The Tylenol Mafia (36 page)

Carl Vergari had been right all along - the cyanide-laced Tylenol capsules had been poisoned during the manufacturing process (packaging is part of the manufacturing process). James Burke used his media ties to distract the public from the evidence that pointed to J&J’s knowledge of the true source of the cyanide-laced Tylenol that killed Diane Elsroth. An important part of that misinformation campaign was to promote Johnson & Johnson’s “Credo” values.

33

________

Carl Vergari’s substantial progress in the Tylenol murder investigation was largely the result of what the FBI agents in New York City had uncovered. Nevertheless, as of February 16, 1986, the FBI officials in Washington D.C. still seemed perplexed. A key question, said FBI spokesperson, Milt Ahlerich, was whether the tampering occurred at the manufacturing plants, the distribution centers, or locally. Ahlerich said that none of these possibilities had been ruled out, but he said there had been “no significant progress” in the inquiry.

Despite Ahlerich’s contention that there had been no significant progress; there had obviously been a great deal of progress. Most of which had been made by the FBI. Vergari’s depth of knowledge about the evidence was the result of a coordinated investigation between his office and the FBI’s New York City office. The FBI’s forensic analysis had revealed that the tamper-resistant packaging on the bottles of cyanide-laced Tylenol had not been tampered with. The Tylenol in the contaminated bottles had followed the same distribution path, even passing through the same McNeil Pharmaceutical Company warehouse in Montgomeryville within a two-week period. Furthermore, Vergari was now closing in on the repackaging facility where the tamperings had actually occurred.

James Burke continued to claim that it was possible to remove and replace the three layers of tamper-resistant seals, but he admitted that there was no evidence that the packaging had been tampered with at all. “There’s no question you can take the package apart and put it back together again,” said Burke. “The question is this: Is there evidence that that has been done? The FBI says, looking at the package, that they have no evidence that it has been tampered with,” said Burke, apparently conceding that the packaging had not been tampered with. But then, with his next breath, Burke snatched that concession right back up.

Burke said experts within Johnson & Johnson had successfully removed and replaced the seals. “I’m not saying the average person could do it,” he clarified. Nevertheless, Burke said “It is our strong conviction that it didn’t happen in the plant or the warehouse, because we can’t figure out how it could have. And we’ve gone over and over and over again our production methods, and also our distribution methods to see how this could possibly have happened. And we’re even examining things like counterfeiting the labels and counterfeiting the numbers. If it happened, it was an elaborate, elaborate process.”

The experts at Johnson & Johnson, according to Burke, could not figure out how the poisoned pills could have gotten into the bottles during the production process. He said the tamperings did not happen at McNeil “because we can’t figure out how it could have.”

In 1986, the FDA did not have statutory authority to inspect records at OTC manufacturing plants. The FDA did, however, have that authority years later when it conducted inspections at the McNeil plant in Las Piedras, Puerto Rico in 2008 and 2009. The FDA reports from those inspections illustrate just how easily poisoned pills could have gotten into the bottles during the production process. The FDA found that during 2008 and 2009, the Las Piedras plant received 123 mix-up related consumer complaints for Tylenol and Motrin products manufactured there. “Mix-ups” are documented events in which a pill, like an Extra Strength Tylenol pill, for example, is found in the wrong bottling production line at the plant or in the wrong bottle after it is purchased at a retail store.

FDA inspection reports from 2008 to 2010 at the McNeil plants revealed that J&J executives were completely indifferent to the dangerous problems identified repeatedly by their own employees and by FDA inspectors. Johnson & Johnson did not investigate
any
consumer complaints of tampering and drug contamination during that period. The failure of management to investigate incidences of contamination and tampering is a decades-long theme at Johnson & Johnson.

In 1987, Johnson & Johnson received a Regulatory letter from the FDA stating: “Your firm failed to take appropriate measures to prevent [
Delfen
Contraceptive Foam from] being contaminated with objectionable micro-organisms.” Matthew Lewis, the FDA’s district director in Newark, told Gary
Parlin
, the president of J&J subsidiary, Ortho Pharmaceutical, that the company also “failed to conduct investigations of complaints, and it failed to include in the written record the reasons that investigations were not conducted.” McNeil sent two reply letters to the agency, but these were unresponsive to the violations, said Lewis.

In 1985, the McNeil Consumer Products Company had recalled 377,000 bottles of Children’s Tylenol Elixir after finding yeast and mold on the necks of some bottles. Don Phillips, director of the Arkansas Health Department’s Division of Pharmacy Services said the contamination could trigger a reaction similar to a penicillin injection, including skin welts and nausea. J&J told wholesalers nationwide to return batches of the product, but the bottles of contaminated Children’s Tylenol Elixir were not removed from any stores. Incredibly, J&J spokesperson, Robert Kniffin, advised parents to continue to give their children Tylenol from the contaminated lots. Larry Foster said a recall from stores or people’s homes was not necessary because, according to Foster, yeast does not pose a sufficient public health hazard.

