Daley et al v. Portland Orthopaedics Limited et al

Filing 63

ORDER signed by Judge J.P. Stadtmueller on 6/21/2018: GRANTING 48 Defendant DiSanto Technology Inc.'s Motion to Dismiss; GRANTING 53 Plaintiffs' Motion to Seal Documents; DISMISSING with prejudice pursuant to 21 U.S.C. § 1605(e) Plaintiffs' claims against Defendant DiSanto Technology Inc.; and DISMISSING Defendant DiSanto Technology Inc. from this action. See Order. (cc: all counsel) (jm)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN
GUY D. DALEY, STARLYNN DALEY,
DANA HEAL, SHARON HEAL, and
ROBERT NIELSEN,
Plaintiffs,
and
MEDICARE, WISCONSIN PIPE TRADES
HEALTH FUND, UNITED HEALTH
CARE CONTINENTAL, and WEA
TRUST,

Case No. 17-CV-1315-JPS

Involuntary Plaintiffs,
v.
SMITH & NEPHEW INC., MAXX
HEALTH INC., MAXX ORTHOPEDICS
INC., MIPRO US INC., PLUS
ORTHOPAEDICS LLC, DISANTO
TECHNOLOGY INC., and JOHN DOE
CORPORATIONS 1-50,

ORDER

Defendants.
Plaintiffs 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 granted.
1.

LEGAL STANDARD
Federal 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.
For 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
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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).
When 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.”).1 Thus, the Act allows trial courts to dismiss
biomaterials suppliers from lawsuits prior to discovery. 21 U.S.C. §

Plaintiffs responded to DiSanto’s motion as though it was a motion for
summary judgment, providing separately numbered paragraphs containing
factual assertions and citations to evidence. See (Docket #55, #60). This was
helpful to the Court in assessing the parties’ respective positions, but it does not
transform the motion into one for summary judgment since the BAAA
authorizes the Court to consider competing affidavits on a motion to dismiss.
1

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1605(c)(2)(A)–(B). Further, under Section 1605(e), dismissal of a supplier
must be made with prejudice. Id. § 1605(e).2
2.

ANALYSIS
As will 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.
2.1

The BAAA Governs Claims Involving Section 510(k)
Devices

Plaintiffs 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 premarket 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.
Plaintiffs’ 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

A supplier dismissed with prejudice under Section 1605(e) may
nevertheless be rejoined later in the litigation if the evidence reveals a basis for
contribution or indemnification. 21 U.S.C. § 1606(a).
2

