If you have received a medical device, you likely thought it would enhance your life, give you more mobility and ease the pain you had been experiencing. Many patients, however, have experienced unexpected, painful and even fatal side effects as a result of dangerous or defective medical devices.
With advancements in medicine, there has been an increase in the use of medical devices in the treatment of injuries and diseases. Despite these breakthroughs, inadequately tested and regulated devices that have been rushed to the market by companies in a hurry to make a profit have hurt thousands of patients annually in the last decade alone.
While the Food and Drug Administration (FDA) attempts to screen many medical devices before they enter the market, much of their screenings rely on the data supplied by medical device manufacturers, which may be biased and inherently incorrect.
Combined with their 510(k) process, which allows quicker approval of medical devices similar to existing products without the normal testing involved, more defective medical devices have entered the market than ever before.
At Wagstaff & Cartmell, we are proud to be amongst the most well-known firms across the country for representing individuals injured by dangerous drugs and defective medical devices. Our results in this area are substantial, indicating the legal acumen and effectiveness we bring to our cases and our clients.
Medical Device Recall
A recall is a voluntary action that product manufacturers and distributors make to uphold their legal responsibility to protect the health and well-being of their customers and the general public from defective products that pose a risk of injury (known as “product liability“).
Depending on the severity of the defect, additional steps may be taken to further protect consumers such as market withdrawal or stock recovery.
According to the FDA, recalls are categorized into one of three numerical designations (I, II, or III) to show the relative degree of health danger presented by the product being recalled.
These classifications are listed below in order of most to least serious:
- Class I – the most serious recall in which there is a “
reasonable probability” that using or being exposed to the defective product can causesevere negative health consequences or even death.
- Class II – a recall issued when
useof, or exposure to, a defective productmay cause “temporary or medically reversible” health problemsor when the likelihood of severe negative health effects is remote.
- Class III – the least dangerous recall in which using or being exposed to the defective product or device is “not likely” to cause any negative health effects but still presents enough of a danger to issue a recall warning.
The most common reasons for medical device recall include:
Faulty packagingand mislabeling is easily the most common cause of medical devicerecalls. For instance, a recall may be issued if a device label doesnot indicate age or weight-specific usage instructions, or if the outerpackaging is made with non-sterile materials.
- Faulty Device Connection. With medical technology advancing at such a rapid pace, the number of connection and software errors in medical devices – already a leading cause of recalls – is likely to increase even more.
- Particulate Matter. The presence of particulates in intravenous medical devices, often acquired during the manufacturing or packaging process, presents a serious adverse health risk to patients. According to the EPA, particulate matter is a “complex mixture of extremely small particles and liquid droplets that…can affect the heart and lungs and cause serious health effects.”
- Component Change. The medical device change control process is highly complex, and manufacturers must adequately vet design, production and supplier changes to ensure the continued quality and compliance of their product. Failure to do so can harm patients and result in a product recall.
- Leakage. A leak in a medical device’s packaging or the product itself can lead to serious sterility or health issues, depending on the size of the leak and the material it contains. Manufacturers must conduct sufficient testing to detect any signs of leakage current, making them accountable if a leak does occur.
Other common causes of medical equipment failure include design defects, parts failure, material contamination, inadequate testing, process errors, employee error, false or misleading labels, expired dating, vendor changes, faulty wiring and storage issues.
Active Litigation and More Information
Wagstaff & Cartmell is actively pursuing cases regarding the following pharmaceuticals and medical devices:
- Transvaginal Mesh – Used by women, this device has been shown to lead to numerous vaginal, urinary, and GI complications. Learn more about transvaginal mesh lawsuits.
- DePuy Hip Implants – These metal-on-metal implants can cause pieces
of metalto fray in the body leading to tissue death, metalosis, pain, and difficulty walking and standing. For more about DePuy Hip Recall Information.
- Zoloft, Lexapro, Celexa, Prozac, Paxil, Topamax, and Depakote – Children born with heart birth defects, lung birth defects, and other congenital birth defects have been linked to these drugs when taken by women during pregnancy. Read more about Zoloft, Lexapro, Celexa, Prozac, Paxil, Topamax and Depakote lawsuits. Current clients may login for information on active cases: Zoloft clients login
- NexGen Knee Replacements – These devices have been associated with loosening and failure leading to pain and difficulty walking and standing.
- Actos – This diabetes drug has been associated with bladder cancer.
- Yasmin/Yaz – This birth control pill has been linked with blood clots, including pulmonary embolism, stroke, and DVT.
- Shoulder Pain Pumps – These devices are often placed in patients after any type of routine shoulder surgery, but they can lead to chondrolysis (arthritis of the shoulder).
- Accutane – Used to treat acne, this drug has been shown to increase the risk of inflammatory bowel disease including Crohn’s disease and ulcerative colitis.
- Reglan – Commonly used for gastric reflux, this drug is associated with neurologic disorders causing involuntary muscle movements of the body.
- Byetta – This diabetes drug has been linked with pancreatitis and thyroid and pancreatic cancer.