"MA Pharmacy Executives Face Murder Charges in Meningitis Deaths"

ashley8918 · January 2015

Guys, this is FASCINATING (and also awful, obviously)! Or maybe it's just fascinating to me because it's my industry?

http://www.nytimes.com/2014/12/18/us/new-england-compounding-center-steroid-meningitis-arrests.html

http://www.nydailynews.com/life-style/health/mass-pharmacists-arrested-2012-meningitis-deaths-article-1.2048180

So the gist of this story is this:

A compounding pharmacy is a company that does not manufacture drugs, but instead, "combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient." (from the FDA definition). This particular compounding pharmacy did not have proper cleaning or sterility procedures in place, and as a direct result of this, introduced contamination into the drugs that they were compounding and selling. The contaminated drugs ended up killing 64 people, and making several hundred more sick with fungal meningitis.

Generally, in these sorts of cases, the company is subject to government/regulatory action such as forced closure (which did happen here), seizure of company assets and product, fines levied, etc. But in this case, actual criminal murder and racketeering charges are being pursued against certain individuals - employees/executes of the company. This sort of thing is pretty unprecedented in the US (it happens in the EU all the time, but they have vastly different regulations).

I'm interested in what you guys think about whether or not you guys think a murder charge is appropriate in cases like these?

I kind of compare it to drunk driving in a way, in my head. Sure, when you decided to drive drunk you probably didn't intend to kill someone. But you knew that you absolutely had a good chance of doing so. These company executives probably didn't say "hey, let's do it this way because we want to kill people". But they absolutely did know that operating under such conditions could kill people. Especially knowing that their drugs are injected straight into people's veins.

ETF: Fungal meningitis, not bacterial.

velvethelicopters · January 2015

Second degree charges are just saying they acted with extreme indifference, which then caused death. Which is exactly what they did. Looks like they're tying the murder charges to the racketeering charges to keep them federal.

But it's fungal meningitis, not bacterial.

larrygaga · January 2015

I suppose it should be involuntary manslaughter or malpractice more accurately. They may or may not sound flippant, but I do think it's pretty comparable to drunk driving, just on a larger scale. It's so easy to make a mistake when doing this kind of stuff, it's really frightening. I'm a little more forgiving, since I made a ton of mistakes all the time. I don't pass meds or inject people or anything, but I do document (psych) medications and how they relate to behaviors/cognition and mood and if I do it wrong (which is pretty easy) it can affect how our doctors look at a person's mental health. It's so easy to get a small number wrong or spell something slightly wrong and if you are a little bit tired or stressed or stop focusing for even a second you can mess up and not even notice. I don't think the company should get off because it was an accident, but we shouldn't act like it they actually did it on purpose.

unless they did

I didn't read the article, just your summary. I'm lazy.

ashley8918 · January 2015

velvethelicopters said:
Second degree charges are just saying they acted with extreme indifference, which then caused death. Which is exactly what they did. Looks like they're tying the murder charges to the racketeering charges to keep them federal.

But it's fungal meningitis, not bacterial.

Whoops! You're right, I wasn't paying attention to the type of meningitis, I guess. Thanks.

velvethelicopters · January 2015

See, this was more than a one off oops. This is a long term lack of basic manufacturing care, because to properly clean the facility, then restart production to appropriate standards would be hugely expensive, so they said fuck it and kept running with known contamination. 37 of 38 weeks hit action level tests, you do not keep running like everything is fine and good.

It's not a mistake. It's blatant indifference to human life simply to increase profit.

ashley8918 · January 2015

larrygaga said:

I suppose it should be involuntary manslaughter or malpractice more accurately. They may or may not sound flippant, but I do think it's pretty comparable to drunk driving, just on a larger scale. It's so easy to make a mistake when doing this kind of stuff, it's really frightening. I'm a little more forgiving, since I made a ton of mistakes all the time. I don't pass meds or inject people or anything, but I do document (psych) medications and how they relate to behaviors/cognition and mood and if I do it wrong (which is pretty easy) it can affect how our doctors look at a person's mental health. It's so easy to get a small number wrong or spell something slightly wrong and if you are a little bit tired or stressed or stop focusing for even a second you can mess up and not even notice. I don't think the company should get off because it was an accident, but we shouldn't act like it they actually did it on purpose.

unless they did

I didn't read the article, just your summary. I'm lazy.

