The philosophy that federal government intervention increases costs and decreases options and values available to consumers can be analyzed across a plethora of markets. This Note will focus on the epinephrine autoinjector market, specifically looking at Mylan's epinephrine autoinjector known as the EpiPen. Today, the EpiPen is considered the “Kleenex” of epinephrine autoinjectors as it is estimated to control over ninety percent of the market share. From a Darwinist perspective it would appear that because the EpiPen controls most of the market, it must be the most superior product available to consumers. However, as this note will cover, this is likely not the case, and there is ample evidence to prove that EpiPen’s market success is largely due to government regulations and mandates.
This Note will also focus on the 2014 United States District Court case JHP Pharmaceuticals v. Hospira, which dealt with labeling issues surrounding epinephrine autoinjectors. It is quite possible that safer, more efficient, and more affordable versions of the EpiPen may be available to consumers today if it were not for these government interventions. As this note will discuss, courts should decline to follow the overall ruling in JHP Pharmaceuticals v. Hospira because holding that a court is unable to decide a case based on a separate federal agency simply a waste of litigation. However, courts should consider the line of reasoning that where there is no proof that a non-FDA approved drug is any less safe than an FDA-approved drug, the non-approved drug should not be precluded from entering the market.
Consumers in Shock: How Federal Government Overregulation Led Mylan to Acquire a Monopoly over Epinephrine Autoinjectors,
DePaul Bus. & Com. L.J.
Available at: https://via.library.depaul.edu/bclj/vol16/iss1/2