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Knee Replacement Litigation

Faulty knee replacement implants can lead to serious problems. People who suffer complications after receiving a partial or total knee replacement often file lawsuits to receive compensation for their injuries.

*Please seek the advice of a medical professional before discontinuing the use of this medical device.

Number of Lawsuits: High of 1,800 cases MDL (Zimmer)

Plaintiff Injuries: Pain, further knee damage, infection, need for revision surgery

Defendants: Zimmer; Stryker; Smith & Nephew; DePuy

Bellwether Trial Date: Nov. 5, 2015 (first Zimmer bellwether)

MDL Status: Active (Zimmer)

Top Settlement: OtisMed (Stryker) paid $80 million to resolve criminal and civil investigations

Have you developed complications after a knee replacement?

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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.

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 at all.

Consumers who have been injured by defective knee replacement devices may be eligible for compensation, including:

  • Medical bills
  • Pain and suffering
  • Compensation for 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. 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.

  • 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.

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 approximately 300 lawsuits still remain. 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.

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.”

The Pennsylvania Appeals Court
The Pennsylvania appeals court reversed a $20 million verdict award against Zimmer and Public Communications Inc.

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 a person is injured by an implant that is later recalled, that person could limit their ability to file a lawsuit 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.

Author

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.

View Sources
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  2. Corso, J. (2017, March 16). Another Bellwether Drops out of Zimmer Knee Implant MDL. Retrieved from https://www.law360.com/articles/902900?scroll=1
  3. Jones, D. (2017, January 26). Zimmer Gets Win In 3rd Knee Implant Bellwether. Retrieved from https://www.law360.com/articles/885190/zimmer-gets-win-in-3rd-knee-implant-bellwether
  4. Fair, M. (2016, June 6). Zimmer Gets $20M Knee Injury Verdict Trashed in Pa. Retrieved from https://www.law360.com/articles/804139/zimmer-gets-20m-knee-injury-verdict-trashed-in-pa
  5. Bodine, L. (2017, January 6). Judge Admits Causation Expert in Zimmer knee Replacement MDL. Retrieved from https://www.masstortnexus.com/mass-torts-news/judge-admits-causation-expert-in-zimmer-knee-replacement-mdl/
  6. United States District Court Northern District of Illinois. MDL 2272 In Re Zimmer Nexgen Knee Implant Products Liability Litigation. Retrieved from http://www.ilnd.uscourts.gov/mdl-details.aspx?WNesDQBcWakSF/4TSCIYmQ==
  7. U.S. Food & Drug Administration. OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452987.htm
  8. Meier, B. (2010, June 19). Surgeon vs. Knee Maker: Who’s Rejecting Whom? The New York Times. Retrieved from http://www.nytimes.com/2010/06/20/business/20knee.html
  9. In Re Zimmer NexGen Knee Implant Products Liability Litigation, MDL No. 2272, Transfer Order (J.P.M.L. Aug. 8, 2011). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2272-Order_Vacating_CTO-09-12.pdf
  10. Meier, B. (2011, December 22). New Models of Implants Not Better, Study Finds. The New York Times. Retrieved from http://www.nytimes.com/2011/12/23/health/research/new-models-of-hip-and-knee-implants-not-better-study-finds.html
  11. U.S. Judicial Panel on Multidistrict Litigation. (2012 September). MDL Statistics Report - Distribution of Pending MDL Dockets. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets-By-District-September-2012.pdf
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