When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all. There are various types and levels of recalls, and the action required by each is often dependent on the danger related to the particular device or drug.
Because a recall is only issued when there is some type of danger associated with the product in question, using a medical device that has been recalled can lead to serious injuries or even death. If you or a loved one has suffered any type of injury as a result of a defective medical device, the Virginia product liability lawyers at our firm are ready and willing to help you take appropriate action.
Classes of Safety Recalls
The United States Food and Drug Administration (FDA) maintains three separate classes of recalls to be used appropriately based on the level of risk associated with the recalled item. An FDA recall is always categorized as one of the following:
- Class III Recall: Use of the device or drug is unlikely to result in adverse health consequences, but the product does not meet regulatory standards.
- Class II Recall: Use of the device or drug may result in “temporary or medically reversible adverse health consequences” or when the likelihood of serious health issues is remote.
- Class I Recall: Use of the device the device or drug carries a “reasonable probability” of causing “serious adverse health consequences or death.”
The FDA may also issue “Medical device safety alerts” when a product presents an unacceptable risk of “substantial harm.” These alerts may also be considered recalls in certain cases.
Voluntary and Mandatory Recalls
Manufacturers and distributors of medical devices and drugs are expected to remain responsible for the level of quality and safety of their products, from design through and including long-term use and/or consumption. If and when a safety issue is identified, the manufacturer or distributor may issue a voluntary recall. The recall may request that the product in question be returned and professionally repaired or replaced and, in some cases, may result in a product being removed from the market. The FDA reports that almost all recalls in the United States are considered voluntary.
Mandatory recalls present a more serious situation, in that they often are the result a manufacturer or distributor failing to act on a voluntary basis. The FDA, using its authority as a federal agency, may issue a recall order to the maker or seller, forcing distribution to be halted and recall procedures to be followed.
The FDA provides guidelines for manufacturers, importers, and distributors to follow regarding the reporting and documentation of both voluntary and mandatory recalls. Failure to comply with the regulatory procedures may result legal action and fines from the administration, to the extent of its federal authority.
What You Need to Know About Recalled Products
Using a recalled device or drug does not automatically mean that you will be able to collect compensation. In fact, if you were not actually injured in any way, you probably do not have any case for reimbursement at all. Likewise, if you continued to use a product or drug after you became aware of the recall, the likelihood of a successful claim for damages is rather low. However, if you used a device or drug prior to the recall and you experienced harm similar to that which was specified in the recall, you are likely to have a case against the manufacturer or distributor in question.
To determine whether or not you have a valid case, your best option is to contact an experience product liability lawyer. Your attorney will analyze your case and explain your options for seeking compensation.
Contact a Virginia Defective Medical Device and Drug Attorney
If you have been injured or suffered adverse health consequences due to any type of defective medical device or commercially available drug, you may have several avenues for seeking compensation available to you. Contact an experienced Virginia personal injury attorney from Shapiro, Washburn & Sharp to discuss your case. We pledge to help you pursue the compensation you deserve—just as we did in securing a $375,000 settlement for our client who was injured by a defective stepladder in Richmond, VA. Call (833) 997-1774 to schedule your free consultation today.