Exactech Knee Replacement Lawsuit

Our lawyers are accepting new Exactech recall lawsuits in all 50 states.  Below we discuss the litigation, provide the most recent January 2023 updates – including the latest Exactech recall – and what our lawyers believe the average per person Exactech settlement amounts will be.

Exactech Recall

The medical device company Exactech is one of the leading manufacturers of implant systems utilized in joint replacement surgeries.

Exactech recently launched a sweeping recall of all knee replacement implant systems manufactured after 2004 (Exactech Recall Letter). The implants are being recalled because it was discovered that a defect in the packaging caused a polyethylene insert component to degrade before use.

The degraded inserts caused the Exactech knee implants to fail prematurely (sometimes after only a few months), causing acute pain and requiring patients to have revision surgery to replace the implant.  This led to an Exactech knee replacement class action lawsuit in 2022.  These recall lawsuits are now pushing forward in 2023, as we discuss below.

Filing an Exactech Lawsuit

In the last ten years, anyone who had knee replacement surgery with an Exactech implant system may be entitled to pursue a product liability lawsuit and get financial compensation for pain and suffering, medical expenses, and lost income resulting from their implant failure.

Our Exactech lawyers are actively seeking Exactech knee implant recall cases from patients adversely impacted by a defective Exactech knee implant system, including the Opetetrak® or Truliant® knee replacement systems. Contact us about filing an Exactech knee implant lawsuit.


Exactech Class Action September 2023 Update

  • There is a whistleblower lawsuit against Exactech in for allegedly violating the False Claims Act by supplying defective knee replacement devices to beneficiaries of Medicare, Medicaid, and the Department of Veterans Affairs.  Importantly to the Exactech class action, the court ruled that if the government had known of the device’s high failure rate, it would have likely refused payment to Exactech. Furthermore, due to Exactech’s awareness of the complaints and potential obligation to notify the FDA, a jury might deduce that Exactech was knowingly in violation of regulations or statutes.The U.S. government argued last week that the whistleblower provisions in the False Claims Act (FCA) do not violate the U.S. Constitution, urging the continuation of a fraud suit about a knee replacement device. Exactech had filed a new motion to dismiss, based on the argument that only the president has the authority to conduct civil litigation on the government’s behalf and that FCA whistleblower suits infringe on Article II of the Constitution.

    The government pushed back, contending that whistleblowers do not act as federal agents or officers and do not wield the government’s prosecutorial powers.  Exactech’s arguments about separation of powers were also addressed, with the government emphasizing its ability to intervene, dismiss, or even take over whistleblower suits.

    Exactech is worth maybe $4 billion.  So, ironically, you almost hope the whistleblower case fails so there is more money to pay the personal injury claims

  • The Exactech implant recall class action litigation has doubled in size over the summer. Back on Memorial Day this MDL had less than 300 pending cases. Now there are a total of 658 pending cases in the MDL and the monthly volume continues to increase.
  • Exactech lawyer son both sides filed last week a joint brief in support of the Revised Joint Florida and MDL Unified Bellwether Trial Plan. This plan has been developed through discussions to align with the Court’s aim to prevent delays in the trials of Florida cases while adhering to the MDL Order’s discovery regulations. The intention is to preserve resources and prevent redundant discovery in this multi-jurisdictional litigation against a relatively small orthopedic device company. The Court’s Initial Bellwether Order provided a framework for these negotiations, and portions of it are integrated into the joint Revised Plan. The MDL judge had previously denied the Joint Bellwether Plan, citing concerns about additional delays. This is not a bad thing.  You want a judge who wants to push trial dates forward. That is how you get to an eventual Exactech settlement.  But the lawyers want to have a joint status conference with both the MDL judge and the state court judge clarify the challenges faced in discovery and coordination as well as the design of the joint bellwether plans. As the motion points out, it is pretty extraordinary that both parties are looking to jointly modify the schedule.  Normally, it is the defendants’ lawyers trying to stall and the plaintiffs’ attorneys pushing for a quick trial date.

