Our lawyers are handling Exactech recall lawsuits in all 50 states. Our law firm is accepting Exactech knee, hip, and ankle implant failure cases from victims who had a recalled Exactech implant system that subsequently failed, requiring revision surgery. Exactech recall suits are filed in an Exactech class action lawsuit in New York and state courts.
Do not sleep on your rights. Call our lawyers at 800-553-8082 or reach out to us online. You pay no fee or cost unless you get financial compensation for the harm done to you.
Exactech Recall Lawsuit
Exactech has recalled thousands of knee, hip, and ankle implants. Most patients calling our Exactech lawyers have received a letter from their doctor about the recall and want to bring a claim because they have gotten or will soon need revision surgery.
Medical device company Exactech recently announced a major recall of all its knee (and ankle and hip) replacement implant systems made after 2004. This recall came after discovering that defective packing was causing a polyethylene insert component to degrade.
This packaging defect caused many Exactech knee implants to fail prematurely. This replacement failure has forced and will force many patients to undergo unnecessary corrective surgery.
Knee surgery patients with an Exactech knee implant that failed and need revision surgery may be entitled to bring a lawsuit. Our clients are filing Exactech lawsuits seeking financial compensation for their pain and medical expenses. Because the pain and suffering and other harms victims will endure were the cause of an unnecessarily defective product.
Exactech Lawsuit Update for December 5, 2023
Exactech, specializing in joint replacement surgery technologies, announced that its subsidiary BlueOrtho has gained FDA 510(k) clearance for its new ExactechGPS® Ankle system. This groundbreaking technology is said to be the first of its kind for total ankle arthroplasty (TAA), and combines preoperative planning with live intraoperative guidance using advanced tracking and a touchscreen tablet.
Are our Exactech lawyers rooting for the company to succeed? Absolutely. Profits can help pay fair Exactech settlements in this litigation.
Exactech Lawsuit Update for December 1, 2023
The scheduled video status conference on 12/20/2023 at 2:30 PM will now be held as an in-person meeting. This will be presided over by both Judge Garaufis and Magistrate Judge Marcia M. Henry. During this conference, the parties are expected to cover various topics, including a detailed discussion on the proposed case management order relating to the selection of bellwether trials. Additionally, they will discuss potential trial dates for the bellwether cases in this multidistrict litigation.
Exactech Lawsuit Update for November 17, 2023
There are now 882 pending cases in the Exactech implant recall MDL in the federal court system. 40 new cases were added to the MDL over the last 30 days. There are also several hundred cases pending in a Florida state court MDL.
Exactech Lawsuit Update for November 14, 2023
In the Exactech class action, the magistrate judge established protocols for handling pathology specimens and medical devices crucial for evidence. The aim is to maintain these materials as they were at the time of explant, ensure proper chain of custody, and prevent alterations without consensus on testing.
Third-party storage providers will oversee these materials. Plaintiffs paid for the explant – it is still their property. Consistent with most state laws, non-party medical practitioner’s non-compliance, if following instructions, isn’t considered spoliation. Parties can still challenge preservation methods, and the order applies to all cases in or associated with MDL 3044.
Exactech Lawsuit Update for November 1, 2023
Last month, the MDL Judge ordered Exactech to produce 35,000 documents after finding that they were “inappropriately withheld” in discovery. Exactech has already produced those documents, but last week it filed a motion asking the judge to basically take back the finding that these documents were “inappropriately withheld.” Why? Because Exactech’s lawyers are complaining that plaintiffs’ lawyers are using this finding against them in the parallel state court proceedings. In another example of overt pettiness, Exactech complained in the motion about how it will cost $38,000 to produce the documents. Meanwhile, Exactech probably spent 10 or even 20 times that amount in attorneys fees fighting over whether the documents were discoverable and is now spending even more filing the motion to reconsider.
Exactech Lawsuit Update for October 23, 2023
There’s a video status conference in the Exactech class action lawsuit set for December 20, 2023, at 2:30 PM with Magistrate Judge Marcia M. Henry by Zoom. It is fair to say this litigation is not moving as fast as some plaintiffs would like.
Exactech Lawsuit Update for October 17, 2023
The Exactech implant recall MDL added 184 new cases over the last month, bringing the total pending case count up to 842. In June there were only 391 pending cases so this MDL has really grown over the summer.
Exactech Lawsuit Update for October 10, 2023
The parties in the Exactech MDL submitted a joint status report to the judge in advance of this week’s status conference. According to the report, there are 984 cases pending in the Exactech MDL. 811 of which involve knee products, 164 of which involve hip products, and 9 involve ankle products. There are another 327 cases pending in Florida state courts, with 233 knee and 90 hip products.
Exactech Lawsuit Update for October 2, 2023
Lead counsel for the Exactech plaintiffs sent a letter to the Court last week explaining that a major discovery dispute might be developing. According to the letter, Exactech is flat out refusing to produce certain documents requested in discovery, including documents related to other prior litigation against Exactech, and documents involving action taken by European regulatory agencies involving the defective Exactech implants. Exactech’s defense team is contending that these documents are somehow not relevant to the current litigation, which is curious since these types of documents are very typical of what is produced in mass tort MDLs.
