Zimmer NexGen knee litigation allegations

Sixty-year-old Charmaine Crosley was implanted with a Zimmer NexGen knee device on August 10, 2005. She underwent revision surgery six years later – on August 17, 2011. The knee implant is alleged to have caused the plaintiff injury, economic loss, loss of services and loss of consortium with her husband who is also filing this lawsuit. The plaintiffs are seeking damages for pain and suffering, as well as punitive damages against the manufacturer for two specific components – the NexGen Tibial component and the NexGen LPS Flex component.

The Zimmer NexGen knee lawsuit is suing for 15 separate counts:

• Strict liability – defective design
• Strict liability – failure to warn
• Strict liability – manufacturing defect
• Negligence
• Negligent misrepresentation
• Express warranty
• Breach of express warranty
• Breach of implied warranty
• Redhibition
• Loss of consortium
• Violation of consumer protection statutes
• Unjust enrichment
• Punitive damages
• Common law fraud

The plaintiffs are requesting compensatory damages, punitive damages, interest, the cost of the suit, statutory damages, lawyer’s fees and any other relief the courts deem proper.

History of the Zimmer knee lawsuit MDL

In 2010, a study by the American Academy of Orthopaedic Surgeons (AAOS) found that the Zimmer knee implants had an unacceptable failure rate of 36% in the 108 cases investigated. Side effects of the loose joint parts included intense pain, infection, osteoarthritis and immobility. More than a third of these failures required revision surgery, most commonly one or two years after the initial implant. In response, Zimmer voluntarily pulled certain components (the NexGen MIS Tibial parts) from the market for “nonconforming geometry.”

Rumors of multidistrict litigation started in 2011, as the cases began to mount against Zimmer Inc. In early June 2011, there were 28 formal complaints lodged against the company, alleging serious injury, pain and suffering. Two months later, this number had jumped up to 78. Attorneys estimated that hundreds of complaints would emerge in the coming months. MDL 2272 was officially formed on January 12, 2012. As of June 2013, there were 988 lawsuits included in the products liability Zimmer NexGen knee litigation.

What does the manufacturer say about the Zimmer knee lawsuit MDL?

In August 2011, Bloomberg News reported that several attorneys representing plaintiffs in Zimmer NexGen knee litigation were sent warning letters from the manufacturer. According to Roger Williams University law professor David Logan, Zimmer is firing “a shot across the bow to these plaintiffs’ firms. It’s like putting a loaded gun on the table for negotiations. You’re saying, ‘Not only are we not going to give you money, we’re going to go after you as well.’”

Zimmer spokesperson Garry Clark said that lawyers “have a right to advertise truthfully,” but “they don’t have a right to lie about our products.” Texas law firms ran scathing ads about the Zimmer NexGen implants following the release of the AAOS study and prompted individuals to call for a consultation. Several law firms have issued retractions on some of the statements made in their advertising materials, which they admit was based on information from sources that turned out to be unreliable.

Despite the ongoing publicity battle, the MDL will move forward with bellwether trials no later than June 20, 2013. Judge Rebecca R. Pallmeyer will preside over these early cases to determine whether there is enough evidence to take all the cases to trial or if the suits will be thrown out. It is also possible that Zimmer will offer settlements to avoid lengthy and costly litigation. The first official NexGen knee lawsuit will be ready for trial by January 2015.

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Zimmer knee implant lawsuit

Howard filed a complaint in the Northern District of Ohio back in 2002, alleging that defects in his Zimmer knee implant caused it to fail from lack of proper bonding with his natural bone, thereby causing pain and injury. Howard believed that Sulzer failed to remove machine oil residue, in violation of the “Good Manufacturing Practices” imposed by the FDCA. Due to the wealth of similar lawsuits pending, his case was remanded to the Northern District of Oklahoma in 2010 as part of MDL No. 1401. Initially, the Ohio district court refused to dismiss the negligence claim.

The case background

Sulzer designs, manufactures, and distributes knee and hip implants. Typically, the company machines the metal parts and then applies a porous coating to assist the bonding between the device and the patient’s bone. However, they began switching the steps — applying the coating prior to machining the parts. Unbeknownst to the manufacturer, this left oily residue on the implants, despite the fact that Sulzer used an FDA-approved cleaning process. When the error was discovered, Sulzer voluntarily recalled 40,000 implants. This new manufacturing process was used in the Inter-Op shell hip implants and the Natural Knee II Tibial Baseplate knee implants. They initiated a secondary recall for the knee implants and thousands of patients underwent revision surgery to replace the defective parts. Litigation soon followed.

The counter-argument by Sulzer

However, Sulzer filed a summary judgment motion based upon the determination that Howard’s knee replacement was not in the oil-contaminated lot. They believed this fact was obvious grounds for dismissal. The company presented evidence that the device met all the standards of the Pre-Market Approval (PMA) application. The court agreed with the manufacturer and threw the Zimmer knee implant lawsuit out.

Zimmer knee lawyer provides a persuasive appeal

In turn, Howard filed an appeal and his Zimmer knee lawyer was able to prove that he had a right to file a “negligence per se” claim. Under a “negligence per se” claim, an act is considered negligent because it violates a law and causes harm to another person. The attorney argued that there was negligence based on a violation of the Medical Device Amendments, which identifies safety controls, performance standards and premarket approval processes.

Though Sulzer interpreted the law as merely requiring them to have a process for oil residue removal in place, Howard’s lawyer argued that the law also requires them to ensure that the implants are free from oil residue. He added that Howard’s Zimmer knee implant lawsuit was a “parallel claim” to the others in the MDL and, even though this particular device may not have been in the contaminated lot, chemical tests did show that there was mineral oil residue on his implant. Furthermore, there were grounds for litigation based on violation of the Good Manufacturing Practices law, rather than the Pre-Market Approval law.

