ATTUNE Knee Replacement Problems. Knee replacement surgery, hip replacement surgery, and other similar procedures are some of the most commonly performed surgeries in the United States. But what happens when these devices are defective and injure the patient? A recent interview with an experienced litigator, conducted by Farron Cousins on “The Ring of Fire,” explores a patient’s options and specifically looks into allegations against the ATTUNE knee replacement.
Daniel Nigh was interviewed by Cousins in November of 2017. Nigh has managed lawsuits against some of the country’s largest medical device companies. Nigh explained that the ATTUNE knee is a type of device used during total knee replacement surgeries. Nigh estimated that hundreds of thousands of ATTUNE devices had been implanted since 2011. He explained, “If you had a knee replacement in the last six or seven years, you probably have…between a 10 percent and 30 percent chance of having this knee replacement…”
Cousins asked Nigh to explain what, specifically, is the problem with the ATTUNE knee replacement device. After all, there is always a bit of risk when you put a piece of metal into your body, Cousins commented. Nigh explained that the issue with the ATTUNE knee replacement is different. Patients are suffering a condition known as tibial debonding.
In the ATTUNE knee replacement, the tibial plate is a flat piece that is attached to the top part of the tibia—which is your shinbone. In a total knee replacement surgery, the tibial plate is often secured to the tibia with a type of cement. However, with the ATTUNE device, the cement does not stick to the tibia as it should. Nigh explained, “Without cement bonding to the tibia, you’ve basically got this loose part just flapping all around inside of there. You won’t notice it for maybe the first year or so. But in time, as you move on that knee more and more, there’s going to be problems with it.”
Generally, medical devices, such as knee replacements, are supposed to last for many years before they may need replacing. The ATTUNE knee was marketed as lasting for about 15 years, according to Nigh and Cousins. However, the tibial plate could become detached from the bone within a year and a half or two years after surgery.
Once the tibial plate becomes detached, Nigh explained, the patient must undergo an early revision surgery. According to Nigh, this is a tough surgery for the patient—more difficult than the original knee replacement surgery. Recovery could take up to 50 percent longer as compared to a standard knee replacement procedure.
Requiring multiple surgeries and months of recovery time is devastating for many patients. Some lose their jobs because they cannot take off so much time from work. Others may face bankruptcy due to the mounting medical bills. Additionally, many patients suffer from pain and even depression and anxiety after enduring so many procedures.
Nigh commented that, for some medical device manufacturers, the problems patients face is not a surprise. He explained, “When we get into the documents from the company, we oftentimes find out that they knew about these issues and that they were trying to cover it up. We’re early on in this project, but we’ve seen this time and time again with these big manufacturers of medical device companies. We usually see they knew and they failed to warn anybody, because they wanted to protect their profits.”
Nigh also explained the differences between obtaining FDA approval for a medical device and FDA approval for a drug or substance. The FDA provides two ways to obtain approval for a medical device. In approximately 5 percent of medical devices, clinical trials are presented to the FDA. The manufacturer must show that both long-term and short-term trials have been conducted on the device. The FDA carefully examines the trials and may offer pre-market approval.
The preponderance of medical devices are approved through the 510(k) procedure. In fact, the ATTUNE knee replacement was approved through this route. Essentially, the manufacturer shows that the proposed device is similar enough to a device currently on the market—so approval should be given to the new device as well. Cousins remarked that he felt that “…the millions that are spent each year by the pharmaceutical markets helped to get that rule in place.”
Cousins continued, “It seems that at almost every level, it is rigged against consumers. It’s rigged against patients because the FDA wants to give these medical device companies and pharmaceutical companies what they want…every time, it’s that consumer that bears all the risk and suffers the most from any negligence that may happen at any step of the way.”
Nigh agreed: “And I would say even further along what we were saying before, big pharma gets so many protections with the FDA process, but the medical device companies get even more.”
According to Nigh, there has been a surge in issues reported in medical devices—and presently, there more complications from medical devices than drugs. This could be attributed to the “rubber stamp” process the FDA has allegedly implemented for many medical devices.
What if I was injured by a medical device?
If you or your loved one was injured by a medical device, you should consult with an experienced attorney as soon as possible. Medical device claims involve both personal injury and products liability law—both of which are complex legal areas. Without an experienced attorney, you could forfeit your legal rights.
Medical device manufacturers have an obligation produce products that are safe for consumers. If they do not, they may be liable for an injured consumer’s damages.
Damages may include:
- Medical bills
- Lost wages
- The cost of future medical care (such as revision surgeries)
- Pain and suffering
- Emotional distress
- Loss of consortium
- The expenses involved with remodeling one’s home (such as installing a wheelchair ramp)
Each case is unique. Depending on the facts of the case, all of the above damages may be available to a claimant, or just a few may be available. Other types of damages may also be available. Your attorney will carefully examine your claim and determine which types of damages should be pursued.
Your attorney will work closely with you throughout the duration of your claim. Did you know that there are ways you can help your attorney with your case? You should:
- Provide all copies of your medical bills and medical records to your attorney
- Keep a list of all of the expenses you have endured due to your injury
- Always stay in touch with your lawyer and respond to emails, letters, and phone calls in a timely manner
- Be open and candid with your lawyer
- Keep your attorney up to date on any doctor’s visits you have scheduled
These practices allow your attorney to pursue all of the possible avenues of recovery on your behalf.