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Pinnacle Hip Manufacturers Vastly Overstated Implants’ Effectiveness

A new lawsuit indicates Pinnacle hip manufacturers Johnson & Johnson and its DePuy subsidiary aggressively marketed the device as so effective that recipients could partake in “challenging and vigorous athletic activities.” However, many patients who have received the hip implant can hardly walk, require surgery, and live in constant pain due to the device.

James Bishop filed the complaint Friday in the Northern District of Texas. According to his lawsuit, Bishop underwent total hip arthroplasty (THA) on November 6, 2007. His surgeon used numerous DePuy Pinnacle components, including a DePuy Pinnacle acetabular cup, acetabular metal insert liner, and Articul/Eze metal-on-metal femoral head.

After receiving the Pinnacle System, Bishop experienced elevated levels of cobalt and chromium in his blood, a large fluid collection with irregular synovial debris, and significant pain when the implant failed prematurely, causing high-levels of serum ions in his blood and joint effusion, as well as muscle damage and weakness. Consequently, he had to undergo revision surgery with the incumbent additional scar tissue, recovery time, and excruciating pain.

Pinnacle Hip Manufacturers Engaged in Fraudulent Marketing

Pinnacle Hip Manufacturers

Pinnacle Marketing Material

Bishop asserts that he would have gone with a competing hip implant if the Pinnacle hip manufacturers hadn’t aggressively marketed the hip system's superior efficacy and safety compared to other devices.

The hip’s advertising materials described the Pinnacle as superior to other devices due to “TruGlide technology” that allowed the body to create a thin film of lubrications between surfaces that “enhances performance with smooth, natural motion and less friction.”

Pinnacle hip manufacturers explained “fluid film lubrication” to surgeons as synovial fluid which would act as a lubricant between the articulating components, preventing them from having contact with each other to improve wear resistance.

They also widely distributed literature to the orthopedic community, claiming that the Pinnacle hip system was “uniquely designed to meet the demands of active patients like you – and help reduce pain” and that the Pinnacle “recreates the natural ball-and-socket joint of your hip, increasing stability and range of motion.”

Pinnacle hip manufacturers even went so far as to suggest that the hip system was so effective that the recipients could engage in “challenging and vigorous athletic activities,” such as surfing and hiking. However, this is not the case for thousands of individuals who have experienced catastrophic implant failure due to the defective hip and continue to experience significant pain and impaired mobility as a result of J&J and DePuy grossly overstating the safety of the hip system to enhance profits at the peril of patients.

Pinnacle Hip Manufacturers Face Thousands of Injured Hip Patients in MDL

Bishop’s lawsuit joins the almost 10,000 similar DePuy Pinnacle hip claims pending in the federal multidistrict litigation (MDL), alleging that the Pinnacle hip manufacturers defectively designed the metal-on-metal hip system, making it exceptionally prone to failure and shedding toxic metallic debris into the body in the process. The Judicial Panel on Multidistrict Litigation (JPML) has centralized the lawsuits before District Judge Ed Kinkeade in the Northern District of Texas for pretrial proceedings, discovery, and a series of early trial dates to help the parties gauge how juries will respond to evidence and testimony that appears throughout the litigation.

Thus far, Pinnacle hip manufacturers are refusing to negotiate settlements in the MDL. Consequently, parties are pushing for the court to remand multitudes of cases back to District Courts nationwide for individual trial dates. However, this action could flood the entire federal court system where there are typically less than 12,000 jury trials each year. This includes both civil and criminal trials.

So far, bellwether juries have overwhelmingly sided with plaintiffs, awarding massive verdicts to injured patients. Consequently, Pinnacle metal hip manufacturers could face significant liability if future juries respond how they have during the bellwether trials so far.

The hip bellwether plaintiffs claim J&J and DePuy valued marketing above research and development. The companies rushed the hip into production without human clinical trials to capture a greater market share. Instead, they used patients as guinea pigs. Furthermore, they lied to surgeons that the hip was 99 percent successful to increase sales. J&J and DePuy also used cheaper, less safe alternatives in manufacturing the hips to keep costs down and profits up. The resulting defects turned patients’ hips into “ticking time bombs.”

 

 

 

 

By Emily Cox

A new lawsuit indicates that Zimmer hip problems with its M/L Taper replacement system caused it to fail prematurely, necessitating a California man to undergo revision surgery in both hips.

Glen Davis and his wife filed the complaint July 20 in the Northern District of California. The couple allege that Zimmer Biomet, Inc. knowingly designed, manufactured, and sold a dangerously defective hip replacement system with metal-on-metal components that posed a high risk of significant harm to recipients.

