Word: oraflex
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...drug to be considered safe for humans, yet it was found to cause grave deformities in the babies whose mothers took the drug during pregnancy. Diethyl Stilbesterol (DES) also was tested on animals but has been found to cause vaginal and testicular cancer in the offspring of pregnant women. Oraflex, prescribed for arthritis sufferers, was animal-tested and considered safe until more than 150 people who used it died of kidney disease...
Just as A.H. Robins was filing for bankruptcy last week because of a product- liability case, another leading drug company, Eli Lilly, was having its own legal problems. Lilly, a maker of drugs (Darvon, a pain killer) and fragrances (Chloe), faced charges concerning Oraflex, a medicine for arthritis...
...Indianapolis-based company pleaded guilty to criminal charges for not informing federal officials that Oraflex had been linked to deaths and illnesses in foreign countries before it was approved for consumption in the U.S. Lilly also failed to warn consumers that Oraflex could have side effects on the liver and kidneys. In a plea bargain worked out with the Justice Department, Lilly (1984 sales: $3.1 billion) pleaded guilty to 25 counts of unintentional deception, a misdemeanor, and was fined $25,000. Lilly's former chief medical officer, Dr. William Shedden, was fined $15,000 on similar charges...
...Oraflex's troubles began in 1980, when it was marketed in the United Kingdom and eight other countries and submitted to the Food and Drug Administration for approval. The medicine received the FDA stamp in April 1982. Federal investigators maintain that Oraflex was a factor in the deaths of more than 100 people, including at least 26 in the U.S., between the time it first went on sale and August 1982, when it was removed from American store shelves...
...believe the company intentionally withheld information from the FDA and there should have been a felony charge. Their top ) executive could have been fined $150,000 and spent 45 years in jail." Last week's action ended the Government's case against Lilly. But the firm cannot put Oraflex behind it since scores of civil suits in the U.S. and Britain must still be resolved...