Exactech Implant Lawsuit Status
Joint arthroscopies are supposed to enrich patients’ lives by restoring mobility and eliminating chronic pain. Hip, knee, and ankle replacements are highly successful procedures that have well-established success rates of at least 90% after ten years.
The success of these procedures can be attributed to the skill of the physicians performing the surgery and the quality of the joint replacement implants. Surgeons and patients rely on hip, knee, and ankle replacement manufacturers to offer safe, effective products.
Exactech Product Defects
The Exactech recalls relate to the polyethylene components of the following brands of their hip, knee, and ankle replacements:
- Optetrak
- Truliant
- Vantage
Patients who received certain Exactech hip, knee, and ankle replacements marketed under these brands and manufactured after 2004 have experienced higher-than-average failure rates within just a few years after their arthroscopy procedures.
A study by the Australian Orthopaedic Association revealed that the two Exactech’s recalled knee replacement implants studied have a failure rate of 16% within the first three years, compared to 2.5% in other brands.
Hip Replacements
On June 29, 2021, Exactech initiated a recall of its Connexion GXL polyethylene acetabular (socket) liner after observing a risk of excessive edge loading and premature wear of the polyethylene material.
Plaintiffs’ counsel on June 14, 2022, filed a motion to transfer and centralize the 27 defective product lawsuits against the company in the Eastern District of New York.
The U.S. Judicial Panel on Multidistrict Litigation heard oral arguments in St. Louis, Missouri, on September 29, 2022.
Knee and Ankle Replacements
Exactech initiated the recall of the polyethylene insert in knee and ankle replacements on August 31, 2021. The company found that 80% of its inserts manufactured after 2004 were improperly packaged in “nonconforming bags.”
Polyethylene, a type of plastic, begins to degrade when exposed to oxygen and thus requires oxygen-resistant packaging. While vacuum bags were used, they lacked the necessary extra barrier layer composed of ethylene-vinyl alcohol (PVOH). This made the inserts vulnerable to oxygen permeation.
Defective Polyethylene Inserts
The result is that the polyethylene wears down quickly after implantation. As polyethylene wears down, fragments are released into the tissues surrounding the joint replacement. This gives way to complications that lead to failure of the joint replacement.
Joint Replacement Failure
The released polyethylene fragments into the tissues cause inflammation, infections, and osteolysis. Osteolysis is the progressive destruction of the bones. There are no symptoms associated with this process until after the damage has been done. In total joint replacements, this damage leads to the failure of the prosthetic device.
Arthroscopic failure causes the following symptoms and complications:
- Loosening of the device
- Instability of the joint
- Infections
- Frequent or recurring dislocations in hip replacement failures
- Bone fractures
Joint replacement failure is catastrophic for many patients, who often experience severe pain, impaired mobility, and an increased risk for falls. Such failure necessitates painful revision surgery, a more complicated procedure than the original arthroscopy.
Many arthroscopy patients are elderly and cannot undergo revision surgery due to their health statuses. In some knee replacement cases, the symptoms appear after bone destruction or infections are advanced, and amputation above the knee becomes necessary.
Status of Litigation
Litigation is just beginning for these cases. By the company’s own admission, more than 143,000 patients may have been impacted. Due to the significant number of likely victims, these cases are expected to be transferred to MDL.
One federal lawsuit currently underway, Wilson et al. v. Exactech, Inc., Case No. 4:22-CV-136-BRW, alleges the following concerning the Novation Crown Cups and Connexion GXL Liners, components of the hip implants:
- Exactech continued to market and sell the product after they knew it was producing higher than normal wear rates.
- The company falsely represented the products as being less prone to wear than competitor products.
- The product’s design itself promotes excessive wear.
- The company made claims that were not supported by unbiased scientific research.
- The company rushed the product to market without conducting adequate performance testing
- The recall was only issued after the company had developed a replacement product.
- The company failed to warn doctors and patients about the potential for excessive wear and premature failure.
Similar cases are being filed throughout the country, including four cases in New York City alone. Exactech is not communicating directly with patients about the recall. Instead, the company has delegated this to physicians. The passage of time as well as the bureaucracy in the health care system may prevent patients from receiving this information.
Consequently, many patients are unaware that the safety of their implants is in question. Attorney advertising will be a key factor in ensuring the public is informed.
On October 7, 2022, the U.S. Judicial Panel on Multidistrict Litigation granted the motion to centralize the Exactech litigation to the Eastern District of New York and assigned Judge Nicholas G. Garaufis to preside over the litigation. As of the date of the transfer order, a total of 75 cases and potential tag-along cases were pending. Twenty-six of these cases had originated in the Eastern District of New York, and this played a role in the court’s decision to select this district.
The panel noted that no pending claims or potential tag-along claims had been filed regarding the Vantage total ankle replacement systems but stated that the inclusion of these cases in the MDL could be addressed during the conditional transfer order process should such cases be filed. The case is MDL 3044. As of January 17, 2023, 123 cases were pending in the MDL.
On January 26, 2023, plaintiffs filed the Master Personal Injury Complaint with 11 causes of action. The allegations are summarized below.
