Gravitt et al v. Mentor Worldwide, LLC
MEMORANDUM Opinion and Order written by the Honorable Gary Feinerman on 1/11/2018.Mailed notice.(jlj, )
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
CATHERINE GRAVITT and TRAVIS GRAVITT,
MENTOR WORLDWIDE, LLC,
17 C 5428
Judge Gary Feinerman
MEMORANDUM OPINION AND ORDER
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.
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).
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
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.
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 ¶ 58. Earlier medical tests also showed elevated levels of
bromine and other toxins in her blood stream. Id. at ¶ 51.
Ultimately, in Fall 2016, Catherine underwent a third round of surgery—this time, to
remove the MemoryGel implants. Id. at ¶ 60. Surgeons also removed some of Catherine’s
lymph nodes, which were contaminated with silicone. Ibid. Since that time, Catherine’s breast
region and armpits have been very swollen and painful, and later tests suggested that additional
lymph nodes had been contaminated. Id. at 61. As a result of Catherine’s health problems,
Travis has taken full responsibility for supporting and managing the household. Id. at ¶ 119.
Plaintiffs allege that, had Catherine been advised of the risks posed by MemoryGel—
risks that Mentor actively concealed—she would not have consented to breast augmentation
surgery using MemoryGel implants. Id. at ¶ 48. Likewise, Plaintiffs allege that, had Catherine
been aware of those risks, she would have recognized more quickly the link between her
symptoms and a possible silicone leak. Id. at ¶ 49. Plaintiffs claim that Catherine’s injuries—
and Travis’s loss of consortium—are attributable to Mentor’s tortious conduct. Id. at ¶ 63.
Plaintiffs’ claims arise under Illinois tort law. Doc. 1-2 at ¶¶ 66-122. Counts I
(negligence) and III (strict product liability) allege that Mentor breached its duty to Catherine in
manufacturing and marketing Memory Gel—in particular, by failing to warn Catherine and her
physicians, either directly or through reports to the FDA, of the true risks associated with
MemoryGel implants. Id. at ¶¶ 66-80; 99-117. Count II (strict product liability under a failure to
warn theory) similarly alleges that Mentor breached its duty to Catherine by failing to warn her
and her physicians that MemoryGel was more “vulnerable to degradation, deterioration, ruptures,
and leakage” than the company had reported, and thus that it was more likely to cause injury than
publicly known. Id. at ¶¶ 81-98. Count IV alleges that Mentor’s actions resulted in Travis’s loss
of consortium. Id. at ¶¶ 118-22.
Mentor contends that Catherine’s claims should be dismissed as expressly preempted
under 21 U.S.C. § 360k(a)(1) or as impliedly preempted under Buckman Co. v. Plaintiffs’ Legal
Committee, 531 U.S. 341 (2001). Mentor adds that Travis’s loss-of-consortium claim fails
because it is derivative of Catherine’s legally insufficient claims.
Plaintiffs submit that Rule 12(c), not Rule 12(b)(6), is the proper vehicle for moving to
dismiss state law claims on federal preemption grounds. Doc. 18 at 6-7; see Brownmark Films,
LLC v. Comedy Partners, 682 F.3d 687, 690 n.1 (7th Cir. 2012) (“Though district courts have
granted Rule 12(b)(6) motions on the basis of affirmative defenses and this court has affirmed
those dismissals, we have repeatedly cautioned that the proper heading for such motions is Rule
12(c), since an affirmative defense is external to the complaint.”); Bausch v. Stryker Corp., 630
F.3d 546, 561 (7th Cir. 2010) (“Preemption is an affirmative defense, and pleadings need not
anticipate or attempt to circumvent affirmative defenses.”) (citations omitted). Little rides,
however, on the distinction Plaintiffs draw. As an initial matter, a Rule 12(c) motion for
judgment on the pleadings “is governed by the same standards as a motion to dismiss for failure
to state a claim under Rule 12(b)(6).” Lodholtz v. York Risk Servs. Grp., Inc., 778 F.3d 635, 639
(7th Cir. 2015). Thus, in either case, “a complaint must ‘state a claim to relief that is plausible
on its face.’” Ibid. (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)).
