Defective Medical Devices that Commonly Cause Injury

Many Oregonians with medical needs could not have chosen a better time to live than the present. Medical technology continues to improve rapidly. Every year, we seem to hear of new innovations that seemed unreachable only a few years earlier. From pharmaceuticals to medical devices and treatments, many trends in the industry are positive. Many Americans have options that did not exist for previous generations, and as a result are living longer and often with a better quality of life.

But as with all technological advancements, there are sometimes hiccups in the process. Manufacturers and others in the supply chain sometimes make mistakes that injure innocent patients. In this article, we will discuss some of the types of medical devices that have resulted in personal injury, and sometimes even wrongful death.

What Is a “Medical Device?”

This can actually be a complex legal question. For example, a product is subject to regulation by the U.S. Food & Drug Administration (FDA) if it meets the definition of “medical device” set forth in section 201(h) of the federal Food, Drug, and Cosmetic Act. For purposes of this article, we’ll try to pare down the definition.

While not all-encompassing, we will think of a medical device as an instrument, machine or similar item intended for use in diagnosis, treatment, cure, or prevention of disease or other medical conditions, or intended to affect the structure of the body without being metabolized or relying on chemical action inside the body. That’s a mouthful, but a few examples below will help. And if you have any further questions, we’re always here to answer them.

The following list includes both simple and complex items to demonstrate how broad the definition of medical device really is. Examples include:

  • Wheelchair
  • Ultrasound machine
  • Tongue depressor
  • Knee replacement
  • Stent
  • MRI machine
  • Pacemaker

As you can see, the list does not include drugs and medicines, which rely on chemical action or metabolization inside the body.

Dangers Posed by Medical Devices

Medical devices have undoubtedly helped many patients. However, they are sometimes more dangerous than patients realize. While medical devices must obtain FDA approval, they sometimes have very little actual clinical testing.

A number of noted media outlets joined forces to study millions of data points as part of an investigation into the world’s medical device industry, which generates many billions of dollars in revenue every year. According to STAT, the medical device investigation determined that over a period of 10 years, in excess of 1.7 million injuries and almost 83,000 deaths resulting from medical devices were reported to the FDA. Some of the types of products causing the most injury reports were:

  • Hip prosthesis
  • Insulin pump with sensor 
  • Spinal stimulator
  • Surgical mesh
  • Implanted insulin pump
  • Defibrillator

These are only the top causes of injuries. Many other medical devices have been related to thousands of additional injuries.

Also concerning is a Kaiser Health News (KHN) report that the FDA has permitted many reports of injuries and malfunctions related to medical devices to be submitted to an alternative database that may be hidden from public and medical scrutiny. This means that even doctors and scientists who seek to inform themselves of existing problems and dangers may not find important information.

Call with Questions

Given our country’s rate of technological evolution, we can expect amazing medical devices in the future. Unfortunately, we can also probably expect the increases in injuries and deaths related to medical devices to continue to climb. When these personal injuries and unnecessary deaths are caused by the wrongful or unlawful conduct of manufacturers and others, the law provides a remedy.

The experienced products liability and personal injury attorneys at Nelson MacNeil Rayfield fight every day to help ensure that those causing harm are held accountable to the people they hurt. Please give us a call if you have any questions and we will be happy to provide a free consultation.


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