When last we wrote, we had just watched our gorgeous standard poodle puppy, Luca, compete in his first weekend of dog shows. He was still learning the ropes, and, though he looked beautiful, he did not win any points. (Dog shows are worth from one to five points for each breed, depending on the number of dogs of that breed entered in the show. To be an American Kennel Club champion, a dog has to amass fifteen points, with at least two wins in “majors” – shows worth three points or more.) We are thrilled to report that, in one show weekend following those first shows, Luca won four days in a row for a total of eleven points, including both “majors” (three, in fact). He followed this by placing first in the 6-to-9-month male puppy class at the Poodle Club of America national specialty show this week. Here is his win photo! We are over the moon with pride and excitement.
We are pretty sure that the defendant in today’s case feels similarly triumphant. In Briggs v. Endologix, Inc., et al., 2023 WL 2716592 (S.D. Tex. Mar. 30, 2023), the plaintiff alleged that he was injured by the defendant’s implantable aneurysm repair stent graft, a hose-like Class III device inserted into a damaged artery, enabling blood to flow through the “hose” and to avoid the aneurysm. The plaintiff alleged that the device leaked, necessitating two repair surgeries and semi-annual CT scans to monitor the leak. He asserted a long litany of overlapping product liability claims, narrowed after argument to claims for failure-to-warn claims sounding in both strict liability and negligence and for manufacturing defect, along with a loss-of-consortium claim on behalf of the plaintiff’s wife. The defendant moved to dismiss, arguing that, under Riegel, the warnings claims were expressly preempted, and that, even they weren’t preempted, none of the claims satisfied Twiqbal.
Under Texas law, as the court explained, “[a] manufacturing defect exists when a product deviates, in its construction or quality, from the [manufacturer’s] specifications . . . in a manner that renders it unreasonably dangerous.” Briggs, 2023 WL 2716592 at *3 (citation omitted). In other words, the plaintiff was required to show that his stent graft differed from stent grafts of the same model produced and implanted in other patients during the same time period. Id. In Briggs, the plaintiff asserted only that the device and its parts “deviated from product specifications and/or applicable federal requirements . . . because of the use of defective or inadequate materials. . . , posing a serious risk of injury . . . and death.” Id. The court held, “This conclusory assertion is insufficient to plausibly allege a manufacturing defect under Texas law.” Id. As the court emphasized, the plaintiff did not identify from which specifications the plaintiff’s product deviated. Nor could the plaintiff “hang [his] on a Class I recall of the . . . stent graft,” id., because the recall applied to the entire product line. The plaintiff never alleged that his device differed from its intended design or from other grafts of the same model. The court concluded, “Because [the plaintiff did] not allege a manufacturing defect, [he could not] plausibly state a manufacturing defect claim.” Id. Claim dismissed.
Warnings Claims: Preemption
The court explained that, because the graft was a Class III medical device subject to the FDA’s full premarket approval (“PMA”) process, the manufacture could not be liable for failure-to-warn so long as it complied with federal statutes and regulations. Only if the plaintiff asserted that the manufacturer had violated applicable federal requirements could the claim be construed as a “parallel” claim that escaped preemption. On the other hand, “a state-law tort claim that adds to or differs from a federal requirement . . . is preempted by federal law.” Id. at *4 (emphasis in original, citation omitted). In Briggs, as the court explained, the plaintiff alleged that the defendant failed to submit a PMA supplement to change the device’s warnings without prior FDA approval.” Id. But, while a manufacturer is permitted to change a device’s warnings unilaterally through a PMA supplement, it is not required to do so. The plaintiff also “advance[d] a less-than-explicit argument” that the defendant should have used the “changes being effected” (“CBE”) procedure to strengthen the stent’s warnings. But, the court emphasized, though “the CBE process allows a manufacturer to change a device’s warnings without firs submitting a PMA supplement, . . . this is also not a requirement, and an allegation that a manufacturer should have utilized the CBE process to strengthen its warnings is not an allegation that the manufacturer has failed to comply with any FDA requirement.” Id. at *5. Nor did the plaintiff state a warnings claim by alleging that the defendant had attempted to conceal information in its annual clinical updates to physicians. As the court stated, this allegation sounded in fraud and “require[d] far more particulars than [the plaintiff] provided.” Id.
Finally, the court held that the plaintiff’s allegations that the defendant violated regulations related to CGMP (current good manufacturing practices) and sponsor’s records had no connection to the plaintiff’s failure-to warn claims. The court emphasized, “A state-law tort claim is not preempted [unless] the plaintiff alleges that the defendant violated federal requirements and can ultimately show a causal link between the violation and the state-law tort claim.” Id. at *6 (emphasis in original, internal punctuation and citation omitted). Here, because the plaintiff did not alleged that the violation of any federal requirement that was causally related to his failure-to warn claim, the claim was preempted.
In a final touch, the court denied the plaintiff’s request to amend the complaint. The plaintiff had already amended twice, and he “provide[d] no basis or detail for the requested amendment and (to the court’s displeasure) did not provide a proposed amended complaint for the court to review.” But what “doom[ed] the plaintiff’s] request to amend [was his] failure to apprise [the court] of the additional facts” he would include if permitted to amend. “Moreover,” according to the court, “there [was] no reason to believe that any amended pleading could overcome the preemption defense.” Id. at *7. So the court denied the request to amend and dismissed the case, in its entirety, with prejudice. Obviously, we like this no-nonsense decision’s rigorous approaches to preemption and to Twiqbal’s pleading standard.
We will talk to you soon and will keep you posted as Luca seeks the few remaining points for his championship. In the meantime, stay safe out there.