Smith v. Zoll Med. Corp.
| Decision Date | 08 December 2020 |
| Docket Number | No. 1:20-cv-02204-STA-jay,1:20-cv-02204-STA-jay |
| Parties | Doris SMITH, Plaintiff, v. ZOLL MEDICAL CORPORATION, ZOLL Manufacturing Corporation, ZOLL Lifecor Corporation, ZOLL LifeVest Holdings, LLC, and ZOLL Services, LLC., Defendants. |
| Court | U.S. District Court — Western District of Tennessee |
Steven Nauman, Pro Hac Vice, Orlando, FL, William Thomas Hackett, Morgan and Morgan-Memphis LLC, Memphis, TN, for Plaintiff.
Damon Brinson, Pro Hac Vice, Bowman and Brooke LLP, Austin, TX, William B. Jakes, III, Howell & Fisher, PLLC, Nashville, TN, Kim M. Schmid, Pro Hac Vice, Bowman and Brooke LLP, Minneapolis, MN, for Defendants.
ORDER PARTIALLY GRANTING AND PARTIALLY DENYING DEFENDANTS’ MOTION TO DISMISS
Plaintiff Doris Smith, as the surviving spouse of Alex Smith ("the Decedent"), and as an individual, filed this wrongful death/product liability action against ZOLL Medical Corporation, ZOLL Manufacturing Corporation, ZOLL Lifecor Corporation, ZOLL LifeVest Holdings, LLC, and ZOLL Services, LLC (collectively "ZOLL"), alleging various state law claims of strict liability and negligence for the injuries and subsequent death of the Decedent.1 Jurisdiction is predicated on diversity of citizenship, 28 U.S.C. § 1332. Defendants have filed a motion to dismiss the second amended complaint pursuant to Federal Rules of Civil Procedure 8(a) and 12(b)(6) on the ground that federal law preempts all of Plaintiff's claims under Riegel v. Medtronic, Inc. , 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), and Buckman Co. v. Plaintiffs’ Legal Comm. , 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), and Plaintiff has failed to state a claim upon which relief may be granted by insufficiently pleading her claims. (ECF No. 30.) Plaintiff has filed a response to the motion (ECF No. 32), and Defendants have filed a reply to the response. (ECF No. 33.)2 For the reasons set forth below, the motion to dismiss is PARTIALLY GRANTED and PARTIALLY DENIED.
When ruling on a motion to dismiss under Rule 12(b)(6), the district court must determine whether the complaint "state[s] a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A claim is plausible on its face when the plaintiff alleges "factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Plausibility requires showing more than the "sheer possibility" of relief but less than a probable entitlement to relief. Fabian v. Fulmer Helmets, Inc. , 628 F.3d 278, 280 (6th Cir.2010) (quoting Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 ). The mere recitation of legal elements is not enough, and the district court need not give credence to conclusory statements that are not supported by factual allegations. Iqbal , 556 U.S. at 678, 129 S.Ct. 1937. The court must accept all facts alleged in the complaint as true and must read the complaint in the light most favorable to the plaintiff. Lipman v. Budish , 974 F.3d 726, 740 (6th Cir. 2020) (). In a medical product liability action, under the preemption clause of the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 360k, "a plausible cause of action requires, among other things, a showing that the alleged violation of state law parallels a violation of federal law." Hafer v. Medtronic, Inc. , 99 F. Supp. 3d 844, 855 (W.D. Tenn. 2015) (quoting White v. Stryker Corp. , 818 F. Supp. 2d 1032, 1037 (W.D. Ky. 2011) ).
The Court will adopt Defendants’ undisputed description of the background of the MDA. In 1976, Congress enacted the MDA, 21 U.S.C. §§ 360c et seq. , to the FDCA, 21 U.S.C. §§ 301 et seq. The MDA authorized the Food & Drug Administration ("FDA") to regulate medical devices, creating a comprehensive "regime of detailed federal oversight." Riegel , 552 U.S. at 316, 128 S.Ct. 999. Congress specified that "no State ‘may establish or continue in effect with respect to a device ... any requirement’ relating to safety or effectiveness that is different from, or in addition to, federal requirements." Id. at 328, 128 S.Ct. 999 (quoting 21 U.S.C. § 360k(a) ).3
Under the MDA, different devices receive different levels of scrutiny from the FDA. Devices are classified on a scale of I to III; Class III devices, like the ZOLL LifeVest, are those used "in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," or which "present[ ] a potential unreasonable risk of illness or injury." Riegel , 552 U.S. at 317, 128 S.Ct. 999 (quoting 21 U.S.C. § 360c(a)(1) ). Class III devices must receive FDA approval before they are brought to market, and they "incur the FDA's strictest regulation." Buckman , 531 U.S. at 343, 121 S.Ct. 1012. "Premarket approval ["PMA"] is a ‘rigorous’ process[,]" Riegel , 552 U.S. at 317, 128 S.Ct. 999 (quoting Medtronic, Inc. v. Lohr , 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ), requiring "approximately 1,200 hours of FDA review." Spier , 121 F. Supp. 3d at 814 (citing Lohr , 518 U.S. at 477, 116 S.Ct. 2240 ). The FDA "grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ " Riegel , 552 U.S. at 317, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d) ).