Exactech Class Action August 2023 Update

  • Yesterday, the Judge in the Exactech class action MDL granted a motion to compel filed by the plaintiffs last month based on Exactech’s refusal to produce all of the internal documents requested in discovery. Exactech claimed that the document requests were overly broad and too burdensome. The plaintiff countered by narrowing the scope of their request somewhat and the Judge ultimately ordered Exactech to produce 123,321 documents that were responsive to the revised search terms.
  • According to the most recent monthly report from the JPML, there are now a total of 567 pending cases in the Exactech implant recall MDL. That is a huge jump up from last month when there were only 395 pending cases. It also makes Exactech stand out as the only mass tort MDL which saw a high volume of new cases filed over the last month.
  • In a joint status report to Judge Garaufis on August 11th, Exactech lawyers report 422 recall lawsuits in the federal MDL.  Most are knee implant lawsuits, but around one-fifth of the claims are hip and ankle cases.  The state court cases are also moving forward, sometimes outpacing the federal class action. There are 272 pending Exactech lawsuits in Florida’s state courts, where the company’s U.S. main office is located, giving state court jurisdiction. There are also scattered cases elsewhere, 14 cases in Illinois and another 23 claims in various state courts.
  • Lawyers for both sides in the Exactech class action MDL in federal court have submitted a proposed plan for the bellwether trials. The proposal calls for the Exactech MDL in federal court to coordinate its bellwether trials with the Exactech MDL in Florida state court. If the plan is approved, the bellwether trials in the federal MDL would only involve knee implant cases, while the bellwether trials in Florida would be hip implant cases.

Exactech Class Action July 2023 Update

  • Only four new cases were added to the Exactech implant recall class action over the last 30 days. That marks the lowest number of new cases in a month since the Exactech MDL was created almost a year ago. Why the slowdown? This is most likely just a reflection of plaintiffs’ lawyers filing fewer cases in the middle of the summer rather than any underlying issues in the litigation. Expect another slow month before things start to pick up again in the fall. There are now 395 cases pending in the Exactech MDL.
  • Magistrate Judge Marcia M. Henry held a hearing late last month. But it was a slow month for MDL developments.
  • A lawsuit against Exactech on behalf of third-party payers (such as insurance companies) who paid for the company’s defective implants has recently been dismissed. The Exactech MDL judge dismissed the Complaint because it failed to allege the appropriate risk of future harm, such as additional costs. However, the dismissal is without prejudice, which means that the plaintiff can file again within 30 days with an amended complaint.

Exactech Class Action June 2023 Update

  • A dozen more Exactech implant failure lawsuits were added to the MDL over the last month. There are 136 total cases pending in the Exactech class action MDL in the federal court, with another 90 or so cases simultaneously pending in Florida state courts.
  • New implant failure cases continue to get filed in the Exactech recall class action MDL. Just yesterday (May 31, 2023), a new case, Nazario v. Exactech Inc., et al. (1:23-cv-03998), was filed in the MDL using the Short Form Complaint. The plaintiff, Julio Nazario, is a New York resident who had the Optetrak knee replacement implant system installed in November 2011. The implant was surgically removed in February 2022 after the device’s premature failure caused swelling, pain, and loss of motion.

Exactech Class Action May 2023 Update

  • We saw another big block of over 80 Exactech implant recall lawsuits added to the class action MDL over the last month. This follows up on last month’s spike of over 90 new cases, and pushes the total number of plaintiffs in the Exactech class action to 373 (not including those cases in Florida state courts).
  • The pace of the Exactech class action lawsuit in pretrial discovery has been slow.  Records are critical in a case like this.  But no documents from the six custodians identified in January 2023 having been collected yet. Exactech identified the six custodians and search terms “as a starting point” on January 22, but on February 3, they were not prepared to discuss whether they had collected the six custodial files. Despite multiple emails and conferences since then, Exactech has only agreed to add six more custodians, bringing the total to twelve. The slow pace of discovery is causing frustration for the plaintiffs who want these cases to move forward to bellwether trials because trials expedite the settlement process one way or the other.
  • We need to protect the evicence of the problems with the Exactech devices that led to the recall.  Last week, the Exactech MDL Judge issued a new Case Management Order that lays out a system for the collection and preservation of medical evidence such pathology samples and explanted implant devices. The Order requires all medical evidence of this type to be handed over to a third-party medical storage provider.

