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Acetaminophen (Tylenol): Johnson & Johnson and Consumer Safety

Published online by Cambridge University Press:  01 January 2021

John Trinkhaus ,
Jay Nathan ,
Leona Beane  and
Barton Meltzer
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Extract

Controversies associated with the use of Tylenol (acetaminophen) 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 (OTC) analgesics, suggesting development of hepatotoxicity, and an increased risk of end-stage renal disease (ESRD). 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 (especially when contrasted with its response to the 1980s poisonings); in particular, management's efforts to reassure both consumers and company shareholders.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 25 , Issue 1 , Spring 1997 , pp. 49 - 57
Copyright
Copyright © American Society of Law, Medicine and Ethics 1997

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References

Perneger, T.V. Whelton, P.K. Klag, M.J., “Risk of Kidney Failure Associated with the Use of Acetaminophen, Aspirin, and Nonsteroidal Antiinflammatory Drugs,” N. Engl. J. Med., 331 (1994): 1675–79; and Whitcomb, D.C. Block, G.D., “Association of Acetaminophen Hepatotoxicity with Fasting and Ethanol Use,” JAMA, 272 (1994): 1845–50.CrossRefGoogle Scholar
Garnett, L., “Strong Medicine,” Harvard Health Letter, 20 (1995): 4–6.Google Scholar
Arky, R., Physicians' Desk Reference (Montvale: Medical Economies Data Production, 1995): At 2366.Google Scholar
Bradley, J. et al. , “Comparison of an Antiinflammatory Dose of Ibuprofen and an Analgesic Dose of Ibuprofen and Acetaminophen in the Treatment of Patients with Osteoarthritis of the Knee,” N. Engl. J. Med., 325 (1991): 87–91.CrossRefGoogle Scholar
See Perneger, Whelton, Klag, , supra note 1.Google Scholar
See Whitcomb, Block, , supra note 1.Google Scholar
Ronco, P.M. Flahault, A. Editorial, , “Drug Induced End Stage Renal Disease,” N. Engl. J. Med., 331 (1994): 1711–12.CrossRefGoogle Scholar
Strom, B.L., Editorial, “Adverse Reactions to Over-the-Counter Analgesics Taken for Therapeutic Purposes,” JAMA, 272 (1994): 1866–67.CrossRefGoogle Scholar
Tedlow, R. Smith, W., “James Burke: A Career in American Business (A),” Harvard Business School Case Study 9-389-177 (Cambridge: Harvard Business School, 1989): At 11–12.Google Scholar
See id. at 12 (citing “A Painful Headache for Bristol-Myers?,” Business Week, Oct. 6, 1975, at 78).Google Scholar
See id. (citing Kneale, D., “Remedy Ruckus: Tylenol, the Painkiller, Gives Rivals Headache in Store and in Court,” Wall Street Journal, Sept. 2, 1982, at 12).Google Scholar
See id. (citing Power, W., “A Judge Prescribes a Dose of Truth to Ease the Pain of Analgesic Ads,” Wall Street Journal, May 13, 1987, at 33).Google Scholar
See id. at 12–13 (citing “A Pained Bayer Cries ‘Foul,”’ Business Week, July 25, 1977, at 142).Google Scholar
See id. at 20 tbl. 6 (citing “A Pained Bayer Cries ‘Foul,”’ supra note 13; and “Top 200 Advertised Brands Directory,” Marketing & Media Decisions, July 1979).Google Scholar
See id. at 13–14.Google Scholar
See id. at 14 (citing Wall Street Journal, Sept. 2, 1982, at 12).Google Scholar
See id. at 14.Google Scholar
See id. at 20 tbl. 8 (citing “The Race to Grab Up Tylenol's Market,” Chemical Week, Nov. 3, 1982, at 30; and “Top 200 Advertised Brands Directory,” supra note 14).Google Scholar
