Exactech recall cases are being handled by our lawyers and our co-counsel, in all 50 states. Due to our local roots right here in Central Illinois, our law firm is evaluating Exactech ankle, knee, and hip implant failure cases from Exactech victims who were harmed by a defective Exactech system. Our review process is free and confidential. The team of medical reviews at Holder Law Group can analyze your potential claim quickly due to our experience and connections within the industry.
Don't forget your rights. Contact our lawyers by calling 217-840-2652 or contacting us online. Unless you receive financial compensation, you will not be charged any fees.
Exactech has recalled thousands knee, hip and ankle implants. Exactech lawyers received letters from most patients who called our Exactech lawyers about the recall. They want to file a claim as they have had or will need revision surgery. These sorts of surgeries can be life-changing and most of the time the doctor is not at fault.
Exactech, a medical device company, recently announced a massive recall of all its replacement hip (and ankle) implant systems manufactured after 2004. After discovering defective packaging, Exactech announced the recall. The defective packaging was causing the polyethylene insert to fail. Exactech's knee implants were prematurely destroyed by this packaging defect. Many patients will have to undergo corrective surgery because of this replacement failure.
This is particularly true for Illinois victims, especially those in Central Illinois and who received their implants from OSF Healthcare, Carle Hospital, Carle Clinic, and other Central Illinois facilities.
Exactech knee surgery patients who received a failed Exactech implant and are now in need of revision surgery may have the right to file a lawsuit. Exactech lawsuits are being filed by our clients to seek financial compensation for their medical and pain expenses. Because victims suffered pain and suffering, and other damages, because the product was unnecessarily flawed.
The Exactech implant recall MDL Judge will hold a status conference at which he is expected set deadlines for parties to submit joint discovery and case management plans.
Lawyers for both sides presented a joint status report Tuesday to Judge Garaufis, outlining their progress in certain administrative tasks as well as the status of discovery in the 86 cases in Florida state courts.
According to the report, master discovery requests from the Florida plaintiffs were served in December. The deposition of Exactech’s chief medical officer (Dr. Sharatkusuma) is scheduled for February 16, 2023.
Hursey v. Exactech, Inc. et al. Exactech recall lawsuit (1:22cv-07893) is another example of an Exactech implant recall lawsuit that was filed in the Exactech recall action MDL in Eastern District of New York.
Exactech's Truliant Knee System is the implant product in question in this case. It was recalled in February 2022. Hursey had Truliant placed during knee replacement surgery in August 2021. By August 2022, the polyethylene insert had failed and required revision surgery.
Hursey's primary cause of action is strict liability for a manufacturing defect. However, there are other claims.
Hursey, Inc. et. al. is a good example of an Exactech recall suit that was recently filed in the Eastern District. This case concerns Exactech’s Truliant Posterior Supported Knee System.
Mr. Hursey had Truliant installed during knee replacement surgery. Later, he had to have revision surgery because of worsening pain and swelling. It was found that Hursey's swelling and pain were caused by premature failure of the Trulia's polyethylene insert.
Hursey's Exactech recall lawsuit outlines multiple causes of action against Exactech. The primary theory is strict liability due to defective manufacture.
There are currently 80 Exactech lawsuits in Florida pending in addition to the Exactech recall lawsuits that are pending in federal court MDL.
Exactech's lawyers sent last week a letter to Judge Garaufis, highlighting the importance of coordination in discovery in both federal and state court proceedings. Exactech requested coordination of federal-state discovery in Florida. This motion is being opposed by Exactech lawyers for the plaintiffs.
Judge Garaufis, who was at the first status conference regarding the Exact implant recall MDL agreed with plaintiffs that it was necessary to take the steps to catch up to the Exactech state MDL in Florida. Judge Garaufis approved the request to allow Exactech recall cases from new Exactech to be filed directly in MDL at the conclusion of the conference last week. This makes it much easier for everyone.
He also gave several deadline extensions for the MDL initial housekeeping measures. A group of 27 lawyers was appointed by the judge to various leadership positions on the plaintiffs’ litigation leadership committees. There will be a liaison counsel and an executive committee.
This week will see the first status conference in Federal Court's Exactech recall MDL. In Florida, there is an MDL version that is being used in state courts.