Exactech Lawsuit Update for September 19, 2023
In addition to the class action MDL, Exactech is also facing a lawsuit under the False Claims Act alleging that the company defrauded the federal government by selling defective knee replacement implants to Medicare, Medicaid, and VA. In that case, the judge recently ruled that payment to Exactech probably would have been denied if the government had known about the high failure rate of the joint replacement implants. That ruling is potentially significant for the argument being made by the plaintiffs in the class action product liability lawsuits.
Exactech Lawsuit Update for September 10, 2023
In a motion you do not see every day, all parties in the litigation are looking for some relief from the fast moving scheduling order and bellwether trial. A joint brief on behalf of all Exactech lawyers was filed last week asking the MDL court and the Florida state court judge coordinating the state court litigation
Buried in the motion was portions of a transcript of a prior hearing where one of the defense lawyers was taking talking about how small of a company Exactech is and how the scheduling order should take this into account. Wait, what? The average of analyst of the market cap of Exactech is between $4 billion and $6 billion. This is not some mom and pop shop. The Florida Gators play in Exactech Arena for a reason. This is a huge company.
Exactech Lawsuit Update for September 18, 2023
The Exactech class action MDL involving recalled joint implants has begun to build momentum over the summer. There are now 658 pending cases in the MDL and 267 new cases were transferred into the MDL over the summer. The litigation has basically doubled in size since Memorial Day.
Exactech Lawsuit Update for August 23, 2023
In a small victory for the Exactech plaintiffs, the MDL Judge ruled in their favor yesterday on a discovery dispute. The Judge ordered Exactech to product 123,000 internal documents that it had previously withheld on the grounds that the plaintiffs’ document production requests were overly broad.
Exactech Lawsuit Update for August 17, 2023
The Exactech implant recall class action was the busiest mass tort MDL in the country last month. While most MDLs posted record-low volumes of new cases filed over the last month, the Exactech MDL nearly doubled in size over the last 30 days. There are now 567 cases pending in the Exactech MDL. Just 2 months ago there were only 136 pending cases. Meanwhile, the Exactech MDL in Florida state courts has another 272 pending cases.
Exactech Lawsuit Update for August 15, 2023
There are 822 claims in the federal Exactech MDL. Of these, knee implant make up the lion’s share with 665 lawsuits. Hip lawsuits account for 146, and ankle replacement issues total 10.
In Florida state courts, where Exactech’s main U.S. office is based so state court jurisdiction allows victims to sue in Florida state court, there are 272 ongoing lawsuits. These include 191 related to knee problems, 77 associated with hip failures, and 4 focused on ankle failures. Beyond Florida, 14 cases have been filed in Illinois and an additional 23 claims have been filed in various other state courts nationwide.
Exactech Lawsuit Update August 2, 2023
Last week, the parties in the Exactech class action MDL in federal court submitted a proposed bellwether trial plan. In addition to the cases in the federal MDL, there are over 80 Exactech cases proceeding in a state court MDL in Florida.
The proposed bellwether plan would seek to coordinate the 2 state and federal MDLs in a unique way. The plan calls for a series of bellwether trials in the federal MDL that will focus on cases involving Exactech knee implants.
Meanwhile, the Florida MDL would hold bellwether trials in cases involving hip implants. The federal MDL bellwether trials would be selected from an initial pool of 24 knee implant cases.
Exactech Lawsuit Update July 18, 2023
395 cases are now pending in the Exactech class action MDL in the Eastern District of NY. Last month was the slowest month to-date in terms of new case filings with just 4 new cases added to the MDL. The slow month is probably a seasonal thing and we expect new filings to increase in volume as soon as plaintiffs’ lawyers get back from summer vacations.
Exactech Lawsuit Update July 10, 2023
The MDL judge overseeing the Exactech lawsuits dismissed a class action lawsuit filed on behalf of third-party payers but granted the plaintiff, MSP Recovery Claims, permission to file a motion to amend its complaint. MSP Recovery had taken up the right to bring recovery claims against Exactech on behalf of third-party payers.
The judge ruled that MSP Recovery’s lawsuit lacked standing, noting that MSP and third-party payers needed to allege that the risk of future harm materialized, such as additional costs due to the defects. But the judge permitted MSP to file a full motion to amend its complaint within 30 days. Lawyers for MSP recovery filed a motion to extend this deadline, citing summer vacation plans.
Exactech Lawsuit Update July 1, 2023
Magistrate Judge Marcia M. Henry held a hearing this week. But there have been no major developments in the Exactech litigation as we head into summer.
Exactech Lawsuit Update June 16, 2023
Over the last month, 12 new Exactech implant lawsuits were transferred into the Exactech class action MDL. That brings the total number of pending cases in the MDL up to 136, with another 90 cases pending in the consolidated state court proceedings in Florida. At the start of the year, there were 101 pending cases.
