Joyce et al v. Davol, Inc. et al

Filing 30

MEMORANDUM AND ORDER :IT IS HEREBY ORDERED that Defendant C. R. Bard, Inc.'s Motion to Dismiss Plaintiffs Complaint 9 is GRANTED as to Count III (Negligent Manufacture). In all other respects, the motion is DENIED. IT IS FURTHER ORDERED th at Defendant Davol, Inc. shall respond to Plaintiffs' Complaint no later than March 29, 2016. IT IS FURTHER ORDERED that because a Rule 16 conference will be set by separate order, Plaintiffs' Motion for Leave to Propound Discovery or, in the Alternative, Request for Scheduling Conference 25 is DENIED as moot. ( Response to Court due by 3/29/2016.). Signed by District Judge John A. Ross on 2/29/16. (KKS)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

FRANCIS X. JOYCE, and
BELINDA JOYCE,
Plaintiffs,
v.
DAVOL, INC., and C. R. BARD, INC.,
Defendants.

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No. 4:15-CV-468 JAR

MEMORANDUM AND ORDER
This matter is before the Court on Defendant C. R. Bard, Inc.’s Motion to Dismiss
Plaintiffs’ Complaint (Doc. No. 9) and Plaintiffs’ Motion for Leave to Propound Discovery or, in
the Alternative, Request for Scheduling Conference. (Doc. No. 25) The motions are fully briefed
and ready for disposition.1
I.

Background

This products liability personal injury action arises from a hernia surgery that took place
in 2005. On March 13, 2015, Plaintiffs Francis and Belinda Joyce filed a Complaint against
Defendants Davol, Inc. (“Davol”) and C. R. Bard, Inc. (“Bard”)2 alleging that the defective
condition of their mesh plug (Marlex Perfix Large lot # 43EDD126) used in inguinal hernia

1

Bard filed an opposition to Plaintiffs’ motion on October 27, 2015. (Doc. No. 26) Plaintiffs did not file a
reply and the time for doing so has passed.
2

Davol, Inc. is a Delaware company with its principal place of business in Rhode Island. C.R. Bard, Inc.
is the New Jersey parent corporation of Davol, Inc. Thrope v. Davol, Inc., No. C.A. 008-463ML, 2011
WL 470613, at *2 (D. R.I. Feb. 4, 2011).

repairs, known as the “Bard PerFix Plug®,” caused him to suffer “ongoing severe pain, atrophy,
medical bills and missed work.” (Complaint (“Compl.”), Doc. No. 1)
Plaintiffs allege that on December 12, 2005, Plaintiff Francis Joyce underwent a surgical
procedure to repair a right inguinal, or groin area, hernia, during which a PerFix Plug® was
implanted. (Id. at Count I, ¶ 7) Plaintiffs further allege that over time, the mesh plug “created an
inflammatory response in Mr. Joyce’s body, entrapping nerves, eroding and sticking to nearby
structures, and causing extreme pain, necessitating three separate surgeries on August 22, 2011,
October 12, 2011, and January 3, 2012. (Id. at ¶ 10) In his first surgery of August 22, 2011, the
surgeon found entrapment of the ilio-ingunal nerve in the mesh. (Id.) In the second surgery of
October, 12, 2011, the surgeon found erosion of the mesh plug through the deep inguinal ring.
(Id.) In the third surgery of January 3, 2012, the surgeon found residual mesh adhered in the
medial aspect of the right groin, which he had to chisel out. (Id.) Plaintiffs allege that as a result
of the mesh plug, Mr. Joyce incurred the pain and inconvenience of these surgeries, as well as
the pain from the mesh entrapping, eroding and adhering to his nerves and structures. Plaintiffs
further allege that Mr. Joyce will suffer from pain and atrophy into the future, and may require
further medical care.
Plaintiffs assert claims for strict liability product defect (Count I), strict liability failure to
warn (Count II), negligent manufacture,3 design, and failure to warn (Count III), and spousal
injury (Count IV). Bard moves to dismiss Plaintiffs’ complaint for failure to state a claim upon
which relief may be granted.4

3

Plaintiffs have now abandoned their negligent manufacturing claim. (See Doc. No. 12 at 6)
Accordingly, the Court will dismiss that claim with prejudice.
4

Davol and Plaintiffs have stipulated that in exchange for Davol’s waiver of service, Davol has thirty
(30) days after the Court enters a ruling on Bard’s motion to dismiss to respond to Plaintiffs’ complaint.
(Doc. No. 23)

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II.

