United States: IDE Preemption Affirmed In Kentucky

Last Updated: November 16 2018
Article by Michelle Yeary

When it comes to medical device preemption, having Pre-Market Approval ("PMA") is like being dealt pocket aces in Texas Hold'Em Poker. It's the strongest starting hand you can have; a 4:1 favorite over any other two card combo. It means you're starting in the power position. Since the Supreme Court's decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), manufacturers of PMA medical devices are in the power position in products liability litigation. Very little slips by the double-edge sword of express and implied preemption in PMA cases. The same can, and should be said for IDE cases as well. And that's what the Kentucky Court of Appeals said in Russell v. Johnson & Johnson, — S.W.2d –, 2018 WL 5851101 (Ky. Ct. App. Nov. 9, 2018).

Defendant manufactures medical catheters. The catheter was approved by the FDA via the PMA process in 2004. Id. at *1. In 2015, the FDA approved use of the catheter under the Investigational Device Exemption ("IDE") to the MDA which allowed the catheter to be used in a clinical trial to evaluate its safety in certain cardiac ablation procedures. Plaintiff underwent a cardiac ablation procedure as part of the clinical trial in which defendant's catheter was used. Id. After plaintiff's procedure the catheter did receive full pre-market approval. Id. at *4.

Plaintiff suffered complications during the procedure and subsequently filed suit alleging defendant was liable for strict liability, negligence, lack of informed consent, failure to warn, breach of warranties, fraud, and unjust enrichment. Id. at *2. Defendant moved to dismiss all claims on the grounds of preemption and the trial court, relying on Riegel, granted the motion. Id. Plaintiff later asked the court to set aside its ruling based on defendant's voluntary recall of other catheters, but not the one used on plaintiff. The court denied that motion. Plaintiff appealed both rulings.

Not surprisingly, plaintiff's primary argument was that the court should discount Riegel because at the time of plaintiff's surgery, the device had not yet received pre-market approval. Id. at *4. But the court found the argument contradicted by numerous courts to have considered the issue. Some courts find that timing of the grant of PMA to be immaterial. Id. While others find IDE approval to be synonymous with PMA. Id. This certainly follows the logic of Riegel. Riegel adopted a two-step test for preemption and the first step is whether the FDA has established requirements applicable to the device. Riegel concludes that a PMA does in fact establish such requirements. Well, so does an IDE.

[b]ecause IDE devices are subject to a level of FDA oversight and control that is, for the purpose of a preemption analysis, identical to that governing PMA devices, the body of preemption law governing PMA devices applies equally to the IDE device at issue in this case.

Id. (citing Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th Cir. 1997).

Thwarted by authorities from other jurisdictions on the issue, plaintiff next urged the court to rely on a Kentucky Supreme Court case decided before RiegelNiehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997). Id. Niehoff rejected preemption in an IDE case relying on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). But as we all know, Lohr dealt with a device approved via the §510k "substantial equivalence" process. As pointed out above, the IDE process is more analogous to the PMA process and therefore, in a post-Riegel world, Riegel is controlling. In Niehoff, the manufacturer also stopped the clinical trial before the FDA considered its PMA application. Id. Whereas in Russell, the device was granted PMA just over one year after plaintiff's procedure. Id. at *5.

In deciding the preemption question in the current case, the court started its analysis with the clear cut statement that "there is no presumption against preemption" in an express preemption case. Id. After checking that box, the court looked at the device at issue and concluded that "approval after being subject to both the IDE and PMA processes, satisfies the first prong of Riegel." Id. at *6. So, to survive preemption, plaintiff cannot be alleging a claim that is different or additional to FDA's requirements regarding safety and effectiveness. Id. That means, plaintiff in his complaint must allege three things: "violation of a federal requirement; violation of an identical state violation; and a link between the federal violation and [plaintiff's] injury." Id. Plaintiff went 0 for 3.

The court could find no allegations of federal violations, or even a cite to a federal regulation. No factual support for any alleged violation. No allegations that his injury was caused by a federal violation. All plaintiff did was allege the device was defective – "in other words, the FDA should have imposed more stringent requirements – an attack precisely prohibited by the MDA." Id. at *7.

Failure to allege a parallel violation required dismissal of plaintiff's strict liability, negligence, failure to warn, and fraud claims. Id. at *7, *8. Plaintiff's informed consent claim failed because plaintiff signed a detailed consent form that was approved by the FDA. Any claim that the consent was inadequate would impose a different or additional requirement on the defendant. Id. at *7. Claims that the device breached warranties regarding safety and effectiveness "directly contradict the FDA's conclusion that the catheter was safe and effective." Id. at *8. As would an unjust enrichment claim premised on a claim that plaintiff did not receive safe and effective medical care. Id. Finally, plaintiff failed to allege a parallel federal statute to the Kentucky Consumer Protection Act. Id. So, all of the claims were properly dismissed as preempted. The appellate court also upheld the trial's court's decision that any attempt at amendment would be futile. "Additional time would not have transformed [plaintiff's] claims into parallel state claims." Id.

As for the motion to set aside the dismissal based on the recall, the court again upheld the trial court's decision. A final judgement can be set aside based on newly discovered evidence which could not have been learned via due diligence in time for a new trial. Id. at *9. But new evidence is not events that occur after entry of a final judgment – such as the recall here. Id. Moreover, the new evidence needs to be relevant. The recall was of different catheters, not the one used in plaintiff's procedure. Id. Next, the voluntary recall "negated neither federal preemption nor FDA approval." Id. The FDA was aware of adverse events and of the recall, but did not withdraw its approval of the device. And, a recall is not a presumption that FDA regulations have been violated. A recall doesn't turn a "preempted claim into a parallel cause of action." Id.

No doubt defendant had pocket aces going into this appeal, but Jim Murdica and Kara Kapke from Barnes & Thornburg and Lori Hammond from Frost Brown Todd deserve a shout out for knowing when to go all in!

This article is presented for informational purposes only and is not intended to constitute legal advice.

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