Williams v. Mentor Worldwide LLC

CourtDistrict Court, N.D. Ohio
DecidedSeptember 30, 2019
Docket4:18-cv-00899
StatusUnknown

This text of Williams v. Mentor Worldwide LLC (Williams v. Mentor Worldwide LLC) is published on Counsel Stack Legal Research, covering District Court, N.D. Ohio primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Williams v. Mentor Worldwide LLC, (N.D. Ohio 2019).

Opinion

PEARSON, J. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION

JESSICA WILLIAMS, ) ) CASE NO. 4:18CV0899 Plaintiff, ) ) JUDGE BENITA Y. PEARSON v. ) ) MEMORANDUM OF OPINION MENTOR WORLDWIDE LLC, ) AND ORDER ) [Resolving ECF Nos. 22, 43, 45, 47, 48, Defendant. ) and 49]

The following motions are pending: Defendant Mentor Worldwide LLC’s Motion to Dismiss Plaintiff's Amended Complaint (ECF No. 22); Pro Se Plaintiff Jessica Williams’ Motion to Strike Defendant’s Notice of Supplemental Authority (ECF No. 43); Pro Se Plaintiffs Motion for Judgment on the Pleadings (ECF No. 45); Pro Se Plaintiff's Motion to Strike Defendant’s Opposition to Plaintiff's Motion for Judgment on the Pleadings (ECF No. 47); Defendant’s Motion to Strike Under Rule 12(f) (ECF No. 48); and, Pro Se Plaintiff's Motions to Strike Defendant’s Motion to Strike Under Rule 12(f) and “to Strike Defendant’s Opposition to Strike Plaintiff Jessica Williams’ Motion to Strike Plaintiff's Motion for Judgment on the Pleadings” (ECF No. 49).

(4:18CV0899) The Court has been advised, having reviewed the record, the parties’ briefs,' and the applicable law. For the reasons that follow, the Court grants the motion to dismiss, denies the motion to strike Defendant’s notice of supplemental authority, grants Defendant’s motion to strike under Rule 12(f), and denies as moot the other two (2) motions. I. Background Pro Se Plaintiff was first surgically implanted with Mentor Saline Breast Implants in 2002. Amended Complaint (ECF No. 17) at 7.9. Over the next several years, Plaintiff had five additional surgeries, all of which involved Mentor Saline Breast Implants. ECF No. 17 at J 8. Plaintiff underwent these additional surgeries for many reasons, such as needing replacement implants due to ruptures, a hematoma, and a post-operative infection. ECF No. 17 at JJ 10-21. In 2011, years after her surgeries, Plaintiff alleges that she started to experience various injuries, including arthritis, joint swelling, skin ulcers, depression, shortness of breath, vision loss, severe fatigue, Sjogren’s syndrome, discoid lupus, and cognitive problems. ECF No. 17 at ¥ 23. Plaintiff alleges she was eventually diagnosed with Systemic Sclerosis in 2014. ECF No. 17 at □ 26. Plaintiff asserts four (4) claims against Defendant for injuries allegedly relating to her Mentor Saline Breast Implants: (1) failure to warn, (2) negligence (failure to warn), (3) manufacturing defect, and (4) “device malfunction.” ECF No. 17 at 4] 30-34. All of Plaintiffs

' The Court has considered Defendant’s Notice of Supplemental Authority (ECF No. 41). pertinent and significant authorities come to a party’s attention after the party’s brief has been filed, a party may promptly advise the Court by serving and filing a Notice of Supplemental Authority that sets forth the citation(s). See, e.g., Fed. R. App. P. 28(j). However, this option is not to be used to reargue issues already raised in the briefs.

(4:18CV0899) claims and allegations relate solely to the safety and effectiveness of her Mentor Saline Breast Implants. The Mentor Saline Breast Implants are Class III medical devices as defined by 21 C.F.R. § 878.3530. The most stringent controls apply to Class III devices under the Medical Device Amendments of 1976 (“MDA”), 21U.S.C. § 360c et seg., to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seg. See Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Because of their Class III status, the commercial sale of Mentor Saline Breast Implants to healthcare professionals was conditioned upon the device receiving Premarket Approval (“PMA”) from the Food and Drug Administration (“FDA”). See 21 C.F.R. § 878.3530(c). On November 12, 1999, Defendant submitted a PMA application for its Saline Breast Implants.” On May 10, 2000, the FDA found that the Mentor Saline Breast Implants as designed, manufactured and labeled were safe and effective, and the FDA issued an Approval Order.’ Thereafter, Mentor Saline Breast Implants could only be sold to healthcare professionals in

> See PMA Approval Order and Summary of Safety and Effectiveness for P990075 (ECF No. 22-3). Courts regularly take judicial notice of approval letters and other documents on the FDA’s website. See Kodger v. Zimmer Biomet Holdings, Inc., No. 1:17-CV-1350, 2017 WL 4348997, at *1 (N.D. Ohio Sept. 29, 2017) (taking notice of FDA approval letter attached to defendant’s motion to dismiss). Under federal law, courts are required to take judicial notice of PMA approvals, which are reflected in the Federal Register. See 44 U.S.C. § 1507 (“The contents of the Federal Register shall be judicially noticed... .”). > See Federal Register/Vol. 66, No. 130, July 6, 2001 Notices, TABLE 1: List of Safety and Effectiveness Summaries for Approved PMAs Made Available from January 1, 2001 to March 31, 2001 (ECF No. 22-4).

(4:18CV0899) accordance with the design, manufacturing, and labeling specifications approved by the FDA. ECF No. 22-4; see also 21 C.F.R. § 801.109. These approvals remain in effect and have never been suspended or revoked. II. Standard of Review In deciding a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), the Court must take all well-pleaded allegations in the complaint as true and construe those allegations in a light most favorable to the plaintiff. Erickson v. Pardus, 551 U.S. 89, 94 (2007) (citations omitted). A cause of action fails to state a claim upon which relief may be granted when it lacks “plausibility in th[e] complaint.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 564 (2007). A pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Ashcroft v. Igbal_, 556 U.S. 662, 677-78 (2009) (quoting Fed. R. Civ. P. 8(a)(2)). Plaintiff is not required to include detailed factual allegations, but must provide more than “an unadorned, the-defendant-unlawfully-harmed-me accusation.” /d. at 678. A pleading that offers “labels and conclusions” or “a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. Nor does a complaint suffice if it tenders “naked assertion[s]” devoid of “further factual enhancement.” Jd. at 557. It must contain sufficient factual matter, accepted as true, to “state a claim to relief that is plausible on its face.” Jd. at 570. “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 misconduct alleged.” /gbal, 556 U.S. at 678. The plausibility standard is not akin to a “probability requirement,” but it asks for more than a sheer possibility that a defendant has acted unlawfully. Twombly, 550 U.S. at 556, Where a complaint

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Bluebook (online)
Williams v. Mentor Worldwide LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/williams-v-mentor-worldwide-llc-ohnd-2019.