence regarding the defect and whether the alternative was feasible (technically and economically) and whether the alternative would have reduced or avoided the risk of harm is beyond the ken of the average juror.” Id. at *16 (citation omitted). According to Dr. Rosenzweig, the defendant’s product had two defects. First, it was made with polypropylene, and in his opinion, “all mesh products fabricated from polypropylene . . . are unsafe and unsuitable for implantation in the human body,” and instead, “the Burch procedure, a surgical option, was the best approach to treat stress urinary incontinence.” Id. at *19, *20 (emphasis in original). Second, the defendant’s product had a “heat-sealed” edge, which purportedly made the mesh stiffer at that area, leading to complications. Id. at *19.
Clearly, given Dr. Rosenzweig’s meat-axe testimony that all mesh products made from polypropylene are unsafe and unsuitable for implantation in the human body, Plaintiffs’ proposed alternative design (TVTs in general) was dead on arrival, which the opinion recognized. Id. at *20, *25. However, it buried the lead on that point and instead explored other higher analytical issues.
First, the Court pointed out an inherent flaw in lazy plaintiffs relying merely on a class of products as an alternative design, as opposed to a specific product, given the differences in design profiles that may exist within the class, such as pore sizes or weight. “[T]hose design differences can alter performance and safety.” Id. at *19. That includes consideration of what unique risks that each particular TVT product could create, as detailed in the opinion. Id. at *21. “Therefore, the plaintiffs’ repeated reference to TVT does not constitute identification of a reasonable alternative design when the safety data related to that class of products vary considerably.” Id. at *19. In particular, “a design is not a safer alternative if, under other circumstances, it would impose an equal or greater risk of harm than the design at issue . . . . Similarly, the plaintiff must show the safety benefits from the proposed design are foreseeably greater than the resulting costs, including diminished usefulness or diminished safety.” Id. at *20 (citing Casey v. Toyota Motor Engineering & Mfg. No. Am., Inc., 770 F.3d 322, 331 (5th Cir. 2014)). These are both useful points for defendants in design defect litigation.
The Court also noted that many TVTs would have the same design characteristics that Dr. Rosenzweig considered to be “defects.” For instance, Plaintiffs relied on a medical journal article that compared the product at issue with the defendant’s own TVT product. However, as the majority observed, that TVT product was made from the same mesh material and had the same heat-sealed edge that Dr. Rosenzweig categorically described as defective. Fajardo, 2021 WL 5989909, at *19-*20. The only difference between the two devices, per the study, was their placement in the body, but “Dr. Rosenzweig did not testify that the risk of harm to [the plaintiff] would been reduced or avoided if a retropubic sling was used.” Id. at *20. As such, the study did not support a reasonable alternative design. Id. Thus, Plaintiffs’ reliance on their expert’s absolutist defect position precluded them from pursuing the more nuanced Bifolk 1 prong of design defect analysis.
Fajardo also addressed the requirement that any reasonable alternative design had to bear some connection to the needs and experience of the patient herself, while not unreasonably increasing costs. It noted that Plaintiffs had failed to produce evidence that “an alternative design was available that would have met [this plaintiff’s] needs and have avoided or reduced the risk of harm without unreasonably increasing cost.” Id. at *25 (emphasis added). Fajardo analogized to a federal case applying Connecticut law involving water treatment pumps, where the plaintiff failed to produce evidence of an alternative design “that would meet the plaintiff’s system specifications [and] that would have avoided or reduced the risk of harm without unreasonably increasing cost.” Id. at *25 (citing Water Pollution Control Authority v. Flowserve US, Inc., Docket No. 3:14-cv-00549 (VLB), 2018 WL 1525709, *25 (D. Conn. March 28, 2018)) (quotations omitted).
