Patients expect medical devices to improve their health, mobility, and quality of life. When an implanted device fails, however, a patient may face additional pain, diagnostic testing, revision surgery, rehabilitation, and uncertainty about what went wrong. Learning that the device has also been recalled can raise even more questions.
A medical device recall can provide important information about a product and potential safety concerns, but a recall does not automatically establish that a manufacturer is legally responsible for every patient's injuries. Likewise, patients may have viable claims involving defective medical devices even when no formal recall has been issued.
At McLaughlin Law Firm, we represent patients harmed by defective medical devices, including failed hip and knee replacement products. Understanding what a recall means is an important first step for patients who are concerned about an implanted device.
What Is a Medical Device Recall?
A medical device recall generally occurs when a manufacturer removes a product from the market or takes corrective action because of a problem with the device. The U.S. Food and Drug Administration also plays a role in monitoring medical device safety and communicating information about recalls.
A recall can involve products ranging from external medical equipment to devices that have already been surgically implanted in patients. Depending on the problem, the response may involve correcting the device, changing instructions, monitoring affected patients, removing unused products, or addressing implanted devices.
Reasons a medical device may be recalled can include:
- Defective components or materials
- Manufacturing problems
- Premature device failure
- Incorrect labeling or instructions
- Problems with packaging or sterility
- Software or programming defects
- Unexpected risks identified after the device reaches the market
- Design problems that may affect patient safety
For patients with implanted devices, a recall does not necessarily mean the device must immediately be removed. Medical decisions should be made with the patient's healthcare providers based on the specific device and medical circumstances.
Does a Recall Prove a Medical Device Was Defective?
A recall can be important evidence, but it does not automatically prove every element of a product liability lawsuit.
The existence of a recall may help identify a known problem with a particular model, component, or manufacturing process. However, an injured patient still generally needs to establish how the device involved in their case caused or contributed to their injuries.
For example, thousands of patients may have received the same type of implant, but their experiences can vary. Some devices may continue functioning while others fail prematurely. A lawsuit involving a recalled device therefore requires examination of the individual patient's medical records, implant information, symptoms, and treatment history.
Our Denver medical device injury lawyers can investigate whether a recalled or allegedly defective device may be connected to a patient's injuries.
What Are the Different Types of Medical Device Recalls?
The FDA classifies recalls according to the level of health risk associated with the problem. These classifications can help patients understand the seriousness of the issue that prompted the recall.
The general recall classifications include:
- Class I recalls, involving situations in which use of or exposure to the product presents a reasonable probability of serious adverse health consequences or death
- Class II recalls, involving products that may cause temporary or medically reversible adverse health consequences or where the probability of serious consequences is remote
- Class III recalls, involving products that are not likely to cause adverse health consequences but violate applicable requirements
A recall classification can provide useful context, but patients should not make treatment decisions based solely on the classification. Their physician can evaluate whether the particular device is functioning properly and what medical response, if any, is appropriate.
What Happens if Your Hip or Knee Implant Is Recalled?
Learning that an implanted hip or knee replacement is subject to a recall can understandably cause concern. Patients may wonder whether the implant is failing even if they have not experienced obvious symptoms.
The appropriate response depends on the device and the reason for the recall. A healthcare provider may recommend monitoring the implant, performing imaging, conducting laboratory testing, or taking other steps based on the patient's symptoms and medical history.
Patients concerned about a recalled implant may want to gather:
- The manufacturer and model of the implant
- The date of the original surgery
- Implant identification information
- Medical records from the procedure
- Recent imaging results
- Records of follow-up appointments
- Documentation of new or worsening symptoms
- Information received concerning the recall
These records can help healthcare providers determine whether further evaluation is necessary and may also become important if the patient later pursues a legal claim.
Can You File a Lawsuit if Your Medical Device Has Been Recalled?
A recall by itself does not necessarily mean every patient who received the product has a lawsuit. A legal claim generally involves an injury or other legally compensable harm connected to the device.
For example, a patient whose hip implant fails and requires revision surgery may face significant medical expenses, pain, rehabilitation, and time away from work. If evidence shows that a defect in the device contributed to that failure, the circumstances may support a product liability claim.
Potential injuries associated with defective orthopedic implants can include loosening, fractures, instability, dislocation, tissue damage, bone loss, and other complications. Some patients may require one or more revision procedures to remove and replace failed components.
The circumstances of the failure, rather than the existence of a recall alone, are critical when evaluating a potential lawsuit.
Can You File a Medical Device Lawsuit Without a Recall?
Yes. A formal recall is not necessarily required for a patient to pursue a defective medical device claim.
Problems sometimes become apparent through patient complaints, adverse event reports, medical studies, litigation, or other evidence before a manufacturer announces a recall. In other situations, a problematic device may never be formally recalled.
Evidence in a medical device case can come from many sources, including:
- Medical and surgical records
- Imaging and laboratory results
- The patient's explanted device
- Manufacturer documents
- Device testing
- Adverse event information
- Expert analysis
- Scientific and medical research
Patients should therefore not assume they have no options simply because they cannot find their implant on a recall list.
Why Is Preserving the Medical Device Important?
When an implanted device is removed during revision surgery, the physical product itself may become important evidence.
The explanted device may show wear, fracture, corrosion, loosening, or other signs that help experts determine how it failed. If the device is discarded or returned to another party without appropriate arrangements, potentially valuable evidence could be lost.
Patients who know they are scheduled for revision surgery may want to discuss preservation of the removed device with their attorney before the procedure. This can allow appropriate steps to be considered before the implant changes hands.
Other physical evidence, such as packaging, implant identification cards, labels, and manufacturer correspondence, should also be preserved when available.
Does a Recall Mean You Need Revision Surgery?
Not necessarily. A legal concern about a medical device and a medical decision about surgery are separate issues.
Removing an implanted device generally requires another medical procedure, and surgery itself carries risks. A physician may recommend continued monitoring rather than immediate removal when an implant is functioning properly and the patient is not experiencing concerning symptoms.
Patients experiencing potential signs of implant failure should seek medical evaluation. Depending on the device, warning signs may include:
- New or increasing pain around the implant
- Swelling or inflammation
- Reduced mobility
- Difficulty walking or bearing weight
- Instability in the affected joint
- Clicking, grinding, or other unusual sensations
- New symptoms after a period of successful recovery
Patients should discuss these symptoms with a qualified healthcare professional rather than attempting to determine on their own whether a recalled device has failed.
What Compensation May Be Available in a Medical Device Case?
A defective medical device can create losses extending far beyond the cost of the original implant. A patient may need additional medical treatment, revision surgery, physical therapy, medication, or future procedures.
Depending on the facts and applicable law, a claim may seek compensation for medical expenses, lost income, pain and suffering, physical limitations, and other losses resulting from the defective device.
Revision surgery can be particularly significant. Removing and replacing an implant may be more complicated than the original procedure, and recovery can interfere with work, mobility, and daily activities.
Evaluating the full impact of a device failure is therefore an important part of determining the damages associated with a claim.
Talk to Our Denver Medical Device Injury Lawyers
If you are dealing with injuries or complications involving a recalled or defective medical device, our attorneys are here to help. We can investigate the device, review the circumstances surrounding its failure, and explain your legal options for pursuing compensation. Call us today or connect with us online to schedule a consultation.
