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In Elk Grove Village, Illinois, early on the morning of Wednesday, September 29, 1982, twelve-year-old Mary Kellerman, like thousands of schoolchildren on any given day, awoke complaining of a sore throat and runny nose.  Her parents gave her a capsule of Extra-Strength Tylenol, a common over-the-counter remedy at the time for the cold symptoms she was exhibiting.  Shortly after, Mary lapsed into convulsions and within a few hours, the young middle-schooler was dead.  She was only the first.

Adam Janus, a 27-year-old post office supervisor and volunteer paramedic in the nearby village of Arlington Heights, Illinois, who had immigrated from Poland with his parents as a child, came home from work that same morning feeling ill.  He picked up a bottle of Extra-Strength Tylenol at a grocery store on his way home and took two of the capsules, intending to head to bed.  Before he got there, though, he collapsed.  Paramedics called to the scene worked desperately to save him, but nothing they did seemed to work.  Janus was rushed to a nearby hospital where he was pronounced dead about 3 p.m.  At the time, it was the second unusual, but seemingly unrelated death of two people with virtually nothing in common.  

Then, things got strange.

It wasn't until paramedics were called back to the Janus house a second time, five hours later, that anyone became suspicious.

Charles Kramer, the fire lieutenant on duty at the time, recalls being intrigued by the second call of a "man down" at that same address, especially since the paramedics had come back from the first call talking about how strange it was that a healthy young man just seemed to drop dead.

Kramer decided to go over to the house. When he pulled into the driveway, he found a scene of chaos. Neighbors were standing in the driveway and lining the nearby sidewalks. Screams could be heard coming from inside the house.

Kramer walked in and saw a team of paramedics working on Adam Janus' brother, Stanley, who had suddenly collapsed.

What happened next will be forever etched in Kramer's memory. As Stanley lay on the living room floor, his pupils fixed and dilated, one of the paramedics looked up at Kramer with fear-filled eyes.

"This is what happened to the first guy. It's the same thing as this morning. We're losing him," he told Kramer.
Daily Herald, "Why Tylenol deaths might go unsolved", quoted in AMERICAN FRAUD and The Tylenol Murders
[WARNING: The linked site pushes a conspiracy theory surrounding the Tylenol poisonings; however, the Daily Herald article appears to be a direct transcription from a reputable local newspaper, so I have opted to use it because it provides a level of detail not found in other online sources.  I suggest healthy skepticism regarding the rest of the site, however.]

As paramedics worked frantically and unsuccessfully to save 25-year-old Stanley Janus, a noise suddenly emanated from the next room.  Charles Kramer looked up to see Stanley Janus's wife, 19 year-old Theresa, collapse before his eyes.  At first suspecting she had fainted from the emotion of the moment, he soon realized that she was displaying the same symptoms as her husband and her brother-in-law.  Although she would cling to life for three more days, she was brain-dead almost immediately.

Now it was obvious to the authorities that they had something unusual on their hands, but they still had no idea what.  As they mulled possibilities of a deadly bacteria or virus in the house , toxic gas, a poison introduced from some unknown source, or other causes, it would be an off-duty nurse who stepped forward to make the key connection.

[Helen Jensen, RN, BSN, a retired Arlington Heights village nurse], clearly remembers the dinner-time telephone call to her home Sept. 29, 1982, asking her to please come to Northwest Community Hospital in Arlington Heights because something strange was going on.

Village paramedic Adam Janus, 27, died unexpectedly that afternoon. Shortly thereafter, two other family members died while at his home making funeral arrangements, explains Jensen, who now sits on the village Board of Trustees.

Leaving her dinner half-eaten and wearing shorts, Jensen dashed to the hospital, where she encountered a gaggle of medical experts and Janus' Polish-speaking widow Theresa standing largely ignored in the corner of the room.

"I introduced myself and asked her to tell me what exactly happened," Jensen says. "Her brother-in-law was there, and he interpreted for me while she told me the story."

Adam Janus had been feeling ill and left work early. On the way home, he stopped at the grocery store and purchased a bottle of Tylenol. After eating a light lunch, he took two pills and headed to bed, but he immediately collapsed in convulsions and died within hours. At the Janus home later in the day, Janus' brother Stanley took two pills for back pain, and his wife, also named Theresa, also took two for a medical condition. Both deaths mirrored Adam Janus'.

