Acetaminophen (Tylenol): Johnson & Johnson and Consumer Safety

Journal of Law, Medicine and Ethics

Volumn 25, Issue 1, 1997, Pages 49-57

  Trinkhaus, John ^a   Nathan, Jay ^a   Beane, Leona ^a   Meltzer, Barton ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; PARACETAMOL;

CHEMICALLY INDUCED DISORDER; CHRONIC KIDNEY FAILURE; DRUG CONTROL; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; INFORMATION DISSEMINATION; JOHNSON AND JOHNSON; LEGAL ASPECT; LEGAL LIABILITY; LIVER DISEASE; PROFESSIONAL PATIENT RELATIONSHIP; REVIEW; RISK ASSESSMENT; SAFETY; UNITED STATES;

JOHNSON AND JOHNSON; PROFESSIONAL PATIENT RELATIONSHIP;

ACETAMINOPHEN; ANALGESICS, NON-NARCOTIC; CONSUMER PRODUCT SAFETY; DRUG AND NARCOTIC CONTROL; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; HUMANS; INFORMATION DISSEMINATION; KIDNEY FAILURE, CHRONIC; LIABILITY, LEGAL; LIVER DISEASES; RISK ASSESSMENT; UNITED STATES;

EID: 0031082356     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1997.tb01396.x     Document Type: Article

References (80)

