Last year, the FDA issued more than 3,000 recalls of defective medical devices. Dozens of the recalled devices were Class I recalls, reserved for defective medical products that pose a reasonable likelihood of causing serious injury or wrongful death.
With this many known defective and dangerous devices on the market, it is easy to understand why personal injury attorneys continue to represent countless individuals harmed by these dangerous products. What may not be so easy to understand is just who is liable for your injuries.
Is It Medical Malpractice?
When you suffer an injury and you believe that a hospital or medical professional is to blame, medical malpractice must be considered. Given that medical devices can malfunction while under the care of, or soon after receiving treatment from, a doctor or hospital, many times the starting point of a personal injury inquiry will be reviewing the conduct of medical professionals for negligence and errors.
In some particular circumstances, a medical professional’s decision to use a defective medical device can amount to malpractice. An obvious example would be if a physician knew a device was defective yet used it anyway without emergency circumstances requiring its use. In this situation, the physician’s judgment and treatment are below the appropriate level of care required of doctors.
This is not the typical situation, however. When hospitals and medical staff use medical devices, they do so with the belief that the device—having been approved by the FDA—is safe for use. As long as it is properly stored and appears free from damage, a device may be used according to accepted guidelines.
Who Is Responsible?
If defective medical device injuries are not typically medical malpractice claims, then what are they? Product liability claims.
Again, because of the proximity in time to medical treatment, many investigations begin from a medical malpractice perspective. However, when it becomes apparent that a defective medical device in any way caused the user’s injuries then product liability law will likely come to the fore.
Product liability claims relating to medical devices are unique and complex. Despite what many think, FDA approval of a device does not mean the device is not defective and does not insulate those responsible from a lawsuit.
Most product liability claims will be brought against the manufacturer of the defective product, but other potential liable parties include:
- Testing Laboratories
- Sales Representatives
Medical device lawsuits can arise from defects in design or manufacturer, but they can also arise from defects in marketing. Failure to warn of known side effects, provide adequate instruction, or to otherwise cause injuries through insufficient or incorrect representations can also be grounds for a product liability claim.
Lowe Eklund Wakefield Co., LPA – Representing the Injured in Cleveland, Ohio, and Across the Nation
With thriving medical malpractice and product liability practices, the team at Lowe Eklund Wakefield Co., LPA has the resources and experience required to thoroughly vet your medical device case and help you take legal action against all liable parties.
If you or your loved one were injured by a defective medical device or by medical malpractice, call or email now for your free consultation.