nurseratchit
Research Enthusiast
Agree it is pretty cool and this is a good find. Just as long as people are aware it’s only right about 50% of the time so it’s more useful if you already know a bit about the subject.
Eli Lilly Sues Peptide Vendor
- Thread starter noteablequotable
- Start date
Agree it is pretty cool and this is a good find. Just as long as people are aware it’s only right about 50% of the time so it’s more useful if you already know a bit about the subject.
Anybody, can sue anyone, for any reason.Vague language isn't really going to save you if the intention is more or less clear. This isn't an episode of suits.
And, people tend to forget - a gazillion dollar company is in no way shape or form barred from suing you just for the hell of it. You still have to defend yourself from an army of lawyers, that alone is enough to bankrupt the average clinic or peptide shop
YoYoFat
Registered
Please don’t.As someone very familiar with applicable law in the healthcare space, I find these citations… amusing at best, and not applicable to the grey market whatsoever. In fact, these citations don’t even apply to compounding pharmacies or med spas, they’re inapt.
YoYoFat
Registered
Preach.
nurseratchit
Research Enthusiast
I’ve had fun intentionally stumping it a few times. If you correct it, it will apologize and sometimes then produce more accurate information. I have used it for peptide research but then look to confirm the info elsewhere.
For paid version is significantly better at research, but it has clear limitations in scope unless you re-prompt and rephrase until it stops looping the same crap
nurseratchit
Research Enthusiast
Good to know. Yeah, I always remember “garbage in, garbage out.” It does an amazing job of sifting through all the garbage on the internet but still catches a lot of stinkers.
Since you decided to shit on gpt, I can't ressist giving it a try too - does this make more sense?
As someone very familiar with applicable law in the healthcare space, I find these citations… amusing at best, and not applicable to the grey market whatsoever. In fact, these citations don’t even apply to compounding pharmacies or med spas, they’re inapt.
1. Patent Infringement:
- Patented Compound: Tirzepatide is protected by patents from Eli Lilly. Any sale or distribution of this compound without a licensing agreement from Eli Lilly constitutes patent infringement.
- Research Disclaimer Defense: Vendors try to claim "research purposes only" as a defense. However, this is rarely successful if the vendor is selling directly to consumers or if it can be shown that the compound is marketed for human use.
- Real Cases: Eli Lilly has taken legal action against vendors who misuse this disclaimer. For instance, legal precedents exist where courts ruled against research peptide vendors because their actual sales practices contradicted the "research-only" label, and consumer sales were evident.
- Burden of Proof: Evidence of customer communication, marketing material, and financial transactions can demonstrate that the vendor’s true intent was to sell to consumers. If a vendor claims “research purposes” but their customer base is overwhelmingly individuals using the peptide, that’s clear proof of intent to infringe.
2. FDA Violations:
- Prescription-Only: Tirzepatide is a prescription medication. Vendors who sell it without proper FDA approval for human consumption are in violation of FDA regulations.
- Unapproved New Drugs: Selling tirzepatide without FDA approval for consumer use violates regulations regarding unapproved new drugs. The FDA has issued warning letters, seized products, and taken vendors to court for such violations.
- Labeling & Misbranding: If the product is not properly labeled (e.g., lacking approved instructions for use, correct warnings, or dosage information), the vendor may face additional FDA penalties.
- Example Cases: The FDA has a history of targeting companies selling research peptides like SARMs, which were similarly marketed as research-only but sold for human use.
3. Unlicensed Medical Practice:
- Medical Advice & Dosing: If a vendor gives dosing instructions, suggests health outcomes, or provides specific advice to customers about peptide use, they could be seen as practicing medicine without a license.
- Implications: This opens up the vendor to lawsuits from consumers, particularly if adverse health outcomes occur from incorrect usage. This civil liability, on top of regulatory penalties, increases legal exposure significantly.
- Risk to Health Spas & Wellness Clinics: For businesses like health spas that sell tirzepatide and similar peptides directly to consumers, even careful language that implies medical advice may lead to liability claims for unlicensed medical practice.
4. Civil Liability & Customer Lawsuits:
- Negligence & Adverse Effects: Vendors could face civil lawsuits from consumers if peptides lead to negative health outcomes. If the vendor gave any advice (even indirect or implied), they may be liable for negligence.
- Strict Liability: If a product sold without proper regulatory oversight causes harm, vendors can be held responsible under strict liability principles, meaning they could be liable even if they followed other legal precautions.
- Example Cases: There have been cases where individuals who experienced severe side effects from non-regulated peptides sued the vendors, arguing they had not been properly informed of the risks.
5. Tax Fraud & Accounting Issues:
- Improper Classification of Sales: Vendors who list sales as "research-only" but are selling primarily to consumers may face tax fraud charges for misrepresenting the nature of their business.
- Underreporting Income: If a vendor hides or underreports the true nature of their business to avoid taxes or to disguise the sale of illegal substances, they could be investigated for tax fraud.