In December 2007, Davis received a Zimmer M/L Taper Hip System during right hip replacement surgery. Surgeons used the same system during a subsequent procedure for his left hip in August 2008. Both implants included Zimmer Versys cobalt-chromium femoral heads. In January 2017, Davis underwent revision surgery for his left hip. Surgeons removed his right hip in March 2018. Surgeons from both procedures noted that adverse local tissue reactions from corrosion caused the extensive hip problems. Normally, manufacturers specifically design these implants to prevent these types of reactions.

“The mechanism of failure in Plaintiff’s device was exactly the same mechanism of failure that Defendants had marketed and warranted would not occur because of the Zimmer M/L Taper Hip System design and composition,” the lawsuit notes. “It was also the same failure mechanism that the medical and scientific community had been studying and documenting in modular device designs since the 1990s.”

Zimmer Hip Problems Litigation

Currently, Zimmer faces dozens of similar complaints over hip problems involving the company’s metal-on-metal designs. All of the lawsuits allege that the Zimmer M/L Taper Hip Prosthesis and the Zimmer VerSys Hip femoral head are patently defective and dangerously incompatible with a tendency to fret and corrode, generating toxic metallic debris that accumulates in nearby tissue and the bloodstream, leading to blood poisoning, pseudotumors, and the body rejecting the implant. Consequently, the implants fail prematurely, necessitating risky removal surgery.

More than 100,000 patients have received these Zimmer hip replacements throughout the nation. As more individuals realize that Zimmer could have prevented their life-changing hip problems, many expect that the size of the litigation will continue increasing rapidly.

A group of patients filed a motion this past month to centralize all Zimmer lawsuits over hip problems from the VerSys, M/L Taper, and M/L Taper with Kinectiv Technology, requesting the Judicial Panel on Multidistrict Litigation (JPML) to consolidate the claims before District Judge Donovan Frank in the District of Minnesota to streamline pretrial proceedings.

The Zimmer hip problems lawsuits are the latest to emerge in a number of litigations over dangerously defective metal-on-metal hip replacement systems that the JPML has already centralized as their own separate MDLs. These litigations involve the DePuy ASR, DePuy Pinnacle, Biomet Magnum, Wright Converse, Stryker LFit v40, and Stryker Rejuvenate among other systems.

Metal-on-metal hip designs have enjoyed increasing popularity in recent years. However, the hip components carry high rates of failures and hip problems that often result in the need for revision surgery within a few years of implantation.

A new knee implant lawsuit against Stryker and Mako Surgical Group over substantial design defects associated with the Restoris Multi-Compartmental Knee (MCK) implant has been transferred to the federal court system.

Hazel Perry filed the complaint this past month in the Superior Court of Gwinnett County. She alleges that the Mako Restoris MCK system is dangerously defective. The knee implant failed in less than a year after implantation, necessitating a subsequent hospitalization and risky revision surgery.

The manufacturers succeeded in removing the case to the Northern District of Georgia this past week. They petitioned for the transfer due to diversity of citizenship between the parties. Mako is a subsidiary of Stryker. However, their headquarters are in different states. Stryker’s is in Michigan, while Mako’s are in Delaware and Florida. Perry resides in Georgia.

In October 2015, Perry received the Mako Restoris MCK knee implant during a total replacement surgery on her right knee. According to the lawsuit, the knee implant was loosening significantly by May 2016. In June 2016, she required revision surgery to address the substantial damage. The surgical pathology report identified the defective knee implant as causing the failure.

“As a direct and proximate result of the defective Restoris MCK, Plaintiff has suffered catastrophic injuries and damages, including medical expenses, mental and physical pain and suffering, and loss of consortium,” the lawsuit says. “In the future, Plaintiff will require therapeutic medical care and other necessary expenses.”

The Mako Restoris MCK is a knee implant system that Stryker and Mako designed specifically for use as part of robotic-assisted surgery, which Stryker also manufacturers. The Mako robotic arm helps surgeons follow a planned path for removing bone and cartilage in joint replacement surgery.

Knee Implant Litigation

A growing number of individuals are coming forward to take knee implant companies to task for debilitating problems from several different systems that manufacturers have released in recent years. These defective knee replacement systems have unreasonably high failure rates, resulting in necessary knee revision surgery to address problems from the knee implants, including blood poisoning, pseudotumors, and incapacitating pain.

Many of these device failures are due to tibial loosening and tibial base plate failures. Recent problematic knee designs include the DePuy Attune Knee, Exactech Optetrak Knee, and Arthrex iBalance Knee among others.

The District Judge presiding over hundreds of hip replacement lawsuits regarding significant issues with the Smith & Nephew Birmingham Hip Resurfacing System approved specific protocols this week for preserving explanted devices.

