Medical research continues to discover new life-saving drugs and treatments, but the financial toll can be more than many people can handle. What should be preventable deaths from life-threatening illnesses are instead fatalities.
Such is the case in Colorado, where a pharmaceutical company won the right to take the fight over a price cap created by state lawmakers to trial. In a Denver courtroom on September 5, 2025, a Tenth Circuit Court of Appeals panel gave a split decision that will allow Teva Pharmaceuticals to challenge Colorado’s Epinephrine auto-injectors affordability law.
In the decision, the panel also affirmed the lower court’s denial of Teva’s motion to dismiss for violation of Fifth Amendment rights. A similar case involving Amneal Pharmaceuticals is also up for appeal. At stake are state protections that keep the price for a two-pack of the allergy pens capped at $60 for both the insured and uninsured, which is around 10% of the previous cost.
It Seems Like a Handy Thing To Have Around
Tens of millions of Americans suffer from at least one type of life-threatening allergy, which for them means that a potentially fatal anaphylactic reaction is always one peanut or bee sting away. Epinephrine emerged as a treatment for anaphylaxis at the beginning of the 20th century, but its effectiveness was limited by the proximity of a victim to a medical facility when the allergic reaction occurs.
Using technology developed by the U.S. military, EpiPens were officially approved by the Food and Drug Administration (FDA) in 1987. Sold in a two-pack because multiple doses are sometimes required, EpiPens deliver a 0.3mg dose of epinephrine (0.15mg for children). The process to use one is relatively straightforward: pull the blue safety cap, jab the orange tip into the victim’s thigh (which could be your own), hold it in place for three seconds, then remove and call 911.
The exact number of lives saved by EpiPens can only be estimated, but it’s not a reach to consider the device to be a game-changer for those suffering from a severe allergic reaction. While effective, EpiPens aren’t perfect. They’re intended to be a stopgap instead of a complete treatment, allowing the victim to seek further medical attention at a hospital or a doctor’s office. Doses have an expiration date of between 12 and 18 months. Having to frequently replace the devices factors into perhaps the biggest issue with EpiPens — the cost. For those without insurance, costs for a pair of the pens can be close to $800, although generic versions are usually much less expensive.
In a state law that went into effect on January 1, 2024, Colorado placed a $60 price cap on two-packs of EpiPens. This affordability program for EpiPen pricing applies to both insured and uninsured patients. It required manufacturers to make injectors available at that price for Coloradans with prescriptions and to offer reimbursement to pharmacies if necessary.
If You Prick Us, Do We Not Bleed?
As might be expected, manufacturers of EpiPens were less than enthused by Colorado’s law. Teva Pharmaceuticals and Amneal Pharmaceuticals (AmGen) filed separate suits against Colorado Attorney General Philip Weiser and members of the Colorado State Board of Pharmacy before the law went into effect. Claiming violation of the taking clause in the Fifth Amendment, the companies sought a preliminary injunction blocking enforcement and a summary judgment. Colorado counterfiled to fight the claim.
The state won in the lower court, but the federal appeals court didn’t agree with all aspects of the previous judgment. While the denial of the motion to dismiss was affirmed under state sovereign immunity granted by the Eleventh Amendment, the order issued by Judge Bobby R. Baldock stated that Teva Pharmaceuticals has the right to seek injunctive relief and remanded the case back to the district court. If the pharma companies are successful, the cap for uninsured patients will be eliminated.
Research and development costs for pharmaceutical firms can be staggering, but that defense often pales in the court of public opinion when Americans can’t afford life-saving medicine. Much like insulin for diabetics, EpiPens are essential for those with dangerous allergies. How much that lifeline is going to cost in Colorado is a matter for the courts.
Related Resources
- FTC Investigates Possible Inflation of Specialty Drug Costs (FindLaw’s Law and Daily Life)
- Can I Sue a Restaurant for a Food Allergy? (FindLaw’s Law and Daily Life)
- Regulatory Takings (FindLaw’s U.S. Constitution)
