In August 2021, Exactech recalled about 200,000 knee, hip, and ankle prosthetics manufactured since 2004. The products are said to have been shipped in defective packaging (off-specification) that allowed the product polythene components to oxidize before the expiry of their shelf lives. At least 142,732 defective inserts have already been used on patients nationwide. The effect of this is that the implants may fail early, leading to complications for thousands of people that will require surgical correction.
After the recall, Exactech wrote to surgeons urging them to stop using the defective implants and follow up with patients to determine if they needed additional hip or knee replacement surgery. Victims of these defective prosthetics are filing for claims directly in the Exactech class action lawsuit in New York and State Courts (Re: Exactech Polyethylene Orthopedic Products Liability Litigation, MDL No. 3044). These include those whose defective Exactech implants failed, requiring surgery.
If your implant fails, you will likely experience certain symptoms, such as implant noise or grinding, pain, swelling, instability, and inability to bear weight. Follow up with your doctor to assess if you had any recalled prosthetics or are experiencing any of these symptoms. You should consult our Exactech lawyers for advice and help file a product liability lawsuit. You may be entitled to financial compensation for your pain and medical expenses, and Stephens & Stephens can help.
Progress of the Exactech Lawsuit
When Exactech realized its products were defective, it acknowledged and owned the problem by stopping knee and ankle implant surgeries. Apart from writing to doctors, they also instructed hospitals to return their recalled device inventory- this might make the compensation process much more manageable.
Later in 2022, Exactech expanded the recall of the hip and ankle replacement implant to include other 40,000 acetabular hip liner components. The company again wrote to healthcare providers advising them of the new recall.
In October 2022, the JPML officially consolidated the Exactech implant recall lawsuits into a class action MDL in the Eastern District of New York. The panel assigned the Exactech MDL to US District Judge Nicholas Garaufis of the Brooklyn-based Eastern District of New York, where many cases have been filed. The plaintiffs wanted a different judge, but the panel chose Judge Garaufis, who is more conversant with complex multidistrict litigation.
Even though the defendant favored the consolidation, it preferred the Northern District of Florida, where the company headquarters are located. As of February 2023, new plaintiffs in the federal MDL could file their cases directly in the MDL using a short-form complaint.
The plaintiffs also asked the panel to include all the cases involving the recalled products in the MDL, even though none had received Novation hip implants, MCS, ankle implants, or the Acumatch. And if the cases materialize, they will be included in the MDL as tag-a-longs.
In December 2022, Judge Garaufis also approved the appointment of 27 attorneys for various positions in the plaintiffs’ leadership committees, including the executive committee, liaison counsel, and steering committee.
Another 50 Exactech hip and ankle lawsuits filed in Florida State Courts were consolidated into a State MDL Class Action, and the lawsuit may go to trial before the federal MDL. The judge of the State MDL in Florida has already issued an order scheduling the first bellwether test trial for November 2023. By January 2022, the state MDL in Florida had grown to 80 cases.
In December 2022, Exactech lawyers filed a motion in both class actions to coordinate the discovery processes in the state and federal class actions.
The plaintiffs’ Liaison Counsel created a website to publish the MDL proceedings, including court orders and deadlines, to inform lawyers and the public about the MDL status.
In Mach 2023, the private equity companies behind Exactech lawyers wrote to the MDL judge requesting a pre-motion conference on a motion to dismiss complaints against them. They argue they were not involved in designing, manufacturing, packaging, or selling the recalled prosthetics. The plaintiffs are suing these companies alongside Exactech because they have great control over the decision-making and running of Exactech. The plaintiffs must prove that the parent company had domination and control over the subsidiaries.
As of April 19, there were 290 cases in the federal MDL and over 80 cases in the Florida State MDL, and the number is increasing by the day. The science day for the class action MDL is scheduled for May 10, 2023. It allows the lawyers on both sides of a product liability claim to make presentations and educate the court on the evidence and science surrounding the litigation.
About the defective Exactech prosthetics
The company launched a recall after discovering a defect in the knee replacement system vacuum-sealed packaging, causing it to oxidize before use. These polyethylene inserts should be packaged in a vacuum and not exposed to oxygen during packaging and storage as they degrade from oxidation. When the patient is implanted with an oxidized knee insert, it quickly loses its functionality, causing mobility, discomfort, friction, and pain, requiring an unnecessary replacement.
