The Johnson & Johnson's Tylenol Controversies

            




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THE TYLENOL OVERDOSE CONTROVERSY CONTD...

Slowly, people became aware that though safe in proper doses, Tylenol could be dangerous even in a little overdose. Even twice the prescribed dose could damage the liver. Unfortunately, overdoses could happen due to many reasons. For children, Tylenol came in kid-pleasing flavors and was marked as a "SAFE" alternative to Aspirin. As children liked the flavor, they could just take another dose. It was also found that in many cases, one parent was not aware that the other had given the dose, and accidentally gave a second dose. Also, parents were not aware about the strengths and doses of Tylenol line of products. Acetaminophen was also harmful to people with liver problems, if taken along with alcohol and certain other medicines or on an empty stomach.

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However, Tylenol was marketed with the ad line "Nothing’s Safer." The required warning labels as per the US Food and Drug Administration rules only stated alcohol-related risks. Some health practitioners felt that stronger warnings against overdoses were very important.

According to analysts, inspite of the bad publicity and legal settlements, which cost the company millions of dollars, J&J refused to put explicit warnings on its Tylenol labels. The company had only made just cosmetic changes on the warning label. After the Keele case, J&J added to the extra strength package: "Not for use for children." In 1994, after Benedi’s case, it added a warning about using any pain reliever after a drink. Analysts said that J&J resisted writing the kind of label that would really alert people about the dangers of taking overdoses. For example, according to J&J it resisted warning customers about possible liver failure because the company felt that "organ specific" warnings would confuse people. Similarly, the company resisted warning about the risk of death to avoid suicides: If people knew that acetaminophen was potentially deadly, they might use it for suicide. In response to the studies revealing Tylenol-related liver damages, J&J advised its sales representatives not to discuss the issue with the doctors. Rather than taking some concrete measures to prevent patients from taking overdoses, J&J recommended that the patients should keep a log for doses taken. The recommendation was made in a patient education brochure given to the doctors. According to media reports, at least 100 suits had been filed against J&J over acetaminophen poisonings between 1990 and 1997. In four cases, the company reportedly made out-of-court settlements under agreements that required the plaintiffs to maintain silence about the terms. Analysts felt that the huge profits were the main reason behind J&J’s reluctance to make people aware of Tylenol’s side effects. Wall Street analysts estimated J&J’s revenue for Tylenol at $1.3 billion a year in 1996. The fact that acetaminophen was available at about half the price suggested that J&J’s profit margin was very high. J&J spent a major part of this profit to strengthen Tylenol’s image. According to Advertising Age, the company’s domestic ad budget for Tylenol was $250 million in 1997, more than Coca-Cola spent on Coke.

Analysts remarked that J&J’s response to the overdose issue was in steep contrast to its quick and sincere efforts in 1982. Burke had taken personal responsibility for the public’s safety. The American Association of Poison Control Centers reported about 100 deaths a year from acetaminophen. This figure seemed to be understated since hospitals were not required to report such cases.

An article published in 1997 commented on the alternatives available to Ralph Larsen , J&J’s new CEO, "He can rewrite the label, putting on it the verbal equivalent of a skull and crossbones. Or he can go on paying off victims, and hope for the best. Which is the moral choice? Which, in the long run, is the best business decision?"

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