Monday, February 14, 2011

Res Ipsa and Preemption Meet Cute

It's Valentine's Day, so we blow a kiss towards our true love, preemption. But while we love preemption, we must confess ill will toward the "parallel claim" end-run around preemption. We have had our flings with some other doctrines, such as res ipsa loquitur. See, e.g., No Trout in the Milk. Like a meet-cute RomCom, a recent case brought all these themes together in one nice little package. Last week a federal court dealt with an interesting effort by plaintiffs to establish a parallel claim via res ipsa loquitur. Cafferty v. Cayuga Medical Center et al., 2011 U.S. Dist. LEXIS 12245 (N.D.N.Y. Feb. 8, 2011). The opinion is pretty straightforward. You might even say it speaks for itself.

A plaintiff underwent eye surgery, involving clear lens extraction of the left eye with implantation of an interocular lens. After the surgery, the plaintiff presented with certain symptoms and was later diagnosed with Toxic Anterior Segment Syndrome ("TASS"). TASS is related to "an unwanted material gaining access to the anterior segment of the eye." Cafferty, 2011 U.S. Dist. LEXIS 12245 at * 5. It's pretty hard for the unwanted material to get to the anterior segment of the eye except during a surgical procedure. But none of the experts in the case could identify the specific cause of the plaintiff's TASS, even after viewing a video of the eye surgery.

The surgery included use of a couple of Class III medical devices for which one of the defendants had been granted premarket approval by the FDA. That defendant did what we would do -- it shouted "preemption!" And the plaintiffs did what we would expect them to do -- they shouted "parallel claim!" More specifically, the plaintiffs argued that their negligent manufacturing claim was not preempted by the MDA because "they allege that one or more of Alcon's products deviated from the manufacturing process and was manufactured improperly in violation of federal regulations. Accordingly, Plaintiffs contend, said claim parallels, rather than adds to, federal requirements." Id. at * 10.

What makes a claim parallel? This question is garbed with theoretical majesty. We are reminded of our high school geometry teacher, who tried in vain to explain non-Euclidean geometry to us. The dissipations of the last 35 years probably prevent accurate recollection, but we seem to recall that everything hinged on how many lines could go through a point and be parallel to another line. Euclidean geometry said there could be only one such parallel line. One mathematician said there were two. Another said none. Lobachevsky and Riemann figured in there somewhere, but don't ask us where. And Deborah Harry had something to do with parallel lines. Anyway, there's a reason why we went to law school.

But we don't even have to answer the knotty theoretical question. We just want -- courtesy of our old friends Twombly and Iqbal -- actual facts as to the parallel federal violation. Some courts have allowed plaintiffs to spew conclusions that the defendant violated the FDCA, without specifying the violation or providing a single fact. And our contempt for that position is a matter of record. It speaks for itself.

The court in Cafferty confronted this issue at the summary judgment stage. So it insisted not only on a specific factual allegation of a parallel federal violation -- it actually insisted on an evidentiary showing. Plaintiff's opposition to summary judgment argued that "Alcon most likely violated federal regulations and requirements in connection with the manufacturing" of the devices in question. Id. at *12. Yet, "Plaintiffs fail to direct the court to any evidence in the record that Alcon violated any federal regulations, much less regulations governing the PMA process." Id.

Here's where the plaintiffs got clever. One of their negligence claims in the case was grounded on res ipsa loquitur. As a quick refresher, res ipsa loquitur 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 of the left-behind scalpel example. Basically, the plaintiffs in Cafferty contended that TASS is like a left-behind scalpel. There would've been no TASS absent contamination during the surgery, and there would've been no contamination absent some sort of manufacturing defect. And, in fact, the court permitted the plaintiffs to proceed with their overall res ipsa loquitur negligence claim.

It turns out that the court in Cafferty was pretty clever in its own right. The court took the preemption point seriously and dismissed the negligence claim relating to the alleged manufacturing defect of the Class III medical devices. The court read the Supreme Court's Riegel decision to acknowledge "that under the federal law governing the PMA process, there is no demand that a product be risk-free, only that its benefits, if manufactured according to specifications, outweigh its risks." Id. Consequently, "one may not infer a manufacturing defect without creating a duty that adds to, rather than parallels, federal requirements in contravention of Supreme Court precedent." Id. at *13. As we say, that's pretty clever. We might've taken the simpler (simplistic?) route and said that there have to specific facts supporting a parallel claim, and that res ipsa loquitur cannot be a substitute for such facts -- particularly, as here, where res ipsa loquitur just meant that something likely went wrong during the operation, and not necessarily a manufacturing defect.

We're not keeping a "Preemption vs. Latin Phrase" scorecard (Mens rea? Alea iacta est? Ad nauseam? Or the motto of our high school cafeteria, fidem clam scit?), but if we did, preemption is up 1-0.