United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
FEINERMAN UNITED STATES DISTRICT JUDGE
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.
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.
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).
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.
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.
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).
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.
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.
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.
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.
Catherine's Experience With MemoryGel
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 ¶
52. Had Mentor disclosed ...