SAN FRANCISCO (Legal Newsline) - A federal appeals court has dismissed an Arizona man's lawsuit against Medtronic over the company's pain pump, which allegedly left the man paraplegic.
The U.S. Court of Appeals for the Ninth Circuit ruled Monday that Richard Stengel's original state law claims were preempted by federal law, and that any amendments he could make to his complaint would be futile. The decision affirmed an Arizona federal judge's ruling.
"To the extent the Stengels' claims are based on the theory that state law required Medtronic to warn consumers about the dangerous condition of its pain pumps without first receiving an order to do some from the Food and Drug Administration, the state law establishes a requirement different of the (federal Food, Drug and Cosmetic Act)," wrote Senior Judge John Wallace, who was appointed to the court in 1972 by President Richard Nixon.
"To the extent the Stengels' claims are based on a theory that Medtronic caused them injury by failing to comply with its duty to report information to the FDA, their claims threaten to skew the delicate balance of statutory objectives sought to be achieved by the FDCA."
Stengel had a Medtronic pump implanted in his abdomen and began receiving medication through a catheter implanted in his spine in 2000. Five years later, he began experiencing paralysis in his lower extremities caused by an inflammation in his spine that had formed at the tip of the catheter.
The catheter and inflammation were removed, but not before Stengel was rendered permanently paraplegic.
Richard and wife Mary Lou filed suit in an Arizona state court, but it was removed by Medtronic to federal court. The suit alleged four claims under Arizona law - negligence, breaches of express and implied warranties and strict liability.
The federal judge granted Medtronic's motion to dismiss, though the Stengels had asked for leave to amend their complaint to re-allege the same four claims under a new theory that Medtronic failed to implement procedures to evaluate complaints about the pump and failed to report information to the FDA.
The judge did not allow them to amend the complaint, ruling that the new "failure-to-warn" claim was impliedly preempted. The pump had received premarket approval from the FDA prior to its use by Stengel.
Wallace wrote that the court was bound to follow the lead established by the U.S. Supreme Court.
"In (Buckman Co. v. Plaintiffs' Legal Committee, 2001) the plaintiffs alleged that the defendant made fraudulent misrepresentations to the FDA regarding the intended use of its bone screws and that the devices were improperly given market clearance as a result," Wallace wrote.
"The Supreme Court held that the claims were preempted because, although the defendant had allegedly violated federal requirements, allowing the plaintiffs to bring a state cause of action to remedy the injuries caused by the violations would interfere with the congressional scheme."
The court wrote the federal government is tasked with filing lawsuits over noncompliance and not private litigants.
Wallace noted that it may seem harsh to deny compensation to Stengel, but that the court was bound by the direction established by the Supreme Court.
Fellow Senior Judge John Noonan, an appointee of President Ronald Reagan in 1985, didn't see it that way.
"Has Congress or the Supreme Court created such freedom from liability for the manufacturers of such sensitive devices that only in nonexistent cases are the manufacturers subject to suit for damages?" he wrote.
"Are individuals injured by the malfunction of such devices without remedy against the manufacturers of them? That appears to be the conclusion of this court today with its holding that the (Medical Device Amendments) explicitly preempts and implicitly preempts any state remedy of damages for violation of a state requirement paralleling the MDA."
Noonan's dissent goes on to question which Supreme Court precedents the majority follows and says more applicable cases would allow Stengel's case to move forward.
From Legal Newsline: Reach John O'Brien by e-mail at email@example.com.