Houston-based Hicks Thomas LLP has filed a federal court injunction for EMED Technologies Corp against RMS Medical Systems (Repro-Med Systems Inc) to stop RMS from distributing and selling two products, safety needles and home infusion pumps, designed for Subcutaneous Immunoglobulin (SCIg) infusion. The motion followed a determination from the FDA (Food and Drug Administration), which said the products are “misbranded” and “adulterated,” making them potentially dangerous.
The devices, typically used at home, are for the treatment of Primary Immunodeficiency, a potentially fatal disease treated with infusions of human-derived immunoglobulin. The safety needles were first developed by the founder of EMED Technologies, Paul Lambert, who filed suit against RMS last year for patent infringement.
John B. Thomas and Eric Grant, attorneys from Hicks Thomas LLP, filed the motion for a preliminary injunction on March 24 in the United States District Court for the Eastern District of California. In it, they documented that the FDA issued a warning letter that requested RMS to “immediately cease…commercial distribution” of three of its SCIg infusion products.
A copy of the supporting papers and motion are available for download here: Injunction & Supporting Papers.
One day after Hicks Thomas LLP filed the motion for an injunction, lawyers for RMS filed a motion to withdraw counsel, stating they were unaware of the FDA’s warning against the company. View a copy of the motion here: Cohen & Gresser LLP Motion.
In the letter, the FDA stated “quality system violations” and “adulteration / misbranding violations,” which were discovered during an inspection of RMS facilities last year. During the inspection, the agency found several modifications to the infusion pumps and determined they “could significantly affect safety and effectiveness” of the products.
According to the motion filed by Hicks Thomas LLP, RMS continued to state that the FDA found “no safety concerns.”
Two weeks after the FDA’s warning letter, RMS issued a product recall, explaining that a potentially defective bagging component could compromise the safety of the devices. “Due to the nature of the possible defect in the bagging component,” RMS stated, “…the products packaged in the bag, with the defective seal, may have been compromised.”
However, according to the motion, the recall only applied to devices made after January 2016, even though the defective seal affected devices as far back as September 2014, as set forth in the FDA inspection report.
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