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Brooks v. Mentor Worldwide, LLC

United States District Court, D. Kansas

September 23, 2019

AMBER BROOKS and JAMIE GALE Plaintiffs,
v.
MENTOR WORLDWIDE, LLC, Defendant.

          MEMORANDUM AND ORDER

          KATHRYN H. VRATIL UNITED STATES DISTRICT JUDGE.

         On February 14, 2019, Amber Brooks and Jamie Gale filed suit against Mentor Worldwide, LLC. Complaint (Doc. #1). Plaintiffs allege that Mentor manufactured and sold defective silicone breast implants which injured plaintiffs. Plaintiffs sue Mentor under several theories: negligence and negligence per se based on manufacturing defects and a failure to warn (Count 1), strict products liability based on failure to warn (Count 2) and strict products liability based on manufacturing defects (Count 3). This matter is before the Court on Mentor’s Rule 12(b)(6) Motion To Dismiss Plaintiffs’ Complaint (Doc. #10) filed April 15, 2019.[1] For reasons stated below, the Court sustains Mentor’s motion.[2]

         Factual Background

         Highly summarized, plaintiffs’ complaint alleges the following:

         In 1976, Congress passed the Medical Device Amendments (“MDA”) to the federal Food Drug and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices are subject to regulation depending on their classification. The FDA eventually classified silicone gel-filled breast implants as Class III devices. Among other requirements, the FDCA required manufacturers of these implants to submit pre-market approval applications (“PMAs”) with data showing a reasonable assurance of safety and effectiveness. Although it initially denied pre-market approval, the FDA approved Mentor’s PMA on November 17, 2006. The FDA conditioned its approval on Mentor conducting six post-approval studies to further assure the safety of the devices. For a variety of reasons, Mentor did not properly conduct these studies, or report negative test results to the FDA.

         On September 11, 2009, Jamie Gale received Mentor silicone gel breast implants. After receiving them, she began to experience health problems, including skin rashes, inflammation, fatigue, brain fog, aching, weight gain, hair loss, gastrointestinal issues, rising blood pressure, food allergies, severe hearing loss and dry eyes. On May 24, 2017, an MRI showed extracapsular silicone around both implants. On July 25, 2017, Gale had the implants surgically removed. After that, some of her symptoms and conditions improved or disappeared, while others remained.

         Amber Brooks received Mentor silicone gel breast implants on March 4, 2016. After the surgery, Brooks also began to experience health issues, including muscle and joint pain, fatigue, vaginal infections, dry eyes and blurry vision, weight loss, enlarged tonsils, rashes, fevers and chills, insomnia, chest pain, constipation and dizziness. Approximately six months later, she was hospitalized for sepsis and a life-threatening staph infection. On February 17, 2017, Brooks had her implants surgically removed. After that, some of her symptoms and conditions improved or disappeared, while others remained.

         Plaintiffs allege that Mentor’s breast implants caused their injuries. Plaintiffs sue Mentor under several theories: negligence and negligence per se based on manufacturing defects and failure to warn (Count 1), strict products liability based on failure to warn (Count 2) and strict products liability based on manufacturing defects (Count 3).

         Legal Standards

         In ruling on a motion to dismiss under Rule 12(b)(6), Fed. R. Civ. P., the Court assumes as true all well-pleaded factual allegations and determines whether they plausibly give rise to an entitlement of relief. Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). To survive a motion to dismiss, a complaint must contain sufficient factual matter to state a claim which is plausible – and not merely conceivable – on its face. Id. at 679-80; Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). To determine whether a complaint states a plausible claim for relief, the Court draws on its judicial experience and common sense. Iqbal, 556 U.S. at 679. Plaintiffs make a facially plausible claim when they plead factual content from which the Court can reasonably infer that defendant is liable for the misconduct alleged. Id. at 678. However, plaintiffs must show more than a sheer possibility that defendant has acted unlawfully – it is not enough to plead facts that are “merely consistent with” defendant’s liability. Id. (quoting Twombly, 550 U.S. at 557). Where the well-pleaded facts do not permit the Court to infer more than the mere possibility of misconduct, the complaint has alleged – but has not “shown” – that the pleader is entitled to relief. Id. at 679. The degree of specificity necessary to establish plausibility and fair notice depends on context; what constitutes fair notice under Fed. R. Civ. P. 8(a)(2) depends on the type of case. Robbins v. Okla., 519 F.3d 1242, 1248 (10th Cir. 2008).

