What Is a Defective Medical Device?

What Is a Defective Medical Device?

The patents protected by intellectual property laws are an indispensable tool for fostering innovation, and this is particularly true with the increasing advent of life saving medical devices. However, too often, even after extensive testing, things can go wrong, threatening the life of those the devices are intended to save.

A defective medical device is any object used for medical purposes that has an existing flaw or errs in a manner that can harm patients. Essential medical devices that are defective injure or impair thousands of patients and medical operators every year, so it's important that you know the risks.

What Common Medical Devices Can Be Defective?

Types of defective medical devices can include:

  • Surgical instruments
  • Surgical robots
  • Laser eye surgery devices
  • Pacemakers
  • Implants
  • Hernia, pelvic, or any other internal mesh
  • Metal hips or other prosthetic devices
  • Hearing aids
  • Contraceptives

A common defect in many medical devices is electrical outages, which can impact pacemakers, for example. Electrical failures may be responsible for a range of problems with other internal devices as well, but primarily are a problem during operations that utilize precision machinery.

Medical defects can also include ruptures or other breaks that cause the device to stop working or harm the user. Silicone implants, if not replaced after a certain number of years, may leak or even pop. Metal hips or contraceptive inserts can also fracture, causing complications.

What Kind of Harm Can Come from a Defective Medical Device?

At the most severe, a pacemaker that fails can cause the death of its user, as pacemakers are essential for maintaining a fully functioning beating heart. Even more common is a defect that interrupts a lifesaving or otherwise critical surgical procedure. In the case of brain or heart surgery, surgical robot failure can lead to a misplaced incision, possibly causing complications or death. A defective laser during eye surgery may prove equally catastrophic.

Breast implants that rupture can cause serious consequences if they are made of silicone and leak beyond the scar tissue to other parts of the body. While saline implant fluid is largely harmless, silicone gel cannot be absorbed by the body. A small or silent leak that doesn’t change external shape or appearance can cause significant complications, the least of which requires corrective surgery to replace the implant.

In the past decade, the US Food and Drug Administration (FDA) reportedly received near 5.5 million adverse impact reports regarding medical devices. Over 10 percent of the reports involved an “explant”, referring to the operation to remove an implanted device.

Technology continues to advance, and implants are becoming more common all the time for a variety of different functions. Unfortunately, this has predictably corresponded with a rise in the number of medical defects.

Surgical failures involving defective instruments are the greatest risk to human health. This is because surgical instruments often don’t undergo as much testing in the field as other medical devices, given the relative limitations of their use.

Recalls and Regulations

The FDA issues a nationwide recall whenever a medical device is proving consistently defective, ranging in severity across three recall classes and issued as either corrections or removals. The FDA also issues routine medical device safety communications, which one can check if they have uncertainty about the safety of a potential class or brand of medical devices.

Who is Liable When a Medical Device Is Defective and Causes Harm?

The safety of certain medical devices has been seriously questioned in recent years, particularly specific forms of implants that can lead to complications or rupture far too easily.

Lawyers are stepping in to provide a chance of financial relief for victims. When a medical device is defective and causes harm to a patient, that patient may qualify for a product liability claim, which involves a suit against the manufacturer or distributor of the product.

In cases where an individual has been harmed as the result of a product defect, a product liability claim is generally the only path available to financial compensation. A defective product is not a case for medical malpractice. However, if the malfunction is due to improper maintenance, there could be a case of negligence against the hospital.

Class action lawsuits are common in defects that are widespread and lead to a recall, as dozens, hundreds, or even thousands of victims may be eligible to claim damages.

If you have been injured by a faulty medical device, it is wise to seek legal counsel to help with your case. When looking for an attorney, cross-search between lawyers and the defective product in question. There may be qualified attorneys who have had experience with the same medical device, which means they will have a head start on your case from the beginning.

For innovators, legal protection may also prove critical for the continued fostering of your own progress in medical research and the furtherance of lifesaving medical device research and development.

Written by Kyle Hambright, guest editor who enjoys writing on the vast and complex field of personal injuries.