The Tylenol Mafia (28 page)

Throughout the entire crisis, Johnson & Johnson kept reporters at bay, handling their questions only over the telephone. Yet J&J is widely portrayed as having been extraordinarily available to the press. In November 2002, Jack O’Dwyer, of O’Dwyer PR, called for some accuracy in the way J&J’s handling of the Tylenol crisis is portrayed in the media and taught in universities. What sparked his ire was an amicus brief filed by the law firm,
Debevoise
& Plimpton, on behalf of five public relations groups. The amicus brief has a fatal flaw, said O’Dwyer. It cited Johnson & Johnson’s handling of the Tylenol murders in 1982 as an example of ideal communication. The brief said, “Johnson & Johnson maintained an open dialogue with the press and public throughout the crisis.” It went on to state that the company’s “forthrightness with the public not only saved the Tylenol brand and perhaps even J&J itself, it [also] contributed to the way American consumer goods are packaged and labeled to be tamper-resistant.”

O’Dwyer sees it quite differently. Johnson & Johnson was not that open and forthright at all, he says. The Company never held a press conference, but rather chose to handle some 1,500 press calls on an individual basis. “Probably nearly all of these were phone calls,” O’Dwyer says. “Who knows what J&J told or didn’t tell these individual reporters?” Johnson & Johnson’s public stance was that it had no special knowledge of the case and, therefore, had nothing to say to reporters in a press conference, said O’Dwyer. When J&J was ready to re-launch Tylenol in its new tamper resistant packaging, Burke hit the talk show circuit and held three open teleconferences. However, back in early October, when the murders were front-page news almost every day, J&J held no press conferences.

Prior to re-launching Tylenol in tamper-resistant packaging, Burke hosted a pep rally for 2,259 sales representatives. He exhorted them to call on physicians and pharmacists and win back Tylenol’s market share. By year’s end, J&J sales representatives had made more than a million such presentations to promote the reintroduction of Tylenol. J&J gave out $2.50-off coupons toward the purchase of any Tylenol product. McNeil sales reps recovered former stock levels of Tylenol by implementing an off-invoice pricing program that provided retail companies with discounts linked to wholesale purchasing patterns that had been established prior to October 1982. These discounts, known as performance-based rebates, went as high as 25 percent. J&J began running commercials on October 24, 1982, to promote the upcoming launch of Tylenol in tamper-resistant packaging.

“We ran a series of campaigns that said, ‘trust us,’” recalled Larry Foster. “We don’t know what the answer is to this tragedy, but trust us. As soon as we find out what it is, we will tell you.” McNeil Medical Director, Dr. Thomas Gates, appeared in the commercials telling the public, “We want you to continue to trust Tylenol.”

For Burke, the tamper-resistant packaging provided a great opportunity to gain a competitive edge. In a world where consumers had suddenly taken a keen interest in how OTC medicines were packaged, J&J was the first company to sell OTC analgesics in tamper-resistant packages. The new packaging appeared in select markets on November 11, 1982, and was on store shelves nationwide in December. For safety conscious shoppers, the only OTC analgesic in tamper-resistant packaging on the market from late 1982 to early 1983 was Tylenol.

In mid-November 1982, the FDA ran a “public-service” ad in newspapers across the country to ease consumer fears about adulterated OTC drugs. Printed in bold type at the top of the ad was a heading that read: “A Public Service announcement about over-the-counter medicine.” The subtitle read, “From Dr. Arthur H. Hayes, Commissioner, U.S. Food and Drug Administration.” The entire body of the ad was a personal commentary from Arthur Hayes, covering off on Johnson & Johnson’s talking points, namely, that the tamperings could not have been anticipated and were done by a madman at the retail stores.

The poisonings were “a criminal tampering of medicine on store shelves,” wrote Hayes. “We’ve all been shocked by the incident.” Hayes called Tylenol an “innocent product,” and reinforced the message that the tamperings were the actions of a madman, stating, “We can’t guarantee protection against everything that a sick mind might think of.” Like any good salesperson, Hayes closed his sales pitch by asking for the business. “We don’t have to do without the medicines that make our lives more comfortable,” he assured consumers.

