Medical devices have improved the health and quality of life of many people. However, this same technology has also been known to cause injuries to those who have sought relief through their use. These injuries can be the basis for filing a medical device claim.

Before proceeding with a medical device claim, it’s best to be well informed. Here are five things you must know about filing lawsuits over faulty medical devices.

  1. Understand what is considered to be a “medical device”

“Medical device” is the term used by medical professionals when referring to equipment that helps improve or eliminate the negative effects of injuries, disabilities or illnesses. Examples of these devices, which can sometimes fail, include: wheelchairs, stents, joint implants, pacemakers, contraceptive devices, orthopedic pins, vascular grafts, and intraocular lenses. Of course there are many other items which might fall under this definition.

  1. Medical Device Claims fall under Product Liability

As opposed to medical negligence, product liability refers to whether the product (a medical device) was safe or faulty, and therefore the reason for injury or harm. This means that the manufacturer or seller of the product is liable for defects which are found to be dangerous and cause harm to the user of the product.

  1. Medical claims are broken down into three different types.
  • Design Defect: This is the case when the device, though properly constructed, was designed in such a way that the medical device itself is unreasonably dangerous. Quite often injury due to design doesn’t show up right away. It may take time for the flaw in design to present itself. In cases such as these, the manufacturer may still be found liable if he was aware of the problem but didn’t disclose it or make it unavailable.
  • Manufacturer Defect: This is when the medical device was properly designed, but the fault is due to faulty construction. It can also be a shipping or doctor’s office event that causes it to be defective. As long as the fault occurred between the factory and the patient’s receiving the device, it is considered a manufacturer’s defect.
  • Marketing Defect: Medical devices which fail to give adequate warnings, are recommended to the wrong group, or have inadequate instructions which result in harm to the person who uses it, are guilty of marketing defects. The poor instruction or faulty advice isn’t necessarily the fault of the manufacturer or designer, but could be given by a doctor, a promotional campaign, or a sales rep.
  1. Possible defendants in a Medical Device Claim

There are many professionals along the way from the design to the use of a medical device. Almost any of them could be responsible for the defect and include: the manufacturer; the testing facility; the sales representative; the doctor, hospital or clinic; the supplier; the transportation team; and marketing firms.

  1. Challenges Associated with Medical Device Claims

To win a claim of this sort, the device is the most important element. It may be difficult, but it must be maintained in the same condition it was in when it caused injury or harm. Any manipulation of the device prior to the lawsuit can make your case almost impossible to win. The defendants have the right to inspect the faulty device using their experts. If it is found that the device is not in the same condition as it was at the time of the injury, the case could be dismissed.

Internal medical devices that are removed by a medical professional may be difficult to retrieve. It could even be considered medical waste and disposed of. This would make a lawsuit incredibly difficult to win.

These five must-knows about medical device claims will hopefully help you best decide your next course of action. The injuries due to faulty devices can be serious, and legal recourse should be pursued. But be sure you fully understand all the elements involved before you proceed.


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