February 27th marked the last day of the Kransky trial before closing arguments were given and the jury began deliberation. Mr. Kelly, for Plaintiff, continued the cross-examination of defense expert Dr. Cuckler. Mr. Kelly asked Dr. Cuckler why he, rather than those doctors who designed the ASR (Dr. Schmalzried and Dr. Vail), was hired to testify regarding the ASR. Dr. Cuckler agreed that Dr. Vail and Dr. Schmalzried would be in a better position to explain what was going on in the mind of the DePuy executives about safety and efficacy to the extent they had contact with those executives during the design process. Dr. Cuckler also agreed that in the case of a device like the ASR, clinical tests would be the ultimate tests in determining how this device works in the patient.
Mr. Kelly remarked on Dr. Cuckler’s comment that an “astounding” amount of simulator labratory testing had been performed on the ASR. He asked Dr. Cuckler whether this testing predicted that the device would be recalled, whether it predicted the 44% failure rate in the Australian registry, the 8,000 premature revisions that occurred, Dr. Schmalzried’s 23% minimum revision rate at five years, pseudotumors, metallosis, cup loosening, adverse tissue reactions and so on. Dr. Cuckler conceded that the simulator testing performed on the ASR failed to predict any of those things.
Mr. Kelly asked Dr. Cuckler whether patients and doctors had a right to rely on DePuy that the company would sell a product which performed consistent with what it’s “design history of performance” would require, and that it would be at least as good if not better than those devices already on the market when it was launched in the U.S. in 2005. Dr. Cuckler agreed that doctors and patients had the right to both.
Mr. Kelly then discussed the “unanticipated” failure rates which ultimately led DePuy to recall the ASR. No one from DePuy, as part of their analysis as to why the complaints and vigilance department didn’t foresee this high failure coming, went to Dr. Cuckler for assistance. No one within DePuy asked Dr. Cuckler to help determine why their internal data did not lead to the true revision rate. Dr. Cuckler agreed that it was DePuy’s obligation from the moment that a product is put on the market in the United States until the moment it is taken off the market, to be proactive and aggressive in following up on information about complaints, revisions, and unanticipated problems.
Mr. Zellers then conducted a redirect of Dr. Cuckler.
Next, Mr. Calfo for the Defendants called to the stand Dr. Bruce Spinowitz, an internist and a nephrologist. He testified that cobalt and chromium mostly exits the body through the kidney. Dr. Spinoqitz discussed Mr. Kransky’s various risk factors that are believed to lead to chronic kidney disease.
Mr. John Gomez from Gomez Iagmin cross-examined Dr. Spinowitz. Mr. Gomez questioned Dr. Spinowitz’s testimony as to the reasons why Mr. Kransky was admitted to the nursing home in late 2011. He also asked Dr. Spinowitz if the doctor had any conversations with anyone at DePuy about the ASR device in order to reach his conclusion that the device had no impact on Mr. Kransky’s chronic kidney disease. Dr. Spinowitz had not spoken to anyone from DePuy about the ASR device.
Mr. Gomez questioned Dr. Spinowitz’s conclusion that the ASR did not impact his chronic kidney disease, and asked if he was aware that all of the doctors who saw and treated Mr. Kransky for one reason or another recommended the hip be removed. Dr. Kransky’s own nephrologist and internist, Dr. Shannon, recommended Mr. Kransky’s hip be removed and commented that following the revision surgery, he was doing surprisingly well.