Judgment is reversed and Zimmer knee implant lawsuit moves toward trial

The 10^th Circuit reversed the summary judgment awarded to Zimmer, following the Oklahoma Supreme Court’s decision that there is a valid “negligence per se” claim based on a violation of the Medical Device Amendments.  The court published a three-page opinion on May 29^th, contending that: “Oklahoma law allows private individuals to maintain a parallel claim for negligence per se based on violation of a federal regulation whose enforcement lies with a government entity.” They added that the claim “should be allowed to proceed.”

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On May 20, 2013, a Zimmer knee replacement lawsuit was filed on behalf of Frank Toibero and Edwina Toibero against Zimmer Inc., et al. The lawsuit claims that Frank Toibero has suffered permanent injuries as a result of an allegedly defective knee implant that was designed and manufactured by the defendants, called the Zimmer NexGen Knee. Although the plaintiffs are residents of Hawaii, this case is currently proceeding in the U.S. District Court for the Eastern District of Missouri in St. Louis because the defendants conduct a substantial portion of their business in that state. The plaintiffs are seeking compensatory and punitive damages.

Plaintiff required Zimmer knee revision surgery

Knee replacement surgery, or knee arthroplasty, is intended to relieve pain and improve range-of-motion and mobility for patients with knee damage caused by conditions such as osteoarthritis. During this surgery, natural bone is removed to make way for an artificial implant.

Frank Toibero underwent surgery to implant the NexGen Knee in his right knee on November 25, 2009. Prior to the surgery, he and his doctor had been the recipients of marketing information that led them to believe that the implant was a safe and effective device, according to the complaint. However, on March 15, 2011, the plaintiff required a revision surgery to remove and replace the Zimmer NexGen Knee system.

According to the Zimmer knee replacement lawsuit, the plaintiff’s resulting medical complications have left him unable to participate in his usual day-to-day activities. The lawsuit indicates that the plaintiff experiences significant pain, mobility problems, infection, swelling, and inflammation. It also notes damage to the tissues surrounding the implant, as well as damage to the bones.

Zimmer NexGen implant allegedly defective

This Zimmer knee replacement lawsuit alleges that the NexGen Knee implant is defective in design and “unreasonably dangerous.” The plaintiff’s lawyer charges that the defendants had a duty to sufficiently test the implant to determine the potential risk of the loosening of the device, the need for revision surgery, and the possibility of permanent injuries.

The Zimmer NexGen Knee was designed with a porous femoral component, which is manufactured from materials such as a cobalt-chromium-molybdenum alloy and a porous fiber metal. Unlike other knee implant devices, the surgeon does not cement the NexGen Knee into place. Rather, the porous design is intended to allow the natural bone to fuse into the implant, thereby anchoring it.
Although the lack of a cement material eliminates the potential for seepage of the material into the bloodstream, it poses a significant problem for loosening of the device. The porous femoral component does not anchor the implant, and when pressure is applied as the patient flexes the knee, the process of bone fusion is interrupted and the device can fail to adhere properly.

This problem of NexGen device loosening was addressed at a 2010 meeting of the American Academy of Orthopaedic Surgeons (AAOS), where a report (non-peer reviewed) was issued that warned against the use of the device for any patient.

According to this Zimmer knee replacement lawsuit, if the plaintiff had known of the potential risks, including the threat of premature Zimmer knee revision surgery, he would not have had the device implanted.

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Nearly a thousand product liability lawsuits have been filed by plaintiffs across the United States, each alleging that defective components in Zimmer’s range of knee implants caused the systems to fail within a few years. The scale of litigation prompted the U.S. Judicial Panel on Multidistrict Litigation to consolidate cases in the U.S. District Court for the Northern District of Illinois. Zimmer NexGen knee lawsuits were coordinated for pre-trial hearings in order to avoid contradictory rulings and prevent duplicative discovery. A small number of ‘bellwether’ cases – intended to help all parties gauge the likely reaction of juries – are currently being prepared for early trial dates.

Judge Rebecca R. Pallmeyer ordered both sides to select cases for the bellwether hearings no later than June 20, 2013. To be eligible for early trial, a case must have been transferred to the MDL prior to January 25, 2013, and plaintiffs must have provided medically authorized ‘Fact Sheets’ by April 25, 2013.

February 2014 is the proposed date by which cases should be selected for the first trial. Between July 2013 and February 2014, both sides must collect expert witness testimonies. Judge Pallmeyer indicated that the first Zimmer NexGen knee lawsuit will be ready for trial by January 2015. As of May 15 2013, there were at least 988 NexGen product liability cases pending.

Severe Zimmer knee complications alleged

The Zimmer NexGen system was introduced in 1995. Most of the components were approved without extensive clinical trials, as they were considered by the FDA to be “substantially equivalent” to existing medical devices already available and placed on the market via the agency’s 510 (k) fast track process.

However, a number of patients complained of various Zimmer knee complications, including difficulty walking and standing, persistent knee pain, swelling and popping, and crunching and clicking noises emanating from the knee. Some surgeons have suggested that the components can fail to fuse correctly to a patient’s thigh bone. Many patients required revision surgery to correct the problem.

Zimmer NexGen knee lawsuit MDL

When the MDL was established, there were 28 lawsuits on file. Since then, nearly a thousand cases have been transferred to the MDL, and that number is expected to increase as patients continue to file claims against the manufacturer. Plaintiffs who file a Zimmer NexGen knee lawsuit in state courts may end up in the federal system, at the request of Zimmer.

Anyone who has experienced Zimmer knee complications is advised to contact a a product liability lawyer to find out if they qualify for filing a complaint. Litigants with cases currently pending at both a state and federal level are generally seeking any combination of damages for medical expenses; rehabilitation costs and home healthcare; loss of wages; permanent disability damages; damages for pain and suffering.

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Defective devices led to complications, revision surgery

The plaintiff in this Zimmer lawsuit, Edwina Cuevas, states that on December 28, 2007, she underwent knee replacement surgery on her right knee. A few months later, Cuevas had the same surgery to replace her left knee. In both procedures, Cuevas was implanted with the Zimmer NexGen GSF CR-Flex device.

