United States: M.D. Florida Shoots Down All Breast Implant Claims Except For Negligent Manufacturing Defect

Last year's list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts. Yikes. And it is not as if the bad appellate decisions were spread around. Two came from our home circuit, the Third. Two came from the reliably problematic Ninth Circuit. But the 'winner' was the Eleventh Circuit, with three terrible opinions. For defense practitioners, Eleventh Circuit precedents can create something of an obstacle course.

It turns out that good federal district judges in SEC country also can be frustrated with what their appellate brethren hath wrought. Last week we were sent an interesting example of this: Rowe v. Mentor Worldwide, LLC, No. 8:17-cv-2438-T-30CPT (M.D. Fla. March 2, 2018). In that case, the plaintiff sued for negligence, strict liability, and breach of warranty arising out of injuries allegedly caused by a silicone gel breast implant. The breast implants are class 3 devices requiring premarket approval from the FDA. The plaintiff's implants had ruptured. The plaintiff asserted that the defendant failed to conduct proper studies and failed to warn about known risks. The defendant filed a motion to dismiss. The district court wrote a thorough and well-reasoned opinion, concluding that all of the claims save one must be dismissed. All of the claims would have been dismissed had it not been for a pesky Eleventh Circuit case that is unsound and inconsistent with other Eleventh Circuit cases. The district judge acknowledged being stuck, but was none too happy about it. The Rowe court's opinion is laid out logically, and we will do our best to track it.

Pleadings

The court addresses "a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings." Slip op. at 4. We get an Iqbal name-check. The Rowe court recognizes the liberalities of notice pleading, but also recognizes that "[t]here is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material." Id. at 5 The complaint in this case was 60 pages, with 151 pages of exhibits. The negligence claim includes "six separate negligence theories that are confusingly interwoven among each other." Id. at 5. In short, the plaintiff "threw every allegation into the Complaint to see what would stick." Id. at 6. But instead of throwing out the complaint wholesale, the court examined the particular causes of action to see which ones, in fact, would stick.

Preemption Overview

For its preemption analysis, the Rowe court largely relied on the recent Eleventh Circuit decision in Godelia. That ends up having its ups and downs. But the general preemption analysis is straightforward enough. The threshold questions is whether the claims are valid under Florida state law, which governs the case. If not, those claims are gone. If so, the next questions is whether those claims are preempted by federal law.

Negligence failure to warn

The plaintiff does not allege that the defendant failed to give the warning required by FDA. Therefore, the plaintiff must be seeking to impose a warning requirement that is different from or in addition to federal law. Such a claim is expressly preempted by statute. Slip op. at 9.

Failure to report adverse events

As any even semi-faithful reader of this blog knows, we think this claim is hogwash. It should fail both on simple causation grounds as well as preemption. We wrote about this issue earlier this week. Some of you might know that the Ninth Circuit is a devilishly bad place for defendants on this issue. But the Rowe court is not in the Ninth Circuit. Instead, it is Eleventh Circuit law that supplies the framework, and this is one area where the Eleventh Circuit is pretty good, as it sees failure to report claims under Florida law as essentially alleging a claim of fraud on the FDA, which is preempted by Buckman. Slip op. at 10.

Failure to comply with federal laws

The claims under this category pertain to alleged breaches of federal requirements and regulations. One example mentioned in the complaint is failure to do required studies. But Florida law imposes no such requirement. So this claim flunks the preliminary test. Even if the claim somehow survived that test, it would be impliedly preempted. Id. at 11.

Negligent misrepresentation

The plaintiff offered only the most general allegations of failures to disclose the risks of the implants. The court deemed these allegations to fall far short of Fed. R. Civ. P. 9(b), which requires specificity of fraud allegations. The plaintiff "never identifies what the misrepresentations were, when they were made, how they were made, where they were made, or who made them." Id. at 12. In any event, the misrepresentations seemed to involve what was and was not told to the FDA. Accordingly, those claims are impliedly preempted under Buckman. Id. at 13.

Negligence per se

Violation of a federal statute does not establish negligence per se if there is no federal private cause of action. No such federal private cause of action exists here. The complaint does not state a parallel claim, and is therefore impliedly preempted. Id. at 14.

Manufacturing defect

Everything had been gliding along so smoothly up to this point. Now we hit a rough patch. The plaintiff alleged deviations from requirements in the device's PMA, departures from good manufacturing practices, and vague failures to exercise care in the manufacturing process. The defendant argued that the plaintiff never pointed to any device-specific requirements. It supported its argument by citing WolickiGables (11th Cir. 2011). The Rowe court agreed that the Wolicki-Gables standard would require dismissal of the complaint. But recent Eleventh Circuit decisions in Mink and Godelia cut the other way. "The holdings in Mink and Godelia are directly at odds with Wolicki-Gables and appear to announce a new standard the Eleventh Circuit is directing courts to apply." Slip op. at 16-17. (We listed Mink as the eighth worst DDL case of 2017. Here is the post where we explained why we think Mink stinks.) The Rowe court felt stuck. Under recent rulings, the plaintiff could conceivably state a claim under parallel requirement. At the same time, the court recognized that the "negligence count is nearly eviscerated by the Court's ruling on the other theories." Id. at 17. This, just to ensure there really is some there there, the court directed the plaintiff to replead the one surviving claim in an amended complaint.

(This kerfuffle over what to do about competing circuit precedents reminds us of our time clerking on the Ninth Circuit, which is so huge and spread out that, believe it or not, inconsistent holdings proliferate. What to do? Assume there was no en banc decision, which is what it should take to alter circuit precedent. Does a panel need to follow the earlier or later decisions. Your instincts might prompt you to conclude that it is always the most recent precedent that controls. But if the recent decision's reversal of precedent was improper, maybe even illegitimate, because it did not go the en banc route, should it really command respect? We wrote a bit on this issue last year, as part of our extended Fosamax mourning period, and argued that the earlier precedent should control and the later deviation deserves no respect.)

Strict liability – failure to warn

The analysis here is the same as for negligent failure to warn, and so is the result: preempted. Slip op. at 18.

Strict liability – manufacturing defect

Remarkably, the result here is different from the negligent manufacturing defect claim. For some unknown reason, the plaintiff did not ladle any specific federal requirements into this claim. Instead, the plaintiff simply relied on good manufacturing practices. Not good enough. Such allegations do not pass muster under either old or new Eleventh Circuit precedent. Id. at 18.

Breach of implied warranty

Plaintiffs constantly toss in warranty claims as an apparent afterthought. Or maybe it is a no-thought. The Rowe case is controlled by Florida law, and Florida law requires privity. That is all perfectly obvious. Equally obvious is that breast implants are not available for purchase directly by consumers. The plaintiff pretty much conceded absence of privity and absence of a legal basis for proceeding with this claim, by not responding to the argument. The court dismissed the warranty claim.

Final scorecard

All that is left is the negligent manufacturing defect claim. That should be a hard one for the plaintiff to win.

It occurs to us that good district judges such as Rowe's are not the only folks who must grit their teeth and do battle with the Eleventh Circuit's doctrinal wanderings. Defense DDL practitioners are in the same boat. We can relate, inasmuch as the Third Circuit (think of Fosamax) has done us few favors lately. So we commiserate with excellent defense lawyers such as the ones who fought for and won as complete a victory as reasonably possible in the Rowe case. Congratulations to Dustin Rawlin, Monee Hanna, and Allison Burke of Tucker Ellis, and David Walz of Carlton Fields.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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