United States District Court, S.D. Florida
ORDER GRANTING MOTION TO DISMISS
N. Scola, Jr., United States District Judge.
Plaintiff Karen Shapiro brought negligence and strict
liability claims against the Defendant NuVasive, Inc.
(“NuVasive”) for injuries she sustained from a
surgery due to allegedly defective Polyaxial Screws. Now
before the Court is the NuVasive's motion to dismiss.
(ECF No. 12.) For the reasons set forth below, the Court
grants the motion to dismiss (ECF
13, 2020, Karen Shapiro underwent spinal fusion surgery. (ECF
No. 1- 3 at ¶ 6.) The surgeon used the NuVasive SpheRx
DBR II Spinal System, a screw system that consists of various
types of “polyaxial screws, dual ball rods, locking
nuts, and transverse connectors.” (Id. at
¶¶ 7, 14.) Shortly after her surgery, Shapiro's
physician took an x-ray of her back, which showed that
“all of her medical hardware was in an excellent
position.” (Id. at ¶ 8.) At a follow-up
visit to the doctor's office on July 11, 2012, Shapiro no
longer had any complaints of back pain. (Id. at
April 14, 2017, nearly seven years after the surgery, Shapiro
complained of back pain to her physician. (Id. at
¶ 10.) The doctor took another x-ray, which showed
“that the defective pedicle screw at the SI level and
the defective facet screw on the left contralateral side had
broken off and fragments of the screw had become contained
within the bone.” Id. Shapiro needed to
undergo a second spinal surgery to remove the failed screws
and perform a fusion augmentation. (Id. at ¶
brought this suit for strict liability and negligence against
NuVasive, who “was engaged in the business of
designing, manufacturing, inspecting, testing, advertising,
marketing, selling, and distributing…the NuVasive
SpheRx DBR II Spinal System.” (Id. at ¶
13.) Now, NuVasive seeks to dismiss Shapiro's complaint
for failure to state a claim (ECF No. 12.)
considering a motion to dismiss, filed under Federal Rule of
Civil Procedure 12(b)(6), must accept all of the
complaint's allegations as true, construing them in the
light most favorable to the plaintiff. Pielage v.
McConnell, 516 F.3d 1282, 1284 (11th Cir. 2008).
Although a pleading need only contain a short and plain
statement of the claim showing that the pleader is entitled
to relief, a plaintiff must nevertheless articulate
“enough facts to state a claim to relief that is
plausible on its face.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 570 (2007). “But where the
well-pleaded facts do not permit the court to infer more than
the mere possibility of misconduct, the complaint has
alleged-but it has not shown-that the pleader is entitled to
relief.” Ashcroft v. Iqbal, 556 U.S. 662, 679
(2009) (quoting Fed.R.Civ.P. 8(a)(2)) (internal punctuation
omitted). A court must dismiss a plaintiff's claims if
she fails to nudge her “claims across the line from
conceivable to plausible.” Twombly, 550 U.S.
Strict Liability Claims
Florida strict liability law, “the manufacturer of a
defective product can be held liable if the manufacturer made
the product in question, if the product has a defect that
renders it unreasonably dangerous, and if the unreasonably
dangerous condition is the proximate cause of the
plaintiff's injury.” Jennings v. BIC
Corp., 181 F.3d 1250, 1255 (11th Cir. 1999) (citing
West v. Caterpillar Tractor Co., 336 So.2d 80, 87
(Fla. 1976)). The manufacturer can be held strictly liable
for a defective product under three theories: a design
defect, a manufacturing defect, or an inadequate warning.
Id. Here, Shapiro brings strict liability claims
against the manufacturer under the design defect and the
manufacturing defect theories of liability. (ECF No. 1-3.)
NuVasive argues that Shapiro's strict liability claim
must be dismissed because Shapiro did not sufficiently
identify a defect. The Court agrees.
complaint must contain factual allegations about what was in
fact defective about the product.” Witt v.
Howmedica Osteonics Corp., 2013 WL 6858395, *2 (S.D.
Fla. 2013) (King, J.) (strict liability claim dismissed
because there were no allegations about how the product was
defective); Gomez v. Pfizer, Inc., 675 F.Supp.2d
1159, 1163 (S.D. Fla. 2009) (Ungaro, J.) (dismissing the suit
because there were no factual allegations suggesting what was
defective about the products); Rice v. Walker, 359
So.2d 891, 892 (Fla. 3d DCA 1978) (dismissing the products
liability complaint where the plaintiff did not allege facts
showing how the product was defective); cf. Bailey v.
Janssen Pharmaceutical, Inc., 288 Fed. App'x 597,
607-608 (11th Cir. 2008) (upholding the complaint because it
suggests several possible defects existing at the time
plaintiff used the product).
does not identify a defect in NuVasive' product. Instead,
she alleges that seven years after surgery, an x-ray exam
“revealed that the defective pedical screw at the SI
level and the defective facet screw on the left contralateral
side had broken off and fragments of the screw had come
contained within the bone.” (ECF No. 1-3 at ¶ 22.)
Shapiro argues, without citing a strict liability case, that
this allegation is sufficient, and that requiring her to
specify how the product is defective is
“unattainable” and that it is “contrary to
law” to require a plaintiff to definitively prove her
claims at this stage. (ECF No. 16 at 2-3.) However, the law
only requires Shapiro to identify a defect that she contends
caused her injury. See, e.g., Gomez, 675 F.Supp.2d
at 1163. It does not require Shapiro to prove that the screws
used in her surgery were in fact defective.
brings a negligence claim under several theories of liability
including a design defect, a manufacturing defect, failure to
test, failure to warn, and failure to inspect. (ECF No. 1-3
at ¶ 22.) First, Shapiro's allegation of inadequate
testing and inspecting are problematic because they are not
independent bases for a negligence claim. “Under
Florida law, a manufacturer's duty to test is a subpart
of its duty to design a product with reasonable care and,
therefore, is subsumed in the plaintiff's claims for
defective design and failure to warn.” Tsavaris v.
Phizer, Inc., 2016 WL 375008, at *4 (S.D. Fla. Feb. 1,
2016) (citing Adams v. G.D. Searle & Co., Inc.,
576 So.2d 728 (Fla. 2d DCA 1991)). Therefore, the Court