Johnson & Johnson gets it wrong

Just because a company got it right once doesn't mean they'll get it right all the time. Back in the day, one of the great crisis management success stories was was Johnson & Johnson's handling of a case where someone intentionally introduced cynanide into on the shelf bottles of Tylenol in the fall of 1982 in the Chicago area. Seven people died. If you ever have trouble opening your over the counter or prescription drug bottles, you can thank the creep who did it -- whoever that is. No one was ever caught.

Here's a concise summary of the 1982 poisonings, courtesy Wikipedia:

Wednesday morning, September 29, 1982, 12-year-old Mary Kellerman of Elk Grove Village, Illinois, died after taking a capsule of Extra Strength Tylenol. Adam Janus of Arlington Heights, Illinois, died in the hospital shortly thereafter. Adam's brother Stanley of Lisle, Illinois, and sister-in-law Theresa died after gathering to mourn his death, having taken pills from the same bottle. Soon afterward, Mary McFarland of Elmhurst, Paula Prince of Chicago, and Mary Reiner of Winfield, Illinois, also died in similar incidents. Investigators soon discovered the Tylenol link. Urgent warnings were broadcast, and police drove through Chicago neighborhoods issuing warnings over loudspeakers.

As the tampered bottles came from different factories, and the seven deaths had all occurred in the Chicago area, the possibility of sabotage during production was ruled out. Instead, the culprit was believed to have entered various supermarkets and drug stores over a period of weeks, pilfered packages of Tylenol from the shelves, adulterated their contents with solid cyanide compound at another location, and then replaced the bottles. In addition to the five bottles which led to the victims' deaths, three other tampered bottles were discovered.

Johnson & Johnson, the parent company of McNeil, distributed warnings to hospitals and distributors and halted Tylenol production and advertising. On October 5, 1982, it issued a nationwide recall of Tylenol products; an estimated 31 million bottles were in circulation, with a retail value of over US$100 million. The company also advertised in the national media for individuals not to consume any products that contained acetaminophen. When it was determined that only capsules were tampered with, they offered to exchange all Tylenol capsules already purchased by the public with solid tablets. (Wikipedia entry, Chicago Tylenol murders [cites omitted])

Probably over 100 million Tylenol capsules nationwide were recalled in a matter of days by J&J. Given that the cyanide was clearly introduced after bottling, any person's risk of getting a poisoned capsule was probably less than one in a million, roughly the level of risk we allow from your average water contaminant. But J&J's quick action was credited with the almost equally quick rebound of the brand. People today consider Tylenol (acetaminophen) to be an ultrasafe analgesic, although ironically it isn't. It is the leading cause of liver failure in the US. Still, it is very safe from a public relations viewpoint and the J&J action in 1982 has often been cited as a textbook example of how to do it.

Fast forward to last week:

Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled last week in the U.S. and 11 other countries were contaminated with bacteria, according to a report by the Food and Drug Administration.

Agency officials said Tuesday none of the company's finished products tested positive for the contaminants, though such testing is not definitive.

"We think the risk to consumers at this point is remote," said Deborah Autor, director of FDA's drug compliance office, on a call with reporters.

Last week's sweeping recall is the latest quality issue to taint J&J's over-the-counter medicine franchise. In January, the company recalled a line of adult Tylenol pain relievers due to complaints of a moldy smell associated with wooden pallets used to transport the drugs. (Matthew Perrone, MSNBC)

That's bad, but it gets worse. According to the FDA, J&J had inadequate lab facilities to test ingredients, failed to follow up on consumer complaints, including 46 complaints about visible dark specks in Tylenol, had a factory with dirty equipment, some of it in obvious disrepair. Worse still, there was inadequate control and consistency of active ingredients, with some having more than stated and some less.

When the recall notice came out I sent it to my daughter who has two little ones, both under the age of 3. She was furious because she had to throw out a lot of medicine and like many young couples with children they are struggling. Tens of dollars or more worth of over the counter meds for their children has to come out of something else.

Maybe J&J thinks if it's not cyanide they don't have to worry about it for their brand's sake. They do. Ask my daughter.

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I think it's a cultural shift in perspective where everything is considered in light of corporate health to maximize profits for their stockholders. Why else could you get news statements like - X *raised* their prices to remain competitive? Corporations have done their homework in terms of risk assessment. Even if a product killed people as long as it wasn't too many and there's no quality alternative, any proactive response is simply an unwarranted loss in profits.

Why yes I am getting more cynical in my old age.

Regarding cynicism: There was a car (I forgot what brand, NOT a Swedish one) whose fuel tank had an unfortunate tendency to explode during collisions. The company statisticians figured out it would be cheaper to pay compensation to the victims or their next of kin than recalling the car and fixing the problem...(the event was recycled in a film I have also forgotten the name of).

By Birger Johansson (not verified) on 06 May 2010 #permalink

Birger: Ah, yes. The Ford Pinto. Didn't Ford buy Volvo?

If you did a little deeper, you'll find that someone (male) was arrested and jailed for the tampering. He was released from prison in the last couple of years.

J&J - and the rest of Big Pharma for that
matter - is showing the effects of its layoffs.
All those engineers, statisticians, and
QA inspectors were the front line of quality
control. No doubt Merck, Pfizer, and others
will be showing the same problems in their
product lines. Glad the MBAs who argued
"savings" from the downsizing got their bonus.

By J&J employee (not verified) on 06 May 2010 #permalink

I am SO glad I read The Shock Doctrine in 2008 (unfortunately not quite on time to pull the few assets to safety but hey). Just now while researching big (1.5MW and over) windturbine makers, I discovred only that UTC and (re the blades) Dow Chemical have got in the act--these were two BIG napalm makers during Vietnam, in case you younguns don't know--but that another, GE, not only works with Boeing and others on warplanes (and wardrones, I think), but owns. . .well, a good hunk of the financial, healthcare, oil-and-coal, "infrastructure" (don't even think what that means), and other business of the world. I mean, we know this--but not really, until we look it up. Good we can do this more easily now on the Internet (though GE is smooth enough to hide much). So who owns Johnson & Johnson?

"(the event was recycled in a film I have also forgotten the name of)"

Fight Club.

By Penny Lane (not verified) on 07 May 2010 #permalink

J&J - and the rest of Big Pharma for that
matter - is showing the effects of its layoffs.
All those engineers, statisticians, and
QA inspectors were the front line of quality
control. No doubt Merck, Pfizer, and others
will be showing the same problems in their
product lines. Glad the MBAs who argued
"savings" from the downsizing got their bonus.

By J&J employee (not verified) on 06 May 2010 #permalink

J&J - and the rest of Big Pharma for that
matter - is showing the effects of its layoffs.
All those engineers, statisticians, and
QA inspectors were the front line of quality
control. No doubt Merck, Pfizer, and others
will be showing the same problems in their
product lines. Glad the MBAs who argued
"savings" from the downsizing got their bonus.

By J&J employee (not verified) on 06 May 2010 #permalink