Johnson & Johnson’s DePuy’s orthopedics business is in court defending itself against charges that the company sold implants which it allegedly knew, or should have known, would result in higher than average rates of revision surgery.
DePuy is responding with data from the UK and Australia registries which shows 99% survivorship at four years.
The issues surfaced when a patient alleging a failed ATTUNE knee implant filed a lawsuit on December 11, 2017 in the U.S. District Court for the Southern District of Mississippi (Joyce Rogers v. DePuy Synthes Sales, Inc. et al, Case No. 3:17-cv-996-DPJ-FKB.)
In a nutshell, the plaintiff in this case is alleging that some of the ATTUNE knees were failing due to debonding of the tibial baseplate. The company has since redesigned the ATTUNE and is replacing it with the Attune S+.
As in the metal-on-metal hip cases, the plaintiffs are saying that the company knew about problems but didn’t warn surgeons and patients about them even as they were working on an internal fix.
In other words, what did the company know and when did they know it?
The Attune Genesis
Let’s start at the beginning.
DePuy Orthopaedics Inc., introduced the LCS Complete Knee System in 1984, with a reported 92.6% survivorship at 15 years. Building on that, the company introduced the P.F.C. SIGMA System in 1996. According to documents in the Rogers lawsuit, the SIGMA system demonstrated 99.6% survivorship at 7 years.
The SIGMA became one of the most widely used total knee replacement systems in the world.
The company further refined their knee replacement system and came up with the ATTUNE system and received FDA 510(k) clearance for the implant in December 2010. The basis for FDA clearance was “substantial similarity to several prior devices, including, but not limited to the P.F.C. SIGMA Knee System.”
The new system, according to plaintiff lawyers, “purported to feature a gradually reducing femoral radius [with] an innovative s-curve design including a tibial baseplate that was redesigned at the keel from the SIGMA.” Defendant claims the baseplate is defective and failed.
The ATTUNE was introduced in March 2013 at the American Academy of Orthopedic Surgeons (AAOS) annual meeting in Chicago. The company reported that the $200 million project was one of the largest research and development projects in the history of the DePuy Synthes Companies.
The company eventually sold around 400,000 of the devices worldwide.
One of those first 400,000 recipients of the ATTUNE was Joyce Rogers of Meridian, Mississippi, who got her implant on February 2, 2015. She required a revision surgery on November 30, 2016 at the University of Mississippi Medical Center.
