FDA Medical Device Approvals: How a Flawed Process Can Result in Patient Harm

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All medical devices entering the US market must be approved by the US Food and Drug Administration (FDA). The FDA is responsible for protecting the public health by ensuring that only safe and effective medical devices are sold to consumers. However, 1.7 million people have been injured and 80,000 people have died from defective medical devices even though these devices have been through FDA review, clearance, and approval processes.

As detailed in both sprawling investigative reports and television exposes released in 2017, flaws as a result of different FDA review processes have allowed dangerous and defective devices to upend the lives of millions of patients year after year. While the FDA recently announced significant changes to how it will evaluate medical devices before they get to market, millions of already defective devices continue to hurt patients.

For this reason, it is essential to understand the FDA’s role in the approval of medical devices, how such devices are classified and evaluated, how and when recalls occur, and what remedies exist for injured patients as well as the families of those killed by defective medical devices.

Classification of Medical Devices

The FDA classifies medical devices into three classes.

  • Class I: Devices and products that present a “low risk of illness or injury.” Examples include stethoscopes and elastic bandages. Forty-seven percent of medical devices fall under this category, and 95 percent of these are exempt from the regulatory process.
  • Class II: Devices that present a “moderate risk,” such as sutures, some hernia mesh products, and many pregnancy test kits. Fifty-three percent of medical devices fall under this category.
  • Class III: Devices that “support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.” Examples include metal-on-metal hip implants, implantable pacemakers, and breast implants.

Notice, Approval, and Clearance of Medical Devices

The FDA takes different approaches and medical device manufacturers must meet different standards for safety and effectiveness before the FDA gives marketing approval. Which rules and processes apply depend on the nature of the device and the risks it may pose to patient health and safety.

Understandably, the FDA subjects Class I and II devices to less stringent processes than it does to Class III devices and often doesn’t require manufacturers to submit substantial clinical testing and data before granting market approval. But tongue depressors and thermometers are not the devices which have caused so much harm over the years. Rather, the problem lies with how implants and other potentially dangerous Class II or Class III devices make their way to market–often without any testing at all.

The FDA has two main pathways to market approval for medical devices.

  • The Premarket Approval Process (PMA): Pertaining to Class III devices that are “not substantially equivalent” to an approved Class I or Class II device, this process is the FDA’s most stringent and requires the submission of substantial scientific evidence to prove the device’s safety and effectiveness.
  • The Premarket Notification Process (PMN): Also referred to as 510(k) clearance for the statutory section from which it derives, this process is the pathway that 82 percent of all medical devices took to market approval in 2017, according to the FDA’s Center for Devices and Radiological Health. This pathway spares manufacturers from the expensive and lengthy testing and clinical evaluations that would otherwise be required. As a result, this is how most untested, unproven, and defective devices reach patients.

The Problem With 510(k) Clearance

A manufacturer can obtain 510(k) clearance and place its device on the market without testing or clinical evidence if it can demonstrate that the device is “substantially equivalent” to a product already on the market, referred to as a “predicate device.” Class III devices that have only minor differences from predicate devices may be reclassified as Class I or II and are also subject to less-stringent testing requirements than most Class III devices that do not have predicates.

The problem is that the “predicate devices” that manufacturers hang their hats on are often decades old and far removed from the technological and mechanical advancements contained in the new device. FDA data shows that nearly 20 percent of current 510(k) clearances are based on a predicate that is more than ten years old. In addition, the testing done on older devices may not have been as stringent or thorough as it is presently, with new safety and testing methodologies. Making matters worse, many 510(k)-cleared devices are based on predicates which were later shown to have posed significant problems and risks.

This means that a new device or implant can be cleared, marketed, and used to treat patients without any testing or evidence, based solely on its supposed similarity to a significantly older device that may have a tenuous relationship to the new one.

Recalls and Lawsuits Based on 510(k) Cleared Devices

Given this lack of testing and clinical evidence, it isn’t surprising that medical devices continue to be recalled either by manufacturers or the FDA with increasing frequency. These recalls often occur only after thousands of patients have already suffered injuries from the devices, and these injuries become known to the FDA through patient, manufacturer, and physician reporting processes or subsequent studies. It is important to note that some voluntary recalls do not necessarily mean a device is dangerous or defective.

The FDA maintains its MAUDE database to collect reports of problems and adverse events associated with medical devices, and its MedWatch Safety Information and Adverse Event Reporting Program to collect reports of adverse events and announce any warnings and recalls regarding medical devices.

Several widely used and implanted devices have been the subjects of recalls and thousands of lawsuits by injured patients and their families over the past decade, including:

  • IVC filters
  • Sorin Stockert heater-coolers
  • Metal-on-metal hip replacements
  • Transvaginal mesh
  • Bair Hugger blankets
  • Power morcellators
  • Hernia mesh

What Patients Harmed by Dangerous and Defective Medical Devices Can Do

In addition to reporting problems to their healthcare providers and the FDA, those who believe they have suffered injuries or other health problems because of defective medical devices may be entitled to compensation from the device manufacturers or others.

Given the thousands of patients who may also have claims based on the same dangerous device, such lawsuits are often consolidated into multi-district litigation so that the evidence of a product’s problems can be addressed through one federal court. This can add complexity to the already challenging task of holding device manufacturers accountable for the harm they cause and makes it even more imperative that those injured seek out attorneys who have substantial experience with dangerous and defective medical device litigation.

Berman & Simmons Handles Dangerous Drug and Defective Medical Device Claims

When medical device manufacturers put profits before consumer safety, the attorneys at Berman & Simmons are prepared to hold them accountable. With a long record of success handling personal injury cases and more resources than any other firm in Maine, we work to recover full compensation for the harm done to our clients.