It is absolutely easy to make a mistake. That's why robust procedures (such as cleaning and sterility testing procedures) are SO important in my industry. The fact that they purposely operated in unsanitary and generally unacceptable conditions really makes this less able to be attributed to a mistake in my mind.

ashley8918 · January 2015

velvethelicopters said:

See, this was more than a one off oops. This is a long term lack of basic manufacturing care, because to properly clean the facility, then restart production to appropriate standards would be hugely expensive, so they said fuck it and kept running with known contamination. 37 of 38 weeks hit action level tests, you do not keep running like everything is fine and good. It's not a mistake. It's blatant indifference to human life simply to increase profit.

Agreed to all of this. It is absolutely gross negligence, at the very least, on the part of everyone involved.

jenna8984 · January 2015

That is terrifying. There should be charges. My CFO would get thrown in jail if someone below (like me) fudged the financials and embezzled money. Because it's his job to review and approve everything. If you can get thrown in jail for that, then you definitely should be for causing the direct death of people!

I watched a show about back in the 80's before they knew about HIV/AIDS. They would let anyone donate blood and didn't have any testing for diseases since they didn't know about them. Then people who were otherwise healthy but needed blood transfusions were being given infected blood. An infected 8 year old boy (who died at 14) was the face behind the movement to start testing the blood. I find that so scary because what if that's the case right now, and there's some new disease that we don't currently know about and test for that's doing the same thing?! I know these aren't related, because it's lack of knowledge vs. negligence, I just wanted to share it because I found it disturbingly fascinating.

firebabe6519 · January 2015

velvethelicopters said:
See, this was more than a one off oops. This is a long term lack of basic manufacturing care, because to properly clean the facility, then restart production to appropriate standards would be hugely expensive, so they said fuck it and kept running with known contamination. 37 of 38 weeks hit action level tests, you do not keep running like everything is fine and good.

It's not a mistake. It's blatant indifference to human life simply to increase profit.

I agree with this entirely. With blatant disregard to whatever side effects or detrimental effects like this, I have no qualms against murder charges.

novella1186 · January 2015

I really love that individuals are being charged. In my line of work I have to read the medical data on this all the time and I'm sitting at my desk outraged and disgusted that human lives are discarded for profit with virtually no repercussions.

One of our major competitors, a few years ago, developed a product and began experimenting on pigs (standard procedure) to prove the viability or potential uses etc. The pigs immediately died. It was discovered that an unwanted side effect of the product was that it chipped off and formed blood clots which then went to the brain (because this was a spine product so it had a direct route) and caused immediate death.

The FDA stepped in and said "shut it down." When animal studies have that kind of result, it's an all-out NOPE. It ends there. That's it. Pick up your ball and go home.

Well the developers weren't happy about that. And they happened to be surgeons. So they took their product into the operating room. THEY EXPERIMENTED ON HUMAN PATIENTS WITHOUT THEIR KNOWLEDGE. That's fucking sick. That's Nazi shit. Do you know how many regulatory measures, proofs of consent, etc etc etc must be gone through for a patient to even be BRIEFED on what it might entail to have a new product used on them? These people weren't even AWARE of the product.

Four of them died on the operating table.

The company got fined, and went on with business as usual. The surgeons faced no repercussions. When I read the reports, I almost left my fucking industry, although the company I'm working for is luckily known for being extremely ethical.

So maybe it's unprecedented for individuals to face charges, but it's about fucking time.

ashley8918 · January 2015

novella1186 said:

I really love that individuals are being charged. In my line of work I have to read the medical data on this all the time and I'm sitting at my desk outraged and disgusted that human lives are discarded for profit with virtually no repercussions.

One of our major competitors, a few years ago, developed a product and began experimenting on pigs (standard procedure) to prove the viability or potential uses etc. The pigs immediately died. It was discovered that an unwanted side effect of the product was that it chipped off and formed blood clots which then went to the brain (because this was a spine product so it had a direct route) and caused immediate death.

The FDA stepped in and said "shut it down." When animal studies have that kind of result, it's an all-out NOPE. It ends there. That's it. Pick up your ball and go home.

Well the developers weren't happy about that. And they happened to be surgeons. So they took their product into the operating room. THEY EXPERIMENTED ON HUMAN PATIENTS WITHOUT THEIR KNOWLEDGE. That's fucking sick. That's Nazi shit. Do you know how many regulatory measures, proofs of consent, etc etc etc must be gone through for a patient to even be BRIEFED on what it might entail to have a new product used on them? These people weren't even AWARE of the product.

