Exactech Lawsuits (July Update)
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Exactech Lawsuits (July Update)

Dr. Nick Oberheiden
Attorney Nick Oberheiden
Exactech Lawsuits Team Lead

Exactech is a medical implant company in Florida that designs, manufactures, and sells the implants for hip, knee, and ankle replacement surgeries. Recently, Exactech discovered that the vacuum sealing in its packaging was defective. Air got into the packaging and caused the plastic in its devices to oxidize and degrade before they were implanted. In August, 2021, Exactech initiated a recall of all of its implant devices made since 2004. Around 150,000 of them had already been implanted in patients in the U.S.

Lawsuits began to get filed immediately after the recall was announced. They have been consolidated into multidistrict litigation (MDL) in New York City and are nearing the stage when bellwether trials would be held.

The personal injury and Exactech lawyers at the national law firm Oberheiden P.C. aim to represent victims who have been hurt by Exactech’s defective packaging of its products. With our Exactech attorneys’ legal guidance and advice, you can file an Exactech lawsuit and recover the financial compensation that you need to overcome the pain and hardship of going through, and recovering from, a serious corrective surgery.

Update for July 12, 2024: Exactech Lawsuits

Plaintiffs continue to join the litigation against Exactech. With the number of cases pending in the multidistrict litigation (MDL) continuing to increase, this is putting added pressure on Exactech to consider an out-of-court settlement—as its liability exposure continues to grow. If you think you may have a claim, this is one of several reasons why it is important that you speak with a lawyer sooner rather than later.

Otherwise, we do not have any significant updates to report this week. The MDL is continuing to move forward, largely as expected. The next significant deadline under the revised scheduling order is not until late August, when the parties must have their core depositions completed.

Previous Exactech Lawsuit Updates

July 5, 2024 – There have recently been some scheduling updates in the Exactech medical implant litigation. As is often the case, many key deadlines have been extended—though not by much. The last currently scheduled deadline (for the parties’ replies to pre-trial motions) has been moved from April 11, 2025 to June 10, 2025. This means that trial is still scheduled for next summer, which is good news for the patients and families who are seeking financial compensation for the substantial harm caused by Exactech’s defective medical implant devices.

While the trial in the multi-district litigation (MDL) against Exactech may now be less than a year away, it is not too late for new plaintiffs to join (although, as we discussed in our last update, the statute of limitations may soon be expiring for some claims). If you think you may have a claim related to a defective Exactech ankle, hip, or knee impact device, we strongly encourage you to contact us for a free, no-obligation consultation.

June 28, 2024 – There were no significant developments in the Exactech litigation this week, as lawyers for both sides are working behind the scenes to prepare for mediation while also ensuring that they will be prepared to go to trial if necessary. With more than 1,600 cases pending—and more cases being filed weekly—the mediator will have a lot of information to consider, and it will be up to the plaintiffs’ lawyers to clearly and effectively present their case. While a mediator’s role is not to render a decision but rather to help facilitate good-faith settlement negotiations, it will be critical for the mediator to have a clear understanding of the issues with Exactech’s defective devices and how these issues have negatively impacted implant recipients and their families.

While most people who have claims against Exactech and who have not yet filed a lawsuit still have time to do so, time may be running out in some cases. To make sure your lawsuit is not barred by the statute of limitations, you should speak with a lawyer promptly if you think you may have a claim.

June 21, 2024 – Dozens of plaintiffs have joined the federal multidistrict litigation (MDL) involving Exactech implantable joint replacement devices in June, bringing the total number of cases to more than 1,600. This total consists primarily of cases involving defective Exactech’s knee implants (more than 1,300 cases filed), with smaller numbers of cases involving the company’s hip and ankle implant products. There are also currently hundreds of cases pending in state courts across the country.

In the federal MDL, while the parties are continuing to make progress toward trial, they have also engaged a mediator to assist with conducting settlement negotiations. But, new plaintiffs are joining the litigation daily, and potential plaintiffs still have plenty of time to hire a lawyer to help them assert their legal rights against Exactech.

Exactech

Exactech, Inc. was founded in 1985 in Florida by a group of doctors to design and manufacture medical implants. At first, it only sold hip reconstruction devices, but a partnership with a New York based hospital in the 1990s proved to be lucrative and Exactech went public in 1996. In 2005, the company began using the new Connexion GXL polyethylene liner for its hip replacement system, and then moved to knee replacement systems, introducing its Optetrak Logic implant in 2009.