- IRS Involvement: The IRS may investigate vendors if there are discrepancies in their sales records or reported income. If found guilty, this could lead to heavy fines or even criminal charges.
6. Civil Penalties & Lawsuits:
- Breach of Contract: If a peptide vendor has agreements with research institutions or wholesalers and violates those contracts by selling directly to consumers, they could face civil lawsuits.
- Customer Class-Action Lawsuits: Vendors may face class-action lawsuits from consumers, especially if their products cause harm or fail to meet advertised claims. These lawsuits could be based on false advertising, breach of warranty, or negligence.
7. Additional Considerations:
- Tax Evasion: Failing to correctly categorize and report business income related to research peptides sold to consumers may lead to tax evasion charges.
- Jurisdiction Issues: Because of the widespread availability of peptides online, vendors may face jurisdictional challenges, potentially being sued in multiple states or even internationally.
Real-World Case Example
- In 2019, Peptide Sciences faced scrutiny from both the FDA and Eli Lilly for selling patented research peptides like tirzepatide without proper FDA approval or patent licensing. Despite using the "research purposes only" defense, the vendor was found liable due to evidence of consumer sales and marketing. Similar actions have been taken against other peptide providers in recent years, focusing on patent infringement and FDA violations.
Practical Approach to Vendor Risk
- High Risk of Legal Action: Vendors selling tirzepatide and similar peptides under a "research purposes only" label are at high risk of being sued for patent infringement and FDA violations. Even vague customer interactions could be interpreted as intent to sell to consumers, increasing the risk of legal exposure.
- Burden of Proof: Evidence such as emails, website marketing, social media activity, and accounting records showing direct sales to consumers is typically sufficient for a lawsuit to proceed. A lack of records could also lead to tax fraud charges.
Other Potential Risks
- Increased Scrutiny by Law Enforcement: Health spas or clinics offering peptides in a medical setting without proper FDA approval could face investigations by law enforcement or health regulatory bodies.
- Product Liability: If peptides sold lead to injuries, vendors may also be liable under product liability laws, especially if the product wasn't properly tested or labeled.
Ok. But I only asked about selling research tirzepatide. With zero attempt refining the prompt.
As someone very familiar with applicable law in the healthcare space, I find these citations… amusing at best, and not applicable to the grey market whatsoever. In fact, these citations don’t even apply to compounding pharmacies or med spas, they’re inapt.
noteablequotable
Member
They've sent out C&Ds but I think this is the first time they've actually sued a grey market vendor.
clevesand
Member
Agreed. These are very specific test cases that are very intentional. One on mixing anything else with it since the compounders have clearly demonstrated that's what they intend to do when the FDA shortage ends. And the second the domestic gray market that are under jurisdiction of US courts.
noteablequotable
Member
Yup. They were probably just waiting for a vendor to ignore their C&D. I wouldn't be shocked if certain peps got much more difficult to find over the next few months. This will set precedent and I expect a lot of people will close up shop.
YoYoFat
Registered
And it didn't even give you answers applicable to research tirzepatide, but other issues related to FDA approved drugs and compounds.Ok. But I only asked about selling research tirzepatide. With zero attempt refining the prompt.
There's a reason why attorneys are being sanctioned and disciplined left and right by courts and boards for using ChatGPT to conduct legal research and analysis.
YoYoFat
Registered
More sense, perhaps. Does the patent apply to the peptide? No. Does the patent apply to the peptide with a ton of tweaks to make it "special"? Yes. Are the research peptides those special "tweaks"? No. Are those issues cited by ChatCPT applicable to research peptides sold by domestics that clearly indicate they're not pharmaceutical grade nor to be used on humans? No. Will EL be able to successfully pursue randos peddling on TG, Discord, etc.? Not a chance.
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YoYoFat
Registered
I mean, it's a tactic that works insofar as scaring people and shutting them down.
It worked with the compounding pharmacies, right? Even after the FDA did a takesy-backsies.
That is true, although frivolous suits can be short circuited through several legal mechanisms. When you have a huge monster like Lilly with endless resources coming for you, most just scream, cave and roll over. Look at what happened to farmers when Monsanto came for them and what happened to small business owners when the music performance copyright thugs showed up. All just paid and closed up shop.
nurseratchit
Research Enthusiast
I see it now. I thought I remembered some research peptide vendors getting C&D letters a few months ago. Might’ve been Arctic. I think it’s why Amopure now codes their vials on their website. I never heard of Pivotal Peptides before this post but only thing I could find on web was Instagram posts which are now deleted. Did they have a website? Insta doesn’t seem like the most discrete place to be hawking grey market products and they kinda deserve the bitch slap from EL for that. Other reputable US Vendors seem to continue operating just fine by simply maintaining a discrete internet and website presence.
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lazygardener
New_Member
The peptide tirzepatide is patented. Not just the finished medication.
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