A Medical Device Daily

CryoLife (Atlanta), a processor of human tissue for use as implants, last week issued a statement defending itself against a lawsuit expected to be filed against it concerning injury to a patient implanted with allograft processed by the company.

The Keenan law firm reported that it planned to file suit, this past Friday, in Cobb County, Georgia, concerning injury to Michael Hohenbery, an Illinois farm equipment mechanic, as the result of a knee operation. The firm said in a statement that Hohenbery “can no longer work and will be on mega antibiotics and pain mediations the rest of his life.” It charged that he was “severely maimed” by the use of “a contaminated infected knee tissue implant” processed by CryoLife.

Tom Keenan, Hohnebery’s attorney, said that his case “once again proves the unsafe and dangerous practices of Cryolife and the ineffectiveness of the safety regulations. While all states require licensure, testing and health certificates for barbers, nail salon technicians, and masseuses, there are no regulations regarding the qualifications of anyone handling and processing cadaver tissue.”

And it linked Hohenbery’s case to others like it that the firm had previously handled.

CryoLife denied any liability, saying that after it was notified that Hohenberry had been infected, it “conducted an immediate and thorough investigation of the manner in which the transplanted tissue was recovered and handled.” The company said that it “believes that it handled the tissue in accordance with its procedures and in accordance with all applicable industry standards and regulatory requirements.” And it said that it followed the required protocol of notifying the FDA concerning “the incident.”

Ashley Lee, executive VP, CFO and COO of the company, said, “We regret that this recipient experienced a problem following implant of our aseptically-processed tissue... . however, it is our understanding that his knee function was severely compromised prior to his meniscal transplant. Regrettably, the lawyers representing this individual have chosen to make untrue public statements against our company and our tissue processing services in an effort to force us into a monetary settlement of the case. We feel it is important that we address these statements.”

The Keenan firm alleged that “Shockingly, the same deadly organism that devastated Mr. Hohenbery took the life of young Brian Lykins of Minnesota in 2001.”

The firm acknowledged that it also had handled the Lykins case. And it said that Lykins’ death “led the FDA shutdown in 2002 of Cryolife’s tissue business and the passage of 900-plus pages of safety regulations which at the time of passage were insufficient and created large loopholes. The FDA eventually after a year in mid-2003 permitted Cryolife to resume distribution of cadaver tissue but yet less than 30 days later a teenager from Denver was catastrophically infected by diseased knee cadaver tissue.”

“With over 1 million operations a year using cadaver tissues, how many more people will die or be seriously injured from dangerous unsafe practices of Cryolife?” Keenan asked.

In other court action: Kinetic Concepts (KCI; San Antonio) said that, together with Wake Forest University Health Sciences (Winston-Salem, North Carolina), it has filed a patent infringement suit against Innovative Therapies (ITI; Hunt Valley, Maryland) in U.S. District Court for the Middle District of North Carolina.

The federal complaint alleges that a negative pressure wound-therapy device recently introduced by ITI infringes three Wake Forest patents that are exclusively licensed to KCI.

Catherine Burzik, KCI’s president/CEO, said, “We have filed this case because our intellectual property is being knowingly and unlawfully exploited.”

She added, “Our intellectual property is a core asset, representing the work of dedicated engineers, scientists and doctors, as well as millions of dollars in KCI investment each year.”

Since the recent introduction of the ITI device, KCI said it has discovered that the device “unlawfully incorporates inventions covered by the three Wake Forest patents.”

KCI and Wake Forest are seeking damages and permanent injunctive relief in the case.

KCI recently filed state court claims against ITI and three of its principals, all of whom were former employees of KCI. The claims, filed in Texas District Court in Bexar County, Texas, on Jan. 2, include breach of confidentiality agreements, conversion of KCI technology, theft of trade secrets and conspiracy.

KCI is focused on advanced wound-care and therapeutic surfaces. Its wound-care systems incorporate the company’s VAC (Vacuum Assisted Closure Therapy) technology.