Legal standard

In ruling on a motion dismiss under Rule 12(b)(6), the Court must view the allegations in
the complaint in the light most favorable to Plaintiffs. Foster v. Deutsche Bank Nat. Trust Co.,
2012 WL 5285887, 2 (E.D. Mo. Oct. 25, 2012) (citing Eckert v. Titan Tire Corp., 514 F.3d 801,
806 (8th Cir. 2008)). The Court “must accept the allegations contained in the complaint as true
and draw all reasonable inferences in favor of the nonmoving party.” Id. (quoting Coons v.
Mineta, 410 F.3d 1036, 1039 (8th Cir. 2005)). The complaint's factual allegations must be
sufficient “to raise a right to relief above the speculative level,” however, and the motion to
dismiss must be granted if the complaint does not contain “enough facts to state a claim to relief
that is plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 570 (2007)
(abrogating the “no set of facts” standard for Fed. R. Civ. P. 12(b)(6) found in Conley v. Gibson,
355 U.S. 41, 45–46 (1957)). Thus, a dismissal under Rule 12(b)(6) should be granted “only in
the unusual case in which a plaintiff includes allegations that show, on the face of the complaint,
that there is some insuperable bar to relief.” Strand v. Diversified Collection Serv., Inc., 380 F.3d
316, 317 (8th Cir. 2004). The issue on a motion to dismiss is not whether the plaintiff will
ultimately prevail, but whether the plaintiff is entitled to present evidence in support of his or her
claim. Rosenberg v. Crandell, 56 F.3d 35, 37 (8th Cir.1995).
III.

Discussion

A. Bard’s motion to dismiss
Strict liability product defect (Count I) and Negligent product defect (Count III)
In support of its motion to dismiss, Bard first argues that Plaintiffs’ strict liability product
defect claim (Count I) is barred by Comment k to the Restatement (Second) of Torts, § 402A,
which recognizes that prescription medical devices, such as the Bard PerFix Plug®, are

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“unavoidably unsafe” products, for which claims for strict liability design defect are
inappropriate. (Doc. No. 10 at 4-5; Doc. No. 14 at 2-4) (citing Racer v. Utterman, 629 S.W.2d
387, 393 (Mo. Ct. App. 1981) (finding a surgical drape to be an “unavoidably unsafe product”
because of its flammable nature). The Restatement (Second) of Torts, § 402A, states in relevant
part as follows:
(1) One who sells any product in a defective condition unreasonably dangerous to the user or
consumer or to his property is subject to liability for physical harm thereby caused to the
ultimate user or consumer, or to his property, if
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in
the condition in which it is sold.
Restatement (Second) of Torts, § 402A(1). Comment k provides an exception to this rule, as
follows:
k. Unavoidably unsafe products. There are some products which, in the present state of
human knowledge, are quite incapable of being made safe for their intended and ordinary
use. These are especially common in the field of drugs … Such a product, properly
prepared, and accompanied by proper directions and warning, is not defective, nor is it
unreasonably dangerous. The same is true of many other drugs, ... many of which for this
very reason cannot legally be sold except to physicians, or under the prescription of a
physician … The seller of such products, again with the qualification that they are
properly prepared and marketed, and proper warning is given, where the situation calls
for it, is not to be held to strict liability for unfortunate consequences attending their use
…
Restatement (Second) of Torts, § 402A Comment k.
Relying on Hill v. Searle Labs., a Div. of Searle Pharm., Inc., 884 F.2d 1064, 1068 (8th
Cir. 1989) and Anastasi v. Wright Medical Technology, Inc., 16 F. Supp. 3d 1032, 1041 (E.D.
Mo. 2014), Plaintiffs respond that the Eighth Circuit considers Comment k an affirmative
defense to be proven by the defendant, and as such cannot be resolved on a motion to dismiss.
(Doc. No. 12 at 5) Plaintiffs assert that Bard’s reliance on Racer is misplaced because the case
actually proceeded to trial and was submitted to a jury. (Doc. No. 12 at 6)

