It was the best of times . . . . No, our story isn’t nearly as significant as that classic. Rather, it is a tale of two medical device cases that we thought offered an interesting comparison for their numerous similarities and one key difference – the result. This brings to mind vague memories of a popular book series of our youth, Choose Your Own Adventure. The books were written with the reader as the protagonist. After a few pages of a story such as Who Killed Harlowe Thrombey?, the reader is offered two or three options, each of which leads to more options and then to one of about 40 different endings. For an avid reader, it meant a lot of mileage out of one book. Now, it reminds us how changing one or two small facts can make a huge difference in the outcome.
Both cases start out pretty much the same. Two surgically implanted medical devices. Two product failures. Two alleged injuries. Two explanted medical devices. Two devices that were lost, discarded, missing – here you can choose your own adjective without it impacting the story – the devices were unavailable for inspection, they were gone. Two lawsuits filed alleging product defects.
Without the devices, both plaintiffs were going to have to rely on the doctrine of res ipsa loquitur. For those who haven’t thought about res ipsa loquitur in awhile, it is an evidentiary doctrine providing that a prima facie case of negligence exists where (1) the event is of a kind that ordinarily does not occur in the absence of someone's negligence; (2) the event is caused by an instrumentality within the exclusive control of the defendant; and (3) the event must not have been due to any voluntary action of the plaintiff. Think plummeting elevator, dead mouse in a soda bottle, or the classic left behind scalpel.
But this is where our stories diverge and the major plot difference is preemption. Viserta v. St. Jude Medical, Inc., 2012 U.S. Dist. LEXIS 26084 (D.S.C. Feb. 29, 2012) involved a Class III medical device that had received premarket approval from the FDA. Id. at *1. So, we know this story by heart. Plaintiff’s claims are preempted – except where plaintiff pleads a parallel violation claim, which is what they tried here. Specifically, plaintiff alleged that the defendant’s manufacturing materials and/or procedures “did not meet Current Good Manufacturing Practices (“CGMPs”) promulgated by the FDA, and/or they deviated from the FDA’s approval for the [device].” Id. at *2. While the court agreed that plaintiff was attempting to assert a non-preempted parallel claim, it also found that they failed to do so:
[A] plaintiff must allege specific facts as to how a manufacturer violated federal requirements and the causal connection between such violations and the plaintiff’s injuries to survive a motion to dismiss. . . In this case, [plaintiff] makes conclusory allegations concerning defects in [the] manufacturing process, but does not include any factual support as to how [defendant] failed to manufacture the [device] in the manner required by the PMA process.
Id. at *9.
Plaintiff intended to rely on res ipsa loquitur – the device was defective because she suffered an injury. Id. at *10. But, in discussing the need to plead a causal connection, the court focused in on the missing device:
The Amended Complaint is further devoid of any factual allegations concerning the actual condition or observation of the device upon its removal which may possibly provide the required causal connection.
Id. Preemption thus added another step. Plaintiff is required to prove an FDCA violation, not just a device malfunction. Res ipsa doesn’t allow the inference of the latter. Thus, without the device, plaintiff had not pled facts necessary to establish a causal link. Without a causal link, plaintiff failed to state a claim and the court dismissed the complaint.
By contrast, the device at issue in Banks v. Coloplast Corp., 2012 U.S. Dist. LEXIS 26112 (E.D. Pa. Feb. 28, 2012) was not a PMA device and therefore, preemption was not in play. So, instead of a “parallel claim”, the plaintiff was pursuing a garden variety “malfunction theory” case. Under Pennsylvania law, when the product is unavailable, a plaintiff is allowed to use circumstantial evidence to establish a product defect. But the plaintiff must also offer proof of the absence of other reasonable secondary causes for the malfunction. Id. at *6-8.
This case had also advanced a few more chapters and was at the summary judgment stage. So, the court considered evidence that the device had in fact malfunctioned (didn’t perform as intended), that the malfunction occurred shortly after implantation (allowing an inference that the device was defective when it left defendant’s control), and the lack of evidence of abnormal or unintended use of the device. Id. at *8-9. The court also considered arguments about the possibility of surgical error or damage during implant, but found those only gave rise to genuine issues of material fact for the jury and did not warrant summary judgment on plaintiff’s strict liability claim. Id. at *10.
Two cases with similar facts but vastly different outcomes and it looks like we have our old favorite preemption to thank for it. If given a choice in our adventures, we’ll pick the preemption ending every time.