Medical device preemption: How the law protects medical device companies and keeps injured patients from being able to recover for medical device injuries

Is Your Medical Device Failing?

Many people discover something is wrong with their medical device long before they learn about a recall, FDA warning, or lawsuit.

A medical device may be failing if you suddenly develop pain, swelling, loss of function, infection, difficulty walking, difficulty breathing, abnormal device alarms, or the need for additional surgery. In some cases, a device may break, loosen, migrate, fracture, stop working, deliver incorrect therapy, or damage surrounding tissue.

Common signs of medical device failure include:

• Increasing pain around an implant
• New swelling or inflammation
• Difficulty walking or using a limb
• Device malfunction warnings or alarms
• Need for revision surgery
• Unexpected hospitalization
• Recurrent infections
• Device migration or movement
• Broken components
• Loss of the device’s intended function

Revision and Removal Surgeries – Why Does My Doctor Want to Remove My Medical Device?

Patients expect their conditions and lives to improve after the pain of surgery or adoption of a medical device. They trust the system to protect them. They use medical devices hoping they are safe and effective. By and large, they are. But there are outliers. One common way patients come to know they had a failed medical device is a removal surgery or a revision surgery.

What Is Revision Surgery?

When a medical device fails, doctors may recommend revision surgery. Revision surgery is generally a procedure performed to repair, replace, or remove a failed medical device. Examples include:

• Removing a failed ankle implant
• Replacing a defective hip implant
• Revising a knee replacement
• Removing a fractured surgical implant
• Replacing a malfunctioning pacemaker
• Correcting a failed spinal implant

Revision surgery is often more difficult than the original procedure. Patients may experience additional pain, longer recovery times, increased medical expenses, and permanent limitations.

Many medical device lawsuits arise only after a patient undergoes revision surgery because the surgery helps confirm the device’s failure and the resulting injuries.

Some Patient Suffer in Silence Questioning What Happened

Some patients follow a doctor’s suggestion and undergo a procedure or otherwise start using a medical device. Over time it does not provide the improvement they expected, or worse, they experience pain and suffering. Many people search for answers to common questions like these:

• “Why is my implant hurting?”
• “Do I need surgery to remove my medical device?”
• “Why did my medical device fail?”
• “Can a recalled medical device cause injury?”
• “What happens if an implant breaks?”
• “Can I sue if my medical device failed?”

If your have had these questions, or your medical device failed and you required additional treatment, revision surgery, hospitalization, or suffered permanent injuries, you may have legal rights. The law, however, is complex and requires experienced attorneys.

Do You Have a Legal Claim if Your Medical Device Failed?

A joke among attorneys is that the answer to most questions like this is, “it depends.” People can be seriously injured when medical devices fail. When they fail, a surgeon may need to remove them surgically, a patient may die, or suffer from painful, even permanent injuries.

Patients who had a failed medical device may 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, failed to respond to post-market safety signals, or otherwise failed to act or made choices in the design, manufacture, or marketing of its product, injured patients can normally sue the company to recover damages. Normally, but not always.

If FDA approved the product through the PMA process, a legal doctrine known as preemption may limit or bar certain lawsuits against the manufacturer. However, some claims may still proceed when they are based on violations of FDA requirements.

How Do Medical Devices Get on the Market in the United States?

As we mentioned in our medical device practice area page, there are generally two ways medical devices get to patients – through FDA’s PMA or 510(k) process. If FDA approved the product via the PMA process, a legal doctrine, preemption, may prohibit injured people from suing the company. PMA approval does not automatically prohibit lawsuits. It may prohibit many state-law claims that would impose requirements different from or in addition to FDA requirements, but “parallel claims” may survive.

This is because when Congress passed the law that gave FDA power to regulate medical devices, it included language provides a legal defense to medical device companies that can prevent or limit personal injury lawsuits. Courts have interpreted the Medical Device Amendments to preempt many state-law claims involving PMA-approved devices. However, some claims based on alleged violations of FDA requirements may still proceed.

