May 7th, 2010

To All Who Use Our Products — From Bill Weldon

I just wanted to share the following open letter from Chairman and Chief Executive Officer Bill Weldon about the recent recalls at our McNeil Consumer Healthcare company. He asked us to publish it by posting on JNJBTW:

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.

Sincerely,

Bill Weldon

28 Responses to “To All Who Use Our Products — From Bill Weldon”

  1. Howard says

    I worked for JNJ for over thirty years in the quality division or whatever it became. I served under Sellers, Burke, Larsen and finally Weldon. I had a great career and even served for three months on a board of inquiry with a number of associates including the retired dean of the MIT graduate school.

    When we were moving operations to the Island I was responsible for the quality at one of the first plants. I say this to give you some background and authenticate my experience with the company.

    I just want to say how terribly disappointed I am in McNeil. During my career we merged with McNeill and I had many friends and associates there. Having survived many FDA audits, GMP inspections and the like, have I ever thought I would see what I consider what seems to be the general quality degradation of McNeill.

    We always had safeguards and redundancy. We had internal QA under the watchful eye of the ex FDA investigator Hank Avallone, who knew just what was under every rock. I worked with him when he was with the agency as well as when he was with our corporate QA.
    I could go on but I am praying that the shining words of the CREDO and the strength of our management will soon restore McNeill Pharm to the premier company it once was. As you can probably tell I am heartbroken and extremely confused as to how this breakdown could possibly happen. I read the 483 and I shake my head wondering how that could have happened at a domestic JNJ company and this on top of the issues in Puerto Rico.

    My prayers go out to management to find the strength to resolve these issues.

  2. L. Carter says

    My son experienced an adverse reaction to the recalled Zyrtec Syrup. I reported this to Zyrtec Customer Service around April 12th. I just thought I would mention it here because of all the reports that suggest no adverse reactions have been reported.

    My son, almost 3 years old, experienced chronic, severe diarrhea with blood and mucus for an extended time. Following a trip to the emergency room, he underwent numerous tests, including a colonoscopy under general anesthesia. The doctors were stumped. Once we made the connection to the Zyrtec and stopped giving it to him, he got better.

    The remains of the bottle of Zyrtec was submitted to Johnson and Johnson for testing and permission was granted to speak to my son’s doctors. Because of the mild language used in the recall, I am concerned about the integrity of this company and if any follow-up will be made on my report.

  3. Adam Schorr says

    Not to worry. Under the able leadership of Bill Weldon and Colleen Goggins, I have no doubt that before long J&J’s consumer products will be right back up there at the quality level of the CVS and Walgreen’s brands.

  4. Benjamin Drill says

    Best of luck in gaining the consumers confidence back. You run around like a bunch of buckaroos yelling “Yee-haw!”, allowing profit to get big enough to “take care” of what’s being possibly hidden (re: Prempro – this does indeed happen), then when something comes up (Id love to know what it was), and there you are, justifying your committment in paying consultants (as an example) hundreds per hour to tell you what you already know.

    If the intent of the pampered whiney baby boomers is to simply do whatever it takes to retire as fast as possible, you could put your heads in the sand. Just realize that once done, you’re nothing more than an @$$.

    Bravo. Nice work. You’ve lost one consumer so far.

    Benny Drill

  5. Patrick Bols says

    For almost 15 years I was an employee of J&J and very proud of it. J&J quality assurance was top notch and, me being in business development, often perceived it to be ‘overkill’. Meanwhile I moved into the area of GMP manufacturing. So I became way more knowledgeable about GMP violations and requirements. Reading about J&J’s GMP troubles is therefore highly surprising and utterly disappointing. Even this letter of Bill Weldon kind of points the finger at McNeil. Hello Bill, wake up! Were you too busy raking up your 30 million dollars in compensation and did not notice the house was on fire? It happened on your watch – so are you going to do more than writing the above letter? What about your shareholders (of which I am one?) Do you believe we can live with such sloppiness in an area where children’s lives are at stake?
    J&J also outsources to India and China, countries with an even worse reputation for quality. Is there any chance that you may start considering to bring this work back to the USA? Recreating quality jobs that were trashed in a move to produce more profits? That would be a sign for me that J&J is once more serious and honest about its Credo.
    Sincerely

  6. jennifer says

    As a long time stockholder and former employee, all I have to say is that I’m terribly disappointed that JNJ thought it was okay for my child to be put at risk. Stop tweeting and blogging and focus on what’s important. Having lost faith, I’ve put my sell order in.