Soon after her surgeries, Cuevas began experiencing problems with her knee implant devices. While the Short Form Complaint does not specify which complications afflicted Cuevas, it does state she underwent revision surgery on both of her knees in 2012. Revision surgery can be more complex than the initial knee replacement procedure, since the surgeon must remove the original device first. There can also be bone and tissue damage from the first procedure that impacts the success of subsequent surgeries.

Concerns about the Zimmer NexGen components

The first concerns about the Zimmer NexGen CR-Flex were raised in 2006, by a respected orthopedic surgeon and Zimmer consultant, Dr. Richard Berger. At the time, Dr. Berger questioned the high failure rate of the devices that he had experienced with his own patients. Zimmer responded that the problems arose from surgeon error, rather than a defect with the device.

In 2012, the company issued a class II recall of some of the Zimmer NexGen components, which indicates the component parts could cause “temporary or medically reversible adverse health consequences,” according to the FDA. However, the NexGen systems as a whole are still marketed to patients and health care professionals. In addition, those who received the devices prior to the recall have alleged they had no prior warning of potential risks involved with the NexGen devices when they were implanted with the Zimmer products.

Zimmer NexGen knee lawsuit coordination

As more complaints involving NexGen devices became public, injured patients began filing Zimmer NexGen knee lawsuit actions seeking compensation for their injuries. Federal cases have now been coordinated into MDL No. 2272 in U.S. District Court in the Northern District of Illinois, where they are presided over by the Honorable Judge Rebecca R. Pallmeyer. At the time the MDL was established, there were 28 complaints on the docket. Today, that number has grown to more than 900 cases now pending.

Multidistrict litigation is used when a number of cases with similar complaints are filed. The purpose of the MDL is to streamline early trial proceedings for a more efficient legal process. Coordinating cases into a single court may also provide a greater potential for settlements between plaintiffs and the common defendant. At this time, Judge Pallmeyer has appointed attorneys to leadership roles and ordered an Agreed Case Management Plan.

In this current Zimmer NexGen knee lawsuit complaint, the plaintiff is seeking compensatory, punitive, and exemplary damages against the defendant manufacturer, stating the injuries caused by her defective knee replacement devices have resulted in pain and suffering, economic loss, and the need for additional medical treatment.

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Court abandons prior verdict, allowing Zimmer a new trial

However, in an unpublished opinion released on March 1, the Pennsylvania Superior Court has decided to vacate this award and give both Zimmer and its marketing firm a new trial. They concluded that the trial court had inappropriately instructed jurors on causation by placing the burden of proof on defendants to disprove the alleged grounds of Ms. Polett’s injuries. The Superior Court also stated that both defendants – Zimmer and Public Communications Inc. – challenged the adequacy of Polett’s causation evidence, and rather than offer provisional causes, the defendants “properly challenged the lack of a causal connection between the exercise machines and her injuries.”

According to court documents, “The isolated charge palpably misled the jury into believing that Zimmer and PCI were required to present medical evidence that something other than the exercise bike caused Mrs. Polett’s injury. The law does not support shifting the burden of proof to the defense under the circumstances of this case. Because of this error, Zimmer and PCI are entitled to a new trial.”

While Zimmer is now afforded a new trial regarding this particular case, the billion-dollar company still faces hundreds of claims filed in court rooms across the nation. The majority of Zimmer knee replacement lawsuits have been centralized into one federal court, as part of multidistrict litigation. The cases all involve injuries related to the NexGen knee devices, including the Gender Solutions Female model, which was used in Margot Polett. The products liability litigation (MDL No. 2272) has been assigned to the U.S. District Court for the Northern District of Illinois.

Zimmer knee replacement lawsuits have similar allegations

Many patients who received one of the manufacturer’s NexGen implants complained of serious Zimmer knee injuries, including reduced mobility, chronic pain when standing, crunching and popping sounds, loosening of the device, and in some instances – total knee failure. The majority of individuals who have filed complaints against the company say the devices are defectively designed, and because of these flaws they had to undergo further corrective surgeries.

The multidistrict litigation (MDL) presiding in Illinois federal court is handling Zimmer knee replacement lawsuits involving the following components:

• NexGen Complete Knee Solution (LPS-Flex)
• NexGen Knee Solution CR-Flex Gender Solutions Female CR-Flex (GSF-Flex)
• NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components (CR-Flex)
• All NexGen MIS Total Knee Procedure Stemmed Tibial Components
• NexGen Complete Knee Solution Gender Solutions Female LPS-Flex (GSF LPS-Flex) 

Those who have taken legal action for their injuries are hoping the litigation will result in damages for past and future medical expenses, compensation for lost wages and diminished earning capacity, costs related to rehabilitation, and reparation for pain and suffering.

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The Oklahoma City plaintiff claims to have suffered severe physical and mental pain for which she sustained medical and hospital expenses and permanent physical impairment. As a result of her lost wages and diminished future earning capacity, Clote is requesting damages for her pain and suffering, emotional distress, and economic losses, in addition to punitive damages.

Zimmer knee lawyer levels multiple charges against defendant

As noted in the lawsuit, Mary Clote underwent total knee replacement surgery in an Oklahoma City hospital on July 29, 2010, when the GS-Natural Knee was implanted in the patient’s left knee and leg. On or about April 11, 2011, the plaintiff experienced a painful hyper-extension of this same left knee after she attempted to stand up. She alleges that this was based upon the failure, loosening, and/or mechanical malfunction of the Zimmer GS-Natural knee, which she labels as “defective.” In order to alleviate her chronic and excruciating pain, the plaintiff was advised to have Zimmer knee revision surgery to remove the defective device – a procedure which she had on April 20, 2011. Mrs. Clote states that neither she nor her physicians, through any reasonable means, could have detected the defective nature of the GS-Natural Knee prior to its premature failure. Her lawyer argues that due to these Zimmer knee implant problems, his client has suffered and will continue to suffer severe injuries, economic losses, and other damages including permanent instability, loss of balance, and immobility.

