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FDA Slams EpiPen Maker For Doing Nothing While Hundreds Failed, People Died (arstechnica.com)

Posted by BeauHD on from the I'll-be-damned dept.

An anonymous reader quotes a report from Ars Technica: The manufacturer of EpiPen devices failed to address known malfunctions in its epinephrine auto-injectors even as hundreds of customer complaints rolled in and failures were linked to deaths, according to the Food and Drug Administration. The damning allegations came to light today when the FDA posted a warning letter it sent September 5 to the manufacturer, Meridian Medical Technologies, Inc. The company (which is owned by Pfizer) produces EpiPens for Mylan, which owns the devices and is notorious for dramatically raising prices by more than 400 percent in recent years. The auto-injectors are designed to be used during life-threatening allergic reactions to provide a quick shot of epinephrine. If they fail to fire, people experiencing a reaction can die or suffer serious illnesses. According to the FDA, that's exactly what happened for hundreds of customers. In the letter, the agency wrote: "In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died."

The agency goes on to lambast Meridian Medical for failing to investigate problems with the devices, recall bad batches, and follow-up on problems found. For instance, a customer made a complaint in April 2016 that an EpiPen failed. When Meridian disassembled the device, it found a deformed component that led to the problem -- the exact same defect it had found in February when another unit failed.

80 comments

  1. A warning letter by willoughby · · Score: 4, Insightful

    Yeah, that'll teach 'em.

    1. Re:A warning letter by arbiter1 · · Score: 2

      Opens the door for massive lawsuit by families that were effected. In the end if it happen, be very expensive

    2. Re:A warning letter by Anonymous Coward · · Score: 3, Funny

      They were lucky it was not from the UN. In that case it would have been a strongly worded letter.

    3. Re:A warning letter by Anonymous Coward · · Score: 0

      No reasonable prosecutor.. and all that. You know how it goes for the untouchables.

    4. Re:A warning letter by ravenshrike · · Score: 1

      Given that the FDA purposefully slow-rolled all their competitors anything harsher and certain inconvenient facts might suddenly come to light.

    5. Re:A warning letter by wickerprints · · Score: 5, Insightful

      An FDA warning letter is not simply a sternly worded "please stop" message or a slap on the wrist. The phrase "warning letter" suggests a much more benign action than is actually the case.

      The purpose of these letters is is to document in clear terms (1) the scope of noncompliance, (2) whether any previous responses to the Agency were received, reviewed, and found adequate, and (3) any specific corrective and preventive actions the Agency expects the firm to complete and the timeframe in which such actions are to be completed. Failure to do so may result in further legal action without notice. So, a warning letter is basically the "last chance before we shut you down" communication. As a public document, it is also a notification to the public that there is an issue with a product. It's a necessary part of the legal paperwork FDA creates to justify enforcement action.

      Usually, a company works with the Agency to negotiate a path forward to compliance. But if the violation is severe enough, FDA can and does act unilaterally. But you also have to remember that we are talking about a grossly underfunded government agency that has to oversee the safety of not only drugs, but medical devices, cosmetics, and the entire nation's food supply. (Seafood, for example, is a big one.) Frankly, it is amazing that they are able to do what they can with the paltry funding they get from a business-friendly Congress that largely views the Agency as bureaucratic red tape and an impediment to developing cutting edge medicines. Some people would have us do away with any regulation entirely and return to the days of thalidomide and arsenic and snake oil salesmen.

      So if you want to put the blame on anyone here, blame the manufacturer for claiming to follow GMP but not actually spending the money to do it. Blame Wall Street for lobbying for lax regulation. Blame a Republican Congress that uses small government as an excuse to jeopardize public health and safety because their Big Business buddies aren't making enough profits.

      The bottom line is that FDA doesn't have enough regulatory power, doesn't have the manpower, and doesn't have the money to investigate every single company's products and practices that fall in their scope. They largely rely on the industry to be honest with them and with the public. They also rely on patients to report ADRs or product failures, as was the case here with EpiPen. If there is an area where I feel the FDA is especially failing consumers, it is with the overuse of opioids. Too little is being done and the patient risk/benefit profile clearly does not justify the way these drugs are being marketed and prescribed.

