Medtronic Sprint Fidelis: Supreme Court Sides with Medtronic in Key Case

Washington, DCOn Wednesday, February 20, the US Supreme Court handed down its decision in the closely watched Riegel v. Medtronic case. Upholding lower court decisions, the Supremes affirmed by 8-1 the dismissal of a state lawsuit brought against Medtronic by the family of the late Charles Riegel.

Riegel suffered severe injuries in 1996 when a Medtronic Evergreen balloon catheter burst while being used in surgery to unblock a clogged artery. The decision did not involve lawsuits against Medtronic by users of the defective Sprint Fidelis lead used in implantable defibrillators, but may have implications for those cases as well.

Medtronic recalled all Sprint Fidelis leads from the market in October 2007 after the thin leads were found to be defective and dangerously subject to fracturing and malfunction. Malfunctioning Sprint Fidelis leads are known to have caused at least five deaths and many other instances of either delivering unnecessary shocks to users' hearts or failing to deliver shocks when a patient's irregular heartbeat needed to be restored.

In Riegel, Medtronic argued, and the Supremes agreed, a device like the Evergreen (that received FDA pre-market approval) is shielded from state-level lawsuits that might impose standards different from those of the FDA's PMA procedure. The Medical Devices Amendments act, passed by Congress in 1976 in the wake of the Dalkon Shield scandal, gave FDA authority over medical devices and specifically forbids states from imposing requirements on medical devices that are "different from, or in addition to" FDA requirements.

Justice Ruth Bader Ginburg, the sole dissenter to the majority opinion written by Justice Antonin Scalia, said that Congress never intended the Medical Devices Amendments to include ''a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.'' Scalia's opinion replied that it was not the Supremes' business to try to divine congressional intent.

If you're carrying an implantable pacemaker with Sprint Fidelis leads, does this mean that the Supreme Court has just taken away your chance for legal recourse? The answer, although it's complicated, is basically "No." First, the Riegel case was about the Evergreen balloon catheter, which has not been found defective; in fact, although the case will now never be argued on its merits, a lot of evidence pointed toward misuse of the device by Riegel's surgeon rather than any inherent flaw in the device itself.

By contrast, we know, and Medtronic has admitted, that the Sprint Fidelis is a badly designed device with inherent defects that led directly to malfunctions, patient deaths, and further hazardous surgery for some users who needed to have the leads removed. Further, patients who still have the Sprint Fidelis on their implantable defibrillators are subject to anxiety, uncertainty, and the constant and potentially fatal threat of malfunction—all of which is due to Medtronic's faulty device.

The Cornell University law school's Legal Information Institute says, "This does not leave consumers without recourse against manufacturers, however...they may pursue other remedies such as negligent manufacture or breach of express warranty." Additionally, the Supremes' decision bars state lawsuits for devices that have received PMA from the FDA only when state restrictions differ from those of the FDA. Both points seem to leave a lot of room for legal action against Medtronic for the Sprint Fidelis.

The full implications of Riegel v. Medtronic have yet to be figured out, particularly since Congress can pass legislation that specifically invalidates the Supremes' decision. All things considered, though, you'd be better off calling your lawyer before your congressperson if you think you've got a Sprint Fidelis case.