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2. T.V. Perneger, P.K. Whelton, and M.J. Klag, "Risk of Kidney Failure Associated with the Use of Acetaminophen, Aspirin, and Nonsteroidal Antiinflammatory Drugs," N. Engl. J. Med., 331 (1994): 1675-79; and D.C. Whitcomb and G.D. Block, "Association of Acetaminophen Hepatotoxicity with Fasting and Ethanol Use," JAMA, 272 (1994): 1845-50.
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6. See Perneger, Whelton, and Klag, supra note 1.
7. See Whitcomb and Block, supra note 1.
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11. See id. at 12 (citing "A Painful Headache for Bristol-Myers?," Business Week, Oct. 6, 1975, at 78).
12. See id. (citing D. Kneale, "Remedy Ruckus: Tylenol, the Painkiller, Gives Rivals Headache in Store and in Court," Wall Street Journal, Sept. 2, 1982, at 12).
13. See id. (citing W. Power, "A Judge Prescribes a Dose of Truth to Ease the Pain of Analgesic Ads," Wall Street Journal, May 13, 1987, at 33).
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16. 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).
17. See id. at 13-14.
18. See id. at 14 (citing Wall Street Journal, Sept. 2, 1982, at 12).
19. See id. at 14.
20. 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).
21. See id. at 11, 15; and R. Tedlow and W. Smith, "James Burke: A Career in American Business (B)," Harvard Business School Case Study 9-390-030 (Cambridge: Harvard Business School, 1989): at 1-3.
22. See Tedlow and Smith (9-390-030), supra note 19, at 3-4.
23. See id. at 4.
24. See id. at 3-5.
25. See, for example, J. Bernstein, "How to Handle, and Not to Handle, a Public Relations Crisis," Newsday Sunday, Aug. 13, 1995, at 5.
26. See Tedlow and Smith (9-390-030), supra note 19, at 6 (citing E. Sanger, "Can That Be Sterling Stirring?," Barron's, Sept. 12, 1983, at 13).
27. See id. at 6 (citing M. Waldholz, "Speedy Recovery: Tylenol Regains Most of No. 1 Market Share, Amazing Doomsayers," Wall Street Journal, Dec. 24, 1982, at 1). For additional comments on factors contributing to Tylenol's speedy recovery, see: R. Barker, "Picture of Health: Johnson & Johnson Seems to Have Cured What Ailed It," Barron's, Mar. 30, 1987, at 15; T. Moore, "The Fight to Save Tylenol: The Inside Story of Johnson & Johnson's Struggle to Revive Its Most Important Product," Fortune, Nov. 29, 1982; and W. Powell and M. Kastendorf, "Tylenol Rescue: J and J Rushes to Limit the Corporate Damage," Newsweek, Mar. 3, 1986, at 52.
28. See id. at 6 (citing M. Waldholz, "Speedy Recovery: Tylenol Regains Most of No. 1 Market Share, Amazing Doomsayers," Wall Street Journal, Dec. 24, 1982, at 1). For additional comments on factors contributing to Tylenol's speedy recovery, see: R. Barker, "Picture of Health: Johnson & Johnson Seems to Have Cured What Ailed It," Barron's, Mar. 30, 1987, at 15; T. Moore, "The Fight to Save Tylenol: The Inside Story of Johnson & Johnson's Struggle to Revive Its Most Important Product," Fortune, Nov. 29, 1982; and W. Powell and M. Kastendorf, "Tylenol Rescue: J and J Rushes to Limit the Corporate Damage," Newsweek, Mar. 3, 1986, at 52.
29. See id. at 6 (citing M. Waldholz, "Speedy Recovery: Tylenol Regains Most of No. 1 Market Share, Amazing Doomsayers," Wall Street Journal, Dec. 24, 1982, at 1). For additional comments on factors contributing to Tylenol's speedy recovery, see: R. Barker, "Picture of Health: Johnson & Johnson Seems to Have Cured What Ailed It," Barron's, Mar. 30, 1987, at 15; T. Moore, "The Fight to Save Tylenol: The Inside Story of Johnson & Johnson's Struggle to Revive Its Most Important Product," Fortune, Nov. 29, 1982; and W. Powell and M. Kastendorf, "Tylenol Rescue: J and J Rushes to Limit the Corporate Damage," Newsweek, Mar. 3, 1986, at 52.
30. See id. at 6 (citing M. Waldholz, "Speedy Recovery: Tylenol Regains Most of No. 1 Market Share, Amazing Doomsayers," Wall Street Journal, Dec. 24, 1982, at 1). For additional comments on factors contributing to Tylenol's speedy recovery, see: R. Barker, "Picture of Health: Johnson & Johnson Seems to Have Cured What Ailed It," Barron's, Mar. 30, 1987, at 15; T. Moore, "The Fight to Save Tylenol: The Inside Story of Johnson & Johnson's Struggle to Revive Its Most Important Product," Fortune, Nov. 29, 1982; and W. Powell and M. Kastendorf, "Tylenol Rescue: J and J Rushes to Limit the Corporate Damage," Newsweek, Mar. 3, 1986, at 52.
31. See Tedlow and Smith (9-390-030), supra note 19, at 8-9. See also R. McFadden, "Makers of Tylenol Discontinuing All Over-Counter Drug Capsules," New York Times, Feb. 18, 1986, at 1, B4.