The implants involved include:
- Optetrak Knee
- Truliant Knee
- Optetrak Logic Knee
- Vantage Ankle
- Novation Hip
- MCS Hip
- Acumatch Hip
The Exactech knee prosthetics have had some issues in the past. It is alleged that the company was aware of the high failure rate of the OPTETRAK knee implants. Their reports in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) show that the devices were failing at abnormally high rates, with implants receiving many complaints.
The federal government and state sued Exactech for the problems associated with their products, in a lawsuit settled in 2012. The Department of Justice filed a lawsuit against the company for paying orthopedic surgeons to use their implants between 2002 and 2008.
A whistleblower also sued the company under the False Claims Act, alleging that the company had knowingly supplied faulty knee replacements to VA, Medicare, and Medicaid beneficiaries. They were also linked to false claims submitted to Medicare.
In 2016/2017, Exactech users who experienced these failures filed product liability lawsuits against the manufacturer. However, the attorneys couldn’t figure out why the devices were failing. The plaintiffs’ attorneys attributed the earlier failures to their unique finned design feature. They also accused the company of pursuing a silent recall instead of warning consumers of the risk.
Exactech then tried to curb the problem by redesigning the implants. However, the failure persisted even after the company phased out the finned designs of the product. As a result, the company began looking into other possible causes and discovered an oxygenation problem from their defective vacuum-seal packaging. The company then gave a recall notice.
Exactech Fast-Track FDA Approval
From 1994 to 2017, Exactech obtained a 501(k) clearance from the FDA for its Optetrak, Optetrak Logic, and Truliant total knee replacement implant devices. This form of clearance is also known as fast-track approval or premarket notification, as it doesn’t require manufacturers to prove the effectiveness of their products.
Instead, it requires manufacturers to explain the products’ substantial equivalence to a pre-MDA predicate device, after which the FDA clears the product for sale in the US. All the recalled Exactech products were cleared through the 501(k) process. They did not receive full FDA review and approval but were “substantially equivalent” to predicate devices in the market for years. Such products have been frequently mentioned in product liability lawsuits because they are not thoroughly tested for defects.
Exactech Opterak Marketing Questioned
In its marketing, Exactech described Optetrak as “first-in-class” with excellent long-term clinical outcomes. It also told consumers that the Optetrak systems had nearly three decades of clinical success with proven outcomes for patients as its improved design caused less stress on the polyethylene insert components. However, the company’s product performance was lower compared to the competitors.
Also, Exactech authorized sales representatives were always present during the first and corrective surgeries involving their products as per protocol. Thus, they witnessed firsthand the products’ excessively high failure rate and quick degeneration. The sales reps are said to have reported the issues to the company. Instead of investigating the underlying issues, they promoted and sold the products without warning hospitals, surgeons, and the FDA.
Did Exactech conceal their products problems?
It is alleged that Exactech knew that their Opterak products were defective as early as 2012 but took too long before taking action. Evidence suggests that the company’s corporate executives knew their implant systems had high failure rates, which led to complications, unnecessary pain, surgeries, and additional medical expenses to patients.
Despite knowing the underlying problems with their products, the Exactech founders sold the company to a private equity company called TPG Capital in 2018. TPG bought the outstanding Exactech shares at $49.25, converting it from a public company to private ownership. Only years after the acquisition, the company recalled its defective products. If the recall had been done before the company went private, their stock would have been immensely affected, and shareholders possibly filed lawsuits.
It is also alleged that once Exactech discovered their TKA (Total Knee Arthroplasty) implants were failing prematurely, they started to replace the tibial trays of some Optetrak models without notifying the public, doctors, or patients. Their deliberate moves to conceal evidence might lead to high punitive damages from the jury in the litigation. Be a part of this litigation with the help of our Exactech lawsuit attorneys.
What are the expected Settlement Payouts in the Exactech Lawsuit
There are no reported Exactech lawsuit settlements, so we can’t be sure what the settlements will be like. However, the average payout might be $110,000 or higher based on other knee replacement settlements. The payouts may also include punitive damages, amounting to hundreds of thousands of dollars.