The Tylenol Mafia (7 page)

Foster had a reputation of being honest, fair, and ethical, according to public relations experts cited in a case study about the Tylenol crisis. These PR experts thus concluded that Foster’s false statement denying McNeil’s use of cyanide in making Tylenol, while embarrassing, was not a purposeful attempt by Foster to cover anything up. Yet, when the Associated Press reporter who first learned about the use of cyanide in making Tylenol called Foster to confirm this fact, Foster asked him to bury the story. The reporter agreed, stating that he would not run the story unless some other news outlet uncovered the same facts.

It wasn’t long before another reporter, this time from
The Newark Star Ledger
, called Foster to confirm the same information about McNeil’s use of cyanide. Foster also persuaded that reporter to bury the story. It was only after Foster received a call from
The New York Times
that he finally gave up.

In 2002, during an interview at his alma mater, Pennsylvania State University, Foster recounted his cyanide slip-up in a much more favorable light. When asked if he would have done anything differently during the Tylenol crisis, Foster responded:

There was one, the only one time that I gave some misinformation to the press inadvertently, was when I was asked if there was any [cyanide] on the manufacturing site in Pennsylvania where the product was made. I said no, there was
no[
ne], because I had asked that question and was told no. However, in a research lab on the same site, different building, there was a small amount of cyanide - and when I realized I had made the mistake I called the New York Times, and they called the AP and told them frankly, that I gave them the wrong information. They accepted that and ran it very low in the story, the next day’s story, about the misinformation. That’s one thing I think I would have done differently.

On the same day the story of J&J’s erroneous statement regarding the use of cyanide was barely mentioned in the news media; newspapers across the country ran the following statement from Larry Foster:

This is a tragic thing [the Tylenol murders]. Our response is simply that we will continue to be completely honest. The quality of the product will survive this. You can’t indict the whole product. The public is intelligent enough not to do that.

Johnson & Johnson’s public relations team already had the news media and the general public on their side when Chicago police detectives were called to the scene of another suspicious death, this time on Chicago’s North Side.

Paula Prince, a 35-year-old flight attendant, had returned to Chicago’s O’Hare International Airport Wednesday evening, September 29
^th
, after a layover out east. On her drive home, she had stopped off at the Walgreens store on the corner of North Wells Street and North Avenue on Chicago’s North Side and bought a bottle of Extra Strength Tylenol capsules. She then made the short drive to her high-rise apartment on LaSalle Avenue. Once inside her seventh floor apartment, Paula got out of her flight attendant uniform and into a soft robe. She called a friend in her hometown of Omaha, Nebraska, and left a message on her answering machine. Then she went into the bathroom, swallowed one Extra Strength Tylenol capsule, opened a bottle of cold cream, and began removing her make-up.

Paula had the following day off, so she wasn’t missed until she failed to show up for work Friday afternoon. Her sister became concerned and drove to her apartment to check on her. With a spare key, she unlocked the door and then entered the apartment where she soon found Paula’s body lying on the bathroom floor. A bottle of Extra Strength Tylenol capsules was sitting on the vanity. One capsule from the 24-count bottle was missing.

Chicago Police were called to Prince’s apartment at about 5:00 p.m. Friday evening. They took possession of the Tylenol bottle and then rummaged around the apartment until they found the receipt showing that Paula had purchased the Tylenol at the nearby Walgreens store. Later, while viewing video footage from a security camera mounted above the automatic teller machine in that Walgreens store, police found a photo of Paula Prince paying for her bottle of Extra Strength Tylenol. The camera had automatically snapped the picture at about 9 p.m. Wednesday night, when someone withdrew cash from the teller machine.

Chicago Police Superintendant, Richard Brzeczek, said one of the remaining twenty-three capsules in Prince’s bottle contained cyanide, but six others were slightly discolored. The moisture from the two cyanide-laced capsules had leached onto six of the surrounding capsules, causing them to corrode slightly. The Tylenol in Prince’s bottle was from Lot 1801MA, and had been manufactured at the McNeil plant in Round Rock, Texas. This Tylenol, like the Tylenol involved in all the other poisonings, had been shipped to a warehouse in Illinois from Johnson & Johnson’s regional distribution center in Montgomeryville, Pennsylvania. Paula Prince was the seventh and final victim authorities linked to the Tylenol murders.