The New York Times
reported on December 24, 1982, that Tylenol had regained 24 percent of the market for pain relievers, not too far off the 37 percent share the product had held before the crisis. Within a year, sales had returned to their pre-crisis level. Johnson & Johnson emerged from the Tylenol tampering incident more highly regarded than ever before. J&J had never actually addressed the real problem underscored with horrific clarity by the Tylenol murders. Johnson & Johnson put a band-aid on that problem by re-launching Tylenol in tamper-resistant packaging, rather than doing away with the unsealed capsules.

In 1984, Johnson & Johnson tested, but then rejected a system of sealing capsules shut. Robert Kniffin said the company had great hopes for the “
Soniseal
” machine, manufactured by the R.P. Scherer Corporation. Ultimately, J&J decided against using this new technique, saying it found the system wanting. “We found some incidences of leaking in which loose powder would fall to the bottom of the bottle in shipment,” Kniffin said. “Also, we felt that in some instances the capsule could be disassembled without destroying the capsule.”

The Sterling Drug company had been using the Scherer system since September 1984 to manufacture its brand of acetaminophen capsules,
Panadol
, and had experienced no such problems. “To my knowledge we’ve had no adverse reports from customers with regard to cracked or broken capsules,” commented Sterling spokesperson, Terry Kelley.

J&J had been aware of the tampering risk associated with capsules long before the Tylenol murders. Some pharmacists had refused to stock OTC drugs in capsule form. The problem they said was not with the Tylenol analgesic or the packaging, but with the capsule itself, which could easily be taken apart and “spiked.” Tamper-resistant packaging would have done nothing to thwart the Tylenol murders though, because the killer had put cyanide into the capsules
before
they were packaged and delivered to local outlets.

In late October 1982, Dr. Barry Rumack, the director of the Rocky Mountain Poison Control Center, called for an end to the use of capsules. “I believe it is time we remove all products made in capsules from sale,” said Rumack. “It’s too easy to contaminate them.”

Bruce Pfaff, an attorney for some of the Tylenol victims’ families said the issue of tampering was a common subject in trade journals of the packaging industry for 10 years or more before the Tylenol poisonings in 1982.

In February of 1986, FDA Public Information Officer, William Grigg, said that since the seven Tylenol poisoning deaths in 1982, there had been several incidents in which people were poisoned by OTC capsules. Grigg said he did not know how many of these cases involved Tylenol, but he did say that he believed some of them had turned out to be suicides. But how many were murders instead?

The Tylenol brand quickly recovered from the brief drop in sales that followed the Tylenol murders. Three years later, annual sales of Tylenol had grown by 13 percent. About 30 percent of those Tylenol sales were from Tylenol capsules. In 1985, Tylenol accounted for about 15 percent of Johnson & Johnson’s earnings and about $525 million of its total sales of $6.1 billion.

The Tylenol business was very good, and consumers never suspected that the cyanide-laced Tylenol capsules that caused at least seven deaths on September 29, 1982, had actually been planted in an Illinois warehouse. However, some of the evidence buried during the Tylenol murders’ investigation would be unearthed almost three decades later, providing important clues about the Tylenol killers’ true modus operandi. New evidence also emerged in February 1986, when Johnson & Johnson found itself in the midst of yet another Tylenol crisis. The “Chicago nightmare” had come back to haunt James Burke; but this time the crisis was centered in New York City
.

28

________

On Friday, February 7, 1986, Johnson & Johnson executives received good news. Tylenol had captured its largest share ever of the OTC analgesic market. Chairman James Burke worried that things were going almost too well. This foreboding apprehension stayed with him even after the workday ended.

That evening, 23-year-old Diane Elsroth left the Manhattan real-estate firm where she worked as a stenographer and drove through light snow to the home of her boyfriend, Michael Notarnicola, in Yonkers, New York. She planned to spend the weekend there with Michael and his parents, Harriet and John. Diane and Michael had been dating for about three years, and they were unofficially engaged. Michael’s parents were “crazy about” Diane.

