Is this legal?

Slammy1

Platinum Member
Apr 8, 2003
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Well, I walked out on my job Monday. I'm a chemist in the pharmaceutical industry, and the company VP told me I had to do something illegal (release some out of spec material). I've already had an interview, and they wanted someone from there as a reference. I left a message in his voice mail, then called back later and it turned out they told him if he gave me a reference they would fire him. I didn't want to have to go to the FDA, which in a sense I'm legally obligated to do, now I'm thinking I need to do that and maybe contact a lawyer. I found out my last day the previous guy in my position was told to release stuff or be fired a number of times. What do you think I should do?
 

DurocShark

Lifer
Apr 18, 2001
15,708
5
56
I'd go to the FDA as well as contact a lawyer.

The trigger event wasn't an LCD maker fibbing on the response times. Chemicals out of spec can cause signifigant damage to people and/or the environment (depending on the chem and its use).
 

vi edit

Elite Member
Super Moderator
Oct 28, 1999
62,484
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FDA and a lawyer who is familar with the pharmaceutical industry would be my first thoughts...
 

Regs

Lifer
Aug 9, 2002
16,665
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Dude, never talk about this stuff here! I'm working for a competing pharmaceutical company. Last thing you want is to say something that will tip off a news reporter and make the legality of your situation 100x worse.
 

prvteye2003

Diamond Member
Jun 19, 2003
3,876
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Originally posted by: DurocShark
I'd go to the FDA as well as contact a lawyer.

The trigger event wasn't an LCD maker fibbing on the response times. Chemicals out of spec can cause signifigant damage to people and/or the environment (depending on the chem and its use).

 

dpm

Golden Member
Apr 24, 2002
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Originally posted by: Slammy1
Well, I walked out on my job Monday. I'm a chemist in the pharmaceutical industry, and the company VP told me I had to do something illegal (release some out of spec material). I've already had an interview, and they wanted someone from there as a reference. I left a message in his voice mail, then called back later and it turned out they told him if he gave me a reference they would fire him. I didn't want to have to go to the FDA, which in a sense I'm legally obligated to do, now I'm thinking I need to do that and maybe contact a lawyer. I found out my last day the previous guy in my position was told to release stuff or be fired a number of times. What do you think I should do?

Hmm. what happened to the last guy?

I'd got the lawyer and fda way - cover your back!
 

Slammy1

Platinum Member
Apr 8, 2003
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76
To make matters worse, they already have suits against them for people dying from a previous problem. Yeah, I'll let it go here but I'm in the process of contacting a lawyer and the FDA right now.

EDIT: Reported to the FDA, now I'm in the process of finding a lawyer.

EDIT2: Contacted lawyer.
 

TMPadmin

Golden Member
Jul 23, 2001
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My wife is a pharmacist who could possibly distribute the drugs. Not saying this is the case but what if the specs were so far off that they could actually cause an adverse reaction in the body or with a different drug? It's possible that my wife could take the fall. FDA! Lawyer!
 

tk149

Diamond Member
Apr 3, 2002
7,253
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What company do you work for? Time to sell short...

EDIT: BTW, good for you for having the guts to stand up to them.
 

Noirish

Diamond Member
May 2, 2000
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Originally posted by: Slammy1
To make matters worse, they already have suits against them for people dying from a previous problem. Yeah, I'll let it go here but I'm in the process of contacting a lawyer and the FDA right now.

EDIT: Reported to the FDA, now I'm in the process of finding a lawyer.

EDIT2: Contacted lawyer.

Good, that's what a good citizen should do.
 

Feldenak

Lifer
Jan 31, 2003
14,090
2
81
Originally posted by: Slammy1
To make matters worse, they already have suits against them for people dying from a previous problem. Yeah, I'll let it go here but I'm in the process of contacting a lawyer and the FDA right now.

EDIT: Reported to the FDA, now I'm in the process of finding a lawyer.

EDIT2: Contacted lawyer.

Good job!
 

rgwalt

Diamond Member
Apr 22, 2000
7,393
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Originally posted by: Slammy1
To make matters worse, they already have suits against them for people dying from a previous problem. Yeah, I'll let it go here but I'm in the process of contacting a lawyer and the FDA right now.

EDIT: Reported to the FDA, now I'm in the process of finding a lawyer.

EDIT2: Contacted lawyer.

Good move. It is a part of your professional obligation to take this sort of thing to the proper authorities. I'm a chemical engineer. I don't work in industry (I'm in grad school), but it is part of our ethical professional obligation to stay within the guidelines of the law. It takes a lot of character to disobey your boss, quit your job, and report the situation to the authorities. It is good to know that there are people like you in the world. For what it is worth, I'm proud of you.

