What are Defective Medical Devices?
North Carolina Product Liability Lawyers Review Medical Device Claims
Medical devices like joint implants, surgical mesh and defibrillators are intended to save lives. However, a faulty design may prevent the proper function of these devices, or they may become contaminated due to negligent manufacturing practices. These defective medical devices may cause a current condition to worsen or may cause additional injuries and complications. In either case, patients often require additional surgery to remove the defective device and/or to repair injuries. In these cases, victims may be entitled to compensation for additional medical expenses, pain and suffering and other damages from the device manufacturer and possibly the doctor as well.
At Riddle & Brantley, LLP, our product liability lawyers are prepared to assist you with your defective medical device claim. With over 160 years combined legal experience, our attorneys are prepared to fight for compensation for the losses associated with your injuries. We can review your medical history and get information about the medical device that may have caused your injuries. We can also advise you whether there are any relevant class action lawsuits or a multidistrict litigation (MDL) you can join..
What are Common Examples of Defective Medical Devices?
Prior to being sold in the U.S. market, medical devices must go through rigorous testing and get approval from the U.S. Food and Drug Administration (FDA). However, it is ultimately the responsibility of the manufacturing company to assure these devices are safe to use. The following list includes some common defective medical devices subject to recent recalls and lawsuits:
Who is Liable for Defective Medical Devices?
The companies that manufacture medical devices like implants have a duty to test their products to ensure they are safe for use. Then, these companies must submit new devices to the FDA for approval. It is important to note that the FDA does not perform safety tests; it is the company’s responsibility to do so.
The FDA also has a special program called 510(k) approval, for expediting the approvals for medicine and product that patients and medical practitioners sorely need. However, medical equipment manufacturers sometimes take advantage of this program to rush substandard products to the market without adequate testing.
Nevertheless, FDA approval, whether through the 501(k) program or otherwise does not absolve the manufacturers of responsibility for a harmful or defective product. The manufacturing company still must ensure the safety of their products and warn doctors and patients about any adverse side effects. If a medical device contains dangerous product defects, then the manufacturer is generally liable for the injuries and damages that result.
Consequently, thousands of patients affected by faulty medical devices sue the manufacturers for damages caused by their defective products. If a medical implant or other device caused your injuries or condition, then you could be entitled to compensation for your medical bills, pain and suffering, lost wages and other damages. Contact the product liability lawyers at Riddle & Brantley, LLP if you or a loved one has been affected by one of the following defective medical devices:
Manufactured by Bayer Pharmaceutical, the Mirena IUD is a small, T-shaped device that is implanted in the uterus to prevent pregnancy for up to five years. Although a highly effective form of birth control, a Mirena IUD can cause fatal complications in some women. These include perforation of the uterus, pelvic inflammatory disease and pregnancy occurring outside the uterus. Sometimes the device can dislodge and embed into other parts of the body, such as the abdomen or uterine wall, requiring surgery. These side effects have led thousands of affected women to file lawsuits against Bayer.
Metal on Metal (MoM) Knee and Hip Implants
The faulty metal-on-metal construction of some leading knee and hip implants causes them to produce metallic debris that can cause pain and tissue damage. Some of the implants do not bond adequately with the bone and fail prematurely. This leads to dislocation, fracture or repeat surgery in some patients.
Some of the problematic devices include DePuy’s ASR and Pinnacle hip implants, Zimmer Holding’s Durom Cup hip implant and NexGen artificial knee. Other defective hip implant systems include Stryker Corp’s Rejuvenate and ABG II hip stem devices.
Depuy ASR Hip Implants
DePuy’s recalled its ASR and Pinnacle hip implants in 2010 because of metal-on-metal construction and high premature failure rate. Yet, by that time, nearly 93,000 patients already had these defective hip implant systems. Many of these patients brought lawsuits against DePuy for damages when they experienced complications.
Zimmer Persona Knee Implants
In March of 2015, Zimmer issued a product recall for its Persona Trabecular Metal Tibial Plate knee implant. These implants resurface the planes of the joint. However, the uncemented version of the knee replacement implant may loosen, causing pain, instability and possibly knee failure. If your knee replacement surgery utilized a Zimmer Persona implant which later failed, then you may have grounds for a product liability claim.
3M Bair Hugger
The 3M Bair Hugger is a system that keep patients warm during surgery. It includes a disposable, single-use blanket along with an air circulation unit. The unit pumps warm air through the blanket, ensuring the patient’s body temperature does not drop to unsafe levels. More than 80 percent of American hospitals use 3M’s Bair Hugger temperature management systems in millions of surgeries each year.
However, some studies have shown that the system can increase the risk of infection during surgeries. This is especially dangerous during procedures involving transplants and artificial heart valve replacement. Though 3M denies it, the company faces a multitude of lawsuits from patients who claim their infection resulted from product defects in the Bair Hugger.
Transvaginal Mesh Products
The transvaginal mesh is inserted surgically through the vagina to support the uterus, bladder and bowels in women suffering from pelvic organ prolapse (POP). However, after implantation, thousands of women experienced severe pain performing daily activities and/or during intercourse, recurrent infections and other complications. There are 33 different manufacturers of this product. Together, they currently face more than 73,000 lawsuits from women who claim these companies hid the facts about their defective products.
Hernia Repair Products
Similar to transvaginal mesh, physiomesh is an implant that surgeons may place across or inside a muscle tear. This hernia mesh should facilitate the body’s natural healing process. However, many of these products have been subject to hernia mesh recalls. Some meshes are contaminated, or contain manufacturing and/or design defects that cause them to slip. This can result in organ perforation, hernia recurrence and possibly wrongful death.
Implanted in blood vessels, IVC filters trap blood clots to prevent them from travelling to a patient’s lungs, where they increase the risk of death. However, the filters themselves cause severe complications when they break or migrate. A broken or defective filter may travel to other parts of the body or puncture veins. The manufacturers C.R. Bard and Cook Medical face several damage claims from people who say the filters subjected them to physical and emotional trauma.
da Vinci Surgical Robots
Not all medical devices are implants; the da Vinci surgical robot is a tool surgeons may use to preform minimally invasive surgeries. The surgeon operates the robot from a console, which theoretically can allow more precision, speed healing times and reduce complications. However, product defects in the da Vinci surgical system can lead to malfunctions, such as mechanical arm entanglement and jerky motion. This may result in serious surgical errors which may require additional treatment.
Questions about an Injury from a Defective Implant or Medical Device? Contact Our Law Firm Now
If you or a family member are suffering from injuries or damages associated with a defective medical device, then you may be entitled to compensation. The product liability lawyers at Riddle & Brantley, LLP can review your case, free of charge. You only pay when you win; we do not charge attorney fees unless we are successful in obtaining a recovery or offer of settlement.
To learn more about our legal services, contact us at (800) 525-7111 or complete a free case evaluation form today.