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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).
Devices 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.
While 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
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U.S.C. § 321(h). Under these broad definitions, the M-COR is undoubtedly
an “implant,” and Plaintiffs do not argue otherwise.
Though 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 Plaintiffs’ view,
the protections afforded by the BAAA should only extend to devices that
undergo the PMA process, because Congress’ purpose was to shield
component suppliers for implants that have been thoroughly reviewed for
safety and effectiveness. Id.
Whether or not this is a reasonable view as a matter of policy, the
Supreme Court directs that a clear statutory text must be enforced as-is.
Engine Mfrs. Ass’n v. S. Coast Air Quality Mgmt. Dist., 541 U.S. 246, 252
(2004). Unless Congress expresses a clear intention to the contrary, a
statute’s plain language is conclusive. Lamie v. U.S. Tr., 540 U.S. 526, 534
(2004) (“It is well established that ‘when the statute’s language is plain, the
sole function of the courts—at least where the disposition required by the
text is not absurd—is to enforce it according to its terms.’”) (quoting
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Hartford Underwriters Ins. Co. v. Union Planters Bank, N.A., 530 U.S. 1, 6
(2000)). In other words, if a statute’s text gives a clear answer to the
question presented, that is the beginning and the end of the court’s
inquiry. Star Athletica, L.L.C. v. Varsity Brands, Inc., 137 S. Ct. 1002, 1010
(2017).
The answer afforded by the BAAA is unmistakable: no claim can
proceed against a supplier of a component part for an “implant,” a term
which the statute defines very broadly without reference to the type of
FDA review the implant receives. For that reason, Plaintiffs’ reliance on
Lohr and Riegel is misplaced. Lohr, 518 U.S. at 483–84; Riegel v. Medtronic,
552 U.S. 312, 323–26 (2008). In those cases, the parties disputed whether
certain types of state law claims were preempted by the MDA, which
preempts state law “requirements” that are “different from, or in addition
to” federal requirements for medical devices. See 21 U.S.C. § 360k(a). In
Lohr, the Court held that the Section 510(k) process does not impose
sufficiently device-specific requirements to trigger Section 360k(a)
preemption. Lohr, 518 U.S. at 496–501. In Riegel, the Court held that the
PMA process does impose such requirements. Riegel, 552 U.S. at 323–326.
In this case, unlike Lohr and Riegel, the difference between the PMA and
Section 510(k) regulatory pathways is of no moment, for the BAAA’s term
“implant” is not ambiguous as was the MDA’s term “requirements.”
Additionally, in Lohr and Riegel the Court engaged in several
interpretive maneuvers not available here, including applying a
presumption against preemption and consulting Congress’ intentions as
reflected in the legislative history. See Lohr, 518 U.S. at 485–86. Those
canons of construction are not applicable in this case, for here Congress
has provided an express preemption clause, the scope of which is
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determined by the plain meaning of its text. Puerto Rico v. Franklin
California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016). Congress’ intent as
expressed in the BAAA’s text is in no way “garbled,” as Plaintiffs assert.
(Docket #54 at 4). The statute plainly provides that a Section 510(k) device
like the M-COR is an “implant” and is therefore governed by the BAAA,
and no other portion of the statute or its general structure clearly
expresses a different intention. City of Chicago v. Sessions, 888 F.3d 272, 284
(7th Cir. 2018) (“It is well-established that the plain language of a statute is
‘the best indicator of Congress’s intent,’ and that ‘[a]bsent a clearly
expressed legislative intention to the contrary, that language must
ordinarily be regarded as conclusive.’”) (quoting Fed. Nat’l Mortg. Ass’n. v.
City of Chicago, 874 F.3d 959, 962 (7th Cir. 2017)).
Ultimately, Plaintiffs’ argument rests on the supposition that
Congress sought but failed to distinguish between PMA and Section
510(k) devices in the BAAA. Standing alone, this is a specious claim, for it
is unlikely that any regulator could miss the prevalence of Section 510(k)
devices in the marketplace. See Lohr, 518 U.S. at 479 (“[T]he § 510(k)
premarket notification process [has become] the means by which most
new medical devices—including Class III devices—[are] approved for the
market.”). For that reason, we would expect Congress to plainly express
any sought-after distinction between PMA and Section 510(k) devices. It
has not done so. Moreover, it would not make sense for Congress to
punish component suppliers differently based on the type of regulatory
approval obtained by the manufacturer of the final implant, a process in
which the supplier ostensibly plays no part. Most importantly, however,
Plaintiffs’ argument is belied by the statutory text, which dooms their
position from the start. If Plaintiffs believe that a distinction between PMA
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and Section 510(k) devices is appropriate for the BAAA, their remedy lies
with Congress—not this Court.
2.2

DiSanto is a Biomaterials Supplier Protected by the BAAA

Having determined that the BAAA governs Plaintiffs’ claims
against DiSanto, the Court turns to the statutory inquiry as to whether
those claims should be dismissed.3 As noted above, to prevail on a motion
to dismiss under the BAAA, the defendant must demonstrate that: (1) it is
a “biomaterials supplier”; (2) it is not a manufacturer of the failed implant;
(3) it is not a seller of the failed implant; and (4) it did not provide raw
materials or component parts that failed to meet applicable contractual
requirements or specifications. 21 U.S.C. § 1605(a)(1)–(3).
First, DiSanto qualifies as a biomaterials supplier, which is “an
entity that directly or indirectly supplies a component part or raw
material for use in the manufacture of an implant.” Id. § 1602(1)(A). 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 when combined with other component
parts and materials, constitutes an implant.” Id. § 1602(3). A “raw
material” is “a substance or product that[:] (A) has a generic use; and (B)
may be used in an application other than an implant.” Id. § 1602(8).
The affidavits submitted by DiSanto establish that it is a contract
manufacturer whose sole role with respect to the hip implants in this case

In its motion, DiSanto concedes that it manufactured the femoral necks
used in the implants for Plaintiffs Guy Daley and Sharon Heal. (Docket #49 at 2).
However, it asserts that it did not manufacture the femoral neck for Plaintiff
Robert Nielsen’s implant. Id. at 3. Plaintiffs agree, contending that Nielsen asserts
no claims against DiSanto. (Docket #55 ¶ 10). The Court considers any potential
claims by Nielsen against DiSanto to be withdrawn.
3