Exactech Lawsuit Update June 2, 2023
The Exactech class action lawsuit currently has 571 pending lawsuits, with knee implants dominating the claims at 481, representing 84% of the total cases. There’s no shortage of strong claims against Exactech hip and ankle recalls either, with 82 and seven lawsuits, respectively.
In Florida’s Eighth Judicial Circuit in Alachua County, another 185 lawsuits are awaiting trial, where consolidated proceedings have occurred. Knee product claims are again in the majority here at 140, accompanied by 43 hip implant lawsuits and a pair of ankle claim cases. Interestingly, another 23 lawsuits related to Exactech recalls are also pending nationwide in various other state courts.
Exactech Lawsuit Update June 1, 2023
As the number of pending Exactech recall cases in the class action MDL continues to grow, the MDL Judge issued a new Case Management Order (CMO 3), which establishes detailed rules and procedures for preserving physical medical evidence such as explanted implants. A third-party medical evidence storage provider has been retained to act as a repository for this evidence, which could be significant in establishing or supporting individual plaintiffs’ claims. Obviously, the evidence of the degradation of these implants must be preserved for trial if necessary.
Exactech Lawsuit Update: May 15, 2023
For the second month in a row, we saw a big jump in the number of cases pending in the Exactech implant recall MDL. Eighty-three new cases involving defective Exactech implants were added to the MDL over the last 30 days. This brings the total pending case count in the MDL up to 373.
Exactech Lawsuit Update: May 9, 2023
Tomorrow, the MDL working with state court processes in Alachua County, Florida, will host a “Science Day” event. The event will take place on May 10, 2023, in Gainesville, Florida, starting at 9 a.m. Eastern Standard Time. The topics for Science Day include:
- A background on the devices and joint replacement surgery
- How the devices work
- The materials used in the devices
- The design and packaging of the devices
- How each device is manufactured
- The injuries alleged in this litigation
What is the purpose of a Science Day? The parties involved in the litigation present scientific and technical details relevant to the case to the judge on Science Day. It’s often utilized in complex medical device lawsuits like the Exactech litigation to help the judge better understand the intricate scientific or technical concepts important in the litigation. So the purpose of Science Day is not to litigate your position – although lawyers are covertly doing this to some extent – but to educate the court about the science and technology involved in the case without any argument about the case’s merits or legal positioning.
Exactech Lawsuit Update: May 1, 2023
In most mass tort claims, the plaintiffs’ lawyers want to push toward a trial, and the defense counsel wants to slow things down. The Exactech class action lawsuit is no exception.
For example, Exactech has yet to disclose basic information, such as names and contact information of individuals with relevant information as required by Federal Rule 26, and they still need to provide complete copies of all potentially applicable insurance agreements. In contrast, the plaintiffs have provided 337 Preliminary Disclosure Forms, including details of implant and explant surgeries and related records that establish product identification and injury. Exactech claims that Rule 26 disclosures are not fitting for an MDL, but the lack of basic information slows the litigation and frustrates plaintiffs.
Exactech Lawsuit Update: April 19, 2023
We saw a significant jump in new Exactech implant recall lawsuits this month. One hundred eleven new cases were filed in or transferred into the Exactech class action lawsuit over the last 30 days. That is the most significant monthly increase since the start of this litigation, and it brings the total number of pending cases up to 290. This is the start of a new trend that will continue throughout the year. Over 80 Exactech cases are also pending in a state court MDL in Florida.
Exactech Lawsuit Update: March 31, 2023
Defense lawyers for the private equity companies behind Exactech wrote a letter to the MDL judge yesterday asking for a pre-motion conference on a motion to dismiss the plaintiffs’ complaint against them. The letter argues that these companies were not involved in designing, manufacturing, packaging, or selling the Exactech implants.
Plaintiffs are suing these companies because they had a remarkable amount of control over how Exactech was run and the company’s decisions. To pierce the corporate veil to get to these companies, a plaintiff must allege that the parent company had domination and control over the subsidiary.
Exactech Lawsuit Update: March 25, 2023
The FDA is reminding patients and healthcare providers about Exactech joint replacement devices manufactured between 2004 and August 2021 that were recalled in 2021 and 2022 due to defective packaging bags that can lead to accelerated device wear/failure and revision surgery. Patients with well-functioning devices do not need surgery but should contact their healthcare provider if they experience new or worsening pain or swelling.
This ties in with the allegations made in the Varneckas case we reported on yesterday. Monitoring patients can help prevent bone loss and other injuries, so Exactech should have told doctors and patients about their concerns long before the recall.
The FDA recommends that healthcare providers not implant recalled devices and monitor patients for potential device wear/failure or bone loss. Exactech has issued an expanded voluntary recall for knee, ankle, and hip replacement devices packaged in defective bags. The FDA is working with the company to assess the risks of other joint implants with similar packaging.
