Case details

Hip implant entered U.S. market untested, according to lawsuit

SUMMARY

$9153317.94

Amount

Verdict-Plaintiff

Result type

Not present

Ruling
KEYWORDS
chronic pain, muscle, nerve, right hip, tissue
FACTS
On May 31, 2007, plaintiff Gary Kline, 51, underwent a metal-on-metal right hip implant with the Zimmer Durom Acetabular Component (or “Durom Cup”), a hip replacement component manufactured by Zimmer Inc. that was designed to boost durability and range of motion. However, the Durom Cup failed, and Kline had to undergo revision surgery to replace the Durom Cup with another device on Sept. 25, 2008. Kline sued Zimmer Holdings Inc., alleging that Zimmer defectively design the Durom Cup and failed to train surgeons in how properly implant the product. Kline’s claim was added to several other related cases under the initial filing of “Thomas McAllister et al. v. Zimmer Inc. et al.” However, Kline’s claim was the first case to go to trial. Plaintiff’s counsel noted that in 2003, Zimmer bought Centerpulse, which originally developed the Durom Cup as part of its hip resurfacing system in Europe. Centerpulse spent approximately six years performing animal studies, clinical trials, post-operative studies, and peer-to-peer training to implant the Durom Cup in Europe. Plaintiff’s counsel argued that Zimmer was behind other companies in introducing a large head, metal-on-metal device in the United States, so it rushed the U.S. version of the Durom Cup to market without adequate testing or evaluations. Counsel contended that, in order to comply with the requirements of the U.S. Food and Drug Administration, Zimmer changed the plasma coating on the U.S version of the Durom Cup. However, plaintiff’s counsel argued that Zimmer failed to test the product and evaluate it before placing the product in the U.S. market. Counsel contended that the new plasma coating had failure rates of 20 percent to 32 percent or more in medical literature and that because of the sophisticated design of the product, it required a fairly sophisticated implantation technique. Thus, plaintiff’s counsel argued that Zimmer further failed to provide any training to U.S. surgeons or advise them of the unique implantation technique. One of plaintiff’s orthopedic surgery experts, Dr. William Long, was one of the initial lead investigators hired by Zimmer when the product was released in the U.S. Long also implanted the first products in the U.S. and testified that he found significant defects in those products. He also testified as to the nature of the alleged defects. Defense counsel pointed to the Centerpulse testing, and contended that the Durom Cup product was thoroughly evaluated and tested and that nothing was wrong with it. Counsel also contended that contrary to the findings of the surgeon who took care of Kline, Dr. Stephen Mikulak, the cup was not loose and there was no evidence that it failed. Defense counsel further contended that Kline had demonstrated significant pain before the cup was implanted, after the cup was implanted, and after the revision, when a new device was placed. In response, plaintiff’s counsel asserted that the testing done by Centerpulse was only done on the European Cup and not the U.S. version. Counsel also asserted that Kline’s current treating physician and the treating physician that implanted the Durom Cup both opined that Kline had three different experiences with pain and that each experience was different and discrete at different times of implantation. The physicians explained that, initially, Kline had pain prior to the implant from osteoarthritis, that he had pain after the implant from the loose Durom Cup, and that after the implant was taken out, he was left with chronic pain in his right hip due to muscle and nerve tissue being compromised from the two traumatic operations within 15 months., Kline claimed that he is left with significant chronic pain in his right hip from muscle and nerve damage. His current treating physician testified that he has a cyclical pattern where he is weaned off the steroid Prednisone, declines significantly and becomes almost immobile, and is then being placed back on Prednisone and improves to being able to function again. However, the physician noted that the steroid is not meant to be used long term. Plaintiff’s counsel contended that Kline was told that with the Durom Cup, he should expect to recover 98 percent of his function and ability and that he would return to all of the active activities he enjoyed, such as hiking, hunting, fishing, motorcycle riding, and bike riding. However, counsel contended that Kline will not been able to ever gain further function and ability to his hip, nor would he be able to return to the activities he once enjoyed due to the recurrent chronic pain and damage to his body. Defense counsel disputed Kline’s alleged damages, arguing that Kline had demonstrated significant pain before the cup was implanted.
COURT
Superior Court of Los Angeles County, Los Angeles, CA

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