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In Anastasi, a woman who received an allegedly defective hip implant brought a strict
liability design defect claim against the manufacturers. The manufacturers moved to dismiss her
claim, arguing she could not, as a matter of law, state such a claim pursuant to Comment k. 16 F.
Supp. 3d at 1040. In her opposition to the motion to dismiss, Anastasi argued, inter alia, that
Comment k is generally recognized as an affirmative defense, which would require the
defendants to present proof the hip implant was incapable of being made safer at the time of
manufacture and distribution. U.S. District Judge Webber found defendants’ Comment k
argument premature:
Section 402A subjects to liability the seller or manufacturer of a product sold in a
defective condition unreasonably dangerous to an ultimate user or consumer whose
person or property is physically harmed by the product. The design defect claim’s
“unreasonably dangerous” inquiry involves a two-step analysis to evaluate the possible
liability of a manufacturer for injuries caused by its inevitably hazardous product: 1)
whether the product is so unsafe that marketing at all is “unreasonably dangerous per se”;
and 2) if not, whether the product has been introduced into the stream of commerce with
insufficient safeguards and is thereby “unreasonably dangerous as marketed.” The first
prong of the inquiry involves a balancing process in which the product’s utility is
weighed against the potential harmful effects caused by its introduction into commerce.
Only if the product is determined not “unreasonably dangerous per se” does the analysis
proceed to the “unreasonably dangerous as marketed” inquiry, at which point Comment k
becomes applicable. Because the prerequisite “unreasonable dangerous” determination
involves weighing of evidence, consideration of the applicability of Comment k’s bar to
[Anastasi’s] strict liability design defect claim is not appropriate in a motion to dismiss.
Id. at 1041 (internal citations and quotation marks omitted). Likewise, Bard’s Comment k
argument is inapplicable at this juncture. The Court will deny Bard’s motion to dismiss Count I
(strict liability product defect) on this basis.
Next, Bard challenges the sufficiency of Plaintiffs’ allegations of product defect under
either a strict liability or negligent theory, arguing that Plaintiffs fail to identify a specific defect
in the Bard PerFix Plug® or causal connection between any such defect and Mr. Joyce’s alleged
injuries. (Doc. No. 10 at 5-6) For example, as to strict liability, Plaintiffs allege the PerFix Plug®

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was “in a defective condition unreasonably dangerous when put to a reasonably anticipated use,”
and that Plaintiff “was damaged as a direct result of the defective condition of the mesh plug as
existed when the mesh was designed.” (Compl., Count I at ¶¶ 8, 10) Bard complains these are
boilerplate allegations that merely restate the legal standards for product defect without sufficient
factual support. (Doc. No. 10 at 6)
In response, Plaintiffs assert their complaint clearly and specifically alleges the specific
hazard of the mesh plug, i.e., its capability “of causing inflammation, entrapment, adherence
and erosion of nearby structures” and that this hazard caused Plaintiff’s injuries. (Doc. No. 12
at 4) Plaintiffs further allege that “the mesh plug over time created an inflammatory response
in Plaintiff’s body, entrapping nerves, eroding and sticking to nearby structures, and causing
extreme pain, necessitating three separate surgeries.” (Compl., Count I at ¶¶ 8, 10)
“A complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed
factual allegations.” Twombly, 550 U.S. at 555. After all, “Federal Rule of Civil Procedure
8(a)(2) requires only “a short and plain statement of the claim showing that the pleader is entitled
to relief,” in order to ‘give the defendant . . . fair notice of what the . . . claim is and the grounds
upon which it rests.’ ” Id. at 555 (citations omitted). All that is required of this short plain
statement is that the “[f]actual allegations must be enough to raise a right to relief above the
speculative level.” Id. at 570; see also Iqbal, 129 S. Ct. at 1950 (noting that the complaint must
move from “conceivable to plausible”). Indeed, “it would be rare for a plaintiff at the time of the
filing of a complaint to have more factual information than that alleged …, i.e., that the
defendants designed, manufactured and marketed the specified product; that the [plaintiff] used
the product properly for its intended use …; and that the product directly and proximately caused
[an injury].” Turner v. Mylan, Inc., No. 4:09-CV-1816-TIA, 2010 WL 1608852, at *2 (E.D. Mo.

