Williams v. Mentor Worldwide LLC

JESSICA WILLIAMS, Plaintiff, v. MENTOR WORLDWIDE LLC, Defendant.

CASE NO. 4:18CV0899

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION

September 30, 2019

PEARSON, J.

JUDGE BENITA Y. PEARSON

MEMORANDUM OF OPINION AND ORDER

[Resolving ECF Nos. 22, 43, 45, 47, 48, 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 Plaintiff's 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).

The Court has been advised, having reviewed the record, the parties' briefs,¹ 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 ¶ 9. Over the next several years, Plaintiff had five additional surgeries, all of which involved Mentor Saline Breast Implants. ECF No. 17 at ¶ 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 ¶¶ 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 ¶¶ 30-34. All of Plaintiff'sclaims 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 seq., to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. 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.² 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.³ Thereafter, Mentor Saline Breast Implants could only be sold to healthcare professionals inaccordance 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. Iqbal , 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." Id. 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." Id. at 557. It must contain sufficient factual matter, accepted as true, to "state a claim to relief that is plausible on its face." Id. 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." Iqbal, 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 complaintpleads facts that are "merely consistent with" a defendant's liability, it "stops short of the line between possibility and plausibility of 'entitlement to relief.'" Id. at 557 (brackets omitted). "[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.'" Iqbal, 556 U.S. at 679 (quoting Rule 8(a)(2)). The Court "need not accept as true a legal conclusion couched as a factual allegation or an unwarranted factual inference." Handy-Clay v. City of Memphis, Tenn., 695 F.3d 531, 539 (6th Cir. 2012) (citations and internal quotation marks omitted). Pleadings filed by pro se litigants are liberally construed. Urbina v. Thoms, 270 F.3d 292, 295 (6th Cir. 2001). However, this lenient treatment has limits, as "courts should not have to guess at the nature of the claim asserted." Wells, 891 F.2d at 594.

III. Choice of Law

Generally, "[a] federal court sitting in diversity must apply the choice-of-law rules of the forum state." Nationwide Mut. Fire Ins. Co. v. Gen. Motors Corp., 415 F. Supp.2d 769, 774-75 (N.D. Ohio 2006) (Dowd, J.) (citing Klaxon Co. v. Stentor Elec. Manufacturing Co., 313 U.S. 487, 496 (1941); Tele-Save Merch. Co. v. Consumers Distrib. Co., 814 F.2d 1120, 1122 (6th Cir. 1987)). Therefore, the Court must apply Ohio's choice-of-law rules. Ohio follows the Restatement (Second) of Conflict of Laws when determining choice of law issues. See Morgan v. Biro Mfg. Co., Inc., 15 Ohio St.3d 339, 341-41 (1984). Under the Restatement, "a presumption is created that the law of the place of the injury controls unless another jurisdiction has a more significant relationship to the lawsuit." Id. at 342; see also Wahl v. Gen. Elec. Co., 786 F.3d 491, 500 (6th Cir. 2015).

Ohio courts apply the following factors from § 145 of the Restatement to determine which state has the most significant relationship to the lawsuit: (1) the place of the injury, (2) the place where the conduct causing the injury occurred, (3) the domicile, residence, nationality, place of incorporation, and place of business of the parties, and (4) the place where the relationship between the parties, if any, is located. See Morgan, 15 Ohio St.3d at 342. When a plaintiff's injuries occur in more than one state, the court should apply the law of the state where most of the injuries occurred or can be attributed. See Byers v. Lincoln Elec. Co., 607 F. Supp.2d 840, 847 (N.D. Ohio 2009) (O'Malley) (applying Texas law because plaintiff spent nearly 20 years in Texas and only a few months in other states during the time period he alleged his injuries occurred).

Although Plaintiff was implanted and received treatment in both Louisiana and Florida, Louisiana is the state with the most significant relationship to Plaintiff and her injuries. ECF No. 17 at ¶¶ 8-26. Only her initial surgeries and two additional procedures occurred in Florida. ECF No. 17 at ¶¶ 9-10, 18-20. Most of the procedures and treatments Plaintiff received took place in Louisiana. ECF No. 17 at ¶¶ 11-17, 23-26. Particularly, Plaintiff was diagnosed and treated for Systemic Sclerosis entirely in Louisiana, which is the injury she devotes the most space to in her Amended Complaint. ECF No. 17 at ¶¶ 23-26. Additionally, Plaintiff resided in Louisiana throughout all of her implantation and removal procedures. ECF No. 17 at ¶ 6. Therefore, as Louisiana is the state where most of Plaintiff's injuries occurred, under Byers, the Court must apply Louisiana law to Plaintiff's claims. Furthermore, because Louisiana law applies, the adequacy of Plaintiff's claims must be analyzed under Fifth Circuit preemption law.

IV. Analysis

A.

Plaintiff's negligence and "device malfunction" claims must be dismissed under the Louisiana Products Liability Act ("LPLA") because such claims are not cognizable under the Act. The LPLA sets forth four exclusive theories of recovery against a manufacturer: (1) defect in construction or composition; (2) defect in design; (3) inadequate warning; and (4) failure to comply with an express warranty. See McQuiston v. Boston Sci. Corp., No. 07-1723, 2009 WL 4016120, at *6 (W.D. La. Nov. 19, 2009) (citing La. Stat. Ann. § 9:2800.55-58). The LPLA "establishes the exclusive theories of liability for manufacturers for damage caused by their products." La. Stat. Ann. § 9:2800.52 ("A claimant may not recover from a manufacturer for damage caused by a product on the basis of...