Medical Device Recalls

Medical devices are supposed to be thoroughly tested before they come to the market to ensure that they perform as promised and to ensure that all risks of the device are known. If a device presents complications to a patient, the risks are weighed against the benefits in determining whether the device should be released to the public and patients must be warned about the risks so they can make an informed choice.

Unfortunately, sometimes medical devices come on to the market that turn out to be dangerous or that fail to live up to expectations. When this occurs, medical device recalls are the appropriate course of action to alert patients to the risk and to remove the dangerous product from the market. Medical device recalls often trigger legal action as they alert patients to the clear link between a medical device and complications they are experiencing, so if you have used a medical device that has been recalled you should strongly consider getting in touch with a Boston defective medical device lawyer. The Law Offices of Jeffrey S. Glassman, LLC can help.

Types of Medical Device Recalls

The FDA explains medical device recalls in Subchapter 7.1 of the Investigators Operators Manual. Their definition indicates that a “recall is a firm’s removal or correction of a matter that FDA considers to be in violation of the laws it administers.”

Recalls are classified in different ways depending upon whether they are voluntary by the manufacturer; requested by the FDA or ordered under section 515(e) of the FD & C Act. Recalls are also classified based on the risk to the patient of using the different medical device. For example:

  • A Class I recall is ordered when “there is reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
  • A Class II recall is ordered when exposure to a defective device could cause adverse health consequences that are temporary or that can be reversed with medical intervention. A Class II recall is also appropriate if there is a chance of severe health consequences but the possibility of this occurring is remote.
  • A Class III recall is ordered if there is a situation where a product is in violation but where its use is not likely to cause adverse health consequences.

When any type of recall is ordered or voluntarily undertaken by a manufacturer, a recall strategy is chosen regarding the depth of the recall, the need to warn the public and the extent of checks to determine the effectiveness of the recall. When a Class I or significant Class II recall is ordered, the FDA also mandates an inspection to determine the root causes of the problems.

What Happens If Your Medical Device is Recalled?

If you have had a defective medical device used in a procedure, news of a medical recall can be frightening. The information provided about the recall will usually indicate a course of action, which may include undergoing regular medical testing to detect adverse consequences or which may include immediate corrective medical action.

If it is determined that a recalled product has or may cause adverse health consequences for you, you may have a legal right to make a claim against the manufacturer of the medical device. Such cases are often resolved in multi-district litigations or settled outside of court, but your case can also progress to trial to allow you to obtain compensation. To settle or sue, you will need to prove that the medical device caused you unexpected harm when used as intended. The recall is strong evidence that the device was dangerous and that you are entitled to monetary damages.

You have a limited time to take action after a medical device has harmed you, so don’t hesitate to get the help you need to protect your legal rights. The Boston defective medical devices lawyers at the Law Offices of Jeffrey S. Glassman are here to help, so give us a call or contact us online today to schedule a free consultation.

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