Exactech Class Action April 2023 Update

We wrote last month about plaintiffs’ efforst to impose liability on a private equity sponsor of Exactech against TPG Inc., Osteon Holdings, Inc., Osteon Merger Sub, Inc., and Osteon Intermediate Holdings II, Inc. (collectively, “TPG”).  Their lawyers wrote a letter on March 30, 2023 to MDL Judge Nicholas G. Garaufis, asking for a hearing to dismiss the cases because they were not involved design, manufacture, packaging, or sale of any Exactech device.

Plaintiffs’ Exactech lawyers seek to pierce the corporate veil. To state a veil-piercing claim, a plaintiff must allege that the parent’s “exclusive domination and control to the point that the [subsidiary] no longer has legal or independent significance of its own” and “the corporate structure caused fraud or similar injustice.”  The letter claims Plaintiffs have not state a veil-piercing claim for three reasons.

Firstly, defendants argue that the plaintiffs obfuscate the corporate structure to try to connect TPG to Exactech—ignoring the Osteon entities between Exactech and TPG Inc. Second, they say none of Plaintiffs’ allegations are sufficient to prove the “domination and control” required to state a veil-piercing claim. And third, Plaintiffs have not even tried to allege that Exactech “was formed or used by its corporate parents to achieve an improper purpose” or “exist[s] for no other purpose than as a vehicle for fraud.”

TPG argues that Plaintiffs’ claims were successfully asserted against it would upend the entire private equity industry (which might not exactly terrify middle America).  TPG says it would be unprecedented.  But TPG’s activity in the nuances of Exactech might be unprecedented, too.

Again, the whole purpose of this exercise is to make sure there is money to pay Exactech settlement amounts and jury payouts given the size of this litigation and the relative small size of Exactech.

Growing Litigation

This month, we witnessed a significant surge in new Exactech implant recall lawsuits, with 111 new cases either filed or transferred into the Exactech class action lawsuit over the past 30 days. This marks the largest monthly increase since the litigation’s inception, raising the total number of pending cases to 290. This likely signifies the beginning of an ongoing trend for the remainder of the year. Additionally, over 80 Exactech cases are pending in a Florida state court MDL.

Exactech Class Action March 2023 Update

  • The Exactech implant recall class action added 47 new cases over the last monthly period. That is an increase of over 20%, the biggest monthly increase since the litigation started, and it brings the total number of plaintiffs in the Exactech MDL up to 179.
  • Post on the effort to expand the defendants responsible for the Exactech recall
  • New Exactech lawsuits continue to be filed.  A Maine woman filed a new lawsuit alleging that her Exactech knee device, implanted during two knee replacement surgeries in 2012, was defective and caused permanent and debilitating injuries. She underwent a right total knee replacement on January 30, 2012, and a left total knee replacement on October 1, 2012 at the St. Mary’s Regional Medical Center in Lewiston, Maine. The Exactech Knee Device implanted during the surgeries included various components such as the Exactech Tibial Insert, Tibial Tray, and Femoral Component. In 2018, she required revision surgery due to polyethylene liner wear with resulting osteolysis, aseptic loosening of the tibial component, and development of complex regional pain syndrome. She suffers daily knee pain and discomfort, gait impairment, poor balance, and difficulty walking.

Exactech Class Action February 2023 Update

  • On May 10, 2023,  the Judge in the Exactech recall class action MDL will hold a science day during which lawyers for each side will make presentations to educate the court about the various scientific issues and evidence involved in the cases. The Exactech MDL now has 132 pending cases.
  • The Exactech MDL Judge recently finalized the process that allows all future Exactech implant lawsuits to be filed directly in the MDL. Plaintiffs’ Liaison Counsel also launched a new website (www.exactechmdlfilings.com) was also launched by Plaintiffs’ Liaison Counsel to give the public access to key documents relating to the litigation, such as Court Orders and attorney contact information. Judge Garaufis also has plans to hold a Science Day (we will explain Science Day in detail when the date is chosen) and has asked the parties to submit a joint proposal this week for the time frame and logistics of that event.

