Patient Sues CryoLife for $110 million, Alleging Contaminated Implant
BY LAUREN UZDIENSKI, JANUARY 15, 2008
Late last Friday, an Atlanta personal-injury attorney released a statement lambasting CryoLife for "once again severely [maiming] an innocent knee surgery patient." Patient Michael Hohenbery, who received meniscal allograft processed by CryoLife in December 2006, "can no longer work and will be on mega antibiotics and pain medications the rest of his life." He's suing CryoLife for $110 million.
The stock tumbled on the news, reawakening some long-standing fears about the allograft industry. In 2001, 23-year-old Brian Lykins died a few days after receiving a CryoLife implant, and the company eventually settled with the family for $23.0 million; the repercussions for the allograft industry were substantial, with increased surveillance of tissue-processors' operations and the FDA's adoption of Good Tissue Practices in 2005.
The Hohenbery press release indicates that the allograft in this latest case was contaminated with c. sordelli, the same bacteria implicated in the Lykins case. However, in their rebuttal, CryoLife makes no mention of any positive identification of an organism, and concluded that following an investigation, "CryoLife believes that it handled the tissue in accordance with its procedures and in accordance with all applicable industry standards and regulatory requirements." The company also said that the patient had severely compromised knee function prior to the surgery and it intends to "vigorously defend" itself against the lawsuit.
Even with the increased regulatory presence, investors remain wary of allograft. Many orthopedic manufacturers utilize human tissue in their products, but these companies tend to partner with, rather than acquire, tissue processors. The question lingers: how safe is allograft? It's clear from the press releases that we're still waiting on a lot of the facts in the Hohenbery case, but Brian Lykin's remains the only fatality on record for the allograft industry. Though there will always be a risk of infection, increased testing, more stringent regulations on how the tissue is handled and donor suitability assessments can help to limit the risk. Allograft ultimately provides a safe and valid option for thousands of patients, and keeping the risk in perspective is key.
For more information about tissue processing, please see our Allograft report.
