Masimo Corp. (NSDQ:MASI) and Hygia Health Services Inc. settled a year-old lawsuit over labeling on pulse oximeters made by Masimo and reprocessed by Hygia.
Birmingham, Ala.-based Hygia originally filed suit against Masimo in the U.S. District Court for Northern Alabama in early May 2009, after the Irvine, Calif.-based medical device maker sent it a letter threatening a patent infringement lawsuit unless Hygia stopped re-packaging single-use sensors and labeling with the Masimo trademark. Hygia won 510(k) clearance from the Food & Drug Administration to reprocess the sensors, but Masimo alleged that re-packaging sensors intended solely for a single use, and marking them with its corporate check-mark logo, constituted patent infringement.
Hygia’s suit sought to bar Masimo from enjoining the reprocessing. In its counter-claim, Masimo repeated the allegations from the letter it sent to Hygia, accusing the reprocessor of patent infringement.
In dismissing the case, Judge Karon Owen Bowdre granted a permanent injunction to Masimo, enjoining Hygia from “reprocessing, manufacturing, distributing, shipping, advertising, marketing, promoting, transferring, selling, or offering to sell any Masimo pulse oximetry sensor that fails to include prominent labeling on all packaging and the sensor itself stating: “Device reprocessed by Hygia Health Services. Performance not validated or warranted by Masimo,” according to court documents.
Bowdre also enjoined Hygia from placing the Masimo mark on any of the company’s devices that it reprocesses.
“Hygia, its parents, subsidiaries, affiliates, officers, agents, servants, employees, attorneys, and those persons in active concert or participation with them who receive actual notice of this Order shall immediately REFRAIN from representing that any pulse oximetry sensor they reprocess, manufacture, or distribute are made by, authorized by, endorsed by, or otherwise affiliated with Masimo,” Bowdre wrote.