Judge approves $110M settlement over E-Ferol, vitamin supplement linked to 40 infant deaths
By Jamie Stengle, APSaturday, April 10, 2010
Judge approves $110M settlement in E-Ferol case
DALLAS — A federal judge has approved a $110 million class-action settlement against the manufacturer and distributor of an intravenous vitamin E supplement that federal officials have linked to the deaths of dozens of premature infants in the mid-1980s.
U.S. District Judge Sidney A. Fitzwater approved the settlement Friday in the case, which was filed in Wichita Falls in North Texas, according to court documents.
Art Brender, a Fort Worth lawyer representing 369 plaintiffs, said Saturday that the supplement was on the market for four and half months before it was recalled in April 1984. Federal health officials have linked E-Ferol to the deaths of about 40 babies.
E-Ferol was marketed and administered without approval from the Food and Drug Administration as a way to prevent or reduce blindness in premature babies.
Research determined the agent that made the vitamin E water soluble was causing symptoms including kidney and liver failure in the babies, Brender said.
“I think it’s one of the worst cases of corporate greed and malfeasance in history,” Brender said.
The drug manufacturer, Carter-Glogau Laboratories of Glendale, Ariz., and its distributor O’Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Mo., are no longer operating.
David Taylor, a Dallas attorney who represented the companies, said both stopped doing business about 20 years ago but their liability insurance would pay the settlement.
Taylor said his clients were relieved to get a resolution.
Dosage instructions were unclear and the more doses a child was given, the greater the chance of injury or death. Many children who received the supplement weren’t harmed, likely because they got a low dosage, he said.
Indictments were handed down in 1987 for Carter-Glogau and its former president, Ronald M. Carter, along with the former president of O’Neal, Larry K. Hiland. They were convicted of conspiracy, marketing an unapproved drug and misbranding the drug.
The company was fined $130,000 in 1989, and the two executives were sentenced to six months in jail.
Brender, who started the lawsuit in 2003, said the parents in the lawsuit before being contacted by attorneys weren’t even aware their children had gotten the supplement.
The class-action lawsuit includes the parents of 42 infants who were given the supplement and died, and people who as babies got the supplement and suffered damage or need medical monitoring.
There were more than 100 settlements involving E-Ferol in the last decades, said Brender, who estimates that at least 80 babies died from the supplement.
When attorneys tried to find patients who had gotten the supplement, some of the 89 hospitals found to have administered E-Ferol were willing to share that information. But many others had to be forced legally to reveal whether children had gotten the supplement, Brender said.
Tags: Dallas, Dietary Supplements, North America, Nutrition, Texas, United States