Design defect is one of the many charges levied against the defendant, as the GS-Natural knee replacement is referred to as “unreasonably dangerous” by the claimant and her attorney. The lawsuit further contends that Zimmer failed in its duty to warn both the medical community and public about the potential risks and complications of its knee replacement devices, particularly that the GS-Natural knee could malfunction, resulting in serious injury, the need for additional treatment, and future revision surgery. Zimmer is also accused of failing to adequately test and research their knee implants for potential problems and early failures.

Similar allegations raised in Zimmer knee lawsuits

Mary Clote’s Zimmer knee lawyer adopts eight counts against the defendant, including strict product liability, design defect, failure to warn, negligence, breach of implied and express warranties, negligent misrepresentation and punitive damages. Similar to other claims against the manufacturer over its NexGen knee devices, the plaintiff contends that Zimmer knew of the unreasonably dangerous nature of its GS-Natural Flex knee but continued to market this product at the expense of the health and safety of the public. Punitive damages are sought for the alleged “wanton, fraudulent and willful acts” of the defendant in an effort to punish and deter such actions in the future.

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Studies cite high failure rate of Zimmer NexGen Knee

The Zimmer NexGen Knee Replacement System is used to treat patients suffering from severe knee degeneration. Zimmer, Inc. marketed the medical device as a safe and effective knee implant that alleviates pain. The device also reportedly gave patients a greater degree of flexibility and improved mobility.

Once patients started to receive the knee implant, it was plagued by reports of high failure rates and medical complications. The lawsuit states that 85% – 90% of knee devices last up to ten years, but studies revealed that the Zimmer NexGen Knee Replacement System was malfunctioning within a short amount of time after it was implanted in patients. In 2007, a peer review study published in the Journal of Bone and Joint Surgery (British edition) stated that 38% of the knee implants loosened within two years after the patients received them. Fifty-six percent of the patients with a loosened implant had Zimmer knee revision surgery.

Zimmer, Inc. also started to receive complaints about the knee replacement system from its own consultants. Dr. Richard A. Berger, the surgeon who designed and installed Zimmer knee implants for ten years, notified the manufacturer that the NexGen system was defective and had an early failure rate. Dr. Berger conducted a study that concluded the knee implant failed early in 9 out of 100 patients. In 2008, Lawrence Dorr, a Zimmer consultant, also notified the manufacturer that the knee system had a high failure rate. Zimmer, Inc. contested the claims and asserted that the knee replacement systems malfunctioned due to the techniques used by the physicians during surgery.

Complications associated with Zimmer NexGen Knee

When a component of the implant loosens it can cause bone degeneration and severe pain. The patient’s mobility is restricted and performing basic activities becomes strenuous. Other problems linked to the knee replacement system include swelling, inflammation, and difficulty walking and standing.

For some patients, revision surgery is needed to treat the medical problems caused by the knee implant. Due to the severe bone deterioration caused by the artificial system, it is difficult to reconstruct the joint so that a new implant will fit and work properly. Since the other issues associated with a failed knee implant also need to be treated, it increases the risk of additional complications occurring during Zimmer knee revision surgery.

On April 10, 2006, the plaintiff had a Zimmer NexGen Knee Replacement System implanted in her right knee. On May 14, 2007, her physician implanted the knee replacement system in her left knee. When the implants became loose, the plaintiff began to suffer from debilitating pain, swelling, amnesia, difficulty walking, and problems with performing daily activities.

The plaintiff had the artificial knee system replaced in her right knee during revision surgery on April 25, 2010. Since she continues to suffer from pain and instability, Zimmer knee revision surgery for the left artificial knee may be needed in the near future.

Fraud and deceptive marketing practices alleged in Zimmer knee replacement lawsuit

The lawsuit states that Zimmer, Inc. designed a defective medical product, and engaged in fraudulent concealment and negligence. The manufacturer is accused of failing to use reasonable care while designing, testing, selling, and distributing the medical device. According to the complaint, Zimmer, Inc. knew or should have known about the side effects associated with the knee replacement system and the risk of the implant becoming loose, but the company failed to adequately warn consumers or the healthcare community. The lawsuit also contends that Zimmer, Inc. engaged in deceptive marketing practices such as material misrepresentation and omissions of pertinent information in order to present the device as safe and effective.

The plaintiff claims that the NexGen implant caused her to suffer serious and permanent injuries. According to the lawsuit, the Michigan claimant continues to experience Zimmer knee problems and seeks compensation for medical care, rehabilitation, permanent disability, lost income, and pain and suffering. The plaintiff’s husband is requesting compensation for loss of consortium and other damages.

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The plaintiff charges the defendant, Zimmer and Zimmer Holdings, Inc. with negligently manufacturing, designing and distributing a defective product known as the NexGen knee device, which allegedly caused the plaintiff to suffer bodily injuries and significant financial losses. Ms. Goins is requesting compensatory, punitive or exemplary and statutory damages, plus interest fees and costs.

Zimmer NexGen knee lawsuit claims manufacturing defect

According to the plaintiff’s short form complaint, which was drafted by her Zimmer knee lawyer, Ms. Goins was implanted with the NexGen GSF CR-Flex device on May 9, 2011. The surgery was performed in T.J. Samson Community Hospital by Dr. Barrett Lessenberry. While the detailed nature of the claimant’s injuries was not disclosed in the short form complaint, court documents indicate that Ms. Goins underwent revision surgery to correct complications from her NexGen implant. The corrective surgery was performed on August 27, 2012 at Methodist Medical Center.

Numerous plaintiffs who have chosen to pursue legal recourse after receiving the NexGen knee models allege Zimmer failed to adequately test their devices prior to releasing them on the market. The High Flex models produced by Zimmer have been linked to a slew of serious complications, often requiring patients to endure painful and risky revision surgery. Reported complications among Zimmer NexGen knee patients include popping sounds in the knee, chronic pain, persistent swelling, difficulty walking or standing for long periods of time, and a loose feeling in the knee. In this recent complaint, Kathy Goins is requesting damages for pain and suffering, emotional distress and economic loss in addition to punitive damages. Her Zimmer knee lawyer charges the defendant with strict liability- design defect, failure to warn, manufacturing defect, negligence, negligent misrepresentation, breach of implied warranty, unjust enrichment and violation of consumer protection statutes.

