In Riegel v. Medtronic, Inc., 2003 WL 25556778 (N.D.N.Y.), the Riegels sued Medtronic for damages under New York state law after an FDA-approved Class III balloon catheter lead that was placed into the plaintiff's coronary artery ruptured.
Plaintiffs alleged that the catheter was defective under state law and sued in the U.S. District Court for the Northern District of New York.
When the U.S. District Court was initially faced with a motion to dismiss the plaintiff's complaint based upon federal preemption, it did not dismiss the plaintiff's claims for negligent manufacturing, the loss of consortium derivative of negligent manufacturing and breach of express warranty.
Judge Kahn's ruling allowed those claims to proceed to discovery reasoning that if Medtronic was negligent and did not comply with the FDA approved design and manufacturing specifications when it manufactured the device, there would be no conflict between the state requirement and the federal requirement; and consequently, no federal preemption.
At the conclusion of discovery, Medtronic once again moved for summary judgment to dismiss the remaining negligent manufacturing and breach of express warranty claims, along with the derivative consortium claims. However, this time Judge Kahn found that:
(1) neither the plaintiffs, nor their agents, relied on any express warranties; and (2) any express warranties were disclaimed.
Neither the plaintiffs, nor their doctor, or the hospital as their agents had any knowledge of any warranties when Mr. Riegel underwent the heart procedure. As to the negligent manufacturing claim, the District Court found that the plaintiffs did not have the actual allegedly defective balloon, and thus did not have any direct evidence of negligent manufacture.
Moreover, plaintiffs failed to negate the possibility that other causes other than the negligent manufacture may have caused the balloon in the catheter to burst. It was undisputed that the plaintiff's physician exceeded the maximum recommended 8 atmospheres to 10 atmospheres when inflating the balloon catheter. Moreover, it was contraindicated to use a balloon for Riegel's condition without having used a Rotoblater to remove the heavy calcified spicules.
The court concluded from that evidence that no fair minded trier of fact would reasonably conclude that the plaintiff excluded those other causes of the burst.
Accordingly, the court dismissed those remaining causes of action along with the consortium claim
The U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court (Riegel v. Medtronic, Inc., 451 F.3d 104 2nd Cir. 2006) and held that:
(1) state requirements applicable to medical devices that have entered the market pursuant to Food and Drug Administrations (FDA) premarket approval (PMA) process are preempted under MDA;
(2) plaintiff's negligence, strict liability, and breach of implied warranty claims were preempted;
(3) negligent manufacture claims were not preempted;
(4) but plaintiff failed to exclude manufacturer's proffered alternate causes for product failure, precluding recovery for negligent manufacture .