Smith v. Bos. Sci. Corp.
| Decision Date | 27 July 2022 |
| Docket Number | 3:21-cv-815-MMH-LLL |
| Parties | NYOKA SMITH, Plaintiff, v. BOSTON SCIENTIFIC CORPORATION, Defendant. |
| Court | U.S. District Court — Middle District of Florida |
THIS CAUSE is before the Court on Defendant Boston Scientific Corporation's Motion to Dismiss Plaintiffs Amended Complaint and Memorandum of Law (Doc. 15; Motion) filed November 9, 2021. In the Motion, Boston Scientific Corporation (Boston Scientific) requests that the Court dismiss portions of Plaintiff Nyoka Smith's First Amended Complaint and Demand for Jury Trial (Doc. 7; Amended Complaint), filed September 10, 2021. Smith timely filed a response in opposition to the Motion. See Plaintiffs Response to Defendant's Motion to Dismiss and Memorandum in Opposition (Doc. 17; Response), filed November 30, 2021. Accordingly, this matter is ripe for review.
In ruling on a motion to dismiss, the Court must accept the factual allegations set forth in the complaint as true. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Swierkiewicz v. Sorema N.A., 534 U.S. 506, 508 n.1 (2002); see also Lotierzo v. Woman's World Med. Ctr Inc., 278 F.3d 1180, 1182 (11th Cir. 2002). In addition, all reasonable inferences should be drawn in favor of the plaintiff. See Randall v. Scott, 610 F.3d 701, 705 (11th Cir. 2010). Nonetheless, the plaintiff must still meet some minimal pleading requirements. Jackson v. Bellsouth Telecomm., 372 F.3d 1250, 1262-63 (11th Cir. 2004) (citations omitted). Indeed, while “[s]pecific facts are not necessary[,]” the complaint should “‘give the defendant fair notice of what the . . . claim is and the grounds upon which it rests.'” Erickson v. Pardus, 551 U.S. 89, 93 (2007) (per curiam) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)). Further, the plaintiff must allege “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 570. “A claim has facial plausibility when the pleaded factual content allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 556). A “plaintiffs obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do[.]” Twombly, 550 U.S. at 555 (internal quotations omitted); see also Jackson, 372 F.3d at 1262 () (internal citation and quotations omitted). Indeed, “the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions[,]” which simply “are not entitled to [an] assumption of truth.” Iqbal, 556 U.S. at 678, 680. In addition, “[a] court need not accept as true allegations in a complaint that contradict or are inconsistent with judicially-noticed facts.” Chapman v. Abbott Labs., 930 F.Supp.2d 1321, 1323 (M.D. Fla. 2013).[1] Thus, in ruling on a motion to dismiss, the Court must determine whether the complaint contains “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face[.]'” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570).
During a surgery in 2018, Smith's physician implanted a Boston Scientific Obtryx II Halo System and a Boston Scientific Upsylon Y Mesh product (collectively, the “Mesh Products”) into Smith to treat stress urinary incontinence and vaginal vault prolapse. See Amended Complaint ¶¶ 1-2. Boston Scientific designed, manufactured, and marketed the Mesh Products, which are medical devices available only by prescription. See id. ¶¶ 1, 48, 59, 82, 107; Motion at 2-3. According to Smith, Boston Scientific knew or should have known that the Mesh Products had a propensity to cause numerous dangerous complications, including several types of pain, urinary dysfunction, perforation and vaginal scarring, and the need for future surgeries. See Amended Complaint ¶¶ 35-36, 50, 59, 109, 117. Prior to Smith's surgery, the Food and Drug Administration (FDA) and several medical scholars “examined each of these injuries, conditions, and complications, and . . . reported that they [were] casually related to the pelvic mesh products.” Id. ¶¶ 19-22, 37.