      It is sad that people continue to be harmed and die because of the willful negligence of profiteering corporations, but that's hardly a new story.

    6. Re:A warning letter by Anonymous Coward · · Score: 0

      This is outstandingly insightful and clearly written by someone with expertise in the industry. Thanks!

    7. Re:A warning letter by Rockoon · · Score: 3, Insightful

      This.

      The FDA caused the problem to begin with by changing the standards and requiring all delivery systems to be re-certified. Most of the alternatives were phased out because re-certification is too expensive.

      One can argue that Mylan caused the problem by lobbying the FDA to change the standards as it knew that its competitors couldnt afford to re-certify, but it was the FDA that held the power to do it or not do it, and they went ahead and did it.

      The FDA was good up until the thalidomide incident. Thalidomide was causing birth defects all across Europe but not in America because Europe only required Efficacy standards while America only required Safety standards. The one thing Thalidomide had going for it was Efficacy (the stuff worked as advertised.) After the thalidomide fiasco, the FDA took the European scandal opportunity to increase the scope of its power and influence by petitioned congress to add Efficacy testing. It made no sense but the reasons for expanding government power rarely does.

      So now getting anything passed the FDA is insanely expensive, so expensive that real life saving drugs and devices never see the light of day. So now any change to standards for particular devices or drugs regardless of for Safety or Efficacy always removes players from the market purely for financial reasons. Every time, just like this time.

      Fuck the FDA.

      --
      "His name was James Damore."
    8. Re: A warning letter by Anonymous Coward · · Score: 3, Funny

      This is very one-sided. In Pfizer's defense they have released a statement that they have always put profits, err patients, first. You can't expect them to spend a huge amount of money on a small product. They only sell about 1,000,000 of these per year, and the $200M profit barely covers their executive bonuses.

    9. Re: A warning letter by Anonymous Coward · · Score: 0

      Adamis filed a NDA with the FDA in 2014 for a prefilled epinephrine syringe. How long will it take to get approval? Is there some doubt about safety or efficacy?

      http://www.adamispharmaceuticals.com/pipeline/epinephrine-pfs/

    10. Re: A warning letter by Anonymous Coward · · Score: 1

      The FDA is very conservative compared to say the European ema. From years of regulation of a very litigious and deep pocketted industry. Also there is 0 care about the effect of competition and cost to consumer in the regulator process. Even those clearly have effect on real world efficacy. Epipen is a good example, regulation of such devices pushed competitors out . Left the biggest player standing who price gouged, and so people started to use the device out if date etc. also FDA looses a regulatory tool if there is no competition, removing a drug from the market. They couldn't threaten to remove epipen from sale without effective alteenatives. The lawsuits from endangering patients would be massive.
      Another example is biosimilars, generic antibody drugs. The FDA refused to offer a real way to approve generic versions of these drugs. Providing perpetual monopolies past the patent period. The affordable care act forced the FDA to provide an approval pathway. The first of these biosimilars are just getting approved, so expect prices of these to decrease in the next few years . But every biosimilars approval has also had an immediate lawsuit and litigation between the original manufacturer and competitor. It hasn't been easy.

    11. Re:A warning letter by snakeplissken · · Score: 1

      You make an interesting point which has only two tiny flaws:

      1. It's bollocks - http://www.nhs.uk/Conditions/A...

      2. It's bollocks - https://lifestyle.walsallhealt...

      snake

    12. Re:A warning letter by hawguy · · Score: 2

      After the thalidomide fiasco, the FDA took the European scandal opportunity to increase the scope of its power and influence by petitioned congress to add Efficacy testing. It made no sense but the reasons for expanding government power rarely does.

      Isn't it easier to prove efficacy than to prove safety?

      To prove that something works you just have to show that people had an improvement in the condition being treated. You don't need to follow up every side effect and see if it was caused by your drug.

      In any case, why is efficacy testing a bad thing? Shouldn't a drug be proven to actually treat the condition it's supposed to be treating?

