Johnson & Johnson plans to eliminate 900 jobs at Ortho-McNeil-Janssen unit
I first became aware of this story earlier this summer when I went to buy some Motrin at my local Happy Harry’s.. I walked up and down the shelves and was perplexed why I didn’t find some. I assumed that Walgreens must be becoming like Walmart and picking the brands they sold based on who could give them the best sweetheart deal. I went to Rite Aide instead. What, they’re out of Motrin too? They don’t even have a tag or slot on their shelves for it. Is there a recall? No one knew of any. After 4 hours, I finally found one bottle, still on the shelf of a chain grocery store, and snatched that baby up. Finally… R E L I E F…
Then I forgot about it… and I saw this….
Why were they buying back their own products? Were they trying to cover something up, or, prevent a mistake from becoming public? Is that the normal method of recalling a product, and if it is not, what was normal procedure not followed in this case?
In January, the FDA identified problems at a Johnson & Johnson plant in Puerto Rico after the company recalled Tylenol, Motrin and Benadryl products made there. The company said a chemical leached from wooden pallets into the products, imparting a musty odor that later made some consumers ill with temporary gastrointestinal problems.
Now I work around pallets all day. They do have a musty oder. But that oder stays in the wood. When I come home and take off my clothes, the same clothes which were in close proximity to those wooden pallets, they have no musty pallet oder. They may smell like BO, but they don’t smell like pallets. And you expect me to believe that tiny little pills inside a glass container, vacuumed sealed with cotton packed on top, surrounded with printed intructions, placed inside individual cardboard cases, which themselves are bundled 48 on a wooden pallet, upon opening,… carry that musty pallet oder in amounts so strong, that it gives consumers temporary gastrointestinal problems? Bullshit.
The human symptoms point to bacteria on the pills. For some reason, the line about the pallets, whether sanctioned by the FDA or not, is a dodge to deflect the true story.
In the FDA report, linked above, the closing of the Fort Washington Plant was because the Fort Washington Plant did not ensure….the rejection and withholding from approval any raw material product that contained a “known” contamination of gram negative organisms. Translated: they knew it was contaminated with deadly bacterial organisms and sold it anyway!
Raw material lots had known contamination with gram negative organisms and were approved to use for manufacture of several finished lots of Childrens and Infants Tylenol drug products, which remained within expirations dates on the market.
Translated: Medicine for infants running a fever, with immune systems being down for other reasons, were knowingly and willingly, given a bacterial infection organism known to cause severe gastronomical problems. Is Hakin employed by Al Qaeda? Surely that could be the only reason such a callous act could occur. Or is this the new standard today’s corporate America now upholds?
In fact, Food and Drug Administration inspection reports going back to 2003 chronicle a build up of problems at the now-shuttered plant in Fort Washington, Pa., at the center of the widespread recall of Tylenol, Motrin, Benadryl and other over-the-counter drugs. But it was only after a political change in Washington, that consumer protection stepped up.
Just recently, at an inspection of the Lancaster plant, inspectors wanted to know why some consumers found maximum-strength tablets in regular-strength Pepcid bottles, or mint-flavored tablets in berry-flavor bottles.
The problems were compounded by having to repeatedly ask for documents, and waiting days to receive what should have been readily available, including things as basic as an organizational chart.
(It should be noted that the newest report does not give any examples of product quality being affected by the litany of carelessness. Nor does it advocate a recall of any of the plant’s products.) What the report does note, is that no one is monitoring the operation. Records that should be accessible at a moments notice, simply aren’t there.
One common theme of the FDA report is that J&J employees frequently took days or weeks to provide records to the FDA inspectors, sometimes despite multiple requests. When the records eventually were provided, they sometimes were wrong or incomplete, the report said. “Organizational charts were requested on 06/23/10 and requested approximately 10 times before receiving full information … on 07/01/10,” read one example.
Another key point of the report was a finding that the plant failed “to thoroughly review” how product quality was affected by equipment problems that occurred during the manufacturing process.
The report said J&J displayed a similar lack of vigor in probing the Berry Tablets problem and looking into consumer complaints that products made at the plant were ineffective. The report said a J&J employee used the wrong testing sequence to see how Imodium EZ Chew Tablets dissolve and used the same filter and syringe to take multiple samples of the dissolved tablets. WTF?
Ok that’s the small problem. The big problem is that all corporations are doing the same thing. Why?
Could the previous years of Republican policy of instructing the FDA to turn a blind eye to malpractices in companies that were large Republican donors have anything to do with it? Could the philosophy that businesses need to be freed for endless taxes and bureaucratic red tape be the core of the problem, and not the solution?
The problems were noted as early as 2003 but no action occurred until 2009.
The approach being advocated by Delaware’s Republican Senate Candidate is dangerous to the health and safety of every American. When businesses are not regulated by our government, then we have no knowledge or method to reckon against their harmful acts. In this case, the company was just lazy. They made a conscious decision not to comply with acceptable methods of testing, and assumed no one could hold them accountable for it. In this case, your tax money was used by the Federal Drug Administration to go into a facility, investigate it’s methods, and finding several contamination issues, use it’s authority to close it down. This is a prime example where government is good. This is a prime example of why we need more government, not less. This is what happens when you don’t mind the candy store, which is exactly what Christine O’Donnell is proposing when she says do away with bureaucratic red tape. We need someone minding the candy store. We just need it.