Moreover, the Seventh Circuit has held—in the context of Rule 12(b)(6) motions based
on a statute of limitations affirmative defense—that “dismissal is proper without further
pleading” provided that “it is plain from the complaint that the defense is indeed a bar to the
suit.” Jay E. Hayden Found., 610 F.3d at 383; see also Collins v. Vill. of Palatine, 875 F.3d 839,
842 (7th Cir. 2017) (“Although the statute of limitations is an affirmative defense, dismissal
under Rule 12(b)(6) … is appropriate if the complaint contains everything necessary to establish
that the claim is untimely.”); Chi. Bldg. Design, P.C. v. Mongolian House, Inc., 770 F.3d 610,
613-14 (7th Cir. 2014) (“[A] motion to dismiss based on failure to comply with the statute of
limitations should be granted only where “the allegations of the complaint itself set forth
everything necessary to satisfy the affirmative defense.”) (citation and internal quotation marks
omitted); Indep. Tr. Corp. v. Stewart Info. Servs. Corp., 665 F.3d 930, 935 (7th Cir. 2012)
(“[W]hen a plaintiff’s complaint nonetheless sets out all of the elements of an affirmative
defense, dismissal under Rule 12(b)(6) is appropriate.”); Balmes v. Ill. Bell Tel. Co., 2016 WL
1019764, at *3 (N.D. Ill. Mar. 15, 2016) (“[N]o rule categorically prohibits courts from ruling on
arguments about timeliness on Rule 12(b)(6) motions.”). That is the case here as to Mentor’s
preemption defense. In addition, due to the undersigned judge’s participation in the Mandatory
Initial Discovery Pilot Project, see Standing Order Regarding Mandatory Initial Discovery Pilot
Project at ¶ A.3, Plaintiffs also now have the benefit of Mentor’s answer, which explicitly raises
federal preemption as an affirmative defense. Doc. 19 at 50, 54. Accordingly, the court will
consider Mentor’s Rule 12(b)(6) motion as filed.
“There are no special pleading requirements for product liability claims in general, or for
Class III medical device claims in particular. The federal standard of notice pleading applies, so
long as the plaintiff alleges facts sufficient to meet the … ‘plausibility’ standard applied in”
Twombly and Ashcroft v. Iqbal, 556 U.S. 662 (2009). Bausch, 630 F.3d at 558. “A claim has
facial plausibility when the plaintiff pleads factual content that allows the court to draw the
reasonable inference that the defendant is liable for the misconduct alleged.” Id. at 558 (quoting
Iqbal, 556 U.S. at 678). “In applying that standard to claims for defective manufacture of a
medical device in violation of federal law, moreover, district courts must keep in mind that much
of the product-specific information about manufacturing needed to investigate such a claim fully
is kept confidential by federal law.” Ibid.
Although the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq.,
“has long required FDA approval for the introduction of new drugs into the market,” it was only
with the passage of the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et
seq., which amended the FDCA, that Congress “imposed a regime of detailed federal oversight”
on medical device manufacturers—an area that had traditionally been left to the States. Riegel v.
Medtronic, Inc., 552 U.S. 312, 315 (2008). The MDA contains an express preemption provision,
codified at 21 U.S.C. § 360k(a), which provides, with certain exceptions not relevant here:
[N]o State or political subdivision of a State may establish or continue in
effect with respect to a device intended for human use any requirement—(1)
which is different from, or in addition to, any requirement applicable under
this chapter to the device, and (2) which relates to the safety or effectiveness
of the device or to any other matter included in a requirement applicable to the
device under this chapter.
21 U.S.C. § 360k(a)(1) (emphasis added). Under that provision, “[m]edical device
manufacturers who subject their Class III devices to the rigorous premarket approval process are
protected by federal law from civil liability so long as they comply with federal law.” Bausch,
630 F.3d at 550. However, “[t]hat protection does not apply where the patient can prove that she
was hurt by the manufacturer’s violation of federal law.” Ibid.
The Supreme Court has twice addressed the scope of express preemption under
§ 360k(a). In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court held that “[n]othing in
§ 360k denies [a State] the right to provide a traditional damages remedy for violations of
common-law duties” as to products granted PMA “when those duties parallel federal
requirements.” Bausch, 630 F.3d at 551 (quoting Lohr, 518 U.S. at 495). In Lohr, then, “the
Court gave lower courts clear instructions to allow [state law tort] claims to proceed when they
are based on claimed violations of federal law.” Id. at 552. A decade or so later, the Court held
in Riegel “that, to the extent the state tort law underlying the [plaintiffs’] claims would require a
manufacturer’s device to be safer (but perhaps less effective) than the model device approved by
the FDA, those requirements would ‘disrupt the federal scheme no less than state regulatory
law to the same effect.’” Ibid. (second alteration in original) (quoting Riegel, 552 U.S. at 325).
