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

Most of our reports on the InFuse litigation have been positive -- credits rather than debits.  Last week, we had to move to the other side of the ledger and report on case that in our belief was definitely lacking.  But that one case was hardly enough to unbalance the account.  And just a few days later, three new decisions came down pushing the InFuse Litigation even further into the pink. 

For a full accounting, you can examine our InFuse posts here.  We won’t reiterate all that has come before, but overall plaintiffs have met with very limited success in their attempts to use allegations of off-label promotion and/or use to get around the dual protection afforded by PMA express preemption (Riegel) and implied preemption (Buckman).  As today’s post demonstrates, the overwhelming defense wins are not going unnoticed by either federal or state court judges.

These latest InFuse wins come from the Western District of Michigan – the companion cases of Wright v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 7681 (W.D. Mich. Jan. 23, 2015) and Thorn v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 7687 (W.D. Mich. Jan. 23, 2015) – and Florida state court – Buccelli v. Mayer, No. 2014-CA-001667 NC, slip op. (Fla. Cir. Ct. Jan. 27, 2015).

All three cases contain good recitations of both express and implied preemption law, Wright at *8-14; Thorn at *7-13;Buccelli at slip op. 3-5.   More importantly, none buy into plaintiffs’ argument that somehow allegations of off-label promotion require throwing out express preemption.  This was most squarely dealt with by the federal court in its explicit rejection of another one of the few InFuse cases on the red side of the ledger, Ramirez v. Medtronic, Inc., 961 F. Supp.2d 977 (D. Ariz. 2013).  First, the decisions in Wright and Thorn both cite to the lengthy list of other cases to have rejected Ramirez.  Wrightat *21; Thorn at *18.  Second, the court addresses the fact that the reasoning of Ramirez contradicts the language of the MDA’s express preemption provision (§360k) “which applies if federal requirements are applicable ‘to the device,’ not merely to specific uses of devices.”  Id.  Next, the court takes issue with Ramirez’s flawed conclusion that defendant’s alleged off-label promotion violated the FDCA.  In Wright and Thorn, after reviewing the relevant FDA regulations on off-label promotion and misbranding, the court concluded that “off-label promotion is governed by federal law, which sets the parameters and occupies the field for deciding whether a representation is false or misleading” and therefore an off-label use claim “falls within §360k protection.” Wright at *23-24; Thorn at *21. 

Having set the stage as to the applicable law, each court dismisses almost all of plaintiffs’ claims.  Failure to warn claims were dismissed as expressly preempted.  Any claim that alleges that a PMA medical device’s labeling was inadequate seeks to impose a duty that is different from or additional to that required by the FDA and that is prohibited under Riegel.  Wright at *19;Thorn at *16-17; Buccelli at 7-8.  The federal decisions also go on to hold that plaintiffs’ failure to warn claims are not parallel violation claims (a state law claim premised on a violation of federal law) because “there is no state law duty to abstain from off-label promotion.”  Wright at *24; Thorn at *21-22.  Therefore, failure to warn was also impliedly preempted.  Id.  The Buccellicourt used the same reasoning to dismiss plaintiff’s negligent off-label promotion claim as impliedly preempted.  Buccelli at 11 (“Defendant’s duty . . . to abstain from off-label promotion . . . finds no independent source from traditional state law.”). 

Plaintiff in Thorn brought negligence and gross negligence claims premised on four allegations.  First plaintiff alleged a failure to report adverse consequences when seeking approval of the device.  This claim is impliedly preempted and is prohibited by the “no private right of action” provision of the FDCA.  Thorn at *23-24.  Second, plaintiff alleged negligent marketing claims which the court found suffered the same fate as plaintiff’s failure to warn claims.  Id. at *24-25.  Plaintiff’s third negligence claim was for failure to warn of the risks of off-label use.  The court considered this an illegal off-label promotion claim which was impliedly preempted because it “exists solely by virtue of federal regulations, and is not rooted in any traditional state law.”  Id. at *25.  Plaintiff’s final negligence claim was for failure to provide the FDA with updated adverse event information which the court also found impliedly preempted:  “Plaintiff points to no adverse event reporting requirements under Michigan law, and the Court agrees that the requirements are administrative requirements of the FDCA.” Id. at *26.

In Wright and Buccelli, plaintiffs brought design defect claims.  Both courts found those claims expressly preempted. “[A]ttacks on the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device . . . are expressly preempted by §360k.”  Wright at *25.  The Buccelli court reached the same conclusion relying on an abundance of case law in support.  Buccelli at 8.

Finally, plaintiffs in Wright and Buccelli also brought fraud and misrepresentation claims.  In Buccelli, the court distinguished between claims based on allegations of misrepresentations in the device’s labeling which were expressly preempted (like failure to warn claims), Buccelli at 5-6, 9, and those based on misrepresentations in off-label promotion.  As to the latter, both the Buccelli and Wright courts found the claim not preempted.  This is the claim that most often survives preemption.

In contrast to Plaintiff's failure-to-warn claim in Count I, a claim that this Court determined is expressly preempted because the claim would require warnings beyond those specified by the FDA, Plaintiff's fraud claim is not expressly preempted. The state tort law duties underlying Plaintiff's fraud claim are not “different from, or in addition to" federal requirements, which prohibit fraudulent promotion or advertising.  Indeed, mere off-label promotion, divorced from any negligent or fraudulent misrepresentations, is not prohibited by federal law. . . .

Because Plaintiff's allegations of affirmative misrepresentations are based on independent state law duties, neither is the fraud claim impliedly preempted. [T]hese claims would apply to a seller of a product not subject to any federal regulations who engaged in similar alleged misconduct.

Wright at *31-32 (citations omitted).  The Buccelli court, however, went on to dismiss plaintiff’s fraud claims without prejudice because the complaint failed to identify the specific misrepresentations made to plaintiff and/or his doctor, who made those misrepresentations, and when they were made.  Buccelli at 6, 10. 

Both courts also concluded that plaintiffs’ express warranty claims were not preempted.  However, in the federal cases the warranty claims were dismissed because they were disclaimed in the device’s labeling.  Wright at *39; Thorn at *28. In Buccelli, the court dismissed the warranty claim with leave to amend to identify the specific warranties made to plaintiff and his doctor.  Buccelli at 12.

Three more examples of PMA preemption significantly whittling down plaintiffs’ claims.  With this growing body of defense wins in the credit column, it’s hard to imagine the InFuse litigation ever being insolvent.