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Wrongful termination?


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For those that dont know, I am a pharmacist currently working for a small independent infusion pharmacy. I work 2 shifts a week and we have a second pharmacist, who works the other 3. We also have a full time pharmacist in charge. For the last year, we have been compounding both semaglutide and tirzepatide and the pharmacy has been making money hand over fist. Last month, tirzepatide went off the FDA shortage list and the FDA issued guidance for all compounding pharmacies to immediately stop production. The FDA was later sued by the Compounders Association and an injunction was granted. I believe the FDA will issue a statement sometime this month on the matter. So with that out of the way...

When we found out last month about tirzepatide coming off the shortage list, the other part time pharmacist and I independently researched what an "an essential copy" of a brand named drug was and decided our B12 + tirzepatide was just that. A copy. While tirzepatide was on the shortage list, it was fine to make, but after it went off, we told our manager and the owner we could not in good faith continue to check those meds. The owner and the pharmacist in charge said our compounded drug was different enough so that it was not an essential copy but we let them know our intentions. This was on October 9th. At the time I told our other part time pharmacist to email himself a memo of record stating that we could not in good faith check this med as we basically believed it to be illegal to do so, that we researched the FDA guidance and that we were both in good standing at our pharmacy with no write ups etc. Fast forward to last week. I learned they are going to fire the other part time pharmacist tomorrow and that they hired a full time pharmacist to replace him. I learned this new pharmacist gave a months notice at her work so they basically interviewed and hired this pharmacist within 1 week of me and the other pharmacist stating we would not check the medication moving forward. They also informed me I would be initially working 4 days a week for 2 weeks to train the new pharmacist and then I would only work 1 day a week after that. They said they are hoping to grow but that they would re-evaluate my status in the future. The owner also made a strange comment to me at the time saying that they decided not to fire me. Basically I believe I will be training my replacement for 2 weeks and then they will let me go (soon) after they feel the other pharmacist can handle the work and after they determine they did not grow as anticipated. I think the writing is on the wall. It has also been miserable there since we told them last month of our decision and I really dont care to be there. The only thing is the pharmacist they hired AND the pharmacist in charge have exactly 0 experience in home infusion and let me tell you, it takes a while to learn this nook of pharmacy. 

 

My questions are

1. are there any lawyers who specialize in this?

2. is there a case for wrongful termination and if so is it worth pursuing?

For me its not a huge deal but I feel really bad for the other pharmacist as his wife just lost her job and they are having some issues with their kids mental health. This is going to be horrible for him.

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Sorry that's happening to you and your colleague.

The first thing to look at for wrongful termination is any contract of employment, which could include an "employee handbook" or other employment terms that may not constitute or appear to be a contract in the traditional sense. You'd be looking for conditions that curtail their ability to terminate at will or without cause.

The other avenue may be that this is a "retaliatory discharge" for bringing to the attention of management that they are engaged in illegal activity.  But, usually those require (practically if not strictly legally), the reporting of the activity to authorities, otherwise it can be characterized as an "internal disagreement" and insubordination.

In any event, you can be assured that it will be a long, agonizing process to pursue a wrongful termination claim.

For more than generalized answers, you'd need to gather the materials you reference and consult with an employment discrimination lawyer.

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As for the other questions, yes Im here in Texas. And for the illegality, their "lawyers" say its perfectly fine to continue making it so they have their own world they live in. The reality is it's not. They are just making 10s of thousands a day in cash off all the Southlake moms who want to lose those last 10 pounds and they dont want to stop their cash cow. Otherwise I would open my own compounding pharmacy and take every drug on the market, add a vitamin to it and sell it at a fraction of the cost. At best its unethical. I know it's wrong. Oh well.

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Otherwise I would open my own compounding pharmacy and take every drug on the market, add a vitamin to it and sell it at a fraction of the cost.


