The United States continues to have the most expensive healthcare system in the world, a fact that many justify with the advanced medical care available in the states. But still every year thousands of medical devices are recalled for safety concerns and patients suffer injuries from defective and malfunctioning devices.
Our Nashville-based personal injury attorneys have the experience and resources you need to recover compensation for injuries from defective and malfunctioning medical devices.
What Causes Defective Medical Devices?
Medical devices are made to help cure patients, not to harm patients. Unfortunately, in a rush to start earning profits from new devices, some dangerous and unsafe devices are approved before they have been thoroughly tested for safety. The Food and Drug Administration (FDA) is supposed to be responsible for screening and approving new medical devices to make sure dangerous devices do not reach the market, but the FDA often relies on safety testing data supplied by the manufacturers of these devices. Skewed data allows dangerous devices to enter the medical market and harm patients.
Lawsuits involving defective medical devices involve manufacturer error, not a doctor's misuse of a device. Successful defective medical device cases usually involve claims like:
Failure to recall device—Medical device manufacturers can be held responsible for injuries caused by medical devices they know to be unsafe, but have failed to recall.
Failure to properly market—Medical devices are “marketed” to specific groups of people based on the function of that device. Manufacturers talk to doctors about the types of patients that can use their devices, and set guidelines for the proper and safe use of their devices. If a manufacturer, sales representative, or healthcare professional gives misleading information about the use of a device that leads to a patient's injury, that party can be held responsible for the injury.
Failure to warn—If a medical device has certain risks or flaws and the manufacturer fails to warn doctors and patients about those risks, the manufacturer can be held responsible for resulting injuries.
Manufacturer Error—Medical devices that have a manufacturer error result in defective or dangerous devices. An error in the manufacturing process can harm one device or many. The error does not necessarily need to occur during manufacturing; any error that led to a damaged or defective device is included in this category (i.e. a shipping error that left a device defective).
Design flaws—Medical device manufacturers can be held responsible for devices that have design flaws that lead to patient injuries. A design flaw in a medical device means the device was made in an unnecessarily dangerous manner, and could have been made safer for patients.
Defective Medical Device Recalls
In the first six months of 2016, over 500 medical devices have been recalled. Each recall can affect dozens, hundreds, or even thousands of individual devices that have already been sold in the medical market and possible used on patients.
The FDA categorizes recalls into three classes: class I, class II, and class III. Class I recalls are the most serious, and signify that the defective device can have serious consequences on patients. Class III recalls indicates that the defect is not harmful to patients. The most serious recalls of 2016 are listed here.
As a result of lobbying by medical device manufacturers, in the last few years the FDA has both approved more devices and approved devices at a quicker pace. This can lead to dangerous conditions for patients.
For example, in 2014, 233 class I products were recalled due to malfunctioning adhesion on the packages that could lead to contamination of the devices before they are used on patients.
Current Defective Medical Devices
- Da Vinci Robot System
- DePuy hip implants
- Medronic defibrillator wire
- Transvaginal mesh
- Essure birth control
- Olympus surgical scope
- Nuvaring Birth Control
- St. Jude heart defibrillator
- Prisma dialysis
- Knee implants
- IVC blood clot filters
FDA Medical Device Approval Process
The FDA's medical device approval process begins with a classification of the device. Devices are classified as Class I, Class II, or Class III, and they face different regulations based on their classification group. The class categorization of the devices is different that the class categorization of the type of recall. For example, a class I device can have a class III recall, meaning the devices already used on patients will not cause harm.
Class I devices are low-risk devices that do not pose harm to patients. Products in this class include medical gauze, stethoscopes, oxygen masks, ice bags, and scales. The FDA does not regulate these devices.
Class II devices are slightly higher risk. About 43% of all medical devices fall under this category. Class II devices include powered wheelchairs, x-ray machines, and pregnancy test kits. The FDA does regulate class II devices, but uses a lenient set of standards. Manufacturers of class II devices only need to convince the FDA that their device is “substantially equivalent” to other products that have been approved by the FDA.
Class II devices are approved through the “510(k)” system, that requires devices to be similar to already approved class III devices. But the FDA often accepts testing data from the manufacturers that prove the devices meet safety qualifications, but the data can be skewed, misleading, and wrong. Defective products that were approved through this system are not always immediately removed from the FDA's clearance list, so other products that are similar to the defective ones can gain approval through the same process.
Class III devices are vital to patient health, and are often used in surgical procedures, are implanted in to patients, or are used for life support. About 10% of all medical devices are in this category. Examples of class III devices include breast implants and pacemakers. Only class III devices are categorized as “FDA approved”, class I and II devices are “FDA cleared”.
One major problem with the FDA approval process is that it can easily allow drug companies to persuade the FDA to approve their devices. One study found that in 2011, the medical device industry spent $33.3 million on lobbying to get its devices approved.
Contact a Tennesse Defective Medical Device Attorney
If you or a loved one has suffered a serious injury as a result of a defective or faulty medical device, you should speak with an experienced personal injury attorney. Call the offices of Luvell L. Glanton today at (615) 244-4511 to schedule a free consultation and begin your case.