Sumpter et al v. Allergan, Inc. et al
MEMORANDUM AND ORDER : IT IS HEREBY ORDERED that Defendant Allergan, Inc.'s Motion to Dismiss (ECF No. 15 ) and Defendant NuSil Technology LLC's Motion to Dismiss (ECF No. 34 ) are DENIED. Signed by District Judge Ronnie L. White on 09/11/2018. (KCB)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
ROBIN SUMPTER and JOHN SUMPTER,
ALLERGAN INC. and
NUSIL TECHNOLOGY LLC,
MEMORANDUM AND ORDER
This matter is before the court on Defendant Allergan, Inc.' s Motion to Dismiss (ECF
No. 15) and Defendant NuSil Technology LLC's Motion to Dismiss (ECF No. 34). These
matters are fully briefed and ready for disposition.
Plaintiff Robin Sumpter ("Robin") underwent a breast augmentation procedure in 2007.
(Amended Petition ("AP"), ECF No. 6, ili!l 7-18). Upon her doctor's advice, Robin received
silicone gel-filled breast implants instead of saline implants.
(AP, i!l 9). Allergan Inc.
("Allergan") distributed the implants throughout the United States, including Missouri. (AP, i!3).
NuSil Technology, LLC ("NuSil") manufactured the silicone used in the implants. (AP, ii4).
In deciding a motion to dismiss under Rule l 2(b)( 6), a court assumes all facts in the complaint
to be true and construes all reasonable inferences most favorably to the complainant. US. ex rel.
Raynor v. Nat'! Rural Utilities Co-op. Fin., Corp., 690 F.3d 951, 955 (8th Cir. 2012); Eckert v.
Titan Tire Corp., 514 F.3d 801, 806 (8th Cir. 2008).
For years, Robin experienced several problems throughout her body that were similar to
multiple sclerosis. Robin had her implants removed on August 27, 2015. (AP, i!27).
implants had ruptured.
A large fraction of the gel found in Robin's implants
deteriorated to reactive silicone-based materials of low viscosity which traversed tissue and
invaded surrounding muscles.
STANDARD OF REVIEW
To survive a motion to dismiss, a complaint "must contain sufficient factual matter,
accepted as true, to 'state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 556
U.S. 662, 678, 129 S. Ct. 1937, 1949, 173 L. Ed. 2d 868 (2009) (quoting Bell Atlantic Corp., v.
Twombly, 550 U.S 544, 570 (2007). A "formulaic recitation of the elements of a cause of
action" will not suffice. Twombly, 550 U.S. at 555. "The plausibility standard is not akin to a
'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted
unlawfully." Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 556).
Plaintiffs have asserted claims for strict product liability, negligence, and loss of
consortium against Allergan and NuSil. 2
Allergan and NuSil argue that these claims are
preempted by Federal law and are not pleaded with sufficient plausibility or particularity under
Twombly and Iqbal.
Plaintiffs' loss of consortium claim flows from their strict liability and negligence claims.
Therefore, Plaintiffs' loss of consortium claim fails if the underlying claims are dismissed.
Johnson v. Anheuser Busch, Inc., 876 F.2d 620, 625 (8th Cir. 1989) (citing Stephen v. Lindell
Hosp., 681 S.W.2d 503, 508 (Mo. Ct. App. 1984) ("Loss of consortium presents
a derivative claim arising out of the tort claims of the injured spouse. When an injured party
cannot recover, the spouse claiming loss of consortium is also barred as a matter of law from
recovery under that claim.").