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was to machine a piece of metal pursuant to contractual specifications that
eventually became a component of an implant. DiSanto used a piece of
titanium, as specified by MiPro, as the base material to machine the
femoral neck of the M-COR. Titanium has many uses other than medical
device manufacturing. DiSanto thus transformed raw material into a
component part of the M-COR. The femoral necks machined by DiSanto
were not completed medical devices and could not be implanted into a
human being without additional components and numerous other
manufacturing steps and quality checks, which for the M-COR were
performed by others, not DiSanto. DiSanto therefore claims that it
qualifies as a biomaterials supplier as defined in the BAAA.
Plaintiffs disagree. They contend that DiSanto incorporated many
of its own design inputs into the femoral necks it produced. Plaintiffs
theorize that the BAAA does not insulate component “designers” as
opposed to component “manufacturers” who simply follow design
specifications, particularly when, as here, Plaintiffs allege that those “poor
design decisions” contributed to the failure of the M-COR as a whole.
(Docket #54 at 9–10). Specifically, Plaintiffs’ expert opines that DiSanto’s
design was flawed in three ways: (1) it used rolled plate instead of bar
stock; (2) it used a wire EDM machine instead of forging or casting; and
(3) it oriented the plate material incorrectly relative to the grain. See
(Docket #57 at 4–7). According to Plaintiffs, these defects caused the
femoral necks to break, requiring total hip revisions to replace the failed
implants. (Docket #55 at 12–13).
Plaintiffs’ proposed distinction is of their own invention and is
unsupported by any legal authority. What’s more, it is inconsistent with
the BAAA’s statutory scheme, which carefully catalogs the players in
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implant production, including device manufacturers, device sellers, and
component or raw materials suppliers. Even if DiSanto participated in the
design of its femoral necks, a component designer is not a category
recognized in the BAAA. Yet, tellingly, the Act does provide that
manufacturers of the final implant are not immune from suit. In enacting
this scheme, Congress apparently sought to insulate component suppliers
and place all the risk on device manufacturers for the failure of the
implant, whether caused by a flaw in the entire implant or one of its
component parts. In this case, if MiPro is held liable for the harm Plaintiffs
suffered and it believes DiSanto is responsible for indemnity or
contribution, it can seek such relief. Plaintiffs desire a direct route to
DiSanto’s pocketbook, but Congress has forbidden this.
Additionally, Plaintiffs’ designer-manufacturer division is not
realistic. Of course an implant manufacturer like MiPro would expect a
component supplier like DiSanto to apply some of its own metallurgical
or machining expertise to its assigned task. Why else hire a specialized
supplier? Given its lack of skill in this particular realm, MiPro could not
be expected to dictate each and every action DiSanto was to take in
creating the femoral necks. Again, the BAAA forces MiPro to shoulder the
risk that DiSanto might make a mistake in producing a component of the
M-COR. As a result, the Court finds that DiSanto is a biomaterials
supplier under the BAAA despite the design inputs it may have provided
in machining the femoral necks.
The final inquiry the Court must undertake is whether DiSanto falls
outside the BAAA’s protection because it was a manufacturer or a seller of
the failed implant, or because its femoral necks failed to meet applicable
contractual requirements or specifications. 21 U.S.C. § 1605(a)(1)–(3).
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Plaintiffs concede that DiSanto was not a manufacturer or seller of the MCOR. (Docket #55 at 9–10). They argue instead that the components
DiSanto supplied did not meet MiPro’s specifications. Id. at 10–11. Under
the BAAA, a biomaterials supplier may “be liable for harm to a claimant
caused by an implant if the claimant in an action shows, by a
preponderance of the evidence,” that the supplier “fail[ed] to meet
applicable contractual requirements or specifications.” 21 U.S.C. § 1604(d).
Additionally, the failure to meet the contractual specifications must be “an
actual and proximate cause of the harm to the claimant.” Id. § 1604(d)(2).
In this connection, Plaintiffs cite an international quality standard,
ISO 13485:2003, Medical Devices—Quality Management Systems—
Requirements for Regulatory Purposes. This standard was incorporated
by reference into MiPro’s specification. According to Plaintiffs, it required
DiSanto to, among other things, obtain “design and development
validation” to ensure that the femoral necks were “capable of meeting the
requirements for the specified application or intended use.” (Docket #56-3
at 19). Plaintiffs argument goes as follows:
Obviously, the necks were not capable of meeting the
requirements of their intended use in the case of Daley and
Heal. DiSanto chose, without apparent input or approval
from MiPro, the type of raw material stock and the
manufacturing process without apparently validating those
decision [sic]. Those acts constituted a breach of the
Specification MiPro provided to DiSanto and are proximate
causes of the injuries sustained by Daley and Heal in this
case.
(Docket #54 at 11).
There are two strands of argument within this passage, but neither
has merit. First, to the extent Plaintiffs contend that DiSanto was not

