Firm Linked To Infant Deaths Is Indicted
ST. LOUIS (AP) _ The companies that manufactured and distributed a drug linked to the deaths of 38 infants have been charged with concealing the fact that the drug had not been declared safe and problems had been reported.
The federal indictment returned Thursday said E-Ferol Aqueous Solution was marketed without approval from the U.S. Food and Drug Administration, which would have required that it be tested for safety and effectiveness.
The drug contained vitamin E and was used to treat retrolental fibroplasia, a form of eye damage that occurs in premature infants who get large amounts of oxygen to keep them alive.
E-Ferol was made by Carter-Glogau Laboratories Inc. of Glendale and distributed by O’Neal, Jones & Feldman Inc. of Maryland Heights, Mo., in 1983 and 1984. Both companies have changed their names, to Retrac Inc. and O’Neal Inc. respectively. Also indicted were Larry K. Hiland, O’Neal’s former president and chief executive officer, and James B. Madison, the company’s former vice president of operations, and Carter-Glogau’s former president, Ronald M. Carter Sr.
The 32-page indictment charges each of two companies and three company officials with 12 counts of violating the Food, Drug and Cosmetics Act, seven counts of wire fraud, five counts of mail fraud and one of conspiracy.
If convicted, Hiland, Madison and Carter could each be sentenced to 101 years in prison and be fined $142,000. The companies face maximum fines of $142,000.
Federal officials have said the drug was linked to 38 deaths and illnesses in numerous infants across the country before Carter-Glogau voluntarily recalled it in April 1984.
The indictment alleged that O’Neal received reports that several infants treated with the drug died from symptoms associated with the product’s use. Adverse reactions included excessive weight gain, abdominal enlargement and liver problems.
The indictment said O’Neal described E-Ferol as safe and effective even though no clinical tests had been done and that the company told doctors E- Ferol was safe even after adverse reactions had been reported.
FDA officials have said 10 babies treated with E-Ferol died at the Santa Rosa Medical Center in San Antonio, Texas, and five babies died at the University of Tennessee Hospital in Knoxville, and that both hospitals notified O’Neal.
Madison declined to comment Thursday on the charges, as did O’Neal’s lawyer, Fred H. Cagle, Jr. Efforts to reach the other defendants by telephone were unsuccessful. All the defendants face the same charges:
- Twelve counts of violating the federal Food, Drug and Cosmetic Act. The indictment said the company sold a ″misbranded″ drug because E-Ferol was labeled as safe and effective even though the defendants knew of ″serious, life-threatening injuries″ in infants who got the drug.
- Seven counts of wire fraud. The grand jury said the defendants failed to tell hospital employees who called that babies treated with E-Ferol had died. Nor did the defendants inform the callers that no testing of the drug had been done, the indictment said.
- Five counts of mail fraud. The grand jury said the defendants mailed letters to hospitals falsely saying that the FDA had approved the drug as an effective treatment for retrolental fibroplasia.
- One count of conspiracy to commit mail and wire fraud. The defendants marketed E-Ferol without having tests done even though Carter had warned Madison more than a year earlier that an improper formulation ″could kill a few infants,″ the indictment said.
O’Neal began distributing E-Ferol in November 1983. It was the first time that vitamin E was the single active ingredient in a solution that could be injected directly into an infant’s veins.
Doctors had been using oral doses of vitamin E to try to prevent retrolental fibroplasia, but an intravenous solution is easier to administer.