Following the deaths of seven people who had taken poisoned Tylenol capsules, the American over-the-counter drug industry, led by Johnson & Johnson, took steps to protect consumer health and to regain public confidence.
Early in September of 1982, seven people, including a twelve-year-old child, died unexpectedly and suddenly in Chicago, Illinois. An investigation of the incident revealed that all seven were killed by sodium cyanide poisoning; the poison was found to be contained in the Extra-Strength Tylenol capsules that the victims had ingested. Cyanide is an oily, grayish, powdery substance that smells like bitter almonds and is highly toxic. An amount as small as 50 milligrams, a fraction of a teaspoon, is enough to cause almost immediate death. Tylenol was the brand name for the analgesic and fever-reducing drug acetaminophen produced by McNeil Laboratories, a subsidiary of Johnson & Johnson acquired in 1959.
Johnson & Johnson, organized by two brothers in the late 1800’s, had originally produced its products for use in the medical industry. One of its first products was a first aid kit used by railroad workers as they laid tracks across the United States. Johnson & Johnson was a responsible manufacturer of contraceptives, bandages, and sutures. The company had a rigid code of ethics, serving its customers first and employees second. Johnson & Johnson had developed a formal creed that social concern and profitability must be linked and actively devised a public image of gentleness. It was one of the most trusted companies in the world.
McNeil Laboratories produced Tylenol in 1955, shortly before the company was acquired by Johnson & Johnson. Although Tylenol was sold over-the-counter, Johnson & Johnson’s promotion for the product was limited to the medical profession. It was not until Bristol-Myers marketed Datril in 1975 that Johnson & Johnson developed a public marketing plan for Tylenol. Tylenol quickly acquired a worldwide market share of 34 percent of industry sales. In 1976, Johnson & Johnson produced Extra-Strength Tylenol, which contained 500 milligrams of pain reliever per pill and was stronger than any other pain reliever then on the market. It was expected to command a 50 percent market share by 1986.
Johnson & Johnson appointed David Collins as chairman of McNeil Consumer Products. Coordinating Johnson & Johnson’s response to the Tylenol tragedy became his responsibility, together with the chairman of the board of directors for Johnson & Johnson, James E. Burke. Collins was convinced that the company was not at fault, but no chances were to be taken with public safety. Johnson & Johnson immediately took responsibility and notified the U.S. Food and Drug Administration (FDA). The lot from which the tainted pills came was recalled, and production of Extra-Strength Tylenol was stopped until it could be determined how the poisonings occurred.
Chicago City Health Department employees test Tylenol for the presence of deadly sodium cyanide at their lab in October, 1982. Seven people died in September when they took Extra-Strength Tylenol capsules that were laced with the poison.
The recall involved thirty-one million bottles by the time it was completed and cost the company $240 million. This was an expensive move for Johnson & Johnson, but the company wanted to be sure that no additional deaths occurred from Extra-Strength Tylenol use. The company also stopped airing commercials for the product and posted a $100,000 reward for information leading to the arrest of the person or persons involved in the poisonings. Johnson & Johnson had a history of staying relatively closed to publicity, but when the Tylenol tragedy occurred, the company decided to open up to the press and the public. Its aim was to prevent any other deaths from occurring.
Johnson & Johnson set up task forces to try to save the company’s public image. Employees viewed a tape designed to improve morale. Johnson & Johnson had a right to be concerned about public attitude, given that it had spent a great deal of time and effort building its image and that the company was committed to promotion of the public good.
Johnson & Johnson knew that the poison was introduced into the product outside the plant when it was discovered that one victim had ingested Tylenol that was manufactured at a different plant in Round Rock, Texas. Investigators concluded that tampering had occurred after the product left the plants. They searched for clues as to who the terrorist was and how he or she gained access to the Tylenol. The theory that emerged was that someone removed the product from the shelf at the retail outlet, filled a few capsules with cyanide, and then returned the product to the shelf. Cyanide is a caustic. It could not have been introduced into the product by a disgruntled factory employee because of the length of time it took the product to reach the market. Cyanide would have deteriorated the gelatin coating on the capsules, making it obvious that the product was not usable.
The police followed hundreds of leads and made several arrests. One of the persons arrested was Roger Arnold, who had a penchant for chemistry, worked at a food warehouse, and had kept cyanide in his home. Also arrested were Robert and Nancy Lewis, who tried to extort one million dollars from McNeil Corporation. Even though Robert Lewis was convicted of fraud and extortion, authorities believed that Lewis had not tampered with the Tylenol; he only wanted to profit from the tampering. In the meantime, the search continued for someone who might try again with the same or another product. Authorities believed that the person responsible may have been acting on a grudge against Johnson & Johnson. At the same time, authorities were concerned about “copycat” incidents. Most food and drug products at that time offered no defense against tampering, and almost two hundred incidents were reported in the two months following the Tylenol poisonings. Some of these involved eyedrops contaminated with bleach and acid; others involved cooking oil and laxatives contaminated with paint thinner. Although the search for the terrorists continued, real leads never emerged.
Johnson & Johnson was left with several problems. It had to prevent tampering from occurring again, fight off lawsuits filed because of the deaths, and reestablish Extra-Strength Tylenol as a safe product in consumers’ minds.
