United States District Court, E.D. Wisconsin
GUY D. DALEY, STARLYNN DALEY, DANA HEAL, SHARON HEAL, and ROBERT NIELSEN, Plaintiffs,
SMITH & NEPHEW INC., MAXX HEALTH INC., MAXX ORTHOPEDICS INC., MIPRO U.S. INC., PLUS ORTHOPAEDICS LLC, DISANTO TECHNOLOGY INC., and JOHN DOE CORPORATIONS 1-50, Defendants. and MEDICARE, WISCONSIN PIPE TRADES HEALTH FUND, UNITED HEALTH CARE CONTINENTAL, and WEA TRUST, Involuntary Plaintiffs,
Stadtmueller U.S. District Judge
bring this action under the Court's diversity
jurisdiction to recover for injuries sustained as a result of
failed hip replacement implants. All of their claims are
premised on Wisconsin statute or common law. (Docket #36).
Presently before the Court is a motion to dismiss by
Defendant DiSanto Technology Inc. (“DiSanto”).
(Docket #48). DiSanto machined the femoral neck component of
Plaintiffs' hip implants pursuant to a contract with
Defendant MiPro U.S. Inc. (“MiPro”). Those hip
replacement implants are known as the M-COR Modular Hip
System (the “M-COR”). DiSanto argues that, as a
mere supplier of a component part used in the M-COR, the
claims against it are preempted and barred by the
Biomaterials Access Assurance Act (“BAAA”), 21
U.S.C. § 1601 et seq., which insulates
biomaterials suppliers from liability in medical device
failure litigation, subject to a few narrow exceptions.
DiSanto's motion to dismiss pursuant to the BAAA is fully
briefed and, for the reasons stated below, it will be
Rule of Civil Procedure 12(b) normally governs motions to
dismiss a complaint. Rule 12(b)(6) allows a party to move to
dismiss a complaint on the ground that it fails to state a
viable claim for relief. Fed.R.Civ.P. 12(b)(6). To state a
claim, a complaint must provide “a short and plain
statement of the claim showing that the pleader is entitled
to relief.” Fed.R.Civ.P. 8(a)(2). In other words, the
complaint must give “fair notice of what the. . .claim
is and the grounds upon which it rests.” Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555 (2007). The
allegations must “plausibly suggest that the plaintiff
has a right to relief, raising that possibility above a
speculative level[.]” Kubiak v. City of
Chicago, 810 F.3d 476, 480 (7th Cir. 2016) (citation
omitted). In reviewing the complaint, the Court is required
to “accept as true all of the well-pleaded facts in the
complaint and draw all reasonable inferences in favor of the
plaintiff.” Id. at 480-81.
motions to dismiss brought pursuant to the BAAA, Congress has
provided special protocols. See 21 U.S.C. §
1603(a)(2); Mattern v. Biomet, Inc., Civ. No.
12-4931 (ES), 2013 WL 1314695, at *1 (D.N.J. Mar. 28, 2013).
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.” 21 U.S.C. §
1603(b)(1). It 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,
” and if the defendant: (1) is not a manufacturer of
the failed implant; (2) is not a seller of the failed
implant; and (3) did not “furnis[h] raw materials or
component parts for the implant that failed to meet
applicable contractual requirements or specifications.”
Id. § 1605(a)(1)-(3); see also Whaley v.
Morgan Advanced Ceramics, Ltd., No. 07-cv-00912, 2008 WL
901523, at *2-3 (D. Colo. Mar. 31, 2008).
addressing a BAAA motion to dismiss, the Court must rule
solely on the basis of the pleadings and any affidavits
submitted under Sections 1605(c)(2)(A) and (B). 21 U.S.C.
§ 1605(c)(3). The submission of affidavits concerning
the supplier's liability does not automatically convert a
BAAA motion to dismiss into a motion for summary judgment, as
would typically occur in any other civil litigation.
See Fed. R. Civ. P. 12(d); Marshall v.
Zimmer, No. 99-093-E, 1999 WL 34996711, at *3 (S.D. Cal.