"That's the secret of being a good nurse — you have to listen," Jensen says.

After hearing Adam Janus' widow's story, Jensen felt she had to go to the Janus home — against protocol and warnings that because the cause of death had yet to be determined, she might be in danger — to confirm what she believed was the common factor in the deaths.

"When something needs to be done, I do it and don't worry about protocol," Jensen says. "I didn't go through the right channels, I just did it, and I would do the same thing again. There is such a thing as nursing intuition, and if you spend enough time dealing with people, you get a feel for what is real and what is not, and I was positive this was it.
Nurse.com: Nurse Connected Dots in Tylenol Murders

At the Janus home, Jensen and her police escorts found a receipt for a bottle of Tylenol in a wastebasket, and soon located an opened bottle in the kitchen missing six capsules.  She took the bottle back to Northwest Community Hospital and turned it over to skeptical authorities, insisting they needed to test it.  

In the meantime, an off-duty firefighter, Phillip Capitelli, monitoring the frenetic activity on his scanner at home, called the station to see what was going on and spoke to  Charles Kramer.  A mention of the proposed Tylenol connection triggered the recollection, which he related for Kramer, of a phone conversation he had earlier in the day with his mother-in-law, who told him of the sudden death of her co-worker's young daughter, Mary Kellerman, after taking Tylenol.  

Normal capsule, left.
Cyanide capsule , right
By morning, toxicology tests delivered the answer.  Capsules in the Janus' bottle were found to contain potassium cyanide.  Cyanide was also confirmed in the bottle of Tylenol from which Mary Kellerman had been given her single capsule.

Soon, another victim, 27 year-old Mary Reiner of nearby Winfield, was discovered to have died at another hospital on the same day after taking two Tylenol capsules for mild headache.  Mary McFarland of Elmhurst collapsed and died at work at the Bell Telephone Center in Lombard after taking Tylenol capsules for a migraine.  Paula Prince of Chicago also died of cyanide poisoning from tainted Tylenol capsules that same day, but her body was not discovered until two days later.  Subsequent tests confirmed the presence of cyanide in the blood of all the victims.

Local authorities began pulling Tylenol from the shelves of area stores, in some cases going door-to-door collecting the medicine from homes in the neighborhoods near stores where victims were known to have purchased tainted bottles.  Police cars cruised through neighborhoods broadcasting warnings over loudspeakers warning residents not to use the pain killer and to return the product to local stores where it was purchased, or to the police.  

Johnson and Johnson, the maker of Tylenol, was contacted as soon as the link to the drug was discovered.  At the time, Tylenol products accounted for more than 35 percent of the over-the-counter pain-reliever market, a share that brought the company $500 million in sales annually.  Tylenol initially responded with a limited recall of product bearing batch numbers of lots from which the lethal capsules had come.  However, the retail establishment leaped far in front of the company's efforts; in Chicagoland, and then nationally, stores pulled Tylenol products from their shelves.  The FDA recommended consumers avoid Tylenol capsules until the situation could be "clarified".  Six days after the first deaths, with the adverse publicity threatening their valued brand name, Johnson and Johnson responded with a nationwide recall of all Tylenol products.  As their share of the OTC pain-reliever market plummeted from over 35% to a paltry 8%, Johnson and Johnson would take back 31 million bottles of product at an estimated cost in excess of $100 million.

Local law enforcement was quickly reinforced by the state.  A task force was formed with the Illinois Attorney General as head,  Product tampering at the time was not a federal crime, so federal law-enforcement authorities were not officially involved, but the FBI lent technical and investigatory assistance.  As millions of bottles of recalled Tylenol were inspected and tested, local, state, and company officials tried to determine how the poison had gotten into the capsules.  The possibility of introduction during the manufacturing process was soon dismissed, and tampering while in the distribution chain was subsequently deemed unlikely after an initial investigation of one suspect who worked at a distribution center that supplied stores where the tainted product was found.

