Defective Medical Devices

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Medical devices are an essential part of healthcare, and are used to diagnose and treat all types of illnesses and other medical issues. Unfortunately, those medical devices are sometimes faulty or are used improperly, and patients are put at risk of further medical troubles. If a patient suffers harm as a result, the use of defective medical devices can lead to a products liability claim against a designer, manufacturer, or medical professional. If you have been injured by a defective medical device, please contact an attorney today to discuss your options.

Defective Devices

A medical device is a product that is used to treat or diagnose a patient. Medical devices are used every day by healthcare professionals, and span a wide range of products. Some examples include:

  • Hip or knee replacements;
  • Surgical mesh;
  • Ventilators;
  • MRI systems;
  • Pacemakers;
  • Vascular stents; and
  • Infusion pumps.

Unfortunately, some of these devices may be defective. A device may fail to function properly, thus allowing a medical condition to progress without proper treatment. Defective diagnostic devices may delay diagnoses, meaning that an illness or condition can take its course without treatment. A malfunctioning medical device may cause an injury or even worsen the very condition it was designed to treat. Patients with defective devices implanted in them, such as surgical mesh or joint replacements,  may need further surgery to remove the devices.

Who Is Responsible

Defective medical devices can give rise to products liability claims. Depending on the type of defect in the medical device, several different parties may be held responsible for a patient’s injuries. This may include the designer, manufacturer, seller, medical professional, hospital, or any other responsible party.

FDA Approval

Before any medical device can be put on the market, it must be approved by the FDA. However, the testing and approval process may not always be rigorous, and sometimes, devices are approved but later found to be dangerously defective. Further, after FDA approval, it is the manufacturer’s responsibility to make sure the product remains safe.

Like any other product, there may be problems in the manufacturing process of a medical device, which can cause dangerous defects for which a manufacturer may be liable. Additionally, doctors or other medical professionals may misuse medical devices. Such misuse may cause injury to a patient or may result in a misdiagnosis and delayed treatment. If a healthcare professional uses a medical device improperly and a patient is harmed as a result, the medical professional or a hospital who employs him or her may be liable for the patient’s injuries.

If a medical device is found to be faulty, the manufacturer must inform the FDA and the public of the defect and issue a recall. If it does not do so, it will be liable for any resultant problems and injuries.

Failure to Warn

Another major area of concern with medical devices is the failure to warn. Many medical devices come with risks and side effects, and physicians have the responsibility to adequately warn their patients of the risks involved with a device’s use. Manufacturers also have the responsibility to disclose those risks to the purchasers of their products. If the users of medical devices are not properly warned of the devices’ dangers and side effects, the health care providers or manufacturers may be liable for the injuries that the users suffer.

If you have been injured because of a defective medical device, please contact a medical malpractice attorney at Woodruff Johnson & Evans Law Offices for an initial consultation at our offices in Aurora, Chicago, or Champaign.


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