By: Martin Merritt, esq.
Past President, Texas Health Lawyers Association
Past Chair, DBA Health Law Section
martin@martinmerritt.com
“Please Tell Me you Didn’t. . . How to Keep Clients Out of the Jailhouse, Poorhouse and Lawyers Out of the Nuthouse” -Blog
As you can tell, I love talking about health law & litigation issues, and general wellbeing, if you have any health law questions or better yet, need to refer a case, just call or drop me an email and I will happily talk.
In three years of law Law school, I learned the skills necessary to move from a state of simple confusion (e.g. answering, “I don’t know”), to the more professionally confused, “it depends.” (We also learned we can’t get paid as well for “I don’t know.”)
So, as a health lawyer, when I am asked “what’s the deal with weight loss GLP-1 drugs.” I follow my training and answer, “It depends.”
On August 12, Kirkland & Ellis filed as many as six lawsuits over the drug Retatrutide. I like to think of this case as Pirates of the Caribbean II, which follows the original federal case in 2025, in the continuing series of Eli Lilly vs. Anyone else who tries to make money in the GLP-1 weight loss business.
Much like the Jack Sparrow movies, it is hard not to cheer for the pirates when running from the Royal Navy.
And so, lets look at “Pirates II,” Eli Lilly v. Striker Pharmacy, LLC, Case No. 4:26-cv-06563, filed Aug. 12, in federal District Court in the Southern District of Texas.
At first read, I am really having a hard time getting past simple confusion. The case doesn’t make much sense at all to me. Sure, the pirates might be selling Retatrutide illegally, but Eli Lilly can’t sell it either. The FDA hasn’t approved it yet.
The causes of action Eli Lilly asserted are for violations of the Texas Food Drug & Cosmetic Act, Tex. Health & Safety Code §431.045, et. seq., which are confusingly tacked on with a statutes from a half dozen other states, including Alaska and Connecticut.
My first thought is that, since no one can sell Retatrutide, seems like “this lawsuit would be a job for the government.”
So I looked it up, and I was right. The S.D. of Tex. court has already told Eli Lilly once, that “private suits” for violations of statutes like the Texas Food Drug and Cosmetic Act, are (oh, how did they put it?) . . .“not a thing.” See Eli Lilly and Company v. Revive Rx, LLC, 817 F.Supp.3d 708 (S.D. Tex. 2025).
But Ely Lilly sued the “pirates” anyway.
Patents, “Pirates” and FDA rules on compounding GLP-1 Drugs. In a nutshell, big giant pharmaceutical companies are the only ones who can afford the $2.8 billion price tag to get a new drug approved by the FDA. In exchange, these big giant pharmaceutical companies are allowed a monopoly on the sale of that particular drug for a number of years, after which time, it goes “generic.”
In order to gain exclusivity, any big giant pharmaceutical company will first patent the formula for its new drug, which is the case with these new GLP-1 drugs. The formula is not a “secret.” The word “patent” comes from the Latin verb patere, meaning “to lie open” or “be open.” In other words, the formula for the molecule is published and available for anyone to research and that means the drug could be copied by any lab with the formula and motivation to do so.
In the case of prescription drugs regulated by the FDA, however, the patented drug is absolutely useless, until the FDA approves the drug for sale in the United States. This “lack of FDA approval” normally would preclude anyone from being motivated enough to attempt to manufacture a “pirated” bootleg copy of someone else’s drug.
(But what if they did, and people lined up to buy it anyway?)
This was the plot in Southpark: The End of Obesity. There is a difference between “commercially available” and “commercially accessible.” If only rich people can afford the price FDA approved version, then you are going to get bootleg black market copies of the one that isn’t yet approved.
In order to understand the differing rules, let’s take a look at two drugs by Eli Lilly. One is Tirzepatide, which already has FDA approval, and the other is Retatrutide, which has not yet been approved by the FDA, but likely will be.
“Tirzepatide” is sold by Eli Lilly under the Brand names Mounjaro and Zepbouind. The drug was patented in 2016 and approved by the FDA in 2022, granting Eli Lilly the exclusive right to sell the stuff, with a couple of exceptions:
- if Eli Lilly could not keep up with demand temporarily, or
- if a patient has a need for the FDA approved drug, but in a dose or formula that isn’t “commercially available,”
a compounded version can be legally sold based upon a patient-specific prescription. These are exceptions that actually have been used, but wouldn’t last long, or apply to that many people.
Compounding pharmacies began advertising on Facebook, that they could sell FDA approved Tirzepatide for a fraction of Eli Lilly’s price. Which sellers are really not supposed to do.
This led to what I call “Pirates of the Caribbean I,” Eli Lilly v. Revive Rx, LLC., based upon the Texas Food Drug and Cosmetic Act. The case ended, at least as far as I can tell, when the court told Eli Lilly there is “no such thing” as a private cause of action for violations of the Texas Health & Safety Code.
But, in Pirates of the Caribbean II, the Rise of Retatrutide, Case 4:26-cv-06563 (2026), Striker Pharmacy LLC is accused of doing something altogether different. It is selling a drug from a residential cul-de-sac near White Rock Lake, which has never been approved for human use by the FDA.
Ely Lilly tries to make the case that it is filing this suit to “protect the public.” I don’t really get the “warm and fuzzies” reading this part of the lawsuit. But, just because they are big and rich, doesn’t mean they aren’t right.
I don’t see any legal way to sell Retatrutide in the United States until the FDA approves it. This creates liability for the compounding pharmacies in lawsuits and for prescribers before licensing boards.