Exactech Lawsuit Update: March 24, 2023
New Exactech lawsuits continue to be filed. Last week, a new lawsuit, Varneckas v. Exactach, was directly filed in the New Jersey class action. The plaintiff in this case, underwent bilateral total knee replacement surgery at the Hospital for Special Surgery in New York in February 2018. She was implanted with the recalled Optetrak Logic PSC Polyethylene Tibial Insert components. In April 2021, she underwent left total knee revision surgery due to the accelerated wear of the insert. She also experiences pain in her right knee and will likely require revision surgery of the right knee to remove the remaining recalled polyethylene tibial insert.
She accuses the defendants of actively and fraudulently concealing from her and her doctors the significant risks associated with the device and the need for diagnostic procedures to promptly diagnose the insidious process of the toxic polyethylene particles degrading and causing osteolysis. Her suit claims that they should have informed her surgeons to call their patients back for periodic radiologic monitoring for polyethylene chemical degradation and attendant osteolysis and that their failure caused severe bone loss. As a result, she now has pain and discomfort, gait impairment, poor balance, and difficulty walking.
Exactech Lawsuit Update: March 22, 2023
Forty-seven lawsuits were added to the Exactech implant recall class action MDL last month. That brings the total number of pending cases up to 179. It also marks the most significant monthly volume of new cases since the MDL began last year.
Exactech Lawsuit Update: February 20, 2023
The judge in the Exactech recall class action MDL has scheduled a “Science Day” for May 10. Science days are standard in mass tort MDLs involving product liability claims. They give lawyers for each side the opportunity to make presentations designed to educate the court on the scientific issues and evidence involved in the litigation.
There are now 132 cases pending in the Exactech MDL and at least 80 pending in Florida state courts.
Exactech Lawsuit Update: February 1, 2023
In the last two weeks in the Exactech class action, MDL Judge Garaufis finalized the process, allowing direct filing of all future cases in the MDL using a short-form Complaint. Plaintiffs’ Liaison Counsel also created a website to publish court orders, deadlines, and other critical information to help lawyers and the public remain informed about the MDL proceedings.
Later this week, the parties will submit a joint letter with proposals for a Science Day. A Science Day is a class action lawsuit staple in 2023. This is an informal hearing for lawyers on both sides to educate the MDL judge about the medical and scientific issues in the case.
Exactech Lawsuit Update: January 20, 2023
The Judge in the Exactech implant recall MDL will hold a status conference next week at which he is expected to set deadlines for the parties to provide joint discovery and case management plans.
On Tuesday, lawyers for both sides submitted a joint status report to Judge Garaufis outlining their progress on specific administrative tasks and discovery status in the 86 consolidated cases in Florida state court.
The report notes that master discovery requests by the plaintiffs in the Florida cases were served in early December. The deposition of Exactech’s leading medical officer (Dr. Sharat Kusuma) is set for February 16, 2023.
Exactech Lawsuit Update: January 14, 2023
Hursey v. Exactech, Inc. et al. (1:22-cv-07893) is another excellent example of a recent Exactech implant recall lawsuit filed in the Exactech recall class action MDL in the Eastern District of New York.
The implant product in the case is Exactech’s Truliant Knee System, which was recalled in February 2022. Hursey had the Truliant implanted during knee replacement surgery in July 2021, and by August 2022, the polyethylene insert component had already failed, requiring revision surgery.
Hursey’s primary cause of action in the lawsuit is strict liability based on a manufacturing defect, but several other claims are asserted.
Exactech Lawsuit Update: January 9, 2023
An excellent example of a recent Exactech recall lawsuit filed in the Eastern District of New York is Hursey v. Exactech, Inc. et al. (1:22-cv-07893). The case involves Exactech’s Truliant Posterior Stabilized Knee System.
Mr. Hursey had the Truliant system implanted during knee replacement surgery. He was later forced to undergo revision surgery due to worsening pain and swelling. During that revision surgery, it was discovered that Hursey’s pain and swelling were due to premature failure of the polyethylene insert in the Trulia.
Hursey’s Exactech recall lawsuit asserts multiple causes of action against Exactech, with the primary theory being strict liability based on defective manufacture.
Exacteh Lawsuit Update: January 7, 2023
A new study is planned to follow up on patients who have received or will receive a Truliant knee prosthesis.
Exactech Lawsuit Update: January 1, 2023
In addition to the Exactech recall lawsuits pending in the federal court MDL, there are now 80 Exactech lawsuits pending in a state court version of an MDL in Florida.
Last week, lawyers for Exactech sent a letter to MDL Judge Garaufis stressing the importance of coordinating the discovery in federal and state court actions. To that end, Exactech filed a motion in the Florida proceedings seeking federal-state discovery coordination. The plaintiffs’ Exactech lawyers are opposing this motion.
Exactech Lawsuit Update: December 27, 2022
At the initial status conference in the new Exact implant recall MDL, Judge Garaufis agreed with the plaintiffs that the measures should be taken to get caught up to the Exactech state MDL already underway in the Florida courts. At the end of last week’s conference, Judge Garaufis granted the request to allow new Exactech recall cases to be filed directly in the MDL. This makes it easier for everyone.
He also issued several expedited deadlines for the initial MDL housekeeping measures. The judge formally approved the appointment of 27 lawyers to serve in various positions on the plaintiffs’ leadership committees for the litigation. There will be an executive committee, liaison counsel, and a plaintiffs’ steering committee.