Exactech Class Action Lawsuit January 2023 Update

  • We now have a class action lawsuit pending for the Exactech recall in New York.  The class action is the result of Exactech lawyers filing a motion with the JPML asking for the creation of a new Exactech class action lawsuit. This is a big step towards an eventual settlement.
  • In mid-December 2023,  the judge in the Exactech recall MDL named 27 lawyers to the plaintiffs’ leadership committees for the litigation. There will be an Executive Committee, a Steering Committee, lead counsel, and liaison counsel.  So we are now moving forward.
  • The class action is the result of Exactech lawyers filing a motion with the JPML asking for the creation of a new Exactech class action lawsuit. This is a big step towards an eventual settlement.
  • In mid-January 2023, parties for both sides in the Exactech recall MDL in federal court submitted a joint status report to Judge Garaufis before the status conference. The status report advised that the consolidated proceedings in Florida state court now have 86 pending cases, and discovery is starting to get underway. Master discovery requests were served last month, and the deposition of Exactech’s chief medical officer, Dr. Sharat Kusuma, is scheduled for February.

Exactech agrees to a class action lawsuit.

So there is no longer any dispute as to whether there should be an MDL Exactech class action lawsuit. Exactech advised the MDL panel to favor a new class action lawsuit consolidating all Exactech implant recall lawsuits in federal courts.

In its response, Exactech also agreed with the plaintiffs that the Eastern District of New York would be the most appropriate venue for the MDL. Exactech’s consent effectively guarantees that the JPML will grant the request and form a new MDL for the Exactech recall cases.

What does this mean for your Exactech lawsuit?  It means that if you file in federal court – which would seem to be the best place for victims to file – your Exactech lawsuit will be consolidated in front of a single judge in New York.

So if you are in California, Texas, Illinois, or any other state, your case for pretrial discovery will be housed in New York.  If there is no Exactech settlement at the end of the pretrial discovery (and likely a few trials), your case will be remanded back to your home state for trial.

There are no guarantees in litigation.  But our Exactech lawyers believe that these lawsuits will very likely settle long before there is a trial.

Twenty-seven Exactech recall lawsuits

The JPML motion lists 27 Exactech recall lawsuits pending in 11 federal districts. Exactech attorneys seek to have the MDL established in the Eastern District of New York, and Exactech will almost certainly request the Northern District of Florida as the venue. Exactech is headquartered in Florida and has a brand name in northern Florida that it would hope has some sway with juries.

Nine more Exactech recall lawsuits are filed.

It has been less than a month since a motion was filed with the JPML asking for the Exactech recall lawsuits to be consolidated in a new MDL. At that time, 26 Exactech implant recall cases were pending in federal courts. Since then, another nine lawsuits have been filed against Exactech over its recent implant recall, bringing the total number of pending Exactech cases in federal courts up to 36. This will undoubtedly increase the likelihood that the JPML will grant the motion and create a new MDL for the Exactech recall cases.

Exactech recall expanded

This summer, Exactech was recently forced to expand the scope of the recall of its joint replacement implants. Exactech sent a new recall letter to healthcare providers last week, notifying them that the recall of hip and ankle implants initiated in February was not being expanded to cover an additional 40,000 implant components. The expanded recall covers acetabular hip liners in Exactech’s Connexion, Novation, and other brand implant systems.

This latest news comes just as the JPML created a new MDL Exactech class action lawsuit that is up and rolling in 2023.

About Exactech

Exactech is an international medical device company specializing in surgical implants used in joint replacements (e.g., knee, hip, and ankle). Exactech also makes surgical tools and technologies for orthopedic surgeons.
exactech recall lawsuit
Exactech is headquartered in Gainesville, Florida, but it has international offices in 8 different countries, employing over 900 people worldwide. The company was originally founded in 1985 by a group of orthopedic doctors. Initially, the Exactech business was focused entirely on hip replacement implants, but in the mid-1990s, they entered the knee implant market. In 2017, Exactech began making ankle and foot replacement implants.