Currently there are more than 400 lawsuits against Smith & Nephew in the federal court system over allegations that its metal-on-metal hip designs are patently defective and prone to early failure, necessitating risky revision surgeries to repair the damage, as well as remove and replace the faulty implant. Due to Smith & Nephew’s aggressive marketing techniques and the exceedingly high number of hip replacement surgeries each year, most experts anticipate the litigation could expand exceedingly fast in the coming months.

In May 2017, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal lawsuits involving Smith & Nephew Birmingham Hip Resurfacing (BHR) system defects. The panel centralized pretrial proceedings before Judge Catherine C. Blake in the District of Maryland as part of a federal multidistrict litigation (MDL) to reduce duplicate discovery and circumvent conflicting pretrial rulings that could further delay these injured individuals from taking Smith & Nephew to task for concealing its hip implants' dangerous defects to maximize profits from the devices.

Birmingham Hip Implant Preservation Protocol

Judge Blake issued the case management order Tuesday, approving essential protocol for managing explanted Birmingham Resurfacing implants, dictating how parties and the court will identify, preserve, and handle the evidence going forward.

According to the order, the court expects the parties to make “good faith efforts” to preserve any explanted systems in their possession, as well as those in the possession of non-party medical practitioners, facilities, and hospitals. Furthermore, they are to extend this same effort to preserve any blood, fluid, tissue or serum samples.

Judge Blake also ruled that the parties cannot conduct any testing or analysis without an agreement by all parties or a court order. The court strictly prohibits destructive testing that would damage or destroy evidence without the written consent of all parties or a court order.

Smith & Nephew’s Birmingham hip implant was among the first metal-on-metal hip replacement systems to hit the market. However, serious concerns about the devices' safety were raised before its FDA approval. Wright Medical even tried to stop the device from receiving FDA approval. In 2006, the company filed a citizen’s petition with the FDA, asking the agency to reject the BHR’s application due to substantial concerns over the adequacy of the clinical trials Smith & Nephew was using to obtain premarket approval.

As part of the pretrial proceedings, the court will soon select a small group of representative test cases to prepare for early trial dates. These bellwether trials allow the parties to evaluate the relative strengths and weaknesses of their positions and may eventually help guide Birmingham hip settlement negotiations.

As hip replacement lawsuits continue to mount throughout the federal court system over significant issues with the Zimmer VerSys femoral head and M/L Taper with Kinectiv Technology, the manufacturer is fighting a recent request to centralize the federal hip component litigation for pretrial proceedings.

Currently, Zimmer-Biomet is facing approximately two dozen of hip component lawsuits alleging that the medical device manufacturer exercised gross negligence in designing the implants and continued aggressively marketing the components for use in metal-on-metal hip systems even as catastrophic failures, resulting in painful and debilitating complications, came to light.

Plaintiffs assert that the Zimmer M/L Taper Hip Prosthesis and Zimmer VerSys Hip femoral head are clearly defective and exceedingly dangerous when paired together. The metal-on-metal components are prone to fretting and corrosion, expelling metal debris into the bloodstream to accumulate in organs and localized tissue, resulting in heavy metal poisoning, pseudotumors, tissue death, implant component failure, and the need for additional risky surgeries.

Recent court documents indicate that more than 100,000 of these Zimmer hip replacement systems have been implanted in innocent patients throughout the U.S. As more people become aware that Zimmer knew that the hip implants were significantly dangerous but continued putting patients at risk to maximize profits, experts expect the litigation to expand by leaps and bounds.

Zimmer Hip Component MDL Request and Opposition

This past month, a group of plaintiffs filed a motion to consolidate all Zimmer hip component lawsuits over the VerSys, M//L Taper and M/L Taper with Kinectiv Technology. The group asked the Judicial Panel on Multidistrcit Litigation (JPML) to transfer cases currently pending throughout the federal court system to U.S. District Judge Donovan Frank in Minnesota to better serve judicial efficiency.

Given the inherent similarities regarding questions of fact and law present in all the lawsuits over the Zimmer hip components pending in at least 10 different district courts, plaintiffs assert that centralization is essential to avoid duplicative discovery and conflicting pretrial rulings that can further delay the dissemination of justice for those Zimmer has harmed.

Zimmer filed a response July 11 in opposition to consolidations, arguing that creating a formal hip component multidistrict litigation (MDL) is unnecessary.

“Just 20 federal lawsuits properly within the scope of Plaintiffs’ proposed MDL have been identified for transfer,” the motion states. “Plaintiffs provide no reason to suggest that the pace of filings will increase.”

While Zimmer firmly opposes the motion to consolidate, the manufacturer suggests that if the JPML does establish an MDL, then the litigation should be transferred to U.S. District Judge Sarah Evans Barker in the Southern District of Indiana.

Hip Component Litigation

In recent years, the JPML has opted to centralize similar metal-on-metal hip replacement lawsuits in separate federal MDLs, including DePuy ASR, DePuy Pinnacle, Stryker LFit V40, Stryker Rejuvenite, Biomet Magnum, Wright Conserve, and other defective systems.

