Inhalers Potentially Linked to 17 Fatalities

Public Citizen (PC), a national non-profit consumer organization, is urging the Department of Health and Human Services to launch a criminal investigation of Schering-Plough Corporation, claiming that 17 deaths suffered by users of Schering-Plough inhalers were related to defects in the products.

According to PC, the deaths, all of which occurred between 1998 and 2000, were linked to two brands of the inhalers that lacked albuterol, the active ingredient used to treat asthma attacks. The group contends that all of the deaths occurred during the time during which the lots allegedly lacking albuterol were shipped. The inhalers were sold under the brand names Proventil and Warrick. Schering-Plough manufactured 59 million of the inhalers, which were all manufactured before September 30, 1999.

According to PC, the first death occurred in September 1999 and Schering-Plough was notified in January 2000. Schering-Plough launched a limited recall of one million inhalers in September 1999 unrelated to the death, but PC says that several of the deaths could have been prevented had Schering-Plough expanded the recall sooner. However, the organization claims that Schering-Plough waited an additional three months after the death, before it expanded the recall to include all of the potentially defective inhalers. A spokesperson for Schering-Plough disputes PC's claim, asserting that the recall was a precautionary move and that each of the inhalers returned to the manufacturer pursuant to the recall has been tested and contains the active ingredient.

PC has reported, however, that it believes the absence of albuterol is linked to the deaths. Specifically, the organization contends that Schering-Plough 10 of the deaths occurred in users of inhalers belonging to the recalled lots. Additionally, the organization noted that for the other seven fatalities, batch numbers were not available.

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