Who Is Liable?
If you or a loved one has suffered health complications and you suspect that a medical device is to blame, you have legal recourse. Product liability laws protect consumers from entities who manufacture and distribute dangerous or defective products. The laws are quite straightforward - if you're selling a product, you owe your customers a duty to ensure that your product is safe and free of hazards which could cause an injury.
Sometimes, the manufacturer may not discover a danger until the product has already been on the market. In these instances, they are required to notify the public through warning labels and public announcements.
People who sell or distribute these products must also notify their customers of potential dangers. So in the case of a dangerous medical device, your doctor should either not prescribe the device, or provide you with a strong warning about the associated dangers.
Common Dangerous Devices
Dangerous medical devices affect men and women of all ages. Specific devices which have been in the news lately include:
Essure is a permanent form of birth control manufactured by Bayer. A coil is inserted into the fallopian tubes with the intention of inducing scar tissue to develop and block fertilization.
Issues with this product have prompted over 5,000 women to file complaints with the FDA between 2002 and 2015. Adverse effects include intense pain, organ damage, metal allergy symptoms, and chronic autoimmune diseases.
In 2016, the FDA responded by requiring a black box warning label for the product "designed to call attention to serious or life-threatening risks." This decision resulted in a great deal of public outcry, as many felt that the dangerous device should have been removed altogether.
Transvaginal mesh is a surgically implanted medical device designed to treat pelvic floor disorders such as pelvic organ prolapse (POP) or stress urinary incontinence (STI). The FDA first warned consumers of the dangers of this device in 2008, when they classified it as moderate-risk. In 2016, the FDA upgraded it again, to a high-risk device.
Common complications include:
- Mesh erosion
- Pain during sex
- Organ perforation
- Urinary problems
These complications often require additional treatments and surgeries. Victims should consider joining the thousands of other women who have filed product liability lawsuits against the negligent manufacturers of these products.
Metal hip replacements have been linked to several serious health problems, such as metallic debris being released into the body. This can lead to swelling, severe pain, and blood poisoning. In response, many manufacturers have withdrawn their devices from the market.
These cases may vary slightly from other defective device claims. While most cases are product liability claims, sometimes a medical malpractice suit may be more appropriate. It depends on whether the complications are due to a product defect or a surgeon's mistake.
A power morcellator is a tool used during hysterectomies and for uterine fibroid procedures. Recently, medical professionals discovered that this machine could spread previously undetected uterine cancer throughout the abdomen during the procedure. This can rapidly advance the spread of the disease and contaminate new parts of the body. Patients who reported no symptoms before surgery have discovered advanced cancer shortly after the procedure.