In 2010, Exactech bought the company that it had been contracting with to manufacture the net compression molded polyethylene bearings that it used in its implants. These polyethylene bearings were exceptionally smooth and did not suffer as much wear during use, making them ideal for knee, hip, and, starting in March, 2016, ankle replacement prosthetics.

In 2018, Exactech was merged into the company TPG, Inc., a private equity firm that focuses in the healthcare field, for $737 million. TPG then brought the company private, taking it off the stock exchange. Soon thereafter, an advisor in TPG became the co-executive chairman of Exactech, and four years later he became the company’s CEO – just the most prominent example of how thoroughly TPG was in control of Exactech and its products.

Exactech’s Products

Over its course of existence, both as Exactech and as a part of the private equity firm TPG, Exactech has focused on medical implants for use in three types of joint replacement surgery:

  1. Total hip replacements
  2. Total knee arthroplasty
  3. Total ankle replacements

Each of these three medical devices share some important similarities, but also have some differences as well.

Exactech Hip Replacement Devices

In a total hip replacement procedure, the surgeon will make an incision in the hip, dislocate the leg from the hip, and remove the femoral head from the femur and make a deep pocket in the bone for the artificial femoral stem, which is made of metal alloy. Then, in the acetabulum, or the hip socket where the femur had connected to the hip, the surgeon will remove some bone and cartilage to make room for a metal shell that looks like half of a sphere. The surgeon then adds a liner that fits onto the head of the femoral stem and into the metal shell that has been attached to the hip bone. This creates a ball-in-socket joint that mimics the hip, with the liner between the metal components.

Importantly, the liner that goes between the metal stem that has been implanted into the femur and the metal cup that has been implanted onto the hip can be made of:

  • Metal
  • Ceramic
  • Ultra-high-molecular-weight polyethylene, or UHMWPE

This type of polyethylene is an extremely strong plastic, with the highest impact strength of any type of thermoplastic. It is also ideal for hip implants because it:

  • Produces very little friction when rubbed
  • Resists abrasion extremely well
  • Self-lubricates

These characteristics are extremely important for hip replacement devices because every leg motion rotates the ball inside the socket of the joint. Any amount of friction or abrasion can cause wear and tear that increases the amount of friction and abrasion created by motion, making the joint get progressively worse as time goes on and it gets used.

The only major downside to using UHMWPE in hip replacement implants is that it is a plastic that oxidizes when it comes into contact with oxygen.

Exactech’s hip replacement implants all use UHMWPE in the liner within the ball-in-socket joint.

Exactech Knee Replacement Implants

In a total knee replacement surgery, an incision is made down the middle or to the side of the knee. There, the bottom of the thigh bone, the femur, meets the upper end of the shin bone, the tibia, at the kneecap, called the patella. These three bones are covered with cartilage in a way that nearly completely eliminates friction during use. If this cartilage gets compromised by an injury, disease, or normal wear and tear, the resulting friction in the knee can become debilitating.

After making the incision, the surgeon would cut off the damaged bones and remove them. Exactech knee implants would then be added to replace what was removed. In a total knee replacement, that would be everything. The bones would be replaced with a:

  1. Femoral cap, which replaces the bottom of the femur,
  2. Tibial tray, which replaces the top of the tibia or shin bone,
  3. Patellar cap, which replaces the bone that had been removed and the cartilage that had been lost from the rear of the kneecap, and
  4. Tibial insert, which acts as a replacement for the cartilage that had been lost.

Together, the arrangement facilitates the hinge-like movements of the knee as it bends and straightens.

To do this well and without creating friction, Exactech’s knee implants use UHMWPE plastic in the tibial insert and the patellar cap.

Exactech Ankle Replacement Implants

In a total ankle replacement surgery, an incision is made down the front of the ankle and the bottom of the tibia, or shin bone, and the top of the talus, or footbone, are removed. Metal prosthetics are then attached to the bones to replace what was removed. A plastic insert is then added between these metal parts to replace the cartilage that had worn away or been removed during the procedure. This insert reduces the friction created when the new prosthetics rotate around.

