Repro-Med Systems, Inc. v. Emed Technologies Corporation, 2:13-cv-01957

Background

EMED Technologies (defendant moving for injunction) and Repro-Med Systems (RMS, plaintiff) are the two primary U.S. manufacturers of devices for subcutaneous immunoglobulin (SCIg) therapy; RMS’s Freedom 60 pump is dominant in the market.
FDA inspected RMS facilities in June 2015 and issued a February 26, 2016 warning letter alleging violations concerning the Freedom 60, Freedom Edge pump, and HigH‑Flo needle set (adulteration/misbranding and promotion outside cleared indications).
EMED alleges RMS made false or misleading public statements (brochures, a March 11, 2016 customer letter, and SEC filings) claiming FDA clearance/no restrictions/no safety concerns, and that RMS’s conduct constitutes unlawful/unfair competition under California’s UCL.
RMS recalls/corrections arose from defective packaging seals affecting sterility for some HigH‑Flo needle sets; the FDA letter criticized RMS’s corrective‑action verification.
EMED moved for a preliminary injunction to bar RMS’s sales of the Freedom 60, Freedom Edge, and HigH‑Flo sets in California; RMS opposed, arguing preemption, agency jurisdiction, and that EMED cannot show the Winter factors.
The court denied EMED’s preliminary‑injunction motion, concluding EMED failed to show likely irreparable harm and that the balance of hardships tips in its favor.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether EMED is likely to succeed on the merits of a UCL claim based on RMS’s alleged false/misleading statements	RMS’s FDA warning letter shows RMS’s statements are false/misleading and unlawful under the UCL	RMS: FDCA preempts, FDA has primary jurisdiction, warning letter not dispositive; statements are not false	Court did not resolve merits because other Winter factors not met
Whether EMED will suffer irreparable harm absent injunction	Loss of sales, revenue, and market share from RMS’s continued sales and misleading statements; UCL typically affords injunctive relief only	RMS: EMED offered no evidence of actual lost sales or market share—only speculation	Denied — EMED failed to show likely irreparable harm (speculative evidence insufficient)
Whether balance of hardships favors an injunction	Injunction needed to prevent anti‑competitive conduct and protect EMED’s market position	Injunction would bar RMS from selling longstanding products in a major market, likely cause nationwide spillover, and harm RMS’s customer relationships	Denied — hardships do not tip sharply in EMED’s favor; injunction would impose substantial harm on RMS
Whether public interest supports preliminary injunction	Public interest favors truthful marketing and safety	Public interest disfavors broad ban that may block legally cleared sales and disrupt patient access	Court did not reach full analysis after finding Winter factors unmet; public interest not enough to overcome failure on irreparable harm and equities

Key Cases Cited

Winter v. Natural Resources Defense Council, 555 U.S. 7 (2008) (establishes four‑part preliminary injunction test and requires likelihood of success and irreparable harm)
Alliance for the Wild Rockies v. Cottrell, 632 F.3d 1127 (9th Cir. 2011) (permits sliding‑scale approach but requires irreparable injury and public‑interest showing)
Schrier v. University of Colorado, 427 F.3d 1253 (10th Cir. 2005) (heightened scrutiny when movant seeks to alter status quo)
Univ. of Texas v. Camenisch, 451 U.S. 390 (1981) (purpose of preliminary injunction is to preserve relative positions until trial)