Knee Replacement Lawsuit
The number of patients undergoing a knee replacement surgery has doubled over the last decade and more than tripled in the 45-to-64 age group, reports Fox News. With nearly 1 million customers each year, joint replacement is a booming $7 billion industry. Philadelphian surgeon Dr. Nicholas DiNubile says the success of the market can be attributed to “Boomeritis.” He explains, “It’s this mindset of ‘fix me at any cost, turn back the clock.’”
Background on knee replacement devices
The problem with knee replacements is that they were originally designed for senior citizens who would be taking it easy, but wanted to lessen the pain and stiffness of everyday life. Baby boomers, on the other hand, are looking to stay active – to continue running, skiing, playing tennis, or doing whatever pursuits they were enjoying before the surgery. Currently, “no one in the country tracks the long-term performance of artificial hips and knees,” reports the NY Times. That means hundreds of thousands of patients are being outfitted with devices with safety ratings that are questionable, at best.
There have been a number of knee replacement products rushed to market without adequate studies conducted to test for safety. This means that patients may need revision surgery far sooner than they expected – in some cases, within less than five years.
The result has been a litany of knee replacement problems requiring secondary surgeries to remove faulty devices and a flood of knee replacement lawsuits against manufacturers of these devices.
Manufacturers of orthopedic devices must go through the Food and Drug Administration’s (FDA) rigorous process to prove the safety of their products before they may be sold to consumers. However, there is one loophole that has been causing a lot of trouble. Through the agency’s 510(k) pre-market program, companies may release knee implants without testing – as long as they are substantially similar to another product already on the market. Unfortunately, many of these devices are failing at alarmingly high rates.
Complications of total knee replacement may include:
- Deep vein thrombosis (15% of all patients)
- Persistent pain, swelling or stiffness (8-23%)
- Prosthesis failure within five years (2%)
- Nerve injuries (1-2%),
- Fracturing, chipping and migration of device components (1-2%), and
- Infection of the joint (<1%), a potentially life-threatening side effect
Zimmer knee implants
The NY Times reported that Dr. Richard A. Berger, a prominent orthopedic surgeon in Chicago, has led the charge to recall the Zimmer NexGen CR-Flex replacement knee. Even though Zimmer paid the surgeon over $8 million to promote their product to patients during the last 10 years, the knee replacement problems with the Zimmer implants were too overwhelming to ignore.
During his first year of performing surgeries with Zimmer knee replacements, Dr. Berger’s x-rays revealed that the artificial knee was loose and not fused to the bone. His patients were walking, but they reported pain. The company had information on the NexGen product, but could not point to any studies conducted on the uncemented flexible model of NexGen because the FDA had not required the company to test it before marketing.
Dr. Berger joined forces with another surgeon, Dr. Craig J. Della Valle, to conduct their own study. They presented their findings at a national meeting of the American Association of Orthopedic Surgeons. They found that Zimmer knee implants failed early in 9 percent of the 100 patients studied. Half of all patients noticed signs of looseness, requiring some to have another knee revision surgery to fix the problem.
Recalls on Zimmer knee devices
In April 2010, Zimmer sent a letter to surgeons, describing the problem and urging them to apply cement on the tibial component during implantation as a safeguard. In September 2010, the FDA issued a Class II Zimmer knee recall for the Complete Knee Solutions Tibial MIS Components. In December 2010, another recall was issued for the LPS Femoral Components. And in January 2012, Zimmer was forced to pull the Natural-Knee II Durasol All-Poly Patella knee implant components off the market.
Complications prompt knee replacement lawsuits
In one of the recent cases against Zimmer, plaintiff Monica Hunsinger was implanted with the NexGen device on May 4, 2009 and began experiencing complications within two years. During her revision surgery, she suffered intraoperative bleeding and needed to transfer to another hospital for emergency treatment and an additional operation.
Hundreds of similar knee replacement lawsuits allege that the device did not provide additional flexion beyond 120 degrees, as the manufacturer claimed, and that the premature cracking, loosening and failure were unacceptable. So far, more than 600 plaintiffs have sought compensation for damages such as medical expenses, loss of income, rehabilitation, home health care, pain, suffering, and permanent disability.
Meanwhile, the Securities & Exchange Commission filed a case against Zimmer, stating that the company essentially bribed surgeons to use their products with paid consulting agreements. The manufacturer paid out $169.5 million to settle the charges.
Zimmer just one of many manufacturers facing litigation
DePuy is another company that is facing scores of knee replacement lawsuits. They were forced to issue knee implant recalls for their Hylamer liners (which had a 67.6% failure rate within five years), the LCS Knee Orthopedic Knee Implant Meniscal bearing insert (for improper labeling), and the LCS Duofix Femoral Component (which had a revision rate of 1.45% in Australia).
Other product recalls were issued for the following knee replacements:
- Stryker – Scorpio CR and PS components
- Stryker – Duracon Total Knee
- Stryker – Unicompartmental Knee System
- Smith & Nephew – Oxinium Genesis II and Profix II
- Smith & Nephew – Journey Uni Tibial Baseplate
- Biomet – Vanguard CR
Legal recourse for injured patients
Hundreds of knee replacement claims have been filed in both state and federal courts across the nation. More than 600 people have filed a Zimmer knee lawsuit alleging its NexGen device suffers design and manufacturing defects. People who have experienced premature failure of prosthetic knee devices are encouraged to contact an attorney to help determine eligibility for filing a knee replacement lawsuit.
- The New England Journal of Medicine, Minimally Invasive Total Knee Arthroplasty for Osteoarthritis http://www.nejm.org/doi/full/10.1056/NEJMct0806027
- ABC News, Experts Say FDA Should Abandon Approval Process http://abcnews.go.com/Health/recall-knee-hip-replacement-devices/story?id=14182520#.UZDflaJay8A
- NY Times, Surgeon vs Knee Maker - Who’s Rejecting Whom? http://www.nytimes.com/2010/06/20/business/20knee.html?pagewanted=all&_r=0
- The Legal Examiner of Kansas City, Surgeons Urge Recall of Zimmer NexGen Knee Replacements http://kansascity.legalexaminer.com/medical-devices-and-implants/surgeons-urge-recall-of-zimmer-nexgen-knee-replacements.aspx?googleid=287890
- Fox News, Baby Boomers Fueling Boom in Knee, Hip Surgeries http://www.foxnews.com/health/2011/05/23/baby-boomers-fueling-boom-knee-hip-surgeries/#ixzz2TAzI4CRN