United States District Court, E.D. Pennsylvania
EDUARDO C. ROBRENO, J.
products liability case, an individual asserts both
negligence and strict liability claims against a prescription
medical device manufacturer. In doing so, the Court is
presented with an important question of state law that has
often been raised but has effectively evaded review by the
Pennsylvania Supreme Court: does Pennsylvania law recognize a
strict liability claim for a manufacturing defect of a
prescription medical device?
Court predicts that the answer to this question is
“no.” But given the growing debate among federal
district courts regarding this issue, the Court certifies the
question to the Third Circuit.
Sarah Rosenberg suffered from stress urinary incontinence
(“SUI”) that required surgical intervention.
Compl. ¶¶ 1, 7, ECF No. 1. On November 12, 2012,
Plaintiff's doctors implanted Defendant C.R. Bard,
Inc.'s Align synthetic mesh system in Plaintiff to treat
her SUI. Id. ¶ 7. Following this procedure,
Plaintiff began experiencing complications such as severe
lower quadrant pain, dyspareunia, and mesh erosion.
Id. ¶ 8. According to Plaintiff, these
complications required further medical care and treatment,
including surgical interventions. Id. Plaintiff
alleges that she is more likely than not to need to undergo
additional procedures related to complications that she
attributes to Defendant's pelvic mesh system. See
Id. ¶ 21.
alleges that she neither knew nor could have reasonably known
that her complications were related to design or
manufacturing defects of the pelvic mesh system until July
27, 2017. Id. ¶ 9. Further, Plaintiff alleges
that, despite safety communications from the FDA in 2011
observing the risks associated with pelvic mesh systems as
well as various reports from physicians, patients, and the
World Health Organization noting complications from pelvic
mesh implantation, Defendant continued to advertise and
promote its pelvic mesh system as a safe and effective
treatment for SUI and pelvic organ prolapse. Id.
¶¶ 10-15, 17. According to Plaintiff, Defendant
knew that its pelvic mesh system had a defect attributable to
erosion, shrinkage, and/or hardening of the mesh material and
that there could be life-changing and irreversible
complications from pelvic mesh removal. Id. ¶
16. Plaintiff further alleges that Defendant failed to
provide sufficient warnings of the risks of pelvic mesh
implantation and concealed the known risks associated with
pelvic mesh implantation. Id. ¶¶ 17-22.
filed a complaint against Defendant, originally bringing
thirteen causes of action, including strict liability,
negligence, and fraud. ECF No. 1. Defendant then filed a
motion to dismiss for failure to state a claim. ECF No. 6. In
her response in opposition to Defendant's motion to
dismiss, Plaintiff abandoned all but three of her original
causes of action: (1) strict liability for design and
manufacturing defects, (2) strict liability for failure to
warn, and (3) negligence. ECF No. 10. Plaintiff's
abandoned claims (Counts IV-XIII) will be dismissed with
Court heard argument on Defendant's motion to dismiss,
and the motion is now ready for disposition.
may move to dismiss a complaint for failure to state a claim
upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). When
considering such a motion, the Court must “accept as
true all allegations in the complaint and all reasonable
inferences that can be drawn therefrom, and view them in the
light most favorable to the non-moving party.”
DeBenedictis v. Merrill Lynch & Co., 492 F.3d
209, 215 (3d Cir. 2007) (internal quotation marks removed).
To withstand a motion to dismiss, the complaint's
“[f]actual allegations must be enough to raise a right
to relief above the speculative level.” Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555 (2007). This
“requires more than labels and conclusions, and a
formulaic recitation of the elements of a cause of action
will not do.” Id. Although a plaintiff is
entitled to all reasonable inferences from the facts alleged,
a plaintiff's legal conclusions are not entitled to
deference, and the Court is “not bound to accept as
true a legal conclusion couched as a factual
allegation.” Papasan v. Allain, 478 U.S. 265,
pleadings must contain sufficient factual allegations so as
to state a facially plausible claim for relief. See, e.g.,
Gelman v. State Farm Mut. Auto. Ins. Co., 583 F.3d
187, 190 (3d Cir. 2009). “‘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. (quoting Ashcroft v. Iqbal, 556 U.S.
662, 678 (2009)). In deciding a Rule 12(b)(6) motion, the
Court limits its inquiry to the facts alleged in the
complaint and its attachments, matters of public record, and
undisputedly authentic documents if the plaintiff's
claims are based upon these documents. See Jordan v. Fox,
Rothschild, O'Brien & Frankel, 20 F.3d 1250,
1261 (3d Cir. 1994); Pension Benefit Guar. Corp. v. White
Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir.
dismissing a complaint as deficient, the Court should grant
leave to amend. See Fletcher-Harlee Corp. v. Pote
Concrete Contractors, Inc., 482 F.3d 247, 252 (3d Cir.
2007). The Third Circuit has previously held that
“[d]ismissal without leave to amend is justified only
on the grounds of bad faith, undue delay, prejudice, or
futility.” Alston v. Parker, 363 F.3d 229, 236
(3d Cir. 2004).
moves to dismiss Plaintiff's complaint for two reasons:
(1) Pennsylvania law bars all strict liability claims for
prescription medical devices, and (2) Plaintiff's
negligence claim is insufficiently pleaded. Each argument is
discussed in turn.
Pennsylvania Law Bars All Strict Liability Claims for
Pennsylvania's Strict Liability Law
general matter, Pennsylvania has adopted the strict liability
formulation set out in Section 402A of the Restatement
(Second) of Torts. Tincher v. Omega Flex, Inc., 104 A.3d
328, 394-99 (Pa. 2014); Webb v. Zern, 220 A.2d 853,
854 (Pa. 1966). Pursuant to Section 402A, a plaintiff may
recover under a theory of strict liability if his or her
injury was caused by a product in “a defective
condition unreasonably dangerous to the user or
consumer.” Restatement (Second) Torts § 402A; see
also Phillips v. A-Best Prods. Co., 665 A.2d 1167,
1170 (Pa. 1995). A plaintiff may establish a “defective
condition, ” and thus assert a strict liability claim,
by showing that the product suffered from a design defect,
failure-to-warn defect, or manufacturing defect. Id.
are, however, situations where strict liability is
unavailable as an avenue of relief for plaintiffs alleging
harm caused by a product. Specifically, pursuant to comment k
of Section 402A, manufacturers of “unavoidably unsafe
products” are exempted from strict liability to the
extent that the product at issue is “properly prepared,
and accompanied by proper directions and warning, is not
defective, nor is it unreasonably dangerous.” See
Restatement (Second) of Torts § 402A cmt. k (emphasis in