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Drug & Device News

By ALM Staff | Law Journal Newsletters |
August 26, 2010

Class Action Settled Decades After Infant Deaths

A settlement has been reached in a class action suit involving the deaths in the 1980s of 40 infants who were given E-Ferol, a vitamin E supplement manufactured by the now-defunct Carter-Glogau Laboratories Inc. and distributed by O'Neal, Jones & Feldman Inc. The $110 million settlement was approved by Judge Sidney Fitzwater, chief judge of the U.S. District Court for the Northern District of Texas. The FDA never approved E-Ferol, which was administered intravenously to premature babies to prevent blindness and lesser visual impairments. The plaintiffs' suit claimed that the manufacturer and distributor led hospitals to believe the supplement had indeed received federal approval, and that it caused problems such as liver and kidney failure in hundreds of babies. A 1980s investigation of E-Ferol, conducted by the Centers for Disease Control and Prevention, found that the emulsifier Polysorbate 80 was the cause of the problems.

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