Starting in 2016, Exactech designed and manufactured implants to use in these total ankle replacement procedures. Their design uses UHMWPE as the plastic insert between the metal components.

Defects in the Manufacture of the UHMWPE Cause Problems

The strength and smooth texture of UHMWPE make it ideal for use in medical implants, including those for ankle, knee, and hip replacements.

However, it is not perfect. There are two important, and related, downsides to using this type of plastic in medical inserts:

  1. It oxidizes, or degrades when it comes into contact with oxygen
  2. The sterilization process must be done correctly

If the sterilization process is not done correctly, then the plastic oxidizes more rapidly than it would, normally.

Exactech cut corners during the sterilization process that sped up the degradation caused by oxidation. Then it put the UHMWPE devices into packages that had defective vacuum sealing linings, allowing oxygen into the package and starting the oxidation process well before it was ever implanted in a patient.

UHMWPE Oxidation

When UHMWPE is exposed to oxygen, it degrades. The plastic begins to get brittle, it does not reduce friction as well, and it starts to flake off. That debris flaking off from the degrading UHMWPE causes chronic inflammation in the area around the implant. That inflammation can cause an autoimmune response in the region, which can lead to osteolysis, or bone resorption. This attacks the bone structure surrounding the implant, leading to a catastrophic failure of the implanted device, which requires an immediate corrective surgery.

Worse, in some cases, the osteolysis can be so bad that it completely destroys the patient’s bone structure around the implant, creating severe medical complications.

But osteolysis is not the only problem caused by UHMWPE oxidation. Less common adverse outcomes include localized:

  • Necrosis, affecting the bones, soft tissues, and muscle tissues
  • Collection of periprosthetic fluid, which can slow down the recovery process and increase the risk of an infection

For these reasons, it is essential to keep UHMWPE products from getting exposed to oxygen.

Poor Sterilization of UHMWPE Speeds Up the Oxidation Process

Manufacturers of implantable medical devices have to take steps to sterilize their implants before selling them to hospitals and surgical centers. When it comes to polyethylene devices, including those using UHMWPE, there are two main ways to accomplish this:

  1. Gamma ray radiation, and
  2. Ethylene oxide.

Radiating the UHMWPE with high-energy gamma rays is more common than ethylene oxide because it has an extra benefit; it enhances the durability of the UHMWPE by creating crosslinks in its chemical structure. Using even higher energy rays makes this crosslinking happen more, making the UHMWPE even more durable.

However, doing so has a downside: It breaks the carbon-hydrogen chains in the substance. This allows these free atoms to join into the crosslinking and, if these atoms are exposed to oxygen, they speed up the oxidation process and the degradation of the UHMWPE.

That downside, though, can be mitigated. Many implant manufacturers remelt the UHMWPE after sterilizing it. This eliminates the free carbon or hydrogen atoms that can join the crosslinking and get exposed to oxygen to degrade the plastic. In 2007, an additional mitigation strategy was discovered: Infusing the UHMWPE with vitamin E proved to be an effective antioxidant.

Most implant manufacturers take both of these steps.

Exactech did not. After sterilizing its UHMWPE with gamma rays, the company did not completely remelt the UHMWPE, and it did not add an antioxidant like vitamin E. It chose not to, even though in its own marketing materials, Exactech acknowledged how important they were.

Then, Exactech took the devices, now extra prone to oxidation, and put them into packaging that did not keep oxygen out of it.

Defective Packaging Allows Oxidation to Begin Immediately

The Exactech sales model was very inventory intensive: Due to the difficulties in predicting exactly what size of an implant would be necessary for a given patient, hospitals needed to have a wide variety of sizes available in the operating room. This meant that Exactech salespeople often traveled with lots and lots of models and sizes of implants in circumstances that lacked environmental controls to keep them from oxidizing. It also meant that the shelf life for each of those implants needed to be long enough – up to eight years – for them to be sold reliably.

Internal documentation revealed that Exactech was perfectly aware of the potential for the UHMWPE in their implants to oxidize, and also of the importance of packing them in vacuum-sealed bags to keep oxygen out until the bag was opened. That documentation also showed that Exactech had protocols in place to test the packaging and ensure quality control.

However, an investigation conducted by the U.S. Food and Drug Administration (FDA) in 2021 found that this protocol was not being followed.

