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Defective Medical Devices: Malpractice or Product Liability?

Medical devices, while intended to aid in diagnosis, treatment, or prevention of disease, can sometimes lead to injuries or adverse events. These injuries can result in significant physical and emotional distress, often necessitating personal injury claims.

When a medical device injury occurs, the patient may have grounds for a personal injury claim. This claim can be based on medical malpractice if the injury resulted from a healthcare professional's negligence, such as improper use or failure to monitor the device. Alternatively, a product liability claim may be appropriate if the injury was caused by a defect in the device itself, regardless of the healthcare professional's actions.

In both cases, the injured party must demonstrate that the device was defective, that the defect caused the injury, and that they suffered damages as a result.

Product Liability Claims for Defective Medical Devices

A medical device injury can arise from various factors:

  • Defective design. A device may be designed with flaws that make it prone to malfunction or failure, leading to unintended harm to the patient.
  • Manufacturing errors. Errors in the manufacturing process can result in defective components or assembly, increasing the risk of injury.
  • Failure to warn. Sometimes, manufacturers do not include proper warnings or instructions about avoiding certain dangers associated with the device.
  • Device-related complications. Even when used correctly, medical devices can sometimes lead to unforeseen complications or adverse reactions in certain patients.

If you or a loved one are injured because of issues caused by the manufacturer, distributor, or a person involved in supplying the device, like those above, you can pursue a product liability claim. People pursue these claims when a company fails to uphold its duty to create and sell a safe product.

Medical Devices & Malpractice Suits

In a malpractice lawsuit involving a medical device injury, the following elements must typically be proven:

  1. Duty of care. The healthcare provider had a legal duty to exercise reasonable care in the use of the medical device. This is generally assumed for professionals in their field.
  2. Breach of duty. The healthcare provider failed to meet the standard of care expected of a reasonably prudent professional in the same field under similar circumstances. This often involves demonstrating that the provider used the device improperly, failed to monitor it adequately, or selected an inappropriate device for the patient's condition. In some cases, improper use of a device can lead to injury and doctors may be liable if they do not offer adequate use or care instructions.
  3. Causation. The healthcare provider's breach of duty directly caused the patient's injury. This requires establishing a link between the provider's negligence and the harm suffered.
  4. Damages. The patient suffered actual harm, such as physical injury, pain and suffering, emotional distress, or financial loss.

Talk with Our Injury Attorneys

Zayas Law Firm has been helping clients hold those responsible for their injuries accountable since 1990. We have decades of collective experience and are known for offering personalized, attentive counsel.

Get started on your case today by calling (860) 854-9156 to discuss your defective medical device case.