In the days following the Tylenol-related deaths, Johnson & Johnson’s major concerns were removing the product from store shelves in an attempt to prevent more deaths and trying to discover where the cyanide entered the system. Once the product had been removed from shelves and the initial danger eliminated, Johnson & Johnson executives began to try to salvage the Tylenol brand. Johnson & Johnson remarketed Extra-Strength Tylenol in January of 1983 in new tamper-proof packaging. The package had triple seals and a warning to consumers not to use the product if any seals were broken or damaged. Johnson & Johnson offered to replace any Tylenol packages that had been thrown away and established a toll-free telephone number for that purpose. Johnson & Johnson also offered coupons good for $2.50 toward the purchase of Tylenol to encourage consumers to try the product. Although the odds were against Johnson & Johnson, the company worked hard to restore consumer trust in its products. Attempts included sixty-second advertising spots featuring McNeil’s medical director, Thomas Gates.
Other companies had suffered huge losses in similar situations in the past. Procter & Gamble
The real horror, however, was that most foods and drugs were not protected against tampering. The FDA formed a committee to develop standards for tamper-resistant packaging. Other companies, such as Kraft, Borden, and Procter & Gamble, were forced to review their packaging practices. Some of the preventive safety measures used were tight plastic bands or shrink wraps, vacuum seals, and blister packages. Nonprescription drug companies requested tougher packaging laws, with an estimated cost to the industry of about $6 billion per year. The long-range impact was that all companies producing over-the-counter drugs and some food companies would be required to develop tamper-proof packaging for their products. Marketing experts believed that safer packaging measures would ultimately cost consumers price increases of 1 to 2 percent. Some packaging companies would increase their business by 60 to 70 percent.
The Tylenol poisonings also encouraged some companies to alter their products to make them more difficult to contaminate. Many drug companies, for example, stopped selling their products in the form of capsules, which could be opened; rather, they offered solid “caplets” as an alternative to tablet forms.
Food is harder to contaminate than many drugs because people generally swallow medications in pill form without tasting them. Nevertheless, the food industry was greatly affected by the deaths. Copycat tampering continued, even with products already using tamper-proof packaging. Gerber Products had been using bubble tops on baby food for more than twenty years, yet there were reports of glass fragments in as many as 250 Gerber jars. Gerber had to recall more than forty thousand jars of baby food. There were also reports of urea in Gatorade soft drinks in California and hundreds of reports of pins, needles, and other foreign objects in Girl Scout cookies. Tampering was not limited to the United States; poisonings were reported also in Japan and Great Britain. A long-range effect of the Tylenol deaths was that other types of industries began to develop tamper-proof, tamper-resistant, and tamper-evident packaging, especially in the food industry.
-
Beck, M. “The Tylenol Scare.” Newsweek, October 11, 1982, 32-36. Gives detailed information about the Tylenol deaths, including names and relationships of the victims, background information about the days following the deaths, and information about how the deaths were traced to Tylenol. Contains pictures of the victims, diagrams showing the product distribution chain, and an inset explaining cyanide and its effects. -
Church, G. J. “Murder by Remote Control.” Time, October 18, 1982, 16-19. A continuation of the Tylenol report containing information about where additional poisoned capsules were found. Contains an inset outlining the personality of someone who might be guilty of poisoning Tylenol. -
Gardner, Judith. “When a Brand Name Gets Hit by Bad News.” U.S. News & World Report, November 8, 1982, 71. Outlines the steps to save the Tylenol brand. Discusses the impact of other product disasters on the companies involved. -
Kessler, Felix. “Tremors from the Tylenol Scare Hit Food Companies.” Fortune, March 31, 1986, 59. Discusses the vulnerability of foods and describes particular poisoning scares and product recalls. Points to safety measures being taken to protect consumers from copycat poisonings. -
Koepp, Stephen. “A Hard Decision to Swallow.” Time, March 3, 1986, 59. Discusses the change from capsules to caplets that Tylenol underwent after the second rash of poisonings. Also discusses the resulting cost to Johnson & Johnson and the impact on other drug companies. Contains a picture of Chairman James Burke holding an oversized caplet. -
Skrzycki, Cindy, with Dan Collins and Manuel Schiffres. “Tampering with Buyers’ Confidence.” U.S. News & World Report, March 3, 1986, 46-47. Highlights what companies have done to safeguard their products from tampering. Illustrations show consumers what to look for to determine if a product has been tampered with. An inset contains an interview with Johnson & Johnson chairman James Burke. -
Spiro, Peter. “Chaos by the Capsule: The Consumer’s Nightmare.” The New Republic, December 6, 1982, 10-11. Short article discussing copycat poisoning as a possible American trend. Points out how quickly American consumers lose faith in a product and how this sometimes borders on hysteria. -
Sturdivant, Frederick, and James D. Stacey, eds. The Corporate Social Challenge: Cases and Commentaries. 7th ed. New York: McGraw-Hill, 2000. Contains a case that provides excellent background for the original Tylenol episode. Also contains cases and commentaries on the ethical responsibility of businesses, consumer welfare, and the environment. Contains a bibliography with more than three hundred entries as well as a complete index. Excellent for the college-level researcher of corporate social responsibility. -
Trafford, Abigail, James Mann, and Alex Kucherov. “Lessons That Emerge from Tylenol Disaster.” U.S. News & World Report, October 18, 1982, 67-68. Highlights sales information for Tylenol. Graphs and diagrams indicate the market share of painkillers as compared to other over-the-counter drugs. Also indicates what measures may be taken to prevent future poisonings.
Nixon Signs Law to Protect Consumer Safety
U.S. Congress Requires Product Warranties
Consumer Product Safety Commission Bans Lead Paints
FDA Approves the First Cholesterol-Lowering Drug
FDA Approves Prozac as an Antidepressant
Bridgestone/Firestone Announces Massive Recall