New Jersey Defective Medical Device Lawyers

Steps to Take If You Suspect a Medical Device Injury

The FDA regulates the nation’s medical device industry. The agency approves devices for the U.S. market and monitors their safety and effectiveness.

All too often, a device enters the market even though it contains a defect that can harm patients. Due to the defect, the manufacturer may voluntarily recall the device and report recall information to the FDA. The agency then informs the public. (In rare cases, the FDA will order a recall.)

The FDA places medical device recalls in three categories:

• Class I. The device is “dangerous or defective” and “predictably could cause serious health problems or death.”
• Class II. The device poses “only a slight threat of a serious nature” or might cause only a temporary health issue.
• Class III. The device is unlikely to cause health problems or have a defect in its labeling.

The recall date is important. It can serve as the date that starts the running of the statute of limitations. This is the time period in which an injured consumer or surviving family member may file a product liability lawsuit.

In many cases, a manufacturer recalls a medical device only after it has harmed a large number of people. Frequently, no recall is issued at all.

If you believe that you or a family member suffered harm due to a defective medical device, you should take immediate steps to protect your health and your rights – regardless of whether the manufacturer recalled the device.

The steps you should take include:

Talk to your doctor.

See your regular doctor or a specialist. Describe your complications. The doctor can help you to address the problem. For instance, you may need to undergo immediate revision surgery.

File a report with the FDA.

You can help the FDA to monitor the safety and effectiveness of medical devices. If you experience an “adverse event,” you can file a report through the FDA’s MedWatch program.

Gather your medical information.

To the best of your ability, keep all information you received about the medical device and related treatment. If a doctor removes the device, ask the doctor to preserve it. The device’s serial number, for instance, could be important in your legal claim.

See a lawyer.

Given the time limits on filing a defective medical device claim, and the amount of investigation and preparation that goes into these cases, you should see a lawyer as soon as possible.