There are more than 600,000 total knee replacement surgeries every year in the U.S., and the number is growing. One study predicts primary knee replacement procedures will increase to 3.48 million annually by 2030.
Knee implants are often useful solutions to pain and limited mobility. However, in recent years some of these devices have failed or been linked to serious injuries. In some instances, consumers suffer injuries that increase their pain and restrict their mobility more than they experienced before the implant.
Knee implant manufacturers are legally responsible for marketing their products properly and adequately warning consumers and health care professionals about their risks. Ideally, device makers properly design and test their products before they reach consumers. They are also responsible for monitoring their products for problems after they’ve received approval. But critics argue that the U.S. Food and Drug Administration (FDA) approval process doesn’t do enough to keep unsafe devices off the market. The agency’s Premarket Notification or 510(k) program determines if a proposed knee implant is equivalent to a device already on the market. If so, the new implant doesn’t have to be tested before approval.
Fortunately, patients who are injured by the negligence of knee device manufacturers can turn to the courts for help. Consumers have started holding device makers responsible for defective knee replacement devices, including Zimmer’s NexGen and Natural Knee System implants, Stryker’s Scorpio implants and Smith & Nephew’s OXINIUM devices.
Some consumers experience emotional anguish over long-term health and financial burdens resulting from defective devices.
Why Might Someone File a Knee Implant Lawsuit?
Joint replacement devices must support body weight while allowing mobility. Knee replacement devices use three components to accomplish this: Femoral (lower end of thigh bone), tibial (upper end of shin bone) and patella (kneecap) components.
Proper device design is crucial to the safety and effectiveness of these devices. If the devices are improperly designed or manufactured, consumers may experience problems.
Older devices use a cement-like adhesive to hold device components in place. However, they can carry a risk of the cement breaking off the bone. Some recent devices, like NexGen implants, can be used with or without cement. The uncemented technique allows the bone to fuse into the implant.
Unfortunately, some consumers with uncemented devices have experienced loosening of the joint and other complications, which can cause the products to fail prematurely.
Artificial joints are generally expected to last at least 15 years, but some fail much sooner:
- A 2010 study from the American Academy of Orthopaedic Surgeons found Zimmer knee implants failed at a rate of 36 percent and more than a third of all cases required a follow-up procedure known as revision surgery.
- A separate study forced Johnson & Johnson subsidiary DePuy to acknowledge a 49 percent failure rate within six years. The company previously reported only a 13 percent failure rate. In 2010, DePuy issued a recall for its PFC Sigma Knee Systems after the FDA warned the devices didn’t have the necessary approvals.
Other complications can be a result of the knee replacement surgery itself, most notably an infection. Patients with these types of injuries may choose to pursue a medical malpractice case against the hospital or surgeon.
Notable Knee Replacement Lawsuits & Settlements
Thousands of lawsuits alleging injuries from defective knee replacements have been filed in federal and state courts across the country.
Generally, these claims allege that device makers failed to properly design, manufacture and market their devices. In other words, the makers neglected or ignored their duty to make sure the products were safe and would do what they claimed to do.
For example, in 2015, Honolulu resident Manuel A. Sanchez filed a federal lawsuit in Hawaii against Johnson & Johnson and DePuy Orthopedics over his 2011 left knee replacement involving a DePuy Sigma Femoral Posterior Stabilized Insert. According to his lawsuit, he developed complications and an infection within months of the surgery and ultimately, the following year, underwent a revision total knee replacement. The cement had not affixed to the original implant, although it had affixed to the bone. About 16 months after the lawsuit was filed, all parties stipulated to its dismissal. Although there is no indication on the docket as to the reason for the dismissal, often these kinds of dismals signal a settlement has been reached.
Francine Snead, an Illinois resident, filed a lawsuit in 2015 against Smith & Nephew claiming her Genesis II total knee replacement failed after surgery in 2011 and that she had to have follow-up medical care and a long rehabilitation. But the docket in that case doesn’t reflect a resolution or any activity after 2015.
In 2012, a Louisiana man, Henry Bias, sued Smith & Nephew over his 2000 total knee arthroplasty after which he said he had to undergo painful, complex and risky follow-up revision surgeries to remove and replace failed components of his Genesis II system. But that federal lawsuit was dismissed about six months later on legal grounds.
Lawsuits also bring attention to risks associated with some devices. This is particularly important because device makers may be slow to recall problematic devices — such as the case with DePuy’s Sigma implants — if they recall the devices at all.
Consumers who have been injured by defective knee replacement devices may be eligible for compensation For:
- Medical bills
- Pain and suffering
- Lost employment wages
- Punitive damages
First Three Bellwether Trials Result in Wins for Zimmer
At its peak, 1,800 cases related to Zimmer’s NexGen implants were consolidated into multidistrict litigation (MDL) in the Northern District of Illinois, making it the largest MDL against a knee replacement manufacturer. That number has shrunk significantly in recent years following bellwether trial wins for Zimmer.
Bellwether trials are essentially test trials that help set the tone for similar cases contained within an MDL. Losing a bellwether trial often provides incentive for a defendant to settle, while wins for the defendant can motivate remaining plaintiffs to drop their case.
Nov. 6, 2015
In the first bellwether trial, Kathy L. Batty alleged that the femoral and tibial components of her NexGen GSF LPS-Flex knee prostheses were prone to premature loosening, which caused her to undergo revision surgery. Batty suffers from degenerative joint disease and had both knees replaced with the NexGen Flex system in 2009. Severe pain led her to have both implants replaced two years later. Batty accused the company of making misleading claims in its marketing, implying that patients could engage in activities that the implants actually could not withstand. In the court documents, Zimmer cited evidence that there is no increased rate of loosening of the NexGen implants and argued that Batty’s surgeon was properly warned of potential risks.