Following inspections, the company determined that the cyanide was not introduced into the bottles at the factory, which left only one other possibility. The Food and Drug Administration (FDA) and law enforcement agencies realized that someone had methodically taken the Tylenol bottles off the shelves at the stores where they were sold, filled the capsules with cyanide and returned them back to the shelves at a later period. Investigators had no evidence as to who might have committed the heinous crime and there was continuing fear that more deaths might occur unless they caught the Tylenol terrorist
[...]
Investigators discovered that the cyanide laced capsules were placed in six Chicago area stores: Jewel Foods in Arlington Heights, Jewel Foods in Grove Village, Osco Drug Store in Schaumburg, Walgreen Drug Store in Chicago, Frank's Finer Foods in Winfield. and another undisclosed retail outlet. Each store contained one tampered bottle with approximately three to ten tainted capsules, except for Osco Drug Store where two cyanide laced bottles were recovered.
Howellschools.com, The Tylenol Terrorist: Death in a Bottle [PDF]
Inspecting the recalled Tylenol
Of the millions of bottles of Tylenol recalled, over 1.5 million were tested for cyanide.  Ultimately, three unopened bottles were found to contain the poison in addition to the five that had led to the seven deaths.  It was hard to tell exactly what kind of crime authorities were dealing with.  Was it terrorism?  No individual or group has ever (plausibly) claimed responsibility for the poisonings, or made any demands or expressed any grievances.  Was it a targeted murder with additional victims as decoys, as would actually be carried out in a 1986 copycat incident?  Investigators could find no likely suspects fitting that profile among the acquaintances and relatives of the victims.  Were they dealing with a sociopath, killing random victims just to experience it, ala Leopold and Loeb?  Authorities were stumped --  and were to remain stumped.  Over the course of the investigation, a number of suspects were considered to one degree or another, but officials could not develop enough evidence to charge anyone with the crime, which remains unsolved to this day.
 
Preparing for a press conference during the crisis
Between the assassination of President Kennedy and 9/11, no other news story generated the volume of media coverage devoted to the unfolding investigation into the Tylenol poisonings.  With the public painfully aware of how vulnerable everyone was to such an attack, paranoia gripped the nation. Every deviation from perfect health was immediately suspected as a potential poisoning.  Poison control centers were swamped.  One hospital received 700 calls in one day and emergency rooms were overflowing.  One desperately overloaded center is reported to have testily told callers that if they had been poisoned with cyanide, they would already be dead.
Along with a nationwide scare, the poisoned capsules brought with them copycats, who attempted to simulate the tamperings in Chicago. In the first month after the Tylenol related deaths, the Food and Drug Administration counted 270 incidents of suspected product tampering. Although, the FDA thinks this number may have been inflated by the hysteria of consumers who blame any type of headache or nausea on food and medicine they think may have been poisoned. The FDA estimated that only about 36 of the cases were, "true tamperings."
Tamara Kaplan, "The Tylenol Crisis: How Effective Public Relations Saved Johnson & Johnson"

Survivors of the victims would initiate lawsuits against Johnson and Johnson  for ten to fifteen million each for negligence in packaging its product.  The company finally settled with the claimants in 1991 for an undisclosed sum.

Triple-sealed tamper-resistant
Tylenol packaging
It was becoming painfully apparent, not just to Johnson and Johnson, but to the entire overt-the-counter drug industry, that the public trust in their product had suffered a severe blow.  As Congress began debating the nation's first anti-product-tampering legislation making tampering with a product in order to cause harm to others a federal felony, and the Food and Drug Administration began proposing regulations to prevent a repeat of the Tylenol killings, the leading industry players were already racing ahead of the regulators.  By mid-November, McNeil, the division of Johnson and Johnson that manufactured Tylenol, announced the re-introduction of Extra-Strength Tylenol in triple-sealed tamper-resistant packaging.  Competitors began to follow suit.  When the FDA regulations (which do not mandate any specific means of making a product tamper-resistant) were subsequently issued, most major pharmaceutical manufacturers were already in the process of implementing some means of tamper-resistant or tamper-evident packaging.
Tamper-resistant packaging is defined as a package that has "an indicator or barrier to entry, which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." According to the FDA, blister packs (tablets or capsules "individually sealed in clear plastic or plastic compartments with foil or paper backing"), film wrappers ("transparent film - wrapped securely around the entire product container"), aerosol containers ("believed to be inherently tamper-resistant because of their design"); tape seals; break-away caps, and foil paper or plastic pouches that "must be torn or broken to obtain the product" are examples of anti-tampering measures.
emedicinehealth.com, FDA Overview: Anti-Tampering Regulations

