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Although his surgeon didn’t know it, Brian Lykins’ knee implant had been recovered from a decaying corpse. The contaminated knee cartilage, implanted last November, had been harvested from the body of a man who had shot himself to death and then had lain undiscovered for at least 19 hours, according to attorney Don C. Keenan. Three days after Lykins’ surgery, the 23-year-old Minnesota electrical engineering student slipped into septic shock and died — the result of a massive bacterial infection. Kennesaw, Ga.-based CryoLife Inc. supplied the contaminated tissue that killed Lykins, according to Keenan, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. On July 12, Keenan sued CryoLife in Georgia’s Cobb County Superior Court on behalf of Lykins’ family, claiming that the company’s negligence in obtaining and processing human tissues for implants had led to Lykins’ death. Lykins v. CryoLife, No. 021056-13-24 (Cobb Super. July 12, 2002). ‘RIPE FOR SUITS’ CryoLife’s operations are emblematic of a booming industry with virtually no regulation, Keenan said. “Anyone with a chainsaw and a pickup can get into this business.” It’s also an industry ripe for suits, if Keenan has characterized it accurately, and he seems poised to lead a potentially lucrative wave of litigation against CryoLife and both nonprofit and for-profit companies that either secure or process tissue and have been relatively unscathed in the courts. Until now, such companies have been known more for saving lives; now they may face millions in judgments and new government regulations, a pretrial death knell for some of them. Keenan is not the first lawyer to file a wrongful-death suit against CryoLife linked to transplant tissue contamination, but he’s quickly becoming the best-known, thanks to his determination to, as he says, “make a lot of noise.” Since the Lykins suit was filed, Keenan said his firm has been hired by 26 clients who received CryoLife implants and subsequently developed infections. The firm also has identified 54 potentially contaminated CryoLife tissue cases and an additional 30 involving potentially contaminated heart valves. On Aug. 13, the FDA ordered CryoLife to recall much of the tissue it had shipped to hospitals and to quarantine most of the tissue it has processed within the past 11 months. The recall took place after the CDC traced Lykins’ infection to a CryoLife cadaver. The quarantine effectively has closed half of CryoLife’s operations, its president and CEO, Steven G. Anderson, acknowledged during a recorded teleconference with investors on Aug. 14. The company is also the target of a Securities and Exchange Commission inquiry into the timing of executives’ sales of stock, which has plummeted amid the contamination allegations. And it is a defendant in a spate of shareholder suits related to the FDA and CDC inquiries. Stock prices, which have climbed as high as $43.04 and fell to $1.40 over the past 52 weeks, closed at $2.21 on Aug. 28. The federal agencies’ actions are the result of Lykins’ death and have been exacerbated by the publicity from Keenan’s suit. TRANSPLANT PIONEER Founded in 1984, CryoLife describes itself as the industry leader in supplying implantable living human tissues for use in surgeries in the United States and Canada. The firm also procures pig heart valves for use in human hearts and manufactures a surgical glue that replaces stitches and staples. It created the world’s first biologically engineered heart valves and was one of the first biomedical firms to preserve for implants at sub-zero temperatures human tissues obtained from cadavers. It supplies 70 percent of the nation’s heart valves for implantation and 90 percent of the vascular and soft tissues. The Atlanta Business Chronicle, in 2000, named CryoLife CEO Anderson as one of Wall Street’s rising stars. In 2001, Forbes Magazine named CryoLife as one of of its 200 best small companies in America. The Forbes list was published just nine days before Lykins died. For fiscal year 2001, CryoLife reported record revenues of $87.7 million. It listed a 2001 net income of $10.2 million. However, last March, while the FDA was conducting a weeklong inspection, CryoLife announced it was restating its FY 2001 financial results. At the suggestion of the SEC, it reduced its reported income by $1 million, to $9,166,000. David M. Fronk, CryoLife’s vice president of clinical research, wouldn’t discuss the Lykins case because it is pending litigation. Fronk noted that the company itself doesn’t harvest — or recover — body tissue, but depends on a network of “finders.” But he said CryoLife would never accept tissue from a body that had been dead more than 24 hours. Fronk said that since the recall, which the company has appealed, company executives have had “numerous discussions” with the FDA. The agency is specifically concerned about whether CryoLife’s methods of testing, processing, decontaminating and preserving human tissues really work, he said. “They believe it was inadequate, that we could have done something differently, done something more,” he said. Fronk said that on Aug. 14, the FDA exempted CryoLife human heart valves from the recall and quarantine. And the company is continuing to ship tissues processed and preserved prior to Oct. 3, 2001, and not included in the recall, he said. He said he did not know how much tissue frozen before that date CryoLife still may have in storage. But the human tissues that CryoLife preserves in liquid nitrogen have a shelf life of 10 years, he said. NEW BREED OF PERSONAL INJURY Keenan insisted his suits aren’t just about money. “Rarely do we have a case that begins with