      The cost to bring a drug to market is excessive, but that doesn't mean that drugs should be sold without any proof that they work.

    13. Re:A warning letter by Trailer+Trash · · Score: 0

      Yeah, that'll teach 'em.

      That's my thought. Isn't the entire point of the FDA to keep shit like this from happening in the first place? I thought the entire reason they existed and drive the price of medicines up is that I can be assured that the medicines are proven effective and reliable. If all they're going to do is send stern letters after the fact then let's disband them. I can personally send pissy letters to people - I need the FDA to do a little more than that.

      --
      Do you have ESP?
    14. Re:A warning letter by Anonymous Coward · · Score: 0

      It's more complicated than that. The device was approved years ago, but there has been some bad batches that have not been reported or recalled properly. The saga has probably been going on for some time between FDA and Mylan, but now the FDA is actually flexing it's muscles. The next step after this is a forced recall.

      Now why couldn't they do this a 6 months ago? Well probably because Epipen was lacking significantly large competitors that could actually offer an alternative product at sufficient volume, which is why they could price gouge last year. There has been a few approvals of epipen competitors early this year, and with a number of alternatives the FDA probably feels it has enough backup in the market to actually be credible able to enforce Epipen off the market unless Mylen complies. This public letter is the last chance before they go down this track.

      Interesting example of FDA can flex it's muslces in other ways.. Pfizer had a high profile biosimilar approval rejected because the fill and finish plant they want to use was sited for issues in there processes on other products. This wasn't a rejection of the drug manufacture etc itself. Just the last step of packaging the product and not because the method itself was unsound, but the plant itself had serious issues that pfizer had ignored. Those issues were previously lost in the noise of pfizer news, but a rejection of a new drug product gets attention. See http://www.fiercepharma.com/regulatory/fda-rejects-pfizer-s-epogen-biosimilar-for-a-second-time

    15. Re:A warning letter by Rockoon · · Score: 1

      In any case, why is efficacy testing a bad thing? Shouldn't a drug be proven to actually treat the condition it's supposed to be treating?

      Ask anyone that cant get a drug that works because testing for their rare condition will never be done because the drug also works for some common condition.

      Good intentions for the sake of good intentions costs lives. Your policy is equivalent to murder.

      --
      "His name was James Damore."
    16. Re:A warning letter by hawguy · · Score: 1

      In any case, why is efficacy testing a bad thing? Shouldn't a drug be proven to actually treat the condition it's supposed to be treating?

      Ask anyone that cant get a drug that works because testing for their rare condition will never be done because the drug also works for some common condition.

      Good intentions for the sake of good intentions costs lives. Your policy is equivalent to murder.

      That's what off label prescribing is for -- if your doctor thinks that a drug will treat your condition even if that's not the primary purpose of the drug, he can prescribe it for that condition. But drug companies shouldn't be allowed to shot-gun all of their drugs on the market without any proof that they treat any condition at all.

      So call off the police, I haven't murdered any one.

    17. Re: A warning letter by Brockmire · · Score: 1

      No. This is a manufacturer QA problem. The product is designed and produced. They just need to have quality testing and do basic product recalls when they fuck up. It is a combination of asshole and incompetence that was completely avoidable if they weren't fucking cunts.

  2. Give us a break! by Anonymous Coward · · Score: 0

    Profits are up year-over-year and you're complaining about this? Come on! Profit!

  3. Thorough Investigation by ThisIsNotAName · · Score: 5, Insightful

    I'm sure that with the Mylan CEO being the daughter of a U.S. senator, there will be a thorough investigation of all of this.

    1. Re:Thorough Investigation by ThisIsNotAName · · Score: 2

      I intended to end that with a </s>.
      *sigh*

    2. Re: Thorough Investigation by Anonymous Coward · · Score: 0

      Don't worry, us ACs got it.

    3. Re: Thorough Investigation by Anonymous Coward · · Score: 0

      We don't have assburgers

    4. Re:Thorough Investigation by Anonymous Coward · · Score: 0

      They'll certainly find out who dared put all of this information together and allow it to be leaked to the public and make an example of them once and for all.

