Class III Medical Devices: At Your Own Risk
State vs. Federal Courts
For starters, it’s much easier for injured patients (plaintiffs) to sue in the state rather than federal courts.
“Many federal courts require claimants to assert perhaps overly detailed factual allegations to support their claims even before claimants are able to gain access to that information because it’s held by the defendants (i.e. the manufacturers),” Yvonne Flaherty, Minneapolis-based medical device and pharmaceutical liability attorney, said.
The preference for state courts has various other reasons, too.
Lawyers prefer to sue in state court, according to Holly Ennis, pharmaceutical and medical device liability attorney and activist based in Florida.
"It’s a little more laid back, the laws aren’t as strict, 99 out of 100 plaintiffs would prefer to be in state court,” Ennis said.
1970 Classification of Medical Devices
Growing medical technologies led to an increase in medical devices, prompting the FDA to classify and regulate devices based on comparative risk. Today, the challenges of suing device manufacturers in state courts apply only to Class III medical devices.
Class III devices are subjected to the FDA's most stringent approval process, pre-market approval (PMA), in which the FDA is supposed to thoroughly evaluate the safety and effectiveness of each individual device.
Class III medical devices are considered life-saving, known to “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury,” according to the FDA.
In contrast, Class I and II devices are subject to a less rigorous 510(k) FDA approval process. The 510(k) process relies on the similarity of the new medical device to a device that has already been approved.
Class I and II medical devices include tongue depressors, bedpans, powered wheelchairs and pregnancy tests. In other words, the new device is not evaluated on its own.
Despite the fact that Class I and II devices are less invasive than Class III devices, patients can sue for damages related to them in state court – but not in relation to the riskier Class III devices.
1976 Medical Device Amendments (MDA)
There's a history that created this situation in courts. Prior to 1976, medical devices were not federally regulated. So, states developed their own regulations.
In the early 1970s, the Dalkon Shield intrauterine device reportedly injured as many as 200,000 women. Congress responded by enacting the 1976 Medical Device Amendments (MDA) to the 1938 Food, Drug and Cosmetic Act, which set forth federal regulations for medical devices.
To avoid confusion, the MDA had a provision that prevented states from having laws that are "different from" or "in addition to" federal medical device regulations. In legal parlance, this is known as “federal preemption,” meaning that federal trumps state.
Riegel v. Medtronic: The Case That Changed Everything
There are a number of influential court cases, but Riegel v. Medtronic (2008) is the landmark Supreme Court ruling that changed everything.
Even attorneys can find this area of the law difficult to grasp and work with, Ennis said.
“That case is the most significant impediment to filing a lawsuit right now for anybody that’s injured by Class III medical devices," Ennis said. "I don’t want to say it’s insurmountable, but it’s very difficult."
What Happened in the Landmark Case
In May 1996, Charles Riegel was undergoing coronary angioplasty surgery in Albany, New York, when the Evergreen Balloon catheter used to dilate his artery burst. Riegel required emergency surgery and advanced life support.
Riegel and his wife sued Medtronic, which now operates in 140 countries and is the largest medical device manufacturer in the world. The plaintiff's theory of liability focused on Medtronic's negligent manufacture, design and labeling of the catheter.
The case was heard in district court, the U.S. Court of Appeals for the Second Circuit, and later, the Supreme Court. All courts agreed that because the device had gone passed the FDA’s more rigorous PMA approval process, the state tort (personal injury) claims were barred due to federal preemption – meaning, patients can’t sue in state court.
Impact on Patient Claims
Courts have provided clarification as to how the Riegel decision should be applied in real life, and the legal doctrine set forth in the case has evolved over time.
The 1976 Medical Device Amendments said that state laws cannot be "different from" or "in addition to" federal laws. State law is “parallel” to federal law.
Parallel claims may address manufacturing defects in state courts if state law aligns with federal law, as provided in the Riegel decision.
“The majority of courts that have addressed Riegel have held that manufacturing defects claims are one example of a ‘parallel claim’ (i.e. where state law aligns with federal) that are viable post-Riegel. The other examples include, at least in some jurisdictions, certain failure to warn claims – it’s a narrow subset of failure to warn claims, as well as breach of warranty claims,” Flaherty said.
Failure to warn claims are generally based on the manufacturer’s failure to report certain adverse events to the FDA as required by federal law.
Breach of warranty, in the simplest terms, is when a manufacturer makes an express or implied representation that a product was going to work in a certain manner and it does not.
“There are claims that can be brought, but they are narrowly defined, and they tend to require a fair amount of specific facts in order to satisfy the criteria of the courts to get you into that window of claims,” Flaherty said.
Two other areas of exception have evolved, but results have so far have varied between jurisdictions.One is when the manufacturer deviates from the FDA-approved design.
In these instances, Flaherty said, the manufacturer is always going to try to argue that it’s a design defect – in which case federal preemption would protect manufacturers because the design was approved by the FDA in the PMA process.
The second of these exceptions occurs when the manufacturer deviates from the FDA-approved design and the blame is categorized as a manufacturing defect.
Under this circumstance, there’s no express federal preemption, manufacturers aren't protected and the case can proceed.Despite these evolving exceptions, Riegel still presents significant hurdles to injured patients. It's complex and heavy, Flaherty said.
“Complex for lawyers, even more complex for non-lawyers,” she said. "I think that lawyers that specialize in this area grapple with the language of Riegel v. Medtronic as do the courts."
Impact on Medical Device Testing and Safety
Riegel v. Medtronic regrettably may have worsened things for consumers when it comes to medical device safety, according to Ennis. The case may have led manufacturers to view preemption as a blanket preemption, leading to less thoroughly-tested medical devices entering the market.
"That’s not to say that they don’t test their medical devices, but I think that a lot of manufacturers feel that they’ve gotten a free ride," Ennis said.
“When things are caught, the manufacturers aren’t so quick to recall devices or take them off the market because they’re making so much money selling them,” she continued. “They’re just going to keep on selling them until they’re absolutely forced to take them off.”
Impact on Injured Patients
A long and arduous history, defined by Riegel v. Medtronic, has led to a legal atmosphere in which patients are unable to bring claims protected under federal preemption. Patients in this situation are denied their Seventh Amendment rights to a trial by jury in civil court cases.
“Unfortunately, the way the law stands under Riegel, a manufacturer could issue a press announcement, they could walk into a courtroom and say, ‘Our devices are defective, they had a terrible design, completely defective, we acknowledge it hurt people,’ and unfortunately, there are limited, if any legal remedies for that,” Flaherty said.
Because of this, patients injured by Class III medical devices struggle to find representation. Lawyers will pass on the cases protected by preemption, Ennis said.
“A lot of attorneys, once they see it’s a Class III medical device and there’s preemption, they don’t even want to get involved because they know it’s going to be such a fight, such a long labor-intensive and financially-intensive fight to even get past preemption."