Although metal-on-metal hip designs have enjoyed increasing popularity in recent years, the hip systems have been linked to extraordinarily high failure rates and painful complications that are often irreparable and necessitate revision surgery within a few years of implantation.

The JPML will likely hear oral arguments for the motions during a September 27, 2018, hearing in San Francisco, California.

 

 

A new lawsuit alleges that Johnson & Johnson and its DePuy unit released their Pinnacle hip replacement system without any clinical trials to ensure that the implant was safe or even worked, generating massive profits while using patients as guinea pigs for the ultimately defective hip system.

Karolyn White and her husband, Gervis White, filed the complaint July 10 in the Eastern District of New York. White indicates that she received the Pinnacle hip implant in June 2009 during total hip replacement surgery. She maintains that J&J and DePuy could have saved countless individuals from painful, debilitating, and sometimes irreparable injuries that usually require additional risky surgeries to address in any capacity if only they had exercised any level precautionary safety testing before placing the device in the stream of commerce.

The attorney who led the legal team that won a staggering $1.04 billion verdict against J&J and DePuy in late 2016 placed the blame for egregious injuries directly on the companies cutting corners to rush the device to market.

“The problem is that DePuy, Johnson & Johnson Pinnacle metal-on-metal was never tested in one single human being before they started selling it,” he said. “And the company basically made guinea pigs out of everyone who received it.”

Consequently, White was a participant in an experiment-for-profit gone terribly awry. She suffered catastrophic Pinnacle hip implant failure that will follow her for the rest of her life. Because of the defective Pinnacle device, White developed “serious and dangerous side effects, including, but not limited to component loosening, component mal-alignment metallosis, pseudotumors, infections, fracture of the bone, dislocation, metal sensitivity and pain, irritation and discomfort, as well as the need for additional procedures to remove and replace the device, as well as other severe and permanent health consequences,” her lawsuit states.

FDA Loophole Allowed Pinnacle on the Market Without Clinical Trials

J&J and DePuy allegedly rushed the metal-on-metal hip implant to market without ever testing it on humans, pushing for faster profits at the expense of patient safety. Like many other medical device manufacturers, Depuy and J&J used a regulatory loophole to fast-track the metal-on-metal Pinnacle implant through the FDA clearance process.

The FDA’s 510(k) regulatory pathway allows medial device manufacturers to skip clinical trials, provided that the manufacturers can demonstrate that devices are “substantially equivalent” to ones already in use.

In 2013, public health experts appealed to the FDA to close the loophole, citing that human studies “might have identified the high revision rate of the ASR,” another metal-on-metal hip replacement device based on Pinnacle's design that DePuy recalled in 2010 due to skyrocketing early failure rates. Ultimately, J&J and DePuy reached a $2.5 billion settlement agreement to resolve thousands of ASR lawsuits.

“As thousands of Americans are painfully learning, there are unknown risks with devices that enter the market without clinical data showing safety and effectiveness, and implanted body parts cannot be recalled as easily as defective auto parts," the experts wrote.

As concerns over metal-on-metal hips continued to grow, the FDA began taking measures to close this regulatory loophole in 2013. The agency noted the “unique risks” inherent to all metal-on-metal implants and said it would begin to require manufacturers to prove implant safety through clinical trials or stop selling them. Unsurprisingly, many manufacturers simply stopped selling the devices, quietly removing the products from the market and sneaking off like thieves in the night with their ill-begotten profits from thousands of human guinea pigs.

Pinnacle Hip Problems

A one-time “consultant surgeon” for DePuy, Dr. Tony Nargol, testified at a recent trial that he tried to warn DePuy that metal-on-metal Pinnacle hips were failing at high rates at his England hospital.

Dr. Nargol detailed “horrible, rotten, damaged flesh” he’d found inside some patient’s bodies while removing and replacing their Pinnacle hip implants.

“It’s quite unbelievable in the bad cases,” Dr. Nargol said. “You go in there. You touch a muscle, and it just disintegrates. It just liquefies. It’s just destroyed in your hand.”

The surgeon testified that DePuy was in “total denial,” when he reported the Pinnacle hip’s horrific side effects. Instead, the company ignored his warnings and put the blame on doctors. Dr. Nargo’s hospital eventually issued its own recall, checking patients for pseudotumors and high levels of toxic cobalt and chromium from the metal-on-metal wear releasing metallic debris into the patients’ bodies.

Dr. Herbert Huddleston also testified in the trial, telling jurors that even he did not know that Depuy had not tested the implants in humans and detailing grotesque findings in the high numbers of revisions he had performed due to Pinnacle hip failure.