We disagree with aspects of this system because preemption can prevent some injured patients from obtaining compensation, even when they have suffered significant injuries. When a medical device fails, and patients are injured, the government often have to pay for the medical bills or insurers have to pay, which can increase costs for everyone else. As a practical matter, medical costs are often shifted to patients, private insurers, Medicare, Medicaid, or other public programs. Even if insurers cover medical costs, there is no recovery for pain and suffering or economic losses.

If the device failed because of something the company did wrong, the people should not bear the costs, the company should. Thus, KBD has fought several preemption cases.

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, 360e, and 360k. 

Under § 360(c), medical devices are categorized into three classes. This is supposed to be based upon the degree of risk they pose.

What are Class I Medical Devices?

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. Federal preemption largely does not apply to these medical devices.

What are Class II Medical Devices?

Class II devices are subject to more strict requirements. Many Class II devices reach the market primarily through the 510(k) process, under which a manufacturer demonstrates that the device is substantially equivalent to a legally marketed predicate device. Historically, many medical device lawsuits concern 510(k) products. Indeed, many lawfirms would reject PMA medical device cases.

What are Class III Medical Devices?

FDA approves the last group, Class III devices, through the pre-market approval (“PMA”) process. FDA generally requires Class III devices to undergo the PMA process because they are life-sustaining, life-supporting, implanted, present potentially significant risks, or are otherwise unsuitable for classification into Class I or II. The PMA process often requires clinical data and extensive FDA review of the device’s design, testing, manufacturing information, and labeling. This may come from clinical trials or clinical studies.

Medical Device Preemption Under the Medical Device Amendments

When Congress created this Class III PMA 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.
§ 360k(a).

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 learns of new safety information, it may have reporting obligations and may need FDA authorization before implementing certain design, manufacturing, or labeling changes. Some safety-related changes can be made through specialized FDA procedures. The medical device company may be unable to change the device without the FDA being involved.

One rationale underlying preemption is that Congress entrusted FDA with evaluating the safety and effectiveness of PMA-approved devices, and courts have recognized limits on state-law claims that would effectively impose different requirements. Put more simply, the basic idea, the underlying public policy at play here is that because the FDA – a specialized agency of experts – is involved, that Agency 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, some injured patients have been able to maintain lawsuits against medical device companies.

Plaintiffs may 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).

The Supreme Court has recognized that some state-law claims may survive preemption when they are based on conduct that independently violates FDA requirements and also gives rise to liability under state law. 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 when the alleged violations of the FDA regulation.

Preemption May Limit Patients’ Recovery

The federal preemption doctrine limits many state-law claims involving PMA-approved devices. However, courts have recognized certain “parallel claims” based on alleged violations of FDA requirements, and those claims may proceed when they satisfy both federal preemption doctrine and applicable state law.

Medical devices fail. People get hurt. If it happened because of foreseeable risks that a company should have prevented, because of a design choice, a manufacturing issue, or other omission or act, the company – not taxpayers or healthcare insurance subscribers, should be responsible. Injured patients should have a meaningful opportunity to seek compensation when they can prove that a manufacturer’s product injured them. In an ideal world, the FDA could protect the public by preventing and correcting these risks, 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 meantime, the attorneys at KBD will keep fighting to overcome preemption when people are injured by medical devices.

Does a Medical Device Need to Be Recalled Before You Can Bring a Lawsuit?

No.

Many defective medical devices are never recalled.

Patients may have claims involving:

• FDA recalls
• FDA safety communications
• FDA warning letters
• Adverse event reports
• Manufacturing defects
• Design defects
• Failure to warn claims
• Post-market safety failures

In many cases, injured patients learn of problems through their physicians or through increasing symptoms long before a formal recall occurs.

Contact KBD Attorneys

The FDA has stated that it is continuing to review information related to this potentially high-risk device issue and will provide updates as additional information becomes available. (U.S. Food and Drug Administration)

If your child suffered a serious birth injury, hypoxic brain injury, HIE diagnosis, cerebral palsy, or other neurological complications following neonatal resuscitation, KBD Attorneys can help evaluate whether a defective medical device may have played a role.

Contact us confidentially at 855-KBA-LAWS (855-267-3127) or electronically.

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).