Author: By Robert K. Jenner
If a medical device that was supposed to help you ends up hurting you, it seems obvious that you should be able to take the company that made it to court. But the law in this area is surprisingly complicated, and for the most dangerous category of devices, the answer is often “no.” A recent decision from the federal court in Maryland — DiToto v. Nevro Corporation, decided on May 21, 2026 — is a useful window into how this works, and into the narrow path that still lets injured patients have their day in court.
What happened to Mr. DiToto
Perry DiToto suffered from chronic back pain. In the summer of 2020, he was introduced to sales representatives from Nevro Corporation, a company that makes spinal cord stimulators. A spinal cord stimulator is a device that is surgically placed in the body and sends small electrical pulses to the spine to block pain signals before they reach the brain.
For a free legal consultation, call,
(888) 585-2188
He first went through a trial run with temporary wires, and it seemed to work — he reported real improvement in his lower back pain. According to his lawsuit, the sales representatives then made a series of promises about the permanent version: that it would deliver lasting pain relief, let him return to normal daily activities, and would not damage his spine or nerves. He also says those representatives had no medical training, even though they were the ones helping adjust an electrical device wired to his spinal cord.
In October 2020, doctors implanted the permanent device — a model called the Senza II. For a while it seemed to help. Then, in May 2022, while a Nevro representative was helping him adjust the device over the phone, it allegedly delivered two strong, painful jolts down his right buttocks, leg, and foot. He later described the feeling like his leg was being blown off, and his mobility never fully recovered. The device was removed in February 2023, but he says he still depends on a cane and a wheelchair, lives with constant pain, and has a significantly reduced quality of life.
Why you usually can’t sue
Complete a Free Case Evaluation form now
Here is where the law gets tricky. The Senza II is what the government calls a “Class III” device. The FDA sorts medical devices into three groups based on how risky they are. Class I covers low-risk items like bandages and examination gloves. Class II covers moderate-risk products like powered wheelchairs and surgical drapes. Class III is the highest-risk category — implants, life-sustaining equipment, and anything that could pose a serious danger if something goes wrong.
Call or text (888) 585-2188 or complete a Free Case Evaluation form
Before a company can sell a Class III device, the FDA puts it through a long, demanding review called “premarket approval.” The agency examines the design, the manufacturing process, and the labeling, and signs off on every detail. Once that approval is granted, the company must build the device with almost no changes from the exact specifications the FDA approved.
Because the FDA has already reviewed all of that, federal law generally blocks patients from suing in state court over these devices. The legal term is “preemption,” and it comes in two forms that both showed up in this case.
The first form is the more familiar one. When Congress wrote the law governing medical devices, it included a provision saying that states cannot impose requirements on a device that are “different from, or in addition to” what federal law already requires. The U.S. Supreme Court explained how this works in a 2008 case called Riegel v. Medtronic. The idea is that a state jury should not be allowed to second-guess the FDA by deciding a device should have been designed or labeled differently. If a lawsuit would effectively force a manufacturer to meet a standard the FDA did not impose, the lawsuit is thrown out.
The second form is less obvious. The federal food and drug law also says that only the United States government — not private individuals — can sue to enforce that law. So a patient cannot get into court simply by claiming a company broke an FDA rule; that kind of claim belongs to the government alone. Put the two rules together and they create a tight squeeze. You cannot win a lawsuit that asks for more than federal law requires, and you cannot win one that is really just an attempt to enforce federal law itself. That combination has ended thousands of injury cases before they ever reached a jury.
The exception that kept this case alive
But preemption is not a total shield. Courts have recognized an important exception for what are called “parallel” claims, and the Supreme Court has made clear that judges should not assume Congress wanted to wipe out state lawsuits unless it said so clearly.
The exception works like this: federal law protects a manufacturer only when the manufacturer follows the FDA’s rules. It does not protect a manufacturer that breaks them. So if a patient can show that the device he received did not match what the FDA actually approved — that the company failed to follow its own federally approved specifications — that lawsuit is allowed to proceed. It is not asking for a new rule on top of federal law, and it is not a private attempt to enforce federal law. It simply runs alongside, or “parallel” to, what federal law already demands.
To use this exception, a patient has to do two things: point to a specific federal requirement the manufacturer failed to follow, and explain how breaking that rule also broke a state law that already existed on its own. A claim that only accuses the company of an FDA violation gets thrown out; one that ties the violation to an independent state-law duty can survive.
That was the heart of Mr. DiToto’s case. He claimed his stimulator put out more electrical power than the FDA had approved, meaning the device that was built and sold to him deviated from the design the government had signed off on. He also claimed that Nevro had a pattern of failing to honestly report problems to the FDA — alleging the company misreported adverse events more than 1,900 times between 2015 and 2020 — and that it was actually he, not the company, who told the FDA about the malfunction he experienced.
What the court decided
One important point about timing: this ruling came at the “motion to dismiss” stage, the very beginning of a lawsuit. At that point the judge does not decide who is telling the truth. The court assumes the patient’s version of events is true and asks a narrow question — if everything he says is accurate, is there a valid legal claim? The judge has not found that Nevro did anything wrong, only that Mr. DiToto is allowed to try to prove his case.
Mr. DiToto brought nine claims in total. The judge, Senior U.S. District Judge Richard Bennett, let eight of them move forward.
The manufacturing-defect claims survived because Mr. DiToto did more than just say “the device broke one day” — courts have made clear that pointing to a malfunction is not enough. He claimed the device was defective when it was built, leaving the factory not matching its FDA-approved design, with the painful shock as evidence of that defect. At this early stage, the judge ruled, that was enough.
His claims for failure to warn and failure to report problems to the FDA also survived. Maryland law recognizes a duty to warn about dangerous products, which can include warning a regulator like the FDA. Because federal law already requires honest reporting, a claim built on dishonest reporting runs parallel to federal law rather than adding to it.
The claims based on the sales representatives’ promises — fraud, a violation of Maryland’s consumer protection law, false advertising, and broken warranties — survived for a similar reason. Those claims were not attempts to regulate the device’s FDA-approved design; they were about whether the company was honest in how it marketed and sold the product. Federal law already requires voluntary public statements to be truthful, so a state claim demanding honesty adds nothing new.
Why this matters
For anyone harmed by an implanted medical device, DiToto is encouraging. It does not erase the preemption defense — that wall is still there, and it is still high. Manufacturers of FDA-approved devices remain heavily protected, and many lawsuits never get past it. But the case confirms that the wall has a door. If a patient can point to a specific way a manufacturer failed to follow the FDA’s own approved requirements, and can tie that failure to a state law that stands on its own, the courthouse doors stay open.
The case is far from over. Mr. DiToto will still have to prove what he has so far only alleged. None of it has been decided. But he will get the chance to try — and for an injured patient facing a federal preemption defense, getting that chance is the whole ballgame.