Four of them died on the operating table.

The company got fined, and went on with business as usual. The surgeons faced no repercussions. When I read the reports, I almost left my fucking industry, although the company I'm working for is luckily known for being extremely ethical.

So maybe it's unprecedented for individuals to face charges, but it's about fucking time.

YEP. You just perfectly summed up my thoughts on this. Unprecedented? Yep. Necessary/right? 10000000x YEP.

To the bolded: WHAT THE FUCKING FUCK WERE THEY THINKING? They already god damned fucking knew the effects of the product. No "experimenting" fucking necessary. JESUS FUCK. How did an entire group of people all agree to this fucking shit?! Was not a single one of them sane?

So many FUCK words.

huskypuppy14 · January 2015

This has been all over the news here for the last couple years. This is way more than a mistake. They knew exactly what they were doing and the last sentence of the article is this:

The indictment said Mr. Chin instructed his technicians to “prioritize production over cleaning and inspecting” and that he instructed them to “fraudulently complete cleaning logs.”

They knew their facilities were not clean, and they didn't care (it's called a clean room for a reason!). Then even though they knew their facility failed tests, they then didn't then test the medications made in those facilities for sterility . I work for a biotech company, and we have to test all samples for sterility before we inject them into mice. The fact that they didn't test those samples and forged records and improperly labeled some of the medication even though it was expired or untested, definitely makes it criminal IMHO.

ashley8918 · January 2015

jenna8984 said:

That is terrifying. There should be charges. My CFO would get thrown in jail if someone below (like me) fudged the financials and embezzled money. Because it's his job to review and approve everything. If you can get thrown in jail for that, then you definitely should be for causing the direct death of people!

I watched a show about back in the 80's before they knew about HIV/AIDS. They would let anyone donate blood and didn't have any testing for diseases since they didn't know about them. Then people who were otherwise healthy but needed blood transfusions were being given infected blood. An infected 8 year old boy (who died at 14) was the face behind the movement to start testing the blood. I find that so scary because what if that's the case right now, and there's some new disease that we don't currently know about and test for that's doing the same thing?! I know these aren't related, because it's lack of knowledge vs. negligence, I just wanted to share it because I found it disturbingly fascinating.

I agree. It is crazy to me that we treat money with more concern than human lives sometimes. WHAT?!

ashley8918 · January 2015

huskypuppy14 said:

This has been all over the news here for the last couple years. This is way more than a mistake. They knew exactly what they were doing and the last sentence of the article is this:

The indictment said Mr. Chin instructed his technicians to “prioritize production over cleaning and inspecting” and that he instructed them to “fraudulently complete cleaning logs.”

They knew their facilities were not clean, and they didn't care (it's called a clean room for a reason!). Then even though they knew their facility failed tests, they then didn't then test the medications made in those facilities for sterility . I work for a biotech company, and we have to test all samples for sterility before we inject them into mice. The fact that they didn't test those samples and forged records and improperly labeled some of the medication even though it was expired or untested, definitely makes it criminal IMHO.

Whoa. I must have missed that last sentence. HELL TO THE FUCKING NO. I work in oral and injectable pharmaceutical manufacturing. Do you know what we prioritize over quality? LITERALLY NOTHING. EVER. Quality is the absolute most important thing in the world in this industry.

huskypuppy14 · January 2015

novella1186 said:

I really love that individuals are being charged. In my line of work I have to read the medical data on this all the time and I'm sitting at my desk outraged and disgusted that human lives are discarded for profit with virtually no repercussions.

One of our major competitors, a few years ago, developed a product and began experimenting on pigs (standard procedure) to prove the viability or potential uses etc. The pigs immediately died. It was discovered that an unwanted side effect of the product was that it chipped off and formed blood clots which then went to the brain (because this was a spine product so it had a direct route) and caused immediate death.

The FDA stepped in and said "shut it down." When animal studies have that kind of result, it's an all-out NOPE. It ends there. That's it. Pick up your ball and go home.

Well the developers weren't happy about that. And they happened to be surgeons. So they took their product into the operating room. THEY EXPERIMENTED ON HUMAN PATIENTS WITHOUT THEIR KNOWLEDGE. That's fucking sick. That's Nazi shit. Do you know how many regulatory measures, proofs of consent, etc etc etc must be gone through for a patient to even be BRIEFED on what it might entail to have a new product used on them? These people weren't even AWARE of the product.