Unlike in Lohr, the Court in Riegel “found that the state requirements implicit in the [plaintiffs’]
common law claims were different from or in addition to the federal requirements and [thus]
were preempted under section 360k.” Ibid.; see also McMullen v. Medtronic, Inc., 421 F.3d 482,
490 (7th Cir. 2005) (concluding that the plaintiff’s state law claim was preempted because it
“would impose on [the defendant] a requirement that is in addition to federal requirements”).
Riegel “took care, however, to limit its holding to claims that the device at issue ‘violated state
tort law notwithstanding compliance with the relevant federal requirements.’” Bausch, 630 F.3d
at 552 (quoting Riegel, 552 U.S. at 330).
Against that legal backdrop, Mentor contends that Catherine’s claims should be
dismissed because the complaint “is devoid of any well-pled allegations that the premarketapproved implant at issue in this case was not designed, manufactured, and labeled in accordance
with the specifications approved by the FDA through the PMA process.” Doc. 12 at 15. To
determine whether Mentor is correct, it is instructive to examine the Seventh Circuit’s decision
in Bausch, which held the plaintiff’s claim to fall outside the preemptive scope of § 360k(a).
The plaintiff in Bausch alleged that the hip-replacement device at issue—known by its
brand name, Trident—“was implanted in her body six days after the [FDA] informed the
defendants that a component of the Trident hip system was ‘adulterated’ and that the
[defendants’] manufacturing processes failed to comply with federal standards.” 630 F.3d at
549. The Bausch plaintiff further alleged that, by the time the Trident system was implanted into
her body, the defendants had received numerous complaints “that the Trident was failing after it
was implanted.” Id. at 559. The defendants subsequently “recalled a component of the Trident
bearing the same catalogue number as the one that had been implanted in [the plaintiff’s] body.”
Id. at 549. Given these alleged design and manufacturing defects, the plaintiff claimed “that the
Trident product was unreasonably dangerous, causing [her] to suffer an unstable right hip, pain,
suffering, disability, and what is euphemistically called ‘revision’ surgery—in [the plaintiff’s]
case a second major operation in which the Trident product was removed and replaced with a
different product.” Id. at 558-59. The Seventh Circuit held that because the plaintiff’s state law
claim “that she was injured by [the defendant’s] violations of federal law in manufacturing the
device implanted in her hip … would not impose on defendants any requirement ‘different from,
or in addition to, any requirement’ imposed by federal law,” the claim was not preempted. Id. at
553 (quoting 21 U.S.C. § 360k(a)((1)).
Plaintiffs’ allegations here are largely of a different kind. The parties agree that the
express requirements set forth in the FDA’s November 2006 letter qualify as federal law for
purposes of the preemption analysis. Doc. 12 at 15; Doc. 18 at 4; see 21 C.F.R. § 814.80 (“A
device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a
manner that is inconsistent with any conditions to approval specified in the PMA approval order
for the device.”); 21 C.F.R. § 814.82(a) (“FDA may impose postapproval requirements in a PMA
approval order or by regulation at the time of approval of the PMA or by regulation subsequent
to approval.”); 21 C.F.R. § 814.82(c) (“Failure to comply with any postapproval requirement
constitutes a ground for withdrawal of approval of a PMA.”). The key question, then, is whether
Plaintiffs have alleged that Mentor violated any of those requirements, or any other requirements
set forth by regulation or statute.
Plaintiffs allege that Mentor’s execution of the studies required by the November 2006
letter was deficient in numerous respects—from the number of study participants, to the followup rate, to the nature of the data reported. As noted, Plaintiffs allege that Mentor failed to make
certain disclosures regarding possible reasons why women in the core study underwent reoperation. Doc. 1-2 at ¶¶ 30(a)(4)-(7). Plaintiffs do not allege, however, that the November
2006 letter or any other federal law required Mentor to provide more detailed reasons for reoperation than it actually provided. Ibid.; see Doc. 12-1 at 3. The same is true of other studies.
Plaintiffs allege, for example, that the large post-approval study’s follow-up rate after the third
year was 21%, declining further in year seven (20%) and year ten (0%). Doc. 1-2 at ¶¶ 30(b)(2)(3). But the November 2006 letter does not require any particular follow-up rate for that study.
