labeling grandfathered drug in standard format doesn't misrepresent it as FDA-approved

Belcher Pharms., LLC v. Hospira, Inc., -- F. Supp. 3d --, No. 8:17-cv-2353-T-30AAS, 2020 WL 102744 (M.D. Fla. Jan. 7, 2020)

“Epinephrine—a drug that is a medical necessity—has been in short supply on and off for nearly a decade.” Hospira has made epinephrine since before 1938, so Hospira is “arguably” grandfathered under the FDCA and has never received FDA approval.  Regardless, “the FDA asked Hospira to ramp up manufacturing to manage the epinephrine shortage in 2010, which Hospira did.”   

Belcher launched an FDA-approved epinephrine ampule (it does not sell a prefilled syringe, as Hospira does), in 2015. By early 2017, there was no longer a shortage of epinephrine ampules, so the FDA asked Hospira to discontinue its unapproved ampule, but to continue manufacturing its still-scarce prefilled epinephrine syringe. Hospira complied, and Belcher saw an increase in the sales of its epinephrine ampule.  After this, the FDA asked Hospira about extending the expiration dates of the prefilled syringe, and the FDA then told healthcare providers that the expiration dates were extended by 9 months past the earlier 21-month expiration date.  

Becker sued Hospira for false advertising and for common law unfair competition, for allegedly marketing its epinephrine products—both the ampule and prefilled syringe—as FDA-approved.  The court granted Hospira, “which did everything the FDA requested to manage a severe shortage of a medically necessary drug,” summary judgment.    After the FDA told Hospira to discontinue its epinephrine ampules, the FDA asked Hospira about extending the expiration dates of its prefilled syringe. Hospira sent the FDA its shelf-life analysis, and shortly thereafter the FDA told healthcare providers that the expiration dates for Hospira’s prefilled syringe were extended for 9 months past their 21-month expiration date. Hospira’s ampules had a 24-month expiration date, while Belcher’s ampule had an expiration date of 12 months, which the FDA later extended to 17 months.   Belcher alleged the following as false advertising:  

1. Hospira’s product labels, which include as indications for use that the epinephrine products (a) can treat cardiac arrest, (b) can be administered intravenously, and (c) can prolong the effects of anesthesia; 2. Hospira’s misleading advertisements as to its epinephrine products’ shelf life on its packaging; and 3. Hospira’s comparison of its epinephrine products to [FDA-approved] Adrenalin, which conveyed the message that its products were generic Adrenalin.

The court found that placing the products on the market with indications for use and shelf life on product labels and packaging, in standard format for FDA-approved drugs, could not, in itself, be a misleading claim of FDA approval. It was too great a stretch to argue that presence on the market in this was a representation of FDA approval.   

That left the comparison claim: Hospira compared its products to FDA-approved Adrenalin, thus allegedly implying that it was a FDA-approved generic.

First, internal Pfizer emails and an email response to a drug distributor who inquired if Hospira was marketing the generic version of Adrenalin were not “commercial advertising or promotion.”   An Injectables Product Availability Report on its website did qualify, but couldn’t be shown to be material. Even if the court assumed it was misleading, that didn’t connect up to Belcher’s evidence that consumers believed Hospira’s epinephrine products were a generic version of Adrenalin approved by the FDA. “Belcher has not shown that a single consumer ever viewed the Injectables Product Availability Report or was misled by it. Without evidence that a consumer viewed the Injectables Product Availability Report, Belcher cannot show that the misleading statements had a material effect on purchasing decisions.”