The California Court of Appeal, 2d District, upheld an $8.3 million verdict against DePuy Orthopaedics, Inc., and in favor of a grandfather whose life was ruined by a DePuy ASR XL metal-on-metal hip implant.
Plaintiff Loren Kransky died while the appeal was pending, after suffering poisonous cobalt and chromium debris from the defective implant. The jury found DePuy strictly liable under Montana law for the defective design of a hip implant that doctors ultimately had to remove in a risky and painful revision surgery. The jury awarded him more than $8.3 million:
- $338,136.12 in economic damages for medical expenses and,
- $8 million in noneconomic damages.
DePuy challenged several evidentiary rulings, including the exclusion of evidence related to the hip implant’s clearance by the FDA, and the admission of certain testimony by Kransky’s expert witness and his treating physician. DePuy also argued that the jury’s verdict was not supported by substantial evidence and is internally inconsistent.
In a forceful smackdown of defense arguments, the court ruled, “The trial court did not abuse its discretion in any of its evidentiary rulings. We conclude that the verdict is supported by substantial evidence and is not irreconcilable. We conclude that the $8.3 million compensatory damages award is not so grossly out of proportion as to shock the conscience.”
The case is Sherly R. Kransky v. DePuy (PDF), Case No. B249576.
High rate of problems
Kransky was one of many patients who experienced problems with an ASR XL
implant. As early as 2006, surgeons began to observe an unusually high rate of problems with the ASR XL. These problems included “component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain.”
Data from national registries of hip implants around the world began reflecting higher than expected rates of revision surgery for the ASR XL. Australia, one of the first countries where DePuy sold the ASR XL, showed a five-year revision rate of 22 percent, as did English and Welsh registries. (DePuy’s other metal-on-metal hip implants on the market at the time averaged five-year revision rates of approximately 4 percent.) In 2010, when the failure rates of the ASR XL implant were widely known, DePuy voluntarily recalled the implant before the FDA took any action.
On the recall form DePuy filed with the FDA, DePuy checked a box to indicate that the recall was the result of a “defective product that would affect product performance and/or could cause health problems.”
In February 2012 an orthopedic surgeon successfully performed the revision surgery, removing the ASR XL. A biomedical engineer analyzed Kransky’s ASR XL implant and found evidence of “much more than normal” metal wear on the implant. The engineer also found black-stained tissue attached to the back of the implant’s cup. The engineer concluded that the ASR XL implant was defective because of excessive rim loading (the engineering term for when the head of the implant gets too close to the rim of the cup) that released a harmful amount of toxic metal debris.
Trial court rulings
At trial, the court exluded evidence that the FDA cleared the device for sale, because DePuy would mischaracterize the evidence and confuse the jury regarding the FDA’s approval, because the agency had cleared the implant under an abbreviated review process provided by section 510(k) of the Food, Drug, and Cosmetic Act, rather than under the FDA’s comprehensive Premarket Approval process, which is much more rigorous and focuses more specifically on the safety of the device.
The trial judge also denied defense motions to exclude opinion testimony by Kransky’s primary care physician, Thomas Trotsky, that chromium and cobalt debris from Kransky’s ASR XL implant was poisoning Kransky and that the implant was killing him. DePuy argued that Dr. Trotsky was not qualified to give such opinions because he was not a toxicologist. The court denied the motion, ruling that Dr. Trotsky had “sufficient qualifications to treat plaintiff and report the results of his treatment.”
Craig Swenson, an orthopedic surgeon with extensive experience with the ASR XL implant, testified as an expert witness for Kransky. He showed the jury pictures from five other revision surgeries that he had performed on other patients with the ASR XL implant. He used these pictures and information about these surgeries to explain to the jury how he believed the ASR XL failed and how it showed signs of such a failure.
DePuy objected to the admission of the pictures and to Dr. Swenson’s testimony about his other patients, arguing that it was improper expert testimony because his opinions were anecdotal and based on his “own personal experiences” rather than clinical studies, and that Kransky had not disclosed the pictures or any details about the other patients until a few days before trial. The court allowed Dr. Swenson to testify on direct examination, but delayed cross-examination to give DePuy an opportunity to take an additional, mid-trial session of Dr. Swenson’s deposition and to prepare for crossexamination on the five surgeries.
Damages not excessive
The trial court did not abuse its discretion in ruling that the $8 million verdict “does not shock the conscience” or “appear driven by passion or prejudice.” The jury heard evidence of Kransky’s severe pain, his loss of mobility, and his sincere and realistic fear of dying during the revision surgery.
Kransky testified that the defective hip gave him constant, debilitating, stabbing pain that prevented him from getting any rest. His “other illnesses would come and go,” but “[t]he hip [pain] was always there,” and there was “no way” to “get rid of any of the pain.”
For about five years Kransky could barely walk. He testified, “I would fall and I couldn’t trust myself to go out and mow the lawn.” He could no longer play with his grandchildren or attend their athletic events.
For nine months Kransky was confined to a wheelchair. At one point Kransky’s mobility problems prevented him from showering or going to the bathroom on his own. Kransky testified, “Well, my daughters are nurses, so they would help me [shower and go to the bathroom]. It’s very embarrassing to have your daughter have to help you do personal things like that. That went on for quite some time.”
“My relationship with my wife, my kids, my grandkids,” Kransky testified, “it was all gone.”
The appeals court said, “The proper measure of compensatory damages must be determined solely based on the facts of each case, and juries have wide latitude in this regard. Because we find nothing in the jury’s verdict here to shock our conscience, the $8 million damages award is not excessive as a matter of law.”