NexGen implants linked to early failure rates

In 2010, clinical research performed by leading knee surgeons demonstrated that certain components of Zimmer NexGen knee implants were prone to unreasonably high failure rates.  Studies revealed that 9 percent of patients who were implanted with the NexGen CR-Flex Porous Femoral components needed corrective surgery within two years, and more than a third of those patients experienced early symptoms of knee failure and loosening. Most artificial knees are designed to last up to 15 years, but Zimmer’s “High Flex” models have been known to fail within one to two years after implantation, as was the case with Tennessee plaintiff Kathy Goins, according to her Zimmer knee lawyer.

While Zimmer has recalled certain components of the NexGen MIS and MIS Tibial system amid reports of the knee devices loosening, there is no word of a Zimmer knee recall on the company’s High Flex models. The majority of patients who have taken legal action by filing a NexGen knee lawsuit against Zimmer have had to undergo revision surgery owing to the device’s early failure.

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Zimmer knee replacement problems led to revision surgery

The new Zimmer knee lawsuit was filed in Pennsylvania on January 18, 2013. The plaintiff in the complaint, Sandra Stevenson, states she underwent knee replacement surgery on January 21, 2011, when she received a NexGen LPS-Flex device for her right knee. Stevenson alleges that after complications with her NexGen device, she was forced to undergo revision surgery on her knee on August 1, 2012.

In her complaint, Stevenson asserts that neither she nor her physician could have known about the risks associated with Zimmer knee replacement problems at the time she underwent her initial surgery. Zimmer continues to refute claims of design and manufacturing defects in the device, arguing that complications are a result of surgical error.

Early failure rate cause for concern

Patients have reported Zimmer NexGen knee complications like loosening of the device, persistent pain, and reduced mobility. Some doctors have attributed the complications to a design flaw in the implant that prohibits the device from fusing to the thigh bone in some patients. In some cases, patients must undergo revision surgery within a shorter than expected period of time to remove the defective implant and replace it with a new device.

Revision surgery is a complicated procedure that carries additional risk if there is bone damage from the initial device. Most patients who have revision surgery find the cost is higher and the recovery time after surgery is longer. Although revision surgery may correct the problems for some patients, it is a long road to full mobility for many of them.

Short form complaint filed by plaintiff

In this recent Zimmer knee lawsuit, Stevenson has filed a short form complaint with the intention of consolidating her case with others in the Illinois MDL. Her lawyer has adopted the Master Long Form Complaint as the amended complaint for her lawsuit. Stevenson is claiming multiple causes of action in her complaint, including negligence, strict liability and breach of warranty. She is seeking compensatory and punitive damages to compensate her for her pain and suffering, economic loss and medical bills.

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A Zimmer knee lawyer working for the plaintiffs filed the case on January 11, 2013 in the U.S. District Court for the Northern District of Alabama. The complaint alleges Zimmer ‘defectively manufactured, designed and sold’ their NexGen CR-Flex product, causing one of the plaintiffs to suffer injuries. The case relates to the multidistrict litigation (MDL 2272) now under way in the U.S. District Court for the Northern District of Illinois.

The plaintiffs reside in Alabama. According to court documents, the husband was implanted with the device in January 2007, and required revision surgery in March 2011. The couple is suing for compensatory damages.

NexGen implants marketed for active lifestyles

Worldwide, knee implants are estimated to be worth $7.2 billion for Zimmer. They began developing implants in 1968, and released their first prosthetic device five years later. They first introduced the NexGen Complete Knee Solutions in 1995. The devices promised the same 120 degree level of flexibility as was standard for knee implants of the time – but Zimmer aimed to increase that to 155 degrees, closer to the flexibility found in a real human knee. They spent the next decade expanding the range, in order to provide for patients who were “expecting to maintain an active lifestyle”.

In 2003, the NexGen Cr-Flex Porous Femoral Component was approved by the FDA. It uses a revolutionary cobalt-chromium-molybdenum alloy to cap the thigh bone where it connects to the knee. The porous fixative is designed to encourage bone growth and was intended to eliminate the risk of blood poisoning that comes with cement fixatives. However, the FDA has received numerous reports of adverse events and complications related to the NexGen line. Most cases point to loosening of the components as the cause of their injuries.

Zimmer knee replacement problems

A 2010 study at Rush University Medical Center looked at 108 patients who had been fitted with NexGen devices. The study found that 9.3% of NexGen implants needed revision surgery because of loosening. Radiographs showed a further 36% of implants had become loosened (without associated pain).

Zimmer knee replacement problems generally occurred within two years of surgery, significantly less than the 12-15 year lifespan of a knee implant usually expected by doctors.

Zimmer knee recall affects several components

Several Zimmer NexGen products have been targeted for recall by the FDA. In September 2010, the NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays and MIS Modular Tibial Plates and Keels were all recalled.

The NexGen LPS-Flex GSF Femoral Component was recalled in December 2010 after the FDA received reports of the components collapsing. It was found that several of the implants had “non-conforming geometry”.

In November 2012, the FDA recalled the NexGen Stemmed Nonaugmentable Tibial Component, citing a legally invalid cleaning process at the manufacturing stage, which may have caused allergic reactions in several patients.

Zimmer knee lawyer can establish liability

Complications arising from faulty NexGen Flex devices have resulted in more than 700 lawsuits to date. A Zimmer knee lawyer can help affected individuals evaluate their legal options and seek compensation for their injuries.

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Zimmer has been developing knee implants since 1968, and released their first prosthetic device five years later. Knee and hip implants have been a major part of Zimmer’s $4 billion yearly business ever since. The NexGen CR-Flex Porous Femoral Component was introduced in 2003, and uses a cobalt-chromium-molybdenum alloy to cap the thigh bone where it connects at the knee. The fixative is porous, designed to encourage bone growth.