Don’t know diddly squat about a termination lawsuit but tell me more about this new investment opportunity.
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7 hours ago, UTGrad98 said:

As for the other questions, yes Im here in Texas. And for the illegality, their "lawyers" say its perfectly fine to continue making it so they have their own world they live in. The reality is it's not. They are just making 10s of thousands a day in cash off all the Southlake moms who want to lose those last 10 pounds and they dont want to stop their cash cow. Otherwise I would open my own compounding pharmacy and take every drug on the market, add a vitamin to it and sell it at a fraction of the cost. At best its unethical. I know it's wrong. Oh well.

Interesting on the unethical.  It's illegal or unlawful because of FDA rules and laws.  The most fundamental of those is that the FDA must approve medications for safety and efficacy.  And that's ok.  Secondarily, it must approve most manufacturing facilities for approved drugs.  Ok, but we're getting a little further a field here.

Where it gets fucky is that FDA also grants periods of post-approval exclusivity independent of the patent laws.  That's getting downright dubious.

So, as long as you are making "quality" drugs that follow the "recipe" of approved drugs in all material ways, it may be unlawful, but I don't think it's actually unethical in any grand moral sense.  Maybe as a violation of pharmacist ethics, of which I am ignorant.

But back to your situation, I suspect the illegality is sufficiently unclear (and their position is supported by opinion of counsel), that the whole situation is unfortunately easily characterized in a lawsuit as insubordinate/disgruntled employees rather than retaliatory action.

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https://federal-lawyer.com/whistleblower-lawyers/fda/

Can't vouch for these people, but they might be worth contacting. 

Keep/generate/maintain a paper trail and document shit from now on. Keep a dated log book with notes and observations and whatever else. Don't trust your memory to put it all together later on down the road. 

Keep in mind that you currently have absolutely no standing whatsoever for a wrongful termination claim, given that you remain employed... 

Good luck. 

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16 minutes ago, UT_OB1 said:

Can you teach me how to make semaglutide in my bathtub?  Or can I just pay you $50 for month supply?

That's actually a good question. You can buy 100mg from Sigma for $3000, but I don't think it would be made for human use. So in some country there must be a manufacturing plant making it for the pharmaceutical company, Novo Nordisk but also selling it to others. Interestingly, the Chinese patent was scheduled to expire in 2026, but a court ruled in 2022 that all patents on semaglutide were invalid. So, the bottom line is that semaglutide is probably being manufactured in China and then distributed via grey market channels across the world. Although, it could be made in bathtubs, it probably isn't because it is easy enough to get it from some manufacturer in China.

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One other thing relating to this whole semaglutide compounding deal.  You see a lot about the FDA exempting from various regulations due to shortages, which lets compounders "off the hook" while the shortage exists.

What you don't see is much in the way of patent Infringement suits.  On the one hand, you might think compounding pharmacies are below pharma's infringement radar, on the other, pharma will basically stop at nothing to preserve exclusivity.

And that puts another spin on this.  I have been a patent practitioner for 30-plus years and I have never heard of employees "rebelling" because their employer is infringing a patent.  Thus, I have never heard of an employee being fired or having a adverse employment action because of protesting patent infringement.  Like the FDA stuff, it is illegal or unlawful, if proven, but I'm not sure it rises to the level of unethical.

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1 hour ago, TwiceHorn said:

One other thing relating to this whole semaglutide compounding deal.  You see a lot about the FDA exempting from various regulations due to shortages, which lets compounders "off the hook" while the shortage exists.

What you don't see is much in the way of patent Infringement suits.  On the one hand, you might think compounding pharmacies are below pharma's infringement radar, on the other, pharma will basically stop at nothing to preserve exclusivity.

And that puts another spin on this.  I have been a patent practitioner for 30-plus years and I have never heard of employees "rebelling" because their employer is infringing a patent.  Thus, I have never heard of an employee being fired or having a adverse employment action because of protesting patent infringement.  Like the FDA stuff, it is illegal or unlawful, if proven, but I'm not sure it rises to the level of unethical.