So how does Christine O’Donnell, Republican for Senate, feel this problem should be taken care of? What is the official republican response to having bacterial infectous diseases knowingly placed in bottle of infant Tylenol drops and sold to unsuspecting consumers?
They call for an investigation of the FDA.. No shit. When bacterial contamination known to cause gastro-intestinal problems is knowingly sold to very sick and hospitalized infants… their reaction is to call for an investigation of the FDA…
Chistine O’Donnell says so on her website.
To promote jobs, we need to do away with bureaucratic red tape…… Meanwhile babies die. (But no. … we can’t kill the unborn. Let’s wait till they’re delivered,.. then kill them with bacteria knowingly left in their medicine bottles by one of our big contributors…..)
If we get caught…… we’ll spend a $1000 dollars to pay off a congressman who will then call for an investigation of the FDA ..
So if your reading this, you’re human. Let me ask you,.. how do you want your tax dollar spent? Do you want it spent on someone investigating the actual manufacturing plants to determine whether what’s popped in your mouth is clear of feces and bacterial contamination? Or do you want it spent on investigating the motives of the watchdog organization that is looking after your best interests…?
Christine is wrong on this one… Her Republican Party is out of touch with America and this: the willingness to look the other way when bacterial containments are knowingly put into infant’s medicine, and sold;…. proves it without a doubt.
8 comments
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September 29, 2010 at 2:59 pm
Duffy
You’re mixing apples and oranges here. You’re trying to conflate jobs and job loss with efficacy of regulations. The argument is not whether or not we need the FDA or how oversight should work. Regulations are a cost of doing business. When you’re costs increase, you have to either increase the cost of your product as an offset or find overhead reductions (i.e. labor cost). That means either hiring cheaper people or fewer of them. We have a price floor on labor in the form of minimum wage so you can’t go below that. The only other way to cut labor costs is to have fewer people.
As for J&J’s behavior in this matter, that’s entirely separate. It sounds like that plant is very poorly run. I’m not bothered that they cannot product an org chart but it does say something about how poorly the plant is run.
Pharma is the most tightly regulated industries in the nation and with good reason. The FDA appears to have done it’s job in this instance and they s/b applauded for it. That doesn’t mean that the FDA isn’t onerous in it’s regulations in other areas or that it does not need to be reformed. That again, is a completely different discussion.
It’s basic economics. In order to make money you have to charge more than it costs you from end to end, to produce a product or provide a service.
Raw materials, labor, regulations, taxes, physical plant, design, testing, marketing/advertising, clinical trials, etc. are all part of that equation. All of those costs must be covered or you will simply go broke. Full stop.
September 29, 2010 at 3:21 pm
kavips
Going broke, or… posting a record profit? Going broke is one thing, but to follow push the envelope for additional dollars, … is not…
That probably accounts a little for the difference in the outrage, I would surmise… lol.
For the record, 900 jobs were diluted off the sales force. and 300 jobs were deleted because the plant was closed.
Point being, that not regulating sufficiently created an environment where sloppy practices occurred, resulting in a plant shutdown and reduction of sales force because the item they were selling, had all been recalled.
Point is, earlier enforcement could have saved jobs.
September 30, 2010 at 10:16 am
Scott Spencer
Thanks Kavips for doing a great job getting the dirty facts out on the FDA being asleep at the switch and corporate interests looking out for themselves instead of the people. In this case, sick babies who are vulnerable to the contaminated medicine that is supposed to help them were the victims of the politics of neglect fostered by corporate campaign contributions. Anyone championing cutting regulations is not a champion of the people. Following regulations effectively and consistently contribute to fair competition, safety, reliability and economies of scale which increases profits and jobs over the long-term. However, the corporate temptation to cut corners to boost short-term profits and bonuses is the reckless behavior that regulations are intended to provide protection for unsuspecting consumers. Unfortunately, campaign contributions have resulted in a government of the people, by the lobbyists for the corporations. Regulations and enforcement are not the priority in a country that emphasizes short-term political and profit gains and we have plenty of poster child candidates for this – Wall Street financial train wrecks, food safety violations, BP Gulf oil spill, sub-prime mortgage scams, etc.
September 30, 2010 at 12:52 pm
Duffy
Going broke, or… posting a record profit? Going broke is one thing, but to follow push the envelope for additional dollars, … is not…
Point taken. However you do have to remember that the CEO’s job is to maximize stakeholder value. If he’s in a precarious position w/ the board he may well do stupid things like cut corners to keep himself employed.
Smart corporations find a balance between maximizing profits/value and good community relations. Many of them do it badly because they’re lazy or stupid.
Point being, that not regulating sufficiently created an environment where sloppy practices occurred, resulting in a plant shutdown and reduction of sales force because the item they were selling, had all been recalled.
