People can be seriously injured when medical devices fail. A lot of times, the device must be removed, which requires surgery. They consequently incur medical bills, require medical care in the future, lose income from missed work, and suffer pain and other non-monetary loses. Marriages can be disrupted, and many people struggle to return back to normal.
If this happened because a medical device company designed a product that was unsafe, failed to warn about its risks, failed to provide adequate instructions to use the device, or otherwise failed to act or made choices in the design, manufacture, or marketing of its product, people who were injured as a result can normally sue the company to recover damages. Normally, but not always.
As we mentioned in our medical device practice area page, there are two ways medical devices get to patients – through FDA’s PMA or 510(k) process. If the product was approved by the FDA via the PMA process, a legal doctrine, preemption, may prohibit injured people from suing the company. This is because when Congress passed the law that gave FDA power to regulate medical devices, it included language that courts have interpreted to mean people cannot sue if the product was cleared through the PMA process. Thus, lawsuits are preempted by the law giving FDA exclusive authority to deal with these kinds of medical devices.
We disagree with this system because it does not give patients a mechanism by which they can recover. When a device fails, and patients are injured, the government has to pay for the medical bills or insurers have to pay, which can increase costs for everyone else. If the device failed because of something the company did wrong, the people should not bear the costs, the company should.
So we at KBA fight to have this law changed or at least limited. For example, we are involved in the Essure litigation where this is an issue, but fortunately, Plaintiffs have overcome this legal hurdle so far. It is also an issue in the BHR hip litigation, which Plaintiffs have survived as well. Nonetheless, preemption has prevented thousands of people from being able to recover for their losses.
The beginning of the end – the Medical Device Amendments
The law that gives the FDA power to regulate certain products is called the Food, Drug, and Cosmetics Act. Congress amended it to add medical devices in 1976. The Medical Device Amendments. See, e.g., 21 U.S.C. §§ 360c-1; 21 U.S.C. §§ 301 et seq.
Under § 360(c), medical devices are categorized into three classes. This is supposed to be based upon the degree of risk they pose.
The first group, Class I devices, include things like tongue depressors. They are subject to minimal requirements from FDA because their long use and simplicity reasonably assures patient safety. Class II devices are subject to more strict requirements and must be cleared by the FDA through what is commonly called the 510(k) process. The last group, Class III devices, are approved by FDA through the PMA process because they are believed to be more novel devices and present a greater risk of injury. The PMA process generally requires clinical testing and FDA review of the device’s design history, testing, and labeling.
When Congress created this system, the law included an express pre-emption provision that states:
Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement — (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
After the medical device company submits the required information to FDA, the FDA “weigh[s] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” 21 U.S.C. § 360c(a)(2)(C). If FDA approves the device, the medical device manufacturer cannot “make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” unless it submits an additional application for FDA review. 21 U.S.C. § 360e(d)(5)(A)(i); see also Riegel v. Medtronic, Inc., 552 U.S. 312, 319 (2008).
So as the medical device company is monitoring risks – learning from medical articles, adverse events, clinical studies, and other sources as discussed on our medical device litigation practice area page – if it learned of risks associated with the device, it generally has to go back to the FDA. It cannot just change the device without the FDA being involved. The basic idea is that because the FDA is involved, it should make decisions about the medical device and courts should not be able to second-guess the FDA’s decision making.
Avoiding preemption to recover damages for injuries caused by medical devices.
While many lawsuits involving medical devices that the FDA has approved through the PMA process may be preempted, many injured patients have been able to maintain lawsuits against medical device companies. We have noted the Essure litigation that the attorneys at KBA are actively litigating, including attorney Justin Browne who serves on the Plaintiffs’ Steering Committee, as one such example. The BHR hip litigation is another example. Other medical device failures like Abbott’s X and Medtronic’s Y may not survive, but further investigation is necessary.
Plaintiffs can survive preemption when they show their claims are consistent with FDA requirements. State law requirements, including the claims we discussed on our medical device litigation practice area page, are “different from, or in addition to,” requirements under the FDA statute if: (1) “the Federal Government has established requirements applicable to” the challenged medical device and (2) the state law requirements are “different from, or in addition to” those requirements and “relate to safety and effectiveness.” Riegel v. Medtronic, Inc., 552 U.S. 312, 321-24 (2008).
This exists when there is “a damages remedy for claims premised on a violation of FDA regulations.” Id. at 330. Put simply, injured people may be able to sue a medical device company for injuries caused by a medical device that the FDA approved through the PMA process when the alleged violations of the FDA regulation.
This is what Plaintiffs in the Essure litigation alleged. Plaintiffs there allege Conceptus and Bayer failed to report adverse events, which are incidents where the device causes or contributed to a death or a serious injury, or malfunctioned in a way that would be likely to cause or contribute to a serious injury or death. The Essure manufacturers received thousands of complaints. There were not reported to FDA, as required by FDA regulations. Plaintiffs, therefore, brought failure to warn claims, and they survived preemption. The Plaintiffs in the BHR litigation survived in a similar way.
Medical devices fail. People get hurt. If it happened because of foreseeable risks that a company should have prevented, the company – not taxpayers or healthcare insurance subscribers, should be at fault. People injured by these devices should be compensated for their pain and suffering. In an ideal world, the FDA could protect the public, but it is virtually impossible unless we are going to dedicate enormous resources to do so and that does not seem feasible. The civil justice system provides another check and balance to help protect patients, but it is restricted under current law.
In the meanwhile, the attorneys at KBA will keep fighting to overcome preemption when people are injured by medical devices.
1. There is also a Changes Being Effected (“CBE”) process to enhance “the safety of the device” with newly acquired information. 21 C.F.R. § 814.39(d)(1).
2. See, e.g., Mink v. Smith & Nephew Inc., 860 F.3d 1319, 1326 (11th Cir. 2017); Stengel v. Medtronic Inc., 704 F.3d 1224, 1233 (9th Cir. 2013); Walker, 670 F.3d at 577; Bass v. Stryker Corp., 669 F.3d 501, 510 (5th Cir. 2012); Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010); In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010).