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Apr. 20, 2010) (citing Houston v. Mylan, Inc., No. 8:09-CV-306 (D. Nev. Nov. 20, 2009)).
Moreover, Bard is certainly aware of what defects the plug is alleged to have. See In re Kugel
Mesh Hernia Patch Products Liability Litigation, MDL No. 1842, No. 07-MD-1842-ML (D.R.I.),
involving claims surrounding allegedly defective hernia repair patches designed and
manufactured by Defendants Davol and Bard. The Court will deny Bard’s motion to dismiss
Count I (strict liability product defect) and Count II (negligent product defect).
Strict liability failure to warn (Count II) and Negligent failure to warn (Count III)
In further support of its motion to dismiss, Bard argues that Plaintiffs fail to allege facts
showing their failure to warn claims are not barred by the “learned intermediary” doctrine. (Doc.
No. 10 at 6-7; Doc. No. 14 at 8) The learned intermediary doctrine provides that a manufacturer
has a duty to warn a physician of the risks involved with its product. The physician then acts as a
“learned intermediary” between the manufacturer and the patient so that any warning given to
the physician is deemed a warning to the patient. Redd v. DePuy Orthopedics, 48 F. Supp.3d
1261, 1270-71 (E.D. Mo. Sept. 8, 2014) (citing Kirsch v. Picker Int’l, Inc., 753 F.2d 670, 671
(8th Cir. 1985); Doe v. Alpha Therapeutic Corp., 3 S.W. 3d 404, 419 (Mo. Ct. App. 1999)). Bard
argues Plaintiffs fail to specify who Bard failed to warn and that to the extent Mr. Joyce is
alleging that Bard failed to warn him of the alleged defect of the PerFix Plug®, his claims are
contrary to Missouri law and must be dismissed. In addition, Bard argues that Plaintiffs fail to
allege any facts regarding the labeling that accompanied the PerFix Plug®. (Doc. No. 10 at 7)
Plaintiffs respond that such allegations are not necessary to survive a motion to dismiss.
(Doc. No. 12 at 6) In Redd, 48 F. Supp. 3d 1261, the district court noted that Missouri’s learned
intermediary doctrine is typically asserted as an affirmative defense to a failure to warn claim
and that a plaintiff is not required to plead facts tending to negate it in order to survive a motion

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to dismiss. Id. at 1271 n. 5 (citing Alpha Therapeutic Corp., 3 S.W. 3d. at 418-21; Stanger v.
Smith & Nephew, Inc., 401 F. Supp. 2d 974, 984 (E.D. Mo. 2005); Wright v. American Home
Products Corp., No. 06-CV-4183-NKL, 2008 WL 1820902 at *3 (W.D. Mo. Apr. 18, 2008)). See
also Bohnenstiehl v. Wright Medical Group, Inc., No. 4:13-CV-853, at *3 (E.D. Mo. Jan. 29,
2014), where the district court denied defendant’s motion to dismiss plaintiff’s failure to warn
claims despite defendant’s argument that plaintiff was required to allege what warnings were
given and how they were deficient. The Court will deny Bard’s motion to dismiss Count II (strict
liability failure to warn) and Count III (negligent failure to warn) on this basis.
Negligence claims (Count III)
Next, Bard argues Plaintiffs’ negligence claims fail to plead facts showing how Bard
breached any duty to Plaintiffs or how any such breach proximately caused Plaintiffs’ injuries.
(Doc. No. 10 at 9) Plaintiffs do not address this argument in their memorandum in opposition.
Under Missouri law, “ ‘[i]n an action for negligence, generally, a plaintiff must allege
ultimate facts which if proven, show: (1) the existence of a duty on the part of the defendant to
protect the plaintiff from injury; (2) failure of the defendant to perform that duty; and (3) injury
to the plaintiff resulting from such failure.’ ” Menz v. New Holland N. Am., Inc., 460 F. Supp.
2d 1058, 1067 (E.D. Mo. 2006) aff'd, 507 F.3d 1107 (8th Cir. 2007) (quoting Pro Service
Automotive, L.L.C. v. Lenan Corp., 2005 WL 3371054 at *13 (W.D. Mo. Dec. 12, 2005)). Thus,
to recover on a claim for negligent design or failure to warn, a plaintiff must establish that the
defendant failed to use ordinary care to either design the product to be reasonably safe or
adequately warn of the risk of harm from the alleged defect. Id. See also Stanley v. Cottrell, Inc.,
784 F.3d 454, 463 (8th Cir. 2015) (citing Stevens v. Durbin–Durco, Inc., 377 S.W.2d 343, 347
(Mo.1964); Blevins v. Cushman Motors, 551 S.W.2d 602, 607-08 (Mo. 1977)).

