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This post is from the non-Reed Smith side of the blog.

We’re going to be right up front with you today.  It’s a work day.  It’s the World Cup.  The US is playing Belgium in the Round of 16 at 4:00 EDT.  We don’t want to miss it.  And soccer — unlike sports like football and baseball — has no time-outs, no 7th inning stretch.  There aren’t even any commercials.  You look away for a minute to answer an e-mail, you could miss the only goal of the game.  So, we’ll get right to the point.

Medtronic scored another InFuse victory in Dunbar v. Medtronic, No. 2:14-cv-01529-RGK-AJW, slip op. (C.D. Cal. Jun. 25, 2014).  The allegations in this complaint, like all of the others we’ve previously discussed, focus almost exclusively on off-label use of the Class III, PMA spinal fusion device.  Seeing Class III and PMA in the description of the medical device should almost certainly guarantee a defense win on preemption as most courts have acknowledged that there is only a “narrow gap” between Riegel preemption and Buckman preemption in which plaintiffs can state a claim.  And that is why the InFuse plaintiffs have tried, with only limited success, to get courts to recognize a preemption exception when a PMA device is used off-label.

The complaint at issue in this case combined the claims of 29 plaintiffs alleging injury after implantation of the InFuse device in a manner they allege was inconsistent with the device’s FDA approval and labeling.  Slip op. at 1-2.  Medtronic moved to dismiss all of the claims on the grounds of express and implied preemption as well as various other claim-specific defenses.  The opinion contains a straight-forward discussion of express and implied preemption, summing up that “narrow gap” with a reminder that “[e]ven if a state claim runs parallel to federal requirements and escapes express preemption, it may still be subject to implied preemption under §337(a) and Buckman.”  Id. at 3.  Likewise, this decision is no different than every other post-Riegel case in its conclusion that the first prong of Riegel (whether the FDA has established device-specific requirements) is met by the fact that the device underwent the pre-market approval process.  The PMA process subjects the device to a “rigorous review” on safety and efficacy and “post-approval manufacturing requirements.”  Id. at 4.

Applying Riegel and Buckman, the court found all of plaintiffs’ claims, except fraud and breach of express warranty, were preempted.  And the warranty claims weren’t sufficiently pled to state a claim.

Failure to warn:  A failure to warn claim “seeks to impose . . . labeling or warning requirements that go beyond what federal law requires” and therefore “is expressly preempted by the MDA.”  Id. at 4, 5 (dismissing both strict liability and negligent failure to warn).

Design Defect:  Plaintiffs’ design defect claim “attack[s] the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device.  To prevail on this claim, a jury would have to make findings that conflict with those of the FDA.”  Id. at 5.  Both negligent and strict liability design defect claims are preempted.  Id.

Negligent Off-label Promotion:  The court found that plaintiffs’ claim was parallel to the FDCA’s prohibition on off-label promotion (relying on unpublished Ninth Circuit decision) and therefore not expressly preempted.

However, there is no claim for illegal off-label promotion rooted in traditional state tort law. Therefore, any common law claim arising from such an action exists only by virtue of the FDCA.  Permitting this claim to proceed would essentially allow a private litigant to attempt enforcement of the FDCA.  Buckman bars such an action under §337(a).  Therefore, Plaintiffs’ negligence claim based on off-label promotion is impliedly preempted.


Negligent Violation of Federal Law:  Once again, vague allegations of violations of federal law aren’t enough.  Plaintiffs didn’t allege a violation of a particular federal requirement applicable to the device and therefore, the court was unwilling to infer either that these unidentified regulations were parallel to the FDCA or whether the claim could exist independently from the FDCA.  This type of unsubstantiated claim is insufficient to overcome either express or implied preemption.  Id. at 5-6.

Negligence per se:  We haven’t spent too much time on negligence per se claims in the InFuse litigation, primarily because even our least favorite InFuse decisions tended to get it right – that is they dismissed the claim.  That changed with the California appellate decision in Coleman v. Medtronic, Inc., earlier this year.  See our post here.  But fortunately, that decision was accepted for appeal by the California Supreme Court and under California rules, the appellate decision no longer exists.  Wish we could blink away a few other decisions so easily.  In Dunbar, we get the type of negligence per se analysis we can get behind:

While courts have generally allowed a negligence per se claim based on violation of a federal statute, the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such a claim fails.

. . .  As Buckman concluded, [§337(a)] leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with
the medical device provisions.  Allowing a litigant to assert a negligence per se claim based on violation of the FDCA would frustrate congressional intent regarding the regulation of medical devices, and interfere with the federal statutory scheme, which amply empowers the FDA to punish and deter fraud against the Administration.  Stated differently, a negligence per se claim alleging violation of the FDCA is nothing more than a private right of action under the FDCA for damages.  Since the latter is not available as a result of §337(a), the Court finds that the former is preempted as well.

Id. at 6.

With all of those claims preempted, the court was left with fraud/misrepresentation and breach of express warranty.  For the most part, courts have ruled that fraud/misrepresentation claims survive preemption and Dunbar is no different.  The claims aren’t expressly preempted because they are parallel to the federal prohibition on “false or misleading promotion” and they aren’t impliedly preempted because they are traditional state law claims.  Id. at 7.  Where these claims more often fall apart is failure to meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b).  Fraud claims must be pled with specificity.  While the Dunbar complaint contained many of the “boilerplate” allegations that do not satisfy Rule 9(b), it also contained allegations about “fraudulent research” relied on by plaintiffs’ surgeons.  These are just allegations, but the court found they were enough to survive a motion to dismiss.  Id.  Proving them will be a different story, for another day.

Finally, the court found plaintiffs’ breach of express warranty claims were not preempted for the same reasons the fraud/misrepresentation claims weren’t.  Id. at 8.  Here though, plaintiffs “alleged no facts demonstrating that Medtronic made any affirmations specifically to Plaintiffs or their surgeons, so as to form the basis of the bargain.”  Id.  The claim also failed for failure to plead notice.  Id.

Can another InFuse win be followed by a USA win?  Go USA!