With an initial bellwether trial scheduled for next year, the Florida state MDL is already ahead of federal MDL in terms timeframe. Many lawyers from both sides have urged the federal MDL judge to speed up the process.
Separate plaintiffs' Exactech lawyers have written to Judge Nicholas G. Garaufis asking him to immediately allow direct filings in federal MDL and to name attorneys to the leadership committee of the plaintiffs.
Recently, the Exactech recall lawsuits filed in federal court were consolidated into a new MDL class action. 50 Exactech lawsuits regarding recalled ankle and hip implants were filed in Florida state courts. They were consolidated into an MDL class action.
A state Exactech lawsuit may be tried in state court before the federal class action. The Florida judge who presided over the Exactech state lawsuits in Florida issued an order scheduling the first trial for November 2023. This trial will be de facto a bellwether trial for all Exactech lawsuits.
Officially, the JPML has consolidated Exactech joint replacement recall lawsuits in a new class action MDL. All lawsuits regarding the Exactech ankle replacement and knee replacement systems will now be centralized within the Eastern District.
Judge Nicholas G. Garaufis has been given the MDL. Judge Garaufis, a Senior Judge, was appointed to the bench by President Clinton in 2000.
Exactech did not oppose the consolidation. However, the joint replacement company had been pressing for the MDL in the Northern District of Florida, where it is headquartered. Judge Garafis will oversee the Exactech recall cases.
The pace of Exactech implant recall lawsuits is rapidly increasing with the imminent launch of a new MDL. Exactech has been the subject of 75 recall lawsuits in federal courts since June 1. These cases are often filed by multiple plaintiffs in groups. With 75 new cases filed in the Eastern District of New York, it continues to be the most popular venue. Not coincidentally, many of our Exactech attorneys are able to assist clients who have had surgery at the Hospital for Special Surgery, New York City.
The U.S. The U.S. It is a significant step in the right direction for victims to receive fair settlement amounts for the damage they have suffered due to the Exactech recall.
Exactech's recall has just grown. Exactech had to expand its recall of hip and ankle replacement implants. Exactech issued a recall notice to healthcare providers last week, advising them that the February implant recall was being extended to include additional 40,000 acetabular liner components for its Connexion, Novation and other brands of implant systems.
The JPML is currently considering whether to combine the increasing number of Exactech recall lawsuits into one new class action MDL. Our lawyers are unable to imagine a situation where an Exactech lawsuit would not be filed. We anticipate the court to rule within this month.
Exactech's lawyers submitted a response in writing to the JPML's recent MDL motion. Exactech informed the panel that it supports consolidating all Exactech recall lawsuits in federal courts into a new MDL. Exactech agreed to the Eastern District preference of New York as the venue preference for the plaintiffs. This should almost guarantee that the JPML will form a new Exactech Class Action lawsuit to handle these recall cases.
Exactech has been remanding all of its ankle and knee replacement implant systems for nearly four months. However, the vast majority of patients who were affected by the recall have not been notified.
Exactech sent an explanatory letter to orthopedic surgeons in February to inform them of the recall. Exactech did not make any further attempts to contact patients beyond providing a sample patient letter. Exactech has notified only a small number of patients who have Exactech defective implants. This means that there are approximately 150,000 of these patients.
Exactech has not filed a class action lawsuit against it, and new recall lawsuits are still relatively slow. Nine new product liability lawsuits against Exactech were filed in federal court during May. In April, nine Exactech recall cases had been filed.
Exactech recall affected approximately 150,000 patients. Exactech left the notification letters up to the individual doctors to inform patients. However, a large number of these patients are still unaware of the recall. Exactech recall lawsuits will likely increase in number by the end the summer.
This slow pace delays the Exactech class action lawsuit that will deal with all these lawsuits. Exactech lawyers waited until enough lawsuits were filed before they could go to the MDL Panel to seek a class action.
A group of Exactech Knee Implant Recall Plaintiffs filed a motion to the Judicial Panel on Multidistrict Litigation, June 2022, for a new MDL Exactech Class Action lawsuit to be created for the consolidated handling all future Exactech recall lawsuits.
Patients who received defective ankle and knee replacements from Exactech have been filing product liability lawsuits since February's Exactech recall announcement. According to the JPML motion, 27 Exactech recall cases are currently pending in 11 federal districts.
