Federal Court Issues Preliminary Injunction in Favor of EMED
June 26, 2015
El Dorado Hills, CA - EMED Technologies Corporation announces that on June 17, 2015, a Federal Court for the Eastern District of California, located in Sacramento, California, issued a Preliminary Injunction against Repro-Med Systems, Inc. (dba RMS Medical Products) and in favor of EMED.
RMS is under court order to remove from public access defamatory Safety Bulletins, marketing material, or web-content implying or stating that EMED’s Infusets are not cleared by the FDA, are not compatible with the FREEDOM60® Infusion System, or are otherwise “unsafe.” This order also states that RMS must eliminate, from the FREEDOM60® Infusion System User Manual, restrictions that discourage customers from using Infusets and VersaRate® by threatening to invalidate the pump’s warranty. The Injunction provides in part:
A preliminary injunction is hereby issued against RMS, its officers, employees, agents, subsidiaries, affiliates, related companies, successors, resellers, distributors, and all those in concert or participation with them who receive actual notice of this order.
RMS must refrain from making statements that are inconsistent with EMED’s 510(k) clearances for its Infusets (K935642 & K140133) and VersaRate® (K123729).
RMS must refrain from stating that only RMS rate sets may be safely used with the FREEDOM60®.
RMS must not condition the warranty of the FREEDOM60® to its use with RMS rate sets.
“EMED is gratified to be vindicated and pleased that we can now confirm to our customers that our devices can be used with the FREEDOM60® with its warranty remaining intact. This order ensures that patients are free to use devices that expand available options and optimize their clinical experience,” said Paul Lambert, EMED President and CEO.
Mr. Lambert continues, “EMED has been developing devices to optimize immune globulin administration therapy for Primary Immune deficient patients for over a decade. We have been working with the FDA and European agencies under rigorous guidelines to ensure that our devices are designed and tested under stringent standards and that they meet current world regulatory requirements.
“Our paramount design criteria are the therapeutic efficacy, safety and comfort of both clinicians and patients. We are proud to have pioneered several innovative developments resulting in important clinical contributions.”
About EMED
EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. Also, with our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies, and we are confident that these endeavors will benefit generations to come! In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.
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