When a device causes widespread injuries, has improper labeling, or otherwise fails to do what it claims, the FDA or device manufacturer can initiate a recall. Unfortunately for the people who are hurt, recalls often come too late, if at all.
In recent years, several complaints have emerged over knee replacement devices. They include allegations that some popular knee replacement components have failed prematurely or loosened, leading to injuries, including pain, infection, inflammation, and bone or muscle damage. Some knee implant makers have been sued. DePuy and others have recalled some knee devices.
Multiple factors can influence whether or not a device is recalled. They include factors like widespread public outcry over injuries and whether government regulators choose to get involved. Perhaps most of all, recall decisions can be influenced by economics. If a product is profitable and the manufacturer believes it can cast doubt on the alleged link between the device and any injuries, it may find little incentive to pull that product from the market. Device makers also worry that admitting a problem could open the door to lawsuits, which affect a device maker’s bottom line.
But if you believe you’ve been injured by a joint replacement device such as a knee implant, you don’t have to wait for a recall before exercising your legal rights. You may be entitled to compensation whether or not the device is recalled. But if your device is recalled, how you respond can affect any legal claim you have. It’s always a good idea to contact a qualified product liability attorney to find out if have a legal claim and how to protect that claim if your knee implant is recalled.
Concerns Over Popular Knee Replacement Devices
According to data publicized by the American Academy of Orthopaedic Surgeons (AAOS) in February 2012, 4.5 million Americans, or 5 percent of the population over age 50, have had at least one knee replacement surgery. The devices have become very popular over the past decade, with the total number of knee replacement surgeries doubling. In 2010 alone, nearly 700,000 procedures were performed.
Although the AAOS has reported that most people who receive knee replacements experience reduced pain, consumers are still worried about some of these devices. They worry that some devices are not as durable or safe as their marketing suggests, and may require costly revision surgery. Hundreds have filed lawsuits against knee device makers like Zimmer, alleging injuries caused by premature device failure and loosening.
By 2008, various concerns led to calls to remove some devices from the market. DePuy recalled its LCS Knee Implant-Meniscal devices because of label errors, which stated the wrong size. The company later recalled a model sold outside the United States, the LCS Duofix Femoral Component, for more serious reasons. A substance used in manufacturing called alumina had lodged into joint surfaces, causing pain and swelling in patients who received the implant. The product was also linked to increased revision rates.
More recently, DePuy recalled its PFC Sigma Knee Systems after the Food and Drug Administration (FDA) warned that the products didn’t have proper approvals. The company claimed that the products properly bypassed approval procedures because they were custom-made devices. But the FDA disagreed and sent a warning letter to the company in 2010, which led to the recall.
Reports of adverse effects by consumers, health care professionals and researchers can encourage regulators to pressure device makers to issue recalls. But there is no guarantee that the devices makers will comply. Regulators may be forced to seek a court order to get a device maker to pull a product from the market. Indeed, that type of government pressure is rare, with injured consumers usually ending up in court while the product remains on the market. Manufacturers can also choose to voluntarily recall products without much government intervention.
In addition to the DePuy knee products mentioned above, the following knee products have also raised concerns, from labeling errors to durability issues:
|Zimmer||NexGen LPS, CR and MIS
Natural Knee System
|Stryker||Scorpio CR and PS components*
Duracon Total Knee*
Unicompartmental Knee System*
|Smith & Nephew||Oxinium Genesis II and Profix II*
Journey Uni Tibial Baseplate*
*denotes products that have been partially or completely recalled
Protecting Your Legal Rights During a Recall
Knee replacement manufacturers, like all device manufacturers, are under a legal duty to properly design, manufacture and test their products. They also have a duty to warn the public about problems. If you were injured because a device maker failed in any of these duties, you may need costly medical treatment, including revision surgery.
If a device maker recalls the product that injured you, it may offer a new implant or some type of compensation for medical treatment. It’s important to realize that you are not required to follow the manufacturer’s recommendations for treating your injuries. You should always consult your own doctor for guidance on the most appropriate medical treatment.
It’s also important to understand that you aren’t limited to the compensation offered under a recall. What the device maker offers under a recall may not be enough to treat your injuries and address other losses you may experience, like lost earnings or limited mobility. You may actually be eligible for more compensation by filing a lawsuit. Consider consulting a qualified attorney about your legal options.
An attorney can also help you avoid doing something to hurt your legal claim, if you decide to file one. For example, an attorney can help you avoid these pitfalls during a recall:
Waiving Your Legal Rights
You should always be careful what you sign because you may be waiving your right to file a lawsuit. A qualified attorney can help you understand any documents that have been given to you.
Giving Too Much Information to Help Line Representatives
Device makers use help lines to collect information about your injuries. That information could be used to limit your legal claim if you decide to file a lawsuit. You could also inadvertently say something that makes your injuries seem less severe than they really are, especially if you don’t yet know the extent of your injuries. Again, it’s best to seek a qualified attorney’s guidance.
Handing Evidence over to a Device Maker
Device makers may encourage your doctor to share information about your injuries, to persuade you not to file a claim, or to even turn over your defective device. Only your lawyer should give legal advice, including advice on whether to release your implant. Your right to medical treatment like revision surgery should not be conditioned on giving up the device that could be evidence in your case. Consult your attorney for more advice on how to protect yourself. You should also seek a second opinion if you’re concerned about any medical advice given by your health care provider.
Again, many qualified attorneys provide this assistance at no cost to you. Usually, they are only paid if you file a successful legal claim. So if you believe you’ve been injured by knee replacement device, contact an attorney. Whether or not your knee device is recalled, your willingness to take action can help bring attention to device risks.