As alleged in the Amended Complaint, Boston Scientific had a duty to “provide accurate, reliable, and completely truthful information regarding the safety and any dangerous propensities” of the Mesh Products. Id. ¶ 64. Smith asserts that Boston Scientific failed to adequately warn her, her health care providers, or the public of the Mesh Products' risks or the frequency, magnitude, and scope of those risks. See id. ¶¶ 34, 67-68, 71, 109, 111, 114-15. Because Boston Scientific provided inadequate warnings, Smith and her healthcare providers were unaware that using the Mesh Products exposed her to these risks. See id. ¶¶ 47, 69, 71, 118, 120. Smith alleges that, as a proximate cause of Boston Scientific's failure to warn, her physician implanted the Mesh Products into Smith. See id. ¶¶ 77, 118, 120-21. The Mesh Products caused Smith to experience numerous types of physical and mental pain, recurrence of incontinence, perforation and vaginal scarring, additional medical treatment, and financial loss. See id. ¶¶ 42, 77, 124. According to Smith, her injuries are “of the exact type” reported by the FDA and the other medical literature. Id. ¶ 125.
Based on these and other allegations, Smith initiated this action on August 23, 2021, by filing a Complaint for Damages and Jury Demand (Doc. 1; Complaint). After the Court sua sponte struck the Complaint, see Order (Doc. 5), filed August 27, 2021, Smith filed her Amended Complaint. In the Amended Complaint, Smith alleges three causes of action. In Count One, Smith asserts a negligence claim based on Boston Scientific's product design, manufacturing, testing, and warnings. See Amended Complaint ¶¶ 48-78. In Count Two, she alleges that Boston Scientific is strictly liable for its defective design of the Mesh Products. See id. ¶¶ 79-106. And, in Count Three, Smith asserts another strict liability claim based on Boston Scientific's failure to adequately warn physicians and patients of the Mesh Products' risks. See id. ¶¶ 107-23.
In its Motion, Boston Scientific asks the Court to dismiss Count Three and the portion of Count One that alleges a negligent failure to warn. See Motion at 15. Boston Scientific states that, under Florida law, “a manufacturer has no duty to warn of product risks where those risks are obvious or already known to the product's user.” Id. at 8. Boston Scientific then represents that federal courts have applied this rule to the learned intermediary doctrine and held “that ‘a manufacturer's duty to warn physicians is limited and does not extend to risks already known to the medical community.'” Id. (quoting Aquino v. C.R. Bard, Inc., 413 F.Supp.3d 770, 790 (N.D. Ill. 2019)). Boston Scientific contends that the FDA publications and other medical literature cited in the Amended Complaint demonstrate that the medical community knew the risks of the Mesh Products before Smith's physician recommended that she receive the Mesh Products.[3] See id. at 9-13. Boston Scientific further argues that, because the medical community already knew of the Mesh Products' risks, Boston Scientific had no duty to warn Smith's physician. See id. at 14. Thus, according to Boston Scientific, Smith's citations to the FDA publications and other literature fatally undermine and render implausible her allegation that Boston Scientific had a duty to warn of the Mesh Products' risks. See id.
In her Response, Smith asserts that Boston Scientific misrepresents both allegations of the Amended Complaint and the law. See Response at 6-9.
Smith argues that, in the Amended Complaint, she alleges that Boston Scientific hid the magnitude and frequency of the problems caused by the Mesh Products. See id. at 7. In addition, Smith contends that some of the injuries she alleges-including neuromuscular pain and lifelong, life-altering pain- were not known to the medical community at large and that the magnitude and severity of the complications were not known. See id. at 9. In addition, she argues that Boston Scientific misrepresents Florida law. See id. at 7-8.
Having reviewed the filings and applicable law, the Court finds that the Motion is due to be denied because Boston Scientific has not provided authority demonstrating that Florida law supports its position. In this diversity action, the Court must apply Florida law. See Salinero v. Johnson & Johnson, 995 F.3d 959, 964 (11th Cir. 2021). Under Florida law, a manufacturer has a duty to warn “where a product is inherently dangerous or has dangerous propensities” unless the danger is obvious or already known to the product's user. Rodriguez v. New Holland N. Am., Inc., 767 So.2d 543, 544-45 (Fla. 3d DCA 2000) (per curiam) (quoting Siemens Energy & Automation, Inc. v. Medina, 719 So.2d 312, 314 (Fla. 3d DCA 1998) (per curiam)) (addressing a negligence claim); see Pinchinat v. Graco Children's Prods., Inc., 390 F.Supp.2d 1141, 1146 (M.D. Fla. 2005) (). For a manufacturer of prescription drugs or medical devices, the Florida Supreme Court has instructed that the duty to warn is “directed to the physician,” who acts as a learned intermediary between the manufacturer and the patient. Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla. 1989); see Salinero, 995 F.3d at 964.
Here Boston Scientific does not...
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