Rather, apparently contemplating attrition, the letter requires only that Mentor disclose “the
follow-up rates versus the stated goals.” Doc. 12-1 at 3. Likewise, although Plaintiffs allege that
Mentor’s summary of findings for the device failure and informed decision studies had certain
limitations, they do not allege that those limitations violated any terms of the November 2006
letter or other requirement of federal law. Doc. 1-2 at ¶¶ 30(c)(2), 30(e)(2); see Doc. 12-1 at 4.
Plaintiffs similarly allege that Mentor’s adjunct post-approval study reported on fewer than half
the patients within certain study cohorts, but not that this violated the FDA’s requirements,
including those in the November 2006 letter, for such studies. Doc. 1-2 at ¶ 30(f)(2); see Doc.
12-1 at 5. And while Plaintiffs imply that Mentor’s enrollment of only 35 women in its focus
group study was inadequate, nowhere do they allege that Mentor violated the agency’s regulatory
baseline (if any), or any requirements in the November 2006 letter, for the number of participants
in a post-PMA focus group study. Doc. 1-2 at ¶ 30(d)(5); see Doc. 12-1 at 4.
These features (or, rather, non-features) of Plaintiffs’ complaint distinguish the abovereferenced allegations from those in Laverty v. Smith & Nephew, Inc., 197 F. Supp. 3d 1026
(N.D. Ill. 2016). There, the defendant was alleged to have “received hundreds of adverse reports
regarding” its product, which it then concealed from the agency. Id. at 1029. Thus, the Laverty
complaint alleged not that the required follow-up studies were faulty, but instead that the
defendant did not report information concerning the product’s performance that it, in fact,
possessed. Laverty concluded that because the plaintiffs “alleged that [the defendant] failed to
disclose information relevant to the safety and effectiveness of its device in violation of the rules
the FDA set forth as a condition of premarket approval,” they had pleaded a violation of federal
law and thus stated the type of claim permitted by Lohr. Id. at 1033 (emphasis added).
Here, by contrast, the above-referenced methodological defects in Mentor’s post-PMA
studies are not alleged to have violated federal law or hidden important facts from the FDA. To
the contrary, Plaintiffs acknowledge that Mentor’s post-approval studies revealed a nontrivial
risk of rupture: “[S]ince Mentor began post-approval studies in 2007, Mentor found 43.5% of
implants retrieved from patients participating in the large post-approval study had ruptures, and
25% of 97 implants that were explanted and returned to Mentor for evaluation from August 2000
to August 2009 in the Core Study had ruptured.” Doc. 1-2 at ¶ 42.
Nonetheless, the complaint does allege that Mentor violated federal law with respect to
certain other aspects of its post-PMA studies: (1) that Mentor’s core study follow-up rate after
nine years was no more than 59 percent, Doc. 1-2 at ¶ 30(a)(2), despite the November 2006
letter’s requirement that Mentor “continue [its] Core Study until all patients have completed their
10-year evaluation,” Doc. 12-1 at 3 (emphasis added); (2) that Mentor reported results for the
core study for only six years, rather than the ten years required by the November 2006 letter,
Doc. 1-2 at ¶ 30(a)(3); Doc. 12-1 at 3; and (3) that Mentor included some 500 fewer patients in
its large post-approval study than the 41,900 required by the November 2006 letter, Doc 1-2 at
¶ 30(b)(2); Doc. 12-1 at 3. The complaint also alleges that “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 that the company therefore knew, but “failed to warn consumers, healthcare
providers, and the FDA[,] that a significant gel bleed was a potential risk of MemoryGel”
implants, in violation of 21 C.F.R. §§ 803.50 and 814. Doc 1-2 at ¶¶ 24(a)-(b), 32-33, 40-41.
Finally, the complaint alleges that Mentor’s manufacturing facilities failed to comply with
applicable agency regulations, and that, after inspecting its facilities, the FDA cited Mentor for
its compliance failures on six separate occasions. Doc. 1-2 at ¶¶ 24(d)-(f) (citing 21 C.F.R.
§ 820); 35-36. Because Plaintiffs plausibly allege that those shortcomings in Mentor’s postPMA testing and manufacturing processes violated federal law, those claims are not preempted
by § 360k(a). See Bausch, 630 F.3d at 556; Laverty, 197 F. Supp. 3d at 1033; Hornbeck v.