         The Court need not accept as true those allegations which state only legal conclusions. See Iqbal, 556 U.S. at 678; Hall v. Bellmon, 935 F.2d 1106, 1110 (10th Cir. 1991). Rather, plaintiffs bear the burden of framing their complaint with enough factual matter to suggest that they are entitled to relief; it is not enough to make threadbare recitals of a cause of action accompanied by conclusory statements. Twombly, 550 U.S. at 556. A pleading that offers labels and conclusions, a formulaic recitation of the elements of a cause of action or naked assertions devoid of further factual enhancement will not stand. Iqbal, 556 U.S. at 678.

         Analysis

         I. Applicable Law

         Because this is a diversity case, the Court will apply federal procedural law and the substantive law that the forum state would apply. See Sylvia v. Wisler, No. 13-02534-EFM, 2019 WL 1384296, at *2 (D. Kan. Mar. 27, 2019) (citing Evans v. Orion Ethanol, Inc., No. 09-1245-MLB, 2011 WL 2516929, at *1 (D. Kan. June 23, 2011)); see also Burnham v. Humphrey Hosp. Reit Trust, Inc., 403 F.3d 709, 712 (10th Cir. 2005)). For the purposes of diversity jurisdiction, choice-of-law rules are substantive. Sylvia, 2019 WL 1384296, at *2. Accordingly, the Court will apply Kansas choice-of-law rules for torts. Under these rules, the lex loci delicti doctrine requires the Court to apply the law of the state where the wrong occurred. Id. (citing Ling v. Jan’s Liquors, 237 Kan. 629, 634 (1985)). Where the wrong occurred is where plaintiff suffered injury. Id. (citing Ling, 237 Kan. at 634).

         Mentor asserts that Kansas law should apply to Gale, and that Missouri law should apply to Brooks. Mentor argues that unlike Gale, who resided in Kansas before, during and after the alleged injury, Brooks has been a Missouri resident at all material times. Specifically, although Brooks allegedly received her implants in Kansas, all of her alleged injuries occurred in Missouri. Mentor points to plaintiffs’ complaint, which specifies that “soon after” surgery – that is, after she returned home to Missouri - Brooks began experiencing symptoms, and that six months after the surgery - while still living in Missouri - she was hospitalized with sepsis and a staph infection. Complaint (Doc. #1) ¶ 12. According to Mentor, Brooks “is not suing her plastic surgeon and makes no allegation that any injury occurred in Kansas during her implantation surgery.” Defendant Mentor Worldwide LLC’s Memorandum In Support Of Rule 12(b)(6) Motion to Dismiss Plaintiffs’ Complaint (Doc. #11) at 8. Rather, she is suing the manufacturer of the allegedly defective implants, which caused injuries when she returned to Missouri. In response to Mentor’s motion to dismiss for failure to state claim, plaintiffs do not argue where Brooks’ alleged injury occurred, nor do they mention what state law applies to her claims.

         For the purposes of this analysis, and absent argument to the contrary, the Court assumes that Brooks suffered her injuries in Missouri. All of her injuries which the complaint lists, including the physical ailments and infections, occurred after Brooks had returned to Missouri. See Ling, 237 Kan. at 634 (applying Kansas law because injuries occurred in car accident in Kansas even though liquor was sold in Missouri). Accordingly, pursuant to ...


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