Chicago Mayor Jane Byrne held a news conference late Friday night after learning about the death of Paula. Byrne asked all city residents to turn in their Tylenol to local police stations, along with a note detailing where and when it was purchased. “Don’t take Tylenol,” she warned, “not even tablet or liquid form.”

Byrne’s warning scrolled across the television screens of nearly 8 million Chicago-area viewers over the weekend. The televised announcement apparently had an impact, not only in Chicago, but also in the Chicago suburbs. By late Saturday afternoon, more than 1,500 bottles of Tylenol products had been turned in to Chicago’s northwest suburban police stations.

Cook County Medical Examiner, Dr. Robert Stein, also addressed the press during Mayor Byrne’s Friday night news conference. Stein described the early results of tests being conducted to detect approximately when the adulterated Tylenol capsules had been filled with cyanide. Stein and his staff had opened several Extra Strength Tylenol capsules Thursday morning, dumped out the acetaminophen, and then refilled the capsules with cyanide from the cyanide-filled capsules in the Janus and Kellerman bottles. These “test capsules” showed no signs of corrosion 36 hours after they had been filled with cyanide.

The following day, Stein said tests indicated that the cyanide could have remained in the adulterated capsules “for at least 48 hours” without revealing any “tell-tale” signs of their content. “We’re at 48 hours now,” said Stein. “They [the test capsules] still look normal.”

If these test-capsules did not show signs of corrosion soon, the theory that cyanide would eat through the gelatin-based shells of the Tylenol capsules in just a couple days would be completely debunked. Also discredited, because of the timeframe involved, would be the theory that the tamperings had occurred at the local retail stores. Nevertheless, just prior to Mayor Byrne’s news conference, the FDA had unofficially cleared Johnson & Johnson of any responsibility for the tamperings.

The FDA, via network news broadcasts, informed consumers on Friday night that Johnson & Johnson bore no responsibility for the tamperings. This exoneration seemed premature at the time, because at this point, just two days into the investigation, the FDA could not have conducted even a preliminary investigation of Johnson & Johnson’s Tylenol manufacturing and distribution network. Standard FDA inspections of manufacturing plants take place over a matter of days, often lasting several weeks.

Recently, an FDA inspection of McNeil’s Tylenol manufacturing plant in Fort Washington, conducted in November 2010, required 25 full-day visits from FDA inspectors. In October of that same year, the FDA had conducted a 19-day inspection of McNeil’s Tylenol manufacturing plant in Las Piedras, Puerto Rico. But on October 1, 1982, just two days after the Tylenol murders, the FDA claimed to have already determined that the tamperings could not have happened within Johnson & Johnson’s manufacturing and distribution network. The FDA was astonishingly ill equipped to make any such determination.

In a report to the U.S. Congress on April 26, 1982, the U.S. Government Accountability Office (GAO) stated that the FDA could only estimate that somewhere around 200,000 to 300,000 OTC drug products were on the market. The GAO concluded: “Without information on the number of OTC products marketed, the FDA is unable to evaluate the relative magnitude of any identified problem with an OTC product. The net effect is that FDA is unaware of (1) the number of individual OTC products currently being marketed and (2) whether these products are safe and effective as determined by any type of FDA review.”

Incredibly, up until 1997, the FDA had no statutory authority to inspect records or documents at OTC drug manufacturing plants. The FDA could inspect only those records that were on display at the time of the inspection or voluntarily provided by the manufacturer. Companies like Johnson & Johnson were not inclined to provide this type of information to the FDA. Large manufacturers, said the FDA, were more likely than small ones to provide only limited access or no access at all to current Good Manufacturing Practices (cGMP) related documents.