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Plaintiffs allege Defendants failed to use ordinary care to manufacture and design the
PerFix Plug® to be reasonably safe so that it would not, over time, cause inflammation,
entrapment, adherence, and erosion of nearby nerves and structures, and pain. Plaintiffs further
allege Defendants failed to use ordinary care to adequately warn of the risk of harm from the
mesh plug with reasonably anticipated use and that such failures directly caused or directly
contributed to cause the damages alleged in Count I. (Compl., Count III at ¶¶ 4, 5) The Court
finds these allegations satisfy the standard set forth in Twombly and Iqbal in that they raise a
reasonable expectation that discovery will reveal evidence of Plaintiffs’ negligence claim.
Twombly, 550 U.S. at 556. The Court will therefore deny Bard’s motion to dismiss Count III.
Spousal injury (Count IV)
In Count IV, Plaintiff Belinda Joyce alleges loss of consortium based on Mr. Joyce’s
alleged injuries. “[A] loss of consortium claim is wholly derivative, and thus rises or falls with
the success of the underlying claims of the injured spouse.” Menz, 460 F. Supp. 2d at 1067-68
(citing Wright v. Barr, 62 S.W.3d 509, 537 (Mo. Ct. App. 2001)). In light of the Court’s ruling
that Mr. Joyce’s claims survive Bard’s motion to dismiss, Mrs. Joyce’s claims survive as well.
In sum, accepting the Complaint’s well-pleaded allegations as true, and liberally
construing it in Plaintiffs’ favor, the Court finds Plaintiffs’ Complaint alleges enough facts “to
raise a right to relief above the speculative level …” Twombly, 550 U.S. at 555. Thus, the Court
denies Bard’s Motion to Dismiss, save Plaintiffs’ negligent manufacturing claim in Count III.
B. Plaintiffs’ Motion for Leave to Propound Discovery or, in the Alternative,
Request for Scheduling Conference
In their motion, Plaintiffs seek leave from the Court to propound generalized
interrogatories and requests for production on Bard to move the case forward. Alternatively,
Plaintiffs request a scheduling conference. Bard opposes the motion, asserting it is premature to

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conduct written discovery while its motion to dismiss is pending and before Davol files a
responsive pleading. The Court has now ruled on Bard’s motion to dismiss, and will set the case
for a Rule 16 conference by separate order. Therefore, Plaintiffs’ motion will be denied as moot.
Accordingly,
IT IS HEREBY ORDERED that Defendant C. R. Bard, Inc.’s Motion to Dismiss
Plaintiffs’ Complaint [9] is GRANTED as to Count III (Negligent Manufacture). In all other
respects, the motion is DENIED.
IT IS FURTHER ORDERED that Defendant Davol, Inc. shall respond to Plaintiffs’
Complaint no later than March 29, 2016.
IT IS FURTHER ORDERED that because a Rule 16 conference will be set by separate
order, Plaintiffs’ Motion for Leave to Propound Discovery or, in the Alternative, Request for
Scheduling Conference [25] is DENIED as moot.

Dated this 29th day of February, 2016.

_________________________________
JOHN A. ROSS
UNITED STATES DISTRICT JUDGE

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