According to the motion, the Eastern District of New York is suggested as a potential venue for the Exactech lawsuit. Exactech is likely to request the Northern District of Florida, where its headquarters are located. Update: New York prevailed.
Exactech, a global medical equipment company, is based in Gainsville. Exactech was established in 1985 and has been a leader in the development of surgical implant systems that can be used in joint replacement surgery.
Exactech began a nationwide recall in August 2021 of all its ankle and knee replacement implant systems made after 2004. Nearly 150,000 U.S. knee replacement implants are affected by the recall. Exactech's implant systems are used for knee replacement surgery. This is total knee arthritis ("TKA")). TKA knee replacement surgery can be used to alleviate severe arthritis pain and also to correct deformities and trauma to the knees.
These are the Exactech products that were recalled:
SystemRelease DateOPTETRAK(r)1994OPTETRAK Logic (r)2009TRULIANT(r)2017VANTAGE(r)2016
Exactech initiated the recall after discovering that the vacuum seal packaging used in its knee replacement systems had a defect which caused the polyethylene insert to oxidize prior to use. TKAs are made up of polyethylene. These inserts can't be exposed to oxygen during packaging or storage. The chemical reaction of oxygen exposure to polyethylene inserts can cause premature wear and degradation.
Polyethylene inserts should be treated with great care when being packaged, stored, and processed. They will deteriorate if they are exposed to oxygen. This is what happened for many of you reading this. What does a TKA experience when an insert becomes brittle? The knee of the patient is no longer able to function properly with the knee replacement system. This causes discomfort and loss of function.
Over time, this causes excessive friction and wear to the polyethylene inserts. Exactech's knee replacement systems are at risk of premature failure due to this. This often leads to the need for revision surgery.
Exactech patients who suffered failure of the Exactech knee replacement system because of this manufacturing defect felt significant pain and limited mobility in their knees. The knee replacement system eventually failed and the patient must have corrective revision surgery. Anyone who has undergone knee surgery will not want to have it again.
Exactech sent a letter to doctors about the recall. Exactech sent a letter to doctors advising them to stop using Exactech implants for knee and ankle replacements. Hospitals and doctors are also asked to return any recalled devices. This was an honest letter, as far as the letters go. Exactech has admitted the problem and is now falling on its sword.
Patients who have had an Exactech knee system implanted in their surgery are urged to consult their doctors. Exactech implant patients should be kept in a list by doctors so that they can be closely monitored for any signs of possible insert failure.
Exactech also provided doctors a draft letter that they could send to their patients. You may have already received this exact letter. It explained the Exactech recall and was not much different than what our lawyers had explained.
Exactech ankle or knee replacement implant system may fail if there are signs such as pain, swelling, inability bear weight, grinding in the joint or instability in the knee and ankle. To evaluate the Exactech implant's status, surgeons will order X-rays.
Exactech, a medical device manufacturer, has a legal obligation that ensures their products are safe for their intended purposes. Exactech's recall notice admits that Exactech's ankle and knee replacement implants were defective. This means that Exactech will not be held liable for any injuries or damages.
If an Exactech Knee Replacement was implanted after 2004, then anyone may be eligible to file a product liability suit. A successful Exactech recall lawsuit could award damages to plaintiffs for pain and suffering, medical expenses and lost wages.
Exactech settlements are more likely to be reached if there is a valid claim than if there is a trial. The evidence Exactech made is not limited to the plaintiffs' lawyers. These cases are strengthened by Exactech's admissions after the recall.
Exactech's knee replacement system has a history of high failure rates, and other problems. Exactech obtained 501(k), abbreviated FDA clearance, for its knee replacement systems in order to avoid the FDA review and approval process. Exactech knew from the beginning that its OPTETRAK knee-replacement implant system had a much higher failure rate than other devices.
Exactech's Manufacturer & User Facility Device Experience (MAUDE), reported that the devices were failing at an unusually high rate when compared to other implant types. Exactech was aware of an increase in incidents several years back from the time it received MAUDE reports. Exactech implants are the subject of so many complaints in MAUDE, that even a 500-word search is impossible. It cannot display all Exactech complaints.