Four of them died on the operating table.

The company got fined, and went on with business as usual. The surgeons faced no repercussions. When I read the reports, I almost left my fucking industry, although the company I'm working for is luckily known for being extremely ethical.

So maybe it's unprecedented for individuals to face charges, but it's about fucking time.

Novella,would you mind PM me more details about this case. I'd like to read more about it.

ashley8918 · January 2015

huskypuppy14 said:

novella1186 said:

I really love that individuals are being charged. In my line of work I have to read the medical data on this all the time and I'm sitting at my desk outraged and disgusted that human lives are discarded for profit with virtually no repercussions.

One of our major competitors, a few years ago, developed a product and began experimenting on pigs (standard procedure) to prove the viability or potential uses etc. The pigs immediately died. It was discovered that an unwanted side effect of the product was that it chipped off and formed blood clots which then went to the brain (because this was a spine product so it had a direct route) and caused immediate death.

The FDA stepped in and said "shut it down." When animal studies have that kind of result, it's an all-out NOPE. It ends there. That's it. Pick up your ball and go home.

Well the developers weren't happy about that. And they happened to be surgeons. So they took their product into the operating room. THEY EXPERIMENTED ON HUMAN PATIENTS WITHOUT THEIR KNOWLEDGE. That's fucking sick. That's Nazi shit. Do you know how many regulatory measures, proofs of consent, etc etc etc must be gone through for a patient to even be BRIEFED on what it might entail to have a new product used on them? These people weren't even AWARE of the product.

Four of them died on the operating table.

The company got fined, and went on with business as usual. The surgeons faced no repercussions. When I read the reports, I almost left my fucking industry, although the company I'm working for is luckily known for being extremely ethical.

So maybe it's unprecedented for individuals to face charges, but it's about fucking time.

Novella,would you mind PM me more details about this case. I'd like to read more about it.

------------HI IM A BOX------------

Me too, if you are comfortable. No biggie if not.

novella1186 · January 2015

ashley8918 said:

huskypuppy14 said:

novella1186 said:

I really love that individuals are being charged. In my line of work I have to read the medical data on this all the time and I'm sitting at my desk outraged and disgusted that human lives are discarded for profit with virtually no repercussions.

One of our major competitors, a few years ago, developed a product and began experimenting on pigs (standard procedure) to prove the viability or potential uses etc. The pigs immediately died. It was discovered that an unwanted side effect of the product was that it chipped off and formed blood clots which then went to the brain (because this was a spine product so it had a direct route) and caused immediate death.

The FDA stepped in and said "shut it down." When animal studies have that kind of result, it's an all-out NOPE. It ends there. That's it. Pick up your ball and go home.

Well the developers weren't happy about that. And they happened to be surgeons. So they took their product into the operating room. THEY EXPERIMENTED ON HUMAN PATIENTS WITHOUT THEIR KNOWLEDGE. That's fucking sick. That's Nazi shit. Do you know how many regulatory measures, proofs of consent, etc etc etc must be gone through for a patient to even be BRIEFED on what it might entail to have a new product used on them? These people weren't even AWARE of the product.

Four of them died on the operating table.

The company got fined, and went on with business as usual. The surgeons faced no repercussions. When I read the reports, I almost left my fucking industry, although the company I'm working for is luckily known for being extremely ethical.

So maybe it's unprecedented for individuals to face charges, but it's about fucking time.

Novella,would you mind PM me more details about this case. I'd like to read more about it.

------------HI IM A BOX------------

Me too, if you are comfortable. No biggie if not.

No problem

velvethelicopters · January 2015

@novella1186‌ - can I get the PM also? I'm 99% sure I know what you're talking about.

I'm in the industry, but as trainer/compliance for production. So the MA case is my area. It's so infuriating to me. My company is so careful, yet mistakes happen. We get FDA in and fines and major headaches. Yet our mistakes aren't likely to be fatal, plus we catch them and self report because we caught X but Y was ran on the same line and might have been missed. Yet here's a company doing nothing right and trying to hide it. Damn right I am all for prosecution to the highest possibly. Hell, I'd be in favor of prosecution of ANY employee who knew how fucked up it was. Use the whistle blower protection before people die from contaminated drugs.

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