Plaintiffs Claim Zimmer Ignored Durom Cup Failure Rate
Lynette and Mark Kerby, two plaintiffs from Utah, have filed a complaint against Zimmer Holdings, Inc. regarding the defendants’ Durom Acetabular Component, a hip implant also called the Durom Cup.
The Zimmer Durom Cup hip lawsuit was filed on May 7, 2013. It has been transferred into the Zimmer multidistrict litigation (MDL) No. 2158 for the sole purpose of pretrial proceedings. The mass litigation is currently underway in the U.S. District Court for the District of New Jersey under Judge Susan D. Wigenton. The MDL allows for a more efficient pretrial discovery process, while affording all plaintiffs individual trials.
Plaintiff required revision surgeries
The Zimmer Durom Cup is surgically implanted into patients during hip arthroplasty procedures, which involve the removal of the natural, damaged hip joint and insertion of the artificial prosthesis. The procedure is often used in cases of severe damage from arthritis or physical trauma, and it is intended to restore range-of-motion and alleviate joint pain.
Lynette Kerby underwent total hip arthroplasty procedures for both her right and left hips in 2007. Subsequently, the plaintiff began experiencing significant pain and she could no longer carry out her daily activities. The complications from the Zimmer Durom Cup necessitated a revision surgery in 2011, during which surgeons removed the failed device from her right hip. The plaintiff underwent a similar revision surgery in 2012 to remove the left hip implant. However, according to the Zimmer Durom Cup hip lawsuit, the plaintiff continues to experience pain and suffering, emotional distress, disfigurement, and the likelihood of permanent physical disability.
Complaint notes lack of adequate clinical studies
Over 420,000 patients undergo a total hip arthroplasty each year. Traditional hip implant devices are made of metal or ceramic, with a polyethylene, metal-backed bearing. Surgeons have long noted the propensity of the bearing to succumb to wear and tear damage. Zimmer designed the Durom Cup hip replacement as an alternative to traditional devices, and during their marketing campaign, they claimed the implant was more durable and afforded more range of motion.
When Zimmer submitted the Durom Cup to the FDA for approval, they did so via a 510(k) application, claiming that the Durom Cup was equivalent or similar to traditional models. This application allowed the defendants to bypass the standard, rigorous inspection process, and FDA approval was granted without pre-marketing clinical studies. The plaintiffs’ Zimmer hip lawyer argues that the defendants are liable for failing to adequately test the Durom Cup to establish its safety and efficacy.
Fraudulent concealment alleged
The defendants predicted that the failure rate of the hip implant device would be 5.7 percent. A review of patients from 2006 to 2010 revealed an estimated failure rate of more than 24 percent. This failure rate is, according to the Zimmer Durom Cup hip lawsuit, “unacceptably high” and “much higher than similar products.”
The plaintiffs’ complaint details concerns raised by an orthopedic surgeon and consultant to Zimmer, Dr. Lawrence Dorr, M.D. Dr. Dorr had warned the defendants in 2007 regarding the high failure rate, noting that although the implant was intended to fuse to the bone, it was instead loosening in many patients and causing significant pain. According to this lawsuit, the defendants did not take prompt action, and they failed warn patients and healthcare professionals about the risks of early hip failure. The Zimmer hip lawyer charges the defendants with fraudulent concealment, which allegedly led to the plaintiff’s ongoing injuries.