Medtronic, Inc., 2014 WL 2510817, at *3-4 (N.D. Ill. June 2, 2014).
Plaintiffs may proceed with those claims, however, only if they pass through a second
legal filter. As Bausch explained, the Supreme Court in Buckman held that the FDCA impliedly
preempts “‘fraud-on-the-agency’ claims, i.e., claims not related to a field of law that states had
traditionally occupied, from claims based on state law tort principles.” 630 F.3d at 557. Thus,
under Buckman, federal law preempts a plaintiff’s claims to the extent they seek to deploy state
law in the service of “[p]olicing fraud against federal agencies” based on statements that federal
law required the defendant to make to the agency. 531 U.S. at 347. The reason, Bausch noted, is
that federal law already “empowers the FDA to deter and punish fraud” and that, as a result, “the
‘balance sought by the [FDA] can be skewed by allowing fraud-on-the-FDA claims under state
tort law.’” 630 F.3d at 557 (quoting Buckman, 531 U.S. at 348). Applying these principles,
Buckman concluded that because the plaintiff’s state law claims that the defendant “made
fraudulent representations to the FDA as to the intended use” of the relevant product, 531 U.S. at
346-47, were based “solely” on “FDCA disclosure requirements,” federal law impliedly
preempted them, id. at 352-53.
That said, Buckman does not preempt claims like those asserted in Bausch—“tort law
claims based on manufacturing defects” or the manufacturer’s failure to warn of the product’s
known and unacceptable risks. 630 F.3d at 557. Thus, although the Bausch defendants
contended that there was no “‘traditional state tort law’ claim for an ‘adulterated’ product in so
many words,” the Seventh Circuit explained that “the federal definition of adulterated medical
devices is tied directly to the duty of manufacturers to avoid foreseeable dangers with their
products by complying with federal law.” Ibid. It follows, the Seventh Circuit held, that
“evidence showing a violation of federal law shows that the device is adulterated and goes a long
way toward showing that the manufacturer breached a duty under state law.” Ibid.; see also
Buckman, 531 U.S. at 352-53 (distinguishing the claims in Buckman from those in Silkwood v.
Kerr-McGee Corp., 464 U.S. 238 (1984), which were “not based on any sort of fraud-on-theagency theory, but on traditional state tort law principles of the duty of care owed by the
producer of plutonium fuel pins to an employee working in its plant,” and those in Lohr, which
“arose from the manufacturer’s alleged failure to use reasonable care in the production of the
Here, several of Plaintiffs’ claims that survive express preemption—that Mentor’s core
study follow-up rate was 59 percent rather than the required 100 percent, that Mentor reported
results for the core study for six years rather than the required ten years, and that Mentor
recruited 500 fewer patients than the number required for its large post-approval study—are
impliedly preempted under Buckman because those shortcomings breached no “well-recognized
duty owed to [Catherine] under state law,” such as “the duty of a manufacturer to use due care in
manufacturing a medical device.” Bausch, 630 F.3d at 558. Rather, as in Buckman, those claims
are unconnected to any traditional state tort duty, and thus “the existence of [the relevant] federal
enactments is a critical element in their case.” 531 U.S. at 353. The complaint contains no
allegation to the effect that, had Mentor kept better track of core study participants, reported on
the results of the core study for a longer time period, or recruited the requisite number of
participants for its large post-approval study, the company would have been any more likely to
reveal the dangers of MemoryGel. Thus, unlike in Bausch, Mentor’s violations of those federal
reporting requirements do not tend to make it more likely that Mentor breached a state law duty.
See Bausch, 630 F.3d at 557; Stengel v. Medtronic Inc., 704 F.3d 1224, 1235 (9th Cir. 2013)
(Watford, J., concurring) (“Central to the Court’s reasoning in Buckman was that the state law
claim there ‘exist[ed] solely by virtue’ of the federal enactments, because state law traditionally
had no role to play in policing ‘the relationship between a federal agency and the entity it
regulates’”) (alterations in original) (quoting Buckman, 531 U.S. at 347, 353); Vincent v.
Medtronic, Inc., 221 F. Supp. 3d 1005, 1011 (N.D. Ill. 2016) (“To the extent that Vincent brings
claims based solely on Medtronic’s noncompliance with the FDA’s supplemental premarket
approval procedures, those claims are impliedly preempted.”).
