The company recalled 40 widely used children's pain and allergy medications, saying some may have a higher concentration of their active ingredients, while others may be contaminated. J&J has had four recalls in the past year of over-the-counter medicines.
In an FDA report issued on Tuesday, inspectors said they found thick dust, grime and contaminated ingredients at the J&J plant that produces Children's Tylenol and dozens of other products recalled last week.
This infuriated the member of Congress who chairs a sub-committee which oversees the FDA:
Democratic Representative Rosa DeLauro sent a letter to the Food and Drug Administration asking questions about how the agency can respond to recalls and quality control lapses.
'I am concerned that the agency does not possess the authority to take appropriate action to address potentially criminal behavior by a corporation,' DeLauro wrote in the letter to FDA Commissioner Margaret Hamburg.
DeLauro, in her letter, said the company's 'disregard' for manufacturing standards was 'both unnerving and unethical.'
'The corporate oversight observed at this facility appears to be symptomatic of reckless behavior that is clearly unacceptable,' she wrote.
The Reuters report then noted:
J&J has called the manufacturing problems unacceptable and vowed to fix them. The company has suspended production at the Pennsylvania plant where the recalled children's products are made.
Moreover, the company CEO took to the blogsphere (via the company's JNJ BTW blog) to give his response (below in its entirety).
To All Who Use Our Products,
We have a responsibility at Johnson & Johnson to provide you with the highest-quality products possible, and we have worked hard to fulfill that responsibility day-by-day for over a century.
The recent recalls of some over-the-counter medicines from our McNeil Consumer Healthcare operating company are a matter of great concern. They are a disappointment to me, and to the employees of the Johnson & Johnson Family of Companies. You can be confident that we will make whatever changes are needed at McNeil to fully restore the quality of its manufacturing.
As reported, McNeil has suspended all manufacturing operations at its facility in Fort Washington, Pa., until we can be sure that they are operating under the standards we demand of ourselves, and which our customers expect of us. McNeil has also retained independent quality experts to assist in this regard and is re-evaluating quality systems and manufacturing processes across the organization.
I have been assured that the chance of a serious medical event from the recalled products is remote. Even so, this does not give us comfort; one of our companies has let you down.
For now, please check your infants’ or children’s forms of TYLENOL®, MOTRIN®, ZYRTEC® or BENADRYL® and discard any medicines that are being recalled. You can check the list of recalled lots, apply for refunds, and get more information about the recall at McNeil’s dedicated website (http://mcneilproductrecall.com), or by calling 888-222-6036.
We will work hard to earn back your confidence.
This seems like a very important case, because it involves a pharmaceutical company apparently violating its most fundamental responsibility, to provide pure, unadulterated medicine to the public. While the current case did not apparently lead to major health consequences to patients (as did the case of the contaminated heparin), it still suggests very basic flaws with Johnson & Johnson's operations.
Thus, what is striking about the CEO's message is its remote tone. He characterizes the problems at the factory as a reason for "great concern" and "a disappointment." Such language seems designed to reduce the CEO's own connection to the problems at the factory. This is the language one might use to describe someone else's conduct. (For example, Politician X's vote on the bill "caused me great concern," and "was a disappointment.")
On the other hand, although the CEO wrote about collective responsibility, ("we have a responsibility at Johnson and Johnson,"), he never suggested he had any responsibility or was accountable for what happened.
Of course, we have frequently seen language like this when health care organizations are accused of practices that violate their fundamental responsibilities, or could threaten health and safety. Rather than embracing responsibility, often leaders use language that suggests a fear of admitting anything that could create legal liability.
However, supposedly the rationale for entrusting so much power, and providing so much compensation to CEOs and other top executives, including those of health care organizations, is the tremendous responsibility they undertake. In fact, the Johnson & Johnson 2010 proxy statement provides this justification for the executives' stratospheric pay:
Pay for Performance —All components of compensation should be tied to the performance of the individual executive officer and his or her specific business unit or function and/or the Company overall.
• Credo Values— The manner in which financial and strategic objectives are achieved is important. While not always quantifiable, the manner in which employees achieve results should also be a key element of the individual performance review process. During the performance review process, the Company’s set of core values—trustworthiness, respect, responsibility, fairness, caring and citizenship—as set forth in Our Credo should be used to assess how objectives are achieved.
• Accountability for Short- and Long-Term Performance — Annual performance bonuses and long term incentives should reward an appropriate balance of short- and long-term financial and strategic business results, with an emphasis on managing the business for the long-term.
It then goes on the emphasize the company's Credo:
Importance of Credo Values
For more than 65 years, the Johnson & Johnson Credo has guided the actions of the Company and its executive officers in fulfilling their responsibilities to the Company’s customers, employees, community and shareholders. In assessing the executive officers’ contributions to the Company’s performance, the Committee not only looks to results-oriented measures of performance, but also considers how those results were achieved— whether the decisions and actions leading to the results were consistent with the values embodied in the Credo— and the long-term impact of an executive officer’s decisions. Credo based behavior is not something that can be precisely measured and, thus, there is no formula for how
Credo-based behavior can, or will, impact an executive’s compensation. The Committee and the Chairman/CEO use their judgment and experience to evaluate whether an executive’s actions were aligned with the Company’s Credo values.
Thus, last year Mr Weldon's total compensation was $19,847,026. Such an amount ought to pay for a vast amount of responsibility and accountability. (Also, the total compensation of Ms C A Goggins, the Worldwide Chairman of the Consumer Group, who I presume to the the executive just below the CEO who is responsible for products made by the factory which had to be closed, was $5,345,737.)
So again the rules for the executives of big health care organizations seem to be heads they win, tails we lose. They are paid enough to turn them into a new aristocracy supposedly because of the tremendous responsibility and accountability they assume. However, when things go wrong, responsibility and accountability vanish in a haze of concern and disappointment (with other peoples' actions.)
On Health Care Renewal we continue to be concerned with and disappointed about our dysfunctional health care system, and its worsening problems with costs, quality and access as long as it is lead by people who can become rich without any responsibility or accountability for their actions. The robber barons that arose in the late 19th century lead our country and the world into the great depression. The new health care robber barons will soon lead us into the great health care depression.