In these strangest of times, we find ourselves seeking comfort in the familiar. Many times each day, we dial the numbers of faraway loved ones, just to hear their voices (the twenty-something Drug and Device Law Rock Climber has threatened to block our number). We gravitate toward favorite foods of our childhood (we just resorted to Amazon to replenish our peanut butter supply). And we have watched our favorite Downton Abbey episode six times ("Of course I'll marry you, you old booby. I thought you'd never ask.").
So we were drawn to today's case, Cofresi v. Medtronic, Inc., et al., - F. Supp. 3d -, 2020 WL 1887862 (W.D. Tex. Mar. 30, 2020), because it deals with issues we brief over and over again in our representation of medical device manufacturers. In Cofresi, the plaintiff underwent left inguinal hernia repair with one of the defendants' mesh products. About a month later, he was diagnosed with a right inguinal hernia and with an infection at the site of the left hernia repair. He underwent a second surgery, during which surgeons repaired the new hernia with a different defendant's mesh product and addressed the issues they attributed to the first surgery. The plaintiff alleged that he developed additional symptoms and that he was scheduled for another mesh revision surgery. He sued the manufacturers of both hernia mesh products, asserting the usual litany of product liability claims sounding in negligence and strict liability. The defendants filed separate 12(b)(6) motions, both of which are addressed in the court's decision, arguing that the plaintiff had not alleged sufficient facts to satisfy federal pleading (Twiqbal) standards. The court explained that it needed to analyze the claims only against a strict liability standard, because "a manufacturer logically cannot be held liable for failing to exercise ordinary care when producing a product that is not defective." Cofresi, 2020 WL 1887862 at *3. (We like that) The decision includes separate analyses of the defendants' separate motions, but the key points and holdings are the same, and we will consider them together.
Design Defect
Both defendants argued that the plaintiff had failed to plead the elements of his design defect claim. To prevail on a design defect claim under Texas law, a plaintiff must prove that a safer, feasible alternative design existed at the time of his alleged injury. The plaintiff alleged that the "alternative design" was a product made from organic tissue, not the synthetic mesh that composed both defendants' products. The court held that mesh made from organic tissue was not an "alternative" to the defendants' synthetic mesh products - it was an entirely different product. And, under Texas law, an entirely different product does not satisfy a plaintiff's burden to prove that a safer, feasible alternative design exists. As the court explained, "[T]hat Plaintiff now believes that [organic tissue mesh] would have been a better choice does not mean that it is an 'alternative' under the law." Id. at *4. The court held that the plaintiff had failed to state a claim for design defect sounding either in negligence or in strict liability. That's quite familiar to us and our readers.
Manufacturing Defect
In Texas, "[a] manufacturing defect exists when a product deviates, in its construction or quality" from the manufacturer's own specifications, "in a manner that renders it unreasonably dangerous." Id. (citation omitted). The court held, "Nowhere in the [Complaint] does Plaintiff allege that a particular mishap occurred in the manufacturing process that rendered the [defendants' products] unreasonably dangerous" or that the products deviated from the manufacturers specifications in a manner that rendered the products unreasonably dangerous. Id. As such, the plaintiff had not adequately pled a manufacturing defect against either defendant. That's familiar, too.
Warnings Causation
Regular readers of this blog may recall that warnings causation is one of our pet issues. In Texas, like most everywhere else, a plaintiff cannot prevail on a failure-to-warn claim unless he can prove both that a warning was inadequate and that the inadequate warning was the proximate cause of his injuries; in other words, that a different or stronger warning would have altered the prescribing physician's decision to prescribe the product. In this case, the court held that the plaintiff had not pled either element of the claim - he had not included specific allegations identifying how the products' warnings were inadequate or what additional information the warnings should have included, and he had not adequately pled that his surgeon would have altered his prescribing decision if the warnings had been different. That's a well-trodden TwIqbal path.
Other claims
The plaintiff asserted gross negligence and punitive damages claims against both defendants. The court held that, although it was a "close call," the plaintiff had not adequately pled that the defendants "acted with an extreme degree of risk or [were] consciously indifferent to the safety of others" by creating their products. The court also held that "merely listing claims for defective construction/composition and breach of express warranties" [was] not enough to meet the pleading standard. Id. at *7. This result, we wish was more common.
Bottom line: the court held that the plaintiff had not adequately pled any of his claims against either defendant, and it granted both defendants' motions. But here's something else that is familiar: plaintiffs get too many bites of the apple when they had every opportunity to do it right the first time. All of the plaintiff's claims were dismissed without prejudice, and he was given 21 days to re-plead his claims. We'll keep you posted on that. Meanwhile, a bowl of Cap'n Crunch is calling our name. Stay safe out there.
This article is presented for informational purposes only and is not intended to constitute legal advice.
