When a product is recalled, class action lawsuits are not the only threat. Recalled products can also give rise to droves of individual actions. This is the case for Exactech, Inc., a manufacturer of implants, instruments, and technologies for joint replacement.
Following an initial pause in elective procedures at the start of the COVID-19 pandemic, the number of hip arthroplasty surgeries has grown at a steady pace. These procedures commonly use acetabular liners to increase the stability of the total hip arthroplasty. Now, Exactech, a manufacturer of acetabular liners, is under fire nine months after the U.S. Food and Drug Administration (“FDA”) announced a Class II recall of the Exactech Connexion GXL acetabular polyethylene liner in June 2021. A Class II recall involves situations in which consumers may experience temporary or medically reversible health consequences or the likelihood of serious adverse health consequences is remote.
This recall affects just shy of 90,000 liners that were distributed before Exactech removed the liner from the market in 2019, and occurred after Exactech issued an alert to representatives and healthcare professionals about the potential for premature liner wear in certain patients, recommending that patients either return for exam or, when exhibiting early signs of wear, undergo another procedure to replace the recalled liner with Exactech’s HXLPE Vitamin E liner.
Exactech is defending itself in both state and federal courts across the country as it faces a growing number of individual lawsuits by hip replacement plaintiffs, the most recent of which was filed on March 15, 2022 in the U.S. District Court for the Southern District of New York. Among other things, these lawsuits allege that Exactech’s Connexion GXL hip liner is defective and that the company knew or should have known its product would wear prematurely. In this latest lawsuit, a New York resident alleges that he suffered injuries from the premature wear of the liner and that he needed a total right hip arthroplasty revision six years after his original surgery. The plaintiff asserts a number of product liability causes of actions, including strict liability, negligence, breach of warranty, and fraud, and he seeks $10 million in statutory, compensatory, and punitive damages.
With tens of thousands of Exactech Connexion GXL hip liners affected by the recall, the New York lawsuit is unlikely to be the last. It is certainly not the last that Exactech will see this year. Just last month, the company expanded an earlier recall of nearly 150,000 Ultra-High Molecular Weight Polyethylene inserts used in knee and ankle replacements. And Exactech has faced mounting litigation related to these products during the first part of 2022.