We talk a lot about preemption here.  Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts.  That isn’t surprising.  Preemption can end a litigation, and we all want to hit the game-winning home run.

But plaintiffs know that too.  So, rather than taking preemption head on, we often find ourselves dealing instead with plaintiff’s attempts to get around it via “parallel violations” claims.  Now, we have problems with the very existence of such claims.  Among other things, they often appear to be improper attempts to bring private rights of action under the FDCA.  But, unfortunately, they exist, and courts recognize them.  Given that reality, however, we’d like courts to at least view them with a scrutinizing eye.  The court in Cline v. Advanced Neuromodulation Sys., Inc., 2014 U.S. Dist. LEXIS 56669 (N.D. Ga. Mar. 31, 2014), did just that.

In Cline, the plaintiff had an opportunity for limited discovery (which we’ll discuss later) into the PMA specifications that came with the approval of an implantable pulse generator (“IPG”) implanted into plaintiff. Plaintiff then filed her third amended complaint in an attempt to state parallel violation claims related to the failure of her IPG.  It didn’t go exceedingly well.  The court lowered the microscope to look at those claims for what they really were, and almost all them did not survive.

The court disposed of plaintiff’s strict liability parallel violation claims due to their very nature.  Strict liability claims are
based on, well, strict liability.  They generally do not involve a standard of care:

“Georgia’s strict liability provision does not require the violation of any standard of care, let alone a standard that parallels federal regulations.  Therefore Plaintiff’s claim under strict liability cannot be genuinely equivalent to Defendant’s requirements under federal law, and is thus preempted.”

Id. at *12-13.

The court also closely inspected plaintiff’s negligence parallel violation claims.  Plaintiff claimed that the battery in the IPG
did not meet a supposed FDA requirement that it last ten years.  Id. at *14.  The court found no such FDA requirement.  The supplemental PMA involving the new battery stated that it “could” last ten years. But the FDA did not affirmatively adopt this performance standard.  And courts cannot create that standard by implication:

The FDA’s promulgation of performance standards for medical devices is governed by 21 U.S.C. § 360d.  Under this section, “the FDA may require that a device meet certain performance standards if it determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.”  Walker v. Medtronic, Inc., 670 F.3d 569, 573 (4th Cir. 2012), cert. denied, 133 S. Ct. 162, 184 L. Ed. 2d 234 (2012) (quotation omitted).  The FDA does not establish a performance standard by implication.  On the contrary, performance standards come into existence through typical rulemaking procedures including publication in the Federal Register followed by a comment period.  21 U.S.C. § 360d(b).

. . . Plaintiff fails to allege that the FDA followed the rulemaking procedures set forth in the statute to promulgate an actual performance standard mandating a ten-year battery life.

Id. at *15-16.  Moreover, in its Summary of Safety and Effectiveness Data, the FDA acknowledged that the battery failed 1.9% of the time.  “[G]iven the FDA’s tolerance of some battery failure in [the IPG], it makes little sense to conclude that,
without more, the failure of a battery to last ten years gives rise to a parallel claim.”  Id. at *16.  The court held that this claim was not viable.

Plaintiff also claimed defendant’s testing of the new battery via mathematical projections that were based on older battery models didn’t satisfy 21 C.F.R. §820.30(g)’s requirement that testing be done “under actual or simulated use conditions.”  Id. at *17.  The court scrutinized the basis for this claim and saw nothing in the federal regulation declaring that mathematical models do not simulate use conditions: “Plaintiff’s allegations fail to plausibly allege that Defendant’s use of mathematical projections in its testing of the . . . battery was in violation of § 820.30(g).”  Id. at 18.

The court also addressed plaintiff’s claim that an FDA Form-483, warning letter and recalls could be the bases for plaintiff’s state-law parallel violation claims.  The FDA inspector’s observations in the Form-483 weren’t related to the problems about which plaintiff was complaining: “Plaintiff lists a number of critical observations, but fails to allege how they are linked to her claims.”  Id. at *19.  The same was true for the warning letter, which the court properly noted “does not represent a final Agency determination regarding a manufacturer’s compliance”: “like the Form-483 above, this letter addressed procedures and issues that are not probative of Plaintiff’s alleged battery weld failure.”  Id. at *19, 20.  A number of the recall notices
and device correction updates cited by plaintiff also were not “directly relevant to plaintiff’s injury.”  Id. at *20.  Plaintiff threw all these allegations into the complaint, and the court wasn’t moved.  None of them related to plaintiff’s injury.

Plaintiff tried to base a failure to warn claim on defendant’s failure to timely file adverse event reports with the FDA.  Such
claims should always fail.  Not only are they improper attempts to privately enforce the FDCA, they are subject to Buckman
preemption.  But the court didn’t need to address either of those problems.  It instead set the claim aside based on a point-by-point analysis of plaintiff’s failure to satisfy proximate causation:

First, the FDA’s disclosure of MDRs to the public is not guaranteed. . . .  Second, Plaintiff does not clearly allege that
Defendant outright failed to file an MDR for these events; only that they were not timely filed.  Defendant may have
subsequently reported each incident to the FDA outside of the 30-day MDR deadline with enough time for the FDA to publicly disclose this information  . . . . Third, . . .  Plaintiff has not alleged that the FDA’s disclosure of Defendant’s  timely filed MDRs would necessarily provide Plaintiff with specific, actionable information.  . . .

Fourth, even if Defendant withheld these MDRs, it is implausible that the failure of a single implanted device due to battery weld issues over a six-month period would prompt action from the FDA, Plaintiff, or Plaintiff’s medical providers.

. . .

Id. at *28-29.  This was an empty-all-the-barrels denial of plaintiff’s claim.

The court also disposed of plaintiff’s fraud claim. It wasn’t pleaded with the required particularity.  Moreover, her claim that a sales rep told her on the day of her surgery that the battery would last ten years was insufficient to allege the justifiable reliance element of a fraud claim.  She had already presented herself for the surgery, and the surgery was not done on an emergency basis.  Id. at *33-34.

The court did, however, let stand plaintiff’s express warranty claim, as well as a negligence claim based on recalls of the battery due to weld cracks that, at least plausibly, could have been related to her injuries.  Id. at *10-12, *20-25.  But we’ll take that.  The court, while recognizing parallel violations claims, scrutinized them and, for the most part, exposed them as improper.  Its decision significantly limited the claims and, with it, the range of discovery available to plaintiff.

Speaking of discovery, as we mentioned, the court granted plaintiff discovery into the FDA’s PMA specifications for the IPG so that plaintiff could determine whether she could state a parallel violation claim.  Id. at *3.  One of the reasons for pleading standards and TwIqbal, however, is to avoid unnecessary discovery, not create it.  While we appreciate that the court limited plaintiff’s discovery, that authorization still allowed plaintiff to go fishing for a claim that presumably did not exist beforehand.  Moreover, it seemed fruitless.  Almost all plaintiff’s claims were subsequently dismissed.  And the principal claim that survived was based on a product recall, something that plaintiff needed no discovery to learn about.