Plaintiffs seek Zimmer knee lawsuit settlements and jury awards

This innovation replaced traditional cement fixatives, which had the potential to break down, pollute nearby tissue and enter the bloodstream. However, the elimination of one risk created another – the loosening of the femoral component, a problem that has been widely reported by patients and physicians.

Zimmer knee replacement lawsuits have increasingly grown in number, resulting in the current MDL in Illinois. The litigation concerns several Zimmer NexGen models: the CR-Flex, the GSF CR-Flex, the GSF LPS-Flex, the LPS-Flex and the MIS Tibial.

Zimmer knee recall

Zimmer has recalled from the market several component parts used in conjunction with the NexGen knee system. In September 2010, its NexGen Complete Knee Solution MIS Tibial Components, NexGen TM Tibial Trays and MIS Modular Tibial Plates and Keels were all recalled. The NexGen LPS-Flex Gender Femoral Component was recalled in December 2010.

On November 26, 2012, the FDA announced a class II recall of the NexGen Stemmed Nonaugmentable Tibial Component. The reason cited was an invalid manufacturing cleaning process which may have resulted in third-body particles causing allergic reaction.

Zimmer knee replacement lawsuits

So far, more than 700 lawsuits have been filed against Zimmer for complications arising from allegedly faulty NexGen Flex devices. Plaintiffs seek Zimmer knee lawsuit settlements or jury awards after having suffered complications as a result of receiving a NexGen Flex implant. Individuals who believe they are affected are advised to consult with a Zimmer knee lawyer to determine if they are eligible to file litigation.

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Zimmer knee lawsuit alleges injury, revision surgery

The recent complaint was filed in the Western District of Michigan on December 27, 2012. The short form complaint was used in the action in order to adopt the master long form complaint after the transfer of the case to the MDL is complete. The plaintiff, Lurran Kitchen-McElrath, alleges she suffered pain and injury after receiving Zimmer NexGen CR-Flex devices in both her right and left knees.

The initial surgeries for Kitchen-McElrath took place in May, 2010. By August, 2011, the plaintiff was forced to undergo revision surgery on her right knee, followed by revision surgery on her left knee in March 2012.

No Zimmer NexGen knee recall

Despite the growing Zimmer knee litigation, the manufacturer has not issued a Zimmer NexGen knee recall, asserting that there is no evidence of a design defect, or of a higher-than-normal rate of premature device failure. However, problems with the NexGen Cr-Flex device have not only been reported by patients, both also investigated repeatedly by medical researchers.

A 2010 non-peer reviewed report, titled, “The High Failure Rate of a High-Flex Total Knee Arthroplasty Design,” which was authored by orthopedist Dr. Richard Berger and Dr. Della Valle, documented a high 36% rate of loosening of the implant and the need for revision surgery in 8.3% of patients that received the Cr-Flex model. Though the company has not validated the findings in this report, it has suggested that instances of early failure of the device are likely the result of poor surgical technique, rather than a manufacturing defect.

In her complaint, Kitchen-McElrath is seeking compensatory, punitive and exemplary damages from Zimmer, to compensate her for pain and suffering, economic loss and medical bills. Her spouse, Troy McElrath, is also listed on the complaint, claiming his wife’s injuries have led to loss of companionship and consortium.

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The plaintiffs allege via the short form complaint that the defendant, Zimmer, Inc., failed to properly warn the public of the associated risks with the NexGen knee implant, a medical device that allegedly caused both plaintiffs to suffer emotional distress and other damages after being implanted with the artificial knee system.

Zimmer knee lawyer alleges NexGen defects

Recipients of the NexGen CR-Flex implant have reported a host of complications such as chronic pain, bone loss, tissue damage, loosening of device and knee failure. Plaintiff Nelda Shaw had the NexGen GSF LPS-Flex implanted in her left knee on May 19, 2008, and required revision surgery in November 2011 due to complications. Ruth Wilson received the NexGen GSF CR-Flex device on September 19, 2011 and underwent revision surgery in November 2012 – a little over one year later. Both plaintiffs are demanding compensatory damages for pain and suffering, emotional distress, economic loss, and are also seeking punitive damages.

Most knee replacements are marketed to last up to 20 years, but the NexGen device has been linked to early Zimmer knee failure rates caused by an alleged design flaw. According to a report titled, “The High Failure Rate of a High-Flex Total Knee Arthroplasty Design” conducted in 2010, of the 108 NexGen implant patients studied, 8.3 percent underwent revision surgery due to femoral loosening and pain, and 36 percent of the study group suffered loosening of the device.  Despite medical concerns and patient reports of complications with the NexGen implants, the model remains available to this day.

Zimmer knee lawsuits centralized in multidistrict litigation

The Zimmer NexGen knee multidistrict litigation (MDL No. 2272) merges cases involving several Zimmer NexGen knee models including the GSF CR-Flex, GSF LPS-Flex, LPS-Flex and the MIS Tibial. The MDL joins multiple lawsuits involving a particular product line to be coordinated under one judge for pre-trial litigation. Allegations raised in the Zimmer knee lawsuits contend that the NexGen device is prone to early failure rates and premature loosening, causing plaintiffs to undergo revision surgery.

On behalf of plaintiffs Ruth Wilson and Nelda Shaw, their Zimmer knee lawyer adopts multiple counts against the defendant including strict liability – design defect, failure to warn, manufacturing defect, negligence, misrepresentation, unjust enrichment and breach of implied and express warranty

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The MDL unifies product liability lawsuits involving Zimmer NexGen implants that have similar allegations, namely Zimmer knee failure due to an allegedly defective design.

Zimmer knee failure commonly cited in NexGen litigation

According to the complaint, Carletha McGuire was implanted with the NexGen CR-Flex device in her right knee on January 23, 2006 at The Cedars Medical Center. Similar to other patients who received the NexGen device, McGuire developed Zimmer knee problems that indicated revision surgery. She underwent surgery on January 20, 2009 and consequently suffered injuries as a result of the implantation and removal of the device.

