Tice v. Bos. Sci. Corp.

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ALLISON TICE, PLAINTIFF, v. BOSTON SCIENTIFIC CORPORATION and JOHN DOES 1-3, DEFENDANTS.

No. 5:22-cv-763

United States District Court, N.D. Ohio, Eastern Division

January 23, 2023

MEMORANDUM OPINION AND ORDER

HONORABLE SARA LIOI UNITED STATES DISTRICT JUDGE

Before the Court is defendant Boston Scientific Corporation's (“Boston Scientific”) motion to dismiss the complaint for failure to state a claim. (Doc. No. 4 (Motion).) Plaintiff Allison Tice (“Tice”) filed an opposition (Doc. No. 9 (Opposition)), and Boston Scientific filed a reply (Doc. No. 10 (Reply)). For the reasons discussed herein, Boston Scientific's motion to dismiss is granted, but Tice is granted leave to amend her complaint.

I. BACKGROUND

Tice filed her complaint on June 3, 2021, in the Court of Common Pleas, Summit County, Ohio (Doc. No. 1-1 (Complaint)) alleging that a medical device (the Spectra SCS) produced by Boston Scientific was implanted in her spine on June 3, 2019, but failed on or about August 19, 2019, causing Tice “severe pain, bodily injuries and burns throughout” her body. (Id. ¶¶ 8, 14-16; see also Doc. No. 4-1, at 1.^[1]) On May 11, 2022, Boston Scientific removed this action to federal court, invoking this Court's diversity jurisdiction.^[2] On the same day, Boston Scientific filed the instant motion to dismiss. Tice filed an opposition and Boston Scientific filed a reply. The matter is now ripe for the Court's review.

II. STANDARD OF REVIEW

In the context of a motion to dismiss under Fed.R.Civ.P. 12(b)(6), the sufficiency of the complaint is tested against the notice pleading requirements of Fed.R.Civ.P. 8(a)(2), which provides that a complaint must contain “a short and plain statement of the claim showing that the pleader is entitled to relief[.]” Although this standard is liberal, Rule 8 still requires a plaintiff to allege sufficient facts that give the defendant “fair notice of what the plaintiff's claim is and the grounds upon which it rests.” Dura Pharms., Inc. v. Broudo, 544 U.S. 336, 346, 125 S.Ct. 1627, 161 L.Ed.2d 577 (2005) (quotation marks and citation omitted). Thus, “[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true,” to state a plausible claim. Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct.1955, 167 L.Ed.2d 929 (2007)).

A claim is facially plausible “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556). Plausibility “is not akin to a ‘probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully.'” Id. “[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged-but it has not ‘show[n]'-‘that the pleader is entitled to relief.'” Id. at 679 (quoting Fed.R.Civ.P. 8(a)(2) (second alteration in original)). In such a case, the plaintiff has not “nudged [his] claims across the line from conceivable to plausible, [and the] complaint must be dismissed.” Twombly, 550 U.S. at 570; see Iqbal, 556 U.S. at 683.

A complaint need not set down in detail all the particulars of a plaintiff's claim. However, “Rule 8 . . . does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.” Iqbal, 556 U.S. at 678-79 (stating that this standard requires “more than an unadorned, the-defendant-unlawfully-harmed-me accusation”). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. at 678 (citing Twombly, 550 U.S. at 555). The complaint “must contain either direct or inferential allegations respecting all the material elements to sustain a recovery under some viable legal theory.” Scheid v. Fanny Farmer Candy Shops, Inc., 859 F.2d 434, 436 (6th Cir. 1988) (internal quotations marks omitted) (emphasis in original), abrogated on other grounds by Buckhannon Bd. & Care Home, Inc. v. W.Va. Dep't of Health & Human Res., 532 U.S. 598, 121 S.Ct. 1835, 149 L.Ed.2d 855 (2001).

