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We write on a gorgeous spring day in suburban Philadelphia, with Passover imminent for us and Easter for many we love.  Today’s decision contains more than enough “good” to sustain the positive vibe. Ward v. Zoll Lifevest Holdings LLC, 2021 WL 7907066 (D.D.C. Sept. 20, 2021) is a D.C. District case from last September that didn’t show up on Bexis’s search until just now.  The plaintiff, who had suffered a heart attack, was fitted with the defendant’s wearable defibrillator.  The device is designed to detect heart arrhythmias and to administer an electric shock to restore the wearer’s normal rhythm.  The device is supposed to sound a warning before it administers the shock.  The wearer can then prevent the shock by pressing a button on the device.  The plaintiff alleged that his device failed to sound a warning before it administered an unnecessary shock, which knocked him to the ground and caused physical and emotional injuries.  He filed suit in federal court, asserting claims for design defect, manufacturing defect, negligence, and breach of express warranty.  The defendant moved to dismiss all of the claims.

Design Defect

The defibrillator is a Class III device, which means it underwent the FDA’s full premarket approval (PMA) process before it was approved for marketing.  The defendant argued that the design defect claim was barred because, under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), state law design defect claims against manufacturers of Class III devices are expressly preempted by the medical device amendments to the FDA.  As the court explained, the only exception relates to claims that are “truly parallel to the federal requirements at issue” and are not based on state law requirements that are different from, or in addition to, the federal requirements.  Ward, 2021 WL 7907066 at *2 (citation omitted).  To assert such a “parallel claim,” a plaintiff must point to specific federal requirements that the manufacturer violated and that were causally connected to the alleged injuries.

The plaintiff argued that he had asserted just such a parallel claim by asserting that, by failing to sound an alarm before delivering a shock, the device did not conform to its FDA-approved design.  But the Complaint did not say this, instead asserting a traditional design defect claim of “precisely the type . . . that courts have held are expressly preempted by the MDA.”  Id.  at *3 (citation omitted).  The court concluded, “. . . [T]he plaintiff cannot escape preemption by recasting his claim through his opposition brief, [and] the court therefore grants Defendants’ motion to dismiss [the design defect claim].”  Id.

Manufacturing Defect

The defendant argued that the manufacturing defect claim was “merely a design defect claim disguised in manufacturing defect clothing” and should be dismissed for the same reasons.  The court disagreed.  As the court explained, “[m]anufacturing defect claims are capable of threating the ‘narrow gap’ between express and implied preemption . . . .” The only such claim that can survive preemption “is one where the defect was caused by a problem in the manufacturing process that deviated from” the approved manufacturing specifications. Id. at *4.  The court held that the plaintiff had identified at least two such potential problems in the manufacturing process, one that resulted in the failure of the alarm to sound before the shock was delivered and on that resulted in too many unnecessary shocks.   Even if those flaws were widespread in the manufactured devices, the court emphasized, they still could be the result of manufacturing defects.

The defendant also argued that the manufacturing defect claim was inadequately pled because it did not identify the ways in which the device deviated from the FDA-approved manufacturing specifications, but the court held that the defendants “demand[ed] too much at the pleadings stage” and allowed the manufacturing defect claim to move forward.

Express Warranty Claim

The plaintiff asserted that the defendant’s sales representative assured him that any shock the device delivered was only a “mild jolt,” while FDA documents suggested that the shocks were so painful that they should occur only when a patient is unconscious.  The court held that, accepting the allegations as true, this express warranty claim passed muster.

The plaintiff also asserted that the defendants assured him that the device would “save his life.’   The court held,

This statement cannot form the basis of a parallel claim for express warranty.  It is not a statement holding Defendants’ product out as meeting a higher standard than that required by the FDA.  Rather, this representation is one where an essential element of the claim will be proof that a device granted a PMA is not safe or effective, which necessarily conflicts with the FDA’s contrary finding.

Id. at *5 (internal punctuation and citations omitted).   The court concluded, “Such a warranty claim is directly preempted by Riegel.”  Id.  

Failure-to-Warn Claims.

As the court explained, the “failure-to-warn claim involve[d] two separate theories.  The first theory involved the plaintiff’s allegation that he was not provided a complete set of warnings.   While a “parallel” warnings claim can survive if it alleges that a manufacturer did not provide the warnings the FDA requires, this was not what the plaintiff alleged.  Instead, he alleged that he should have been provided additional warnings beyond those the FDA approved, and Riegel preempts such claims.

The second theory asserted that, had defendants reported alarm failures and inappropriate shocks to the FDA, patients such as the plaintiff would have been made aware of the incidents and, thus, “warned” of them.  But, the court explained, “suffice it to say that unless both the state-law claim and the applicable federal law contain a requirement that Defendants report adverse events to the FDA, there is no parallel claim.”  Id. at *6.  But the plaintiff “allege[d] only the possibility, under state law, that manufacturer may discharge their duty to warn by reporting to a third party.   This is not enough to make a state-law claim parallel.”  Id. (citations omitted).   Warnings claims dismissed, and Ward has been added to the D.C. section of our failure to report 50-state survey.


Finally, the court held that the negligence claim, like the design defect claim, sought to impose state law requirements that were different from or in addition to federal requirements;  thus, it also was preempted under Riegel.

Ward is mostly good, and it is well-reasoned in the limited instances where it allows claims to proceed.  We will keep you posted on further developments.  In the meantime, have a safe weekend, and enjoy celebrating if you are.