North Carolina Defective Medical Device Lawyers
Patients understand that certain medical products such as pacemakers, catheters, artificial joints, hip implants, pelvic mesh, blood clot filters and insulin devices, carry certain risks. Patients rely on the fact that the product has been FDA-approved and the benefits of using the product to diagnose or treat a condition outweigh the known risks. But no patient in North Carolina should be exposed to hidden dangers and hazards when they use a medical device or have one implanted. Unfortunately, many medical devices harm consumers because of poor design, defects in manufacturing or a failure during use, and injuries can be devastating.
Manufacturers of medical devices are required to make and market products that are safe and effective when used as directed and to warn adequately of known risks. Before medical devices can be used in hospitals or doctor’s offices, the devices must go through a safety review by the Food and Drug Administration (FDA). If a consumer is harmed due to a product defect or a failure to provide adequate warning, the manufacturer may be held liable for the harm caused. Manufacturers can be found at fault for both medical equipment used in hospitals and personal devices.
If you believe that you have been harmed by a medical device in North Carolina, it is important to talk with a qualified product liability attorney.
The medical device lawyers at Hardison & Cochran are investigating cases of injury and harm caused by medical devices. Determining where the fault lies in a product liability case can be challenging and require extensive resources.
Let a lawyer at Hardison & Cochran review the specifics of your injury and explain your legal options for seeking compensation. We are available for a free consultation to discuss your injury.
Recalls Often Occur Only After Many People Harmed by Faulty Medical Device
The U.S. Food and Drug Administration regulates medical devices including surgical implants and prosthetic limbs and more complex technologies such as heart pacemakers and x-ray equipment. The FDA categorizes medical devices based on their risk of causing injury. Only the highest risk medical devices such as implantable infusion pumps and mechanical heart valves are required to receive FDA approval before marketing. Other moderate-risk devices such as most catheters and dialysis equipment receive less scrutiny and may be cleared for marketing based on the manufacturer’s claim that the device is substantially similar to a product already on the market.
In some cases, the FDA will order follow-up studies after approval of a medical device to provide more information, such as a device’s performance over long-term use. Ninety percent of the nearly 400 post-market surveillance studies that the FDA ordered from May 2008 to February 2015 were for orthopedic devices and devices such as certain kinds of implantable surgical mesh, according to a General Accounting Office report to Congress.
Problems with some medical devices only become apparent after the products are in widespread use in doctor’s offices, clinics and hospitals. Usually, neither the patient nor the doctor was aware of the risk the medical device posed when used. Manufacturers must report to the FDA any incidents in which a medical device contributes to an injury or death of a patient. Each year, the FDA receives thousands of reports of side effects and injuries caused by medical devices and dangerous drugs. The reports are important because they help FDA regulators spot trends and detect problems with medical devices so the problems can be corrected.
The FDA can order the recall of a medical device if the product is defective, or could pose a health risk, or is both defective and a health risk. The manufacturer may recall a defective product before being ordered by the FDA. But the recalls often occur only after the medical device has injured or caused the deaths of many people.
How Can a Medical Device Lawyer Help You?
The product liability attorneys at Hardison & Cochran will determine if the medical device that caused your injury is already the subject of a recall or ongoing litigation. In meeting with an attorney, it is important for you to bring any information that you have about the artificial joint or type of medical product that caused your injury, including specific brands and model numbers if you have that information.
The defective medical device that you received may be part of a bigger problem. Thousands of consumers may have been harmed by a medical device. If many people have sustained injuries because of the same flaw in a medical device, the case may become part of a class-action lawsuit or multi-district litigation. A class action may be the appropriate way to pursue a complex medical device injury claim if the legal issues in dispute with the product are the same for all members of the lawsuit. One plaintiff or a small group of plaintiffs represent all of those who have claims.
Multi-district litigation allows for complex civil cases in which there are common questions of fact to be consolidated with other similar cases to streamline the pretrial proceedings and help federal courts manage the cases more efficiently. The cases remain separate and do not share in the same verdict or settlement.
Contact an N.C. Product Liability Law Attorney
If you or someone you love has been harmed by a medical device, take the first step to understand your legal options by contacting a North Carolina medical device injury lawyer at Hardison & Cochran.
We believe that medical device manufacturers should be held accountable for the harm their defective products cause. If you have been injured by a defective medical device, it is important to meet with an attorney who handles cases of product liability as soon as possible. You want to work with an accomplished law firm that has the resources to pursue an investigation wherever it leads and work to identify the potentially responsible manufacturers. Our North Carolina medical device attorneys have a proven record of success in both settlements and the courtroom.