Abstract

Controversies associated with the use of Tylenol are not new to Johnson & Johnson. Reported cases of poisoning in 1982 and 1986 raised serious concerns about both the life of the analgesic and the well-being of consumers. In 1994, the results of two clinical studies raised product safety concerns about acetaminophen-based over-the-counter analgesics, suggesting development of hepatotoxicity, and an increased risk of end-stage renal disease. The alarm created by the studies is not of the same magnitude as the 1980s poisonings and the circumstances differed in that the findings did not only apply to acetaminophen-based analgesics; nonetheless, the implications of the latter are equally significant. Still operating by the same company credo, how Johnson & Johnson has handled the link between acetaminophen and hepatotoxicity and ESRD is of interest ; in particular, management's efforts to reassure both consumers and company shareholders.