Exactech Optetrak Knee Implants

Optetrak® is Exactech’s proprietary knee replacement implant system. Optetrak was first launched in 1994, and it was Exactech’s initial entry into the knee replacement implant field.
Since 1994, Exactech has repeatedly obtained 510(k) FDA clearance for various Optetrak devices and tibial inserts, including the Optetrak PS, Optetrak Hi-Flex PS, Optetrak Finned Tibial Tray, Optetrak Offset Tibial Tray, Optetrak RBK Tibial Insert, Optetrak RBK Tibial Tray, Optetrak CR Slope, and Optetrak Logic. These devices are used for knee replacement surgery, referred to as total knee arthroplasty (“TKA”). The primary indication for TKA is to relieve severe pain associated with arthritis and may also be used to correct knee trauma or minor knee deformities.
During a TKA procedure, the surgeon makes an incision over the knee and prepares the femur by removing any diseased bone and drilling a hole for the femoral component of the Optetrak implant. The Optetrak femoral implant is then fixed in place using surgical cement. Next, the surgeon performs the same preparation on the bone located at the bottom of the knee (the proximal tibia). The tibial tray of the Optetrak is then implanted using surgical cement.
Once the femoral implant and tibial tray components of the Optetrak are in the plant, a third part of the system, called the “tibial insert,” is implanted. The tibial insert is made from polyethylene and is designed to absorb friction between the two parts during movement.

Problems With Optetrak Knee Implants

The Optetrak knee implant system was approved under the abbreviated 501(k) FDA clearance process, which means it was never subject to a full FDA review and approval. The Optetrak was successful in the decade following its initial release in 1994. More recently, however, the implant system has been plagued by abnormally high failure rates.
In 2012, an article published in the journal Orthopedics and Traumatology highlighted “poor results” displayed by the Optetrak knee replacement systems and suggested it was related to a design flaw. In 2016, the Australian Registry, a preeminent, internationally recognized orthopedic implant registry, identified the Optetrak as an implant with a higher-than-expected revision rate. Specifically, the Optetrak was found to have the worst failure rates among all knee replacement implants at five years (6.6%), seven years (7.9%), and ten years (9.6%).
Exactech was aware of these abnormally high failure rates, and they were getting a flood of incoming reports about implant failures from around the U.S. beginning in 2012. Reports in the Manufacturer and User Facility Device Experience (MAUDE) indicated instances of revision due to “loose tibial component,” “aseptic loosening,” “polyethylene wear,” “pain and visible loosening,” and “pain, limited mobility, knee swelling, and sensitivity” due to a “loose” joint. These early onset failure MAUDE reports are representative of the increased rate of incidents of which Defendants had become internally aware. There are so many complaints about the Optetrak devices in MAUDE that a search maxes out (at 500) and cannot show them all.
Reports of the excessively high failure rates of the Optetrak implants sparked many product lawsuits against Exactech by patients who experienced premature implant failures. These previous Optetrak implant lawsuits alleged that the high failure rate was evidence of general design defects, including the unique “finned” design feature of the original Optetrak system.
Exactech responded to this situation by pursuing a “silent” recall in which they gradually phased out the finned design without announcing anything. This alteration to the design of the Optetrak failed to decrease the alarmingly high failure rates, which eventually led Exactech to discover the problem with the defective vacuum-seal packing, which was causing the polyethylene inserts to degrade and malfunction prematurely.

Recall of Exactech Knee Implants

In 2021, Exactech took the first steps towards a sweeping nationwide recall of all its knee replacement implant systems manufactured after 2004. The recall impacts an estimated 147,000 knee replacement implants in the U.S. The Exactech implant systems are utilized in knee replacement surgery, referred to as total knee arthroplasty (“TKA”). TKA knee replacement surgery is generally used to treat chronic pain associated with arthritis, and TKAs are also used to correct knee trauma and deformities.
Exactech has several different lines of knee replacement implant systems that are covered by the recall. These include:
  • Optetrak® (1994)
  • Optetrak Logic® (2009)
  • Truliant® (2017)
Exactech initiated the recall after discovering that the vacuum-seal packaging used for its knee implant systems was defective. The defective packaging allowed too much air in and caused the polyethylene insert component in the implant systems to oxidize before the product was used. The oxidation significantly degraded the polyethylene of the inserts after packaging, impairing the ability of the inserts to function correctly in the knee replacement system. Over time, the impaired polyethylene inserts caused excessive friction and wear, triggering the premature failures of the Exactech knee replacement systems.
Early failure of the Exactech knee replacement system due to this manufacturing defect can devastate patients. Implant failure causes significant pain, swelling, and lack of mobility in the knee. Eventually, patients who experience implant failures must undergo corrective revision surgery to replace the defective implant.

