EMED Technologies said today that it is seeking a federal court injunction against competitor Repro-Med Systems to keep the company from selling home infusion pumps and needles for subcutaneous immunoglobulin infusion.
The company has retained Houston-based Hicks Thomas LLP in seeking the injunction, which it said is being carried out after the FDA determined the products are “adulterated” or “misbranded” and potentially unsafe.
Last June, EMED filed a patent infringement suit against Repro-Med for infringing on its patent for subcutaneous infusion pumps, saying that “EMED pioneered the development of needle sets specifically optimized for infusion of immunoglobulin to patients with PIDD,” according to court documents.
The new suit was filed this month in the U.S. District Court for the Eastern District of California, according to a press release.
The firm representing EMED said that after EMED filed the motion for injunction, Repro-Med Systems counsel Cohen & Gresser withdrew, saying that “RMS never told them that the FDA warned the company of violations,” according to a press release.
Last week, Repro-Med Systems updated on a warning letter it received in February over issues the FDA found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps.
The company said it submitted a response to the warning letter a week earlier to the FDA, 3 days before the required response date set by the federal watchdog.
Repro-Med said the letter responded “in great detail” to the issues brought up in the letter from the FDA, but said it would not publish the response letter due to proprietary details required to complete the response.
The company said there were no safety concerns raised in the response, and that it has not been requested to withdraw any products from the market, according to an SEC filing.