Oraflex

ORAFLEX, A PAINKILLER for arthritis patients sold by Indianapolis, Indiana-based pharmaceutical giant Eli Lilly, is believed to have killed 49 people in the United States after the company illegally concealed evidence of several hundred deaths caused by the medication in overseas markets. Oraflex, known as Opren outside of the United States, went on the overseas market in 1980. From January 1981 to June 1982, Lilly received reports about problems with the medication in the United Kingdom and other countries where the drug was sold. The reports said that four people died from liver failure after taking Oraflex, three people suffered kidney or liver problems, and three developed jaundice. Lilly put Oraflex on the U.S. market in May 1982. On August 5, 1982, Britain banned the drug and Lilly voluntarily withdrew Oraflex from the U.S. and international markets.

Federal law requires companies to inform the Food and Drug Administration (FDA) of any adverse reactions from new drugs but Lilly did not do so. In 1985, Lilly pleaded guilty to 25 criminal counts for failing to inform federal officials of four deaths and six illnesses that occurred after patients took Oraflex. However, FDA officials declared that Oraflex had been linked to 49 deaths in the U.S. and several hundred abroad. The pharmaceutical company received the maximum penalty of $25,000, or $1,000 for each count. All of the counts were misdemeanors. Federal authorities did not charge the company with intentional deception. William Shedden, former vice president and chief medical officer of Lilly Research Laboratories, pleaded no contest to 15 criminal counts related to the drug and was fined $15,000.

In Britain, Lilly became the target of a lawsuit launched by 1,300 Britons who claimed that they [Page 590]had become ill, or that relatives died from taking Oraflex. In 1988, 1,000 of these plaintiffs settled with Lilly for an estimated £6 million ($10.9 million) to £7 million ($12.8 million). The company continued to deny that it intentionally withheld medically significant information.