Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Gravitt v. Mentor Worldwide, LLC

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

January 11, 2018

CATHERINE GRAVITT and TRAVIS GRAVITT, Plaintiffs,
v.
MENTOR WORLDWIDE, LLC, Defendant.

          MEMORANDUM OPINION AND ORDER

          Gary Feinerman, Judge

         Catherine and Travis Gravitt, a married couple, filed this suit in the Circuit Court of Cook County, Illinois, against Mentor Worldwide, the manufacturer of a silicone breast implant called MemoryGel, which the Food and Drug Administration (“FDA”) has classified as a Class III medical device. Doc. 1-2. Catherine brings claims under Illinois tort law for Mentor's alleged noncompliance with the FDA's premarket approval process for Class III devices, alleged failure to warn consumers of the risks posed by MemoryGel implants, and allegedly defective design and manufacture of the implants. Travis brings a loss of consortium claim. Mentor removed the suit to federal court, Doc. 1, and now moves under Federal Rule of Civil Procedure 12(b)(6) to dismiss the complaint, Doc. 11. The motion is granted in part and denied in part.

         Background

         In resolving a Rule 12(b)(6) motion, the court assumes the truth of the operative complaint's well-pleaded factual allegations, though not its legal conclusions. See Zahn v. N. Am. Power & Gas, LLC, 815 F.3d 1082, 1087 (7th Cir. 2016). The court must also consider “documents attached to the complaint, documents that are critical to the complaint and referred to in it, and information that is subject to proper judicial notice, ” along with additional facts set forth in Plaintiffs' brief opposing dismissal, so long as those additional facts “are consistent with the pleadings.” Phillips v. Prudential Ins. Co. of Am., 714 F.3d 1017, 1019-20 (7th Cir. 2013). The facts are set forth as favorably to Plaintiffs as those materials allow. See Pierce v. Zoetis, Inc., 818 F.3d 274, 277 (7th Cir. 2016). In setting forth those facts at the pleading stage, the court does not vouch for their accuracy. See Jay E. Hayden Found. v. First Neighbor Bank, N.A., 610 F.3d 382, 384 (7th Cir. 2010).

         A. MemoryGel

         Mentor manufactures a product called MemoryGel, a breast implant made of silicone gel. Doc. 1-2 at ¶ 6. The FDA has classified silicone breast implants as Class III medical devices-a classification reserved for devices that pose an especially significant risk to patients. Id. at ¶¶ 15-16. Under 21 U.S.C. § 360e, a Class III device manufacturer must obtain premarket approval (“PMA”) from the FDA before marketing the device to the public. Id. at ¶ 16. As part of the PMA process, the manufacturer must provide the agency with a description of the manufacturing process and a summary of studies addressing the device's risks and benefits. Id. at ¶¶ 17(b), (d); see 21 U.S.C. § 360e. The manufacturer must also provide the agency with “[a]ny other data or information relevant to an evaluation of the safety and effectiveness of the device known or that should be reasonably be known to the manufacturer from any source.” Doc. 1-2 at ¶ 17(g); see 21 U.S.C. § 360e.

         In a letter dated November 17, 2006 (the “November 2006 letter”), the FDA provided Mentor with PMA for the use of MemoryGel as a breast augmentation device. Id. at ¶ 20; Doc. 12-1. In connection with that approval, and pursuant to its authority under 21 C.F.R. §§ 814.80 and 814.82, the FDA required Mentor to conduct six-post approval studies designed to address issues not raised during the PMA process. Doc. 1-2 at ¶ 21; Doc. 12-1 at 3-5. Specifically, the FDA required Mentor to conduct: (1) a core post-approval study to assess the long-term clinical performance of breast implants among women who had participated in the studies supporting the company's PMA application; (2) a large post-approval study to assess long-term outcomes and identify rare adverse events among a new sample of 40, 000 patients who had not participated in the earlier studies; (3) a device failure study to describe the modes and causes of failure of MemoryGel implants; (4) a focus group study to improve the form and content of patient labeling; (5) an annual physician-informed decision survey to monitor how patient labeling is distributed to women considering silicone gel breast implants; and (6) an adjunct survey to provide performance and safety information about silicone gel implants from 1992 to 2006, when the agency barred new patients from being treated with such implants. Doc. 1-2 at ¶ 21; Doc. 12-1 at 3-5. Pertinent here, the November 2006 letter required that Mentor “continue [the] Core Study until all patients have completed their 10-year evaluation” and report that study's results for ten years, and include 41, 900 Mentor silicone gel patients in the large post-approval study. Doc. 12-1 at 3.

