Photo of Michelle Yeary

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

These wins are becoming routine – but we’re not taking them for granted.  In fact, we’ve given them their own label on the blog and we highly recommend you peruse this collection if you are facing off-label promotion allegations.  It is an overwhelming body of precedent establishing that almost all claims in pre-market approved (“PMA”) medical devices are preempted and that off-label use does not change the analysis or the conclusion.   And one of the great benefits of tallying up all of these favorable decisions from courts across the country is citing them to courts considering the issue.  Both of the recent InFuse wins demonstrate that the vast authority supporting preemption is quite compelling.

A quick reminder of the core issue in the InFuse litigation.  The InFuse bone graft device is a Class III, PMA device.  The Supreme Court has determined that the PMA process imposes federal requirements that preempt state law tort claims.  That express preemption combined with the implied preemption of claims that seek private enforcement of the FDCA leave only a “narrow gap” through which a claim must fit to survive.  Plaintiffs most often used method for threading that needle is to allege a parallel claim – a violation of a state law duty that is genuinely equivalent to federal requirements.  Since so few claims even come close to being parallel claims, the InFuse plaintiffs allege that because their surgeons implanted the device in an off-label manner, the standard preemption analysis shouldn’t apply.  First, they argue that the PMA requirements for InFuse should be inapplicable to off-label uses and without specific requirements, the first prong of the express preemption analysis isn’t met.  Alternatively, even if the requirements apply, plaintiffs allege their claims are parallel claims because the FDA prohibits off-label promotion.

Neither the District of Delaware nor the District of Arizona bought plaintiffs’ arguments.  Rather, both courts found the reasoning of the majority of courts to have considered the issue much more persuasive.  Perhaps the most important take-away from the decision in Martin v. Medtronic, Inc., ___ F. Supp.2d __, 2014 WL 3635292 (D. Ariz. Jul. 23, 2014) is the further dilution of one of the few negative InFuse decisions — Ramirez v. Medtronic Inc., 961 F.Supp.2d 977 (D.Ariz.2013).  Martin is now the second District of Arizona case to reject Ramirez and adopt the majority reasoning that preemption applies to off-label uses (the other is Scovil v. Medtronic, Inc., __ F. Supp.2d __, 2014 WL 502923 (D. Ariz. Feb. 7, 2014).   Martin, 2014 WL 3635292 at *5-6.

Analyzing each of plaintiffs’ claims, the Martin court found them either preempted or insufficiently pleaded.  First the preempted claims.  Fraud and negligent failure to warn claims based on the device’s labeling are expressly preempted as an attempt to impose different or additional written warnings/labeling beyond that required by the FDA.  Id. at *8, *14.  Plaintiff’s strict liability and negligent design defect claims met the same fate.  Id. at *13, 14.  The court likewise dismissed as preempted plaintiff’s claim for strict liability failure to warn based on off-label promotion.  Id. at *10-11.  The court also concluded that plaintiff’s claim that defendant was negligent in promoting the device for off-label uses was impliedly preempted.   “Defendants’ duty . . . to abstain from off-label promotion exists solely by virtue of the federal prohibition of off-label promotion and finds no independent source from traditional state law.”  Id. at *14.

Where preemption stops (in the court’s view TwIqbal picks up.  The court, consistent with many of the InFuse rulings, held that plaintiff’s fraud claims based on misrepresentations or omissions in defendant’s off-label promotion were not preempted because they parallel federal requirements that manufacturer’s promotions not be false or misleading.  Id. at *9.  However, even though plaintiff’s complaint contained several alleged misrepresentations it was devoid of any connection between those alleged misrepresentations and plaintiff or her surgeon.  There were no allegations identifying which of the alleged misrepresentations were made to and relied on by plaintiff and/or her surgeon.  Id. at *9-10.  Plaintiff’s breach of express warranty claim is dismissed for almost the same reason – failure to allege which specific warranties were made to her or her surgeon.  Id. at *16.

On failure to warn, this is a Stengel jurisdiction.  So, plaintiff was permitted to allege a failure to report adverse events to the FDA claim.  But Martin reminds plaintiffs that pleading a failure to report is not enough.  They also have to allege how that failure to report caused their injury.  Moreover, a general causation allegation is insufficient.  The complaint must contain “factual content that would support the causal nexus.”  Id. at * 12.  Of course, on these pleading issues plaintiff is being afforded an opportunity to amend her complaint.

Turning to Delaware, the court never had to get to TwIqbal, finding all of plaintiff’s claims preempted.  The simple and straightforward decision is Scanlon v. Medtronic Sofamor Danek USA Inc., 2014 U.S. Dist. LEXIS 102387 (D. Del. Jul. 28, 2014).  Scanlon starts off just like Martin – rejecting both of plaintiff’s general off-label arguments:

[A]llegations of off-label use and the promotion thereof do not immunize a plaintiff’s claims from preemption. . . . Moreover, contrary to plaintiff’s suggestion, plaintiff’s off-label promotion allegations do not somehow turn plaintiff’s claims into parallel claims that are not preempted.

Id. at *16.  The court didn’t mince words, choosing to rely on the InFuse precedent, in dismissing the bulk of plaintiff’s claims:

Plaintiff’s negligence cause of action would impose requirements on Medtronic – to perform and report additional studies – which are different from and in addition to those imposed by the FDA. Plaintiff’s failure to warn cause of action would require that Medtronic provide warnings in addition to or different from those required by the FDA. To the extent plaintiff’s cause of action for negligent misrepresentation alleges that Medtronic failed to disclose material facts, plaintiff has not alleged that Medtronic’s warning label for the infuse device did not comply with the FDA. Therefore, any “material facts” which plaintiff asserts are missing would require a change in those warnings or disclosures required by the FDA. Each of these causes of action is expressly preempted.

Id. at *17.  The court went on to find plaintiff’s fraud and misrepresentation claims also preempted.  To the extent plaintiff’s claim was for “fraud on the FDA” it was preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  To the extent plaintiff’s claim was based on alleged misrepresentations made to the public, the court was unwilling to find a parallel violation.  “While such conduct (making false representations regarding the infuse device) might violate the FDCA, such conduct would not exist apart from the FDCA.”  Id. at *19-20.  So, the claim falls outside the permissible “narrow gap.”

Two more great additions to our InFuse collection.