See id. at 11, 15; and Tedlow, R. Smith, W., “James Burke: A Career in American Business (B),” Harvard Business School Case Study 9-390-030 (Cambridge: Harvard Business School, 1989): At 1–3.Google Scholar
See Tedlow, Smith, (9-390-030), supra note 19, at 3–4.Google Scholar
See id. at 4.Google Scholar
See id. at 3–5.Google Scholar
See, for example, Bernstein, J., “How to Handle, and Not to Handle, a Public Relations Crisis,” Newsday Sunday, Aug. 13, 1995, at 5.Google Scholar
See Tedlow, Smith, (9-390-030), supra note 19, at 6 (citing Sanger, E., “Can That Be Sterling Stirring?,” Barron's, Sept. 12, 1983, at 13).Google Scholar
See id. at 6 (citing Waldholz, M., “Speedy Recovery: Tylenol Regains Most of No. 1 Market Share, Amazing Doom-savers,” Wall Street Journal, Dec. 24, 1982, at 1). For additional comments on factors contributing to Tylenol's speedy recovery, see: Barker, R., “Picture of Health: Johnson & Johnson Seems to Have Cured What Ailed It,” Barron's, Mar. 30, 1987, at 15; Moore, T., “The Fight to Save Tylenol: The Inside Story of Johnson & Johnson's Struggle to Revive Its Most Important Product,” Fortune, Nov. 29, 1982; and Powell, W. Kastendorf, M., “Tylenol Rescue: J and J Rushes to Limit the Corporate Damage,” Newsweek, Mar. 3, 1986, at 52.Google Scholar
See Tedlow, Smith, (9-390-030), supra note 19, at 8–9. See also McFadden, R., “Makers of Tylenol Discontinuing All Over-Counter Drug Capsules,” New York Times, Feb. 18, 1986, at 1, B4.Google Scholar
See Tedlow, Smith, (9-390-030), supra note 19, at 10–11.Google Scholar
See id. at 11.Google Scholar
Leape, L.L. et al. , “System Analysis of Adverse Drug Events,” JAMA, 274 (1995): 35–43.CrossRefGoogle Scholar
Bates, D. et al. , “Relationship Between Medication Errors and Adverse Drug Events,” Journal of General Internal Medicine, 10 (1995): 199–205.CrossRefGoogle Scholar
Bates, D. Kuperman, G. Teich, J., “Computerized Physician Order Entry and Quality of Care,” Quality Management in Health Care, 2, no. 4 (1994): 18–27; and Bates, S., “Tylenol Verdict Puts Spotlight on Drug Labels,” Washington Post, Oct. 22, 1994, at A1.CrossRefGoogle Scholar
Kahn, K., “Above All Do No Harm: How Shall We Avoid Errors in Medicine?,” JAMA, 274 (1995): 75–76.CrossRefGoogle Scholar
Nordenberg, T., “The Center for Drug Evaluation and Research,” FDA Consumer, 30 (1996): 30–31.Google Scholar
See, for example, Tomkieviez, S., “How Far Can You Trust Generics,” Wellness Letter, 11 (Dec. 1994): At 7.Google Scholar
Clive, D.M. Stoff, J.S., “Renal Syndromes Associated with Nonsteroidal Antiinflammatory Drugs,” N. Engl. J. Med., 310 (1984): At 563, 567.CrossRefGoogle Scholar
See id. at 568–69.Google Scholar
See id. at 563. See also, Marasco, W.P. Gikas, R., “Ibuprofen-Associated Renal Dysfunction: Pathophysiologic Mechanisms of Acute Renal Failure, Hyperkalemia, Tubular Necrosis, and Proteinuria,” Archives of Internal Medicine, 147 (1987): 2107–16.CrossRefGoogle Scholar
See Clive, Stoff, , supra note 35, at 566–67.Google Scholar
See Marasco, Gikas, , supra note 37Google Scholar
Colburn, D., “How Safe is Tylenol?,” Washington Post, Nov. 1, 1994, at 10.Google Scholar
Johnson, Johnson, , “Statement on Acetaminophen Paper in JAMA” (Dec. 19, 1994) (on file with authors); and Johnson, Johnson, , “OTC Pain Killers and Kidney Disease” (undated) (on file with authors).Google Scholar
See Colburn, , supra note 40.Google Scholar
