Tennessee Defective Medical Device Lawyer Sid Gilreath
Compassionate and committed legal representation for your medical device failure case from award-winning Tennessee product liability attorneys
Millions of Americans depend on medical devices and equipment to improve their quality of life.
From hip implants to knee replacements, these medical devices play an important role in the happiness and well-being of the patients who require them. So when medical equipment fails or doesn't adequately fulfill its intended purpose, the consequences can be devastating for those individuals who rely on them.
The Food and Drug Administration (FDA) is the federal agency charged with "protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices." One way this agency accomplishes its mission is by issuing recalls on medical products or devices that fail to meet the FDA's safety standards.
Unfortunately, FDA recall warnings are often too late for many unsuspecting patients, causing them to suffer due to a defective medical device.
Many such medical devices are not even clinically tested or properly analyzed before receiving approval from the FDA and released on the market.
Help is just a phone call away.
If you or a loved one have experienced physical, emotional or financial injury from a defective medical device, you may be entitled to compensation for your loss.
Contact our Tennessee product liability lawyers to discuss your legal options and seek justice in your defective product case.
Recent Defective Medical Device FDA Recalls
See real-time news and instant updates on the latest medical device recalls from the FDA database.
What should I do if a defective product has injured my family or me?
- Secure the product in a safe place.
- Secure any documentation about the product including packaging, manuals, instruction booklets etc.
- Do not give the product to the manufacturer for "testing." All defective product cases are won or lost in the early days following the accident. Remember, a defective product must be secured immediately. Never assume that no one will want the wreckage of a destroyed automobile or ATV. Manufacturers are always on the lookout to secure and destroy evidence. If the evidence cannot be bought or found put everyone on notice, including owners, tow operators, wrecking yards, police impounds, and the like. If they are directed to preserve important evidence and fail to do so, they can be subject to suit for destruction of evidence.
- Contact a lawyer. It is critical to the success of your case that you consult with a qualified attorney who specializes in product liability immediately if you have been injured by a defective product. The laws are complex and filings have a specific time limit. Do not delay in protecting your rights.
Product Liability: Verdicts & Settlements
CaseDefective product -
Verdict$44 million recovered for paralyzed child
CaseRear-end car accident -
Verdict$13 million recovered for two paralyzed plaintiffs
CaseDefective product -
airbag and seatbelt system
Verdict$6.5 million recovered for paralyzed woman
CaseBus accident -
defective school bus breaks
Verdict$3.9 million recovered for paralyzed teenager
CaseDefective product -
Verdict$1.5 million recovered for injured plaintiff
3 Classifications of Medical Device Recalls
If a product or device does not meet the safety laws administered by the FDA, then a recall will be issued forcing the removal or correction of the marketed product.
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 cause severe negative health consequences or even death.
- Class II - a recall issued when use of, or exposure to, a defective product may cause "temporary or medically reversible" health problems or 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.
Top 5 Reasons for Medical Device Recalls
When looking at the recall trends in the medical device industry, a few commonly occurring themes emerge. The top five causes of medical device failure are:
- Packaging/Labeling. Faulty packaging and mislabeling is easily the most common cause of medical device recalls. For instance, a recall may be issued if a device label does not indicate age or weight-specific usage instructions, or if the outer packaging 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.
Major Recalls and Commonly Recalled Devices
Medical device failure is a spreading epidemic in this country, as evident when the annual number of reported recalls issued for medical equipment increased by 97 percent from 2003 to 2012. This rise in defective medical devices has consequently led to a massive increase in the number of people injured or killed as a result, leading to more class action settlements, product liability cases and pharmaceutical liability lawsuits.
Here are a handful of the biggest cases of medical device failure in recent years:
- Hip replacement. Hundreds of thousands of Americans undergo artificial hip surgery each year, and nearly one-third of these operations involved metal-on-metal devices up until 2007, when it was discovered that these devices often wear out prematurely and expose patients to toxic metals. Since then, a massive number of lawsuits have been filed against several high-profile medical device companies, including Stryker, Biomet, DePuy, Smith & Nephew, Wright and Zimmer.
- Knee replacement. In 2013, it was estimated that as many as 4.4 million Americans sought relief from joint pain by undergoing knee replacement surgery. So when artificial knees are found to be defective or poorly designed, thousands suffer as a result. In recent years, there have been an increasing number of replacement knee recalls from Attune, Biomet, Conformis, DePuy, Oxinium, Oxford, Smith & Nephew, Stryker, Zimmer and other manufacturers.
- Insulin pumps. Medtronic, the world's largest medical technology company, already has a history of putting their patients' health and lives at risk with their defective bone graft treatment system. Once again, Medtronic is now facing numerous lawsuits over reported insulin pump failure involving the MiniMed insulin pump system.
- Hernia mesh. Hernia repair surgery is very common in America, and a synthetic or animal-derived surgical mesh is often used to support damaged or weakened tissue. The FDA has reported that recalled mesh products are the main cause of hernia repair complications such as bowel perforation, obstruction, pain, infection, recurrence and adhesion.
- Cardiac devices. The steady stream of recalls on defective pacemakers, defibrillators, ICDs and other cardiac devices is quite alarming to the millions of Americans who depend on them. Major cardiac device manufacturers like Biotronik, Medtronic, Guidant Corporation (now Boston Scientific) and Sprint Fidelis have all been at the center of major defective medical device lawsuits.
- Transvaginal mesh. While relatively few urogynecologic surgical mesh products have been recalled, the FDA issued postmarket surveillance study orders in 2012 which caused many manufacturers to quietly withdraw their mesh products from the market. The orders came after a number of women nationwide experienced severe post-surgery complications like bleeding, infection and cases where the synthetic mesh cut through the vaginal walls and began to erode nearby organs. Since then, some mesh products still remain available on the market today and thousands of lawsuits have been filed against transvaginal mesh manufacturers.
What to Do if You've Been Injured by a Defective Medical Device
If you or a loved one are experiencing pain which you believe is caused by a hip replacement, knee implant or another medical device, you should immediately seek medical help from your doctor. If it is determined that a defective medical device is to blame, then it is time to look into your legal options.
Representing victims of defective products in Knoxville, Nashville, Memphis and throughout the Southeast, the experienced Tennessee defective product lawyers at Gilreath & Associates will wage war on your behalf against the medical device manufacturers and insurance companies who have caused you and your family pain and suffering.
For the last 35 years, award-winning attorney Sid Gilreath has helped thousands of clients across 12 different states receive the just compensation they deserve for personal injuries, and he won't stop until he achieves the best possible outcome in your case - even if that means going to court against big medical device companies and insurance corporations. We are committed to our clients, and we'll fight for you every step of the way because we genuinely care about your welfare.