“The bone and soft tissue around the hip start to look like pieces of cheese…except pitch black pieces of cheese,” Dr. Huddleston told Eyewitness News of the damage from the Pinnacle hip implants. “Sometimes we get in there and it looks like it’s filled with old oil that you’ve drained from your car.”

DePuy’s Reaction to Pinnacle Hip Catastrophic Failures

By 2004, DePuy knew from its own investigation that its metal hip implant released metallic debris into the body, settling into major organs and killing "the bone and soft tissue around the hip.”

In 2010, on of DePuy’s own Pinnacle design surgeons, who received royalties from Pinnacle sales, wrote to marketing executive expressing concern about the company’s “head in the sand response” to metal hip problems, saying that it was “unethical to continue to market the product until the issues are elucidated. These products are harming patients.”

In response to a 2008 “Complaint Crisis” due to an increasing number of patients undergoing painful revision surgeries to remove and replace the defective implant, DePuy created a marketing PowerPoint with creative solutions to the ongoing crisis.

“Let’s train our sales force not to report revisions,” the DePuy PowerPoint suggested. “And if our sales force will not report the revisions, it will make us look better with the FDA, it’ll make us look better compared to our competitors.”

Meanwhile, the hip remained on the market for five more years as thousands suffered from entirely preventable injuries, as DePuy and Johnson & Johnson made billions.

 

bone cementA new lawsuit indicates that DePuy knee replacement SmartSet GHV bone cement is dangerously defective, resulting in mechanical loosening of implants, premature failure, and additional risky surgical procedures.

Osa Green filed the complaint against Johnson & Johnson and its DePuy unit this past month in the Western District of Louisiana. Green alleges that the DePuy SmartSet GHV Bone Cement is not only defective but incredibly dangerous. Furthermore, she indicates that the manufacturers concealed these defects to protect the product’s profitability. Green maintains that she would not have consented to the bone cement for her knee replacement surgery if the manufacturers had disclosed known problems with the product.

In August 2016, Green underwent right total knee replacement surgery. During the procedure, she received a DePuy PFC Sigma knee replacement system. Her surgeon used DePuy SmartSet Bone Cement to bond the components together. As a result of the defective nature of the bone cement, Green soon began experiencing severe, chronic pain, instability, discomfort, and difficulty walking.

Green claims that the asceptic loosening of the bone cement caused the implant to fail prematurely. By August 2017, a bone scan showed that the tibial baseplate was loosening. A month later, she had to undergo revision surgery. However, her lawsuit indicates that revision surgery has significantly lower success rates with much higher risks.

“Unfortunately, a failed total knee prosthesis often causes severe bone loss,” the lawsuit states. “Therefore, revision surgeries on a failed total knee due to loosening often require reconstruction of the severe bone loss.”

“The success rate of a revision surgery is much lower than that of the initial total knee replacement and the risks and complications are higher, including limitations in range of motion, the ability to walk, and even death,” the lawsuit continues.

DePuy SmartSet GHV Bone Cement Defects

DePuy SmartSet GHV Bone Cement is part of a class of bone cements known as high viscosity (HV) cements. Some studies have suggested that these cements are less effective than low or medium viscosity cements. The lawsuit cites a Journal of Anthroplasty study’s findings that HV bone cements, like SmartSet GHV, are causing tibial component debonding even in implants that are normally reliable.

“The primary reason the SmartSet GHV Bone Cement fails is mechanical loosening. The mechanical loosening is caused by a failure of the bond between the tibial baseplate at the implant-cement interface,” the lawsuit states. “Mechanical loosening means that the attachment between the artificial knee and the existing bone has become loose. Such loosening will eventually result in failure of the device.”

When bone cement begins to fail, the knee replacement components loosen considerably and can cause extreme pain and loss of mobility, as well as wear away the bone. This continues until the pain becomes unbearable, or the device fails taking knee function along with it. Consequently, most decide to undergo revision surgery to replace the implant entirely.

Tibial baseplate loosening is familiar ground for DePuy as it has affected numerous of its other knee implants. This includes the company’s DePuy Attune Knee that is the subject of hundreds of lawsuits over common catastrophic implant failures. In 2016, the Journal of Knee Surgery published a study, noting a spike in DePuy Attune Knee loosening and failures with concerns directed at problems at the implant-cement interface.

 

A new case report details substantial risk factors from knee revision surgery, highlighting how the procedure to remove a knee implant following failure and the subsequent use of antibiotic spacers to fight off infection may have caused a 65-year-old man to suffer acute kidney failure.knee revision surgery kidney failure

The medical journal Case Reports in Nephrology published the report's findings this past month. University of Illinois at Chicago researchers indicate that this case is just one example of a common knee revision surgery complication, emphasizing the significant risks of this typical two-stage procedure.

