Illinois Appellate Court Revives Medical Device Lawsuit Dismissed by Federal Pre-Emption

According to the report of this Illinois Appellate Court (1st District) decision, new ground is being broken in a lawsuit brought by Senayda Norabuena against Medtronic Inc. The suit, which was first dismissed on motion, involved the use of a Medtronic medical device implanted in a spinal fusion surgery.

The appeals panel for the 1st District held that the lawsuit, brought by Norabuena and her husband, against Medtronic involved parallel state law claims that are not pre-empted by federal law.

The justices found the plaintiffs’ pleadings were insufficient and ordered Cook County Circuit Court Judge John P. Callahan Jr. to grant them leave to file an amended complaint.

Before 1976, medical devices like Medtronic’s Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device — simply called Infuse by the 1st District panel — was regulated by the states.

However, Congress amended the Federal Food, Drug and Cosmetic Act so that medical devices would fall under the purview of the U.S. Food and Drug Administration (FDA).

Since the amendment, the U.S. Supreme Court has ruled that a state law claim cannot be brought against a medical device manufacturer if the state law goes beyond what the federal law requires.

In order for a state claim to succeed, the state law has to run parallel to the federal law. In this case, the panel held that, under Illinois law, a manufacturer’s duty to warn about the improper usage of a product occurs when parallel to a federal prohibition on misbranding of the medical devices.

One of the justices, Justice Cynthia Y. Cobbs, wrote, “Our research has revealed no Illinois case addressing the issue of parallel requirements.”

One of the attorneys representing the Norabuena family is Ryan M. Griffin, who stated that, “It sets the stage for Illinois to allow causes of action based on clear violations of federal law.”

In July 2002, the FDA granted pre-market approval for the Infuse product. Medtronic warned of the device’s restrictions: It should be used only on one level of the spine, and it should be inserted into the spine with an anterior approach. The metal cage that comes with the device should also be used.

Norabuena was brought to Northwestern Memorial Hospital for leg and back pain. She was diagnosed with a degenerative disk disease in the lumbar section of her back as well as left lumbar radiculopathy.

According to the lawsuit, the doctor who did the surgery, Dr. Michael Haak, did not use Infuse in the manner as stipulated on the device’s label when he performed surgery on Norabuena in September 2012. Dr. Haak implanted the Infuse device in multiple sections of her back using a posterior approach and he did not use its metal case.

The surgery did not go well and more than a year later, a different doctor told Norabuena that she had bone that forms outside the skeleton of the body and formed in her back. She continued to experience constant pain as a result of the surgery.

According to Griffin, Norabuena’s counsel, the removal of the devices from her spine would be too risky to be undertaken. In the lawsuit filed by Norabuena and her husband, Miguel Torres, the defendants were Medtronic, Medtronic Sofamor Danek USA Inc. and Northwestern Memorial Healthcare. The lawsuit was filed in September 2015.

Norabuena was injured by the Medtronic product that was advertised and which pushed the so-called “off-label” uses of Infuse to physicians, medical publications and surgeons. The plaintiffs also accused Medtronic of not informing FDA about the side effects of using Infuse for off-label purposes.

This appeal centered around the dismissal of Norabuena’s lawsuit against Medtronic. Northwestern Memorial is not a party to the appeal. Circuit Court Judge Callahan dismissed the lawsuit in August 2016 finding that the claims were pre-empted by federal law.

The 1st District panel only partially agreed with Judge Callahan. The panel found that there is no law in Illinois requiring medical device manufacturers to report adverse events to a federal regulatory agency. State law does require manufacturers to inform third parties about their products, but the panel found that this is not the same as requiring a medical device manufacturer to warn the FDA.

The panel found that Infuse’s marketing is not approved by the FDA. Although medical devices can be used for off-label purposes, Medtronic is not “prohibited from providing additional warnings during that promotion.” The 1st District panel found that the plaintiffs pleadings were insufficient. The appeals panel ordered that the trial judge give the plaintiffs an opportunity to amend their complaint. The dismissal order was found to be without prejudice and the plaintiffs were ordered to be allowed to amend those pleadings.

Senayda Norabuena, et al. v. Medtronic, Inc., et al., 2017 IL App (1st) 162928.

Kreisman Law Offices has been handling product liability lawsuits, medical device lawsuits, Medtronic device lawsuits and medical negligence cases for individuals, loved ones and families who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 40 years in and around Chicago, Cook County and its surrounding areas, including Calumet City, Winnetka, Westchester, Alsip, Blue Island, South Holland, Arlington Heights, Morton Grove, Evanston, Elmhurst, Elk Grove Village, Chicago and Tinley Park, Ill.