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Protracted lawsuit against Stanford Blood Bank ends

Case put spotlight on conditions under which people donated blood

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.

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Comments

Like this comment
Posted by wauggee
a resident of Crescent Park
on Jun 7, 2013 at 11:40 am

If indeed "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.", why in the world did Stanford encourage this guy to continue donating blood? In hindsight, this appears to be a disaster waiting to happen.


Like this comment
Posted by Marty
a resident of Evergreen Park
on Jun 7, 2013 at 6:36 pm

I've donated blood many times. However, I always bathe thoroughly before going to a blood bank, in part because bacteria is always present on skin, and in part because I would never rely 100% on a quick alcohol swab.

This man's infection was so severe that I wonder if he sought help in a timely manner.


Like this comment
Posted by Stanford Grad
a resident of Duveneck/St. Francis
on Jun 8, 2013 at 11:41 am

I agree with the first part of Marty's comment; take all precautions any time you go into a hospital, and even more for any sort of invasive test.

As for the second comment, what constitutes a timely manner? Infections can often seem trivial at first. Some infections become very serious very fast. But suppose Bul, a man without health coverage, didn't zip into a doctor's office right away and shell out what might be a significant amount of money for him? He would not have been alone, in this richest country in the world, but one that does not offer health care to all its citizens. Please, let's be careful before we "blame the victim."

Futhermore, is there any excuse for Stanford's failure to maintain high safety standards? I don't think so. Is there any excuse for the way they hid information that they were ethically, if not legally, bound to release? That doesn't look good either. A hospital that does an incredible amount of good for its patients should also hold itself to a high standard on all fronts, including dealing with its own mistakes.

I'm glad that the case was finally settled, so that justice delayed was not completely justice denied.


1 person likes this
Posted by Sarah
a resident of Mountain View
on Aug 18, 2015 at 1:06 pm

Hi;
I need someone to assist me. I am a Blood Donor. Have been since 1979. The last time I went to help the blood bank and someone who needs healthy blood; this is what happened:
First off it was Saurday; I never go on Saturday but felt it was a good day as any.
I work all week and usually go after work when they are open for blood donations.
As I was at the computer and started to answer the usual questions a woman came up to me ( I assume she was a vulonteer) and asked if I needed a hot towel (or something)for my hands. I was shocked and stunned. I have NEVER had anyone ask such a question. I brought this to the attention to the nurse that takes your vitals and after that (I had left)it went down hill fast.
I asked why all of a sudden I was presented with such question. Never got an answer. What I have gotten is ridiculous excuses, insults, emails that not only leaves you stunned but you ask the question; What is going on? All I wanted was an answer as to why all of a sudden I am being asked such a question when donating blood?
Will someone pls help me out. I do not deserve such insulting emails. I would like an answer and at this point an apology is much overdue.



1 person likes this
Posted by 10 Gallon hat
a resident of Another Palo Alto neighborhood
on Aug 18, 2015 at 2:12 pm

As the spouse of a major blood donor with a rare type (who also does not have the virus mentioned), I am concerned when I read things like this. We have not experienced problems, but I would like to keep it that way and be aware. I am mainly looking for evidence that Stanford took responsibility, dealt with the complaint honestly and expeditiously, and improved their procedures as a result. At least there is no evidence of scorched earth tactics, and Stanford seems to have tried to take responsibility, but the article was murky and far from reassuring. I am not going to assume anything but would love to know more. Is there a more comprehensive response from Stanford (that clearly addresses these concerns?)


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