Whitcomb, D. Sessenheim, D.M. Rakel, J., “Management of Acetaminophen Ingestion in the Outpatient Setting,” Journal of Clinical Overcomes Management, 2 (1995): 37–42.Google Scholar
See Johnson, Johnson, , “Statement on Acetaminophen Paper in JAMA,” supra note 41; and Johnson, Johnson, , “OTC Pain Killers and Kidney Disease,” supra note 41.Google Scholar
Whitehall Laboratories, “Some Things to Consider If You Take Acetaminophen” (1992) (on file with authors).Google Scholar
See id.Google Scholar
Graudins, A. Aaron, C.K. Linden, C.H., Letter, “Overdose of Extended-Release Acetaminophen,” N. Engl. J. Med., 333 (1995): 196.CrossRefGoogle Scholar
Temple, A., McNeil Consumer Products Company, “Dear Doctor” (Dec. 22, 1994) (on file with authors).Google Scholar
Nelson, E. Temple, A., Letter, “Acetaminophen Hepatotoxicity, Fasting, and Ethanol,” JAMA, 274 (1995): At 301.CrossRefGoogle Scholar
See, for example, Sandler, D. Burr, F. Weinberg, C., “Nonsteroidal Anti-Inflammatory Drugs and the Risk of Chronic Renal Disease,” Annals of Internal Medicine, 115 (1991): 165–72.CrossRefGoogle Scholar
See Ronco, Flahault, , supra note 7.Google Scholar
See Perneger, Whelton, Klag, , supra note 1.Google Scholar
See Whitcomb, Block, , supra note 1.Google Scholar
“Heard by Our Editors,” Health Confidential, 9 (May 1995): At 3.Google Scholar
See Whitcomb, Sessenheim, Rakel, , supra note 43.Google Scholar
Antonio Benedi v. McNeil, No. 94-2596 (E.D. Va. 1994), aff'd, 66 F.3d 1378 (4th Cir. 1995).Google Scholar
See id. at 1381.Google Scholar
See id. at 1381–82.Google Scholar
See id. at 1382 (citing one plaintiff's expert who noted sixty reports received by McNeil, by the end of 1992 of cases of liver injury linked to consuming “therapeutic doses” of Tylenol with alcohol). See also Bates, S., “A Bitter Pill for Winner in Tylenol-Damage Suit; $5 Million Fails to Settle Va. Man's Concerns,” Washington Post, Jan. 17, 1996, at D1 (citing Hyman Zimmerman, a liver specialist at George Washington University, who testified as an expert for Dr.Zimmerman, Benedi cited about 170 reported cases of severe liver damage attributable to acetaminophen during the past two decades, of which about 20 percent were fatal.).Google Scholar
See 66 F.3d at 1382. See also Bates, , supra note 59.Google Scholar
See 66 F.3d at 1382. See also Associated Press, “Tylenol Suit Gets Man $8.8 Million,” Daily Press, Jan. 18, 1996, at C10.Google Scholar
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).Google Scholar
66 F.3d at 1383.Google Scholar
See id. at 1387–88.Google Scholar
See, for example, cases filed in 1995 and 1996 in Pennsylvania, Kentucky, Florida, . See New Service Reports, “Painkillers May Be Fatal to Some, Suits Claim,” Record (New Jersey), Jan. 17, 1996, at A12; Bosworth v. McNeil, Inc., No. A05002 1997 LEXIS 1106 (Pa. Super. Apr. 21, 1997); Jennings, M., “Tylenol, Alcohol Can Be Fatal Mixture; Suit Says Risks Weren't Disclosed,” Courier-Journal (Kentucky), June 2, 1996, 1A; and Reuters North American Wire, “Lawsuit Claims Tylenol Killed Florida Man,” Feb. 6, 1995.Google Scholar
Brennan, T.A. et al. , “Incidence of Adverse Events and Negligence in Hospitalized Patients: Results from the Harvard Medical Practice Study I,” N. Engl. J. Med., 324 (1991): 370–76.CrossRefGoogle Scholar
See Bates, et al. , supra note 30.Google Scholar
See Leape, et al. , supra note 29.Google Scholar
See Graudins, Aaron, Linden, , supra note 47.Google Scholar
See Whitcomb, Sessenheim, Rakel, , supra note 43.Google Scholar