The FDA's regulatory role does not end with approval of the initial PMA application. "Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Riegel , 552 U.S. at 318, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6)(A)(I) ). If a manufacturer wishes to make such changes, it must submit a PMA supplement and can implement the proposed changes only with the FDA's approval. Riegel , 451 F.3d at 110 (citing 21 C.F.R. § 814.39(a) ). A PMA supplement is subject to the same rigorous standards of review as the initial PMA application. Riegel , 552 U.S. at 319, 128 S.Ct. 999 (citing 21 C.F.R. § 814.39(c) ).
The present action involves an FDA-approved, PMA Class III medical device — the ZOLL LifeVest wearable cardioverter
defibrillator.4 According to the second amended complaint, the Decedent was prescribed a ZOLL LifeVest by his physician due to an underlying heart condition that could "cause arrhythmia and result in sudden cardiac arrest or death." (Sec. Am. Compl. ¶ 47, ECF No. 31.) The LifeVest is designed to be worn by patients who are at risk of sudden cardiac arrest in order to provide immediate protection while the patient's physician plans for his long-term therapeutic needs. (Id. ¶ 29.) The LifeVest provides this protection by continuously monitoring the patient's heart rhythm and delivering treatment shocks to the patient when an arrhythmia is detected. (Id. ¶ 30.)
The LifeVest accomplishes this through two primary component systems: a garment and a monitor. (Id. ¶ 31.) The LifeVest's garment is worn underneath the patient's clothing and houses four electrocardiogram
sensors along with three therapy electrodes. (Id. ¶¶ 31, 32.) The electrocardiogram sensors monitor the electrical signals emitted by the patient's heart, while the therapy electrodes deliver electrical shock treatments to the patient when an arrhythmia is detected. (Id. ¶ 32.) The four electrocardiogram sensors and three therapy electrodes are connected through a series of wires and cables to a central distribution node, which is connected to the LifeVest's monitor. (
Id. ¶ 33.) The monitor houses the LifeVest's computer system and is worn around the patient's waist or from a shoulder strap. (Id. ¶¶ 31, 34.) The monitor uses proprietary software and algorithms to interpret the electrical signals received from the patient's heart and to commence electrical shock treatment in the event of an arrhythmia. (Id. ¶ 34.) The LifeVest is powered by a rechargeable battery pack inserted into the monitor. (Id. ¶ 37.)
When the LifeVest detects a patient arrhythmia
requiring electrical shock treatment, the LifeVest progresses through a treatment sequence. (Id. ¶¶ 35, 36.) First, the LifeVest sounds an audible alarm to determine whether the patient is responsive. (Id. ¶ 35.) If the patient is conscious, he has time to respond to the alarm by pressing two buttons on the LifeVest's monitor, which will terminate the treatment sequence. (Id. ) If the patient does not respond to the alarm, the LifeVest issues an audible warning that an electrical shock is about to be administered and that bystanders should stand clear. (Id. ) If the patient still does not respond to the alarm, the LifeVest administers an electrical shock to the patient through the therapy electrodes. (Id. ) If the patient's heartbeat returns to normal after receiving an electrical shock, the LifeVest returns to its monitoring function. (Id. ¶ 36.) If the patient's arrhythmia
continues, the LifeVest repeats the treatment sequence up to five times, depending on how the device was programmed by the patient's physician. (Id. )
Plaintiff alleges that, by receiving premarket approval for the LifeVest, Defendants are required by federal law to manufacture, produce, refurbish, and distribute every LifeVest in a condition that complies with the design specifications and manufacturing requirements approved by the FDA. (Id. ¶ 44.) Relevant specifications and requirements include: manufacturing, producing, refurbishing, and distributing the LifeVest with a properly functioning battery pack and battery pack charger; manufacturing, producing, refurbishing, and distributing the LifeVest with properly functioning battery pack connections, wires, cables, and battery pack...
To continue reading
Request your trial