The tamper-resistance standards establish a level of security that protects the consumer, obviously, but less apparent is the protection it affords the manufacturer.  By conforming to the federal regulation, the producer establishes its intent to package its product responsibly in accordance with accepted standards, and in so doing, helps to protect the company against product liability claims for negligence in its packaging.  When conservative think tanks tally the cost of regulation, you can rest assured they do not include a line item for that little offset.

No one has ever been charged with the Tylenol killings.  One suspect, James W. Lewis, was convicted of trying to extort one million dollars from Johnson and Johnson and served 13 years in prison for that crime.  Although he remains a suspect and as recently as 2009 a search of his home was conducted in connection with the still-open investigation, authorities have not found sufficient evidence to charge him with the crime.  In an unexpected turn, the FBI recently sought to obtain DNA samples from several potential suspects, including Ted Kaczynski, the convicted Unabomber.  Thus far, no charges have been forthcoming.  At the time of the initial investigation, Johnson and Johnson offered a $100,000 reward for information leading to the conviction of the person responsible for the Tylenol poisonings.  The reward has never been claimed.


Thirty-one days after the first of the deaths from tainted Tylenol, my youngest child was born; my eldest was ten weeks shy of his fourth birthday at the time.  My kids are now, save for the youngest, in their thirties and -- one of them, at least -- raising yet another generation.  None of them have ever known a time when you could walk into a store, take  a bottle of medicine off the shelf, unscrew the top, and find nothing between you and the product inside but a ball of cotton.  For both generations, the Tylenol killings, I'm sure, seem as distant and unconnected to their world as the Mad Bomber, was to mine.  But unlike George Metesky, who was little more than a weird historical footnote in my time, my kids encounter the impacts of the Tylenol killings virtually every day.

The lives of my kids and grandkids -- and all of us -- are immeasurably safer than they were three decades ago.  In some peoples' worldview, safer, more secure lives are some sort of affront to their warped view of "freedom".  In the world in which I live, people are free to come together and act on a shared desire to create that safer, more secure life.  I like it that way.


And that, dear Kossacks, is where regulation comes from -- not from bored bureaucrats sitting in an office in Washington trying to think up ways to make life miserable and expensive for some innocent and unsuspecting businessman, but from real tragedy and human suffering brought about, all too often, by people who shirk what should be obvious responsibilities, who neglect basic diligence, who sacrifice safety for profit.  They bring suffering on those who trust them, and society adopts measures to make sure it never happens again.  We have to force them, through regulation, to behave as they should have been behaving all along.  That's how regulation came to be.


You can submit online public comments on proposed rules and regulations at Regulations.gov
(h/t  to stusviews)


Previous installments of How Regulation came to be:
1938 Food, Drug, and Cosmetic Act
The Iroquois Theater Fire
Radium Girls - Part I
Radium Girls - Part II
Radium Girls - Part III
Construction Summer
Red Moon Rising
The Cherry Mine Disaster, Part I
The Cherry Mine Disaster, Part II
Ground Fault, Interrupted
The Cocoanut Grove
DK GreenRoots: Donora
Confined Spaces
The Hotel Fires of 1946 - Part I
The Hotel Fires of 1946 - Part II
Our Lady of the Angels
The Great Molasses Flood
Toy Safety
The Power of One: Frances Oldham Kelsey
Santa Barbara
The Scofield Mine Explosion
The Triangle Shirtwaist Fire (reposted 24 March 2011)
The Cincinnati Who concert tragedy
The Flexner Report
The Eastland Disaster
El Cortito -- the short hoe
The Buffalo Creek Act of God
The Rehabilitation Act of 1973
The Memphis Yellow Fever Epidemic - Part I
The Memphis Yellow Fever Epidemic - Part II
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