July 7, 2015, PLLR E-Newsletter
Laser orientation mark was burned too deeply, causing hip implant to fail
The plaintiffs alleged that the device’s orientation mark—lasered into the implant to assist surgeons in positioning it—was burned too deeply, damaging the device’s structure and making it brittle and prone to fracture. The jury awarded $4.5 million. Warner v. Wright Med. Tech., Inc.
Alan Warner had a Profemur R artificial hip implanted to replace a previous implant. About three years later, while he was at home, he felt a sharp pain in the left groin area and was unable to walk. The next day, he went to the hospital, where doctors diagnosed a left femoral stem fracture and determined that the implant had snapped at the stem.
Warner, 62, underwent revision surgery, but the new implant also failed, causing an anterior dislocation. He underwent closed reduction surgery to his hip, followed by another hip revision with a different manufacturer’s system. He ultimately underwent multiple surgeries to treat dislocations and infections resulting from the original failure.
Warner and his wife sued Wright Technology, Inc., which manufactured the Profemur R, alleging that the device failed because of a manufacturing defect. The plaintiffs offered evidence that the implant had fractured in the area of an orientation mark, which had been burned into the device with a laser to assist surgeons in positioning it. The mark was burned too deeply, the plaintiffs asserted, causing the titanium alloy surface to melt and re-solidify as aluminum oxide. The altered structure was more brittle and prone to fracture, causing it to snap under the weight of normal stresses, the plaintiffs contended.
The plaintiffs’ expert testified that a laser mark with a heat-affected zone deeper than 25 microns is unnecessarily deep and may damage the implant stem’s structural integrity. Much shallower marks are still visible, he testified, and would not cause the structural damage that led to the fracture here. He also testified that the laser mark on Warner’s implant had a heat-affected zone of more than 100 microns.
Wright denied that a manufacturing defect had caused the implant to fracture and argued that the surgeon had selected too small a device, causing a lack of contact with, and support from, the surrounding bone.
The plaintiffs countered that Warner’s surgeon was a former spokesman for the manufacturer and taught other surgeons the technique for implanting the device.
The jury found that the implant was defectively manufactured and that the defect was a substantial factor causing Warner’s injury. It awarded $4.5 million, including $4 million to Warner for past and future pain and suffering and $500,000 for his wife’s loss of consortium.
Citation: Warner v. Wright Med. Tech., Inc., No. BC475958 (Cal. Super. Ct. Los Angeles Cnty. June 12, 2015).
Plaintiff counsel: AAJ member George E. McLaughlin, Denver; and Steven R. Vartazarian, Los Angeles.
Plaintiff experts: Reed Ayers, materials science, Denver; Mari Truman, biomechanics, Warsaw, Ind.; and Myron B. Stachniw, orthopedic surgery, Galesburg, Ill.
Defense experts: Brad James, metallurgy, Menlo Park, Calif.; Jorge Ochoa, biomedical engineering, Bellevue, Wash.; Irina Timmerman (in-house), medical research, Memphis, Tenn.; and Robert Windsor, physical medicine, New York City.