Ryan

 

Slammy1

Platinum Member
Apr 8, 2003
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It's not black and white, the morality of it all is hard to define. It's not a myocardial drug where a slight assay variance could cause it to be mis-prescribed. But it is definitely contaminated with toxins. I cannot say at such a concentration as they would cause injury but they are definitely there. And there are people at the plant who will definitely be hurt by this decision, some of whom are my friends. Only time will tell if it was the correct decision, I do not hold an arrogance that I'm absolutely correct in the matter at all. It weighs heavy on me that others come to harm as a consequence of my actions. But I did not go into pharmaceuticals for the money, instead in some vain hope I might improve the quality of life for others. Perhaps that is in itself an arrogance, or a vanity, and in my life's experience the greatest wrongs arise from arrogance and self centeredness. But I am obligated to the law, which sometimes is contradictory and at times meaningless. Only time will tell.
 

rgwalt

Diamond Member
Apr 22, 2000
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Originally posted by: Slammy1
It's not black and white, the morality of it all is hard to define. It's not a myocardial drug where a slight assay variance could cause it to be mis-prescribed. But it is definitely contaminated with toxins. I cannot say at such a concentration as they would cause injury but they are definitely there. And there are people at the plant who will definitely be hurt by this decision, some of whom are my friends. Only time will tell if it was the correct decision, I do not hold an arrogance that I'm absolutely correct in the matter at all. It weighs heavy on me that others come to harm as a consequence of my actions. But I did not go into pharmaceuticals for the money, instead in some vain hope I might improve the quality of life for others. Perhaps that is in itself an arrogance, or a vanity, and in my life's experience the greatest wrongs arise from arrogance and self centeredness. But I am obligated to the law, which sometimes is contradictory and at times meaningless. Only time will tell.

This isn't a philosophical situation. The FDA approval for the drug has specific guidelines that must be followed for the drug to be used for human consumption. If those guidelines aren't followed (out of spec as you said) and you were told to release the drug anyway, it violates the law. It is your ethical professional obligation to report this situation to the FDA. Morality and friendship has nothing to do with it. I'm sorry your friends may get hurt, but you took on an obligation when you took this job. It may be "grey" from a moral standpoint, but as far as professional ethics are concerned, it seems pretty cut and dry. I wouldn't feel bad about what you did.

Best of luck to you in the near future. I'm interested in going into the pharm. field when I finish my PhD working on computer-aided drug design.

R
 

merlocka

Platinum Member
Nov 24, 1999
2,832
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Dude. If you are actually going to seek legal action you need stop talking about it in a public forum.

If you really spoke to a lawyer, and that wasn't the first thing they told to you do, then you probably need to find a better lawyer.
 

rgwalt

Diamond Member
Apr 22, 2000
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Originally posted by: merlocka
Dude. If you are actually going to seek legal action you need stop talking about it in a public forum.

If you really spoke to a lawyer, and that wasn't the first thing they told to you do, then you probably need to find a better lawyer.

I doubt he is seeking legal action... He probably employed the lawyer to protect himself from litigation. I could be wrong though...

R
 

Sundog

Lifer
Nov 20, 2000
12,342
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Congrats...I deal with the FDA on a weekly basis. Talk with the FDA through your laywer.
 

DrPizza

Administrator Elite Member Goat Whisperer
Mar 5, 2001
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www.slatebrookfarm.com
Originally posted by: tk149
What company do you work for? Time to sell short...

EDIT: BTW, good for you for having the guts to stand up to them.

I was thinking the same thing! Darn it, his profile is off, can't even figure out which city to narrow it down ;)

edit: And, bravo to you for standing up for your ethical obligations. Among the reasons I left engineering was a lack of attention to ethics. It was always "build a better mousetrap" without any consideration of what harm the better mousetrap was doing to society.
 

merlocka

Platinum Member
Nov 24, 1999
2,832
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Originally posted by: rgwalt
Originally posted by: merlocka
Dude. If you are actually going to seek legal action you need stop talking about it in a public forum.

If you really spoke to a lawyer, and that wasn't the first thing they told to you do, then you probably need to find a better lawyer.

I doubt he is seeking legal action... He probably employed the lawyer to protect himself from litigation. I could be wrong though...

R

Agree that I'm not sure of the details here, but I admire his actions and if he is seriously looking to protect himself or "bust" his employer he needs to be very careful about what details he reveals. I'd rather see his employer get what's coming that be able to read about the details (however interesting) on ATOT.