      When are we going to start giving proper actual consequences to the decision-makers in all these corporations? Why do *they* still get to live when murdering en-masse just for a few bucks more?

    5. Re:Thorough Investigation by DNS-and-BIND · · Score: 1, Informative

      You left out the part where Sen. Manchin, her father, is a Democrat. Funny that. It's almost like that's an inconvenient truth and we'd like to keep the Dems clear of any whiff of scandal.

      Fun fact: 77.67% of criminals (convicted of felonies and sentenced to prison sentences) working in the United States elected offices are Left Wing officials while 22.33% are Right Wing.

      --
      Shutting down free speech with violence isn't fighting fascism. It IS fascism!
    6. Re: Thorough Investigation by Anonymous Coward · · Score: 0

      So what you are saying is Democrats are three times as likely to prosecute corruption as Republicans. Yeah, at least they don't turn a blind eye to the incredibly egregious cases of corruption on their own team.

      If only more Republicans could do that.

    7. Re: Thorough Investigation by Anonymous Coward · · Score: 0

      If the Democrats suspected that, don't you think the numbers would be a little more in their favor? I would say it is one of two things, they do less with respect to corruption, or they are just better at hiding it. It should be up to the Democrats to PROVE the Republicans are doing the same thing that they do, but the numbers actually say otherwise.

    8. Re: Thorough Investigation by Anonymous Coward · · Score: 0

      Visit South Carolina some time...we just don't prosecute the obvious corruption by the ruling Republican Party.

    9. Re:Thorough Investigation by Anonymous Coward · · Score: 0

      You are joking right. Mueller is much too busy investing rumors and these murders go free. Love the dems. This is the way they work. They are as bad or worse than the republicans.

      We need to get rid of them and get more options.

  4. Invalidate their patents, dismantle both companies by Anonymous Coward · · Score: 2, Insightful

    This is really simple.

    Both companies should be ban hammered into the oblivion for public defrauding and endangerment. Make a good fucking example of 'em so the others fall in line.

    Oh, what am I saying- these companies own the American government. The only thing the FDA can do is send nasty letters. The moment they consider doing anything serious, money will be exchanged behind the scenes, and the whole thing will go away quietly.

    Nice country ya'll got there. At least you got your freedom though, right? Freedom to pay exorbitant prices for life saving medication and freedom to die when that medication fails to work.

  5. Slam bam thank you ma'am. by fustakrakich · · Score: 2

    Yeah, that'll teach 'em.

    Well sure, if it's a firmly worded letter.

    This is all bullshit. Unless their patents and copyrights and corporate charter are revoked, it's just silly nonsense that will make no difference. There's no point in getting worked up over it.

    --
    “He’s not deformed, he’s just drunk!”
  6. We don't need no stinking regulations dept. by Anonymous Coward · · Score: 0, Offtopic

    Trump's FDA... A few dead here, a few dead there,... pretty soon it adds up to the cost of writing a letter. A few more dead and it'll be a second letter.

  7. Needed to raise prices... by Anonymous Coward · · Score: 0

    ...to pay the legal costs.

  8. Let's see a negligient homicide charge! by chromaexcursion · · Score: 3, Interesting

    How to shake up the barrel!

    1. Re:Let's see a negligient homicide charge! by drew_kime · · Score: 4, Interesting

      Exactly. Elements of involuntary manslaughter (AKA negligent homicide):

      1. Someone was killed as a result of the defendant's actions.
      2. The act either was inherently dangerous to others or done with reckless disregard for human life.
      3. The defendant knew or should have known his or her conduct was a threat to the lives of others.

      --
      Nope, no sig
    2. Re:Let's see a negligient homicide charge! by Anonymous Coward · · Score: 0

      When a pattern of failed parachutes emerges then you bet they do. Especially if it can be proven that the manufacturer knew there was a problem and refused to take action to address it.

    3. Re: Let's see a negligient homicide charge! by Brockmire · · Score: 1

      Not automatically, but if the parachute guys put defective release mechanisms on them and knew they were defective, then yes, they should be charged. Common fucking sense.