Exactech was sued in product liability cases by users who suffered premature implant failures as a result of these failures. We have returned to those lawsuits and our lawyers have read them. Exactech's knees were failing was not explained by the attorneys who filed these lawsuits. They were circling the problem. Exactech lawyers didn't understand the reason Exactech knees failed.
Exactech's early lawsuits involving Exactech's implant parts did not know that this high failure rate was due to the unique "finned design" that Exactech implants have. Exactech was accused of not warning consumers about the risk in these knee replacement lawsuits. Instead, they pursued a silent recall that slowly replaced the finned design and did not recall them. Exactech's recall revealed the oxygenation problem that caused the wear of these components.
Exactech's decision to phase out the finned design did not reduce the unusually high failure rate of their implant systems. They began to investigate other flaws, which eventually led to the recall notice being issued for the defective vacuum-seal package.
Exactech obtained 501(k), clearance from FDA multiple times for its Optetrak and Optetrak Logic total knee replacement implant systems. These systems and components were manufactured between 1994 and 2017.
Fast-track approval is also known as FDA 501(k), because it doesn't require the manufacturer prove safety or effectiveness. This pathway, also known as "premarket notification", requires that the manufacturer explains the device's substantial equivalent to a preMDA predicate device.
The FDA could then "clear the device" for sale in the United States. The FDA cleared all components of Plaintiff's Optetrak Device for marketing under the 510 (k) process. However, they were not given full FDA approval or clearance.
The biggest loophole in 510(k), is that the device manufacturer can prove that the untested device is "substantially equal" to a predicate device, which has been on the marketplace for many years. Full testing is not necessary. These 510(k), products are often brought up by product liability lawyers. Medical devices that have not been fully tested are more likely to be defective.
The Optetrak Total Knee System is Exactech’s most popular knee replacement implant. Opterak was the subject of more than half of all calls to Exactech's lawyers in the first three months after the recall. We will now focus on Opterak, but most of the information our attorneys provide about the merits and implications of Operterk claims can be applied to all Exactech lawsuits.
The Opterak is a semi-constrained cemented knee joint prosthesis. It is made up of a mixture of metal-based and polyethylene components. As you can see, the Optetrak consists of the following components: a patellar cap and femoral caps, tibial insert and tibial tray. The patellar cap is made from polyethylene, as well as the tibial insert.
Exactech promoted the Optetrak's "first-in class" product materials and claimed that the Optetrak achieved excellent long-term clinical results. Exactech promoted Optetrak's clinical success over nearly three decades and demonstrated outcomes for patients. This was due to the improved design of the polyethylene insert components.
Optetrak's performance has been poor when compared with its competitors. The Optetrak was identified by the Australian Orthopaedic Association as having a higher than expected rate of revision. The 2020 Australian National Joint Replacement Registry shows that the rate of revision for total knee replacements using an Optetrak is far higher than international guidelines.
Exactech knew from the beginning about the high failure rates of the Optetrak implant. Exactech already had clinical evidence to show that Optetrak's knee implants were failing at a higher rate than Exactech claimed. This was as early as 2012. Reports of early failure and revision relating to the Optetrak implant had begun to accumulate in FDA's MAUDE databank. All of these reports indicated the same reasons for early revision of the Optetrak implants.
Exactech, like most orthopedic implant makers, has a general policy of having their authorized sales representatives present at surgery to supply implant components to the surgeon. This allows the hospital to have all possible sizes and components in stock for any future surgeries. Both for original and revision surgeries, Exactech sales representatives were available.
Exactech representatives witnessed firsthand numerous cases of Optetrak's premature failures. The surgeons often also noted the evidence of plastic inserts deterioration. These sales reps would often take the part from the surgeon and return it to the company for analysis and inspection.
Exactech's sales representatives were required to report the findings to Exactech's engineering and medical departments. They were then required to conduct an investigation and analyze the component that was removed (also known by retrieval analysis) and report the findings honestly and fully to the FDA. This didn't happen. Exactech's representatives reported the problems to the company. Exactech sold the implants and continued to promote them without notifying surgeons, patients or FDA about the evidence that Optetrak was susceptible to premature failure.
Exactech was aware of the issues in 20212 but did not change the marketing materials, labeling or inserts to properly and accurately warn patients and physicians about the increased risk of Optetrak failure. Exactech initiated a safety recall for the Optetrak, and other implant systems in August 2021.
