Medical Device Injury And Liability: 6 Things To Know

If you have suffered catastrophic injuries or congenital conditions, your doctor may have advised you to use specific medical devices to improve your quality of life. In some cases, your doctor may have required you to use these tools throughout your life, especially if what you have is something irreversible.

However, there are cases when these devices fail to serve and uphold their ultimate purpose. These happen when manufacturers unintentionally made a mistake during production. So, instead of aiding you with your problems, they only worsen your condition due to some malfunctions.

Such cases are called medical product liability. If you or your loved ones have suffered because of defective devices, you may file a lawsuit against the manufacturer of the said equipment. However, proving your claims will not be easy, especially when you’re going against manufacturers with reputable names.

That’s why it would be best to hire a lawyer from your local malpractice firm. They will evaluate your case and help you get compensated for your losses. In addition, you might want to learn the following to help you understand how medical claims work:

  • What Is A Medical Device? 

Manufacturers of medical devices are subjected to federal laws and governed by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health. This organization establishes the standards that every company must follow to ensure product quality and functionality.

According to the FDA, a medical device is defined as follows:

  • A medical device is used to diagnose the patient’s condition, and cure, mitigate, treat, or prevent the disease.
  • A medical device is operated to affect the body’s function, including its structure.
  • A medical device does not achieve its purpose by conducting chemical reactions inside and outside the body.

Furthermore, these essential definitions will serve as the manufacturer’s basic principle in producing holistic and safe machinery.

  • What Is The Connection Between Surgery And Defective Medical Device?

Through the years, engineering and technology have significantly shaped and improved how medical facilities function and address the needs of their patients. If these tools fall into the wrong hands, though, disasters may occur, leading to surgical errors.

To avoid such cases, each device must be tested, operated, and examined many times before use. If the operating surgeon lacks the necessary skills and experience of installing the device, it will only cause more harm than good to the patient.

Likewise, this could happen even if the device is free from defects. Surgical errors due to a lack of skills will always be unacceptable and inexcusable. However, if the implant or device fails during the surgery or months after the operation, the fault will be on the manufacturer’s side.

  • What Are The Different Medical Devices?

Medical devices come in various forms, shapes, and, most importantly, functions. Each device has a different purpose. Some may be used in diagnosing the condition of the patient, while some are used to treat them. Here are some common medical devices that may result in extreme harm if found to be defective:

  • Transvaginal mesh implants
  • Breast implants
  • Heart stents
  • Insulin pumps
  • Intrauterine devices (IUDs)
  • Hip replacements

If these implants and devices are found to contain defects or malfunction during the application, they may cause serious irreversible injuries and damages to the patient, including death.

  • What Are The Liabilities Of Manufacturers?

Because defective medical devices may lead to potentially life-threatening conditions, the government has subjected every producer to strict rules and regulations. If they fail to meet any of these, it may result in a product liability lawsuit against them.

Manufacturers can be liable for the following:

  • Faulty Designs – If the device was not designed correctly and resulted in injuries and damages to its users, manufacturers may be held liable for this reason.
  • Lack Of Testing – Medical devices should undergo a series of tests and multiple phases of trials before they are released in the market. If they are released without proper evaluation and approval, they may be liable for problems that may arise, especially if they try to hide the flaws of their devices.
  • Reckless Manufacturing – The device manufacturer will be accountable for all the damages resulting from manufacturing problems. Manufacturing defects may also happen if the device is not assembled correctly.
  • Failure To Warn – All devices, medical or not, should have a warning stating the potential hazards and dangers of using the product. If injuries occur due to a lack of caution, the manufacturer will be liable for all of the consequences resulting from negligence.

These things may be hard to prove, but your personal injury lawyer will go through all the facts to hold the manufacturers liable for their mistakes.

  • Who Are Other Potential Defendants In Your Claims?

In a product liability lawsuit, all people involved in the chain of distribution, from manufacturers, suppliers, and end-users, may become one of the defendants. You may sue any of the following for malpractice and liabilities:

  • Manufacturers – The first entity you’ll most likely file a case against are the manufacturers of medical devices. However, these companies will surely have a lineup of the most expensive lawyers to defend cases filed against them.
  • Medical Professionals – Your doctor may be held liable if he fails to warn you about the side effects and potential risks of using the device, especially for treating their condition.
  • Medical Facilities – As they are a part of the distribution chain, they could also be liable for the damages you received due to defective devices.
  • Retailers – Most medical devices are delivered right through medical facilities by the manufacturers. Because retailers are the last stop before end-users, they may be liable for selling faulty devices.

While you can file a lawsuit against them all at once, proving your claims will be more complicated than dealing with a single defendant.

  • What Are The Damages You May Receive In Product Liability Cases? 

Depending on your case, you may be compensated for economic or non-economic damages. Usually, plaintiffs receive both of them as one is the result of another. For example, loss of income may result in poor quality of life and inconvenience.

Here are the damages you may include in your claims:

  • Economic Damages – These include past, present, and future medical expenses, mental health care, income loss, and potential income loss.
  • Non-Economic Damages – These are non-monetary losses, including pain and suffering, emotional distress, loss of companionship, loss of quality of life, and inconvenience.

Final Words

According to experts, medical product lawsuits are one of the most challenging types of personal injury claims. Doing this by yourself will only result in failure and a lost chance of getting compensated. Therefore, your best course of action would be to hire experienced medical malpractice or personal injury lawyer to prove your claims.

If you’re worried about the legal fees, don’t think about it yet, as most law firms offer a contingency payment plan. This is an excellent arrangement so you can focus on the case.


Medical Device News Magazine
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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