Is the FDA Changing Its Ways on Medical Device Screenings?

April 15, 2019

When surgically implanted medical devices work well, they help make people’s lives better; but these devices can do serious damage when something goes wrong. Medical devices such as pacemakers, hip and knee replacements, breast implants, heart stents, transvaginal mesh, drug pumps, and metal rods that stabilize spines and broken bones can cause injuries and even death during an implant procedure, or problems may not arise until years later. Injured patients may suffer without knowing the cause and require additional surgery or procedures to attempt to solve the problem. A medical malpractice attorney can help.

Unlike drugs and pills, many devices don’t go through human testing before being offered to patients. Due to the number of devices that have been causing debilitating injuries, the Food and Drug Administration (FDA) is now considering changing how it assesses medical devices before allowing them to be sold. Unfortunately, for many individuals suffering from painful or even life-threatening device-related problems, these reforms are coming too late.

If you or a loved one has suffered harm due to a faulty medical device, you should seek legal representation to determine whether you can be compensated for both economic damages, such as medical costs and lost wages, and non-economic damages, such as pain and suffering and loss of life’s enjoyment. However, due to the complexity of the law, your case must be handled correctly and competently by an attorney experienced in medical device malpractice.

Why Problems With FDA-approved Medical Devices

The FDA is the federal organization that approves devices, and it is supposed to examine and possibly recall faulty devices when incidents arise. Unfortunately, many products get to the market without being adequately tested.

In situations where device failure would obviously be life-threatening, the FDA requires some sort of human testing, called premarket approval. But a large number of medical devices enter the market through loopholes that allow products to be approved for sale without clinical trials in humans.

Medical device manufacturers who believe their device is “substantially equivalent” to one that has been cleared by the FDA or marketed before 1976 can apply to enter the U.S. market under the FDA 510(k) process. This process bypasses the rigorous FDA Premarket Approval (PMA) process to evaluate the safety and effectiveness. The result is that higher-risk devices can be cleared based on earlier devices, even those that have been recalled for safety problems. Also, manufacturers can circumvent clinical trials by informing the FDA they are marketing an “updated version” of a device with minor changes.

What Can Be Done

The FDA now acknowledges that some devices have caused major problems and has elevated the risk level of those products following reports of injuries. The agency admitted that their approval framework needs to be modernized to reflect advances in technology, safety and a new generation of medical devices.

Plans to make changes to the process include:

  • Pushing back on manufacturers that base any new device’s marketing application on one that’s more than 10 years old.
  • More actively watching how devices perform once they’re on the market, rather than relying on patients’ reports.

What Are Types of Defective Medical Device Claims?

Patients damaged by faulty medical device claims may seek compensation in lawsuits that fall under three categories:

  • Defective design — there are issues in the design of a device even if appropriately manufactured
  • Defective marketing – product may have been marketed without informing the patient of the dangerous disclaimers involved
  • Defective manufacture – product was damaged during manufacturing or distribution.