From what I have read the fda has never been sued after taking a drug off the shortage list. It's all about money now, not an actual shortage. I'll be interested to see how this all plays out. 

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Get in contact with Peter Cohron. He's a pharmacist but also an attorney in Kentucky. If he can't give you advice he can point you in the right direction. You might also consider reaching out to Trent Rexing with Mayer. He co-owns a pharmacy with another pharmacist and they just opened up a sterile lab. He's an OU grad but did law at SMU. 

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On 11/15/2024 at 7:49 AM, UTGrad98 said:

From what I have read the fda has never been sued after taking a drug off the shortage list. It's all about money now, not an actual shortage. I'll be interested to see how this all plays out. 

Implicit in some of my postings above, but unsaid explicitly, I applaud your stance.  But, I might remind you that the regulations involved are, intentionally or otherwise, to the great benefit of big pharma, as well as being ostensibly public protection measures.  So what they're doing is "malum prohibitum" not "malum per se."  Yes, your employer is being greedy af, at the expense of the greediest mf'ers in our whole greedy economy.

However, my sense of it is that this is something that your employer will likely win on and your ethics (here I mean personal ethics rather than what the law or business requires) may be best applied by GTFO.  I could be wrong there

Edited by TwiceHorn
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not much to go on, but I suspect twice is right - whistleblower/retaliatory termination type causes of action are likely lacking due to ambiguity. not sure there's another basis there isn't a protected class in play - whether existing or not it doesn't appear to be the reason. I also doubt there's a handbook/contract based claim either. so absent a compelling case on retaliatory termination, there's likely nothing there. not an employment lawyer, a corporate one that has to deal with this enough to have talked to employment lawyers dozens of times about possible claims.

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15 hours ago, troph said:

not much to go on, but I suspect twice is right - whistleblower/retaliatory termination type causes of action are likely lacking due to ambiguity. not sure there's another basis there isn't a protected class in play - whether existing or not it doesn't appear to be the reason. I also doubt there's a handbook/contract based claim either. so absent a compelling case on retaliatory termination, there's likely nothing there. not an employment lawyer, a corporate one that has to deal with this enough to have talked to employment lawyers dozens of times about possible claims.

 

Now what if what he was asked to do goes against the state board of pharmacy?

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10 minutes ago, Bevo said:

 

Now what if what he was asked to do goes against the state board of pharmacy?

I think Texas whistle blower law is the Sabine pilot case and I don’t recall the elements but it’s a hard cause of action to establish in Texas. Shocker I know.

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The Sabine Pilot doctrine is a narrow exception to Texas' employment-at-will doctrine that protects employees from being fired for refusing to commit an illegal act. The key elements of a Sabine Pilot claim are: 
  • The employee was an at-will employee 
  • The employee refused to perform an illegal act 
  • The employee was terminated solely because of the refusal
  • The illegal act must be one that is subject to criminal penalties. Some examples of illegal acts that employees may be asked to commit include: Forging safety documents, Releasing confidential information, Providing customers with unprescribed medications, and Disposing of hazardous materials in an unsafe way.
40 minutes ago, Bevo said:

But, if he turned them in to the state board, I would think that would protect him some from retaliation, no?

There might be federal protection not sure. Texas law is quoted above.

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I kinda fucked up the wording on that. TSBP allows the compounding of commercially available drugs under certain conditions. It prohibits what they call "essentially copies of commercially available products". But that's a pharmacy issue, not a pharmacist issue. A pharmacist compounding what is essentially a commercially available product isn't even listed on the schedule of administrative penalties. 

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On 11/17/2024 at 9:15 PM, HRSchenker said:

I kinda fucked up the wording on that. TSBP allows the compounding of commercially available drugs under certain conditions. It prohibits what they call "essentially copies of commercially available products". But that's a pharmacy issue, not a pharmacist issue. A pharmacist compounding what is essentially a commercially available product isn't even listed on the schedule of administrative penalties. 

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So he should do it, or should he NOT do it?

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