Defective Medical Devices
Dangerous or defective medical devices -- such as faulty surgical instruments, implants, pacemakers, and prosthetics -- can give rise to a product liability claim if a person who undergoes surgery or uses a medical device is injured or dies as a result.
Although closely monitored by the U.S. Food and Drug Administration (FDA), a product can be defective in its design, manufacturing process, or marketing strategy. In most instances, state lawsuits over federally-approved medical devices face stringent legal obstacles and often receive increased national attention.
The Burden of Proof: Strict Liability
If a person suffers injuries from the use of a defective medical device, the burden of proof is strict liability. Strict liability is applied in product liability cases. In these civil cases, strict liability claims mean that the plaintiff doesn't have to prove that the defendant acted in a careless (or negligent) manner.
Transvaginal Mesh Lawsuits
Many women suffering from pelvic prolapse or stress urinary incontinence have turned to transvaginal mesh implants for relief. Unfortunately, mesh implants have been linked to a number of painful and serious complications. Mesh erosion, the most common complication, occurs when the mesh begins to deteriorate into small sharp pieces that can perforate nearby organs. On July 13, 2011, the FDA announced that patients undergoing pelvic organ prolapse repair with a surgical mesh may be at a greater risk for mesh complications than women pursuing other surgical treatments.
Then, on April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately. These products have been withdrawn from the market because the FDA determined that the manufacturers did not demonstrate "reasonable assurance of safety and effectiveness" of these medical devices. Women suffering mesh complications may be able to file a claim seeking compensation for medical bills, pain and suffering, and other damages.
LASIK Eye Surgery
LASIK surgery is widely used to correct several types of vision problems, and it is normally very successful. But when things go wrong, the patient may have a legal claim against the surgeon or against the manufacturer of the LASIK equipment. The consequences of complications from LASIK eye surgery can be significant. Improper use or malfunction of the equipment can result in damage to the cornea. Patients can also suffer cornea damage simply because they were not good candidates for the procedure. In particular, people with large pupils, thin corneas, or dry eyes are more prone to experiencing complications from the surgery.
Metal Hip Replacement Lawsuits
Liability for injuries caused by metal-on-metal hip replacements is generally placed on the manufacturer. However, in certain circumstances, the surgeon who performed the procedure may be liable for medical malpractice. Medical malpractice occurs when a healthcare provider acts in a way that falls below the level of care practiced in the profession, and the patient is injured as a result. For example, a surgeon may have made an error while implanting a metal hip, misdiagnosed a patient, or failed to inform a patient about the known risks associated with the procedure.
Da Vinci Robotic Surgery Lawsuits
In a robotically-assisted procedure, a surgeon uses a robot to manipulate instruments, allowing for more precise control of actions such as incision and removal. Robots reduce the stress and fatigue experienced by surgeons, especially during longer operations. In addition, the robotic arms are remarkably steady. Unfortunately, there have been numerous reports that the da Vinci robots have injured patients. These patients, in turn, are filing a growing number of lawsuits against the manufacturer, Intuitive. Some of these lawsuits have alleged that the da Vinci robot failed to let go of a patient's tissue.
How a Products Liability Attorney Can Help
Filing a product liability lawsuit alleging a medical device defect is a complicated undertaking, often requiring medical evidence, expert witnesses, and a detailed knowledge of product liability law. As a result, it's in your best interests to consult with an experienced attorney before deciding on a course of action.
Contact an experienced product liability attorney near you today.
Defective Medical Devices Articles
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