Side Effects for a Pain Killer

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.

The 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.

Consumer groups were outraged with the light fine, calling it "a slap on the wrist." Said Dr. Sidney Wolfe, director of the Washington-based Public Citizen Health Research Group: "We 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.