FORT WORTH - All Jacque Gibson White has left of her daughter, Rachel, are memories, painful memories of stroking her baby's head and holding her tiny hands every day of the four short weeks she lived at the intensive care nursery at Cook Children's Medical Center.

Rachel Eskew was her only child. Born prematurely, she had difficulty breathing. But Rachel was a fighter. White noted in her diary a ray of hope: On Feb. 25, 1984, three days after she was born, Rachel's doctors pegged her survival chances at 85 percent. Then Rachel suddenly took a turn for the worse. She died March 20, 1984. Doctors initially told White that the cause of death was kidney and heart failure for unknown reasons.

Two years later, the hospital learned that Rachel was among dozens of premature babies nationwide who died after being given E-Ferol Aqueous Solution, an intravenous vitamin E preparation intended to help prevent blindness. But the hospital didn't notify White of the finding. In fact, it would be 11 more years before she learned why her daughter died.

Many other hospitals, perhaps fearing costly lawsuits, also kept families in the dark about the potential link between the deaths or disabilities of their babies and the administration of E-Ferol, which had been marketed without the approval of the Food and Drug Administration.

Now, a federal lawsuit is aiming to force hospitals to disclose the link. At issue is whether hospitals must contact former patients or their families after it is discovered that some aspect of their care may have harmed them.
Cook Children's stance is that notification by the hospital violates doctor-patient confidentiality. Other hospitals have adopted policies to notify patients or families if hospital doctors ascertain that medical or pharmaceutical errors led to serious injury or death, policies that White's attorney maintains should be required of all hospitals.

In the E-Ferol cases, the disclosure issue has taken on urgency because time is running out for parents and patients who survived to sue the corporations that manufactured and sold E-Ferol and the hospitals that administered it.
The statute of limitations in state courts expires 20 years after the babies suffered illness or died. The drug was recalled on April 11, 1984, as death reports mounted from hospitals across the country.

The E-Ferol tragedy resulted in criminal prosecutions of corporate executives. Three executives at two companies that manufactured and sold the drug were convicted of fraud, misbranding and selling an unapproved dangerous drug; they were sentenced to six months in federal prison.
Outrage over the deaths prompted congressional hearings that exposed weaknesses in the nation's regulatory system for pharmaceutical drugs.
But it was never fully ascertained how many deaths or injuries to premature babies the drug caused.

FDA reports indicated that the drug was administered to more than 1,000 babies at more than 100 hospitals, including Cook Children's, Harris Methodist Fort Worth and Baylor Medical Center of Dallas. Based on information provided by hospitals, the FDA reported that at least 38 babies died out of about 100 who suffered such adverse reactions as blindness or damage to the kidneys, liver or brain.

There were no autopsies in some deaths because doctors blamed the babies' prematurity and related ailments, such as underdeveloped lungs.
That's the position taken by some hospitals that resist disclosing the names of babies who were given E-Ferol.Cook Children's spokeswoman Carolyn Bobo would not comment on any individual case, instead offering a statement:
" In 1984, neonatologists at Cook Children's cared for several infants whose families were later involved in litigation related to use of E-Ferol, a drug used to treat babies born with extreme prematurity. Neonatologists followed standard care guidelines for these infants. The FDA notified physicians and hospitals throughout the United States that E-Ferol should be withdrawn from use. Neonatologists at Cook Children's stopped use of the drug immediately.
" Physician testimony clearly indicates that these infants suffered from extreme prematurity and complications related to extreme prematurity, and that use of E-Ferol was not a significant factor in their care, health or survival at Cook Children's."

Seeking the victims
One of the experts who exposed the dangers of E-Ferol was Dr. Robert Brown, a pediatric pathologist at Cook Children's.
Brown had studied E-Ferol syndrome in 1984 and 1985 with partial funding from the hospital and published his findings about the drug's harmful effects in an April 1986 article in Pediatrics, the journal published by the American Academy of Pediatrics.

After Rachel's death, her doctors asked Brown to perform an autopsy consultation, in which the initial autopsy is scrutinized. In his report, dated Dec. 15, 1986, he concluded that Rachel died of E-Ferol syndrome.
Brown wrote to one of Rachel's physicians that he would be willing to meet with Rachel's doctors and her parents "to discuss these new findings."
Brown also notified the hospital's administration. But no one told White.
Nor did the hospital notify others whose infants received E-Ferol.
That became a central issue in a long-running liability lawsuit in state district court in Tarrant County.

The company that manufactured E-Ferol, Carter-Glogau Laboratories of Glendale, Ariz., and the drug's distributor, O'Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Mo. -- have been willing to offer settlements in cases where it can be proved that infants received large enough doses of E-Ferol to cause health problems or death, said Dallas lawyer David Taylor, who represented the corporations in about 20 E-Ferol cases in North Texas.

