Photo of Rachel B. Weil

We were in western Tennessee last week for an argument.   We stayed at a beautiful and venerable hotel, most famous for twice-daily “march of the ducks.” Every morning, at 11 a.m. sharp (at least 30 minutes after guests have packed the lobby), an elevator door opens, and a uniformed “duck master” leads a perfect procession of mallard ducks down a red carpet to the lobby fountain, where the ducks climb steps and jump in.   There they spend the next six hours, splashing and snacking, ‘til, at 5 pm, with just as much ceremony, they march back to the elevator and are returned to their rooftop habitat.   They are rotated back to a duck farm after three months, where they live out their lives as wild ducks while new recruits take the next three-month shift at the hotel. It is altogether delightful, and the hotel capitalizes with “all things duck” – duck-shaped butter served with morning toast, duck-shaped soap at the sink, duck-shaped chocolates on the pillows. (And no duck served in any hotel restaurant!)  It all fits together perfectly.

Unlike today’s case, a duck out of water from both jurisdictional and substantive perspectives. In Jones v. Medtronic, Inc., 2019 U.S. Dist. LEXIS 137304 (D. Ariz. Aug. 14, 2019), the plaintiff underwent three spinal fusion surgeries using the defendants’ intervertebral body fusion devices, their spinal fixation system, and their Infuse bone graft material The plaintiffs’ spine failed to fuse. She filed suit, asserting the usual product liability claims and alleging that the defendants’ bone graft material was not supposed to be used with the particular fusion devices used in her surgeries but was designed only for use with another fusion device. She alleged that the fusion devices used in her surgeries were known to “migrate, subside, and [be] expulsed,” which prevented them from containing the bone graft material long enough for spinal fusion to occur.   Jones, 2019 U.S. Dist. LEXIS 137304 at *3. The defendants moved to dismiss the complaint pursuant to Rules 12(b)(2) (lack of personal jurisdiction) and 12(b)(6).

Motion to Dismiss for Lack of Personal Jurisdiction

In their 12(b)(2) motion, the three defendants argued that the plaintiff had not made a prima facie showing that the court had either general or specific personal jurisdiction over them. As an initial matter, the court found that one of the defendants had waived its objections to personal jurisdiction because it had not raised the issue when it filed a motion to dismiss an earlier version of the complaint. With respect to the remaining defendants, the court found that it did not have general personal jurisdiction because the defendants were not incorporated in Arizona and did not have their headquarters or principal places of business in Arizona. With respect to specific personal jurisdiction, the court explained that, under Bauman, the plaintiff was required to make a sufficient showing that the defendants purposefully directed their activities toward Arizona or “performed [acts] that resulted in it availing [themselves] of the laws of Arizona.” Id. at *10.   The court explained that the plaintiff had not adequately alleged that the defendants maintained manufacturing facilities in Arizona or that her claims arose out of or were related to the defendants’ forum-related activities.   The plaintiff’s fusion surgeries were not performed in Arizona, and the court emphasized that “the plaintiff’s status as a resident of Arizona is insufficient to confer personal jurisdiction” over the defendants. Id.  As such, the court held, it did not have personal jurisdiction over either defendant.   This left one defendant, and the court addressed the 12(b)(6) motion with respect to that defendant.

Motion to Dismiss for Failure to State a Claim

Manufacturing Defect: The plaintiff alleged that the fusion devices had a manufacturing defect because they “had a tendency to migrate, subside, and be expulsed from the implant site.” Id. at *11. The court explained that, under Arizona law, a manufacturing defect is a “flaw[] as a result of something that went wrong in the manufacturing process.” Id. at *12 (citations omitted). The court held that the plaintiff’s “conclusory allegations” were “insufficient to state a plausible” manufacturing defect claim. Id.

Design Defect: The plaintiff alleged that the spinal fixation system had design defects that prevented the plaintiff’s spine from fusing. Because the plaintiff’s design defect claim did not “clearly identify whether [it was] based in negligence or strict liability,” id. at *15-16, the court considered both possibilities, and held that the plaintiff’s pleadings did not satisfy either standard.  The facts asserted in the complaint did not “support [a] claim that the . . . spinal fixation system fail[ed] to meet the purpose for which it was designed,” as a negligent design claim would require, according to the court.  Nor did the complaint adequately allege that the spinal fixation system “was unreasonably dangerous and failed to perform in a reasonably safe manner” or that its benefits did not outweigh its risks, alternate tests of a strict liability – design defect claim. Id. at *17. As such, the court held, the plaintiff had not pled a plausible design defect claim sounding in either negligence or strict liability

Failure to Warn: Because the fusion devices were Class III medical devices, any warnings claims were subject to express preemption under Riegel. The court explained that, “in order to avoid preemption, a plaintiff has to sue for conduct that violates a federal requirement . . . but cannot sue only because the conduct violates that federal requirement ([to avoid] implied [Buckman] preemption).” Id. at *19. Here, the plaintiff alleged that, because the (allegedly) “correct” fusion device failed to include certain warnings required by FDA, she was implanted with the “wrong” fusion device. Problem was, the defendants asked the judge to take judicial notice of the 2009 label, presumably in effect for the plaintiff’s 2010 surgery, which contained the specific warning the plaintiff alleged was missing.   The plaintiff admitted that she hadn’t been able to find that label – she only had labels from 2002 and 2015. You know what the court held here. (We would have had fun briefing the “warnings causation” argument if, in fact, plaintiff had been allowed to proceed with a claim that a warning was allegedly missing from a product that was never implanted in her.)

The judge similarly dispatched “adulteration” and “misbranding” claims.   The “adulteration” claim was based on the substitution of one fusion device for the other, which, the court observed, was effected by the surgeon, not the defendants. The misbranding claim made little enough sense that we won’t belabor it except to note that the court held that the claim “[flew] in the face of logic.” Id. at *23.

In sum, the complaint was a “hot mess,” in the words of some new Tennessee friends we made this week, and it mercifully and properly was dismissed.   We really like this decision, especially the judicial eye rolling evident throughout. We’ll keep you posted on similar victories. Meanwhile, if you are going to be in western Tennessee, email us and we’ll point you in the direction of the ducks!