Kilmer v. Medtronic, Inc.
| Decision Date | 13 April 2021 |
| Docket Number | CASE NO. 1:20-cv-01277-AWI-HBK |
| Parties | NANCY KILMER, Plaintiff, v. MEDTRONIC, INC.; MEDTRONIC USA, INC.; MEDTRONIC PUERTO RICO OPERATIONS, CO.; AND MEDTRONIC LOGISTICS, LLC, Defendants. |
| Court | U.S. District Court — Eastern District of California |
ORDER ON DEFENDANTS' MOTION TO DISMISS
Plaintiff Nancy Kilmer has alleged that she suffered personal injuries arising from her use of a medical device that was manufactured and placed into the stream of commerce by Defendants Medtronic, Inc., Medtronic USA, Inc., Medtronic Puerto Rico Operations, Co., and Medtronic Logistics, LLC.1 Medtronic now moves to dismiss Kilmer's claims pursuant to Federal Rule of Civil Procedure 12(b)(6). For the following reasons, the Court will grant in part and deny in part Medtronic's motion.
Kilmer filed her complaint with allegations that her Medtronic-brand SynchroMed II Programmable Implantable Infusion Pump System ("SynchroMed II Device" or "Device") caused her injuries when it twice failed to deliver prescribed medication as programmed and insteaddelivered an opiate overdose. Doc. No. 1 ("Compl."), ¶¶ 30, 35, 39.2 The Device is a programmable drug infusion system implanted in the body for drug delivery. Id., ¶ 11. It consists of an infusion pump connected to a thin, flexible catheter that attaches to the intrathecal space in the spinal canal. Id. In operation, an implanted Device delivers medication to the patient by way of a clinician-administered injection into the pump's reservoir fill port. Id., ¶ 12. A battery-powered machine dispenses a programmed dose of medication from the pump to the catheter (and eventually the patient's intrathecal space). Id.
Kilmer had a SynchroMed II Device implanted on April 19, 2006, to administer medication to treat lumbar disc displacement without myelopathy, post lumbar spine surgery syndrome, and chronic intractable pain. Id., ¶¶ 20-22. Her Device included a pump (Model No. 8637-20) and a catheter (Model No. 8709). Id., ¶ 22. It was initially used to administer morphine, but later used to administer hydromorphone and clonidine instead. Id., ¶ 23. On August 19, 2008, the pump in Kilmer's Device malfunctioned, causing her to suffer an onset of pain, a clammy feeling in her legs, vomiting, and withdrawal symptoms. Id., ¶ 24.
On August 8, 2012, Kilmer had her Device's pump removed and replaced with a new pump (Model No. 8637-20) that connected to her original catheter. Id., ¶ 26. The second pump was used to administer hydromorphone, clonidine, bupivacaine, and fentanyl. Id., ¶ 27. Kilmer underwent a pump refill procedure on July 22, 2014. Id., ¶ 28. Following the procedure, she was hospitalized and diagnosed with an overdose of hydromorphone after she started feeling light-headed, had a funny taste in her mouth, and became tired, dizzy, and short of breath. Id., ¶¶ 28-29. Kilmer underwent another pump refill procedure on September 7, 2018. Id., ¶ 30. After she reported feeling like there were "clouds in her head," Kilmer received an anti-overdose drug (Narcan) and was later hospitalized and diagnosed with an opiate overdose. Id., ¶¶ 30-31.
On December 20, 2018, Kilmer had her second pump removed and replaced with a new pump (Model No. 8637-20) that connected to her original catheter. Id., ¶¶ 32-33. The third pumpwas used to administer hydromorphone. Id., ¶ 34. Following a pump refill procedure on March 19, 2019, Kilmer reported feeling like she was "high." Id., ¶ 35. She again received Narcan and was monitored until overdose symptoms were resolved. Id. A few days later, Kilmer spoke with a Medtronic representative who informed her that Medtronic was aware of pump overdoses occurring during refill procedures but that Medtronic did not know why these overdoses were happening. Id., ¶ 36. In light of the latest malfunction, in July 2019, Kilmer had her third pump removed and replaced with a Flowonix-brand pump. Id., ¶ 38.
Kilmer filed her complaint against Medtronic on September 8, 2020. Therein, she pleads eight counts under California law: strict liability manufacturing defect (¶¶ 74-81); negligent manufacturing defect (¶¶ 82-89); strict liability failure to warn (¶¶ 90-97); negligent failure to warn (¶¶ 98-105); negligence per se (¶¶ 106-114); breach of express warranty (¶¶ 115-119); breach of implied warranty of merchantability (¶¶ 120-127); and breach of implied warranty of fitness for a particular purpose (¶¶ 128-137). Kilmer also seeks punitive damages. Id., ¶¶ 138-140. Broadly, Kilmer bases her claims on her second and third Medtronic pumps and her original catheter. Id., ¶ 39. She alleges that the pumps and catheter "failed to deliver the prescribed medication as programmed, resulting in overinfusion and causing [her] to suffer damages including pain and suffering; mental anxiety and anguish; pump removal and replacement; and medical bills in amounts to be proven at trial." Id.