Not conducting quality control on the packaging proved to be a critical problem. In order to prevent oxidation in the UHMWPE, the vacuum-sealed packaging needed to have an ethylene vinyl alcohol (EVOH) barrier in it. Exactech did not manufacture this packaging in-house. Instead, it contracted with a local supplier, Hillman Supply, Inc.

The packaging that Exactech purchased from Hillman Supply, Inc. contained the EVOH layer.

The packaging that Hillman Supply delivered to Exactech, though, did not contain the EVOH layer.

The lack of any quality control on the packaging meant that Exactech did not notice that it was getting the wrong bags.

For 17 years.

Exactech Recalls All Implants Since 2004

Reports of problems related to the early failure of Exactech’s implants started to trickle into the company early on. However, Exactech’s process for receiving, investigating, and forwarding these complaints on to the FDA were minimal, at best.

Reports of problems related to the early failure of Exactech’s hip, knee, and ankle implants began to accumulate in medical literature around 2020. Exactech’s response was to blame the surgeons for using poor techniques and patients for high activity levels, even while failing to investigate its defective implants after they had been removed in a corrective surgery, and to recommend that surgeons consider using Exactech’s new models of liners when conducting the revision procedure.

By June, 2021, though, the fallout from Exactech’s problems could be contained no longer. The company initiated a series of Class 2 product recalls with the FDA, as well as related notifications:

  1. June 29, 2021: A recall of hip replacement implants
  2. August 30, 2021: A recall of knee and ankle implants
  3. September 15, 2021: An Urgent Field Safety Notice about the knee and ankle implants
  4. February 7, 2022: An Urgent Medical Device Correction about defective knee and ankle implants, in which Exactech notified healthcare providers about the degrading UHMWPE inserts for the first time
  5. August 11, 2022: An expansion of the hip replacement recall, in which Exactech admitted that the packaging was faulty, had been since 2004, and that all of Exactech’s devices and implants had been compromised

Even then, though, Exactech failed to adequately communicate the details about the recalled Exactech implant, leaving many patients who had Exactech’s defective and degrading implants inside of them unaware of the dangers and the recall. Instead of notifying patients and medical providers, Exactech directed the Exactech implant recall notifications to its distributors and sales representatives.

Victims to Need Corrective Surgeries to Replace Defective Implants

Generally, people who undergo a total knee, hip, or ankle replacement and receive an implant can expect the implant to last around 20 years.

But reports indicate that Exactech’s knee replacement implant was failing at a rate of 19.4 percent after seven years, and 22 percent at 10 years.

When it fails, the patients who have the device inside them:

  • Can suffer significant pain at the site of the implant
  • Suffer a decrease in their range of motion
  • Are at risk of developing severe osteolysis, necrosis, and an infection
  • Need to undergo a painful, debilitating, and costly revision surgery

Corrective revision surgery for a total hip, knee, or ankle replacement are significant procedures that often require an overnight stay in the hospital. They are also expensive, costing around:

  • $40,000 for a hip procedure
  • $35,000 for a knee replacement
  • $24,000 for an ankle replacement

They also require substantial physical therapy afterwards in order to achieve the desired outcome. Furthermore, the most common group of patients who need a hip, knee, or ankle replacement are the elderly – the very group that is most at risk of complications and a difficult recovery. If Exactech had correctly manufactured and packaged its implants, such a corrective surgery would not be medically necessary for this group of at-risk patients.

All of these losses build up for patients whose recalled Exactech implants fail and they need to get them taken out and replaced. Because the corrective surgery is only necessary because of Exactech’s oversights, these patients deserve to be compensated.

Product Liability Claims Against Exactech

To recover financial compensation for these losses, plaintiffs across the country have been filing lawsuits against Exactech, whether an Exactech knee replacement lawsuit, hip replacement, and ankle replacement lawsuit, and against its current parent company TPG, Inc., alleging that the medical device maker violated products liability laws. They also claim that the companies breached express and implied contractual warranties, committed fraud and misrepresentation, and acted negligently in making and marketing their implants.

The main thrust of the claims, though, are related to products liability. Companies that design, manufacture, and market products can face three types of products liability allegations:

  1. Defective design
  2. Defective manufacturing
  3. Defective marketing

Plaintiffs and victims of Exactech’s conduct are alleging all three in their Exactech recall lawsuits, and are claiming that the law should hold the defendants strictly liable for its conduct.