The companies, which went out of business after the scandal but still exist in little more than name only to resolve lawsuits in about 20 states, have settled about 130 E-Ferol lawsuits nationwide. The settlements include cases involving the deaths of six infants in Tarrant County.

Not a single case has gone to trial.
But the companies do not know which babies received the drugs. They know only which hospitals received E-Ferol, information O'Neal provided to the FDA during the recall.
" My client [O'Neal] sold the product to the hospitals -- the FDA did not know which patients got the drug," Taylor said. "Only the hospitals knew.
" In some cases, hospitals made extraordinary efforts to reach families; in other cases they didn't. As today, there was a lot of pressure on litigation, and some hospitals are afraid to get sued."

Cook Children's reported to the FDA that it had given the drug to seven infants, according to an FDA document dated June 12, 1984. But attorney Dwain Dent of Fort Worth, who has represented the families of 21 infants in product liability lawsuits involving E-Ferol, believes the number of babies who died or suffered health damage because of E-Ferol nationwide and in Tarrant County is much higher than the official figure because the FDA relied on potentially incomplete reports from the hospitals as the tragedy unfolded.
Dent asked the court to force disclosure of the names, and Cook Children's resisted.

Bobo, the hospital's spokeswoman, declined repeated requests for interviews with hospital officials or attorneys and declined to answer questions about infants who received E-Ferol.
Court papers outline the hospital's key position that revealing the information would violate doctor-patient privilege.
Former hospital President Peggy Troy testified in 1999 that it was a doctor's responsibility to tell a patient if he or she has been injured or harmed or given an illegal drug such as E-Ferol.

In one exchange during the deposition, Troy acknowledged that the hospital did not intend to volunteer the information to the patients or their parents.

Dent: "I'm asking if you, as the executive officer of the hospital, have visited with any committees about notifying parents of these children that they received this ... drug during 1984 in your hospital?"
Troy: "No."
Dent: "And is it on any agenda for the future?"
Troy: "No."
Dent: "And do you intend to ever give them notice?"
Troy: "No."

In their rulings in favor of disclosure, two state courts rejected the hospital's claim of doctor-patient privilege.
In an Oct. 18, 2002, order, District Judge Tom Lowe said he had to balance the patients' right to privacy with their "right to know that they have been administered an illegal, non-FDA approved and potentially harmful or lethal drug."

"Of concern to this court is that some child may be suffering consequences of E-Ferol toxicity and may not know it," Lowe wrote.
After the 2nd Court of Appeals in Fort Worth upheld Lowe's conclusion, the hospital asked the Texas Supreme Court to review the ruling.
Dent then dropped the case. He said he feared that it could be years before the Supreme Court took up the case.

" The kids might lose their rights to file a complaint," he said.
Instead, Dent decided to seek class-action status through a lawsuit in federal court in Wichita Falls. The suit was filed May 29 on behalf of two plaintiffs in Texas and Georgia and all others who received E-Ferol as premature infants between December 1983 and April 1984. It has been scheduled for a four-week trial in November 2004 before Senior U.S. District Judge Jerry Buchmeyer.

" We continue to push for disclosure because we think all families [have] got to know if their child got this dangerous drug in 1984," said Dent, who teamed with Fort Worth lawyer Art Brender in the federal lawsuit. "I'm a parent of two. I'd want to know."

The hospital has sued O'Neal and Carter-Glogau in federal court to recoup more than $250,000 in attorneys' fees and expenses it incurred in defending the health-care liability action in state court. In federal court filings, the hospital describes itself as a victim of the manufacturer and distributor.
" Cook was nothing more than an innocent seller of the drug-manufacturing defendants' defective product," the hospital said.
Taylor acknowledged the mistakes the two companies made. But he said they are not willing to pay for the hospital's refusal to turn over the patient names.

" Cook's was in this lawsuit because the plaintiffs wanted information from Cook's, and Cook's refused to provide the patient records," Taylor said. "Our position is that it is not our problem to defend Cook's for refusing to give out information. We are defending the product."
The fee-dispute case is still pending before U.S. District Judge Terry Means in Fort Worth.

Parents not informed
The death of Alice Hernandez's first child, Jose, overshadows her life to this day. Jose Hernandez III, or "Little Joe" as his parents called him, was born at Harris Methodist Fort Worth on Feb. 18, 1984. He died exactly four months later.

Hernandez, 43, of Mesquite, then a pharmacy technician at Harris Methodist H.E.B., went to see Little Joe at the hospital every day, often staying until late at night.

" When he started getting worse, we asked the head of the ICU if they could give us a different doctor or do anything else," Hernandez said. "They said no, there was nothing else they could do.

" The autopsy said he died from underdeveloped lungs. He was fine the first week he was born. He weighed 2 pounds, 9 ounces at birth and was 15 1/2 inches. When he died, he was 9 pounds and his entire body was swollen. He went downhill after he got the drug."

