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 still untangling their wires. The selfie-stick had yet to be invented. We only had one Avengers movie. We hadn’t yet heard of The Good Place or The Marvelous Mrs. Maisel, in fact original programming on Netflix only just began in 2013 (House of Cards). This lawsuit was filed before binge-watching??
And while all of that was coming to be – Robinson sat in the Ethicon pelvic mesh MDL. Until last year when it was remanded to Southern District of Texas. And that’s around the time plaintiff realized she didn’t have the expert evidence she needed on alternative design. So, plaintiff offered two “supplemental” reports from experts designated in the MDL. The reports were not really “supplements,” but rather entirely new opinions by generic experts based on information that was available at the time they authored their original reports. Fortunately, the remand court saw through the disguise and struck the reports as untimely (see post here). Which teed up defendants’ motion for summary judgment and the subject of today’s post.
To start, having had their expert reports on alternative design stricken, plaintiff’s first argument was that Texas law does not require evidence of a safer alternative design in medical device cases. Robinson v. Ethicon Inc., 2021 U.S. Dist. LEXIS 210191, *9-10 (S.D. Tex. Nov. 1, 2021). It is accurate that the Texas products liability statute states that the section on safer alternative designs does not apply to drugs or devices, but that statute also states that it does not supersede Texas common law which does require proof of a safer alternative design in drug/device cases, notwithstanding the statutory exclusion. Id. at *10. Because plaintiff’s design defect claim is a common law claim, the requirement applies. Id.
Plaintiff alleged seven different alternative designs, but upon closer inspection none fit the bill. The first four were actually alternative procedures or alternative products, neither of which is the same as an alternative design. Plaintiff focused her response on whether these different procedures/products had less risk or were economically or technologically feasible at the time of plaintiff’s surgery. But that did not answer the question raised by defendants – whether they were different products or procedures. Plaintiff failed to offer evidence that the alternative procedures/products she was relying on and the product used in her surgery were “essentially the same kind of product and procedure” with the distinction being only “one of degree.” Id. at *15.
Plaintiff’s fifth alternative design was one she offered for the first time in response to defendants’ motion for summary judgment and one for which she had no evidence that it would have prevented her injuries. Id. at *16-17. Plaintiff attempted to rely on testimony from her implanting surgeon that he primarily used the alternative product. But his testimony did not include anything about whether that product was a viable alternative for plaintiff or carried other risks.
[N]either the court nor the jury can make the logical leaps needed to go from this snippet of testimony to the conclusion that a [different product] was a safer alternative design, even viewing the testimony in the light most favorable to Robinson.
Id. at *17. Not to mention, it was also a different product, so this alternative design failed on two grounds.
For alternative design number 6, plaintiff argued that the same device could have been manufactured with larger pores and that meshes with larger pores cause less complications. To support her argument, plaintiff provided evidence that defendant submitted a premarket approval application to the FDA for a mesh with larger pores, but the product was never approved. Id. at *18-19. Under Texas law, an alternative design must “be capable of being developed.” Id. at *21. Lack of FDA approval is clearly an obstacle to development, but the court left open the possibility that a plaintiff with expert evidence that “the FDA likely would have approved this design” may be able to support a safer alternative design. What such expert testimony would need to be is just speculation since plaintiff here did not have a regulatory expert. Id. Plaintiff also had no evidence from a case-specific expert that a mesh with larger pores would have been safer for her. Generic expert testimony on the safety of larger pores did not suffice. Id. at *20.
Finally, as a seventh alternative design plaintiff offered a device made from a different material. Unlike design number 6, the FDA has approved the use of this material for mesh but not for the treatment of urinary incontinence which is what plaintiff was treated for. Plaintiff, citing an old Bone Screw case (talk about days before binge-watching, back then we had to watch commercials!), tried to rely on off-label use. Id. at *22. The court seemed to have the same question we did – so what:
Thus, while the court agrees with [plaintiff] in general that physicians often use their medical training and expertise to prescribe a drug or possibly use a product in a way that the FDA has not approved, it is unclear practically how that impacts the proposed alternative designs in this case and [defendant’s] obligations under FDA regulations.
Id. at *25. So, here to plaintiff was lacking either a regulatory expert on “capable of development” or a case-specific expert on “likelihood of preventing plaintiff’s injury.” Without any alternative design evidence, plaintiff’s design defect claim failed.
That left the court to decide plaintiff’s negligent misrepresentation claim which appears to be a failure to warn claim. So, defendant argued it should be dismissed based on the learned intermediary doctrine. Id. at *29-30. Unfortunately, plaintiff’s implanting surgeon testified that he only warned plaintiff about risks in the product’s Information for Use which did not include the risk of chronic or long-term pain. Had the warnings been included he would have provided them to plaintiff who testified she would not have agreed to surgery with the device. Id. at *31-32. So, eight and one-half years after filing suit, a lone failure to warn claim survives. Just think, in another eight and one-half years maybe we’ll finally have those flying cars we were promised in the 60s.