When resolving a motion to dismiss pursuant to Rule 12(b)(6), the Court may consider the complaint and any exhibits attached thereto, public records, items appearing in the record of the case, and exhibits attached to the defendant's motion to dismiss provided such are referenced in the complaint and central to the claims therein. Bassett v. Nat'l Collegiate Athletic Ass'n, 528 F.3d 426, 430 (6th Cir. 2008); see also Stringfield v. Graham, 212 Fed.Appx. 530, 535 (6th Cir. 2007) (explaining that documents “attached to and cited by” the complaint are “considered parts thereof under Federal Rule of Civil Procedure 10(c)”).

III. DISCUSSION

Although not clearly labeled, Tice contends that her complaint raises state-law claims of (1) strict liability,^[3] (2) negligence,^[4] (3) breach of implied warranty, (4) breach of express warranty, and (5) negligent misrepresentation.^[5] (Doc. No. 9, at 3.) Boston Scientific contends that Tice's complaint must be dismissed because her claims are preempted by federal law. (Doc. No. 4 ¶ 1.) Notwithstanding federal preemption, Boston Scientific also contends that the complaint must be dismissed because it “only contains claims for common law product liability causes of action[, which are] abrogated by the Ohio Product Liability Act” and because the complaint is “impermissible ‘shotgun pleading[.]'” (Id. ¶¶ 2-3.)

A. Preemption Under the Medical Device Amendments

The Medical Device Amendments (“MDA”), 21 U.S.C. § 360c et seq., to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., establishes various levels of oversight for medical devices depending on the degree of risk posed. Class III devices are subject to strict regulation by the Food and Drug Administration (“FDA”) through a rigorous process known as “premarket approval” (“PMA”). See 21 U.S.C. § 360c(a)(1)(C); see also Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (“Class III devices must complete a thorough review process with the FDA before they may be marketed.”); Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (“[T]he ‘premarket approval,' or ‘PMA' process, is a rigorous one.”). During the PMA review, a manufacturer must provide the FDA with a “reasonable assurance” that the device is safe and fit for human use. 21 U.S.C. § 360e(d)(2). In addition, the FDA's PMA review process includes weighing “any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” Id. § 360c(a)(2)(C). After the PMA review concludes, the FDA grants or denies regulatory approval for the reviewed medical device. Id. § 360e(d).

Once a device has received premarket approval, it “may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.” 21 C.F.R. § 814.80. If the manufacturer wishes to make any such changes, it must submit, and the FDA must approve, an application for supplemental premarket approval (“PMA Supplement”). See 21 U.S.C. § 360e(d)(5); 21 C.F.R. § 814.39. The same procedures that apply to applications for a PMA also apply to applications for PMA Supplements. 21 C.F.R. § 814.39(c).

After premarket approval, a device is subject to continued reporting requirements. See 21 U.S.C. § 360i; 21 C.F.R. § 814.84. These requirements include the obligation to submit periodic reports to the FDA informing the agency of any “[u]npublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device” as well as any “[r]eports in the scientific literature concerning the device” that the applicant knows of or reasonably should know of. 21 C.F.R. § 814.84(b)(2). The applicant also must report to the FDA no later than 30 days after “receiv[ing] or otherwise becom[ing] aware of information, from any source, that reasonably suggests that a device . . . (1) [m]ay have caused or contributed to a death or serious injury; or (2) [h]as malfunctioned and this device . . . would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.” 21 C.F.R. § 803.50(a)(1)-(2). The FDA has the power to withdraw premarket approval where it determines that a device is unsafe or ineffective, 21 U.S.C. § 360e(e)(1), and to order the recall of a device where there is a reasonable probability that the device would cause serious adverse health consequences or death. Id. § 360h(e).

The parties agree that the Spectra SCS implanted into Tice's spine was an approved Class III medical device under the MDA. (See Doc. No. 4-1, at 6; Doc. No. 9, at 2.) See 69 Fed.Reg. 58, 446-47 (Sept. 30, 2004) (listing the original April 27, 2004 PMA approval for the Spectra SCS). Further, the parties agree that Tice's state-law claims of strict liability, negligence, breach of implied warranty, and breach of express warranty are preempted under the MDA's express preemption clause, unless Tice's claims are premised on the Spectra SCS violating an FDA requirement for which there is a state law equivalent. (Doc. No. 4-1, at 13; Doc. No. 9, at 6-7.)

The MDA's express preemption clause provides that

no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the

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