Seattle Defective Medical Device Attorneys
Injuries Caused by Faulty Medical Devices
When people get sick or hurt, a number of medical devices are often used in order to treat the illness or injury. Most of the time, these medical devices function properly and treat the illness or injury effectively. But sometimes, medical devices can break or prove to be defective. When this is the case, and the patient gets injured as a result, a product liability claim can be filed to sue the manufacturer, the lab that tested the product, or any individual or organization that was at fault for the defect in the medical device.
Cases involving defective medical devices can be extremely complicated. Because they involve healthcare professionals, many people think these are medical malpractice cases. And due to the fact that medical devices are controlled and regulated by the FDA, winning a product liability case in court can be difficult. It’s important for anyone who’s been injured by a defective medical device to speak to an experienced Seattle product liability attorney who can help.
Types of Defective Medical Devices
There have been many cases of defective medical devices over the years, some leading to class action suits that brought thousands of dollars to those injured. Some recent medical devices that have been shown to be defective are:
- Metal hip implants. These implants are meant to restore a person’s hip function, but many implants failed. Some patients have been diagnosed with metal poisoning, while other implants have had small pieces break off and cause problems with the organs.
- Drug-coated stents. Stents are small tubes inserted into a person’s artery to help open it up. The drugs the stents are coated with provide medication that prevents scarring. There have been many problems found with stents over recent years.
- Defibrillators. Defibrillators, also known as pacemakers, are inserted near a person’s heart to restore function. In 2005, a major recall was issued for a certain type of pacemaker, proving problems could be present with these devices. Unfortunately, some patients were injured before the recall was issued.
- Blood clot filters. These devices are meant to reduce blood clots but have caused punctured organs and other serious complications.
- Transvaginal mesh. This mesh is meant to correct problems with the pelvis but some women have experienced mesh erosion, which can cause complications; or have had their organs perforated from the mesh.
These are just a few of the medical devices that have been approved by the FDA in recent years and found to have severe problems associated with them. Even in the most severe cases, however, it is this FDA approval that makes it difficult for those injured to pursue a case.
Medical Defects and FDA Regulation
Government bodies are some of the most difficult to sue in court. While the FDA is not often the defendant in product liability cases involving medical devices, their approval does protect many manufacturers of these devices.
Because the FDA issues certain standards, requirements, and regulations, manufacturers only need to prove that they complied with these. Showing compliance often helps a defendant’s case in proving that they were not negligent.
Also making cases involving the FDA difficult to prove for the plaintiff is the 1978 case of Riegel v. Medtronic, Inc. In this case, the court decided that the Medical Device Amendments of 1976 protects medical devices that have been given approval from the FDA in the United States. Unfortunately for injured plaintiffs, this case is still used as a precedent today.
Product Liability or Medical Malpractice?
Because medical devices are most often inserted or prescribed by a physician or other healthcare professional, when people are injured they often assume that it’s medical malpractice. This is not always the case. There is a fine line between medical malpractice and product liability.
Medical malpractice has occurred when a doctor or other healthcare professional has been negligent in providing care. So if the medical device was not installed properly, or the doctor neglected to give proper after-care instructions, the doctor may be found negligent, making it a medical malpractice case.
On the other hand, if the doctor acted perfectly reasonably and was not negligent, but there was an inherent defect with the device itself, the case would be considered a product liability case. If the device was defective no matter who inserted or installed it, it’s a product liability case.
Cases involving defective medical devices can be very complicated, and very difficult to prove in court. If you have been injured by a medical device, it’s important you save it if at all possible, as it could be the only evidence that you can take to court. If the device needs to be removed, it’s wise to tell the doctor or surgeon you’d like to keep it so they don’t throw important evidence away.
Don’t Give Up Your Case
Proving a case against a defective medical device can be difficult, but that doesn’t mean injured patients shouldn’t try to recoup compensation for their losses. At Hardwick & Pendergast, P.S., we have the experience needed to help our clients and give them the best chance for a successful outcome. If you have been injured by a defective medical device, contact us today at (888) 228-3860. This is a difficult time, but you don’t have to go through it alone.