The plaintiff seeks damages resulting from personal injury and economic loss. Her husband claims loss of consortium. Her Zimmer knee lawyer adopts multiple counts against the defendant including strict liability-design defect, failure to warn, manufacturing defect, negligence, and breach of express and implied warranties. The McGuires are seeking compensatory, punitive, exemplary and statutory damages, plus interest, fees and costs.

NexGen CR-Flex knee still available despite reported problems

A 2010 non-peer reviewed study of 108 patients who were implanted with the NexGen CR-Flex knee revealed that the device may be prone to early failure due to an alleged flaw in the design. The study, which was carried out by Chicago orthopedist Richard Berger and Dr. Della Valle of Rush University Medical Center, discovered that 8.3 percent of the 108 patients underwent revision surgery due to femoral loosening and chronic pain, and 36 percent experienced loosening of the implant as evidenced by radiographic tests.

Some patients who received the Zimmer NexGen CR-Flex device report an array of complications such as severe pain and loosening of the components. Many have filed suit against the manufacturer in hopes of recovering compensation for pain and suffering caused by alleged Zimmer knee failure, as well as lost wages, emotional trauma and medical expenses.

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The case is a tag-along action to the Zimmer NexGen MDL, which was filed in the Northern District of Illinois. Though hundreds of plaintiffs allege similar problems, no Zimmer knee recall has been mandated for the NexGen knee system.

Zimmer knee lawyer alleges misleading marketing

Zimmer develops, manufactures, distributes and sells the NexGen total knee replacement system, including the NexGen LPS-Flex femoral component. According to Pastusec’s Zimmer knee lawsuit, the defendants knew or should have known that the NexGen knee system, “can loosen or otherwise fail in patients… causing personal injury, significant pain, and loss of movement, and that this injury can only be remedied through subsequent revision surgery and/or knee replacement.” Pastusec’s Zimmer knee lawyer also alleges that the defendants misled health care professionals and the public, “into believing that the Zimmer NexGen Knee was safe and effective for use in knee replacement surgery.”

Hundreds experience knee failure, but no recall on the NexGen system

On June 23, 2005, Judy Pastusec received a Zimmer NexGen knee system. Prior to September 16, 2008, Pastusec’s treating physician was exposed to allegedly deceptive advertising and marketing, making both the plaintiff and his doctor believe that the product was safe. After surgery, the plaintiff began experiencing severe and debilitating pain, as well as other symptoms of a defective implant. After repeated return visits to his physician, Pastusec consented to knee revision surgery. Though thousands of other patients have allegedly experienced similar symptoms, a Zimmer knee recall has yet to occur.

Zimmer knee lawsuit charges failure to warn and negligence

According to his complaint, as a direct and proximate result of the NexGen knee system, Pastusec has suffered and continues to suffer serious bodily injury and harm. He has also been responsible for considerable medical expenses to treat his injuries and condition. He levels counts against the defendants of strict liability, failure to warn, design defect, negligence, and breach of express and implied warranties. He requests punitive and compensatory damages, as well as special damages, legal costs, and double or triple damages as allowed by law.

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The Rhode Island resident is seeking compensation for the economic and non-economic losses she incurred after getting a defective NexGen Flex Knee implant. It remains to be seen how many plaintiffs will receive Zimmer knee settlements in the ongoing litigation against the manufacturer.

Zimmer knee implants approved without clinical safety trial data

In 1999, the FDA granted Zimmer, Inc. approval through 510(k) to market and sell the Zimmer NexGen Flex Knee device. Under the 510(k) approval process, a manufacturer does not have to conduct medical studies showing that the product is safe if the FDA decides it is substantially similar to another device already in the market. As a result, Zimmer was permitted to sell the NexGen Flex Knee device without proving that it was safe for patients to use.

Zimmer, Inc. marketed the knee device as an effective remedy for people with knee joint arthritis and other major knee problems. The manufacturer claimed that the NexGen Flex Knee device allowed patients to have more flexibility and movement in their knee joint. Zimmer, Inc. also stated that the device had a low failure rate and was designed to fit better than other devices in the market. 

Lawsuit alleges Zimmer knee devices are defective

After the Zimmer knee device became available, the FDA received reports that patients were experiencing major medical complications. Some of the Zimmer knee problems experienced by patients included chronic pain, bone loss, tissue damage, difficulty moving around and an inability to engage in normal routine activities. Physicians noticed that the implant would rub against bone as it gradually dislodged from its proper place. Even though the device was supposed to last for 15 years, thousands of patients had revision surgery within two to three years after getting the Zimmer knee implant.

According to the court documents, Souza had a NexGen Flex Knee device implanted into her left knee on August 24, 2009. Shortly after the operation, she began experiencing chronic pain. The medical complications were so severe the plaintiff underwent revision surgery on June 17, 2011 – less than two years after getting the implant.

A medical study published in the Journal of Bone & Surgery in 2005 revealed that the NexGen Flex Knee system did not give patients more flexibility or a wider range of motion than older models of the knee device. Another study published in the journal in 2007 showed that 38% of the knee devices became loose within three years after they were implanted in the patients. On average, 21% of the knee devices needed to be replaced less than two years after the patients received the implants.

In 2010, the New York Times published a story regarding the high failure rate of the Zimmer knee devices. The story focused on the futile attempts made by several doctors since 2006 to inform Zimmer, Inc. that the knee devices were failing prematurely and caused serious complications for patients. Zimmer contended that nothing was wrong with their devices and attributed the problems to the technique the doctors used during surgery.

Hundreds of plaintiffs seek Zimmer knee settlements

The causes of action cited in the lawsuit include negligence, breach of express and implied warranty, and strict liability for design defects. The plaintiff’s Zimmer knee lawyer states that Zimmer, Inc. failed to sufficiently warn patients and physicians of the defects and risk factors associated with the knee device.

