A five-year legal battle between Stanford Blood Bank and a man who claims he developed a severe infection as a result of donating blood has ended, court documents show.
Christopher Bui, 46, a Palo Alto resident, claimed the blood center did not properly sterilize his arm before drawing his blood, according to the complaint filed in 2009 in Santa Clara County Superior Court. One day after his April 10, 2008, donation, he developed a Group B streptococcal infection that infected his collar bone. The situation became life-threatening, and part of Bui's clavicle had to be removed, according to the lawsuit.
Attorneys for both sides did not return requests for comment on the lawsuit. Blood bank spokeswoman Dayna Myers declined to clarify whether the legal battle ended with a financial settlement.
"Stanford Blood Center and Mr. Bui reached a confidential resolution; therefore, we cannot comment further," she said.
In September 2012, the Stanford Board of Trustees had offered to pay $200,000 to Bui in exchange for dismissing the lawsuit, but the offer was rejected, blood bank lawyers told the court in settlement-conference papers.
Stanford Hospital did write off $150,000 in medical bills for Bui, court documents stated.
The type of infection Bui had is highly unusual, and the case also highlights the murkiness of how frequently infections occur from donating blood. Blood banks are not required to report infections to federal or state agencies, experts said.
Federal law requires record-keeping of post-donation complaints, including infections, for U.S. Food and Drug Administration inspection, but blood banks don't have to proactively report infections and other incidents unless a donor dies, an FDA spokeswoman said.
The issue is exacerbated by a lack of national standards that define reactions and data-collection procedures by blood centers throughout the United States, according to a 2009 American Red Cross report.
The dearth in data collection is also due to the rarity of infection, experts said.
"The incidence of infection and thrombophlebitis after blood donation is not known because it is so rare. More than 12 million people give blood every year," said Stephanie Millian, director of biomedical communications for the American Red Cross. Cellulitis and thrombophlebitis skin and vein infections have a one in 50,000 to one in 100,000 probability, according to a 1997 American Red Cross study. The frequency of Bui's type of infection is unknown, blood-donation experts said.
Lawyers for both sides in Bui's case fought for years over records that might show how many donation-related infections occur at the blood bank and what constitutes a suspected infection.
Blood bank staff said they knew of no other cases of infections, promopting a man who works at the center to anonymously contact Bui's attorneys, Joseph Carcione Jr. and Joshua Henderson in May 2012. He pointed them to records the blood bank keeps on patient complaints and post-donation complications, according to a settlement-conference statement.
After the existence of the Stanford's records came to light, Superior Court Judge Peter Kirwan ordered the blood bank to turn over 12,000 Post-Donation Information Follow-up (PDIF) documents related to known or suspected bacterial infections that occurred between Jan. 1, 2003, and April 10, 2008.
The documents record any possible illness experienced by a donor that could have contaminated donated blood. They also contain information about donor infections and complaints, including bruising, bleeding, pain, swelling and fever, according to court papers.
Stanford Blood Bank conducts thousands of blood draws annually: 58,116 blood draws, including 45,769 whole-blood donations, during fiscal year 2011-2012, its website states. Few result in an infection, staff said in court papers.
Staff found six cases in which donors were given antibiotics for possible donation-related infections between Nov. 15, 2003, and July 18, 2005, court documents showed. The nature of the infections and their treatment were not explained.
On Nov. 15, 2012, at Bui's request, Kirwan then decided upon a review of all 12,000 records by an independent doctor or nurse-practitioner. On April 4, the same day Kirwan chose a nurse practitioner to conduct the review, both sides resolved the case, Myers said in an email.
Court records show that Bui's attorneys filed a dismissal on May 1.
In court documents, experts for the blood bank cast doubt on Bui's claim that improper sterilization procedures caused his infection. But while even localized skin and vein infections are rare, that doesn't mean a systemic infection such as Bui's hasn't happened, said Dr. Celso Bianco, an infectious-disease expert and specialist in donor screening and transfusion-transmitted infections.
"This is a very, very rare event. In terms of a generalized infection, I never saw one in all my years involved in the New York Blood Bank. But if I never saw one, it doesn't mean that it doesn't exist," said Bianco, former vice president of medical affairs at the blood bank and the retired executive vice-president of America's Blood Centers in Washington, D.C.
Most infections, when they occur, cause phlebitis (an inflammation of the vein caused by bacteria), or cellulitis (inflammation of connective tissue with severe inflammation of skin layers). Bianco said he rarely saw localized infections. Occasionally he saw abscesses next to needle punctures.
"We have a very large population of bacteria on the skin. Sometimes we don't kill all of them," he said.
Federal protocol requires a double "arm scrubbing" with disinfectant prior to the needle puncture, with a 30-second interval in between the scrubs. When infections occur, the suspected cause is an improperly sterilized skin site, Bianco and others said.
In court papers Stanford denied it had inadequately sterilized Bui's arm, saying the center follows federal protocol. But in a June 2012 court deposition, the bank's director of quality assurance, Patricia Lendio, said Stanford had not audited its phlebotomists since 2005. Blood banks conduct periodic audits of personnel to ensure procedures are done correctly.
The Code of Federal Regulations requires periodic audits but not specifically for sterilizing arms, she said.
Within two months of Bui's reported problems, the blood bank instituted more stringent audits of its arm-scrub sterilization procedures. The audits are now done on a yearly basis, she said.
Assistant Medical Director Christopher Gonzalez said in a deposition that he verbally promised Bui the blood bank would pay for medical costs arising from donation complications if Bui would continue to donate blood. Bui's blood is uncommon because it does not contain a virus found in more than 50 percent of donors. Stanford has actively sought such blood, which is valued for patients with compromised immune systems, according to court papers.
Bui does not have health insurance. Before the 2008 incident, he had two prior complications of an unspecified nature at the blood bank in 2004 and 2006, according to court documents.