Suit Targets Distributor of RU-486

The family of an Orange County woman who died after taking RU-486 and a follow-up drug has sued Danco Laboratories, the distributor of the so-called abortion pill, charging that the company did not sufficiently warn women of potential risks.

Hoa Thuy Tran, a 21-year-old teaching student from Fountain Valley, died in 2003 after taking the two drugs to end a pregnancy. She is one of four U.S. women -- all from California -- who allegedly died of massive infection after taking RU-486, prescribed under the brand name Mifeprex, since it was approved by the FDA in 2000.

The deaths have raised concerns among health officials. The cases are under investigation by the U.S. Centers for Disease Control and Prevention as well as state and local health agencies.

The lawsuit marks the first time Tran’s name has been released publicly. The other women have been identified.

In addition to Danco, Tran’s family sued Planned Parenthood of Orange and San Bernardino counties and the Population Council, a nonprofit research organization that conducted clinical trials on RU-486. The case was filed last week in Orange County Superior Court.

Tran took Mifeprex on Dec. 23, 2003, at a Planned Parenthood clinic in Costa Mesa and was sent home with instructions to take the follow-up drug, misoprostol, a day or two later, the suit said.

She then traveled with friends to Las Vegas, where she collapsed. She died on Dec. 29.

“The main point is that she was not given any warnings of any risk of death, of any risk of infection, of any risk of septic shock,” said attorney Mark G. Crawford, who is representing Tran’s daughter, Destiny Nguyen, 5, and her husband, Charlie Nguyen, who is in the military. “There had been two prior deaths [by then].... There was a risk out there.”

Danco Laboratories did not return calls and e-mails requesting comment on the lawsuit.

Kimberlee Ward, vice president of public affairs at Planned Parenthood, said her organization cannot comment on the suit but “we are very sorry and express our sympathy to the family for any death that has occurred.”

The Population Council has yet to be served with the suit and declined to comment on pending litigation. However, spokeswoman Melissa May said Mifeprex is a safe and effective drug for early abortions.

“Mifeprex has been available in the U.S. for a little more than five years,” May said. “There have been between 400,000 and 500,000 women who have chosen this as an option for early abortion. There has been no causal relationship established between the use of Mifeprex or misoprostol” and the California deaths.

The Clark County coroner’s office, which investigated Tran’s death, did not do an autopsy because there was no indication of foul play or suspicious circumstances, said Coroner P. Michael Murphy.

“We have the death listed as a cardiac arrest with acute undetermined etiology,” Murphy said. “The question is: Is that death actually as a result of RU-486? We don’t have anything in our records that indicate it.”

But Crawford, who is representing the families of two other California women who died after taking Mifeprex, said that Tran’s family contracted with a laboratory to have an autopsy done privately.

The autopsy “determined there was evidence indicative of infection and sepsis,” according to the suit, which also said Tran never would have taken the drugs had she known about the risks or at least “would have obtained the help or care necessary to save her life.”

Through an attorney, the family contacted the U.S. Food and Drug Administration in April about Tran’s death, Crawford said, and in August sent tissue samples from the autopsy to the CDC. The CDC declined to comment on Tran’s case or on the progress of its investigation.

Last July, a month after a Sherman Oaks woman died, the FDA issued a public health advisory warning that four women had died of massive infection after taking Mifeprex. The bacterium causing the sepsis, or blood infection, was identified in two of the cases as Clostridium sordellii, and the CDC is investigating whether it was involved in the other two cases.