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 in the case, which was filed in Wichita Falls, Texas. There were 369 Plaintiffs in the suit. The vitamin supplement was on the market for four-and-a-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 babies. The drug manufacturer, Carter-Glogau Laboratories of Glendale, Arizona, and its distributor O’Neal, Jones & Feldman Pharmaceuticals of Maryland Heights, Missouri, are no longer operating. Each company stopped doing business about 20 years ago, but liability insurance that was in place will fund the settlement.
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, most likely because they only got a low dosage. Indictments were handed down in 1987 for Carter-Glogau and its former president, Ronald M. Carter, along with Larry K. Hiland, the former president of O’Neal. 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.
The parents in the lawsuit weren’t aware their children had gotten the supplement. They became aware when they received notice of the lawsuit. The class-action lawsuit includes the parents of 42 infants who were given the supplement and died, and persons, who as babies, got the supplement and suffered damage or need medical monitoring. There have been more than 100 settlements involving E-Ferol, and it’s believed that at least 80 babies died from the supplement. When lawyers 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 in court to reveal whether children had gotten the supplement. Art Bender, a lawyer in Fort Worth, filed this lawsuit in 2003. He worked hard and eventually got a good result for the families in the lawsuit.
Source: Associated Press
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