Ill-Equipped: Best Practices For Reporting Defective Medical Devices

“Defective medical devices” are a common occurrence in the medical community. In fact, the Food and Drug Administration (FDA) has defined a medical device as “any item, regardless of its size, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

Let’s discuss what you can do if you’ve been injured by a medical device and how to report a defective medical device injury claim.

Recalls For Defective Medical Devices

Medical device recalls are not uncommon: 1 out of every 10 devices are recalled every year because they are defective or have a design flaw that causes problems.

Medical devices are complex devices that often require years of testing and development before they can be released to the market. In fact, many new drugs go through clinical trials that cost anywhere from $1 million to $10 million. Medical devices, on the other hand, go through much less rigorous testing and often no testing at all before they can be released.

The problem is that when a medical device is manufactured, they must fill out FDA Form 3500 each year to report all of the information on their devices. This form is used to track all of their devices so that they can be recalled if they have an issue.

Medical device manufacturers must then complete a recall if their device has an issue that could cause injury or death including:

  • Failure to warn users about an increased risk of death or serious injury
  • Failure to warn users about a new risk of death or serious injury

While medical device recalls are not uncommon, they are still very important in order to make sure that the safest and most effective devices are made available to consumers.

For example, the recent Exactech medical device recall consisted of faulty joint replacement implants. The FDA reports that over 6,000 of these devices were recalled in the U.S.

Recalls and Remediation for Defective Medical Devices

If you’ve been injured by a defective medical device then you may have the right to file a product liability claim against the manufacturer. Before you can do this, however, you will need to file a product recall with the FDA. This is called a “21C” recall. 21C refers to section 21 of the Federal Food, Drug, and Cosmetic Act which requires that a manufacturer issue a recall when it becomes aware of a defect in their product.

  • 21C recalls are required for any medical devices that:
  • Have an altered or missing label that could cause serious harm or death
  • Have a design defect that could cause serious harm or death
  • Have a failure to warn or existing device label that could cause serious harm or death

After submitting your 21C recall request with the FDA, you will then receive notification of your recall as well as instructions on how to remediate your device. The FDA may order your manufacturer to:

  • Stop selling the device in the United States
  • Recall all of the remaining devices so that they can be tested and fixed if necessary
  • Remove the device from the market so that it cannot be sold in the future

Although it may be difficult to get your defective medical device recalled, it is important that you file a product liability claim with the FDA as soon as possible so that you do not miss your chance for compensation. Even though you may have missed the deadline for filing suit with your state’s consumer protection agency, you have not missed your opportunity for compensation in federal court.

How to Handle a Defective Medical Device Injury Claim in Court

In order to win your case when you’ve been injured by a defective medical device, you will need to prove:

  • That your injuries were caused by something other than mere negligence (i.e., you didn’t just trip and fall)
  • That your injuries were caused by manufacturing defects (i.e., there was some type of problem with the design)
  • That your injuries were caused by a breach of warranty (i.e., your manufacturer failed to warn you or provide adequate warnings)
  • That you did everything reasonable to avoid or minimize any injuries which resulted from your defective product

For example, if you suffered an injury because of some poor design choice on part of a manufacturer then there is little you can do about it if you didn’t know about it at the time of purchase. In this case, it would be up to you to prove that you did everything reasonable to protect yourself from this defect prior to your injury occurring. If you did not know about the defect then you may have a tough time proving that it was foreseeable that this defect would cause an injury.

If you’re injured by a medical device and have questions about how to handle your case in court, then talk to an attorney about what options are available to you. You can also contact a lawyer at no cost and get legal advice on how best to proceed with your case.

What If You’re Injured by a Defective Medical Device?

If you’ve been injured due to some type of defect in one of your medical devices then you may be able to file a product liability claim against the manufacturer responsible for making these products. If this is the case then the manufacturer has 90 days from the time that they become aware of your injury to file a product recall with the FDA so that they can fix this defect and prevent further injuries from occurring. If there is no recall within 90 days then you should file suit against the manufacturer for damages as well as for punitive damages if you can prove that their negligence caused all of your injuries.

Medical devices are critical to the health and well-being of patients, but they can also be dangerous if not properly manufactured. If you’ve been injured by a defective medical device then be sure to consult with an attorney as soon as possible so that you can start building your case and protecting your rights.

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