Exactech Lawsuit Update: November 18, 2022
The initial status conference in the Exactech implant recall MDL in federal court will be this week. A state court version of an MDL is already ongoing in the Florida court system.
The Florida state MDL is already far ahead of the federal MDL in terms of time frame, with an initial bellwether test trial set for next year. This has prompted many lawyers on both sides to urge the judge in the federal MDL to expedite the process to catch up.
In a pair of letters to Judge Nicholas G. Garaufis, separate plaintiffs’ Exactech attorneys have asked that he immediately permit direct filings in the federal MDL and to name lawyers to the plaintiffs’ leadership committee.
Exactech Lawsuit Update: November 8, 2022
The Exactech implant recall lawsuits in the federal court system were recently consolidated into a new class action MDL. Meanwhile, 50 Exactech lawsuits involving recalled hip and ankle implants have been filed in Florida state courts and consolidated into a state version of an MDL class action.
An Exactech lawsuit in state court may go to trial before the federal class action. The judge presiding over the consolidated Exactech state court suits in Florida issued an Order scheduling the first trial for November 2023. This trial will function like a de facto bellwether test trial for all Exactech lawsuits.
Exactech Lawsuit Update: October 11, 2022
The JPML has officially consolidated the Exactech joint replacement recall lawsuits into a new class action MDL. All lawsuits involving the recalled Exactech knee or ankle replacement implant systems will now be centralized in the Eastern District of New York.
The MDL has been assigned to Judge Nicholas G. Garaufis. Judge Garaufis is a Senior Judge appointed to the bench in 2000 by President Clinton.
Exactech was not opposed to the consolidation, but the joint replacement company had been pushing for the MDL to be created in the Northern District of Florida, where its headquarters is located. The Exactech recall cases will now proceed through a consolidated discovery process by Judge Garafis.
With a new class action MDL on the horizon, the pace of new Exactech implant recall lawsuits has rapidly accelerated. Since June 1, 75 new recall lawsuits have been filed against Exactech in federal courts. Many of these new cases are being filed by groups of multiple plaintiffs. The Eastern District of New York remains the most popular forum, with 75 new cases filed in that venue. Our Exactech lawyers, not coincidentally, are getting many clients who had surgery at the Hospital for Special Surgery in New York City.
Exactech Lawsuit Update: September 1, 2022
The U.S. Judicial Panel on Multidistrict Litigation will hear on September 29, 2022, arguments on whether to consolidate federal lawsuits alleging Exactech joint failures from manufacturing and design errors into a class action lawsuit. Certifying and MDL and bringing together all of the lawsuits is a huge step forward on the path to victims receiving fair settlement amounts for the harm that has been done to them from mistakes that led to the Exactech recall.
Exactech Lawsuit Update: August 22, 2022
The Exactech recall just got bigger. Exactech was forced to expand the scope of its hip and ankle replacement implant recall. Exactech sent a new recall notice letter to healthcare providers last week advising that the implant recall initiated in February was being expanded to cover another 40,000 acetabular hip liner components in the company’s Connexion, Novation, and other brand implant systems.
This expanded recall comes as the JPML ponders whether to consolidate the growing wave of Exactech implant recall lawsuits into a new class action MDL. Our lawyers struggle to envision a scenario where a new Exactech class action lawsuit is not formed. We expect the court to rule as early as this month.
Exactech Lawsuit Update: August 1, 2022
Lawyers for implant manufacturer Exactech submitted a response to the recent MDL motion filed with the JPML. Exactech advised the panel to support consolidating all Exactech implant recall lawsuits in federal court into a new MDL. Exactech also agreed with the plaintiffs’ venue preference in the Eastern District of New York. This should guarantee that the JPML will agree to form a new Exactech class action lawsuit for these recall cases.
Exactech Lawsuit Update: July 1, 2022
It has been nearly four months since Exactech announced a sweeping recall of all its knee and ankle replacement implant systems. But most patients who received the defective implants have yet to receive any notification about the recall.
When the recall was first initiated in February, Exactech provided orthopedic surgeons with a form letter to send to patients notifying them about the recall. Beyond providing this sample patient letter, however, Exactech has yet to make further efforts to reach out to patients. An estimated 150,000 patients have defective Exactech implants, and only a tiny percentage of them have been notified of the recall.
So there is no Exactech class action lawsuit, and the pace of new recall claim lawsuits remains comparatively slow. Nine new product liability lawsuits were filed against Exactech in federal courts during May. Only nine Exactech recall cases were filed in April.
The Exactech recall covered an estimated 150,000 patients. But many of these patients remain entirely unaware of the recall because Exactech has left it up to individual doctors’ offices to send out notification letters to patients. Look for a significant uptick in Exactech recall lawsuits filed by the summer’s end.
This slow pace is delaying the inevitable Exactech class action lawsuit to deal with all these lawsuits together. Exactech lawyers waited until enough lawsuits were filed to go to the MDL Panel and seek a class action.