Researchers took an in-depth look at an individual’s case, who had a long history of multiple periprosthetic left knee infections. He underwent a revision surgery to remove a failed knee implant. Doctors supplemented the initial surgery with the temporary use of antibiotic spacers to prevent infection.

When surgeons opened his knee, they initially irrigated and debrided the infected cement spacers located on the femur and tibia. Then, the surgery team replaced the contaminated spacers with a cement concoction of tobramycin and vancomycin antibiotics. The patient developed non-oliguric kidney injury within two days of the surgery. The condition quickly advanced to kidney failure, necessitating hemodialysis. Eventually, surgeons had to remove the antibiotic spacer.

“Two-stage revision total knee arthroplasty (TKA) is the standard of care for prosthetic joint infections. The first stage involves removal of the infected prosthesis and placement of an antibiotic impregnated cement spacer; following a period ranging from 4 weeks to 6 months, the spacer is then removed and replaced with a permanent prosthesis,” the researchers wrote. “The advantage to this approach is that antibiotic impregnated spacers provide supratherapeutic levels in the joint without toxic accumulation in serum. However, it remains important for physicians and pharmacists to be aware of antibiotic associated complications in knee revisions.”

Knee Revision Surgery Risk Studies

The case report comes on the heels of another recent knee revision surgery risk study. In April, The Clinical Journal of Pain published a study indicating that three quarters of TKA patients report chronic pain up to six months following surgery.

In February, The Journal of Arthroplasty published research from the OrthoCarolina Hip & Knee Center, suggesting that obesity, abnormal bone structures, and bone loss all contribute to catastrophic knee implant failures. The researchers studied data on 1,106 TKA revision surgeries from 2004 to 2017, focusing on radiographic analysis of 27 cases from their own institute. Researchers found that 26 out of 27 of these patients had preoperative bone deformities. The average body mass index was 38, which indicates severe obesity. Also, 25 out of 27 had radiographic medial tibial bone loss prior to knee implant failure.

Physicians often recommend knee replacement surgery as treatment for bad joint problems. However, these recent findings compound already elevated concerns over significant design problems with several popular knee implants.

A growing number of individuals are stepping forward to take knee implant companies to task for debilitating problems from several different systems that manufacturers have released in recent years. These defective knee replacement systems have unreasonably high failure rates, resulting in necessary knee revision surgery to address problems from the knee implants, including blood poisoning, pseudotumors, and incapacitating pain. Many of these device failures are due to tibial loosening and tibial base plate failures. Recent problematic knee designs include the DePuy Attune Knee, Exactech Optetrak Knee, and Arthrex iBalance Knee among others.

As other plaintiffs anxiously wait for the Judicial Panel on Multidistrict Litigation (JPML) to decide if it will centralize the growing number of hip replacement lawsuits pending in the federal court system over debilitating damage from the Zimmer M/L Taper with Kinectiv and Versys femoral head, a Pennsylvania woman will get her day in court July 31 to take the medical device company to task for not prioritizing patient safety.

Marilyn Adams filed the complaint in February 2017 in the Eastern District of Pennsylvania. Adams alleges that Zimmer failed to properly test its hip replacement components, including the M/L Taper Hip Prosthesis, before releasing them into the stream of commerce, putting hundreds of thousands of patients at substantial risk for serious injuries that require additional risky surgeries to address.

Adams underwent hip replacement surgery in January 2011 and received a Zimmer M/L Taper Hip Prosthesis. After experiencing escalating painful complications, Adams required revision surgery in February 2015 to remove and replace the defective hip implant. Her surgeon noted extensive evidence of adverse local tissue reactions caused by metallic debris from the metal-on-metal hip replacement. Unfortunately, surgery was only able to repair so much of the damage. Adams indicates that many of her injuries are permanent and still does not know when she’ll even be able to resume any level of “normal” activity.

“Plaintiff was caused to suffer and sustain injuries of a permanent nature; to endure pain and suffering in body and mind; to expend money for medical care in the past and in the future; furthermore, Plaintiff was unable to and will in the future be unable to attend to her normal affairs and duties for an indefinite period of time,” the lawsuit states.

Zimmer’s Attempts to Derail Hip Replacement Trial

On May 29, Zimmer filed a motion for summary judgement to prevent the trial from moving forward. The company argued that Adams had awaiting too long to file her complaint. According to the motion, she should have known of Zimmer’s role in her injury in January 2015. Pennsylvania has a two-year statute of limitations. Consequently, Zimmer maintains that Adams missed her window by about a month when she filed in February 2017.

On June 22, Zimmer filed a motion for bifurcation. The company asked the court to try to the case in two phases. First, the court would deal with the statute of limitations issue before moving on to the liability and damages claims at the heart of Adams’ complaint. Zimmer further requested two separate trials with two separate juries to resolve the case issues should the court not rule in favor of its summary judgement motion.