clients saying, ‘You find out what the appropriate regulations should be and take out your big stick and go after the company and make them do it,’” Keenan continued. Typically, in a personal injury case, “You prove the harm, prove the wrong, sue for damages, take your money, and go home. What we’re doing here is something that lawyers rarely venture into — you change the whole regulatory scheme.” Previous litigation against CryoLife has ended in sealed settlements without any conclusive proof that the firm did anything wrong, Keenan said. CryoLife, he said, “bought silence way before the cases could be proved conclusively against them.” Keenan said that when he filed the Lykins suit, “We purposely had a big press conference in Atlanta. We intentionally made a lot of noise initially.” Capitalizing on the publicity surrounding the suit, Keenan said, “The question becomes how much pressure from punitive damages and public exposure brought against this company can bring on the reforms.” Unlike the nation’s network of organ banks and the organ transplant business, firms such as CryoLife that trade in other parts of the human anatomy — from heart valves and veins to bones, ligaments and cartilage — are woefully unregulated, Keenan said. Right now, the only federal laws regulating tissue procurement prohibit harvesting tissue from a body infected with AIDS or hepatitis, he said. The lack of regulation means that tissue can be harvested for implants from cadavers aged 70 and older; from corpses of those with inherited or chronic diseases such as cancer or rheumatoid arthritis; from those who died of infectious diseases such as meningitis, and from victims of violence, drowning or suicide who may have been dead hours before their bodies were discovered, transported to a morgue and refrigerated. There are no regulations that limit the amount of time a dead body can remain unrefrigerated before tissue harvesting is banned, Keenan said. The American Association of Tissue Banks, the industry’s trade association, has voluntary standards regarding refrigeration, among other things. But, Keenan said, “CryoLife chooses not even to be a member of that group.” Keenan said that for two months before he filed suit, he and his staff met with public health officials, academicians, CDC officials and legislators, seeking their answers to the question: “What do you think should be done?” The attorney said that the process convinced him that industry regulations governing the harvesting and processing of human tissues “are quite minimal and clearly not adequate.” His meetings with health professionals resulted in a list of proposed industrywide reforms that Keenan has posted on a Web site devoted to the litigation ( www.cryolifelitigation.com). DEMANDS FOR REFORM Keenan said that after filing the complaint, he gave CryoLife executives 30 days to implement seven reforms. Those reforms included rejecting diseased cadavers, the victims of either drownings or suicides, or cadavers over 70 years of age; testing cadaver tissue when it is first received; sterilizing tissue before distribution, as some other companies do; discarding the entire cadaver, not just the contaminated parts, if any bacteria or fungus is detected; mandatory reporting of contamination to the FDA and the CDC; qualification and certification of individuals who either harvest or process human tissue; and mandatory annual inventory audits. Since the suit was filed, Keenan said, CryoLife has implemented three of those changes. The company now tests tissues for contamination when they are first received and has instituted a routine inventory audit of stored human tissue. Last week, he said, CryoLife began requiring disposal of an entire cadaver if contamination was found in any part of it. The company also has pledged to report instances of contaminated cadavers to the FDA and the CDC. Keenan said that CryoLife had two choices with regard to settling and implementing the other suggested reforms: “Come to the table and negotiate with us or go to trial, and the verdict will be such it will wipe them out.” EVALUATING THE RISKS If these cases go to trial, they likely will shed light on the network of finders or “snatchers” the industry relies on to locate and gather tissue. But courts — and regulators — also may have to wrestle with balancing acceptable and unacceptable risks in a potentially life-saving industry that necessarily depends on cadavers for its product. CryoLife’s Fronk acknowledged that CryoLife tissue transplants obtained from human corpses, called allografts, are not sterilized because the process would irreparably damage the tissue cell structure. “Our technology is a science called cryobiology,” he said. “The premise behind cryobiology is to preserve a viable cell after the tissue is frozen and thawed… . You cannot sterilize the tissue. You cannot ensure it is free from contamination.” So far, Lykins’ death is the only one that the CDC has tracked back to CryoLife tissue. But Dr. Daniel B. Jernigan, a CDC epidemiologist who has been investigating reports of infections associated with human tissue implants, said the agency has confirmed 26 infections in the past two years associated with CryoLife products. That is a very small number compared to an average of 650,000 human tissue implants performed each year in this country, he cautioned. “It is important to remember throughout all this that it is unfortunate when these events occur, but it is rare.” Nonetheless, he suggested that increased scrutiny of CryoLife may lead to changes in the industry. “Regulations, frankly, need to catch up with the technology,” he said.

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