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King v. Danek Medical3/28/2000
specifically the screws and rods, are directly related to the leg pain or the improvement after their removal. I certainly believe Ms. King that she does have less pain both in her leg and her back. I don't think she's making it up, but I don't have an explanation for it.
In response to whether the device had failed, Dr. Brodke testified:
There was very slight loosening of one screw in a sacral pedicle, but that wasn't significant enough to report it as a hardware failure because she had a solid fusion across that, and certainly none of the screws were loose or broken and the rod was not broken. None of the screws were loose - let me rephrase that. None of the screws were loose at their connection to the rod and the rod was not broken, and there wasn't a screw that was broken.
If a pedicle screw was loose enough to cause a nonunion, I sort of consider that a hardware failure although it's not in the classic sense a hardware failure because it's not the fault of the hardware, more the biology of the patient.
B. Tamara Little
An internal fixation device manufactured by Danek was implanted in plaintiff Tamara Little in August, 1993, utilizing pedicle screws, by Dr. William Capicotto, a board certified orthopedic surgeon since 1988. He was a graduate of the medical school of the State University of New York at Buffalo, where he had also done his residency in orthopedic surgery. From 1986 until 1996, he was an assistant clinical professor in the department of orthopedic surgery at State University of New York Medical School. He was a past president of the Western New York Orthopaedic Society.
He testified that he had first seen Little on April 21, 1993, when she was complaining of severe pain in "her back and her right leg," as well as "mild weakness of the toe and ankle extensors on the right side." She had injured her back lifting a "cart of dishes from a bus tray." He stated that her leg was reddish blue and cold, and that he initially was concerned she had a clot in the leg or a "lymphatic obstruction." After a discogram, myelogram, and a CAT scan had been performed on her, Dr. Capicotto determined that she had a "degenerative and painful disc" at L4-5. According to Dr. Capicotto, Little had been in "severe pain" since October, 1992. He discussed with her the possibility of an operation, and both he and a nurse talked with her about the risks to a successful operation if she continued to smoke. In his testimony, Dr. Capicotto described the surgery that was performed on Little on August 26, 1993:
Well, I removed the - the painful discs at L4-5 and L5-S1, and then she underwent a spinal fusion from L4 through the sacrum. Took bone graft from the right side of her pelvis, and I put the internal fixation device in, the TSRH internal fixation device from L4 through the sacrum.
He installed the TSRH device because he believed it to be the "best product on the market."
Dr. Capicotto saw Little in his office on October 5, 1993, at which time she told him that her back felt better than it had "in years." Although she had some aggravation in her right leg, straight leg raising did not bother her. She walked with a reciprocal gait and a minimal limp. She was continuing to do well when seen by Dr. Capicotto on July 13, 1994. However, on October 10, 1994, she complained of "left-sided leg pain," and her husband demanded that she receive narcotic analgesics, to which Dr. Capicotto acquiesced. Dr. Capicotto was concerned that she might be suffering from a "recurrent disc herniation and/or pseudoarthrosis of the lumbar spine." He believed that she had achieved a solid fusion. He testified that on January 3, 1995,
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