Executives at Johnson & Johnson also have an established history of firing whistleblowers. In 1982, when McNeil’s Associate Medical Director, Dr. James Dale, and Senior Scientist, Edward Lemanowicz, told company executives that J&J needed to come clean about the dangers of Zomax, they were fired. In 1996, when Carlos
Labanda
reported that J&J subsidiary
Cordis
deliberately ignored quality control procedures when manufacturing the company’s best-selling coronary stent, he was fired. When Ronnie Belanger, a lab technician at
Cordis
, refused to alter her paperwork to obscure the existence of inferior products, she was fired. So was
Cordis
quality assurance technician, Williams Laws, for complaining to supervisors that products that had failed tests were noted as passing those tests on company documents. In 1999, when Hector
Arce
reported violations of current Good Manufacturing Practices at J&J’s
Eprex
manufacturing plant in Puerto Rico, he was fired. In the 2000s, when Chief Medical Officer, Joel Lippmann, asked J&J to report the problems with faulty medical devices and potentially deadly birth control patches, he was fired. Never once has the Justice Department enforced the laws that prohibit retaliation against whistleblowers, so Johnson & Johnson executives continue to fire employees who attempt to hold them accountable to the law, a basic level of morality, or even to the words in their beloved “Credo.”

OUR CREDO

We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to reduce our costs in order to maintain reasonable prices. Customers' orders must be serviced promptly and accurately. Our suppliers and distributors must have an opportunity to make a fair profit.

We are responsible to our employees, the men and women who work with us throughout the world. Everyone must be considered as an individual. We must respect their dignity and recognize their merit. They must have a sense of security in their jobs. Compensation must be fair and adequate, and working conditions clear, orderly and safe. We must be mindful of ways to help our employees fulfill their family responsibilities. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development and advancement for those qualified. We must provide competent management. And their actions must be just and ethical.

We are responsible to the community in which we live and work and to the world community as well. We must be good citizens - support good works and charities. And bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use; protecting the environment and natural resources.

Our final responsibility is to our stockholders. Business must make a sound
profit,
we must experiment with new ideas. Research must be carried on, innovative programs developed and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times. When we operate according to these principles, the stockholders should realize a fair return.

*****

There may have been whistleblowers in 1982 and 1986 who tried to disclose sensitive information about the Tylenol poisonings, but who were ignored, fired, or simply intimidated from saying what they knew. Any J&J employee who thought for a minute about the Tylenol tamperings would have realized that there were a number of ways to get cyanide-laced Tylenol capsules into bottles at the manufacturing plants and repackaging facilities. Yet James Burke supposedly could not figure out how such a feat could be accomplished.

An example of the type of investigation Johnson & Johnson conducts to ensure that they don’t ever “figure out how” drugs can be adulterated at their plants is made further evident in the reports from FDA inspections at the McNeil OTC drug manufacturing plant in Las Piedras, Puerto Rico in 2008 and 2009. These reports describe dozens of violations and the complete failure of J&J to investigate consumer complaints. The FDA inspection report said: “Even though your firm received 123 mix-up related complaints, from which you received over 50 consumer complaint samples for evaluation, none of them have been confirmed. Your Quality Control Unit considered all complaints as isolated occurrences of unknown origin. Most of the complaint investigations conclude that there is insufficient evidence to absolutely determine that the reported condition occurred at McNeil, even though your firm has reported over 12 mix-up event investigations.”

The FDA concluded: “There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.”

The methods used by McNeil to “investigate” problems with its manufacturing and packaging of drugs have consistently failed to identify or eliminate problems. Its methods of “investigation” were thus designed to fail. So when James Burke said in 1986 that he was unable to figure out how the cyanide-laced Tylenol capsules could have gotten into bottles during manufacturing, it’s helpful to understand exactly how Johnson & Johnson conducts, or fails to conduct, its internal “investigations” and what precisely the phrase “couldn’t figure out” really meant for J&J.

In February of 1986, one week after the death of Diane Elsroth, Carl Vergari was ready to conduct a serious investigation of J&J’s Tylenol manufacturing and distribution network. He had already disclosed a great deal of evidence, all of which pointed to tampering in the Tylenol distribution channel. During the early days of the investigation, while Vergari was talking to the press about important developments in the case, the FBI had said next to nothing. With a growing body of evidence pointing to a Tylenol killer within Johnson & Johnson’s manufacturing and distribution network, the FBI was now conveniently about to find its voice.

34

________

Carl Vergari announced on Friday, February 14
^th
, that he would send investigators to the McNeil plant in Fort Washington to look into the possibility that the adulteration had occurred there. Vergari said the review would examine manufacturing processes and might include looking at employee personnel files. The discovery of the second bottle, said Vergari, increased “the focus of the investigation on the possibility of tampering at the plant.” A tour of the Montgomeryville and Fort Washington plants was scheduled for President’s Day, February 17
^th
.

With the inspection just three days away, Carl Vergari laid out the evidence that Johnson & Johnson had hoped to suppress. He said that based on the FBI tests on the packaging of both bottles of poisoned Tylenol, the tampering most likely occurred at the time of manufacture. The two bottles of poisoned Tylenol capsules had been sent to the FBI labs to determine “to a reasonable degree of certainty, through microscopic examination, whether the metal foil that was heat-welded to the top of the bottle has been tampered with after it left the factory,” said Vergari. “And they say in both cases that their laboratory examination reveals that it was not… that these bottles were not tampered with after they left the factory; that, ergo, the contamination was done at some time during the manufacturing process before the seal was placed on it. What could be clearer than that?”

The official spokespersons for the FBI refused to confirm what was perfectly clear to Vergari and the FBI agents who had actually inspected the packaging. Still, there was no longer any question that the evidence uncovered by FBI agents working with Vergari did not fit the approved theory. The tamperings had obviously occurred before the Tylenol capsules were packaged and shipped to the retail stores.