There is no question that medical devices have revolutionized healthcare. People are able to maintain their mobility and active lifestyles thanks to devices such as artificial knee and hip implants. There is also an array of medical devices that promise relief from various painful and uncomfortable symptoms. For example, transvaginal mesh implants are marketed as devices that will help relieve older women from symptoms of pelvic organ prolapse. However, when a device is defective or does not work as intended, the consequences can be devastating. In such cases, the devices harm their users instead of helping them.
The experienced New York product liability lawyers at Wingate, Russotti, Shapiro & Halperin, LLP, understand the emotional, physical, and financial impacts on victims and their families. We are committed to fighting for victims' rights and helping them secure fair and full compensation for all of their losses. If you have been injured or have suffered adverse health effects as the result of a defective medical device, please contact us to find out how we can help.
People opt for medical devices in the hope of improving their condition. But when the devices are defective, they injure or harm patients. The term "medical device" refers to a device used by doctors or surgeons to treat a disease, illness, injury, or disability. Examples of defective devices that have been recently recalled include metal hip implants, knee implants, intrauterine devices (IUDs), transvaginal mesh implants, and heart stents.
A device may be defective if it was poorly designed, manufactured, or marketed. Defectively-manufactured medical devices are those that have flaws as a result of a mistake during the manufacturing process. Defectively-designed medical devices suffer from design flaws: they have an unreasonably dangerous design that could result in injury.
If a device is defectively marketed, that refers to lack of warning, recommendation, or instruction regarding the use of the medical device. An example would be when a manufacturer fails to post accurate warnings about the dangers posed by the medical device. There are also cases where a manufacturer may advertise or market the product without divulging any information about the potential dangers. Under the law, manufacturers are required to provide consumers with all the data needed to make an informed decision.
Medical devices are supposed to be well-tested before they are introduced in the market. However, if a device results in complications, the U.S. Food and Drug Administration (FDA), which regulates medical device manufacturers, will take adverse events into consideration and determine if a recall is necessary. An FDA recall of a medical device may be placed under one of three classifications depending on the nature and seriousness of the defect and the risk it presents to consumers.
A Class I recall, the most serious kind of recall, is ordered when "there is a reasonable probability" that the use of the defective product will cause adverse health consequences or death. A Class II recall is ordered when exposure to the defective medical device could cause adverse health consequences that are temporary or must be reversed with medical intervention. Such a recall is also issued when the chances of serious problems are remote. A Class III recall is ordered when the product does not conform to standards or is defective, but is not likely to cause adverse health consequences.
IVC filters are surgical implants that are inserted into the body’s primary blood vessel, the inferior vena cava. These filters are capable of preventing blood clots from entering the lungs (a condition known as pulmonary embolism) and other parts of the body. IVC filters are usually implanted in patients who are at high risk of developing deep vein thrombosis and pulmonary embolism. Despite the usefulness of IVC filters, they have been proven to be dangerous to many patients. It can be immensely difficult for surgeons to retrieve the filters after implantation, and sometimes, the filters break apart and their fragments travel to various parts of the body. There have been numerous fatalities resulting from fractured IVC filters.
Composed of naturally occurring minerals, talcum powder, frequently referred to as "baby powder," has been linked to ovarian cancer. The product is manufactured by the company Johnson & Johnson, and its ability to absorb moisture and prevent the drying out of skin is renowned. Unfortunately, there have been numerous claims filed against the maker of baby powder. Most of these claims stem from the belief that if talcum powder comes into contact with female genitalia and reproductive organs, it can potentially lead to cancer. There are also fears that inhaled talcum powder can cause lung cancer. Although Johnson & Johnson have stated that the product is safe, baby powder is currently considered to be "possibly" carcinogenic by the International Association for the Research of Cancer.
Metal-on-Metal Hip Implants
Metal-on-metal hip implants have recently come under fire. These implants are meant to serve as a replacement for broken or dislocated hips, and as their name suggests, they are largely composed of metal components. Unfortunately, when patients move, the implant’s metal pieces can grind together and release metal particles into the body of the patient. There is currently no way to prevent this problem, and metal-on-metal implants have been linked to everything from thyroid problems to heart attacks.
Mentor Breast Implants
In 1992, silicone-based breast implants were banned in the U.S. due to a high rate of rupture and connections to serious illnesses – cancer, rheumatoid arthritis, lupus, fibromyalgia, and more. In 2006, the ban on silicone-based breast implants was lifted, and Mentor received FDA approval for its implants. Mentor breast implants have since been linked to anaplastic large cell lymphoma, among other health conditions. Numerous lawsuits have been filed against Mentor and other breast implant manufacturers.
Hernia meshes are used in roughly 90% of all hernia repair surgeries in the United States, despite their known health risks. They are meant to strengthen the muscle tissue over the hernia, but often end up moving, hardening, and adhering to other internal organs (notably the intestines); causing inflammation, bowel obstruction, foreign body reactions, and chronic pain for victims. Though the FDA has not recalled many hernia mesh models, they are uniformly dangerous for patients and provide very little medical benefit.
Proton Pump Inhibitors
Often used to treat the side effects of severe heartburn, proton pump inhibitors (PPIs) are widely used by patients all over the world. Nexium, Prevacid, and Prilosec are the most popular brands of PPIs, but they have been linked to dementia, bone fractures, and most often, kidney disease. Lawsuits filed against the maker of these drugs, AstraZeneca, allege that the company was aware of these potential side effects, but chose to market the drug without warning the public.
Often used to perform hysterectomies and myomectomies, power morcellators are used to cut apart tissue before surgery. After the tissue is cut by the morcellator, it will be easier for the surgeon to extract it from the patient’s body using minimally invasive techniques. However, in recent times, power morcellators have been linked to uterine cancer, largely in myomectomy patients. When the device is used to dismember fibroid tumors, the resulting fragments of cancerous tissue can spread the cancer throughout the body.
Depending on the circumstances of the case, defendants in a medical device product liability lawsuit may include:
- The manufacturer of the product.
- The laboratory where the defective device was tested.
- The medical sales representative who marketed and sold the device to the doctor.
- The doctor who recommended the medical device and failed to warn patients about potential dangers.
- The hospital that was part of the chain of distribution.
- A retail supplier who distributed the medical device.
In defective medical cases, plaintiffs must prove that they were injured; that a device was defectively designed, manufactured, or marketed; and that the defect caused injury or harm. Defective medical devices may result in serious consequences for patients. Unlike other faulty products that can be discarded or returned to the store, medical devices are often implanted into a person's body. So, if it’s defective or causing serious problems, the device must be removed and/or replaced. This means additional surgery, pain, distress, and expense for the victim.
The experienced New York City injury lawyers at Wingate, Russotti, Shapiro & Halperin, LLP, have successfully represented those who have suffered serious health consequences due to faulty devices. We will fight hard for your rights and ensure that the negligent manufacturer is held accountable for all of your injuries and losses. Please contact us at (212) 986-7353 to obtain more information about pursuing your legal rights.