Kransky v. DePuy Orthopaedics, Inc., No. BC456086 (Cal., Los Angeles Co. Super. Mar. 8, 2013).
When retired prison guard Loren Kransky developed osteoarthritis in his left hip, doctors recommended hip replacement surgery. In December 2007, at age 59, Kransky received the DePuy ASR XL Acetabular System—a metal-on-metal implant in which both the ball and socket components are made of cobalt-chrome molybdenum alloys.
Kransky initially enjoyed relief after the surgery. Over the following year, however, he began suffering hip pain, which worsened to the point where he could no longer walk, use the bathroom freely, or sleep at night. Blood tests revealed that he had potentially toxic levels of cobalt and chromium metal ions in his system, and his physician recommended revision surgery. Kransky was suffering from a number of unrelated health problems, including cancer, and had to enter a nursing home to become strong enough for the surgery. In 2012, he underwent the revision, in which the ASR was removed and a different device was implanted. The surgeon who removed the ASR noted that tissue around Kransky’s joint was metal-stained and necrotic. After surgery, he developed a hematoma, requiring additional surgery, and spent two months recuperating in an assisted care facility. His medical expenses totaled about $340,000.
Kransky sued Johnson & Johnson subsidiary DePuy Orthopaedics, Inc., which designed and manufactured the ASR system, alleging that design defects caused the device to release chromium and metal debris into the surrounding tissues, leading to tissue and bone death around the hip joint and potential chromium and cobalt toxicity throughout the body. Specifically, the plaintiff contended that the ASR’s components were designed to be in a state of constant lubrication, so that the metal surfaces did not touch, but that design flaws led the cobalt-chrome surfaces to contact one another continuously, creating wear and producing flaking that caused the release of nanoparticles of metal debris and metal ions.
In addition to the strict liability design defect claim, the plaintiff also alleged that DePuy was negligent and failed to warn of the device’s risks.
DePuy began selling the ASR overseas in 2004. The plaintiff presented evidence that in 2006 and 2007, several European surgeons DePuy considered “key opinion leaders” in orthopedics told the company that the ASR had failed in their patients, that they were concerned the failures were related to the device’s design, and that they would no longer use the ASR. The plaintiff contended that DePuy covered up and failed to act on those reports after it began selling the ASR in the United States in early 2006.
The plaintiff also presented evidence that a DePuy engineer determined in September 2007 that the ASR’s design caused it to wear excessively and that the company considered redesigning the implant but abandoned those plans in 2008 because the cost could not be justified. The plaintiff contended that in September 2009, DePuy secretly decided to stop making the ASR and made plans to sell off the inventory and discontinue the product the following year. The company announced a “voluntary recall” in August 2010, claiming that new data had come to its attention showing that the device had a failure rate of 12 to 13 percent within five years of the initial hip replacement surgery.
The plaintiff presented current epidemiological evidence that the ASR’s failure rate is as high as 44 percent at the seven-year mark. By comparison, other hip implants on the market have a failure rate of less than 2 percent over the same time period.
DePuy denied that the implant was defectively designed and argued that Kransky had an unusual gait that would have caused any hip implant to wear excessively. The defense also claimed that Kransky had developed an infection and that it was the infection, not the device, that had necessitated the revision surgery.
Finally, DePuy argued that Kransky’s injuries and complaints were the result of years of smoking, his exposure to Agent Orange in Vietnam, vascular disease, cancer, and other preexisting medical conditions.
The jury found that the device was defectively designed and awarded about $8.34 million. The jury found for the defense on the negligence and warning claims.
DePuy has filed a motion for judgment n.o.v. and has expressed its intention to appeal.
Plaintiff counsel: AAJ members Brian Panish and Peter Kaufman, both of Los Angeles; AAJ member Michael A. Kelly, AAJ member Matthew D. Davis, and Khaldoun A. Baghdadi, all of San Francisco; and AAJ member John Gomez, San Diego.
Plaintiff experts: Dennis Bobyn, biomechanical engineering, Montreal, Quebec, Can.; George Samaras, engineering practices, Boulder, Colo.; John Baron, epidemiology, Hanover, N.H.; Robert Harrison, toxicology, San Francisco; and Craig Swenson, orthopedic surgery, San Diego.
Defense experts: Gonzolo Ballon-Landa, infectious disease, San Diego; Avram Edidin, biomechanical engineering, Palo Alto, Calif.; Dennis Paustenbach, toxicology, San Francisco; Marcos Velez-Duran, biostatistics, Washington, D.C.; and John M. Cuckler, orthopedic surgery, Montomery, Ala.
Comment: There are reportedly more than 10,000 lawsuits against DePuy over the ASR implant. More than 7,000 suits are consolidated in a federal MDL in Toledo, Ohio, while others have been consolidated in state courts in California and New Jersey. The Kransky case is the first to go to trial.