  7. Edwin Kuffner says

    L. Carter,

    I was sorry to learn of your son’s illness. As a father of three young children, 3, 7 and 9 years old, and as an emergency physician who has cared for many sick children, I understand how incredibly stressful any health issue with a child, especially your own child can be. I did review the information posted on jnjbtw.com and was glad to read that your son has gotten better. Let me assure you that all reports of adverse medical events associated with the use of any of our medicines are taken seriously by me and by the company. A trained representative from our pharmacovigilence group which monitors adverse events will be following up with you and your child’s physician to request additional information about your son’s illness. I am not sure why your son experienced the effects he did in association with the use of Children’s ZYRTEC®. I would recommend that, if you haven’t already done so, you discuss this situation with your doctor. If you have additional questions please feel free to call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday 8 a.m. to 10 p.m. and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

    Edwin Kuffner, MD
    Vice President of Medical Affairs
    McNeil Consumer Healthcare

  8. Christin says

    I too have a personal account of adverse reactions to one/two of the recalled products.

    It has been 11 months of frustration since my 9 month old son developed an ear infection (May 2009). We immediately started the Tylenol regimen for the ear pain and fevers, saw our Pediatrician and began the antibiotics. Returning 9 days later, the ear infection was still present so we finish up the antibiotic treatment and hoped it would clear. The next week he developed a unusual skin rash, that he had for several weeks. Still having fevers after 3 weeks we saw the pediatrician again and were prescribed a different antibiotic for the ear infection. The next 11 days my son ran fevers between 102 – 104, which were again treated with 3 antibiotics, Tylenol and Motrin to no avail. (At this point the Tylenol/Motrin lasted half as long as it states and when effective only lowered them slightly.) We were then admitted to the hospital, where many unpleasant test and labs were done (again) on our 9 month old son. We were given a ‘Godzilla’ antibiotic and finally his fevers subsided. Upon discharge, we were given the diagnosis of “Unknown Bacterial Respiratory Infection.” Since this episode, we have experienced an unimaginable amount of re-occurring infections. Ear tubes were put in at the end of July. Between June – Sept, we visited the Peds every few weeks to treat a respiratory infection/ear infection. September, he had a seizure from a high fever. He was again tested for pneumonia and various labs. Soon after, my son was diagnosed with Asthma, due to the ineffectiveness of the antibiotics and again an ear infection/respiratory infection. (Keep in mind we are continually treating these ailments with your products, alternating Tylenol/Motrin.) Again we had a recheck for the antibiotics effectiveness and the infections were still present. A few weeks passed and he had another seizure. This time his fever would last for 2 weeks (mostly low grade but we used your products as a recommendation from our pediatrician at any sign of fever b/c of the seizure). We went 2 days without Tylenol/Motrin and he seemed fine, until he had a seizure with vomiting. ER Dr’s could not find any signs of illness other than the fever. We would go on to use 2 rounds of antibiotics and the fever remained until we discontinued the use of your products, both on the recall list.

    You state the the chances of an adverse reaction are minimal. What is considered minimal when your child fits all of the symptoms and the timelines linked to your products contamination? I pray that this is not the cause of my child’s illness but sometimes the answers seem to fall into your lap when you aren’t looking. I have not once questioned the use of your products but now am doing the follow ups necessary to test for this bacterial infection (which i have been told are near impossible for a 21 month old – so he may have to be given Anastasia to confirm). Also, what samples are you testing and who is doing the testing? i have several bottles that were used during the times above, and figure they are a better chance than most to find a contamination.

    I feel for any and every parent that has watched helplessly as their child’s health deteriorates so rapidly.

    Christin

  9. Karen says

    The silence from J&J is overwhelming. Consider the way Jim Burke handled the Tylenol crisis, a model in all business schools of high ethics in corporate America to the silence of Bill Weldon. As a stockholder it is very disappointing to hear major networks calling J&J with a no comment line. And to read the NY Times blog of frustrated consumers who have called the Consumer Care Center with no answer to their questions. What happened to the Credo? Physicians, Patients, Healthcare providers, Mothers and Fathers are suppose to be 1st on the list not last. Bill needs to come out of his office and speak publically outside of Congress and accept the problem, notify the public on actions taken and updates to status of the situation. We expect the leadership at J&J to have the courage to own the problem and resolve it. How else will you reestablish the trust mark of J&J?

  10. Edwin Kuffner says

    Thank you for your comment. I’m sorry to learn of this situation and, as I mentioned in my note back to L. Carter, we do take any report of an adverse event very seriously. In addition to sharing all this information with your physician, which it sounds like you are doing, I also urge you — if you haven’t already done so – to contact our customer contact center to provide them with this information. The Consumer Care Center can be reached at at 1-888-222-6036 (available Monday-Friday 8 a.m. to 10 p.m. and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

  11. L. Carter says

    Christin,

    Similar to your experience, we continued to use the product (later recalled) throughout my son’s illness. When we stopped the Zyrtec for some tests involving tissue samples, he got better. But I restarted the Zyrtec after those tests because of my son’s allergy symptoms, and he got sick again. When we later made the connection with the Zyrtec and stopped giving it to him…. he got better.