Ultimately, Fajardo stated it was theoretically open to the possibility that a specific product on the market might stand in as a reasonable alternative design, but found that “the plaintiffs took a scattershot approach, pointing to different alternatives to the [product] that included surgical options and a class of products known as TVTs. . . . The evidence did not, however, demonstrate that any particular product was safer or more important, would have reduced or avoided the risk of harm to [the plaintiff] when compared to the [defendant’s product].” Id.
The majority in Farjado was unpersuaded by the dissent’s position that Plaintiffs had, in fact, identified a specific name-brand TVT as a reasonable alternative design, which paradoxically would mean that a plaintiff’s expert could, at the same time, claim that the same design could be both an “alternative,” but nevertheless “defective.” Id. at *33. Its response to the dissent boiled down to a few direct points. First, Dr. Rosenzweig, Plaintiffs’ only design expert, did not spare the branded “TVT” from his never-polypropylene stance – “[he] admitted that he considered the [the] branded TVT defective for that reason.” Id. at *19.
Second, “because this case involve[d] complex medical devices with complicated medical risks and injuries, evidence comparing their relative safety data would have had to come from an expert qualified to testify regarding the designs of the  branded TVT and the [defendant’s product], and qualified to explain how use of the  branded TVT would have reduced or avoided the risk of harm to [the plaintiff].” Id. at *22. Dr. Rosenzweig’s absolutist position precluded him from doing so, and Plaintiffs had nobody else. Evidence not provided by an expert cannot be supplemented with circumstantial evidence, as the dissent suggested, because the jury needs “qualified expert testimony about each element of the prima facie case for reasonable alternative design.” Id. at *22 n.20. Plaintiffs failed to produce such expert testimony, which was “fatal to [their] claim under the reasonable alternative design theory[.]” Id. at *22.
Third, the majority did not buy the dissent’s reliance on the implanting surgeon’s testimony. Besides questioning his qualifications to opine on product design and the reliability of any supposed design opinions he may have had, the Court found that his testimony amounted to a preference for branded-TVT, “but that testimony does not establish that it is a reasonable alternative design to the [defendant’s product] that would have reduced or avoided the risk of harm to [the plaintiff].” Id. at *23. Put succinctly, a surgeon’s personal preference, without more, cannot rise to a reasonable alternative design.
The dissent certainly bought the Plaintiffs’ position, but, from a broader defense perspective, the dissent was actually helpful. It forced the majority to respond with more depth and detail in an already favorable opinion about reasonable alternative design. Moreover, for any surgical mesh defense attorney who has confronted “never polypropylene” opinions, Fajardo provides a strange sort of catharsis. Here, when the music stopped and Plaintiffs needed to show they had proffered evidence to merit a safer reasonable alternative design charge instruction, they pointed to another polypropylene device. With the Court reaching the right and sensible result, we can smile at the irony.
Finally, as promised, here is a quick look at the first two issues decided in Fajardo, neither of which pertain to reasonable alternative design, but both are just a bit of eye candy for the legally curious. First, Fajardo considered whether Plaintiffs preserved their right to challenge the failure to give the reasonable alternative design jury instruction by asking the trial court for the instruction in an email before the jury was charged, although they made a formal objection after the jury was charged. Id. at *13-*14. Fajardo held that Plaintiffs’ email was not in technical compliance with Connecticut rules of procedure and was especially critical of Plaintiffs for failing to cite any evidence in that email, which would have warranted a denial of their request. Id. at *14. However, Fajardo ultimately let it go, inasmuch as the trial court did. Id. Bigger battles lie ahead.
Second, the case also involved a lawsuit against the plaintiff’s regular gynecologist, who recommended a sling procedure during an office visit and referred the plaintiff to the implanting physician, for failing to obtain proper informed consent for the defendant’s implant. Id. at *4-*6. That’s right. She sued the gynecologist, not the surgeon who implanted the mesh, for failing to obtain informed consent for the implant. Can she do that? The Court weighed many considerations, and the overly-simplified answer was, no. Id. at *6-*12. But anyone who has a medical malpractice defense practice will be interested in that rationale.
The end. Now go call your mother.