Late last month (June 2022), a group of Exactech knee implant recall plaintiffs filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) for a new MDL Exactech class action lawsuit to be established for the consolidated handling of all future Exactech recall lawsuits.
The Exactech recall announcement in February led to a steady stream of product liability lawsuits by patients who had implanted defective knee and ankle replacements. According to the motion filed with the JPML, 27 Exactech implant recall cases are pending in 11 different federal districts.
The motion suggests the Eastern District of New York as a possible venue for the Exactech class action lawsuit. But Exactech will most likely request the Northern District of Florida, its headquarters. (Update: New York won out.)
Recall of Exactech Knee and Ankle Replacement Implants
Exactech is a global medical device company headquartered in Gainsville, Florida. Since founded in 1985, Exactech has specialized in surgical implant systems for joint replacement surgeries.
In August 2021, Exactech initiated a sweeping nationwide recall of all its knee replacement and ankle replacement implant systems manufactured after 2004. The recall impacts almost 150,000 knee replacement implants in the U.S. The Exactech implant systems are used in knee replacement surgery, called total knee arthroplasty (“TKA”). TKA knee replacement surgery is used to relieve severe pain associated with arthritis and to correct knee trauma and deformities.
These are the recalled Exactech products:
Exactech launched the recall after learning that a defect in the vacuum-seal packaging of its knee replacement systems was causing the polyethylene insert component to oxidize before use. Polyethylene is an integral part of TKAs. But these inserts cannot be exposed to oxygen during the packaging and storing process. Exposing polyethylene inserts to oxygen creates a chemical reaction called oxidization, which causes the premature wear or degradation of polyethylene inserts.
So polyethylene inserts must be handled with a high degree of care when processed, packaged, and stored. If they are exposed to oxygen… what will happen is what did happen for many reading this. How does a TKA feel when the insert degrades? The patient’s knee loses its ability to function properly in the knee replacement system and the patient feels discomfort and a loss of function.
So, over time, the degraded polyethylene inserts cause excessive friction and wear. This causes the premature failure of the Exactech knee replacement systems. The result is often the need for premature revision surgery.
Patients who experienced failure of their Exactech knee replacement system due to this manufacturing defect experienced significant pain and lack of mobility in their knees. Eventually, failure of the knee replacement system requires the patient to undergo corrective revision surgery. No one who has had knee surgery wants to do it again.
What Should Patients with Recalled Exactech Implants Do?
Exactech sent out a letter to doctors regarding the recall. The letter instructs surgeons to stop using Exactech implants immediately in knee and ankle replacement surgeries. Doctors and hospitals are also instructed to return their existing inventory of recalled devices for replacement. As far as their letters go, this was a pretty honest letter. Exactech is falling on its sword and admitting the problem.
As for surgery patients with an Exactech knee replacement system implanted, the recall letter instructs them to consult their doctors. Doctors are advised to maintain an index of all patients with Exactech implants and closely monitor them for signs of potential insert failure.
Exactech also provided doctors with a draft letter to send to their patients – you may have received that exact letter – explaining the basis for the Exactech recall which is not very different from what our lawyers explained above.
If you have an Exactech knee or ankle replacement implant system, signs that the implant may have failed due to the defective insert include pain and swelling, inability to bear weight on the joint, grinding in the joint, or instability in the knee or ankle. Surgeons are instructed to take X-rays when a failed implant is suspected to evaluate the status of the Exactech implant.
Exactech Knee Replacement Implant Lawsuits
Medical device manufacturers like Exactech have a legal obligation to ensure that their products are safe when used for their intended purpose and free of any harmful flaws or defects. The Exactech recall notice effectively admits that the Exactech knee and ankle replacement implants were defective. So holding Exactech liable for injuries and damages the result will be less of a challenge than you would ordinarily have in a typical class action lawsuit.
Anyone who had an Exactech knee replacement implanted after 2004 may be able to bring a product liability lawsuit if that implant subsequently failed and they had to undergo revision surgery. Plaintiffs who bring a successful Exactech knee recall lawsuit would be entitled to damages for (a) pain and suffering; (b) medical expenses incurred in treatment and corrective revision surgery; (c) and any lost income or wages incurred as a result of the knee implant failure.
Our lawyers believe that if you have a viable claim, you are much more likely to get an Exactech settlement than you are to see the inside of a courtroom. Because the evidence of the mistakes Exactech made not just coming from plaintiffs’ lawyers. The strength of these cases are the admissions made by Exactech after the recall.
History of Problems with Exactech Knee Implants
The Exactech knee replacement system has a long history of high failure rates and other problems. Exactech has always obtained 501(k) abbreviated FDA clearance for its knee replacement systems to avoid the full FDA review and approval process. From the very beginning, Exactech was aware that its OPTETRAK knee replacement implant system had a significantly higher failure rate compared to other devices.
Reports on Exactech implants in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) indicated the devices were failing at an abnormally high rate compared to other implants. This early onset failure MAUDE reports are representative of the increased rate of incidents of which Exactech had become internally aware several years ago. There are currently so many complaints about Exactech implant devices in MAUDE that a search maxes out (at 500). So it cannot show all the Exactech complaints.