Plaintiffs allege Allergen is strictly liable because "[i]n manufacturing the subject
implants, Allergan failed to adhere to FDA-approved processes and procedures." (AP,
Plaintiffs further allege that Allergen was negligent because it "fail[ed] to use reasonable care in
designing, manufacturing, labeling, packaging, and selling the subject implants" (AP,
"fail[ed] to manufacture the subject implants so as to avoid an unreasonable risk of harm to
women in whom the implants are implanted, including the plaintiff[.]" (AP,
Plaintiffs allege NuSil is strictly liable because "[i]n manufacturing the subject silicone, NuSil
failed to adhere to FDA-approved processes and procedures." (AP,
allege that NuSil was negligent because it "fail[ed] to use reasonable care in designing,
manufacturing, labeling, packaging, and selling the silicone found in the subject implants" (AP,
and "fail[ed] to manufacture the silicone found in the subject implants so as to avoid an
unreasonable risk of harm to women in whom the implants are implanted, including the
Defendants argue that Plaintiffs' claims are preempted.
"The Medical Device
Amendments of 1976 (MDA) created a scheme of federal safety oversight for medical devices
while sweeping back state oversight schemes." Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.
Ct. 999, 1000-01, 169 L. Ed. 2d 892 (2008). The MDA preempts claims challenging the safety
and effectiveness of premarket approval medical ("PMA") devices. The statute provides that a
State shall not "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 [federal law] 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" relevant
federal law. 21 U.S.C. § 360k(a).
The Riegel Court established a two-pronged test for
preemption under the MDA: (1) the court must determine whether the federal government has
established the requirements relating to the device, and if so (2) the court must evaluate whether
a state claim imposes requirements relating to the safety and effectiveness of the device that are
'different from, or in addition to the federal requirements.'" Riegel, 552 U.S. at 321-22 (citing
§360k(a)). "The Eighth Circuit has explained that '[w]here a federal requirement permits a
course of conduct and the state makes it obligatory, the state's requirement is in addition to the
federal requirement and thus is preempted."' Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979,
986 (E.D. Mo. 2014) (quoting In re Medtronic, Inc., Sprint Fide/is Leads Prods. Liab. Litig., 623
F.3d 1200, 1205 (8th Cir. 2010)).
It is undisputed that the FDA has established regulations and requirements applicable to
the relevant silicone implants. Plaintiffs concede that their claims of defective design and failure
to warn are expressly preempted by §360k. See ECF No. 31 at 4. Plaintiffs' sole remaining
theory of liability is for manufacturing defect.
Generally, manufacturing defect claims that
allege the "manufacturer failed to adhere to the specifications imposed by a device's PMA" are
not preempted at the pleading stage. Hafts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830,
837-38 (S.D. Ind. 2009).
Defendants assert that Plaintiffs' manufacturing defect claim
nevertheless is preempted because it "attempt to impose responsibilities on [them] that are
different from, or in addition to the federal requirements, and is expressly preempted." (ECF No.
16 at 15).
Defendants argue that Plaintiffs' purported manufacturing defect claims are really design
and warning claims that are preempted under the FDA. A manufacturing defect occurs when
something goes wrong in the manufacturing process and the product is not in its intended
condition. Richcreek v. Gen. Motors Corp., 908 S.W.2d 772, 776 (Mo. Ct. App. 1995). The
product is evaluated against the producers'
own standards, and compared to like
products. Richcreek, 908 S.W.2d at 776 (citing Am Law Prod. Liab. 3rd § 28:1 p 13). In a
design-defect case, however, there is no doubt that the product is in the condition intended by
the manufacturer. Richcreek, 908 S.W.2d at 776 (citing Bilotta v. Kelley Co., Inc., 346 N.W.2d
616, 621 (Minn. 1984)). In such case, the "defect" lies in a consciously chosen design. Id.
The manufacturer has deliberately added or omitted the challenged component and has
presumably made that decision after balancing a variety of factors. Id.; Richcreek, 908 S.W.2d
at 776 (quoting Nesselrode v. Executive Beechcraft, Inc., 707 S.W.2d 371, 375-77 (Mo. bane
1986) ("To establish liability in a design defect case, the plaintiff bears the burden of
demonstrating that the product, as designed, is unreasonably dangerous and therefore 'defective',
and that the demonstrated defect caused his injuries."). Defendants contend that Plaintiffs'
allegations relate to the dangerous nature of the silicone materials, rather than regarding a
specific defect in the assembly or production of the silicone.
