On March 8, 2018, an Indianapolis federal court ruled that Johnson & Johnson and Ethicon, its medical device division, were negligent in the design and warnings about its Prolift pelvic mesh and therefore, liable for the damages the plaintiff, a 69-year-old woman who had the mesh implanted in 2009, suffered as a result of using the mesh. The court ordered the company to pay $35 million in compensation, $25 million of which were punitive damages.
A heater-cooler is a device placed inside a patient’s body during surgery to keep his or her body temperature at a consistent, safe level. They are most commonly used in surgeries on the heart or lungs. The devices control patients’ temperatures by moving water through a small unit where it is air-cooled to an appropriate temperature.
Defective medical devices are not limited to those implanted in a patient’s body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not.
When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them.
The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating.
Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year’s case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level.
Many risks of anti-depressants are relatively well-known and publicized. One of the most common side effects of anti-depressants occurs when expectant mothers take them. Selective Serotonin Reuptake Inhibitor antidepressants (SSRIs) have a very high risk of resulting in birth defects in a newborn, reports the National Library of Medicine, part of the National Institute for Health (NIH).
When new products or medical devices are considered for approval for the consumer market, manufacturers must first undergo a rigorous system to have the device approved. The U.S. Food and Drug Administration (FDA) divides approved medical devices into three categories: Class I, II, and III. Class I devices are not subject to as much regulatory control as Class III—Class III devices are usually those which carry a greater risk to the patient or consumer.
In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).