Exactech sent a Dear Doctor letter to announce the recall. Is this a company that made an honest error and admitted it? Not quite.
Exactech and its corporate executives knew that the Optetrak Knee Implant System was defective. There is plenty of evidence to support this. Exactech was well aware that Optetrak implants were more susceptible to premature failure than other implants. However, the recall was not initiated for many years.
Exactech was aware of Optetrak's problems by 2012, or 2014, according to all indications. Exactech founders could have been trying to sell the company by that point. TPG Capital, a private equity firm, announced in 2017 that Exactech was under consideration for acquisition.
TPG completed the acquisition of Exactech in February 2018. TPG purchased all outstanding shares of Exactech stock at $49.25 per share. This effectively converted Exactech into a privately-held company.
Exactech became private in the TPG acquisition, but it was only after a few years that Exactech finally decided to recall its ankle and knee implants. If the recall had been initiated prior to Exactech going private, it could have had a devastating impact on their stock price and may have led shareholders to file lawsuits.
Exactech lawsuits claim that the company knew about early-onset failures in its TKA systems, and began replacing the tibial tray of some Optetrak model models. This was done without the knowledge of many people. Patients, doctors, and the general public didn't know there was a problem. The highest settlement payouts may be made to plaintiffs who had Exactech implants during the period when Exactech seemed to have known of the problem. This is because if this type of evidence is presented to a jury it may not be deemed satisfactory and could result in punitive damages being in place in certain jurisdictions.
Exactech lawsuit lawyers have not reported any settlements or verdicts. We are unable to predict the settlement amount or jury payout for Exactech recall lawsuit. Our attorneys believe you can estimate Exactech's defective implant lawsuit settlement amounts by comparing them with other settlements for knee replacement and personal injury cases involving a knee injury.
Let's begin with a conservative estimate of the settlement amount. In knee injury cases, the average amount of compensation is $110,000. However, the Exactech recall lawsuit settlements will be much higher. A jury will likely see a medical device company far less favorably that the average personal injury victim for a knee injury.
Punitive damages are also on the table. These recall cases will result in a minimum of two-thirds of the settlement amount. Let's now estimate Exactech settlement payouts to be $220,000 by using this method.
Exactech lawyers also analyze other settlements for knee replacement to determine average individual settlement amounts. Other knee replacement mass tort lawsuits settled for an average amount of $200,000.
Exactech's liability is quite clear. In its Dear Doctor letter, Exactech practically indicts it self. This is a strong case for liability, as was the strong liability in knee replacement lawsuits many years ago. Inflation must be taken into account in this calculation. This is the best way to estimate settlement amounts for Exactech recall cases in 2023.
In New York, a federal court filed one of the Exactech lawsuits for knee replacements after the recall. Burke, Exactech Inc.. The case is 1:22-cv-010806 (S.D. NY), was filed March 14, 2022. James C. Burke was the plaintiff. He had an Exactech Optetrak Logic in his left knee in 2013, and another in his right knee two-years later. The Optetrak Logic implant that Burke received only lasted a few years. He claims that he experienced pain, instability and bone loss over the following years. Burke had extensive revision surgery in 2019. Burke hired a personal injury attorney to file an Exactech recall suit.
Burke's Exactech lawsuit relies heavily on Exactech’s February 2022 recall announcement for all Exactech ankle and knee replacement implant systems. Burke's complaint refers to the recall that was based on defective packaging and premature wear by the plastic liner inserts, as evidence that the Optetrak Implant was defective. Burke claims that Exactech knew of the defective inserts but failed to notify doctors and patients. Burke's Exactech recall lawsuit claims that Exactech knew about the defective inserts and negligently failed to warn doctors and patients.
Burke claims ten counts. The primary theory of tort liability in Burke's complaint is strict liability due to a manufacturing defect. Burke seeks punitive and compensatory damages as well as damages for medical expenses and pain.
The federal Exactech lawsuit and the state Florida court cases are both operating in parallel, pushing for trials dates in late 2023 or early 2024.
Contact our legal team at 217-840-2652 if your Exactech knee implant has failed and you need to have corrective surgery. A complimentary case evaluation can be done online.
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