By arguing that strict liability should apply, the plaintiffs in the cases hope to avoid having to prove that the defects were the result of Exactech’s negligence – a mental state that is often tricky to prove, and just another bar to recovery.

Design Defect

Generally, a design is defective if it either:

  • Fails to perform as safely as a typical consumer would expect it to, when used either as it was intended or in a reasonably foreseeable manner, or
  • The benefits of the product’s design do not outweigh the risks inherent in that design.

Exactech plaintiffs claim that the company’s medical implants were defectively designed in the following ways:

  • The plastic could have been made more resistant to oxidation, but was not
  • The packaging could have been sealed better with an EVOH layer, but was not
  • The shelf life of the implants could have been shortened to ensure degraded implants were not used during surgery, but was not
  • Alternative and safer designs existed that would have performed the same function as Exactech’s products but at less risk to patients, but were not used

Manufacturing Defect

Manufacturing defects happen when a product is made dangerous due to a variation from its intended design or from other products in the same production line.

Plaintiffs claim that Exactech should be held liable for the following manufacturing defects related to its implants:

  • The inferior packaging failed to comply with Exactech’s specifications, which called for an EVOH layer to prevent oxidation
  • Lacking environmental controls when storing the packages, which could have reduced the risks of oxidation
  • A complete lack of quality control that allowed for the use of defective packaging for 17 years
  • Inadequate inventory control, including the testing and inspection of implants in storage for signs of oxidation, which would have alerted the company to the shortcomings
  • Poor handling of complaints about early device failure to the company
  • Using shelf life designations for the implants that were far too long, given the uninvestigated potential for oxidation and degradation of the devices

Marketing Defect, or Failure to Warn of Dangers

Companies that make and sell products have a legal obligation to warn people of the dangers of using their products, whether that use is as intended or in a reasonably foreseeable misuse of the product. Furthermore, companies have to warn of potential risks that are known to them, or should reasonably have been knowable.

These types of products liability claims are also referred to as “failure to warn” claims.

The plaintiffs in the claims against Exactech argue that the company knew, or should have known, of the dangers of its devices degrading through oxidation, and that it should have known of the defects in the packaging that were causing them to degrade in storage.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd
Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara
Linda Julin McNamara

Federal Appeals Attorney

Aaron L. Wiley
Aaron L. Wiley

Former DOJ attorney

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (DOJ)

Chris Quick
Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow
Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

MDL Forms in New York

The Exactech situation has all of the elements of a mass tort claim that make them ripe for consolidation. The legal claims involved:

  1. A single defendant
  2. A single course of conduct by that defendant
  3. Hundreds or thousands of victims across many jurisdictions who have been hurt by that course of conduct
  4. Similar losses among those victims

Mass tort claims like these would lead to numerous individual lawsuits getting filed in courthouses across the country. Each of those claims would then demand access to the same types of evidence, leading to duplicative requests and lots of inefficiency.

In years past, mass tort claims like these used to get handled in a class action, where hundreds or thousands of other claims would get added to a lawsuit brought by a few plaintiffs who were representative of the rest of the class.

More recently, mass tort claims have been getting resolved through multidistrict litigation, or MDL.

In an MDL, individual lawsuits by victims are consolidated in one courthouse and before one judge, who then handles all of the pre-trial procedures like:

  • Motions to dismiss
  • Discovery of evidence, including deposing witnesses and disclosing documents
  • Summary judgment motions
  • Evidentiary rulings about what evidence can, and cannot, be presented at trial

As evidence is uncovered, settlement negotiations begin. If they do not resolve the case, then a few representative cases are pulled from the MDL and taken through bellwether trials. The outcome of those cases then alter the settlement negotiations.

The Exactech claims were consolidated into an MDL on October 7, 2022, in the Eastern District of New York. As of June, 2024, there were over 1,500 cases in the MDL. Bellwether trials are being scheduled to take place starting in June, 2025.

Exactech Attorneys at Oberheiden P.C.

The Exactech lawyers at Oberheiden P.C. are taking cases against Exactech for harm caused by their defective medical implants. Contact us online or call our national intake number at 866-781-9539 to get the legal representation you need to recover the compensation that you deserve.

Further Information About Our ExactTech Lawsuit Services

Exactech Lawsuits (July Update)

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