A federal judge in Dallas has approved class certification for all patients who received a potentially deadly intravenous vitamin E solution 20 years ago at hospitals nationwide, including several in North Texas.

U.S. District Judge Jerry Buchmeyer issued a ruling last week in a federal lawsuit that seeks to require hospitals to reveal the identities of all premature babies who received E-Ferol between November 1983 and April 1984. The drug was recalled April 11, 1984, as death reports mounted from hospitals across the country.

The Food and Drug Administration reported that at least 38 babies died and scores of others suffered blindness or damage to their kidneys, liver or brain from E-Ferol poisoning at more than 100 hospitals.

Buchmeyer estimated that the class encompasses 866 patients and their families, based on FDA data that 1,008 premature infants received E-Ferol and subtracting about 140 families that have already sued.

Class certification allows a large number of plaintiffs with similar legal claims to join forces in one lawsuit, which is then tried in one court.

Fort Worth attorneys Art Brender, Fred Streck and Dwain Dent teamed in asking that a Wichita Falls case be certified as a class action. The suit was originally filed by two named plaintiffs to stop the clock on the statute of limitations that was expiring in the state courts 20 years after the babies became ill or died.

The suit was filed May 29 in federal court in Wichita Falls on behalf of Victoria Klein and Ashley Swadley against E-Ferol distributor O'Neal, Jones and Feldman Pharmaceuticals of Maryland Heights, Mo., and the drug's manufacturer, Carter-Glogau Laboratories of Glendale, Ariz.
The companies went out of business after the recall but still exist for legal purposes in little more than name only to resolve lawsuits in about 20 states.
Plaintiffs' attorneys have questioned the accuracy of the official death and injury figures released by the FDA because in many cases, hospital doctors blamed health problems on the babies' prematurity instead of E-Ferol poisoning.

Buchmeyer's order to certify the class will help determine how many patients were killed or suffered severe health damage because of E-Ferol, Dent said.
" Many hospitals knew that children received this drug and never advised the families," said Dent, who has represented the families of 21 patients in product liability lawsuits involving E-Ferol. "But now, because of Judge Buchmeyer's order, these families and the children will find out the truth about their medical history."

In a memorandum opinion issued May 11, Buchmeyer certified as a class all patients who received E-Ferol 20 years ago, as well as their parents, spouses, children, guardians, legal representatives, estate representatives and heirs of deceased patients.

Buchmeyer ordered every hospital or medical provider that administered E-Ferol to disclose the patients' identities to the plaintiffs' lawyers so they can notify each potential class member. The judge also required the hospitals to provide information about the death of any E-Ferol recipient.
Buchmeyer found that the named plaintiffs' claims are representative of the class.

Klein was born March 23, 1984, at Wichita Falls General Hospital and was transferred to Fort Worth Children's Hospital, now Cook Children's Medical Center, where she received 16 doses of E-Ferol. Swadley was born Feb. 18, 1984, at Baylor University Medical Center in Dallas, where she received four doses of E-Ferol.

Both are at a high lifetime risk of chronic liver disease, cervical and vaginal cancer, and other health problems because of their exposure to E-Ferol, their lawsuit says.

Attorneys for O'Neal and Carter-Glogau opposed the class-action certification. Dallas attorney David Taylor, who has represented both corporations in about 20 E-Ferol cases in North Texas, did not return messages left at his office. But in the corporations' answer to the lawsuit, Taylor wrote, "Defendants deny that all children administered E-ferol suffered some degree of 'E-ferol syndrome' resulting in injuries, including severe brain injury, blindness and death."

Dent said the plaintiffs' attorneys planned to fax a message to hospitals alerting them of Buchmeyer's order. The message will be sent to any hospitals that, according to FDA reports, had administered E-Ferol.
" We are asking them to keep all their documents," Dent said.
The E-Ferol tragedy resulted in rare criminal prosecutions of corporate executives in the pharmaceutical industry. Three executives at the companies that made and sold the drug were convicted of fraud, misbranding and selling an unapproved dangerous drug. They were sentenced to six months in federal prison.

E-Ferol facts
E-Ferol, a vitamin E solution given intravenously to premature babies, was intended to help prevent blindness. The drug was marketed and administered without the approval of the Food and Drug Administration. The drug was recalled April 11, 1984, as death reports mounted from hospitals nationwide.