  9. I am shocked - Shocked! by GerryGilmore · · Score: 1, Flamebait

    That such a well-respected pillar of the medical-device community would behave in an un-ethical manner. Especially, Mylan! Why, they are the perfect exemplar of capitalism in health care in America, right? Right? Right? C'mon.....anyone?

    1. Re:I am shocked - Shocked! by fuzzyfuzzyfungus · · Score: 3, Insightful

      It's not as though this is a surprise or anything; but it's a pitiful follow-up to their, um, 'optimistic' pricing practices.

      The whole selling point of their product is reliable delivery even by an unskilled user under duress. The epinephrine is a cheap generic; the autoinjector is $600 of mechanism wrapped around it.

      For that kind of money you deserve excellence; and they don't even appear to be delivering enough to avoid credible charges of negligence. That's just pitiful.

    2. Re:I am shocked - Shocked! by Anonymous Coward · · Score: 0

      They are fucking scum bags. No intelligent person is surprised.

    3. Re:I am shocked - Shocked! by Solandri · · Score: 1, Interesting

      This is a perfect example of the failure of government regulation in health care. If this had been a purely capitalistic system (not that I'm advocating pure capitalism for health care), anyone could manufacture an epi-pen type device. Once word got out that Mylan's product was failing and they weren't doing anything to fix the defect, people would stop buying them and switch to a competitor's product which was reported to be reliable on the net. Mylan's reputation would be tarnished as producing unreliable health products, and they possibly could have gone bankrupt as people stopped buying their other products as well based on their poor reputation.

      The reason there's no competition and Mylan sells the only epi-pen on the market is because FDA regulations have made it prohibitively expensive for a competitor to introduce an alternative into the market. Since it's the FDA's fault there's only one product on the market, the onus is on the FDA to make sure it is reliable and effective. They failed to do that in a timely manner.

    4. Re:I am shocked - Shocked! by Anonymous Coward · · Score: 2, Insightful

      And then we would have hundreds of undependable knockoffs on the market...

    5. Re:I am shocked - Shocked! by Anonymous Coward · · Score: 0

      quote> ... the onus is on the FDA ...

      This is the problem with lassez-faire capitalism: It's easy for the government to avoid auditing the supplier, many-times at the request of that supplier (ie. cronyism). It allows for shoddy merchandise despite government regulations, overpriced goods and consumers unable to "vote with their wallets". The suppliers in turn, realize they have a gutless government and ignore (or write) building codes, labour and immigration laws, delegated laws from the EPA and FCC.

      ... raising prices by more than 400 percent ...

      Why aren't shareholders screaming about the lack of revenue? Because there is only one shareholder, who's decided to not complain. This is the problem with corporations owning corporations (in the same industry): It is less vertical integration and more parasitically feeding from each other's success or failure. This is why most corporations on the Fortune 50 lists are "too big" to fail/jail.

    6. Re:I am shocked - Shocked! by Anonymous Coward · · Score: 2, Funny

      And then we would have hundreds of undependable knockoffs on the market...

      No, what we would have is several free market options based on competition, rather than what we have which is a monopoly. It is sad that we have an idiot like Donald Trump as president instead of a real Republican like Theodore Roosevelt who would have not stood for this crap or the type of bullshit that piss ant Martin Shkreli tried to pull.

      How far we have fallen as a society in just 100 years! I blame the educational system decline and corporate America getting out of control and having it's tendrils firmly embedded in the government.. Lobbying should be outlawed because of shit like this. We would need a constitutional Amendment to make it happen, but it will never happen because too many dollars are changing hands this way for too long.

    7. Re: I am shocked - Shocked! by Anonymous Coward · · Score: 0

      They need the money for research into an injector that works. Research! Think of the children!

    8. Re:I am shocked - Shocked! by DNS-and-BIND · · Score: 2

      You are correct to point out the many problems with capitalism . Dealing with an excess of plenty is a challenge, and it will be a challenge going into the future. Under socialism, there wouldn't be any products at all.