These failures prompted product liability lawsuits in 2016-2017 against Exactech by users who experienced premature implant failures. Our lawyers have gone back and read those lawsuits. The attorneys who filed those lawsuits did not understand why Exactech knees were failing. They were hovering around the problem. But these Exactech attorneys did not – because they could not – fully understand why Exactech knees were failing.
These early Exactech implant lawsuits did understand that the high failure rate of these component parts was related to the “finned” design feature that is unique to the Exactech implants. These knee replacement lawsuits accused Exactech of failing to warn consumers about this risk and instead pursued a “silent” recall in which they slowly replaced the finned design without recalling them. But the Exactech recall shed light on the specific oxygenation problem that caused these component parts to wear down.
Exactech’s phasing out of the finned design failed to reduce their implant systems’ abnormally high failure rate. This eventually led them to investigate other possible flaws, which led to the discovery of the defective vacuum-seal packaging that prompted the recall notice.
Exactech Obtained Fast-Track FDA Approval
Exactech repeatedly obtained 501(k) clearance from the FDA for its Optetrak, Optetrak Logic, and Truliant total knee replacement implant systems and components between 1994 and 2017.
This 501(k) clearance from the FDA is called “fast-track” approval because it does not require the manufacturer to prove the safety and effectiveness of a product. This path, also called “premarket notification”, of 510(k) clearance only requires the manufacturer to explain the device’s substantial equivalence to a pre-MDA predicate device.
The FDA may then “clear” the new device for sale in the United States. All the component parts comprising Plaintiff’s Optetrak Device were cleared for marketing by the FDA under the 510(k) process or were marketed without receiving either 510(k) clearance or full approval by the FDA.
The big loophole created for 510(k) is that the device maker can provide proof that the not thoroughly tested device is “substantially equivalent” to a predicate device that has been on the market for years. So full testing is not required. Product liability lawyers often see lawsuits involving these 510(k) products because – big surprise! – medical devices that are not thoroughly tested are more like to have defects.
Our Exactech Lawyers Are Seeing Exactch Opterak Lawsuits
Exactech’s leading knee replacement implant is the Optetrak Total Knee System. In the first three months of the recall, more than half the calls from victims our Exactech lawyers have had involved Opterak. So we will focus a bit on Opterak for a moment although most of what our attorneys say about the merits of the Operterk claims apply to all Exactech lawsuits.
The Opterak is classified as a knee joint patellofemorotibial semi-constrained cemented prosthesis. It features a mix of polyethylene and metal-based components. The Optetrak is comprised of the following parts: a patellar cap, femoral cap, tibial insert, and tibial tray, as we show above. The patellar cap and tibial insert are made of polyethylene.
Exactech Lawsuits Question Opterak Marketing
Exactech marketed the Optetrak as “first-in-class” and its product materials and claims that the Optetrak had excellent long-term clinical outcomes. Exactech promoted the Optetrak as a system with nearly three decades of clinical success and proven outcomes for patients because of an improved design resulting in low stress on the polyethylene insert components.
In truth, however, Optetrak has performed poorly when compared to its competitors. For example, the Australian Orthopaedic Association, a preeminent, internationally recognized orthopedic implant registry, has identified the Optetrak as an implant with a higher-than-expected revision rate. According to the 2020 Australian National Joint Replacement Registry, the revision rate for a total knee replacement utilizing an Optetrak far exceeds international guidelines for accepted revision rates.
Exactech was aware of the high early failure rates with the Optetrak implants from the very beginning. As early as 2012, Exactech had indisputable clinical evidence that the Optetrak knee implants were failing at a much higher rate than Exactech claimed in its marketing materials. By then, reports of early failure and revision associated with the Optetrak implants had accumulated in the FDA’s MAUDE database. These adverse incident reports indicated similar reasons for premature revision with the Optetrak, all indicating a problem with the implants.
Exactech Sales Reps Aware of Opterak Problems
The general practice at Exactech (as with most orthopedic implant manufacturers) is to have their authorized sales reps present at the time of surgery to provide implant components to the surgeon. This practice relieves the hospital of the responsibility for having in stock all potential sizes and components that may be needed in surgeries. Exactech sales reps were present for the original implant surgery and revision surgery.
Exactech sales reps observed countless first-hand cases of premature failures of the Optetrak. They witnessed clear evidence of premature degradation of the plastic inserts, which was often noted by the surgeons as well. Often these sales reps would take the component from the surgeon to return to the company for inspection and analysis.
The Exactech sales reps were under a duty to report these findings to the engineering and medical departments of Exactech, who were under a duty to do an investigation then, analyze the removed component when available (also known as retrieval analysis), and honestly and thoroughly report such findings to the FDA and the surgeons. This did not happen. Exactech’s sales reps reported the issues to the company. But Exactech continued to promote and sell the implants without alerting surgeons, patients, or the FDA of the growing evidence that the Optetrak was prone to premature failure.
