Sullivan v. Medtronic, Inc.
| Decision Date | 30 October 2020 |
| Docket Number | Case No. 4:20 CV 344 CDP |
| Citation | 498 F.Supp.3d 1106 |
| Parties | Carissa SULLIVAN, Plaintiff, v. MEDTRONIC, INC., et al., Defendants. |
| Court | U.S. District Court — Eastern District of Missouri |
Ellen A. Presby, Van Wey and Presby PLLC, Dallas, TX, Sarah Shoemake Doles, Carey and Danis, St. Louis, MO, for Plaintiff.
Brandon D. Cox, Lori Cohen, Greenberg Traurig LLP, Atlanta, GA, Jonathan T. Barton, Stanton Barton LLC, St. Louis, MO, for Defendants.
Plaintiff Carissa Sullivan has cerebral palsy
and spastic quadriplegia. To reduce her muscle spasticity, Sullivan had a SynchroMed II Programmable Implantable Infusion Pump System ("SynchroMed") implanted in her abdomen. The SynchroMed administers a programmed amount of medication (here, baclofen ) into the intrathecal space of her spine and is made by defendants ("Medtronic"). Sullivan's SynchroMed failed in 2015, causing injuries from baclofen
withdrawal and requiring a pump replacement surgery. Sullivan alleges that the pump failure was caused by manufacturing defects and brings Missouri state law claims for strict liability, negligence, and breach of implied warranty of merchantability. She also seeks punitive damages.
Before me now is Medtronic's Rule 12(b)(6) motion to dismiss. Medtronic argues that Sullivan's claims are preempted by the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act. Medtronic also argues that even if the claims are not preempted, Sullivan has failed to state plausible claims for relief. Because I find that the claims are not preempted and that they meet federal pleading requirements, I will deny Medtronic's motion.
The purpose of a motion to dismiss under Rule 12(b)(6) is to test the legal sufficiency of the complaint. When considering a 12(b)(6) motion, the court assumes the factual allegations of a complaint are true and construes them in favor of the plaintiff. Neitzke v. Williams , 490 U.S. 319, 326–27, 109 S.Ct. 1827, 104 L.Ed.2d 338 (1989). Rule 8(a)(2), Fed. R. Civ. P., provides that a complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." In Bell Atlantic Corp. v. Twombly , the Supreme Court clarified that Rule 8(a)(2) requires complaints to contain "more than labels and conclusions, and a formulaic recitation of the elements of a cause of action." 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ; accord Ashcroft v. Iqbal , 556 U.S. 662, 678–79, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Specifically, to survive a motion to dismiss, a complaint must contain enough factual allegations, accepted as true, to state a claim for relief "that is plausible on its face." Twombly , 550 U.S. at 570, 127 S.Ct. 1955. The issue in considering such a motion is not whether the plaintiff will ultimately prevail, but whether the plaintiff is entitled to present evidence in support of the claim. See Neitzke , 490 U.S. at 327, 109 S.Ct. 1827.
Sullivan was first implanted with a SynchroMed pump in 2005. That device functioned normally until the end of its lifecycle in 2011. On August 29, 2011, Sullivan's original SynchroMed was replaced with a new SynchroMed pump bearing model number 8637-40 (serial number NGV453274H) and model number 8578 sutureless pump connector (serial number N280915008). She retained her original catheter. The device functioned normally at first, but on March 5, 2015, Sullivan began complaining of increased stiffness and the sensation of feeling bugs crawling on her. The SynchroMed alarm began to beep, and plaintiff alleges that the motor in her pump was stalling, seizing, or otherwise failing to deliver baclofen
medication as programmed, causing baclofen withdrawal. (First Amended Complaint, Doc. #31 at Paragraph 11).
The next day, Sullivan went to the emergency room and was admitted with a diagnosis of acute withdrawal secondary to baclofen
pump failure with symptoms of tremors, pruritus, shortness of breath, tachycardia, elevated blood pressure, and hyperthermia. Doctors initiated drug withdrawal protocol. A Medtronic representative examined Sullivan's pump at the hospital and confirmed it was not functioning. Sullivan's doctors recommended "urgent replacement" of her SynchroMed. On March 7, 2015, Sullivan had pump replacement surgery. Both the Medtronic pump and the sutureless catheter connector were replaced with new Medtronic components.