      Capitalism: bread waits for people. Socialism: people wait for bread.

      --
      Shutting down free speech with violence isn't fighting fascism. It IS fascism!
    9. Re: I am shocked - Shocked! by Anonymous Coward · · Score: 0

      So you are saying that without copyright,etc a fee major players could make reliable options for us. Fair enough. Amazon brand vs Walmart brand vs Coca-Cola branded insulin pens make sense.

      But what, specifically, keeps me from making water injection pens and making them look like Coke brand insulin shots? Nothing? Yeah, that will work just fine...

    10. Re:I am shocked - Shocked! by aix+tom · · Score: 3, Funny

      Capitalism: bread waits for people. Socialism: people wait for bread.

      And then you have the American system. Corporations using the government to bully the people into buying overpriced bread that nobody really wants. ;-)

    11. Re:I am shocked - Shocked! by Anonymous Coward · · Score: 0

      This is a perfect example of the failure of government regulation in health care.

      Only if you willfully and deliberately blind yourself as a means of creating a myopic view of the situation.

      Checks name of poster...oh wait, Solandri, yeah, that is what you do.

      If this had been a purely capitalistic system (not that I'm advocating pure capitalism for health care), anyone could manufacture an epi-pen type device.

      If? You are speculating here, and mysteriously pretending that your conjecture has some basis in reality. And I notice a glaring oversight. You are leaving out something...how it is to be functional, safe, and effective.

      Once word got out that Mylan's product was failing and they weren't doing anything to fix the defect, people would stop buying them and switch to a competitor's product which was reported to be reliable on the net.

      Really, and you expect word to have gotten out how quickly, and with what results? Word did not get out about these Mylan failures as it is. Now you expect the net to "magically" produce different results?

      Mylan's reputation would be tarnished as producing unreliable health products, and they possibly could have gone bankrupt as people stopped buying their other products as well based on their poor reputation.

      And the reason that couldn't happen now is? Do you feel obligated to purchase Mylan products?

      The reason there's no competition and Mylan sells the only epi-pen on the market is because FDA regulations have made it prohibitively expensive for a competitor to introduce an alternative into the market. Since it's the FDA's fault there's only one product on the market, the onus is on the FDA to make sure it is reliable and effective. They failed to do that in a timely manner.

      Did they? Why and how? What particulars contributed to this failure you allege? Is the problem you're describing, a lack of effective action, in other words, the opposite of the vaunted "pure capitalism" that you presented as your initial hypothetical? What solutions are you suggesting, you seem to imply that they need to make sure it is reliable and effective, but fail to answer how.

      Maybe instead of such a quick declaration that you have a "perfect example" you should try a more nuanced, and considered approach that doesn't make you come across as a mindless zealot parroting some tedious philosophy book, then going off in a different direction without much coherence or demonstrated examination of your thoughts.

    12. Re:I am shocked - Shocked! by whoever57 · · Score: 1

      The epinephrine is a cheap generic; the autoinjector
      is $600 of mechanism wrapped around it.

      No, it's only about $30 of mechanism wrapped around it. The price is completely unrelated to the cost of manufacturing and entirely due to near-monopoly created by regulations that, strangely, the Republicans don't seem interested in getting rid of.

      --
      The real "Libtards" are the Libertarians!
    13. Re:I am shocked - Shocked! by Anonymous Coward · · Score: 0

      You are correct to point out the many problems with capitalism.

      You are incorrect to be in denial about the many problems with capitalism.

      Dealing with an excess of plenty is a challenge, and it will be a challenge going into the future.

      Yep, excess pollution, excess consumption, excess corruption, all the way to destruction. Plenty of it, and it is a continual challenge. Even to the people who close their eyes and blind themselves.

      Under socialism, there wouldn't be any products at all.

      Under capitalism, the people are the product. And they tend to get eaten.

      Capitalism: bread waits for people. Socialism: people wait for bread.

      I see you've never been to Panera at Breakfast time.

      But if we're going to go with such:

      A capitalist, a man who gives people sawdust, calls it bread, and sings a song to customers how it is healthier for them(Just like a monorail), and cure for all that ails them, then runs away when questioned about all the feces found in it.