Hernandez wishes the hospital had voluntarily told the families about the E-Ferol treatment immediately after it was recalled. She found out that her son had received high doses of the drug only after hearing from another mother whose premature baby girl had died at Harris that spring.Hernandez reached a confidential settlement with O'Neal and Carter-Glogau in 1997.

Though Harris didn't notify parents or patients at the time of the recall, it has taken a different stance from Cook Children's.Harris, also named as a co-defendant in Dent's previous state lawsuit, complied with requests to produce the names and then was released from the lawsuit. Dent still has one new state case pending against Harris. A spokeswoman for Harris, Laura Van Hoosier, declined to comment.

Harris gave Dent the names of 41 of the 80 patients who hospital officials told the FDA had received E-Ferol, saying those were all the names it could retrieve and that some patient records may have been lost, Dent said.
That stance is more in line with recommendations from physician associations, pharmacist groups and consumer advocates, who say that health-care providers should promptly inform patients of serious medical errors.

" Once an organization has determined that a patient was given a dangerous substance or an error has occurred, the institution has a duty to notify patients or their families," said pharmacist Casey Thompson, an expert on patient safety issues with the American Society of Health-System Pharmacists. "Ethically, it would be the right thing to do."

That's not only in the patient's best interest. An often-cited 1999 study of a disclosure policy at the Veterans Affairs Medical Center in Lexington, Ky., found that openly acknowledging serious errors and taking swift measures to prevent similar mistakes actually helps reduce the number of malpractice lawsuits and the amount of damages awarded.

Lawsuits resolved
For Hernandez and White, the delay in notification added to their grief.
" The mothers carry this guilt for such a long time," Hernandez said. "I blamed myself and God for 10 years, until I found out the truth."
The hardest days for Hernandez are Little Joe's birthday and Christmas, when she makes the trip to Fort Worth's Mount Olivet Cemetery to visit his grave.

White did not learn about Brown's finding on her daughter's death until November 1997, after her ex-husband, Brinkley Eskew, responded to an advertisement by Dent's law firm seeking witnesses who had babies at Cook Children's during the time E-Ferol was administered.

At Eskew's request, the hospital released his daughter's records -- without any explanation of what the medical files meant and without acknowledging that she was killed by E-Ferol, Dent said.

Dent later wrote to White to tell her of Brown's findings.
White then sued the two companies in state district court and reached a confidential settlement this year, as had Eskew. Dent dropped White's state liability suit against the hospital before turning to the federal courts.
White, who now lives near Newport News, Va., insists that doctors and hospitals should notify parents when mistakes are made that cause serious health damage or death.

" I spent all these years since she died blaming myself, believing that it was completely my fault that I don't have my child," White, 43, said. "I would not have had to live with that guilt so long had I known."

During the 27 days of Rachel's life, White wrote in her diary every day. Occasionally, she flips through the pages, taking a journey into a distant, never-ending past.

Tale of trouble with E-Ferol
Here is a timeline of the drug E-Ferol, which was manufactured by Carter-Glogau Laboratories of Glendale, Ariz., and distributed by O'Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Mo.

August 1982: O'Neal executive James Madison writes to Carter-Glogau President Ronald Carter inquiring about the feasibility of a water-soluble vitamin E preparation for IV infusion. Madison suggests using deception to get the product to the marketplace before a competitor.

November 1983: O'Neal introduces E-Ferol, and sales exceed expectations. O'Neal sells 25,800 vials in the first five months.

December 1983: A doctor in Hawaii tells Madison that two babies became ill after receiving E-Ferol.

January 1984: A doctor in Spokane, Wash., tells Madison that three babies have died and another is gravely ill. Madison replies that E-Ferol has been proved safe and threatens the doctor with a lawsuit if he goes public with his suspicions.

March 1984: The Centers for Disease Control and Prevention receives reports from hospitals in Cincinnati and Knoxville, Tenn., about unusual illness in 13 premature babies with low birth weights. Eight infants who received E-Ferol died.

April 1984: The CDC contacts the Food and Drug Administration, and O'Neal and Carter-Glogau agree to recall E-Ferol.

July 1987: A federal grand jury returns a 25-count indictment charging Madison, Carter, O'Neal President Larry Hiland and the corporations with conspiracy to commit mail and wire fraud and with violations of the Federal Food, Drug and Cosmetic Act.

1988: Carter, Hiland and Carter-Glogau are convicted. Madison and O'Neal plead guilty to reduced charges.

January 1989: Carter and Hiland are each sentenced to six months in jail and fined $130,000 each. Madison is sentenced to six months in jail and fined $12,000. The two companies are fined a total of $260,000 and ordered to pay $215,000 for the cost of the government investigation.