If you have read more than a few posts on this Blog, then there is a good chance that you realize we have strong views on preemption. You might have also picked up that we think the way an issue is analyzed, not just the ruling after the analysis, matters. We have talked about the recurring issues with purported parallel claims for PMA devices under Reigel more times than we can insert handy links—one link will have to suffice—and many of those posts have raised how implied preemption under Buckman is a real obstacle to navigating the rocky waters of parallel claims. Sometimes it seems that courts forget that a parallel claim not preempted under either express or implied preemption principles has to start with a state law claim that actually exists under the state law. State law is supposed to be the starting point and it should not expand to meet the exigencies of preemption, any more it should expand to overcome poor pleading under Fed. R. Civ. P. 12(b)(6) or TwIqbal.

OK, you say. What does this have to do with manufacturing defect claims and why is there a conundrum, you ask, patience fading like a child asked to wait to open gift-wrapped socks. Bad decisions on pleading parallel claims for PMA devices have made it easier to get to discovery—at least—on manufacturing defect claims, but actual manufacturing defect claims are very hard to prove. Among other things, there are typically records demonstrating that the lot of devices including the one plaintiffs is suing over actually met the prescribed specifications for its release and distribution. Because manufacturing defect claims are fundamentally about the particular product alleged to have produced injury not being as it was designed to be, the lot record evidence and the absence of evidence to the contrary can be dispositive on summary judgment. Our experience is that lots of manufacturing defect claims in medical device cases quietly drop out along the way. If the only claim that escapes preemption or other hurdles at the pleading stage in a PMA device case is a manufacturing defect claim, then a case may linger and soak up judicial resources for a while until an inevitable end.

Knoth v. Apollo Endosurgery US, Inc., No. 5:18-CV-49 DCB-MTP, 2019 WL 5865563 (S.D. Miss. Nov. 8, 2019), may end up being one of those cases. The plaintiff sued over a PMA gastric surgery device, asserted only expressly preempted claims, got a chance to amend, and then had her second complaint teed up on a motion to dismiss. Mississippi has a product liability act that abrogates common law claims, so (skipping ahead and omitted some details) plaintiff only had a few purported state law claims that, if pleaded properly, might avoid preemption of one kind or another. Down in the Fifth Circuit, a case called Bass (fileted here https://www.druganddevicelawblog.com/2014/05/how-to-flunk-bass-v-stryker-paralle.htmland re-fried here) had done what we alluded to earlier. It made it pretty easy to plead a non-preempted manufacturing defect claim for a PMA device. “The Fifth Circuit has determined that a plaintiff who pleads a violation of Current Good Manufacturing Practices—a significantly more general requirement—may succeed.” 2019 WL 5865563, *19. This path was permitted in part because of sympathy to the idea that the plaintiff would need access to the manufacturer’s documents to figure out in what way her particular device had been defectively manufactured. Id. at ** 20 & 27.

Even though her design defect and warnings claims were preempted and her express warranty claim was not—all fairly straightforward and expected rulings—the meat of the decision focused on whether plaintiff met the Bass standard by pleading “that Apollo’s failure to abide by the CGMPs resulted in the defect that injured Knoth.” Id. at *22. Plaintiff offered “several allegations of failure to comply with the [FDCA] – each specifically addressing the issue of spontaneous hyperinflation and the resulting contamination of human blood and tissue,” noted that FDA had sent warning issues on hyperinflation, and apparently offered facts that her injury “is consistent with hyperinflation set forth in the FDA warning.” Id. at **21-24. That was enough to determine that “Plaintiff’s claims for relief are sufficiently plausible.” Id. at *25. The conclusion that a MPLA claim for manufacturing defect was not preempted soon followed. Id. at **27-29.

Here is where we return to our gripe about the order of analysis when it comes to parallel claims. Precious little attention is paid to state law here, except when it comes to abrogation. The MPLA section on manufacturing defect, cited but not quoted in Knoth, requires proof that the particular product at the time it left the manufacturer’s control “was defective because it deviated in a material way from the manufacturer’s specifications or from otherwise identical units manufactured to the same manufacturing specifications.” Plaintiff pled that one or more components in her device “were defective because they deviated in a material way from the manufacturer’s . . . specifications.” While this is non-specific boilerplate and we understand that the court was going to give plaintiff a pass on having supporting facts before discovery, the earlier discussion of Plaintiff’s allegations suggests she was really asserting a design defect claim. In other words, it looks like she claims her device caused her injury because it was designed in a way that posed a risk of the injury she claims, not that her device deviated from otherwise good specifications.

In this case, Knoth identified a specific medical device, the Orbera gastric balloon system, that was manufactured and produced by the defendant. Knoth sets forth specific allegations that the Orbera gastric balloon was unreasonably dangerous and that the defendant was negligent, citing several violations of the CGMPs. For example, allegations that the defendant “failed to accurately establish the in vivo life expectancy of the Orbera gastric balloon system,” “failed to validate the anticipated wear on both healthy tissue and the Orbera gastric balloon prior to their release into commercial distribution,” and “failed to appropriately respond to adverse incident reports that strongly indicated the Orbera gastric balloon was Malfunctioning (sic) [as defined in 21 C.F.R. §803.3], or otherwise not responding to their Design Objective Intent,” taken as true, suggest a defect in the Orbera balloon as manufactured. Amend. Compl. ¶ 81(a), (b), & (h).

Id. at *25 (record citation omitted). Other than throwing in “as manufactured” at the end, these are design defect allegations, allegations in support of a preempted claim. None of these allegations, even with the court’s gloss on them, begins to suggest that plaintiff’s particular device deviated from its specifications, which Mississippi law requires to impose liability for manufacturing defect regardless of anything about federal law. Loading up a complaint with references to purported CGMP regulations should not change the result.