      A socialist, a man who sees the people lacking in healthy and nutritious meals, so makes sure that they know what should be in bread, rather than be exposed to the feces-ridden sawdust that the capitalist tried to foist off on them.

    14. Re: I am shocked - Shocked! by Brockmire · · Score: 1

      Fuck, that's bad info and conclusion. Alternatives have been discussed ON /. the previous times they jacked up pricing. LMGTFY https://www.consumerreports.or... The government needs to make sure they make SAFE products. Having more, cheaper, unregulated devices is about the stupidest thing I've read today. This is purely ignoring manufacturing quality due to fuck face management. I don't make life saving devices and we put more QA into our products. Fuck these no QA assholes.

  10. well by Anonymous Coward · · Score: 0

    I thought that the billionaire-controlled Republican party had been trying to gut product liability laws so that corporations couldn't be held morally responsible for hurting or killing people?

    If they succeeded in that quest to remove all morality, there may be nothing that can be done.

  11. Buy a thesaurus before I slam you by Presence+Eternal · · Score: 1

    Afterwards, they tagteamed with the EPA and suplexed pharmabro. He tried to escape by putting the fda in a half nelson, but was defeated with a Cement Job.

  12. Re:NOTHING IS EVER GOING TO HAPPEN TO THAT COMPANY by PopeRatzo · · Score: 5, Insightful

    The CEO is the daughter of a democrat senator.

    A democratic senator who is a reliable vote for the Republicans. Joe Manchin is the scum of the earth. Being a Democrat in West Virginia means you're a Republican, as we've seen with the sitting governor deciding to formally switch to the GOP.

    There are no recall elections in West Virginia for statewide or federal office-holders.

    --
    You are welcome on my lawn.
  13. The Netherlands had a recall by Skinkie · · Score: 4, Informative

    In The Netherlands there was a recall for two bad EpiPen batches last year. Hence I wonder why the same isn't done in the USA. But for better reasons I switched manufacturer: If you compare EpiPen, Jext and Emerade, you will find that the needle length of Emerade is significantly longer. Therefore penetrating the skin deeper and overcome first world problem: fat. The drug is then delivered in the muscle, where it is supposed to be. Next to that, the operation of the Emerade is more successful without advanced patient instruction and practice.

    --
    Support Eachother, Copy Dutch Property!
  14. The price increase makes sense now by Anonymous Coward · · Score: 0

    The increase in price makes sense now.

    They probably knew of these problems and raised the price since they did not know if once the general public were informed of the issue if the company would lose its "cash cow" product as well to pump up the war chest for any possible litigation related to the failures...........

    or maybe I just watch too much "Law and Order" :-)

  15. Only one way to handle this by bothorsen · · Score: 0

    Okay, so they got slammed. And they may see a 10 or 20 % drop in their sales. So what? They still have a *massive* profit on it. They just raised the price to 400% - assuming the profits were only 20% of the old price, that still leaves a 80% profit today.

    They make a ton of money while apologizing for all the failures of the product.

    That means these guys make profits while people die. And the FDA just slams them? WTF good does this do?

    Those guys need a fine in the magnitude of what EU handed Apple and Google. Otherwise the most profitable thing they can do is - what? Pop quiz, think about it. It's to do absolutely nothing.

    The only way to make a company like this listen is to take away their profits. Otherwise, you're going to see FDA slamming them all the way to the bank for the next ten years.

    But with the current US administration, what are the chances that this will happen? Take this pop quiz too, see the answer yourself. It's probably going to be what you fear :(

  16. Companies should not be allowed to self-investigat by gurps_npc · · Score: 1

    The FDA should investigate all claims of malfunctioning products and charge the company money for doing so.

    Depending on self-policing is not reasonable for medical issues, anymore than it was for EPA regulations of diesel pollution.

    --
    excitingthingstodo.blogspot.com
  17. Drop them. by Going_Digital · · Score: 1

    Oooh, send them a letter that will frighten them! Just drop them from the government recommended medication for use in schools and recommend one of the alternatives instead. Money is the only thing these corporations listen too, cut off the money to punish them.

