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Gravitt v. Mentor Worldwide, LLC

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

June 12, 2018




         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. Mentor removed the suit to federal court, Doc. 1, and the court granted in part and denied in part Mentor's motion under Federal Rule of Civil Procedure 12(b)(6) to dismiss the complaint, Docs. 32-33 (reported at 289 F.Supp.3d 877 (N.D. Ill. 2018)). Plaintiffs then filed an amended complaint; as in the original complaint, 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, and Travis brings a loss of consortium claim. Doc. 37.

         Mentor moves under Rule 12(b)(6) to dismiss the amended complaint. Doc. 38. The motion is granted in part and denied in part. The reader will note that much of this opinion replicates the court's first opinion, a congruence due largely to the fact that the amended complaint strongly resembles the original complaint and that the parties in this round have re-fought many of the battles they joined in the prior round.


         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 MemoryGel, a breast implant made of silicone gel. Doc. 37 at ¶¶ 1, 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, including information derived from investigations other than those proposed in the application from commercial marketing experience.” Doc. 37 at ¶ 17(g); see 21 U.S.C. § 360e.

         In a letter dated November 17, 2006 (the “November 2006 letter”), the FDA granted PMA to Mentor for the use of MemoryGel as a breast augmentation device. Doc. 37 at ¶ 20; Doc. 39 at 20-24. In connection with the 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. 37 at ¶ 21; Doc. 39 at 21-23. 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 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 format 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 the use of such implants on new patients. Doc. 37 at ¶ 21; Doc. 39 at 21-23. Pertinent here, and in connection with the first two of those studies, 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. 39 at 21. Mentor was also required to “update [its] patient and physician labeling” after five and ten years to reflect the core and large post-approval studies' findings. Ibid. The FDA cautioned Mentor that “[f]ailure to comply with any postapproval requirement constitutes a ground for [PMA] withdrawal.” Doc. 37 at ¶ 32.

         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. Id. at ¶ 30(a)(2). Mentor reported study results for only six years rather than the required ten, and the study's reported findings lacked statistical reliability within the subgroups (or cohorts) into which Mentor broke down the data. Id. at ¶ 30(a)(3). Without explanation, Mentor reported the reasons for re-operation for only 36 percent of those members of the primary augmentation cohort who underwent 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 “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 required by the November 2006 letter. Id. at ¶ 30(b)(2); Doc. 39 at 21. Mentor omitted material information for 113 of the 41, 451 patients. Doc. 37 at ¶ 30(b)(2). 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. Id. at ¶¶ 30(b)(2)-(3). Mentor's “skeletal” 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)-(3). 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, some of whom expressed concerns about Mentor's informational materials and proposed recommendations for labeling changes that Mentor ultimately ignored. Id. at ¶¶ 30(d)(2)-(3). 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, FDA 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, 820.100, 820.198). 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.” Id. at ¶ 36. Mentor also underreported both the likelihood that the type of silicone used in MemoryGel implants would leak and the danger posed by the platinum used in the implants. Ibid. Despite “kn[owing] of these risks, ” Mentor nevertheless “covered up the information by terminating studies, sponsoring only self-serving research … and misrepresenting the risks presented by its products.” Ibid.

         Moreover, Mentor failed “to revise its product labeling after becoming aware of otherwise undisclosed dangers in its MemoryGel products.” Id. at ¶ 27. Ordinarily, such adverse events are reported to the FDA, which maintains a publicly searchable and regularly updated database known as “MAUDE.” Id. at ¶ 29. 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 ¶¶ 37-38. Thus, Mentor's “Product Insert Data Sheet” for MemoryGel-which stated that “[t]he overall body of available evidence supposes that the extremely low level of gel bleed is of no clinical consequence”-was materially and knowingly false when published. Id. at ¶ 43. Mentor's “Directions for Use” for MemoryGel, and its consumer labeling more generally, similarly failed to disclose the true risk associated with MemoryGel implants. Id. at ¶ 47.

         Mentor's MemoryGel manufacturing process was also deficient, leading the FDA to cite the company for compliance failures six times from May 2000 to December 2007. Id. at ¶¶ 40-42. 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 ¶ 49. Catherine initially underwent saline breast implantation surgery. Id. at ¶ 50. After a series of complications, she underwent revision, or curative, implantation surgery, during which MemoryGel implants were implanted. Id. at ¶ 51. At that time, Catherine did not know, nor did her physicians advise her, of the true risk that her MemoryGel implants would rupture or leak or of the consequences of their doing so. Id. at ΒΆ 52. Had Mentor disclosed ...

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