The same holds true for Plaintiffs’ claim that “Mentor routinely maintained
manufacturing facilities that failed to comply with applicable law and regulations,” for which the
FDA cited Mentor from 2000-2007. Doc. 1-2 at ¶¶ 35-36. Whatever the nature of Mentor’s
compliance failures, Plaintiffs do not connect them to an allegation that MemoryGel was
defectively manufactured, and thus fail to connect them to a traditional state tort duty of the kind
recognized in Bausch. See Bausch, 630 F.3d at 557 (noting that “the federal definition of
adulterated medical devices is tied directly to the duty of manufacturers to avoid foreseeable
dangers with their products by complying with federal law”). Accordingly, to the extent that
Plaintiffs’ state law tort claims are based on Mentor’s alleged violations of reporting obligations
set forth in the November 2006 letter, or of federal regulations concerning the maintenance of its
manufacturing facilities, the claims are impliedly preempted.
That leaves Plaintiffs’ allegation that Mentor had information suggesting that
MemoryGel ruptures were more frequent than what it reported to the FDA, and thus that Mentor
“concealed its knowledge of known safety risks,” including the risk of MemoryGel implants
bleeding, “from the FDA and the public.” Doc. 1-2 at ¶ 32-33, 40-41. As in Bausch, this
allegation concerns a violation of federal law, insofar as Class III device manufacturers must
report to the agency whenever they “receive or otherwise become aware of information, from
any source, that reasonably suggests that a device [they] market: (1) May have caused or
contributed to a death or serious injury or (2) Has malfunctioned and this device or a similar
device … would be likely to cause or contribute to a death or serious injury, if the malfunction
were to recur.” 21 C.F.R. § 803.50(a). And, crucially, as in Bausch, this allegation is distinct
from those at issue in Buckman. Much like the “well-recognized … [state law] duty of a
manufacturer to use due care in manufacturing a medical device” recognized in Bausch, 630 F.3d
at 553, the allegation that Mentor underreported MemoryGel’s tendency to rupture pertains to the
state law duty of a manufacturer to inform regulators and the public when it has reason to know
that a product is riskier than initially believed. See id. at 558 (noting that “Illinois treats a
violation of a statute or ordinance designed to protect human life or property as prima facie
evidence of negligence”); see also Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 43 (Ill.
2002) (upholding failure-to-warn liability under Illinois law where the manufacturer of IV tubing
connectors was aware of the risk of using a particular type of connector in certain medical
applications, but “gave the medical community no warning at all about the need” to use a
different connector in those applications); Proctor v. Davis, 682 N.E.2d 1203, 1211-15 (Ill. App.
1997) (upholding failure-to-warn liability under Illinois law where the defendant knew that the
drug was an “insoluble, toxic material, which, because of its insolubility, when inserted in the
eye, became … very difficult, if not impossible to remove” and therefore was unsuited to
periocular use, but nevertheless “encouraged and participated in disseminating misleading
information” concerning the drug’s off-label periocular use); In re Testosterone Replacement
Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, 2017 WL 1836443, at *7-8 (N.D.
Ill. May 8, 2017) (holding, on summary judgment, that because “claims grounded in traditional
state law principles of liability, such as negligence, failure to warn, strict product liability, and
fraud that predate the relevant FDCA requirements” are not preempted under Buckman, the
plaintiffs’ off-label marketing claims were not preempted because they involved alleged
“misrepresentations about the safety and efficacy of [the product]” and so did not “depend on a
finding that [the defendant] violated the FDCA or FDA regulations”); Laverty, 197 F. Supp. 3d
at 1035 (“Illinois does recognize a claim for failure to warn predicate on a product
manufacturer’s failure to disclose known defects.”) (citing cases); Rosenstern v. Allergan, Inc.,
987 F. Supp. 2d 795, 801-03 (N.D. Ill. 2013) (denying dismissal of the plaintiff’s negligence and
failure-to-warn claims under Illinois law where the plaintiff alleged that the defendant “failed to
warn [her] and her physicians of the risk of using Botox to treat” her condition and “breached its
duty to [her] … [by] failing to provide [her] and [her] health care providers with sufficient
information as to the product’s known dangers and risks”) (last alteration in original, internal
quotation marks omitted); Sellers v. Boehringer Ingelheim Pharm., Inc., 881 F. Supp. 2d 992,
1007-10 (S.D. Ill. 2012) (same, applying Illinois law).
To be sure, Plaintiffs’ claim that Mentor underreported the frequency of MemoryGel
ruptures is less developed than the allegations of adulteration and lack of compliance in Bausch.
