Acetaminophen (Tylenol): Johnson & Johnson and Consumer Safety

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.

Garnett L. , “Strong Medicine,” Harvard Health Letter, 20 (1995): 4–6.

Arky R. , Physicians' Desk Reference (Montvale: Medical Economies Data Production, 1995): At 2366.

Bradley J. , “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.

See Perneger Whelton Klag , supra note 1.

See Whitcomb Block , supra note 1.

Ronco P.M. Flahault A. Editorial , “Drug Induced End Stage Renal Disease,” N. Engl. J. Med., 331 (1994): 1711–12.

Strom B.L. , Editorial, “Adverse Reactions to Over-the-Counter Analgesics Taken for Therapeutic Purposes,” JAMA, 272 (1994): 1866–67.

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.

See id. at 12 (citing “A Painful Headache for Bristol-Myers?,” Business Week, Oct. 6, 1975, at 78).

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).

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).

See id. at 12–13 (citing “A Pained Bayer Cries ‘Foul,”’ Business Week, July 25, 1977, at 142).

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).

See id. at 13–14.

See id. at 14 (citing Wall Street Journal, Sept. 2, 1982, at 12).

See id. at 14.

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).

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.

See Tedlow Smith (9-390-030), supra note 19, at 3–4.

See id. at 4.

See id. at 3–5.

See, for example, Bernstein J. , “How to Handle, and Not to Handle, a Public Relations Crisis,” Newsday Sunday, Aug. 13, 1995, at 5.

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).

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.

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.

See Tedlow Smith (9-390-030), supra note 19, at 10–11.

See id. at 11.

Leape L.L. , “System Analysis of Adverse Drug Events,” JAMA, 274 (1995): 35–43.

Bates D. , “Relationship Between Medication Errors and Adverse Drug Events,” Journal of General Internal Medicine, 10 (1995): 199–205.

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.

Kahn K. , “Above All Do No Harm: How Shall We Avoid Errors in Medicine?,” JAMA, 274 (1995): 75–76.

Nordenberg T. , “The Center for Drug Evaluation and Research,” FDA Consumer, 30 (1996): 30–31.

See, for example, Tomkieviez S. , “How Far Can You Trust Generics,” Wellness Letter, 11 (Dec. 1994): At 7.

Clive D.M. Stoff J.S. , “Renal Syndromes Associated with Nonsteroidal Antiinflammatory Drugs,” N. Engl. J. Med., 310 (1984): At 563, 567.

See id. at 568–69.

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.

See Clive Stoff , supra note 35, at 566–67.

See Marasco Gikas , supra note 37

Colburn D. , “How Safe is Tylenol?,” Washington Post, Nov. 1, 1994, at 10.

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).

See Colburn , supra note 40.

Whitcomb D. Sessenheim D.M. Rakel J. , “Management of Acetaminophen Ingestion in the Outpatient Setting,” Journal of Clinical Overcomes Management, 2 (1995): 37–42.

See Johnson Johnson , “Statement on Acetaminophen Paper in JAMA,” supra note 41; and Johnson Johnson , “OTC Pain Killers and Kidney Disease,” supra note 41.

Whitehall Laboratories, “Some Things to Consider If You Take Acetaminophen” (1992) (on file with authors).

See id.

Graudins A. Aaron C.K. Linden C.H. , Letter, “Overdose of Extended-Release Acetaminophen,” N. Engl. J. Med., 333 (1995): 196.

Temple A. , McNeil Consumer Products Company, “Dear Doctor” (Dec. 22, 1994) (on file with authors).

Nelson E. Temple A. , Letter, “Acetaminophen Hepatotoxicity, Fasting, and Ethanol,” JAMA, 274 (1995): At 301.

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.

See Ronco Flahault , supra note 7.

See Perneger Whelton Klag , supra note 1.

See Whitcomb Block , supra note 1.

“Heard by Our Editors,” Health Confidential, 9 (May 1995): At 3.

See Whitcomb Sessenheim Rakel , supra note 43.

Antonio Benedi v. McNeil, No. 94-2596 (E.D. Va. 1994), aff'd, 66 F.3d 1378 (4th Cir. 1995).

See id. at 1381.

See id. at 1381–82.

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 Zimmerman Benedi Dr. cited about 170 reported cases of severe liver damage attributable to acetaminophen during the past two decades, of which about 20 percent were fatal.).

See 66 F.3d at 1382. See also Bates , supra note 59.

See 66 F.3d at 1382. See also Associated Press, “Tylenol Suit Gets Man $8.8 Million,” Daily Press, Jan. 18, 1996, at C10.

Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

66 F.3d at 1383.

See id. at 1387–88.

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.

Brennan T.A. , “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.

See Bates , supra note 30.

See Leape , supra note 29.

See Graudins Aaron Linden , supra note 47.

See Whitcomb Sessenheim Rakel , supra note 43.