County Superior Court
Plaintiff: Robert W. Smith, Esq.
Defendant: Mark Nugent, Esq.
M. Robinson, Esq.
Defendants, Davol Inc. (Davol) and C. R. Bard Inc. (Bard)
(collectively, Defendants), bring this Super. R. Civ. P.
12(b)(6) (Rule 12(b)(6)) motion to dismiss against Plaintiffs
Wayne and Rebecca Smith (Plaintiffs) in the above-titled
negligence and product liability action. Defendants assert
that Plaintiffs' Amended Complaint fails to state a claim
upon which relief can be granted because Plaintiffs do not
establish a product "defect" as required under
Rhode Island strict product liability law. Additionally,
Defendants contend that Plaintiffs' claims lack proximate
cause essential to establish product liability and
negligence. Plaintiffs assert that Davol's Composix Kugel
Hernia Patch (patch) meets definitions of
"defective" under Rhode Island strict product
liability law, and that there is sufficient proximate cause
alleged in their Amended Complaint in order to survive a Rule
12(b)(6) motion to dismiss. This Court exercises jurisdiction
pursuant to G.L. 1956 § 8-2-14.
February 7, 2005, Mr. Wayne Smith (Mr. Smith) underwent
surgery to repair a ventral hernia. Doctors implanted a
7.7" x 9.7" patch to repair the hernia. Davol
designed, manufactured, and distributed the mesh patch that
doctors implanted into Mr. Smith. Bard is the corporate
parent and stockholder of Davol, and it participates in the
manufacture and distribution of the patch, in addition to
supplying Davol with material that forms part of the patch.
After implantation surgery, Mr. Smith suffered severe
abdominal pain and tenderness at the site of implantation. On
December 22, 2005, Davol issued the first of several recalls,
which included a recall for the type of patch implanted into
Mr. Smith. Additional recalls were again issued in January
and March of 2006. The patch was recalled due to a faulty
"memory recoil ring" that could potentially break
under pressure. This recall was issued after there were
reports of incidents of ring migration within the body,
intestinal fistulae, bowel perforation, and even death.
reporting his pain and symptoms to his physician, Mr.
Smith's doctor advised him that his hernia repair patch
was subject to a recall due to defects in the product.
Specifically, the product recall included information on
possible symptomology that would suggest necessary removal of
the patch. The recall advised doctors to remain alert for
patients reporting "symptoms that could be associated
with ring breakage such as unexplained or persistent
abdominal pain, fever, tenderness at the implant site or
other unusual symptoms." Defs.' Mem., Ex. A. As a
result of this information-and with notice of Mr. Smith's
reported abdominal pain and tenderness at the site of
implantation-Mr. Smith's physician recommended
explantation surgery to remove the patch.
result of such explantation procedures, Mr. Smith alleges he
suffered severe and continuing physical pain and mental
anguish. Plaintiffs bring this action and assert eight
claims, including: 1) Negligence; 2) Violation of the Rhode
Island Deceptive Trade Practices Act (DTPA); 3) Strict
Product Liability; 4) Negligent Infliction of Emotional
Distress; 5) Intentional Infliction of Emotional Distress; 6)
Breach of Implied Warranty; 7) Failure to Warn; and 8) Loss
of Consortium. Defendants now bring this motion to dismiss
for failure to state a claim upon which relief can be granted
under Rule 12(b)(6).
and Bard maintain that Plaintiffs' claims contained in
the Amended Complaint rely on a nonexistent theory of
"product recall liability" that is unfounded in
Rhode Island law. They assert that because Mr. Smith was
injured by the explantation surgery and not the implanted
patch itself, Plaintiffs' claims for personal injury and
product liability cannot survive a Rule 12(b)(6) motion.
Further, Defendants contend that "[m]anufacturers have
no post-sale duty to ensure that physicians [have]
'sufficient information to inform and assist  in
diagnosing a ring breakage.'" Defs.' Mem. 5.
Additionally, Defendants argue that there is no claim in
negligence under Rhode Island law for a product that merely
has a propensity to produce injury, rather than an actual
malfunction in the product itself. Defendants assert that
under negligence, the Plaintiffs lack proximate cause and
thus their claims cannot survive. Finally, Defendants argue
that all other claims included in the Plaintiffs' Amended
Complaint will also necessarily fail under Rhode Island law
if the Plaintiffs fail to establish a defect and proximate
Plaintiffs contend that their Amended Complaint survives a
Rule 12(b)(6) motion to dismiss because it asserts sufficient
legally cognizable claims. Plaintiffs argue that Rhode Island
product liability law merely requires a defect in the product
at the time it leaves a defendant's control-rather than
an actual malfunction or failure of the product itself-
especially when dealing with recalls for products that are
intended for health purposes and inserted into the body.
Further, Plaintiffs claim that the defect rendered the
product very likely to fail, that, therefore, the product was
unreasonably dangerous, and that the defect was the proximate
cause of Mr. Smith's pain symptoms and resulting injuries
from the explantation surgery. Finally, Plaintiffs contend
that Defendants had a duty to warn patients and to provide
proper information to doctors who may be monitoring patients
for product issues. Plaintiffs maintain that their Amended
Complaint asserts legally cognizable claims sufficient to
provide notice to Davol and Bard and to move past
Defendants' Rule 12(b)(6) motion to dismiss.
sole function of a motion to dismiss is to test the
sufficiency of the complaint." Palazzo v.
Alves, 944 A.2d 144, 149 (R.I. 2008) (citations
omitted). Looking at the four corners of a complaint, this
Court examines the allegations in a plaintiff's
complaint, assumes them to be true, and views them in a light
most favorable to the plaintiff. Barrette v.
Takavonis, 966 A.2d 1231, 1234 (R.I. 2009). This Court
is mindful of the policy to interpret the pleading rules
liberally so that cases are not "disposed of summarily
on arcane or technical grounds." Haley v. Town of
Lincoln, 611 A.2d 845, 848 (R.I. 1992). The complaint
need not include the precise legal theory upon which the
claims are based or even the ultimate facts to be proven; all
that is required is fair and adequate notice to the opposing
party of the claims being asserted. Gardner v.
Baird, 871 A.2d 949, 953 (R.I. 2005) (citations
omitted); see also Berard v. Ryder Student Transp.
Servs., Inc., 767 A.2d 81, 83-84 (R.I. 2001).
Consequently, '"[a] motion to dismiss is properly
granted when it is clear beyond a reasonable doubt that the
plaintiff would not be entitled to relief from the defendant
under any set of facts that could be proven in support of the
plaintiff's claim.'" Goddard v. APG Sec.-RI,
LLC, 134 A.3d 173, 175 (R.I. 2016); Woonsocket Sch.
Comm. v. Chafee, 89 A.3d 778, 787 (R.I. 2014) (quoting
Mendes v. Factor, 41 A.3d 994, 1000 (R.I. 2012)).