DePuy settles first lawsuits for metal-on-metal hip systems

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Recent Cases: Medical Products & Equipment

October/November 2012, Volume 31, No. 5

DePuy settles first lawsuits for metal-on-metal hip systems 

Rundle v. DePuy Orthopaedics, Inc., No. A-11-636272-C (Nev., Clark Co. Dist. Aug. 2012).

Anneliese Rundle, Martha Bender, and Katherine Guy each underwent a total hip replacement in which a surgeon implanted the DePuy ASR Hip Replacement System. Marketing literature for the ASR system described its “high performance metal-on-metal bearings” and touted reduced wear as one of the product’s main benefits over competing products.

After the devices were implanted, the acetabular cup components failed to properly affix to the patients’ bones, and the implants generated excessive metal debris. The women began experiencing pain and burning in their hips and surrounding areas, and all three required revision surgery to remove the implants.

Rundle was diagnosed with aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL)—an immune reaction to metal debris in the body. Bender’s surgeon noted the presence of abnormal fluid and necrotic tissue, including infected bone secondary to metallosis, a disease that destroys the tissues surrounding the artificial joint. Guy’s surgeon discovered that her implant had migrated to a vertical position and that she too had suffered a foreign-body reaction.

Despite extensive physical therapy and rehabilitation, the women now suffer permanent hip pain. In addition, Guy has experienced lumps throughout her body, including a ganglion cyst in the left wrist and a lipoma-type lesion in her back, caused by metal debris from the implant.

Rundle, Bender, and Guy sued DePuy and distributor Precision Instruments, Inc., alleging strict liability design defect and failure to warn, negligence, breach of warranty, violation of the state deceptive trade practices act, deceit by concealment, and negligent misrepresentation. Among other things, the plaintiffs contended that DuPuy conducted inadequate pre-market testing on the implant and that the defendants provided inadequate warnings and instructions. The plaintiffs also alleged that the defendants intentionally concealed the truth about the implant’s dangers.

The plaintiffs were prepared to show that in 2005—the same year DePuy began selling the ASR system in the United States—independent experts warned that the design was flawed because (1) the cup was too thin and prone to deformation, (2) the clearance between the cup and head components was too small and in some patients could lead to jamming of components, and (3) the metal used for the cup and head was prone to increased wear. Moreover, the cup was shown to have a four-fold higher rate of revision than a similar cup in the Australian Joint Registry. Despite the warnings, and despite awareness of growing numbers of failures requiring revision of the implant, the plaintiffs contended, the defendants continued promoting it as clinically superior and failed to warn of the high failure rates or initiate a recall until 2010.

The plaintiffs argued that the failure to adequately warn of the implant’s dangers prevented their treating physicians from timely recognizing that the implants had failed, leading to serious complications. They sought punitive damages, arguing that the defendants knew the ASR system posed an unreasonable risk of harm and acted with conscious disregard for their safety and the safety of other implant recipients.

The parties reportedly settled for about $600,000, including about $200,000 to each plaintiff.

Plaintiff counsel: AAJ members Peter C. Wetherall, Las Vegas; Brian S. Franciskato, Kansas City, Mo.; and Alton M. Maglio, Sarasota, Fla.

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