Of the three main theories of product liability (design defect, manufacturing defect, and failure to warn), we find ourselves blogging way more on the first and third, and not as much on the second. The case law is more varied, more interesting, and just plain more more on design defect and failure to warn than it is on manufacturing defect. Maybe it is easier for plaintiffs and courts to wax nonsensically on design defect and warnings. Some expert somewhere can find fault with any design. That same expert will also readily opine that any warning under the sun could do with more detail, more emphasis, and, again, just plain more more. But a claim of manufacturing defect requires a specific comparison between a specific product and its specs. In most cases, the plaintiff flings a manufacturing defect claim into the complaint as an empty gesture or afterthought. Given the choice, we’d much rather litigate on manufacturing defect, which is concrete and measurable, than on design defect or failure to warn, which are mush. Manufacturing defect is steak. Design defect and failure to warn are scrapple and tapioca. Manufacturing defect is The Sopranos. Design defect and failure to warn are BJ and the Bear. Manufacturing defect is the 2008 Phillies. Design defect and failure to warn are this year’s Phillies and … next year’s Phillies.
When we do see a case focusing on manufacturing defect, odds are that it is a hip replacement case.
The defendant in Cordova v. Smith & Nephew, Inc., 2014 U.S. Dist. LEXIS (EDNY July 30, 2014), seems to have felt the same way we do, as it moved to dismiss all claims against it except those premised on manufacturing defect. The plaintiff claimed that the defendant’s R3 ceramic artificial hip joint hurt her because it deteriorated prematurely due to design and manufacturing defects. She sued under New York law for (a) strict liability based on design defect, manufacturing defect, and failure to warn; (b) negligent failure to warn; (c) breach of express and implied warranties; and (d) negligence. Her husband sued for loss of consortium.
The R3 Ceramic System is a Class III medical device that received premarket approval by the FDA. That means preemption of most of the claims. But the claim of manufacturing defect might linger if the plaintiffs have something substantive and specific to work with on that theory. In Cordova, they possibly did have something. On December 21, 2010, the FDA issued the “Warning Letter” that the R3 Ceramic Systems manufactured at a plant in Germany were adulterated because they were not being produced in conformity with the Current Good Manufacturing Practice requirements set forth in 21 C.F.R. Part 820. Specifically, the FDA found that there was “no process validation study to support the minimum and maximum settings” used to press different sized titanium rings into the liners of the R3 Ceramic Systems. Cordova, 2014 U.S. Dist. LEXIS 104956 at *6. Four months later, on April 22, 2011, the defendant conducted an FDA Class II recall of the R3 Ceramic Systems. So far, so bad. But the plaintiff is out of litigation luck unless the alleged defect connects with the injury alleged. Again, the Cordova plaintiffs have some helpful facts. About six months before the FDA issued the Warning Letter, the plaintiff underwent right hip replacement surgery on June 11, 2010, during which defendant’s R3 Ceramic System was used. Following hip surgery, the plaintiff experienced “continuous periods of grinding sensations, squeaking sounds and limited ranges in motion” in her hip. She was experiencing “great discomforts” from her artificial hip and underwent another surgery to replace the R3 Ceramic System with a different artificial hip device. The plaintiff alleged that the deficiencies in her artificial hip were the same deficiencies identified by the FDA in the Warning Letter. Id. at *8.
We haven’t a clue as to how the facts will pan out on the manufacturing defect claim. But the fact that we are wondering about such facts means that the manufacturing defect claim is probably not susceptible to a motion to dismiss. But remember that the plaintiffs threw everything into the complaint including the kitchen sink. That big, clunky complaint could have pernicious effects on discovery, a judge, or the jury. Thus, the defendant was smart to clear out the doctrinal underbrush by moving to dismiss all those claims that were obviously improper. Obvious to us, anyway. And, we are pleased to report, also obvious to the court.
The design defect claim consisted of the usual incantations. The plaintiff vaguely alleged that the product design was “unreasonably dangerous” and “contrary to safer reasonable alternatives.” She did not claim that the design of the R3 Ceramic System deviated in any way from the design approved by the FDA; the Warning Letter and recalls cited in the amended complaint relate only to a manufacturing defect, not a design defect. The court concluded that the plaintiff’s “design defect claim boils down to a direct attack on the very design approved by the FDA.” Id. at *16. Accordingly, that design defect claim is preempted.
The failure to warn claim – the bête noire of our daily existence – was equally formulaic and empty. The plaintiff alleged that the defendant failed to warn the public that the R3 Ceramic System was defective and that “the instructions and warnings provided were inaccurate and/or inadequate”. Id. at *18. The plaintiff did not claim that the defendant modified or failed to include the labels and warnings that the FDA approved as part of the premarket approval process. Nor did the plaintiff allege that the defendant’s alleged failure to warn violated any other federal requirement. Bottom line: the failure to warn claim was also preempted.
The court held that the breach of express warranty claims would not be preempted to the extent they rely on a manufacturing defect. But the allegations in the complaint did not manage to state the dreaded “parallel” claim. Rather, the plaintiff alleged in a wholly conclusory fashion that the defendant breached express warranties “regarding the performance of the [R3 Ceramic System]” including warranties “that it would be safe to use” and that it was “inspected and accepted in accordance with this defendant’s own and other recognized safety standards”. Id. at *25. The failure to set forth with any detail “the terms of the particular warranty” upon which the plaintiff allegedly relied compelled dismissal under Rule 12(b)(6). Id. at *25-26. Again, the plaintiff’s failure to tie the claim (here, breach of an express warranty) to a violation of federal requirements—for instance, by alleging that the breach was a manufacturing defect in violation of FDA regulations—was also grounds for dismissal.
The court concluded that the breach of implied warranty and negligence claims were preempted to the extent they rely on a design defect or failure to warn theory. But those claims were permitted to proceed to the extent they were premised on an alleged manufacturing defect. Id. at *28.
To our eyes, the defendant made a smart choice in aiming at the non-manufacturing defect claims. The motion to dismiss was properly focused. The proof of the prudence of this decision lies in the result: the defendant got everything it wanted. What remains is a case that is at least intelligible. Whatever the court or jury end up doing with the case, at least the case has been taken out of the cloud cuckoo-land in which we are too often forced to dwell.