IDE Preemption Affirmed In Kentucky

Author:Ms Michelle Yeary
Profession:Reed Smith

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...

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