    1. Re:Drop them. by serviscope_minor · · Score: 1

      Actually it will. An FDA lawyer is essentially saying "fix your shit. You have 10 seconds to comply".

      It's part of the formal legal process. The letter is a matter of public record and basically the last stage before legal action.

      --
      SJW n. One who posts facts.
    2. Re: Drop them. by Anonymous Coward · · Score: 0

      Cheaper to hire a lobbyist and change the rules. Problem solved.

  18. Re:Companies should not be allowed to self-investi by serviscope_minor · · Score: 1

    well that will rule out may about any startup from ever getting to market. Not everything is life and death like an epipen.

    And it wouldn't have worked here. Epinephrine is known to work, and the majority of epipens work too. Unless you're proposing that the fda sample and test every batch, they may well not have caught it anyway.

    --
    SJW n. One who posts facts.
  19. Counterpoint by Anonymous Coward · · Score: 1

    Unless the FDA authorizes them to change something, then they may not change anything about how they manufacture, assemble, market or distribute the product. Their only option is to stop production and wait for a bureaucracy to get around to approving the corrective action.

    1. Re:Counterpoint by sjames · · Score: 2

      Nonsense. They are perfectly free to recall bad batches that were clearly NOT made to the specs and standards that have been approved and replace those units with some that have.

      The letter states that they failed to do that.

  20. Re:NOTHING IS EVER GOING TO HAPPEN TO THAT COMPANY by Hognoxious · · Score: 2

    I bet his family name was originally along the lines of McIninch, because he certainly seems like a true Scotsman.

    --
    Confucius say, "Find worm in apple - bad. Find half a worm - worse."
  21. Don't worry, the market will fix itself by Anonymous Coward · · Score: 0

    Don't worry, the market will fix itself... after hundreds of death.

  22. Re:Misplaced ire by Khyber · · Score: 2

    "NOBODY died on account of this product"

    There are dozens of reported cases where the pen failed to deliver or trigger and the person died as a result, both in the USA and EU. Only the EU forced a recall of the faulty injectors. Perhaps you should actually look into these cases before spouting off about that which you know nothing of.

    --
    Still waiting on Serviscope_minor to wake up to fucking reality and realize that Jessica Price isn't going to fuck him.
  23. Re:NOTHING IS EVER GOING TO HAPPEN TO THAT COMPANY by PopeRatzo · · Score: 1

    because he certainly seems like a true Scotsman

    He may well be a True Scotsman. He certainly is a True Jackoff.

    --
    You are welcome on my lawn.
  24. They Died for Profit, they Died for Jesus by Anonymous Coward · · Score: 0

    God bless these noble Americans for dying to enrich the almighty Corporations and their blessed profits

  25. Re:Misplaced ire by WolfgangVL · · Score: 1

    There are dozens of reported cases where the pen failed to deliver or trigger and the person died as a result

    Wrong.

    They died as a direct result of anaphylactic shock, (a condition they had all been aware of before hand) and trusting their lives to automated medicine. Pointing fingers at the company who's product has made life saving emergencies so damn easy that nobody can even handle doing things manually anymore is stupid.

    Have a little perspective.

    If this was ANY other automation device, the entire slashdot crowd would be pointing and laughing, but since we decided we hate the dude on account of his price gouging, we're all torches and pitchforks.

    --
    You are being ripped off every second of every day, so that advertisers can help rip you off even more tomorrow.
  26. Re:Invalidate their patents, dismantle both compan by i.r.id10t · · Score: 1

    Somewhat this.

    If private property can be taken under "eminent domain" why can't the applicable patent(s) be taken and free license to produce given to multiple corporations?

    --
    Don't blame me, I voted for Kodos
  27. Re:Misplaced ire by Khyber · · Score: 1

    Found the FDA shill. Come back when you've got a clue about Vioxx.

    --
    Still waiting on Serviscope_minor to wake up to fucking reality and realize that Jessica Price isn't going to fuck him.