Have you or a loved one been injured by a defective medical device or implant? If so, you are not alone. Defective medical devices and implants cause thousands of injuries and deaths every year. People just like you routinely undergo medical procedures in the hopes of getting better, when in reality, the device or implant used in the procedure only makes the underlying medical condition worse.
A medical device that is properly working can provide relief for a person who has lost function or never had function in an area of their body. Through billions of invested dollars, the medical device industry has exploded over the last several decades with medical devices and implants that can help a person walk, repair bones, and heal wounds. Doctors across the country often rely on these wonderful devices to help their patients live happier and more fulfilled lives. However, when these devices do not work properly they can cause more harm and injury than they were meant to fix and subsequently result in debilitating injuries, infections, and even death.
Injuries resulting from defective or improperly implanted medical devices can be physically painful, emotionally distressing, and financially costly. If the damage caused by a medical device or implant is severe enough, the resultant injuries can result in temporary or permanent disability, and/or reduction of basic function in the affected area.
FDA Approval Requirements for Medical Devices and Implants
The FDA (Food and Drug Administration) must approve all medical devices and implants before they are allowed onto the market for public consumption. However, this process is sometimes less rigorous than consumers would like to believe.
Generally speaking, new medical devices and implants must go through a pre-market approval process, which requires implant and device manufacturers to provide clinical trial data to prove that a given device or implant is effective and safe for use. Unfortunately for consumers, many new devices and implants never go through this process, because of the FDA’s fast-track process.
The FDA fast-track process allows manufacturers of devices and implants to skip the pre-market approval step if the manufacturer can demonstrate that the device or implant in question bears substantial similarities to a device on the market which has already been approved. This simplified and expedited procedure has been under Congressional scrutiny, and you and your loved ones should not suffer because poorly-tested devices and implants prematurely make their way onto the medical consumer market.
Common Types of Implants and Medical Devices that Fail
During our many years practicing medical device litigation, our legal team has handled cases involving diverse implants and devices. We have worked on cases involving but not limited to:
- Hip Replacements
- MRI Machines/Diagnostic Devices
- Transvaginal Mesh
- Cochlear Implants
- Pins, Rods, Screws, and Plates
Lawsuits and Product Recalls
Since 1976, the FDA deemed many medical devices as “defective,” ranging from breast implants, hip and knee replacements, and for birth control products.
Common Defective Medical Devices Include:
- Pacemakers that stopped or failed to keep a proper heart rhythm
- Any malfunctioning device, such as a pain pump or insulin pump
- Heart valve implants that leak or break, resulting in repeated surgeries or death
- Infections caused by improperly made or non-sterilized devices
- Improperly sterilized gynecological devices that can cause infection, infertility or miscarriages
- Breast implants or any devices that can cause damage to the immune system
- Defective hip implant or knee replacement parts
As a several billion-dollar industry, medical designers and manufacturers have the responsibility to create a product that is safe for use. While the FDA oversees whether or not a device is approved, there is arguably a loophole that allows some products onto the market. Under the 510(k) process almost 95 percent of manufacturers use to have their products approved by the FDA. Under this process, manufacturers are permitted to put a product on the market if the product is “substantially equivalent” to other devices that are already on the market. Many critics have complained that this process allows companies to avoid the more expensive premarket approval method.
In 2013, Johnson & Johnson agreed to pay $4 billion to settle over 12,000 personal injury lawsuits. These lawsuits were filed against the company after it was determined that defective metal hip replacements were leaching dangerous levels of metal ions into patients’ bloodstreams. In some cases, these increased blood levels of metal ions led to debilitating injuries.
DePuy, which was acquired by Johnson & Johnson in 1998, manufactured approximately 93,000 of the defective metal hips. These artificial hips, known as ASR acetabular cups, were found to have a failure rate of 12-13%. In other words, over 11,000 patients received failing units which were later required to be surgically replaced.
In 2009, the FDA issued a recall of approximately 21,000 Kappa Series and Sigma Series pacemakers manufactured by Medtronic. The recall was categorized as a Class I, the most serious class of recall. In the words of the FDA, “A Class I recall indicates reasonable probability that the use of the device will cause adverse health consequences or death.” The recall was issued after it was determined that faulty wiring could cause the affected pacemakers’ batteries to fail.
Who is Liable is a Medical Device or Implant Fails?
Despite strenuous efforts by the Federal Drug Administration, doctors, and other medical professionals to identify and remove dangerous products from the market, there are hundreds of products that are recalled and removed every year because they cause injury, infection, and even death. If you or a loved one has been injured because of a defective medical device, then you should contact an Arkansas products liability lawyer who will review your case with you and address who may be liable for your injuries. Possible defendants include:
- The manufacturer of the device
- The distributor or device wholesaler
- The hospital that installed the device
- A doctor who installs or prescribes device
- Pharmacies that fill medical subscriptions
The injuries that can result from a defective medical device can be catastrophic. A product that has been recalled by the Federal Drug Administration can cause serious injuries including bone loss and death, severe pain, additional surgeries, and even death. Injured patients can generally recover for their injuries by seeking compensation for:
- Previous and future medical expenses
- Disability coverage
- Living expenses
- Pain and suffering
- Wrongful death
Large manufacturing companies who put unsafe products into the medical market and thereby cause devastating injuries should be held accountable for their actions, however, all too often they avoid liability by intimidating injured patients to accept a ridiculous offer to settle. If you have been injured because of a defective medical device we will work on your behalf to secure the compensation you deserve. We have been serving and representing the citizens of Fayetteville for over 20 years, and are prepared to fight for your rights.
Our Medical Device Injury Attorneys Can Help in Arkansas
If you or a loved one has been hurt by a faulty implant or medical device, you don’t have to accept the burden and suffer on your own. Experienced medical device attorney Ken Kieklak can help.
Our devoted legal team has nearly 20 years of experience helping injured clients receive favorable compensation for their suffering. We will advocate aggressively for you and your loved ones by negotiating with the medical manufacturing companies, or trying your case in front of a jury of your peers. Ken Kieklak, Attorney at Law works diligently for you, and we don’t receive payment until you do.
However, you need to act rapidly. The statute of limitations places a cap on how long injury victims have to bring a lawsuit in the aftermath of a personal injury, and once the allotted period of time expires, your recourse will be limited. Contact Ken Kieklak as soon as you are able.
If you believe you have been injured by an implant or a medical device, or if you have questions or concerns, Ken is ready to assist.