After an investigation of the FDA’s procedures for monitoring OTC drugs in 1991, the GAO concluded that the FDA might be unable to fully protect public safety and health or validate compliance with the cGMP regulation, and thus, validate an OTC company’s ability to produce a quality product. The GAO determined that the lack of full access to OTC drug manufacturers’ records and files limited the FDA’s ability to evaluate the effectiveness of these manufacturers’ efforts to analyze complaints, remedy problems, and generally produce a safe and effective product. In effect, reported the GAO, the current situation hindered the FDA from fully carrying out its mandate to protect the public health and provide reasonable assurance of the safety and effectiveness of OTC drugs.

The FDA never even had access to the nearly 300 consumer complaints of Tylenol tamperings, mix-ups, and contaminations that Johnson & Johnson had received in the three years prior to the Tylenol murders. The existence of these complaints was not disclosed until 1991 after J&J had been forced to turn them over to the lawyers handling the lawsuits filed by relatives of the Tylenol murders victims.

By clearing Johnson & Johnson so quickly, without conducting an investigation of the McNeil plants, the FDA may have provided a hint as to the location where the tamperings actually occurred. The FDA may have known all along that an inspection of the McNeil plants was unnecessary, because the adulterated Tylenol had not been bottled there. FDA officials cleared the McNeil plants, but they never said the Tylenol had not been poisoned at a repackaging facility or distribution center in Johnson & Johnson’s channel of distribution.

Instead of bringing in FDA officials to inspect the McNeil manufacturing plants; J&J flew in Cook County Toxicologist, Michael Schaffer, on Monday, October 4
^th
, to conduct a half-day “inspection” of McNeil’s 375,000 square-foot Tylenol manufacturing plant in Fort Washington. Schaffer spent just a few hours at the sprawling plant before declaring, “No human hands touched the Tylenol or its ingredients in the automated mixing and packaging process.” Schaffer then added, “I don’t think it’s impossible, but it’s a million to one” that the contamination occurred at the plant.

Schaffer knew next to nothing about the manufacturing process for Tylenol, and he was unqualified to offer a relevant opinion about the location where the tamperings had occurred. He knew nothing about how McNeil handled the raw materials used in making Tylenol, how the Tylenol was shipped, or how it was handled during distribution. He even failed to inquire about where the Tylenol implicated in the poisonings had been stored from the time it was manufactured in the spring of 1982 until it was shipped to Illinois in late August. With tampering at the McNeil plants ruled out, the Tylenol task force turned its attention to the only scenario it had ever really considered, namely, that someone had put cyanide-laced Tylenol capsules into the bottles in the local retail stores.

Company surveys taken before the Tylenol murders showed that less than one percent of consumers knew that Johnson & Johnson owned the company that made Tylenol. Shortly after the poisonings, however, more than 47 percent of those surveyed were aware of that fact.

“One of the things that
was
bothering me,” said James Burke, “is the extent to which Johnson & Johnson was becoming deeply involved in the affair. The public was learning that Tylenol was a Johnson & Johnson product, and the dilemma was how to protect the name and not incite whoever did this to attack other Johnson & Johnson products.” On the second day of the investigation, Burke had become so concerned about the Tylenol problem that he elevated the management of the crisis to the corporate level and took control of managing the company’s response himself.

According to Larry Foster, the public relations department had complete support from management to immediately make the first important decision that pointed Johnson & Johnson’s public relations program in the right direction. That decision, said Foster, was for the company to cooperate fully with all types of news media.

In reality, only a few J&J employees talked to the press, and only in a tightly controlled environment. They talked to reporters on a one-on-one basis, typically over the telephone.
J&J never held a press conference about the Tylenol poisonings or took questions in an open forum about the tampering incident.
The public has no way of knowing just how many important questions J&J spokespersons refused to answer. James
Burke did make appearances on
60 Minutes
and the
Donahue
Show
, but he made those appearances weeks after the murders for the sole purpose of promoting Tylenol in its new tamper-resistant packaging.