Now before the Court is Medtronic's motion to dismiss. Doc. No. 14. Kilmer has filed an opposition, and Medtronic has filed a reply. Doc. Nos. 20, 25.
Under Federal Rule of Civil Procedure 12(b)(6), a cause of action may be dismissed where a plaintiff fails "to state a claim upon which relief can be granted." Fed. R. Civ. P. 12(b)(6). Dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal theory or on the absence of sufficient facts alleged under a cognizable legal theory. Conservation Force v. Salazar, 646 F.3d 1240, 1242 (9th Cir. 2011); Johnson v. Riverside Healthcare Sys., LP, 534 F.3d 1116, 1121-22 (9th Cir. 2008). To survive a Rule 12(b)(6) motion for failure to allege sufficient facts, acomplaint must include a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Compliance with this rule ensures that the defendant has "fair notice of what the . . . claim is and the grounds upon which it rests." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)) (internal quotation marks omitted). Under this standard, a complaint must contain sufficient factual matter to "state a claim to relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal citations omitted). A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the alleged misconduct. Id. at 663.
In reviewing a complaint under Rule 12(b)(6), all allegations of material fact are taken as true and construed in the light most favorable to the nonmoving party. Mollett, 795 F.3d at 1065; Marceau v. Blackfeet Hous. Auth., 540 F.3d 916, 919 (9th Cir. 2008). But the Court is "not 'required to accept as true allegations that contradict exhibits attached to the Complaint or matters properly subject to judicial notice, or allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.'" Seven Arts Filmed Entm't, Ltd. v. Content Media Corp. PLC, 733 F.3d 1251, 1254 (9th Cir. 2013) (quoted source omitted). Complaints that offer no more than "labels and conclusions" or "a formulaic recitation of the elements of a cause of action will not do." Iqbal, 556 U.S. at 678; Johnson v. Fed. Home Loan Mortg. Corp., 793 F.3d 1005, 1008 (9th Cir. 2015). Rather, "for a complaint to survive a motion to dismiss, the non-conclusory 'factual content,' and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief." Moss v. U.S. Secret Serv., 572 F.3d 962, 969 (9th Cir. 2009) (quoting Iqbal, 556 U.S. at 678). If a motion to dismiss is granted, "a district court should grant leave to amend even if no request to amend the pleading was made, unless it determines that the pleading could not possibly be cured by the allegation of other facts." Henry A. v Willden, 678 F.3d 991, 1005 (9th Cir. 2012) (quoted source omitted).
Medtronic asks that this Court take judicial notice of various documents for purposes ofresolving its motion. Doc. No. 15. Under Federal Rule of Evidence 201, a court may take judicial of adjudicative facts if they are "not subject to reasonable dispute." Fed. R. Evid. 201(b). A fact is "not subject to reasonable dispute" if it is "generally known," or "can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned." Fed. R. Evid. 201(b)(1)-(2).
The seven documents for which Medtronic seeks judicial notice are: (1) the U.S. Food and Drug Administration ("FDA") Premarket Approval Database listing for the SynchroMed II Device, PMA No. P860004 (Doc. No. 14 at Ex. A); (2) the FDA Premarket Approval Database listing for the SynchroMed II Device, PMA No. P860004, Supplement No. S056 (Doc. No. 14 at Ex. B); (3) the FDA Premarket Approval Database listing for the SynchroMed II Device, PMA No. P860004, Supplement No. S039 (Doc. No. 14 at Ex. C); (4) an appendix comparing Kilmer's allegations regarding recalls of the SynchroMed II Device to her specific claims (Doc. No. 14 at Ex. D); (5) an appendix comparing Kilmer's allegations regarding FDA actions to her specific claims (Doc. No. 14 at Ex. E); (6) the FDA Manufacturer and User Facility Device Experience ("MAUDE") Database; and (7) a Medtronic webpage containing hyperlinks to annual neuromodulation product performance reports that were produced and published by Medtronic.
Kilmer does not object to the Court taking judicial notice of the FDA Premarket Approval Database listings. These documents, which are publicly accessible through a searchable database maintained by the FDA,3 are matters of public record that "can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned." Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868, 878-79 (N.D. Cal. 2013). Thus, the Court will take judicial notice of Exhibits A, B, and C of Medtronic's motion.
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