Oct. 21, 2016
U.S. District Judge Rebecca Pallmeyer ruled that the second Zimmer bellwether case did not warrant a jury trial and issued case management orders, including a rare Lone Pine order, which requires all plaintiffs to furnish fundamental evidence to substantiate essential elements of their claim. Pallmeyer issued the ruling after concluding that the plaintiff, Theodore Joas, of Wisconsin, had not presented enough evidence to show under Wisconsin law that a design defect caused his NexGen Flex implant to come loose after just a few years and that there was a safer alternative.
Jan. 26, 2017
An Illinois federal jury took less than a day to rule in favor of Zimmer, rejecting the plaintiff’s claim that the company neglected its responsibility to warn her doctor that the implant could fail in obese patients. The plaintiff, Beverly Goldin, claimed she wouldn’t have had the surgery had she known of the risk of failure. She required revision surgery and said she was left with one leg an inch longer than the other and must walk with orthotics and a cane. The company introduced evidence that it warned doctors about the risk, including pamphlets and instructions given to doctors.
Under Pallmeyer’s Lone Pine order, plaintiffs are required to prove they had NextGen knee components implanted and show clear evidence of loosening through medical records.
The order and the trio of bellwether wins for Zimmer led to many cases being dropped from the MDL, but 348 lawsuits still remained as of Aug. 15, 2017. On March 16, 2017, Pallmeyer granted plaintiff Joan Eckman’s request to dismiss her case against Zimmer. It would have been the fourth bellwether trial in the now-diminishing MDL.
The plaintiffs then asked Pallmeyer to remand all the cases back to the districts in which the lawsuits had been filed, arguing that the bellwether cases had not been helpful in determining the direction of the others because they had relied on facts and circumstances specific to the individual cases that would not apply to the rest. But Pallmeyer denied the motion, saying she intends to conduct at least two more bellwether trials.
Appeals Court Scraps $20M Verdict Against Zimmer
In June 2016, a divided Pennsylvania appeals court reversed a $20 million verdict award against Zimmer and marketing firm Public Communications Inc., ruling that the award was excessive.
Plaintiff Margo Polett was originally awarded $26.6 million in damages in June 2011 after claiming she suffered injuries during a bike ride she took promoting a Zimmer artificial knee product. That award was later reduced after Polett was found 30 percent responsible for negligence.
However, the appeals court eventually stripped the award altogether, saying the defendants should have been granted remittitur of the verdict, or a ruling by the judge that lowers the amount granted by a jury in a civil case if the amount awarded exceeded the amount demanded.
The appeals court acknowledged that while Polett should be entitled to compensatory damages, the reversal came as a result of the jury award being “excessive, if not punitive.”
OtisMed Settles Whistleblower Case
In December 2014, OtisMed Corporation, a subsidiary of Stryker, agreed to pay $80 million to resolve criminal and civil liability related to knee replacement cutting guides sold despite an FDA rejection.
The claim was a so-called whistleblower case, brought on by Stryker sales rep Richard Adrian, who alleged OtisMed distributed faulty femoral cutting guides that never received FDA approval. The guides were directly marketed to surgeons and promised to help assist surgeons in making accurate bone cuts specific to individual patients’ anatomy based on magnetic resonance imaging (MRI) performed prior to surgery.
More than 18,000 of the OtisMed femoral cutting guides were sold between 2006 and 2009.
“With more than 600,000 knee replacements performed each year, patients rely on FDA to help ensure that the devices are safe and work as intended. When manufacturers ignore FDA requirements, they risk endangering patients’ health and quality of life,” said George M. Karavetsos, director of the FDA’s Office of Criminal Investigations. “We will continue to protect the public health by bringing to justice those who disregard FDA regulations.”
Tips for Filing a Knee Replacement Lawsuit
Filing a lawsuit can be a complicated process. There are several things to consider before filing a claim for knee replacement implant injuries.
Things to consider before filing
The law limits the amount of time a person has to file a claim
Each state has different statutes of limitation, so it’s important to talk to an attorney about when and where the injury occurred.
Participating in a recall could affect possible compensation from a lawsuit
If people are injured by an implant that is later recalled, they could limit their ability to file lawsuits if they participate in the recall. It’s best to talk to a qualified attorney — not a device manufacturer’s representative or a doctor — about how to protect legal claims during a recall.
It’s a good idea to consult a qualified device attorney
Knee replacement injuries have already resulted in thousands of lawsuits. Qualified device attorneys are familiar with device manufacturers’ legal strategies and issues that are common in these types of claims. They can offer information on where to file a claim, whether it’s in a person’s best interest to join any potential class action, and how to obtain a possible legal settlement. Every situation is different, and a qualified device attorney can help explain all the legal options.
Free consultations are available
Most device attorneys offer free consultations to help determine if a person has a legal claim. But be sure to ask about fees before hiring any lawyer. Usually, these attorneys work on a contingency basis, meaning they do not get paid unless they win the case or obtain a settlement.
Matt Mauney is a writer and researcher for Drugwatch.com. Before joining the Drugwatch team, he spent 10 years in journalism working for various newspapers and news websites. Matt has a degree in journalism with a double minor in broadcasting and public relations from Georgia Southern University.