When we have problems with our organs or joints, we trust that our doctors will have the answers. But what if our doctors are being sold defective medical devices, or if they are provided with false data regarding the medical devices they use? Unfortunately, this has been the reason for countless injuries caused by defective medical devices in the United States. The medical device industry frequently abuses loopholes in the FDA’s approval process, then sends representatives with unreliable research to sell devices that have not been properly tested. What’s worse is that often device manufacturer’s know about the injuries their devices cause long before they are forced to issue a recall.
Medical Device Defects
Millions of Americans live with medical devices implanted in their bodies. According to a recent Consumer Reports investigation of the FDA approval process for medical devices,
For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients…
Often, doctors are unaware that a medical device that comes so highly recommended to them has actually undergone very little testing. Many times the data they are given by medical device manufacturer representatives is skewed to the device’s favor, or do not disclose problems that other patients have with the device.
Medical Device Recalls
According to a study published in the Archives of Internal Medicine, most of the FDA’s urgent recalls in recent years have involved medical devices they approved under their “fast track” 510(k) approval procedure that doesn’t specifically require human trials. In a recent review of 113 urgent recalls from 2005 to 2009, more than 70% of the recalled devices were found to have been cleared through this fast track 510(k) program, compared with only 19% that were approved through the FDA’s traditional and more stringent premarket approval (PMA) system.
When a manufacturer takes action to remove a product from the market, this is called a recall. It may do so by its own initiative, by FDA request, or by FDA order under statutory authority. Recalls are divided into different categories based on their potential for injury, with a Class I recall being the most serious. These are the classifications of recalls according to the FDA:
- Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
- Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
- Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
What’s particularly worrisome is that many medical devices cleared by the FDA’s fast track 510(k) approval process are the most high risk. From 2003-2007, the FDA approved 228 high risk medical devices through the 510(k) process.
Some recent Class I Medical Device Recalls include:
- GE Healthcare Resuscitation System for Newborns
- ISIS HVT Tracheal Tube
- t:slim Insulin Cartridges by Tandem Diabetes Care
- Puritan Bennet 840 Series Ventilator
- Thoratec HeartMate II Left Ventricular Assist System
- Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes
- St. Jude Medical Riata and Riata ST Endocardial Defibrillator Leads
- Medtronic Implantable Infusion Pump
Injuries from Defective Medical Devices
Injuries sustained due to a medical device may be life threatening, or they may cause severe injury and economic loss. Often when a medical device goes bad, the original condition necessitating the device worsens, and sometimes additional illnesses or injuries come into play.
Other times, a medical device may be recalled due to unacceptable rates of injury, but there are delays in notifying patients who were implanted with the defective device. Most medical devices do not come with a system for the manufacturer to identify patients on whom their devices were used, so they rely on the doctors and medical professionals to contact patients affected by the recall. This leaves room for errors and omissions, so many times patients unknowingly live with recalled medical devices in their bodies.
Contact an Experienced Sacramento Injury Attorney
If you or a loved one have been injured due to a defective medical device, you should call a product liability attorney immediately to protect your legal rights. Every state has a different time limit dictating when you can file a lawsuit for your medical device injury.
Our Sacramento personal injury lawyers have helped numerous patients who have been injured by medical devices, and we would be happy to answer your legal questions. Call us toll free at 916.473.1529 or fill out the form on this page for a free and confidential case evaluation.