According to recent court filings, more than 100,000 thousand individuals have received these Zimmer hip replacement components throughout the United States. In recent months, nearly two dozen of these individuals have filed complaints against Zimmer-Biomet over debilitating complications from the M/L Taper with Kinectiv technology when paired with the Zimmer Versys femoral head. These injured individuals claim that the metal-on-metal design causes implant failure, debilitating pain, and heavy metal blood poisoning as corrosion causes carcinogenic metallic debris to accumulate in local tissues and be dispersed throughout the blood stream.

Zimmer Hip Replacement Potential MDL

The federal complaints all raise similar claims that the Zimmer M/L Taper Hip Prosthesis and Zimmer VerSys are patently defective and unreasonably dangerous when used together as they are inherently incompatible. The resulting metal-on-metal friction causes the components to fret and corrode, creating metal debris that collects in the patients’ blood and local tissues, resulting in the body rejecting the implant and necessitating further surgery to remove the device.

This past month, several plaintiffs filed a motion with the JPML to establish a federal multidistrict litigation (MDL) in Minnesota federal court. They claim that centralization of the federal lawsuits pending nationwide before one judge will help streamline the proceedings. Among other things, consolidation reduces duplicative discovery and circumvents conflicting pretrial rulings, serving the convenience of witnesses, parties, and the judicial system. The panel will likely schedule oral arguments on this motion during a September 27, 2018 hearing in San Francisco, California.

The hip replacement lawsuits over the Zimmer M/L Taper Hip with Kinectiv and Versys components join numerous other similar litigations over other metal-on-metal hip replacement systems. The JPML has already centralized many of these litigations into their own MDLs, including DePuy Pinnacle, DePuy ASR, Biomet Magnum, Stryker LFit v40, Wright Conserve, and Stryker Rejuvenate among others.

Metal-on-Metal hip designs have become exceptionally popular in recent years. However, these designs appear to have high rates of failure and significant problems that often result in the need for revision surgery within a few years.

 

According to recently released documents and interviews with former Olympians, sexual abuse survivors, USA Swimming officials, safe sport advocates, and some of USA Swimming’s leading financial benefactors, USA Swimming missed numerous opportunities to overhaul a perverse American swimming culture where top officials and coaches accepted and even enabled leaders within the sport sexually abusing underage athletes.

Congressional committees have been investigating sexual abuse in Olympic sports. However, these investigations have primarily focused on the issue within gymnastics. However, allegations of coaches sexually abusing young USA swimmers are just now starting to break the surface.

Former Olympic swimmer Ariana Kukors Smith came forward earlier this year with sexual assault allegations against her long-time USA Swimming national team coach, Sean Hutchison. According to Kukors Smith, Hutchison began “grooming” her for a sexual relationship when she was 13 after he became her coach. By the time, she was 15 or 16, USA officials, including former executive director Chuck Wielgus, knew about the inappropriate relations

“I never thought I would share my story because, in so many ways, just surviving was enough,” Kukors Smith said. “I was able to leave a horrible monster…I’ve realized that stories like my own are too important to go unwritten.”

Currently, there are more than 150 coaches on USA Swimming’s permanently banned list. Almost all the coaches on the list are men found guilty of violating the organization’s code of conduct, including provisions to prevent “inappropriate sexually orientated behavior or action.”

However, Chris DeSantis, a New Jersey swim coach, says the actual number is probably much higher than the public list would suggest.

“I would estimate the actual number of coaches who have done something that they should be banned for is north of 1,000,” he said.

USA Swimming Sexual Abuse Lawsuit

In late May, Kukors Smith filed a formal lawsuit in Orange County Superior Court against Hutchison for sexually assaulting her while she was a minor. She also named USA Swimming and the U.S. Olympic Committee in her lawsuit, alleging that top officials knew her longtime coach was sexually abusing her and did nothing to stop him. Kukors Smith maintains that USA Swimming ignored the “open secret” around the pool deck and failed to properly investigate even after The Washington Post reported about an inappropriate 2010 relationship between Hutchison and an unnamed swimmer.

Kukors Smith alleges that veteran Olympic swimming coach Mark Schubert covered up Hutchison’s illegal sexual conduct. She also maintains that, as far back as 2005, top USA Swimming officials, including Wielgus, Pat Hogan, and Murray Stephens, were “well aware that Hutchison was involved in an inappropriate relationship with [Kukors Smith].

Hogan resigned from USA Swimming in February. Wielgus died of colon cancer in April 2017. Stephens, Michael Phelps’ childhood coach, is no longer an executive at USA Swimming but still operates a swim club in Baltimore, MD.