Despite being aware of the problems in 20212, Exactech never changed the labeling, marketing materials or product inserts to adequately and accurately warn patients or physicians of the associated increased risks of early failure of the Optetrak. It was not until August 2021 that Exactech finally initiated a safety recall of the Optetrak and other implant systems.
Exactech May Have Intentionally Concealed Opterak Problems
Exactech put out a really good Dear Doctor letter when announcing the recall. So is this just a good company that made an honest mistake and owned up to it? Not quite.
There is ample evidence that Exactech and its corporate executives knew the Optetrak knee implant system was defective. There is no dispute that Exactech knew that the Optetrak implants had an abnormally high rate of early failure and complication and a greater propensity to wear out prematurely compared to other implants. But that did not trigger a recall for years.
Exactech May Have Hid Concerns Before Selling Company with Optertak and Other Implants
All indications are that Exactech knew about the issues with Optetrak by 2012 or 2014 at the latest. By that time, however, Exactech’s founders may have already been looking to cash out by selling the company. In 2017, it was announced that a private equity company called TPG Capital was in the process of acquiring Exactech.
TPG’s acquisition of Exactech was finalized in February 2018. TPG bought out all the outstanding shares of Exactech stock for $49.25 a share, effectively converting Exactech from a public company to a privately held company.
It was only a few years after Exactech went private through the TPG acquisition that the company finally took the long-overdue step of recall of its knee and ankle implants. Had the recall been initiated before Exactech went private, it would have had a crushing impact on their stock and possibly led to various lawsuits by shareholders.
Exactech May Quietly Replaced Some Defective Implants
Exactech lawsuits allege that the company knew of early onset failures of its TKA systems and, quietly began replacing the tibial trays of some Optetrak models. This was done under the radar and not done for everyone. So patients, doctors, or the general public had no idea there was a concern. A plaintiff who received an Exactech implant may see the highest settlement compensation payouts between when Exactech appeared to know of the problem and the eventual recall. Because if that type of evidence makes its way to a jury, it will not make the jurors happy and it will put punitive damages in play in some jurisdictions.
Potential Settlement Payouts for an Exactech Knee Recall Lawsuit
Our lawyers do not have any reported settlements or verdicts in an Exactech knee implant lawsuit. So we can’t be certain what the possible settlement amount – or jury compensation payout – for an Exactech recall lawsuit will be. But our attorneys believe that you can estimate Exactech defective implant lawsuit settlement amounts by comparing them to other knee replacement settlements and personal injury cases involving knee injuries.
Let’s start with a more conservative settlement amount estimate. The average compensation payout in knee injury tort cases is roughly $110,000. But the settlement amounts in the Exactech recall lawsuits will likely be higher. You have a medical device company that a jury will see far less favorably than the average knee injury personal injury defendant.
Again, Punitive damages will be on the table. So at a minimum, you double the expected settlement amounts in these recall cases. So let’s estimate the Exactech settlement payouts at $220,000 using this method.
Our Exactech lawyers also look at other knee replacement settlements to predict average individual settlement amounts. Some other knee replacement mass tort lawsuits have settled for an average individual settlement amount of $200,000.
The liability of Exactech is pretty straightforward. The company practically indicts itself in its Dear Doctor letter. So liability is strong and the strong liability of knee replacement lawsuits were many years ago. So inflation has to be considered in the calculation. In 2023, maybe the best estimate using this as a settlement amount marker is $300,000 for Exactech recall cases.
Example Exactech Logic Knee Implant Lawsuit
One of the first post-recall Exactech knee replacement lawsuits was filed in federal court in New York. The case, Burke v. Exactech Inc., 1:22-cv-020806 (S.D. NY), was filed on March 14, 2022. The plaintiff, James C. Burke, had the Exactech Optetrak Logic implanted in his left knee in 2013 and another one implanted in his right knee two years later. Burke’s Optetrak Logic implant only lasted a short time and the complaint claims that he suffered pain, instability, and bone loss in the years following the surgery. Eventually, Burke underwent extensive revision surgery in 2019. She hired a personal injury lawyer to bring an Exactech recall lawsuit.
The product liability claims in Burke’s Exactech lawsuit rely heavily on Exactech’s February 2022 recall announcement of all Exactech knee and ankle replacement implant systems. The Burke complaint cites the recall based on the defective packaging and premature wear of the plastic liner inserts as evidence that the Optetrak implant was defective. He claims Exactech knew about these defective inserts and negligently failed to warn doctors and patients. Burke’s Exactech recall lawsuit asserts that the premature failure of his Exactech knee implants after just six years was a direct and proximate result of “accelerated polyethylene wear” in the Optetrak inserts.
The Burke complaint asserts ten separate counts. But the primary theory of tort liability in the complaint is strict liability based on a manufacturing defect. Burke is seeking compensatory damages for his medical expenses and pain, as well as punitive damages.
File Your Exactech Recall Lawsuit
If your Exactech knee replacement implant failed and you had to undergo corrective surgery, contact our legal team today at 800-553-8082 to see if you have a case. You can also get a free case evaluation online.