By Independent Staff Writer
"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 The device was withdrawn for "commercial reasons" in December of 2009 and only officially recalled in March of 2010.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.
