United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
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.
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 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.
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.
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).
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.
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
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.
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 ¶ 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.
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 ¶ ...