Defective Medical Devices
Designed to prevent pregnancy, promote bone growth, and assist with many other health outcomes, medical devices are, if properly tested and marketed, excellent tools that can significantly enhance patients’ lives. Unfortunately, many medical devices do not undergo proper testing. Others are sold for uses not authorized by the Food and Drug Administration (FDA). From IVC filters to hip replacements, a variety of defective devices can result in pain, emotional trauma, or, in rare cases, death. If you believe that your current physical or emotional suffering can be attributed to a defective medical device, it is in your best interest to seek remuneration with the help of a trusted attorney. Your efforts could result in significant compensatory and punitive damages, as well as the ability to speak out and hold device manufacturers accountable for their negligence.
Inferior Vena Cava (IVC) Filters
IVC filters are designed to capture blood clots that break loose from the legs’ deep veins. The cone-shaped devices are implanted just below the kidneys. Without their presence, blockage of the pulmonary artery can occur. Otherwise known as pulmonary embolism, this condition can cause chest pain, difficulty breathing, and ultimately, death. IVC filters are typically prescribed for patients who cannot take blood thinners.
Although IVC filters have saved many lives, there are a lot of risks attached to these devices, which can break, migrate, or perforate organs. Retrievable filters present the greatest concern, as hundreds of reports indicate that they have damaged veins and failed to stop blood clots. Many IVC manufacturers have been accused of hiding these and other problems. Between 2005 and 2010, the FDA received over 900 reports of adverse events involving retrievable IVC filters. According to experts, one of the main contributors to these incidents may have been filters staying in far too long.
C.R. Bard and Cook Medical have been accused of manufacturing multiple dangerous IVC products. A study published in the
Journal of Vascular Interventional Radiology found that Cook’s Celect filter has a 43 percent vena cava perforation rate. Both Cook and C.R. Bard are believed to have downplayed the risks associated with their IVC filters.
INFUSE Bone Grafts
Manufactured by Medtronic, INFUSE bone grafts are utilized in spinal fusions for those diagnosed with degenerative diseases such as arthritis. The grafts’ inclusion of recombinant human bone morphogenetic protein (rhBMP-2) makes them ideal for the promotion of bone growth. Although they are intended to relieve discomfort, these bone grafts can be accompanied by many severe side effects, including back pain, leg pain, and implant failure.
When the device was first approved by the FDA in 2002, it was deemed a game changer. Since then, it has become evident that Medtronic has intentionally concealed some of the bone graft’s more dangerous side effects. Additionally, Medtronic has been accused of promoting unapproved off-label uses of the device. Many recent lawsuits have been filed in the state of Arizona, which is where many of Medtronic’s offices are located. As case filings increase, so does the prospect of multidistrict litigation.
Power morcellators are surgical devices used to remove uterine fibroids or the entire uterus. The devices resemble drills equipped with sharp blades. The main benefit of morcellator use is that it significantly reduces patient downtime. However, most patients will gladly suffer longer downtime if it means a reduced risk of uterine cancer. Unfortunately, the device is believed to spread cancerous cells throughout the abdominal cavity. It has also been linked to the rare and exceptionally dangerous form of uterine cancer known as leiomyosarcoma.The FDA has warned that morcellators should not be used to remove fibroids or perform hysterectomies on most women. Since this warning was issued, major manufacturers such as Johnson & Johnson and LiNA Medical have been targeted with lawsuits alleging that their power morcellators worsened victims’ uterine cancer.
A net-like device designed to provide additional support for women with weakened tissues, transvaginal mesh is a standard treatment for those diagnosed with pelvic floor disorders. Concerns regarding the safety of this device first became prominent in 2008, when the FDA issued a warning regarding the use of surgical mesh for urinary incontinence and pelvic organ prolapse. More recently, the FDA revised its initial classification of transvaginal mesh as a moderate-risk device. But while the transvaginal mesh is now deemed a high-risk device, it is too late for those who, despite being assured of the device’s safety, suffered infection, organ perforation, and urinary problems.
Several transvaginal mesh manufacturers have been targeted by product liability lawsuits, including C.R. Bard, Johnson & Johnson, Coloplast, Boston Scientific, and American Medical Systems Inc. Although the details of each case vary significantly, the primary claims are similar: affected women allege that manufacturers did not sufficiently test mesh product safety or warn consumers of potential health risks.
Despite suffering numerous losing trial verdicts, transvaginal mesh manufacturers continue to insist that their products are perfectly safe. Experts at the FDA clearly do not agree, however, as they have warned that serious side effects are far from rare. Studies reviewed by the FDA remain inconclusive as to whether the transvaginal mesh is more effective than other treatments for urinary incontinence and pelvic organ prolapse. Things do not look good for medical device manufacturers, however, and those who wish to secure compensatory damages stand a good chance of obtaining the remuneration they deserve.
Like most intrauterine devices, Mirena is far more effective than other forms of birth control. Unfortunately, while the IUD is great for preventing pregnancy, its risks are not as minimal as Bayer claimed when it released the product in 2000. Of every 500 women with the IUD, one suffers organ perforation. Other women, although fortunate enough to avoid organ perforation, may experience acne, breast pain, or weight gain. Dozens of lawsuits surrounding Mirena’s risk of perforation have been consolidated in a multidistrict case in the Southern District of New York. Bayer has been accused of downplaying the many risks associated with Mirena and falsely claiming that the device’s less threatening side effects are uncommon.
Defective Hip Replacements
The vast majority of new knee and hip replacements are approved through 501(k) fast-track processes. Often, devices approved through the FDA’s 501(k) program are not entirely tested before being released for consumer use. Many of the devices approved via 501(k) have disturbingly high failure rates. A concerning example of this involves the metal-on-metal hip replacement, which is designed to hold up better to the active lifestyles of younger patients. Although metal-on-metal hip replacements are very durable, they are also linked to metallic and many other conditions. DePuy, Stryker, and many other manufacturers have recalled all-metal products.
In 2012, Stryker recalled and ceased all production of its Rejuvenate Modular and ABG II Modular-Neck Hip Stems. A few years earlier, the company had recalled the Accolade TMZF and the Trident Acetabular PSL. These recalls were voluntary, but they are believed to have occurred only after several adverse reports were brought to light.
In 2010, DePuy recalled the Articular Surface Replacement XL Acetabular system in response to safety concerns. Friction from everyday usage was believed to put patients at risk of metallosis, a condition that involves the buildup of metal debris in the body’s soft tissues.