Nov. 4, 1999) (The Act “is quite clear that the
suppliers can provide affidavits to demonstrate that they are
not subject to litigation for their minimal contribution to a
medical device ultimately designed, made, and sold by the
manufacturer.”). Thus, the Act allows trial courts to
dismiss biomaterials suppliers from lawsuits prior to
discovery. 21 U.S.C. § 1605(c)(2)(A)-(B). Further, under
Section 1605(e), dismissal of a supplier must be made with
prejudice. Id. § 1605(e).
be explained below, the Court finds that DiSanto is protected
as a biomaterials supplier under the BAAA. Consequently, the
claims against it must be dismissed. First, however, the
Court must address Plaintiffs' contention that the BAAA
does not govern their claims at all.
The BAAA Governs Claims Involving Section 510(k)
first argue that the BAAA does not preempt their claims
against DiSanto because the Act does not protect the types of
devices at issue here. Plaintiffs distinguish between devices
that have received pre-market approval (“PMA”)
from the Food and Drug Administration and devices that have
been authorized for sale under the “Section
510(k)” procedure. The M-COR falls within the latter
category. Plaintiffs believe that the BAAA's protection
extends only to claims involving PMA devices because only the
rigorous PMA process results in meaningful assurances of
device safety. No. such distinction can be found in the
statutory text, and Plaintiffs cannot engraft ambiguity into
the statute where none exists.
premise is correct: the PMA process is far more meticulous as
a safety assessment than the Section 510(k) process.
Medtronic v. Lohr, 518 U.S. 470, 477 (1996). During
the PMA process, “[m]anufacturers must submit detailed
information regarding the safety and efficacy of their
devices, which the FDA then reviews, spending an average of
1, 200 hours on each submission.” Id. Yet, not
all devices subject to the PMA process actually undergo it.
See Id. In many instances, devices can be released
to the public without undergoing PMA review if they are
“substantially equivalent” to approved devices
that predate the creation of the PMA process in the Medical
Device Amendments Act of 1976 (the “MDA”).
See 21 U.S.C. § 360e(b)(1)(B).
that fall under this exception to the PMA rule can get to
market if they comply with the less onerous appraisal set
forth in 21 U.S.C. § 360(k). Lohr, 518 U.S. at
478. This is known as the “Section 510(k)”
process, after the number of the section in the original act.
Id. For a Section 510(k) examination, the
manufacturer must submit a premarket notification showing
that its device is substantially equivalent to a preexisting
device. Id. If this is shown, no further regulatory
analysis is done, at least until the PMA process is initiated
for the pre-existing device to which the new device is
substantially equivalent. Id. Section 510(k) review
is minimal, requiring an average of only 20 hours' work.
Id. at 479.
Plaintiffs' premise is correct, their conclusion
concerning the reach of the BAAA is not. The Act draws no
distinction between PMA and Section 510(k) devices. By its
text, the BAAA 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). An “implant” includes “a
medical device” intended by its manufacturer to be
surgically placed in the human body for at least thirty days.
Id. § 1602(5)(A)(i). “Medical
device” is, in turn, defined by reference to 21 U.S.C.
§ 321(h) and includes implants that are intended to
affect the structure or function of the human body.
See 21 U.S.C. § 321(h). Under these broad
definitions, the M-COR is undoubtedly an “implant,
” and Plaintiffs do not argue otherwise.
the statute does not distinguish between the types of review
imposed on implants, Plaintiffs nevertheless maintain that
Congress could not have intended to preempt claims involving
Section 510(k) devices because those devices do not have the
same federal safety oversight that PMA devices do. Plaintiffs
cite Congress' introductory findings in the BAAA, which
include that “under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. § 301 et seq.)
manufacturers of medical devices are required to demonstrate
that the medical devices are safe and effective, including
demonstrating that the products are properly designed and
have adequate warnings or instructions.” Id.
§ 1601(6). According to Plaintiffs, Congress was
referring only to the PMA process here, as the Section 510(k)
process does not require a determination that a device is
safe and effective. (Docket #54 at 8-9). Thus, in