Example Exactech Knee Replacement Lawsuit

A recent Exactech knee replacement recall lawsuit is Hursey v. Exactech, Inc. et al. (1:22-cv-07893). This suit was filed in the Exactech class action MDL.
The plaintiff, Mr. Hursey, had an Exactech Truliant knee system implanted during a knee replacement surgery in July 2021. Just one year later, Hursey had to have revision surgery because the Tuliant implant had prematurely failed. His knee replacement suit asserts numerous causes of action, with the primary theory of recovery being defective manufacture.
Interestingly, the knee system failed so quickly.  The more classic cases our lawyers are seeing are that revision surgery is needed for longer.  This seems more consistent with the oxygenation wearing down the component parts.

Compensation for Recalled Knee Implants

Medical device companies like Exactech have a legal duty to ensure that their products are safe and will not harm consumers when used for their intended purpose. This duty makes manufacturers strictly liable for hidden design flaws or defects that harm users.
The Exactech recall amounts to an admission that the knee replacement implants had a manufacturing defect (the defective packaging). Therefore, Exactech can be held liable for injuries and damages resulting from that product defect.
Anyone who had an Exactech knee replacement system implanted after 2004 may have a valid product liability lawsuit against Exactech if that implant subsequently failed to result in pain and revision surgery. Plaintiffs who bring a successful Exactech knee implant lawsuit would be able to recover damages for (a) pain & 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.

FAQs: Exactech Recall Lawsuits

What should I do if my Exactech implant has been recalled?

If you have a recalled Exactech knee or ankle replacement implant, you should make an appointment with your doctor to discuss your options. Removal or replacement of the recalled implant may be necessary at some point. Still, for now, Exactech is advising doctors to maintain an index of patients with recalled implants and closely monitor them for signs of potential insert failure.

How do I know if my implant has been recalled?

If you have a knee or ankle replacement implant system made by Exactech. Your surgery occurred after 2004, then your implant is almost definitely covered by the recall. The recall covers ALL Exactech total knee replacement systems and ankle replacement systems that were manufactured at any point after 2004. This effectively covers all Exactech knee and ankle implants surgically installed in the last nine years.

How do I know if Exactech made my implant?

Many patients who have joint replacement surgery have no idea what brand of implant system they have. If you had total knee replacement surgery, but you don't know whether Exactech made your implant, you will need to ask your orthopedic doctor or request your medical records from the surgery to determine who manufactured your implant device.

As part of the recall, Exactech is inviting patients with recalled implants to submit "claims for reimbursement" and has hired a third-party administrator (Broadspire) to manage the claim process. Patients should be aware, however, that if they submit a claim for reimbursement to Exactech, they will likely waive their right to file a product liability lawsuit against Exactech for the recalled implant. Patients who submit reimbursement claims to Exactech will get far less compensation than they would otherwise be entitled to if they brought an Exactech recall lawsuit in civil court.

What do you expect for Exactech recall lawsuit settlement amounts?

Our attorneys estimate that Exactech knee replacement recall lawsuits may have a settlement value of $130,000 to $190,000 and ankle replacement recall lawsuits may have a slightly higher value.

Predictions for Exactech settlement amounts at this stage are dicey.  So take these settlement amount projections with a grain of salt.  But they are based on historical settlement amounts in defective knee replacement lawsuits and the specifics of this Exactech recall.

Exactech Knee Replacement Attorneys

If you have an Exactech knee replacement system implanted, you may be entitled to financial compensation for any complications or problems related to the implant. Consult with an Exactech recall lawyer to determine your legal options.  Call 800-553-8082 today or get a free online consultation.  

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