Stop us if you’ve heard this one before. Actually, you certainly have. Just like we keep telling the same stories to our kids and colleagues, we find ourselves on this blog yapping incessantly about preemption, Twombly and causation. That’s no huge surprise, because those are three of the best sieves for filtering out weak drug-and-device cases.
We’re not going to linger on the magic of the number 3. We’re betting most readers of this blog had at least one professor who divided every analysis into three parts. Caesar divided Gaul into three parts. Three points define a plane. Baseball celebrates the Triple Crown — home runs, runs batted in, and batting average (even though stat-heads these days think those aren’t the most important metrics). And then, of course, there’s Moe, Larry, and Curly.
Franklin v. Medtronic, Inc., 2010 U.S. Dist. LEXIS 71069 (D. Col. May 12, 2010) applies all three filters. The opinion (written by a Magistrate Judge and later adopted by the District Judge on June 22, 2010) is a microcosm for some of our favorite themes. Franklin sued Medtronic claiming that an implantable defibrillator battery malfunctioned and caused her injury. She alleged that the defibrillators were negligently designed and manufactured, that the company should have furnished warnings sooner than it did and should have recalled the devices, that the company breached implied and express warranties, and that the company made misrepresentations and negligently inflicted emotional distress. As usual, the plaintiff emptied out Prosser in drafting the complaint.
Before getting to the substantive claims, the court observed that Plaintiff was proceeding pro se. That means that the court will review the pleadings liberally (although Franklin’s complaint had been prepared by an attorney, so that doesn’t get such liberal treatment). But the court emphasized that pro se status does not permit the court to assume or supply facts that weren’t alleged, and Plaintiff was not entitled “to application of different rules.” Franklin, 2010 U.S. Dist. LEXIS 71069, * 8. Got it? Okay. So now the court can slice and dice this case with a clean conscience.
The defibrillators were approved by the FDA pursuant to the premarket approval (“PMA”) supplement process. The PMA process is rigorous and squarely implicates Riegel preemption. That plants us in the middle of the metaphysical debate over whether the claims seek to impose a requirement different from or additional to FDA rules, or whether the claims are under state laws imposing a “parallel” requirement. At this point, we’re not going to say stop us if you’ve heard this before. Even though you have heard it, the Franklin court’s approach to the issue is singularly clear and useful. (When other courts save claims on the “parallel” claims theory, it often sounds like mush. Or maybe it’s non-Euclidean geometry.)
The court begins by tackling the claim that the company should have warned doctors and patients sooner about the battery malfunction. Plaintiff “has not pointed the court to any FDA regulation that requires a device manufacturer to unilaterally contact doctors and patients regarding a potential device defect without FDA involvement.” Id., *17. To proceed with a “parallel” claim, a defendant “‘must demonstrate that a particular federal violation lead to her injuries.'” Id. (quoting Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 282 (EDNY 2009)(emphasis in original). In other words, a plaintiff cannot simply mouth the word “parallel.” Parallel to what? It’s got to be something specific. More often than not, there’s no there there. Further, as Riegel made clear, the PMA process includes review of proposed labelling. Accordingly, section 360c(a)(2)(B) preempts any warning claim.
Similarly, the court dismissed Plaintiff’s claim that the company should have recalled the defibrillators. Again, where is the parallel requirement? The FDA regulation describes a recall as “a voluntary remedial measure to be undertaken on a firm’s ‘own volition.'” Id. (quoting 21 CFR 7.3). A finding that the company was negligent for failing to recall the device would necessarily establish a requirement different from or in addition to the federal requirement. Not parallel.
The claim for breach of implied warranty is controlled by Riegel and is clearly preempted. But the Supreme Court didn’t address claims for breach of express warranty. Lower courts have split. Compare Heisner v. Genzyme Corp., No. 08-C-593, 2008 U.S. Dist. LEXIS 60569 (N.D. Ill. 2008) (express warranty claims not preempted) with In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009) (express warranty claims preempted). The Franklin court came down on the side of preemption, the correct side, because “the PMA process includes a review of a device’s proposed labelling and any representation contained therein.” Franklin, 2010 U.S. Dist. LEXIS 71069, *20.
The claims for negligence per se and misrepresentation gave the court “more pause.” Id. The former claim incorporated a number of FDCA regulations and the latter alleged that the company “failed to duly report information to the FDA” and downplayed risks in a letter to the FDA. Id., at *21. Thus, at first blush, these claims seem vaguely parallel. Note our use of the word “vaguely.” For, as the court sees it, “upon a slightly more probing review, it becomes clear that these claims are likewise preempted.” Id. And here come Twombly and causation riding to the rescue. Of course, Franklin was at the summary judgment, not motion to dismiss, stage. But the court had no difficulty importing the requirement that allegations be more than conclusory. (Indeed, if anything, the requirement of factual substance makes far more sense at the summary judgment stage.)
Turns out that “Plaintiff makes only conclusory allegations that Defendant failed to timely and fully investigate, analyze, and report adverse events and product failures; and also failed to report any labeling, manufacturing, device modifications, or design validations that might be necessary.” Id., at *26. For example, Plaintiff didn’t point to a single adverse event or product failure that should have prompted a warning or recall. Basically, Plaintiff was insisting on the court drawing assumptions or filling in gaps. At most, Plaintiff’s case added up “to a mere ‘suspicion [of] a legally cognizable right of action,'” and did not “state a ‘parallel’ claim for relief as required to overcome section 360k(a) preemption.” Id., at 27 (quoting Twombly, 550 U.S. at 556 n.3). In short, all of the “parallel” play-acting was “formulaic” and couldn’t pass muster. It’s not unusual that Plaintiff’s cannot assemble sufficient facts. It’s refreshing when courts actually notice it and push the trap door button.
The court actually pushes the button twice. Even if there were any meat on the bare-bones allegations of FDCA violations, Plaintiff “failed to allege any facts establishing a causal connection between Defendant’s alleged failure to comply with FDA regulations and her alleged injuries.” Franklin, 2010 U.S. Dist. LEXIS 71069, at * 27. (There’s a lot of failure in that sentence, isn’t there?) Plaintiff didn’t show that any of the regulatory violations made the device less safe. More fundamentally, Plaintiff simply didn’t show that any of the alleged regulatory violations made any difference as far as Plaintiff was concerned.
That’s it. There’s a lot packed into a mere eight pages. But it’s the clarity and rigor of thought that stands out. It’s relevant to many of the cases we litigate. You know how sometimes when you file a brief you attach an opinion because it’s so helpful? We
usually attach three. Anyway, this might be one of those cases.