Strict Liability Based on Manufacturing Defect
Plaintiffs allege Exactech knew or should have known that its products presented unreasonable risks to of harm from polyethylene wear, component loosening, and other serious complications including tissue damage, osteolysis, and the need for revision surgery as a result of the following manufacturing defects:
- The vacuum bags lacking the ethyl vinyl alcohol protective barrier layer were not manufactured according to Exactech’s specifications.
- The packaging materials for the hip, knee, and ankle devices were of an inferior quality.
- The polyethylene components of the implants were degraded due to the above manufacturing defects.
Strict Liability Based on Design Defect
Plaintiffs allege Exactech knew or should have known that its polyethylene products had a defective design when they left its facilities, which made the product unreasonably dangerous.
Strict Liability Based on a Failure to Warn
Plaintiffs claim Exactech knew or should have known that its products were unreasonably dangerous to consumers before they left Exactech’s hands, due to their propensity to wear prematurely, yet the company failed to warn the plaintiffs or the plaintiffs’ health care providers.
Negligence
Plaintiffs claim Exactech breached its duty to exercise reasonable care in the “formulation, manufacture, inspection, labeling, packaging, storage, promotion, advertisement, marketing, distribution, and sale” of the implants and was negligent and careless.
Exactech failed to exercise reasonable care by failing to issue adequate warnings or recall the implants sooner and knew or should have known about the dangers of its implants.
Exactech continued to manufacture and sell the product after it knew about the risks of serious bodily harm to consumers without warnings.
Exactech was negligent in its failure to ensure proper packaging of its products.
Breach of Express Warranty
Plaintiffs claim Exactech expressed multiple false claims that its products performed better than its competitors and would last longer, have lifelong durability, and were clinically proven to reduce wear.
When its products degraded prematurely, instead of taking responsibility, Exactech blamed other factors, such as surgical technique.
Plaintiffs and their surgeons relied on these warranties when deciding to implant Exactech’s devices.
Breach of Implied Warranty
Exactech implied its products were safe by marketing the products to the public.
Negligent Misrepresentation
Exactech’s false claims about the longevity, safety, and quality of its products amount to plaintiff allegations of negligent misrepresentation because it knew about the products’ deficiencies but failed to disclose them. Exactech failed to disclose the negative outcomes of customers and the availability of higher quality products.
Fraud
Exactech’s many misrepresentations about its products were false and misleading, and Exactech knew they were false and misleading according to plaintiff claims.
Fraudulent Concealment
Plaintiffs claim Exactech’s negligent misrepresentation and fraud also constitute fraudulent concealment, a fact that may serve as a basis to toll the statute of limitations.
Punitive Damages
Plaintiffs claim they are entitled to punitive damages because Exactech’s conduct was willful, wanton, reckless, malicious, beyond all standards of decency, and without regard to human life, when it did the following:
Intentionally and recklessly designed, manufactured, and sold defective hip, knee, and ankle implants
Intentionally and recklessly failed to implement quality controls and remove compromised devices from the market
Intentionally and recklessly failed to confirm implants were properly packaged and stored for 17 years
Intentionally and recklessly failed to investigate and follow up on reports of its products failing
Fraudulently misrepresented, omitted, and concealed facts about its products’ failure rates, propensity to wear, defects, and injuries to others
Loss of Consortium
Plaintiffs’ spouses and family members claim to have suffered the loss of their loved one’s “support, companionship, services, society, love, affection, and consortium” and will continue to suffer from these losses as a proximate result of Exactech’s actions and omissions.
What is next in the Exactech litigation?
The Master Answer is due March 13, 2023. The last status conference was on January 25, 2023. The next status conference is scheduled for March 23, 2023, at 2:30 p.m. via video.
History of Litigation against Exactech
Exactech is no stranger to litigation. In a 2017 lawsuit, Marcus H. Talley v. Exactech Inc., the plaintiff alleged that he was harmed by the company’s “finned” tibial tray, which he received as part of his total knee replacement after the company failed to provide warnings about its risks.
The plaintiff asserted that the company knew the product was harmful and engaged in what he termed a “silent recall” of the product. This consisted of slowly and quietly removing the product from the market, but only after they had developed a replacement product.
2020 Whistleblower Litigation
A 2020 qui tam action is pending in The Southern Division of United States District Court in the Northern District of Alabama, alleging the following:
- Exactech knew at least as early as 2008 that their finned tibial trays had a high failure rate of 30-35%, a rate that is ten times higher than comparable devices and six times higher than the rate at which a recall should have been implemented.
- Exactech investigated the product defects and then took active steps to conceal and misrepresent their findings.
- Exactech knowingly submitted false claims to the Department of Veterans Affairs and Medicare by using and billing for faulty, off-branded products.
- Exactech paid kickbacks to an orthopedic doctor in exchange for continuing to purchase the defective products after the doctor had complained about the efficacy of the products.
The court has denied Exactech’s motion to dismiss the case.
2020 Settlement with the United States Government
In 2010, Exactech agreed to pay the United States government $2.99 million in a settlement agreement amid allegations of paying kickbacks to orthopedic surgeons from 2002 to 2008. A criminal case was pursued in conjunction with the conduct. This case was resolved in a deferred prosecution agreement that included fines and an agreement to allow government monitoring.
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