See 630 F.3d at 549, 558-59. Still, the Seventh Circuit has made clear that the substantial
information asymmetries facing plaintiffs in products liability cases involving Class III medical
devices will tend to limit their capacity at the pleading stage to precisely delineate the nature of
the defect. See id. at 560 (noting, among other things, that plaintiffs may need discovery even to
determine whether their claims are design defect claims or manufacturing defect claims, and
emphasizing that certain data relevant to a product liability claim against a Class III medical
device manufacturer are “kept confidential as a matter of federal law”). Thus, to the extent that
Plaintiffs allege that Mentor deliberately underreported the tendency of MemoryGel implants to
rupture, the absence of additional detail does not “show a failure to comply with Rule 8” and
therefore cannot form the basis for “a dismissal under Rule 12(b)(6).” Id. at 560. As the
Seventh Circuit emphasized in Bausch, Rule 9(b)’s particularity requirement does not apply to
the kinds of claims at issue here. Ibid.
Plaintiffs’ allegation that Mentor underreported the frequency of MemoryGel ruptures is
sufficient to support their negligence and product liability claims. See Engelhard v. Wyeth
Consumer Healthcare Ltd., 2015 WL 1159442, at *2 (N.D. Ill. Mar. 11, 2015) (“To establish
that drug manufacturers failed to adequately warn under Illinois law, Plaintiff must show that (1)
Defendants had a duty to warn; (2) Defendants knew or should have known of the danger but
failed to warn Plaintiff of the fact; (3) the omission of such information made the warning
inadequate and the drug defective; and (4) this defect proximately caused Plaintiff’s injuries.”)
(citing Northern Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1037 (Ill. App. 1991)); Sellers, 881
F. Supp. 2d at 1009 (“In Illinois, product liability cases asserting negligence fall under the
standard of common law negligence. The plaintiff in this case must therefore allege ‘the
existence of a duty of care owed by the defendant, a breach of that duty, an injury that was
proximately caused by that breach, and damages.’”) (quoting Calles v. Scripto-Tokai Corp., 864
N.E.2d 249, 263 (Ill. 2007)). Were Plaintiffs to prove that Mentor concealed the true rate of
rupture of MemoryGel implants, Mentor may have breached its state law duty to warn potential
customers—and their physicians—of the product’s risks. Doc. 1-2 at ¶¶ 71-72, 86-88, 104-05;
see Hansen, 764 N.E.2d at 43; Proctor, 682 N.E.2d at 1211-15; Laverty, 197 F. Supp. 3d at
1035; Rosenstern, 987 F. Supp. 2d at 801-04; Sellers, 881 F. Supp. 2d at 1007-10. Moreover, as
to causation, the complaint plausibly alleges both that Catherine would not have consented to the
implant procedure if she had known the true risk of device rupture and that, were they informed
that the risks of MemoryGel implants were higher than disclosed, Catherine’s physicians would
not have recommended that she undergo the MemoryGel implant procedure. Doc. 1-2 at ¶¶ 4849, 76-77, 91-92, 97, 109-110, 116; see Rosenstern, 987 F. Supp. 2d at 801-02 (holding similar
allegations sufficient to allege proximate cause under Illinois law); Sellers, 881 F. Supp. 2d at
1010 (same). And because the court concludes that Catherine’s claims are viable, Travis’s loss
of consortium claim survives as well.
Mentor’s motion to dismiss is granted in part and denied in part. Plaintiffs may proceed
with Catherine’s claim that Mentor violated its state tort law duties by concealing that the risk of
gel bleed associated with MemoryGel was higher than the company publicly revealed, and with
Travis’s associated consortium claim. Plaintiffs’ other claims are dismissed, though the
dismissal is without prejudice. See Runnion ex rel. Runnion v. Girl Scouts of Greater Chi. &
Nw. Ind., 786 F.3d 510, 519 (7th Cir. 2015) (“Ordinarily, … a plaintiff whose original complaint
has been dismissed under Rule 12(b)(6) should be given at least one opportunity to try to amend
her complaint before the entire action is dismissed.”). Plaintiffs have until February 1, 2018 to
file an amended complaint. If Plaintiffs file an amended complaint, Mentor shall respond by
February 15, 2018. If Plaintiffs do not file an amended complaint, the dismissal of the other
claims will convert automatically to a dismissal with prejudice.
January 11, 2018
United States District Judge
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