Johnson & Johnson Under Fire For Recalls

According to Advertising Age, parents are turning to social media networks to lash out at Johnson & Johnson for the third product recall from its McNeil Consumer Healthcare division in less than nine months. (I found additional instances of J&J product recalls related to quality when I checked the J&J website.)

Why does it look like J&J has decided that the best way to deal with customers is to tell them the least amount possible? And why didn’t AdAge link to the Facebook group it references in its article?

Back Story
Johnson & Johnson has long been lauded for how it handled its 1982 Tylenol crisis. In that event, seven people in the Chicago area died after ingesting Extra-Strength Tylenol capsules laced with cyanide. The company immediately issued a recall and immediately became the poster child for how to respond to a crisis.

Scholars have come to recognize Johnson & Johnson’s handling of the Tylenol crisis as the example for success when confronted with a threat to an organization’s existence. Berge (p 19) lauds the case in the following manner, “The Tylenol crisis is without a doubt the most exemplary case ever known in the history of crisis communications. Any business executive, who has ever stumbled into a public relations ambush, ought to appreciate the way Johnson & Johnson responded to the Tylenol poisonings. They have effectively demonstrated how major business has to handle a disaster.” [Case Study; cited source: Berge, T. (1990). The First 24-Hours. Cambridge, MA: Basil Blackwell, Inc.]

Before the recall, Tylenol accounted for 37% of the analgesic market. That market share dropped to 7% immediately after the poisoning but rebounded to 30% a year later.

A Note On Definitions
In the context of the Food and Drug Administration and pharmaceutical recalls, “voluntary” doesn’t mean what you might think that it means, since the recall is being made at the suggestion of the FDA. From the Medical Dictionary:

If a company is found violating a law that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. When a company can’t (or won’t) correct a public health problem with one of its products voluntarily, FDA … can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties–including prison sentences–are sought against manufacturers and distributors.

Current Story
In 2008, J&J recalled 21 Tylenol liquid products made for children and infants by McNeil Consumer Healthcare, a division of J&J. Also in 2008: the infamous “Motrin Moms” fiasco.

In September 2009, J&J recalled more than 20 versions of children’s Tylenol products that had been manufactured between April 2008 and June 2008 (!) because of possible bacterial contamination. A recall that was than a year in the making?

In November 2009, J&J initiated a recall of Tylenol Arthritis Pain caplets “because of consumer complaints of a strange, moldy smell that has caused nausea and other ailments.”

In December 2009, J&J initiated a recall of bottles of Tylenol Arthritis Pain Caplets (100 count) due to an “unusual moldy, musty, or mildew-like odor.”

In January 2010, J&J extended that recall to seven lines of products — Tylenol, Motrin, Benadryl, Rolaids, Simply Sleep and St. Joseph. The “unusual moldy, musty, or mildew-like odor” was “caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials.”

In March, J&J initiated a recall of Zyrtec eye drops because “samples tested as part of the manufacturer’s stability program did not meet product specifications.”

On 19 April, according to the Washington Post, the Food and Drug Administration began an inspection of the Fort Washington PA facility operated by McNeil. Inspectors found “manufacturing deficiencies” that might affect product “purity, potency or quality.” J&J refuses to provide details of the “deficiencies” or identify when plant operations were suspended. A redacted pdf of the inspection report is available from the FDA. Some of these observations beg the question: when did FDA last inspect this facility??

Observation 2: There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Observation 5: Written production and process control procedures are not followed in the execution of production and process control functions.

Observation 6: … failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Observation 7: … employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations …

Observation 8: Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

Observation 12: Laboratory controls do not include the establishment o f scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.

Observation 13: Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.

Observation 16: Samples taken of in-process materials for determination of conformance to specifications are not representative.

Observation 19: Records are not kept for the maintenance and inspection of equipment.

On Friday 30 April — reportedly at 9.15 pm — J&J announced the recall of seven lines of products for children and infants sold in the U.S. and 11 other countries. The 43 products were under the Tylenol, Motrin, Zyrtec and Benadryl brands and were manufactured at the  McNeil Consumer Healthcare facility that flunked the FDA inspection, which also ended on the 30th.

The timing of the release — and the lack of transparency in the process — is resulting in parental frustration. Evidence: Evan D. Owen on the J&J blog:

[Y]our recall announcement at 9:15 pm on a Friday night was deliberate to minimize media exposure. You know very well that consumers watch very little news during the weekend compared to a weekday. Your hopes that this will be “played out” come Monday morning is completely irresponsible. Your press release was vary vague not detailing what products have which issues nor how extensive these issues have become.

And on 4 May, we learned that the recalled products were contaminated with bacteria, not just metals.

How did a company that in 1982 began its discussion of “what to do” with its customers in mind become so lax in production processes and quality controls? And how did a company that set the standard for how to respond in a crisis evolve to one that embodies stereotypical corporate stonewalling?

:: wiredpen permalink
:: Follow me on Twitter!

Advertisements

One thought on “Johnson & Johnson Under Fire For Recalls

  1. Pingback: How the mighty have fallen (or at least taken a hit). | MMC Blog

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s