Hicks Thomas Represents EMED Technologies Seeking Injunction against RMS Medical Products for Infusion Devices FDA Warns Are Adulterated and Misbranded
FDA warns RMS Medical against selling 'adulterated' and 'misbranded' pumps and needle sets
Mar 29, 2016, 01:32 ET
SACRAMENTO, Calif., March 29, 2016 /PRNewswire/ -- California-based medical device manufacturer EMED Technologies Corp. is seeking a federal court injunction to stop competitor Repro-Med Systems Inc. (doing business as RMS Medical Systems) from selling home infusion pumps and needles for Subcutaneous Immunoglobulin (SCIg) infusion, after the U.S. Food and Drug Administration determined the products are "adulterated" and "misbranded" and potentially unsafe.
These infusion devices are used to treat a potentially fatal condition known as Primary Immunodeficiency, for which the standard of care is based on infusions of human-derived immunoglobulin. The infusion devices, often used at home, include special safety needles, originally developed by inventor Paul Lambert, founder of EMED Technologies, which filed a patent infringement lawsuit against RMS in Texas last year.
EMED's motion for preliminary injunction was filed by attorneys John B. Thomas and Eric Grant of Houston-based Hicks Thomas LLP on March 24 in the U.S. District Court for the Eastern District of California. The motion documents that on February 26, the FDA issued a Warning letter to RMS requesting that RMS should "immediately cease ... commercial distribution" of three of its products for SCIg infusion.
A copy of the motion and supporting papers can be downloaded from the Hicks Thomas website at http://www.hicks-thomas.com/documents/Filed-Motion-for-Preliminary-Injunction.pdf.
The day after EMED's motion for an injunction was filed, RMS' lawyers from Cohen & Gresser LLP filed a motion to withdraw as counsel, declaring, among other issues, that RMS never told them that the FDA had warned the company of violations. This motion can also be downloaded from the Hicks Thomas website at http://www.hicks-thomas.com/documents/85-Cohen-Gresser-motion-to-withdraw.pdf.
In the Warning letter to RMS the FDA cited multiple "adulteration/misbranding violations" and "quality system violations" uncovered last year during the agency's inspection of RMS' facilities, including modifications to infusion pumps "that could significantly affect safety and effectiveness."
Yet, RMS continued to tell customers and the public (including in a recent filing with the U.S. Securities and Exchange Commission) that the FDA raised "no safety concerns," according to Hicks Thomas' motion for injunction. According to the motion, RMS continues to advertise that its needle sets are "FDA-cleared" for SCIg infusion when, in fact, the agency determined that usage "falls outside the cleared intended use" of those infusion devices
In contrast to these public statements, two weeks after receiving the FDA warning letter, RMS issued a product recall, stating: "Due to the nature of the possible defect in the bagging component, RMS has concluded the products packaged in the bag, with the defective seal, may have been compromised." RMS stated that the use of the affected products may possibly cause "adverse health consequences, such as infection and illness." The RMS recall only covers products manufactured after January 2016, however, "the packaging problems identified by the FDA stretch back to September of 2014," according to the motion.
Founded in 1997, Texas-based Hicks Thomas, LLP, is a premier litigation firm representing plaintiffs and defendants across the nation. With offices in Houston, Amarillo, and Sacramento, California, the firm provides in-depth experience in cases involving oil and gas, environmental, complex commercial, toxic tort, products liability, corporate governance, securities, banking, insurance coverage, transportation, trade secrets and business litigation. Visit the firm at http://www.hicks-thomas.com.
SOURCE Hicks Thomas LLP
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