At this very early stage of litigation, the Court holds that Plaintiffs have sufficiently
alleged claims of manufacturing defects that are not preempted. As stated, Defendants argue that
Plaintiffs' claim fails because they have not alleged the "particular defect or flaw in the
manufacturing process". (ECF No. 16 at 15, n.9). Plaintiffs, however, alleged a particular defect
or flaw in the manufacturing process. Plaintiffs alleged that the silicone implanted in Plaintiffs'
differed from NuSil's and the FDA's intended result. (ECF No. 40 at 12 (citing AP, iJiJ41-42);
see also ECF No. 31 at 12-13). Likewise, Plaintiffs allege that, due to manufacturing defect, the
products (the gel and/or the implants) Robin received were not the products approved by the
FDA. (ECF No. 40 at 12; see also ECF No. 31 at 12). Even though "the precise contours of
their theory of recovery have not yet been defined," the Court holds Plaintiffs' allegations
sufficiently allege that Defendants did not adhere to FDA manufacturing requirements.
Medtronic, Inc. v. Lohr, 518 U.S. 470, 495, 116 S. Ct. 2240, 2255, (1996).
In addition, Plaintiffs have alleged that the "material fatigue" that led to rupture of the
implants was due to manufacturing defect. Defendants ask, without citation, the Court to hold as
a matter of law that "all materials are subject to fatigue over time" and that "[m]aterial fatigue is
not a manufacturing defect, nor is it suggestive of one." (ECF No. 33 at 4). The Court cannot
make such a factual finding on a motion to dismiss. At this stage, the Court is required to draw
all reasonable inferences and resolve all factual disputes in favor of the non-moving party. Coons
v. Mineta, 410 F.3d 1036, 1039 (8th Cir. 2005); see also Minch Family LLLP v. Buffalo-Red
the nonmoving party's facts as true and grant[ing] all reasonable inferences in that party's favor"
on review of a grant of a motion for judgment on the pleadings). The Court holds that Plaintiffs
have alleged a defect in the manufacturing process and the Court cannot hold as a matter of law
at this stage that Plaintiffs' claims are preempted. Accordingly, the Court denies Defendants'
motions to dismiss based upon preemption.
Further, the Court holds that Plaintiffs have alleged sufficient facts to support their basic
claims of negligence and strict liability. Plaintiffs have not alleged "merely naked assertions that
the proper silicone was not used and the correct manufacturing process not followed." Ortiz v.
Allergan, Inc., No. 14 CIV. 8188 PAC, 2015 WL 5178402, at *4 (S.D.N.Y. Sept. 4, 2015).
Rather, Plaintiffs have extrapolated from the injuries to Robin and the condition of the silicone
that there must have been a manufacturing defect. See, e.g., AP, i135 ("The characteristics of
shell damage are consistent with material fatigue rather than a single event.").
Defendants disagree with Plaintiffs' analysis of the damaged implants whether it is indicative of
manufacturing or design defect and assert that Plaintiffs have not pleaded with specificity the
alleged manufacturing defect. The Court holds that, at this stage, Plaintiffs have pleaded with
sufficient specificity, particularly since they are held to the higher standard of Rule 9. See In re
Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1212 (8th Cir. 2010)
("Manufacturing defect claims are not subject, for example, to the 'particularity' pleading
requirements of Rule 9."). Therefore, resolving all disputes in favor of the non-moving party, the
Court holds that Plaintiffs have plausibly alleged their claims under Twombly and Iqbal and
denies Defendants' motions to dismiss for failure to state a claim.
IT IS HEREBY ORDERED that Defendant Allergan, Inc.'s Motion to Dismiss (ECF
No. 15) and Defendant NuSil Technology LLC's Motion to Dismiss (ECF No. 34) are DENIED.
Dated this 11th day of September, 2018.
UNITED STATES DISTRICT JUDGE
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