A lawyer for one of two people infected with HIV from blood transfusions has notified Florida Blood Services of plans to sue the non-profit blood bank.
Florida Blood Services, which contends it did nothing wrong, received a letter Friday, the day after it revealed that tests failed to detect HIV in donated blood.
History and experts suggest the attorney and his client _ a father in his 20s _ will have a steep hill to climb, unless they can prove Florida Blood Services failed to do its best to prevent the donor from passing on the infection.
For the past 15 years, Florida's Blood Shield Law and the courts generally have protected blood banks that perform the best-available tests on donated blood.
They also have protected the confidentiality of the donors, confounding lawsuits by stopping plaintiff's attorneys from interviewing infected donors to determine if they were properly screened. The same has been true nationally as well.
"Look it up, we got clobbered," said Corey Dubin, president of the Committee of 10,000. The group represents hemophiliacs infected with HIV by tainted blood products before reliable testing of donated blood was introduced in 1985.
"It's an uphill battle. You've got to get an open-minded judge who will apply the law very fairly," Dubin said. "We had judges that didn't understand the technological aspects of it. That can be a problem. And there are a lot of hurdles to get over."
Florida Blood Services contends it has done nothing wrong. Under Florida law, blood is not considered a commodity for sale, so it doesn't have the same liability exposure as other products.
Theresa Wiegman, general counsel for the American Association of Blood Banks, say most states offer similar protections for blood banks.
"You've moved away from a system of strict liability to a negligence standard, given that you can never make blood 100 percent safe," she said. "We make blood as safe as possible, but there's always an inherent risk."
Lawyer Steve Barnes of the Tampa firm of Abrahamson & Uiterwyk, who is representing the man and his young son, acknowledged that Florida's Blood Shield Law gives the blood bank a layer of protection, but only if the donor's HIV could not be detected scientifically.
"It wasn't detected by the specific procedure they used, but there is a procedure they could have used that would have detected it," Barnes said.
He offered no details, but said it involved additional testing.
Florida Blood Services has not released the names of the donor or the recipients, or said where they were treated. Barnes also declined to release the name of his client, but said he was infected in March during abdominal surgery at Helen Ellis Hospital in Tarpon Springs and is "devastated." The hospital declined to comment.
If the lawsuit survives preliminary moves by the blood bank to throw it out of court, it could give Barnes' law firm the power to subpoena Florida Blood Services records and interrogate employees.
"At this point, we have to file the suit to do the investigation," Barnes said.
The other patient was a woman in her 60s, the blood center has said.
This case is different than past cases because it's only the second known HIV infection since American blood banks began using a more sophisticated HIV test three years ago. A lawsuit stemming from the first case, in which a San Antonio, Texas, man was infected during surgery in 2000, is pending.
Florida Blood Services is the primary blood bank for Pinellas, Hillsborough and Pasco counties. It and most other banks have used this test, called nucleic acid testing, to screen for HIV since 1999. The test is highly accurate, but it may not catch donors who have contracted HIV within the past 10 days.
Because of this 10-day window, the U.S. Food and Drug Administration says there is a 1-in-2-million chance of contracting HIV from a blood transfusion, although in practice the risk has been much lower. About 14-million units of whole blood are donated annually in the United States.
Dubin, of the Committee of 10,000, served on the FDA's Blood Products Advisory Committee as the nucleic acid test was being approved. He said some experts disagree on the window and on "how you should be running your testing to look at those window infections."
Some centers also do better than others, and it's worth exploring what happened here, he said.
According to Florida Blood Services, a regular donor gave blood May 11. That blood was found to have been infected with HIV. After retesting the blood and the donor, the bank determined seven local people had received blood products from that donor's previous donation in March.
All were tested, and two were found to be HIV-positive. Center officials say they believe the donor unknowingly became infected just days before he or she gave blood in March.
FBS contends it had followed proper procedures and is neither to blame nor liable. Meanwhile, two FDA inspectors have spent the week poring over records and procedures at the blood bank's labs and offices in St. Petersburg.
"We have done everything we felt was possible to do," said J.B. Gaskins, vice president of marketing, communications and donor services. "To our knowledge . . . we don't see where there has been any kind of variance in the way we conduct our business."
The center was notified Friday of the transfusion patient's intent to sue. Barnes said he planned to file the suit today in Pinellas or Hillsborough counties, with the man and his young child as the plaintiffs. State law allows minor children to sue when a parent is totally and permanently disabled.
Nationally, lawsuits over tainted blood erupted in the late 1980s and early '90s after blood recipients who were infected with HIV before 1985, when testing began, got sick. They included about half of the nation's 20,000 hemophiliacs, who need regular transfusions of blood products to live.
In an attempt to settle the lawsuits from hemophiliacs, in 1998 Congress established the Ricky Ray Hemophilia Relief Fund to make $100,000 payments to those infected between 1982 and 1987.
Hank Uiterwyk, another attorney working with Barnes on the case, said the firm has instructed both the hospital and the blood bank to preserve any samples of blood or plasma from the donor, from any period of time.
"We don't want to spoil the evidence," Uiterwyk said. That is why the suit will be filed so quickly, he added. "There needs to be a lot of research into how it occurred."