United States District Court, E.D. Pennsylvania
I. QUINONES ALEJANDRO, J.
Gloria Cavanaugh filed this product liability and negligence
action claiming injuries allegedly caused by defects in a
Prolene pelvic mesh implant device that was either designed,
manufactured, sold, or distributed by Defendants Ethicon,
Inc., Johnson & Johnson, Secant Medical, Inc., and/or
Secant Medical, LLC (the "Secant Defendants"). This
action was filed as part of the Pelvic Mesh
Litigation in the Philadelphia Court of Common Pleas and
removed to federal court. The Secant Defendants have moved to
dismiss the claims asserted against them pursuant to the
Biomedical Access Assurance Act (the "BAAA" or
"Act"), 21 U.S.C. § 1601-1606, which provides
immunity for certain biomaterials suppliers. The issues
raised by the parties have been fully briefed and are ripe
for disposition. For the reasons set forth, the Secant
Defendants' motion is granted and the claims against the
Secant Defendants are dismissed with prejudice.
procedural and factual histories are known to the parties.
Therefore, only the facts pertinent to the underlying motion
will be discussed. These facts are taken primarily from the
master long form complaint filed in the initial state court
proceeding and the parties' briefs on the underlying
motion. To the extent that any facts are disputed, such
disputes will be noted and construed in Plaintiffs favor. As
noted, the Secant Defendants seek dismissal of Plaintiff s
claims pursuant to the immunity provisions of the BAAA.
for a complaint to survive a motion to dismiss, it "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 (2009) (citing Bell Atlantic Corp. v. Twombly,
550 U.S. 554, 570 (2007)). In determining the sufficiency of
a complaint, the court must accept all well-pleaded factual
allegations in the complaint as true and draw all inferences
in favor of the non-moving party. Phillips v. Cnty. of
Allegheny, 515 F.3d 224, 231 (3d Cir. 2008). However,
"the tenet that a court must accept as true all of the
allegations contained in a complaint is inapplicable to legal
conclusions. Threadbare recitals of the elements of a cause
of action, supported by mere conclusory statements, do not
suffice." Iqbal, 556 U.S. at 678.
the BAAA, however, Congress has provided a modified standard
for the dismissal of a complaint. See 21 U.S.C.
§§ 1601-1606. The Act applies to "any civil
action brought by a claimant, whether in a Federal or State
court, on the basis of any legal theory, for harm allegedly
caused, directly or indirectly, by an implant."
Id. § 1603(b)(1). It further provides that
"[a] defendant may, at any time during which a motion to
dismiss may be filed under applicable law, move to dismiss an
action against it on the grounds that the defendant is a
biomaterials supplier" if the defendant: (1) is not
"liable as a manufacturer;" (2) is not "liable
as a seller;" and/or (3) is not "liable for
furnishing raw materials or component parts for the implant
that failed to meet applicable contractual requirements or
specifications." Id. § 1605(a)(1)-(3).
the BAAA's motion to dismiss procedures, when ruling on a
motion to dismiss, the court must rely solely on the
pleadings and any affidavits submitted under §§
1605(c)(2)(A) and (B). See 21 U.S.C. §
1605(c)(3). Thus, the Act allows courts to dismiss
biomaterials suppliers from lawsuits prior to discovery.
Id. at § 1605(c)(2)(A)-(B). Further, under
§ 1605(e), dismissal must be with prejudice.
1998, Congress enacted the BAAA with the aim of assuring
"the continued supply of materials for lifesaving
medical devices" through provisions insulating the
suppliers of raw materials or component parts of medical
devices from litigation. 21 U.S.C. § 1601 et
seq. The BAAA protects parties who supply either raw
materials or component parts for medical implants
("biomaterials suppliers") from the expenses of
implant failure litigation by providing "expeditious
procedures to dispose of unwarranted suits against the
suppliers." 21 U.S.C. § 1601(15)(B). As noted
above, one such procedure is a motion to dismiss, which a
biomaterials supplier may file under 21 U.S.C. §
prevail on a BAAA motion to dismiss, the Secant Defendants
must demonstrate that they: (1) are "biomaterials
supplier[s];" (2) are not manufacturers of the failed
implant; (3) are not sellers of the failed implant; and (4)
did not provide raw materials or component parts that failed
to meet applicable contractual requirements or
specifications. Id. at § 1605(a)(1)-(3). Under
these motion to dismiss procedures, the Secant Defendants may
meet this burden through the submission of affidavits.
Id. at § 1605(c)(2). This Court must grant the
motion with prejudice, unless: (1) Plaintiff submits a valid
affidavit demonstrating that the Secant Defendants are not
biomaterials suppliers; (2) the Court determines, based
solely on the pleadings and the parties' affidavits, that
one of the three limited exceptions to the BAAA's general
rue of immunity may apply; or (3) Plaintiff has not named the
manufacturer as a party. Id. at § 1605(c)(3).
Notably, Plaintiff has not submitted an affidavit but instead
argues only that her pleading raises a question as to whether
the Secant Defendants are biomaterials suppliers. The
requirements noted above will be discussed separately.
Secant Defendants Are Biomaterials Suppliers
BAAA defines a "biomaterials supplier" as "an
entity that directly or indirectly supplies a component part
or raw material for use in the manufacture of an
implant." 21 U.S.C. § 1602(1)(A). An
"implant" is "a medical device that is
intended by the manufacturer of the device to be placed into
a surgically or naturally formed or existing cavity of the
body for a period of at least 30 days." Id. at
§ 1602(5)(A)(i). A "component part" is "a
manufactured piece of an implant," including a piece
that: "(i) has significant non-implant applications; and
(ii) alone, has no implant value or purpose, but ...