Product Liability

Causes of Defective Medical Devices

Millions of Americans use medical devices every day. These devices can range from simple items to complicated devices such as programmable pacemakers and laboratory equipment. While many people use these devices without any problems, some suffer injuries or adverse effects after using them.

Regulation of medical devices

The U.S. Food and Drug Administration (FDA) regulates the use of all medical devices. The agency publishes records of all approvals via its online database.1 This includes separate data for new device approvals, premarket notifications and premarket approvals. There are also some devices that are exempt from the normal approval process. The FDA refers to these devices as "humanitarian device exemptions."

The FDA applies a rigorous approach to approvals and regularly recalls devices.2

Medical devices that may become defective

There are a number of medical devices that may become defective. These include:

  • Replacement knee joints or implants
  • Replacement hip joints
  • Contraceptive devices
  • Heart valves
  • Breast implants
  • Monitoring equipment
  • Corneal implants

Some products rarely have defects, while others do. These defects often result in a product recall. Alternatively, the FDA may issue additional safety information about the use of certain devices. For example, in Jan. 2013, the FDA3 issued a safety communication about the use of metal-on-metal hip implants.

Why medical devices may be defective

Medical devices can become defective for a number of reasons, including manufacturing errors. For example, a particular part or a step in the manufacturing process might be faulty and cause defects in a small number of devices or in a whole batch.

Design flaws may also result in a defective medical device. Clinical trials may not identify these faults due to specific conditions or because the defect occurs after prolonged use. It is also possible that a health care professional incorrectly uses or fits a medical device, which then leads to an injury.

What to do if you suffer a product liability injury

If you or a loved one has suffered an injury as a result of manufacturing error or other medical device defect, you may be entitled to claim compensation. In order to receive a settlement, you will need to file a defective medical device lawsuit. An experienced attorney will be able to advise you on the steps you need to take. This will include what evidence you will need to demonstrate, for example, that a manufacturing error caused your injury. Your attorney will guide you through all the relevant steps required to file a defective medical device lawsuit and can help you get the compensation you deserve.

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