32. See Tedlow and Smith (9-390-030), supra note 19, at 10-11.
33. See id. at 11.
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36. D. Bates, G. Kuperman, and J. Teich, "Computerized Physician Order Entry and Quality of Care," Quality Management in Health Care, 2, no. 4 (1994): 18-27; and S. Bates, "Tylenol Verdict Puts Spotlight on Drug Labels," Washington Post, Oct. 22, 1994, at A1.
37. D. Bates, G. Kuperman, and J. Teich, "Computerized Physician Order Entry and Quality of Care," Quality Management in Health Care, 2, no. 4 (1994): 18-27; and S. Bates, "Tylenol Verdict Puts Spotlight on Drug Labels," Washington Post, Oct. 22, 1994, at A1.
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40. See, for example, S. Tomkieviez, "How Far Can You Trust Generics," Wellness Letter, 11 (Dec. 1994): at 7.
41. D.M. Clive and J.S. Stoff, "Renal Syndromes Associated with Nonsteroidal Antiinflammatory Drugs," N. Engl. J. Med., 310 (1984): at 563, 567.
42. See id. at 568-69.
43. See id. at 563. See also, W.P. Marasco and R. Gikas, "Ibuprofen-Associated Renal Dysfunction: Pathophysiologic Mechanisms of Acute Renal Failure, Hyperkalemia, Tubular Necrosis, and Proteinuria," Archives of Internal Medicine, 147 (1987): 2107-16.
44. See Clive and Stoff, supra note 35, at 566-67.
45. See Marasco and Gikas, supra note 37
46. D. Colburn, "How Safe is Tylenol?," Washington Post, Nov. 1, 1994, at 10.
47. 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).
48. 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).
49. See Colburn, supra note 40.
50. D. Whitcomb, D.M. Sessenheim, and J. Rakel, "Management of Acetaminophen Ingestion in the Outpatient Setting," Journal of Clinical Overcomes Management, 2 (1995): 37-42.
51. See Johnson & Johnson, "Statement on Acetaminophen Paper in JAMA," supra note 41; and Johnson & Johnson, "OTC Pain Killers and Kidney Disease," supra note 41.
52. See Johnson & Johnson, "Statement on Acetaminophen Paper in JAMA," supra note 41; and Johnson & Johnson, "OTC Pain Killers and Kidney Disease," supra note 41.
53. Whitehall Laboratories, "Some Things to Consider If You Take Acetaminophen" (1992) (on file with authors).
54. See id.
55. A. Graudins, C.K. Aaron, C.H. Linden, Letter, "Overdose of Extended-Release Acetaminophen," N. Engl. J. Med., 333 (1995): 196.
56. A. Temple, McNeil Consumer Products Company, "Dear Doctor _" (Dec. 22, 1994) (on file with authors).
57. E. Nelson and A. Temple, Letter, "Acetaminophen Hepatotoxicity, Fasting, and Ethanol," JAMA, 274 (1995): at 301.
58. See, for example, D. Sandler, F. Burr, and C. Weinberg, "Nonsteroidal Anti-Inflammatory Drugs and the Risk of Chronic Renal Disease," Annals of Internal Medicine, 115 (1991): 165-72.
59. See Ronco and Flahault, supra note 7.
60. See Perneger, Whelton, and Klag, supra note 1.
61. See Whitcomb and Block, supra note 1.
62. "Heard by Our Editors," Health Confidential, 9 (May 1995): at 3.
63. See Whitcomb, Sessenheim, and Rakel, supra note 43.
64. Antonio Benedi v. McNeil, No. 94-2596 (E.D. Va. 1994), aff'd, 66 F.3d 1378 (4th Cir. 1995).
65. See id. at 1381.
66. See id. at 1381-82.
67. 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 S. Bates, "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 Benedi. Dr. Zimmerman cited about 170 reported cases of severe liver damage attributable to acetaminophen during the past two decades, of which about 20 percent were fatal.).
68. See 66 F.3d at 1382. See also Bates, supra note 59.
69. See 66 F.3d at 1382. See also Associated Press, "Tylenol Suit Gets Man $8.8 Million," Daily Press, Jan. 18, 1996, at C10.
70. Daubert v. Merrell Dow Pharmaceutical, Inc., 509 U.S. 579 (1993).
71. 66 F.3d at 1383.
72. See id. at 1387-88.
73. See for example, cases filed in 1995 and 1996 in Pennsylvania, Kentucky, and 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); M. Jennings, "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.
74. See for example, cases filed in 1995 and 1996 in Pennsylvania, Kentucky, and 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); M. Jennings, "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.
75. See for example, cases filed in 1995 and 1996 in Pennsylvania, Kentucky, and 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); M. Jennings, "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.
76. T.A. Brennan 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.
77. See Bates et al., supra note 30.
78. See Leape et al., supra note 29.
79. See Graudins, Aaron, and Linden, supra note 47.
80. See Whitcomb, Sessenheim, and Rakel, supra note 43.