Every year, thousands of patients suffer injuries from defective medical devices. The nature of these injuries range from minor to fatal, and often are the basis for litigation against the manufacturer, the hospital or both. If you or a family member have suffered an injury from a defective medical device, you have the right to recover damages for financial losses, additional medical costs, pain and suffering and more.
There are numerous medical devices and types of equipment that pose dangers to the patient. In many cases, a hospital will have the patient sign a waiver for the use of such devices and provide detailed explanations of risk factors. If the device in question is in good condition and used according to the manufacturer’s instructions, obtaining the patient’s written consent and ensuring they understand the dangers usually absolves the hospital of liability. On the other hand, if the device is defective or fails to operate properly, that can be the basis of a legal claim—regardless of the patient’s knowledge and consent.
How Common are Defective Medical Devices?
Medical devices fall into two broad categories: surgical equipment and implants. The former consists of surgical instruments intended to increase effectiveness, make a procedure less invasive, or assist the surgeon in reaching sites in the body that might otherwise be difficult to access through other techniques. Implants include pacemakers, joint replacements, meshes, contraceptive devices and arterial (IVC) filters intended to trap blood clots and prevent strokes and heart attacks.
The number of injury lawsuits arising from defective medical devices has risen in recent years. This is in part because of a 2019 investigation by Kaiser Health News. The investigation revealed that the U.S. Food and Drug Administration had been keeping a secret database on medical device-related injuries for two decades. Unlike the MAUDE (Manufacturer and User Facility Device Experience) database, these “alternative” records were not accessible to the public, including physicians, bioengineers and even the FDA commissioner. Known as a “registry exemption,” this secret database was established without public knowledge. Responding to the investigation, the director of the FDA’s Office of Media Affairs at the time admitted that any medical device manufacturer could request this exemption, thus avoiding the usual public reporting requirements.
In essence, the FDA had virtually surrendered its authority and oversight over the medical device industry. As a result, hundreds of thousands of injury and malfunction reports received by the regulatory agency were inaccessible to patients and physicians, with grave consequences all around.
The FDA has since discontinued its “alternative summary reporting” program. While the information in this secret database can be obtained by filing a request under the Freedom in Information Act, the process can take months or years.
What are the Most Common Defective Medical Devices?
Any type of medical device can be defective and dangerous. What follows is a list of such products that have been at the center of injury litigation over the past few years.
The first lawsuit over silicone breast implants was filed in 1984. The plaintiff claimed that a leak in the implant had caused her to develop auto-immune disease. During the trial, her attorneys found documents demonstrating that the manufacturer, Dow-Corning, had been aware of the problem; the defendant wound up paying more than $1.7 million in compensatory and punitive damages.
More recently, a new type of breast implant with a textured surface (intended to prevent slippage) has been linked to a rare type of cancer, known as anaplastic large cell lymphoma, or ALCL. Currently, three manufacturers of these implants—Allergan, Mentor Worldwide and Sientra—are being targeted by women who have developed ALCL as a result of these products.
Surgical mesh is used for the treatment of hernia, pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is a type of screen used to reinforce tissues in the body. Made of synthetic material (plastic polymers) or biological materials (taken from bovine or porcine tissues), surgical mesh has been connected to an appalling variety of injuries and infections.
Synthetic surgical mesh and erode into adjacent tissues, contract, perforate other organs and even break through. The result is debilitating pain and infections. Surgery is often necessary in order to remove defective mesh, but this may not always be successful.
Hip Implants and Artificial Joints
Devices used to replace human joints have frequently been in litigation news over the past decade. A major problem with a number of hip replacements is metallosis, a type of metal poisoning. This occurs when microscopic shards of metal flake off of the implant and enter the patient’s bloodstream.
Another problem occurs when replacement joints corrode and break inside the patient’s body, or come loose. This happened with a type of adhesive used to fix artificial knee components in place. The adhesive would lose its grip within a few years, causing serious complications and pain for patients who had them.
Inferior Vena Cava filters are small, wire devices resembling a cellar spider. These are placed in the major artery running from the lower body up to the heart when a patient is at risk of developing deep vein thrombosis (DVT) from a blood clot. These devices have a tendency to fracture, sending metal bits through the bloodstream. They can also come loose and migrate to other parts of the body, putting the patient at serious risk for injury and death.
These are surgical devices that were designed to shred uterine tissue during a hysterectomy, facilitating the organ’s removal. Unfortunately, they also spread malignant cells in women who may have had undiagnosed uterine cancer, spreading it throughout the patient’s body. Plaintiffs in morcellator lawsuits claim they were never warned about the risk.
As is often the case, lawsuits involving medical malpractice and defective medical products are complex and require the expertise of a legal team with experience in handling such cases. The first step is an investigation in order to determine the party liable for the injury or death in question. The initial claim may be filed by the plaintiff suffering the injury, or the surviving family member of someone who has died as a result of the device.
Once liability is determined, the legal team will file the lawsuit and gather evidence. This may involve obtaining company records, interviewing and getting testimony from medical personnel involved, and even hiring an expert witness with knowledge of defective medical devices.
Call Our Utah Defective Medical Device Lawyers Today
Time is of the essence in injury litigation; Utah state law places a four-year statute of limitations on personal injury claims, so it is in your best interest to contact an attorney as soon as your injury is discovered.
The attorneys at Siegfried and Jensen will assemble all the information necessary in order to prepare your case, including:
- medical records
- information on the device
- insurance policies
- testimony and depositions
We can answer all your questions and guide you through the process. Furthermore, it costs you nothing up front; we are paid only if we win your case or secure a settlement. In most cases, injury lawsuits are settled before going to trial.
Call the law offices of Siegfried and Jensen today for your free, no-obligation consultation and case evaluation.