TEXARKANA, Texas -- After dismissing hundreds of lawsuits alleging implantable defibrillator leads are defective, U.S. District Judge Richard H. Kyle of Minnesota maintains the plaintiffs' claims are preempted by federal law and has denied the plaintiffs' request to replead their case.
Medtronic manufactured and sold the leads under the brand name "Sprint Fidelis" by Medtronic.
Stating the plaintiffs' claims are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, Judge Kyle wrote that the court recognized that at "least some plaintiffs have suffered injuries" but that the "plaintiffs assert claims for which the Court simply cannot provide a remedy."
The May 12 order also denies the plaintiffs' request to file an amended master complaint. The plaintiffs argued that the Court's opinion in January that dismissed the claims with prejudice was in error because "dismissal with prejudice is a drastic sanction."
Only placed in patients with life threatening heart conditions, the implantable cardiac defibrillators provide detection and correction of irregular or rapid heart rates. The heart rhythm is monitored through lead wires with electrodes that are placed in the heart to provide necessary correction through electrical shock.
Medtronic voluntarily suspended distribution of the Sprint Fidelis Leads (models: 6930, 6931, 6948, and 6949) in October 2007 because of a potential for lead factures. Medtronic's decision is based on internal performance data that demonstrates the Sprint Fidelis lead viability is 1.4 percent lower than Medtronic's Sprint Quattro Leads.
In an FDA statement on the voluntary recall, the FDA states, "When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break.
Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered."
Doctors and medical advisors advice against patients seeking replacement of the leads as the risks associated with removal far exceed the risk of a lead failure.
Following the recall, plaintiffs began to file lawsuits against Medtronic, which were centralized to the U.S. District Court in Minnesota in February 2008, with new claims also being transferred for pretrial proceedings.
More than 50 suits against Medtronic have been filed in the Eastern District of Texas and transferred to the Minnesotta MDL.
The plaintiffs are individuals implanted with the Sprint Fidelis leads and their family members who claim, among other things, that the leads are defective and are at risk for fracture and that risk has caused emotional distress.
Further, the plaintiffs claim that Medtronic breached express and implied warranties, violated various consumer protection statues in marketing the leads, negligence, fraud, and unjust enrichment. Some of the plaintiff claim physical injuries and others are saying they will need additional medical monitoring.
In response to the allegations, Medtronic argues that the lawsuits lack legal merit because federal law preempts those claims.
Judge Kyle agreed with the defendant in a January opinion that dismissed the plaintiffs' claims. The district court wrote that the claims were preempted by federal regulations and confirmed by the Supreme Court in Riegel v. Medtronic, Inc.
According to court records, every medical device is subject to FDA scrutiny before it can be marketed, the implantable defibrillator lead is in Class III, which is subject to the greatest level of inspection.
The pre-market approval is rigorous, with the FDA weighing the "probable benefit to health from the use of the device against any probable risk of injury or illness from such use."
If the device receives the FDA pre-market approval, the manufacturer cannot change its design, manufacturing processes, or labeling without FDA approval.
Medtronic has manufactured ICD leads since at least 1992, with Medtronic's Sprint Quattro leads gaining approval in 2001 and Sprint Fidelis leads receiving supplemental pre-market in June 2004.
Judge Kyle noted that the U.S. Supreme Court recognized in Riegel that "the plaintiffs' claims threatened to interfere with the pre-market approval process because allowing them to proceed would, in essence, result in retroactive second-guessing of the FDA's decision-making."
Judge Kyle's January opinion stated, "Congress has decided to limit medical-device manufacturers' liability in order to spur innovation, even though individuals are sometimes injured when using medical devices. Plaintiffs' remedy, therefore, lies with Congress, and not with this Court (or any other court)."
The May opinion confirmed the court's previous dismissal of 229 cases that adopted the master consolidated complaint and confirmed the order that the remaining cases should be stayed pending any possible appeal made to the Eighth Circuit.
MDL-1905 In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation