Medical device makers are nearly immune from lawsuits if their devices should injure, kill, or otherwise harm.

A new case from Arizona’s Court of Appeals reaffirms some established law that makes suing medical device manufactures for negligence extremely difficult. Conklin v. Medtronics, Inc, held that the  premarket-approval (PMA) paragraph of the Federal Food Drug and Cosmetic Act (FDCA), 21 U.S. Code § 360e, preempts Plaintiffs from bringing a claim against a medical device maker, in the this case Medtronic, for a claim arising under state law exclusively.

The Conklins had filed suit against Medtronic claiming negligence when a pain medication infusion pump and catheter failed. Plaintiffs alleged that the product was negligently designed and manufactured and that Medtronic breached an express warranty. The Court held that these claims are not allowed as the FDCA preempts them. In other words, the Federal law controls, rather than the State law.

The Court did note, however, that where a State claim arises from parallel facts that may give rise to a claim under the FDCA, that there may be a claim. In this case, the Conklins alleged that Medtronic failed to report device failures, malfunctions, and consumer injuries as required under the FDCA. As the Plaintiff’s allegations under State law run parallel to the Federal law, and if true would constitute a violation of both State and Federal law, that there may be a valid case. This is important because the remedies set forth under State law are usually harsher than those set forth under Federal law.  The Conklins could potentially have a better case under State law.

Therefore, the Court of Appeals narrowly allowed some of the Plaintiff’s claims to survive while at the same time re-iterating that the FDCA preempts State law.

This matters to consumers/users of medical devices. Premarket-approval is a rigorous and lengthy set of tests that the FDA performs on all medical devices. However, the device makers are happy to oblige with the FDA’s PMA process because once the device passes, device makers become nearly immune to negligence-based lawsuits filed against them should their device fail, cause injury, or otherwise harm a user. This is a huge windfall for manufacturers who are no longer responsible for compensating consumers who become injured by their device’s failures.

Following this newest opinion from Arizona’s Appellate Court, we know that Federal law, including immunity from negligence claims for devices that passed pre-market approval, is still the law of the land. We also know that where a device maker violates any portion of federal law, there may be a small window to bring a claim. However, this is a very difficult hurdle to overcome.