USA Swimming’s “Sham” of An Internal Investigation

As concerns surrounding Hutchison’s conduct continued to escalate, the professional swimming organization launched its own investigation.

“To say that the so-called investigation to follow was a sham would do it too much justice,” Kukors Smith’s attorney said.

The investigation was headed by one of Hutchison’s former flames, Susan Woessner. Woessner was USA Swimming’s Safe Sport director. According to Kukors Smith’s attorney, she conducted “absolute bare minimum work and handed over prearranged results to Mr. Wielgus who then boldly announced to the media that the matter had been ‘fully’ investigated and that there was ‘no evidence’ of anything untoward.’"

“USA Swimming’s leaders knew that these were all lies,” he continued. “But they did not care because their golden brand and thus their money generation power had been preserved. And Ariana was viewed as collateral damage.”

Due to her previous relationship with Hutchison, Woessner should never have been considered to oversee the investigation. Woessner resigned in February from the swimming organization after acknowledging a romantic relationship with Hutchison prior to the 2010 investigation that she had failed to disclose at the time.

“Ms. Woessner’s prior close physical and sexual relationship with Hutchison rendered her biased and completely unable to conduct any semblance of an objective inquiry,” the lawsuit states.

While USA Swimming’s investigation found no wrongdoing, Kukors Smith claims the organization should have known about the improprieties. She began swimming for Hutchison when she was 13. By the time she was 15, Hutchison began sending inappropriate text messages. Kukors Smith alleges she was 16 when Hutchison first asked her to text naked photographs. Then, the two began a physical relationship that included “everything but intercourse” until she was 18.

SCNG USA Swimming Sexual Misconduct Investigation

As USA Swimming’s complacency continued to raise more questions than the organization was willing to answer, Southern California News Group launched its own investigation and uncovered thousands of pages of documents that make the organization’s failure to effectively address sexual abuse glaringly clear.

The two decades after the athletic organization hired Wielgus were resplendent in record-shattering Olympic success in stark contrast with the oganization’s inability to check swimming’s rampant sexually abusive culture, turning hundreds of young girls into sexual abuse statistics.

The documents covered nearly a quarter-century and paint a picture of how top USA Swimming officials and coaches enabled the sport’s culture of sexual abuse and misconduct by undermining reforms that other sports have long accepted and refusing to investigate allegations of abuse even when multiple sources came forward with evidence.

“Those in power need to remember that a report or a rumor is not just that,” Kukors Smith said in a statement. “Behind that report is a child who desperately needs help. That child is depending on USA Swimming to do the right thing and report and properly investigate claims.”

SCNG’s Investigation of USA Swimming Primary Claims

  • Top USA Swimming executives, officials and coaches knew of numerous sexual predators in coaching positions for decades and did nothing.
  • Since 1997, at least 590 alleged victims of sexual abuse have been identified in the USA Swimming world. At least, 252 coaches and officials have been arrested, charged or disciplined by USA Swimming for sexual assault or sexual misconduct against athletes under the age of 18. In four of the past six years, “at least 20 swim coaches have been arrested, charged or convicted for sex crimes ranging from rape, sexually assaulting a 3-year-old and 8-year-old, statutory rape, child pornography to secretly videotaping underage swimmers in locker-rooms.”
  • At least 30 USA swim coaches or officials have been “flagged” by USA Swimming after sexual abuse or child pornography allegations or arrests. Most of the coaches and officials on the flagged list continued working in the swim world. Some officials were not banned from the sport even after being convicted of felonies.
  • USA Swimming routinely settles sexual abuse cases before they hit the public radar. Between 2006 and 2016, USA Swimming spent $7.45 million on legal fees. It’s not clear how much of that money was spent to settle sexual abuse cases, but the report notes that USA Swimming “arranged settlement agreements in at least three states with victims of alleged sexual abuse by swim coaches before the cases were even filed with a court.”
  • USA Swimming shelled out over $75,000 to lobbying firms to stop California legislation that would have made it easier for sexual abuse survivors to sue their attackers and their affiliated organizations.

USA Swimming Ignored Warnings

Confidential documents and court records show that Kukors Smith’s molestation is far from an isolated case. Wielgus and other top officials routinely ignored dire warnings about the scope of sexual abuse in swimming.

“I would hate to see our organization ever in the predicament of the current Roman Catholic Church — protecting child molesters!” wrote Richard Shoulberg in an August 2003 email to members of a USA Swimming task force on sexual misconduct. Shoulberg is a Hall of Fame coach of Olympic medalists and world record holders.

However, the organization turned a blind eye to these assertions for decades, leaving young, impressionable girls with big, Olympic dreams to predatory wolves like sheep to the slaughter. Hopefully, now that women are starting to take action against USA Swimming and the sexual predators that it harbors, the public outcry will be enough for the organization to begin instituting some real change.

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