The surgeon noted that "there was evidence of a catastrophic pump failure with a rotor stall that had occurred that could not be remedied by cycling her pump off/on." Sullivan alleges that, as a result of her baclofen
withdrawal, she has severe and permanent injuries, including being unable to void through her urethra, impaired speech, an uncontrollable stutter, and panic attacks. Sullivan alleges that her baclofen withdrawal was caused by manufacturing defects in her SynchroMed which caused the pump to experience motor stalls or seizure. She brings the following three claims under Missouri common law: Strict Liability—Manufacturing Defect (Count I); Negligence—Manufacturing Defect (Count II); and Breach of the Implied Warranty of Merchantability (Count III). She also seeks punitive damages (Count IV).
In 1976, Congress passed the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA). See 21 U.S.C. § 360c et seq. The amendments authorized the FDA to "regulate the safety and effectiveness of medical devices." In re Medtronic, Inc. , 623 F.3d 1200, 1203 (8th Cir. 2010). Through the amendments, which were a response to proliferation (and frequent failure) of medical devices entering the market, Congress "swept back some state obligations and imposed a regime of detailed federal oversight." Riegel v. Medtronic, Inc. , 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) ; see also Medtronic, Inc. v. Lohr , 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ().
The MDA classifies medical devices into three groups (Classes I, II, and III) based on the degree of risk they pose. In general, Class III devices—as the most dangerous—are subject to the highest level of scrutiny by the FDA. This manifests in a rigorous, comprehensive inquiry called "premarket approval," or PMA. See Lohr, 518 U.S. at 477, 116 S.Ct. 2240 (). An applicant seeking PMA for a Class III device must supply information to the FDA, including a description of the device, clinical safety trials, methods of product testing, design of the device and manufacturing controls, outcome evaluation, and proposed labeling. (First Am. Compl. Doc. #31 at ¶ 27). The FDA does not conduct independent testing on a medical device in a PMA application. (Id. ). Following PMA, an applicant must comply with certain FDA requirements and federal regulations, including those set out in 21 C.F.R. Pt. 803, 21 C.F.R. Pt. 820, and 21 U.S.C. §§ 351 – 52. (Id., at ¶ 29). The holder must also comply with specifications imposed during the PMA process for the device. (Id. , at ¶ 78).
SynchroMed is a Class III, premarket-approved device. (Id. at ¶ 26). The FDA approved the original SynchroMed in 1988 (PMA P860004) and has granted supplemental approval for numerous modifications and improvements to the device. (Id. at ¶ 22, 23). SynchroMed is FDA-approved for the intrathecal infusion of baclofen
Starting in 2006, the FDA issued Medtronic a series of warning letters identifying federal manufacturing and quality control violations at their manufacturing plants with respect to SynchroMed. (Id. at ¶ 35, 36). On April 27, 2015, the U.S. Department of Justice and U.S. Department of Health and Human Services filed a complaint requesting a permanent injunction, leading to a court ordered consent decree "imposing a moratorium on the manufacture, sale, and distribution" of SynchroMed. (Id. at ¶ 33). Since receiving PMA, SynchroMed has been subject to at least 72 recalls. (Id. at ¶ 34).
The warning letters issued by the FDA identified "significant deviations" from Current Good Manufacturing Practices (CGMPs), codified at 21 C.F.R. § 820, committed by Medtronic while manufacturing SynchroMed. (Id. at ¶ 38). The letters outlined specific CGMPs that Medtronic failed to follow. (Id. ). Due to these deviations, SynchroMed was found to be "adulterated" or "misbranded." (Id. at ¶¶ 37, 41, 45, 49). The FDA also notified Medtronic on multiple occasions that the violations "may be symptomatic of serious underlying problems in [Medtronic's] manufacturing and Quality Assurance systems." (Id. at ¶¶ 43, 47, 52). Since 2008, the FDA has issued nineteen Class I and II recall actions for SynchroMed to address federal violations. (Id. at ¶ 68).
The July 17, 2012 warning letter states that Medtronic violated 21 C.F.R. § 820.100(a) by failing to establish adequate procedures for corrective and preventive action, including failing to identify "the actions to correct and prevent recurrence of nonconforming product" outlined in (Id. at ¶ 50). This same letter also details Medtronic's failure to "adequately evaluate" "eleven of 11 closed complaints involving motor stalls with unknown cause and no returned...
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