Moreover it never should have gotten to that point. They should have been running a better shop and they wouldn’t have had this problem in the first place.
Point is, earlier enforcement could have saved jobs.
Then why the alarmist headline? This is not a case of lack of regulations, it a case of a corporation acting badly and regulators not doing enough soon enough.
September 30, 2010 at 10:52 pm
kavips
Scott brings up a good point. There’s a balance between regulation and enforcement. Having no regulation, is bad… we’ve seen the results. Too much regulation, is bad…. if you’re older, you’ve seen the results..
Tweaking is what it’s all about. Something neither party will espouse because of the wing-nuts they have at their extremities. Violate one of there “natural laws”, and your nuts give you have hell to pay..
The cost effective way, is to have corporations police themselves. But, if there is no penalty for not doing so, then the cost of policing oneself, gets shoved aside. “Why throw away money for nothing?”
So what we need is a cost effective way to guarantee that corporations police themselves, and that if a CEO makes a shady call, employees within that company will see it’s in their company’s greater good to do things right and by the book, and apply internal pressure to make that happen.
Where we erred, was in removing the cost, or penalty for not doing so.
The history of sexual harassment has a lesson for all. Those of you who are young, do not realize it use to be common practice to try to see who could degrade a fellow female coworker with their sexual inappropriate language.
The law was changed to allow suits. One comment could cost a corporation up into the $100,000’s… Since the company couldn’t afford to lose $100,000 every day of the week, they spent money instead, to educate their staff and fire perpetrators unwilling to change to the new philosophy.
It’s safe to say, since sexual harassment lawsuits have taken place, the culture at the workplace was changed.
But here is the problem. You allow lawsuits to extol large sums from the company. But, at the same time, you have to expand tort reform, just to weed out unnecessary suits that are there solely for extortion.
Extortion costs money.
Therefore you need tough laws on the books. You need the ability to suck large amount of cash out of corporations in non- compliance. You need a large enough regulatory enterprise, to drop in unannounced…. It is the fear of such an apparatus… that will motivate each person in each company, to police themselves.
WE all know, that if no one is watching… it doesn’t matter what we do…….
As for Duffy…
I happen to like alarmist headlines… lol..
September 30, 2010 at 11:03 pm
kavips
The reason for the headline, was that jobs got lost because of McNeil’s poor business practices. It is a reminder that more deregulation may likewise be something we don’t wish for…
When a pendulum swings, it goes forward until a point. After passing the center, every step towards either side, throws it more and more off center. Eventually it’s own weight, overcompensates its forward motion, and it falls back to center…. repeating the entire process on the other side.
The time to insist on less taxes and less regulation, …. if I may be polite, has passed. They were overextended, and now, we must rush back to the safety of more taxes, and the threat of more regulation.
AS we meet success with those tactics, the tendency to pile more and more of those successes on the backs of American businesses, will be too powerful to resist. Eventually we will slow the forward movement to a crawl, and begin the process all over again.
Christine in the Carter years would make sense. Today, she is thirty years too late… or thirty years too early… Following her plan, would be as bad as piling more taxes on companies taxed too much already. She’s just out of her time…
October 1, 2010 at 8:15 am
Duffy
Thanks Kavips. It’s nice to have a sober debate w/o the screeching name calling found some other places.
Here’s’ the thing about taxes: the tax man gets a bite of EVERYTHING not just once but frequently more than once. That is unfair. In lean times government must tighten it’s belt more than you and me. We both know there’s outrageous spending in every level of government and until we have more transparency we’ll never know where that money is going.
How about this: Any worker who comes up with a cost savings for their agency that reduces waste/fraud or abuse gets a financial incentive. Give them %20 the annual savings in a tax free lump sum. You save NCC govt. 100K, here’s a check for 20K now go pay your bills.
October 2, 2010 at 8:39 pm
kavips
That’s an idea I can get behind. Everybody works for money. And putting power to control waste and abuse right down on the front lines where the waste and abuse occurs, is the most effective method.
If you don’t put an monetary reward behind it, you only save on the obsolete programs where no one gets hurt if they go away. No one is going to cost themselves a job by eliminating it. But it saving pipe, or some other expensive item, will make them richer, we all know they will do it.
And , the economic factor is that the 20% of the savings paid back, will probably be spent in this county, this local community, instead of whereever that expensive material was manufactured… quite possibly China.
So on three levels that idea works.
Personally, I like it for the message it sends. .. .. We will pay more for smartness.. In an work environment predominantly run by bullying over personal turfs, it would be nice, if some smart people got recognized for a change…
I do foresee a problem of how, within an organization, to determine who exactly was the one who caused the savings. I can see a lot of hands out, with logic twisted beyond recognition, all expecting in the name of fairness, to have a piece of say $20,000… For example… a worker brings up the idea, and the boss impliments it… Who get’s it?
Too much subjectivity.
And I don’t have time to flush this idea out, but perhaps an email account where the first person in on an idea, gets the credit…
We’ll see. 🙂
(As for screeching name calling… it happens among those devoid of ideas.. .. i I dread the day it catches up to me… lol.. )