    I urge you to make an official report to the Customer Care Center, as well as issuing a Med Watch report with the FDA.

    I have also submitted the remains of the bottle of Zyrtec to McNeil as well as permission for them to speak with my son’s doctors. A McNeil representative contacted me a couple of days ago, and I gave her the full story of my son’s illness from beginning to end and what we are still dealing with today. I do not know how they will test the contents or what they will test for…

    … but I have to say that I have lost all trust in pharmaceuticals and it frightens me to use any medication on my son.

  12. Christin says

    L. Carter,

    I submitted a report to the FDA last week and have yet to speak with anyone at the care center. I will try again to make the report with them as soon as i have a chance. I want them to know just what he experienced in order to prevent this from happening to others or at least help those who are unknowingly affected find answers and get the necessary help to recover.

    I have a couple of the bottles my son was using during the most recent episode which will be available for testing by the FDA as well as McNeil and a third party if possible. I find it hard to believe that this contamination has not been found in the end product, considering the information below;

    “B. cepacia is an extremely resilient species which can survive harsh environmental conditions with minimal nutritional needs. The bacterium’s large genome, twice the size of Escherichia coli (E. coli), allows for this tremendous adaptability and inherent resistance to multiple antibiotics.”

    I hope that your son is doing better as well as yourself and everyone who has been going through this with him. It is a frustrating and exhausting road to travel, especially if its unfairly dealt to you.

  13. Christin says

    tLucas

    Which one are you inquiring about? The ‘Godzilla’ antibiotic? If so, i found in his charts it was Ceftriaxone, which in my research is an effective antibiotic against gram negative bacteria (Dr’s notes also state this suspicion as reason for using this med) but it needs to be paired with another in order to effectively kill the entire bacteria presence for complete recovery and for that reason i believe my son’s recovery was only short lived.

    Are you experiencing any adverse reactions from these products or have ANY suspicion? I am experiencing a lot of resistance from Doctors because they have not been properly informed on this problem and don’t want to preform unnecessary tests. Why haven’t our Healthcare Professionals been properly informed on this issue? Everything on the McNeil site states “contact your HC professional”. McNeil has done a poor job on providing sufficient information and in turn has let its consumers down. Risking our children’s health when they could simply admit this problem and we can get the needed help.

  14. Christin says

    called the customer care line… What a Joke!

    I don’t feel any better about how your company is handling this recall. It would be helpful for you to release all of the information so people can treat their children and move on-isn’t 1-year of our lives enough?

  15. L. Lenhardt says

    I think J&J top management is too busy counting their money, instead of paying attention to properly supervising their operations. Maybe a new set of people at the top is required top fix the problems in a timely manner and avoid them in the future.

  16. BARBARA AMES says

    I AM A FORMER EMPLOYEE,AND A STOCKHOLDER. I CANNOT EMPHASIZE ENOUGH MY DISAPPOINT WITH MY COMPANY CONCERNING WHAT I FEEL IS A LACK OF MANAGEMENT INTEREST IN THE WAY THE INDIVIDUAL COMPANIES ARE RUN. I REMEMBER THAT 20 YEARS AGO, THE FOLKS AT FORT WASHINGTON WERE TALKING ABOUT THE NEED TO UPDATE AND CLEANUP THE MANUFACTURING LINES THERE. I REMEMBER ALSO UNCOMPLIMENTARY COMMENTS BEING MADE ABOUT THE PUERTO RICO OPERATION. I REMEMBER THAT SOME BRAND MANAGERS SEEMED TO FEEL THAT THE ONLY THING THEY HAD TO DO WAS RING UP SALES. THEY DIDN’T FEEL AN OWNERSHIP OF THE BUSINESS. THAT WAS THE BEGINNING OF WHAT HAS BECOME THE END FOR THE GREAT TYLENOL BRAND. I MOURN IT’S LOSS. I LAUGH AT THE LITERALLY HUNDREDS OF NEUTROGENA PRODUCTS WHICH HAVE TAKEN CENTER STAGE. ONCE, J&J WAS A HIGHLY RESPECTED HEALTH CARE COMPANY, THAT HELD THE TRUST OF MOTHERS AND FATHERS AND DOCTORS AND NURSES. SUCH IS NO LONGER THE CASE AND I REALLY AM VERY DISAPPOINTED.

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