The complaint asserts that based on medical findings and the experiences of numerous patients, the Zimmer NexGen Flex Knee device is not suitable for its intended use and is dangerous for patients. Souza and other plaintiffs in the Louisiana MDL are seeking Zimmer knee settlements after incurring serious injuries from the NexGen implants.

Hale claims that after she was implanted with the Zimmer NexGen knee device, she suffered serious injuries that required revision surgery. She seeks in excess of $75,000 in damages.

Lawsuit questions safety of NexGen high-flex knees

According to her Zimmer knee lawsuit, Hale was implanted with the Zimmer NexGen LPS-Flex on November 7, 2008. Zimmer received FDA approval for this device in 1999, and marketed it as a better option for patients who were expecting to maintain an active lifestyle.

By June of 2010, however, the New York Times called into question the safety of Zimmer’s high-flex knee implants. In the article, the Times detailed the efforts of Dr. Richard A. Berger, an orthopedic surgeon and former Zimmer consultant, to bring to light the problems he was seeing in his patients with Zimmer implants.

Hale claims that after the surgery, she experienced serious complications and eventually suffered Zimmer knee failure. She underwent revision surgery on May 2, 2011, to have the implant removed and replaced.

Studies indicate high rate of Zimmer knee failure

Her Zimmer knee lawyer alleges that the manufacturer engaged in misleading advertising regarding the high-flex knees. Patients were told they could recover faster and engage in more active lifestyles. Post-marketing reports, however, showed that the knees were failing because of mechanical loosening. A loose implant can cause pain and wearing away of the bone, and can severely restrict the patient’s daily activities.

Scientific studies also showed problems with these implants. In 2005, a study published in the Journal of Bone and Joint Surgery reported that there was no significant difference between the degree of flexion in a group with traditional implants versus those with the high-flex implants. A later study published in the same journal reported that 38 percent of the LPS high-flex knees were loose after just two years of being implanted, and over half of those patients had to have the device replaced.

Another study published in 2010 revealed that the LPS flex knees were associated with a high incidence of early loosening of the femoral components. The lead author of the study, Dr. S.D. Cho, stated that squatting or kneeling may not even be permitted after implantation.

Claims in Zimmer knee lawsuit

Hale brings counts of design and manufacturing defect, failure to warn, negligence, negligent misrepresentation, breach of warranties and unjust enrichment. Her husband claims loss of consortium.

In one recent case against Zimmer, plaintiff Mary Sippert is seeking relief against the defendant device manufacturing company, alleging that her Zimmer knee device is defective and caused her to suffer a number of complications.

Plaintiffs seek assistance of Zimmer knee lawyer

Sipper filed suit, through a Zimmer knee lawyer, on November 9, 2012, in the U.S. District Court of the Eastern District of Michigan via a short form complaint. Her case joins multidistrict litigation proceeding no. 2272 that is currently ongoing in that court. Her husband is seeking relief as a co-plaintiff, based on claims that his wife’s defective Zimmer knee caused him loss of consortium as she suffered through her injuries. Together, they are seeking relief based on claims of strict liability, negligence, negligent misrepresentation, breach of express and implied warranties, and several other counts.

Zimmer knee problems began three years after implant

According to the facts of Sipper’s case, she initially received her Zimmer NextGen GSF CR-Flex knee implant in her right knee on September 22, 2006. Just over three years later, she required revision surgery to correct her Zimmer knee problems. As marketed, the devices are intended to last 15 years or longer.

Hundreds file Zimmer knee lawsuit actions

Complications stemming from Zimmer knee devices have prompted hundreds of people to file Zimmer knee lawsuit actions. There are currently Zimmer knee multidistrict litigations ongoing in Massachusetts and Illinois.

A multidistrict litigation is unlike a class action in that all cases remain individual, which allows plaintiffs to collect money based on their individual claims rather than sharing a collective award. However, initial proceedings for all cases are heard in a single court, as this helps to expedite the litigation process, allowing the judge to find answers to common questions of law applicable to all lawsuits.

Despite numerous lawsuits based on NexGen Zimmer knee problems, the defendant has not initiated a Zimmer knee recall, asserting that there is no evidence of a device defect. In this latest case, the plaintiff is filing a short form complaint to join the Zimmer NexGen Knee Implant Products Liability Litigation, known as MDL number 2272.

Painful revision surgeries cited by Zimmer knee lawyer

According to the complaint, the plaintiff was implanted with the NexGen GSF CR-Flex device in both her left and right knees on July 27 and October 27 of 2009, respectively.  In January 2011, less than two years after receiving the NexGen device, Taylor developed complications that required painful revision surgeries on her left knee. Neither the plaintiff nor her doctor knew of the potential Zimmer knee problems before she was implanted with the GSF CR-Flex replacement knees.

Her specific injuries were not detailed in the short form complaint, but will be addressed as the multidistrict litigation proceedings unfold. The claims handled in the MDL involve “Flex” or “High Flex” NexGen implants in addition to the MIS Stemmed Tibial Components. Both devices have demonstrated unacceptable failure rates, and have been deemed “defective” by plaintiffs in the current Zimmer MDL.

NexGen Zimmer knee recall?

A recent report at the American Academy of Orthopedic Surgeons revealed that revision surgery was indicated in 8.3% of 108 patients implanted with the Zimmer NexGen CR-Flex knee, while another 1% were awaiting revision surgery. The knee manufacturer issued partial recalls on certain components of the Zimmer NexGen LPS system and NexGen MIS Tibial components in 2010, but hasn’t enforced a full Zimmer knee recall as of late 2012.

Many Zimmer knee lawsuits allege complications ranging from severe pain and loosening of the implant to total knee failure.

On behalf of Pamela Taylor, her Zimmer knee lawyer is seeking compensatory damages for pain and suffering, emotional distress, and for economic loss in addition to punitive damages. The plaintiff adopts multiple counts against Zimmer Orthopaedic Surgical Products, Inc. including failure to warn, design defect, negligence, breach of express warranty and misrepresentation.