Lawsuits over Johnson & Johnson Products Raise Questions about Ethics at the Company

Let’s go back to the fall of 1982, when seven people in the Chicago area collapsed suddenly and died after taking Extra-Strength Tylenol capsules, manufactured by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, which had been laced with cyanide. This was the first known case of product tampering. J&J faced an immediate crisis with little guidance to go by except the company’s Credo. According to the company, it was this aspirational document that helped them to manage the crisis in an ethical manner.

Following disclosure of the tainted product, J&J swiftly removed the product from the shelves of supermarkets, provided free replacements of Tylenol capsules with the tablet form of the product, and made public statements of assurance that the company would not sell an unsafe product. The company became a model for how to handle an ethical crisis. What was in this Credo that so powerfully dictated the actions of the company? Well, here is the key statement as I see it

“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”.

This is an impressive statement and even more impressive reaction to a crisis situation by J&J. In fact, I have used the company’s response to the Tylenol poisoning as an example of ethical behavior. Now I must ask myself:  What Ever Happened to Ethics at Johnson & Johnson?

Fast forward to 2010 and 2011 and let’s look at recent legal challenges to the safety of products made by J&J.

1.      On December 21, 2011 it was announced that Johnson & Johnson, the world’s largest health products company, must defend a lawsuit claiming it misled investors about quality control-failures at manufacturing plants that led to recalls of the popular over-the counter drug, Motrin. Allegedly, top executives made misleading statements about details of the recalls leading to stock losses after the true reasons for the recalls became public. McNeil Consumer Healthcare has been facing numerous lawsuits as studies link Motrin to increased risk of severe allergies such as Stevens Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis.

2.      Earlier in 2011, a lawsuit filed by a group of consumers alleging Johnson & Johnson’s baby shampoo includes potentially cancer-causing chemicals was allowed to go forward, according to federal court Judge Dennis Cavanaugh. The Judge based his decision to let the lawsuit proceed on the presence of a single chemical ingredient found in the shampoo: methylene chloride, which is banned by the Food and Drug Administration for use in cosmetics.

3.     In January 2011, it was announced that J&J might have to shell out up to $1 billion for lawsuits concerning its subsidiary DePuy Orthopaedics and the metal-on-metal hip implants that were found to shed minute metal particles into a patient’s bloodstream over time. Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. (How does this square with its Credo?)

It is worth noting that J&J hiked its product-liability reserves to $570 million at the end of 2010 and allotted $280 million for medical costs of patients directly affected by the recalled hip implants.

4.      Women who have suffered serious injury and disfiguration have filed suit against J&J subsidiary Ethicon, claiming that vaginal mesh manufactured by Ethicon caused them life-altering complications. Upon investigation, a number of doctors and scientists have concluded that J&J Ethicon vaginal mesh and bladder slings do not meet reasonable safety standards.  The FDA issued Public Health Notifications regarding the use of vaginal mesh products to treat pelvic organ prolapse and stress urinary incontinence in October 2008, in February 2009, and in July 2011.   

The FDA received a total of 2,874 reports of vaginal mesh complications and injuries from January 1, 2008 to December 31, 2010.  Many of these reports concerned products manufactured by Ethicon. Lawsuits brought against the company by women claim that they were not adequately warned of the serious and often permanent injuries that may be caused by the vaginal mesh.

How can the culture of a company change 180 degrees? J&J has gone from a highly respected manufacturer of safe consumer products to one that either has shoddy quality control practices and/or ignores the warning signs of possible product defects. In any case, the company’s Credo apparently no longer guides its actions. Unfortunately for the doctors, nurses and patients, mothers and fathers that use J&J products, they no longer can rely on the safety of products manufactured by J&J and its subsidiaries.

Blog posted by Steven Mintz, aka Ethics Sage, on December 26, 2011