Michael and Diane spent Friday night watching television in the ground-floor den of the Notarnicolas’ split-level home until after midnight. At about 1 a.m., Diane said she wasn’t feeling well. Michael went into the kitchen and found an unopened bottle of Extra-Strength Tylenol capsules in the pantry. He tore open the box, ripped off the plastic shrink-wrap, and removed the lid. He then poked a hole into the metal foil that covered the mouth of the bottle and tore it open. He fished out the cotton ball inside the bottle, poured out two capsules and then brought them into the den. Diane took the capsules from Michael’s hand and went off to bed in the Notarnicola’s guest room.

Meanwhile, across the Hudson River, in Princeton, New Jersey, James Burke tossed and turned. Although the Tylenol comeback had been “absolutely brilliant,” there were still nights when the Chicago nightmare crept back into Burke’s normally peaceful slumber. After sleepless nights on the first two anniversaries of the Chicago poisonings, his anxieties had been largely relieved by the “hugely successful comeback of the business; the highest market share in its history, highest sales, highest profits - all in the face of five new competitors.” Burke said he had almost convinced himself that there would never be another tampering incident like the one in Chicago. Still, he worried.

Early Saturday afternoon, when Diane Elsroth missed breakfast and then did not appear for lunch, the Notarnicola family looked in on her. At 1:34 p.m., they called the Yonkers police. Diane Elsroth was dead. Shortly after the paramedics arrived, Mrs. Notarnicola picked up the bottle of Tylenol sitting on the kitchen countertop and swallowed one capsule. By sheer luck of the odds, she avoided the three remaining cyanide-filled capsules still inside that bottle.

Back across the Hudson, Burke went to bed Saturday night looking forward to the Johnson & Johnson earnings call set for Tuesday morning when the company would release its 1985 financial results, including record sales for Tylenol. As Burke drifted off to sleep, his pleasant thoughts of record profits were displaced by the Chicago nightmare. That night he dreamed that the Tylenol poisonings were happening all over again.

On Sunday morning, West Chester County toxicologist, Joan Vogel, removed the lid from the Tylenol bottle recovered from the Notarnicola home. She took a whiff and smelled the telltale scent of bitter almonds.
It’s Chicago all over again
, she thought.

Monday, February 10, 1986

The police returned to the Notarnicolas’ house on Monday and retrieved the outer cardboard box and packaging for the Tylenol bottle and a sales slip showing that the bottle of Extra Strength Tylenol capsules had been purchased about a week earlier from an A&P store in Bronxville, New York. The poisoned Tylenol was in a 24-count bottle of Extra Strength Tylenol capsules from Lot ADF916, and had been manufactured at the McNeil plant in Fort Washington, Pennsylvania. The lot code format had changed somewhat since 1982. Now the first three digits of the lot codes were alpha characters, and the last three digits were numerical. The first and second digit represented the year and month of manufacture, respectively. The third digit identified the plant where the Tylenol was produced. The last three numeric digits represented the batch number.

Since November 1982, Tylenol had been packaged in three layers of tamper-resistant packaging. The Tylenol capsules were sold in packages labeled “safety sealed.” The outer carton was sealed with a “hot-melt” adhesive. The cardboard was thin gauge, so that the flaps, sealed with the permanent adhesive, could not be opened without ripping the box. The cap was sealed to the lip of the bottle with a plastic band that was “heat shrunk” for a tight fit and had to be torn away to be removed. Underneath the cap, an aluminum foil seal was laminated to the lip of the bottle.

Harriet Notarnicola, Michael’s mother, had purchased the Tylenol at the Bronxville
A&P
store on Tuesday, February 4, 1986. She later testified that the package did not appear out of the ordinary in any way, i.e., she saw no evidence that there had been any product tampering. When she returned home after buying the Tylenol, she had placed the unopened box in her food pantry. Michael also later testified that he noticed nothing unusual about the packaging; the flaps to the box were glued shut, the shrink seal did not appear to be disturbed, and the foil seal further securing the capsules had not been broken.

At 4 p.m. Monday afternoon, J&J President David Clare entered Burke’s office. “Jim,” he said, “We have a serious problem.”