Mikos has not objected to Defendants’ request that the Court take judicial notice of the Proclaim DRG Premarket Approval documents. Indeed, this Court has also taken judicial notice of a Class III device’s status as a premarket-approved device. Courts in this circuit “routinely take judicial notice of information contained on state and federal government websites.” United States v. 15, 2021) FDA, Proclaim Dorsal Root Ganglion Neurostimulation System, (Nov. See FDA, Axium Neurostimulator System, (Nov. 4 Mikos alleges 4 The Premarket Approval documents provided by Defendants are also available on the FDA website. 28, 2016 FDA Premarket Approval Letter at 1–2, ECF No. 26, 2016 FDA Premarket Approval Letter at 1, ECF No. Food and Drug Administration (“FDA”) granted approval for the Proclaim DRG device through its Premarket Approval process. Mikos alleges that her pain was caused in part by the fact that Defendants provided her health care providers the incorrect leads with the Proclaim DRG. Over the following two years, the Proclaim DRG caused Mikos to experience “significant pain and discomfort and incur significant medical bills from multiple physician visits, including the ultimate removal of the defective unit from her body on July 15, 2020.” (Id. Days after having the Proclaim DRG installed, Mikos began to experience “throbbing, dull, aching, shooting, stabbing” pain, with a pain level of nine out of ten. Patients are provided a small hand-held controller to program the leads to provide stimulation. 2 from there, into the intervertebral foramen, in which the DRG lies.” (Id. Neurostimulator systems like the Proclaim DRG “consist of electrical leads, an optional extension, and an implantable pulse generator,” and work by threading the leads “into the epidural space and 3 Unless otherwise noted, the Court takes the following facts from the Complaint and accepts them as true. The Proclaim DRG is a neurostimulator system designed to treat chronic pain in the foot, knee, or groin in patients with CRPS. DRG therapy works by stimulating DRGs, which “can reduce pain in specific locations in the body.” (Id.). DRGs are “structures along the spinal column made up of densely populated sensory nerves, and they act like traffic lights, regulating signals and sensations that travel through nerve fibers along the spinal column to the brain.” (Id. To treat her CRPS, on March 1, 2018, Mikos’s treating physicians placed an Implanted Generator Proclaim Dorsal Root Ganglion (“DRG”) Model 3664 (the “Proclaim DRG”) into her back. he hallmarks of CRPS are continuous pain and mechanical hyperalgesia which are disproportionate to the inciting event.” (Id.). It is believed that about 10-20% of cases become chronic and resistant to any treatment. The disease “can be very painful and often arises after trauma, surgery, or a limb immobilization. CRPS “is an array of neuropathic pain conditions that has been known by many names such as Sudeck’s Atrophy, Reflex Sympathetic Dystrophy Syndrome and Causalgia.” (Id. Mikos suffers from Complex Regional Pain Syndrome (“CRPS”) in her right leg. BACKGROUND 3 Factual Background Plaintiff Marilyn J. Having determined that no hearing is necessary to understand the issues underlying the Motion, the Court will deny Defendants’ Request. Jude Medical, LLC.” 2 The Court recognizes that Defendants have filed a Request for Oral Argument on Their Motion to Dismiss (ECF No. Jude Medical S.C., Inc.” to Defendant “St. Accordingly, the Court will direct the Clerk to change the name of Defendant “St. Jude Medical, LLC, a wholly owned subsidiary of Abbott Laboratories. was acquired by parent company Abbott Laboratories, and thereafter became known as St. Jude Medical S.C., Inc.” Defendants aver, and Mikos does not contest, that on January 4, 2017, St. Accordingly, the Court will direct the Clerk to change the name of Defendant “The Abbott Laboratories d/b/a Abbott Laboratories, Inc.” to Defendant “Abbott Laboratories, Inc.” Similarly, Mikos’s Complaint names “St. is a subsidiary of an ultimate parent company, Abbott Laboratories. Defendants aver, and Mikos does not contest, that there is no existing entity named “The Abbott Laboratories.” Rather, Abbott Laboratories Inc. Mikos’s Complaint names “The Abbott Laboratories d/b/a Abbott Laboratories, Inc.” as a Defendant. 2 For the reasons set forth below, the Court will grant in part and deny in part the Motion. 1 The Motion is ripe for disposition, and no hearing is necessary. *** MEMORANDUM OPINION THIS MATTER is before the Court on Defendants Abbott Laboratories, Inc. * THE ABBOTT LABORATORIES, et al., * Civil Action No. 24 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND MARILYN J.
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