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"No more tears."
"The #1 choice of hospitals."
"Everything in life should be this pure."
Johnson & Johnson's slogans over the years have assured consumers, particularly mothers, that their products are - above all else - safe. However, a recent, seemingly endless stream of recalls suggests otherwise.
Children's Tylenol, Motrin Infant Drops, and Children's Benadryl are among the many medications recalled this year for manufacturing and labeling issues. Those products join recalls of Acuvue contact lenses, the allergy medication Zyrtec, and the ASR hip implant, which was sold to approximately 93,000 adults needing hip replacement surgery. A consistent pattern emerges: the company recalls products only as a last resort, and its quality controls seem to allow an inordinate number of dangerous products to reach the market - and enter the bodies of consumers.
J&J may once have cared that its products were safe. Now, it appears the company only cares if they're sold. The company consistently sells products long after it is fully aware that the products present a danger to the public.
And the FDA is helping.
Silent Recalls
In a report by ABC News, an inventory company employee named Lynn Walther tells reporters that J&J hired him to quietly purchase specific lots of Motrin IB. His instructions stated that he should, "simply act like a regular customer while making these purchases. There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."
Johnson & Johnson's Head of Consumer Affairs, Colleen Goggins, stated that the company had nothing to do with the buy-back, and that she didn't "believe there was any intent to mislead or hide anything." It's difficult to believe the now-retired Goggins, considering J&J has a long history of "phantom" or "silent" recalls.
In 2007, the Australia joint registry sent seven separate reports to the company identifying specific problems with the ASR device and detailing the high failure rate. The device was withdrawn for "commercial reasons" in December of 2009 and only officially recalled in March of 2010. Meanwhile, thousands of people received an implant that may cause permanent tissue and bone damage or require a revision, which could mean they will be unable to have a successful future implant.
Other recalls show a similar pattern of attempting to minimize the amount of product recalled - or avoid a recall altogether. Where one might hope that a company would issue a recall as rapidly as possible after being informed of problems, J&J's usual response is to "wait and see", followed by an attempt to remove the product by some other means than a recall. If it does recall the product, the company issues the smallest recall possible, expanding by minute degrees to keep products on the shelves as long as possible.
Hundreds of wrongful death claims were issued over the Duragesic pain-killing patch. The jury determined that J&J was aware of the defects in the Duragestic patches, but neglected to inform doctors and consumers. the company recalled the patch that administered a 75mg/hour dose in 2004 - and waited until 2008 to recall the same patch that administered a 25mg/hour dose.
In Japan, J&J expanded a recall of its Acuvue TruEye lenses five times, from the initial 100,000 boxes to half a million. The expanded recall was only announced in Japan. At the time of the recall notice, J&J rather cavalierly noted that the recall represented less than 1% of all contact lenses made by the company worldwide.
This fact is surely a great comfort to the 500,000 people who put acidic lenses in their eyes. We're surprised a similar statement was not made about the Duragesic pain-killing patches; surely the hundreds of people who died represented only a small - negligible, really - fraction of the product consumed worldwide.
When it comes to consumer safety, though, Johnson & Johnson would almost always prefer to look at the numbers than the people.
Fine Print in Invisible Ink
Johnson & Johnson has been reprimanded, and occasionally sued, repeatedly over the last ten years for not giving their customers adequate warning about the risks of their products. Many jokes are made about reading the fine print - but the fine print can be rather difficult to read if the warnings simply aren't put on the labels at all.
The antibiotic Levaquin is associated with tendon ruptures, particularly in older patients. The company did not warn doctors before changing its label, which meant doctors with previous lots of the medication (or ones who do not read new labels in every new lot) were unaware of the problem. The label change, plaintiffs say, remains inadequate.
The ASR hip implant may have similarly inadequate warning problems. The company's literature on the ASR implant states that it must be placed at precisely a 45-degree angle, rather than the usual range of between a 30-45 degree angle. Though it has yet to be proven that the company did not make sufficient efforts to inform doctors of the dangerous results of placing the implant incorrectly, our sources indicate that surgeons were largely unaware that this particular implant was so sensitive to proper placement.
The company recalled 12 million bottles of Mylanta and 85,000 of Alterna Gel due to insufficient labeling as well: no mention is made of the presence of alcohol in the products from flavoring agents. The company also recalled 9.3 million bottles of Tylenol cold treatments for the same reason, including 40 types of J&J medication specifically made and marketed as being for children.
There's Something in the Water
The range of foreign matter found in J&J products encompasses everything from the aforementioned alcohol to metal and wood particles to glass shavings.
Perhaps most disturbing, however, is the bacteria found at the Johnson & Johnson plant that produced the now-recalled children's medicines. It's called Burkholderia cepacia, and while it produces little risk to healthy people, it can cause serious infections in those with weakened immune systems.
Such as, say, sick children whose concerned mothers gave them Children's Tylenol to combat fever.
The bacteria was found during an investigation by the FDA of the facilities operated by McNeil Consumer Healthcare, a unit of Johnson & Johnson that manufactures many popular medications for the company. J&J executives had previously said that the recall problems were limited to a single plant in Fort Washington, PA, that was shut down for an overhaul. However, the FDA's principal deputy commissioner states that all of the facilities operated by McNeil Consumer Healthcare have deficiencies that could affect the qualtiy of the products being sold.
"The company had an inadequate quality system," Dr. Joshua M. Sharfstein said.
It's a mild rebuke for a serious problem. Johnson & Johnson's quality control system has allowed multiple dangerous products to get to market over the last 10 years - some of which have caused permanent physical damage or even death.
But then, the FDA has never been all that inclined to look closely at Johnson & Johnson's proceedings.
Getting Cozy with the FDA
The House Committee on Oversight and Government Reform recently investigated the "phantom" recall of Motrin as well as individual manufacturing issues that led to the recall. They found that the FDA had visited the McNeil plants multiple times and characterized the relationship between J&J and the FDA as " too cozy."
This isn't the first time that we at Moriarty Leyendecker noted that the FDA seems to be doing an inadequate job of ensuring quality controls are met on Johnson & Johnson products that they endorse. The FDA approved the ASR medical devices too - without asking the manufacturers to put the product through clinical testing and without seeming to notice that of the multiple devices to which the J&J company DePuy claimed the ASR was "substantially equivalent", not a one had ever actually been clinically tested by the FDA.
The FDA also claimed that it was unaware J&J was re-purchasing defective Motrin without informing consumers - a claim that was later refuted in a report by ABC News. In emails obtained by ABC, the company's employees appear to be in cahoots with FDA officials who agreed to allow the company to buy back their product instead of issuing a formal recall
Cozy, indeed.
Cutting Corners Where it Counts
In November, J&J announced that it intended to cut 8,000 jobs globally. It also decided to give its chief executive, William C. Weldon, an 11% increase on his salary. His new paycheck? $25.6 million. Weldon is currently the worldwide chairman of Johnson & Johnson and is currently testifying to Congress about the recent medication recalls.
Of the 8,000 employees cut by Johnson & Johnson, no mention is made of their official job titles. However, we'd like to propose that Weldon's salary might be better spent in hiring some of those employees back - to manage quality control.
Perhaps then Johnson & Johnson might be able to keep dangerously faulty products like the ASR hip implant from reaching the market. Of course, such a proposal precludes the assumption that J&J executives care more about the safety of real people than about lining their own pockets - and there isn't much evidence to support that theory.
Recommended Readings:
Hip Implant Risks May Include Premature Failure
How the ASR XL Acetabular System is Constructed
DePuy Asks Hip Implant Patients to Sign Away Their Legal Rights
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