         Mentor conducted the required follow-up studies, albeit with some omissions and other lacunae. As for participants in the core study who had MemoryGel implants for at least nine years, Mentor's follow-up rate did not exceed 59 percent. Doc. 1-2 at ¶ (30)(a)(2). Mentor reported study results for only six years rather than the required ten. Id. at ¶ 30(a)(3). Mentor reported the reasons for re-operation for only 36 percent of those members of the primary augmentation cohort who had undergone a subsequent operation. Id. at ¶ 30(a)(4). For the revision augmentation cohort, Mentor reported only the most common reason for re-operation. Id. at ¶ 30(a)(5). As for the primary construction cohort, Mentor provided information about the reasons for re-operation for only 53 percent of those participants within the cohort who required re-operation, and also “downplayed” reasons for re-operation within the revision reconstruction cohort. Id. at ¶¶ 30(a)(6)-(7). Similarly, as to participants in the adjunct study-also divided into cohorts-Mentor reported data on only 37 percent of the reconstruction cohort, 50 percent of the revision reconstruction cohort, and 33 percent of the revision augmentation cohort. Id. at ¶ 30(f)(2).

         Mentor's other post-PMA studies had similar deficiencies. For the large post-approval study, Mentor recruited 41, 451 patients, approximately 500 fewer than the November 2006 letter required. Id. at ¶ 30(b)(2); Doc. 12-1 at 3. After three years, Mentor's follow-up rate was 21 percent; after seven years, the rate had declined to approximately 20 percent; and after ten years, Mentor reported no follow-up rate. Doc. 1-2 at ¶¶ 30(b)(2)-(3). Mentor's summary report on the device failure study also had limitations-it did not provide a sample size, results, findings, safety data, recommendations for follow-up studies, or proposed changes to labeling. Id. at ¶ 30(c)(2). Likewise, in its summary of findings for the informed decision post-approval study, Mentor did not provide the study's sample size and disclosed information for only one year. Id. at ¶ 30(e)(2). Mentor's focus group study involved only 35 women. Id. at ¶ 30(d)(5). Overall, halfway through the ten-year post-PMA study period, more than 50 percent of the 80, 000 initial participants were dropped or eliminated; of the participants who remained, significant numbers reported systemic ailments attributable to MemoryGel rupture. Id. at ¶ 31.

         Apart from the six required post-PMA studies, federal regulations required Mentor to report certain other information to the FDA, including information suggesting that MemoryGel may have caused or contributed to a patient's death or serious injury and any complaints about MemoryGel's performance or adverse health consequences, along with procedures for reviewing complaints and ensuring compliance with FDA regulations. Id. at ¶ 24 (citing, among other regulations, 21 C.F.R. §§ 803.50, 814, 820.20, 820.198, 820.100). Notwithstanding those obligations, “[u]pon information and belief, a Mentor chemist of 15 years reported to the FDA that Mentor's implants are more likely to break than the company had reported, ” and Mentor “knew of these risks” but nevertheless “covered up the information by terminating studies, sponsoring only self-serving research, and misrepresenting the risks presented by its products.” Id. at ¶¶ 32-33. In addition, Mentor failed “to revise its product labeling after becoming aware of otherwise undisclosed dangers in its MemoryGel products.” Id. at ¶ 27. In particular, Mentor knew that the risk that MemoryGel implants would “bleed”- releasing toxic chemicals into patients' bodies-was substantially higher than publicly reported. Id. at ¶¶ 37-41.

         Mentor's process for manufacturing MemoryGel was also deficient, leading the FDA to cite the company for compliance failures six times from May 2000 to December 2007. Id. at ¶¶ 35-36. Mentor manufactured MemoryGel with nonconforming products and failed to conduct appropriate risk analyses and quality-control tests. Ibid.

         B. Catherine's Experience With MemoryGel

         After giving birth in 2008, Catherine experienced a significant reduction in breast volume, and her physician recommended breast augmentation surgery. Id. at ¶ 44. Catherine initially underwent saline breast implantation surgery. Id. at ¶ 45. After a series of complications, she underwent revision, or curative, implantation surgery, during which MemoryGel implants were implanted. Id. at ¶ 46. Since that time, Catherine has experienced symptoms causing her “extreme suffering, ” including severe skin rashes and acne, blackouts and periods of disorientation, memory loss, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, and anxiety and depression. Id. at ¶ 49. Those symptoms caused Catherine to leave school and forgo a career. Ibid. In 2011 and 2013, Catherine gave birth to two children who, unlike her first child, were born with significant birth defects. Id. at ¶¶ 53-54.

         By 2016, Catherine's condition had substantially worsened. Id. at ¶ 55. She could not stay awake, felt weak and fatigued, and continued to suffer memory lapses, disorientation, flulike symptoms, and skin rashes. Ibid. An ultrasound examination revealed a lump in Catherine's breast that appeared to be composed of leaked silicone, and a subsequent MRI confirmed that at least one implant had ruptured. Id. at ΒΆ ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.