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authorized to make unilateral design decisions, and therefore any design
input by DiSanto constituted a violation of MiPro’s specification, the
evidence flatly contradicts this position. The specification DiSanto
received from MiPro was not exacting in its detail. It left room for DiSanto
to incorporate design decisions that would achieve the goals MiPro set.
See (Docket #58 at 10). Plaintiffs’ own expert concedes this; indeed, his
theory is not that DiSanto deviated from MiPro’s specification, but that
DiSanto made negligent decisions about the design elements left to its
discretion. See (Docket #57 at 4–7). As explained above, the BAAA does
not remove component suppliers from its protection even when they
make design decisions that allegedly contributed to harm the patient.
And, certainly, ISO 13485 says nothing about whether DiSanto should
have made its own design decisions, only that design validation needed to
be performed “in accordance with planned arrangements,” whatever that
means. (Docket #56-3 at 19). Thus, the mere act of incorporating its own
design input was not a deviation from specifications as contemplated in
the BAAA.
Second, to the extent Plaintiffs believe that the femoral necks were
not capable of meeting the requirements for their intended use, in
violation of ISO 13485, simply because the implants failed, this too is
incorrect. As an initial matter, the specific subsection of ISO 13485
Plaintiffs cite, Section 7.3.6, applies to designers of medical devices, not
component manufacturers like DiSanto. See id. at 8 (providing that ISO
13485 governs the conduct of organizations that provide “medical
devices”). Similar to the BAAA, the “design” at issue in ISO 13485 is that
of the final implant, not its component parts.

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Furthermore, the cited standard is, at best, an open-ended
statement which could conceivably be violated by any defect whatsoever
in the final product. Given that the purpose of the BAAA is to broadly
shield component suppliers from liability in implant cases, see 21 U.S.C.
§ 1601, it follows that deviation from design specifications should be more
specific than what Plaintiffs have alleged, which amounts to no more than
a claim of negligence. Stated another way, it would be absurd for the
“design deviation” exception to the BAAA to incorporate the functional
equivalent of negligence liability, otherwise all state-law negligence claims
could survive the BAAA’s preemption clause. Plaintiffs cite no court
espousing their view of the “design deviation” exception, and this Court
will not be the first.
For these reasons, the Court concludes that DiSanto is a
biomaterials supplier whose conduct does not fall within any of the
exceptions to the protection of the BAAA. This, in turn, requires that the
Court dismiss the claims against it with prejudice.4
3.

CONCLUSION
For the reasons stated above, the Court is obliged to granted

DiSanto’s motion to dismiss the claims against it pursuant to the BAAA.5
In passing, Plaintiffs cite Janusz v. Symmetry Medical Inc., 256 F. Supp. 3d
995 (E.D. Wis. 2017), a recent case involving similar allegations of a faulty
femoral neck in an M-COR. One of the defendants who manufactured the
femoral neck sought summary judgment, but not pursuant to the BAAA.
Whatever the reason behind the defendant’s choice not to invoke the BAAA, the
result is that the Janusz decision has little bearing on the Court’s resolution of this
case.
4

At the end of their brief, Plaintiffs make a request for additional
discovery pursuant to Section 1605(c)(1)(B)(i), which allows a court to permit
discovery on issues directly relevant to whether the biomaterials supplier met
applicable contractual requirements or specifications. 21 U.S.C. § 1605(c)(1)(B)(i).
5

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Accordingly,
IT IS ORDERED that Defendant DiSanto Technology Inc.’s motion
to dismiss (Docket #48) be and the same is hereby GRANTED;
IT IS FURTHER ORDERED that Plaintiffs’ motion to seal certain
exhibits filed in connection with their response to DiSanto’s motion
(Docket #53) be and the same is hereby GRANTED;
IT IS FURTHER ORDERED that Plaintiffs’ claims against
Defendant DiSanto Technology Inc. be and the same are hereby
DISMISSED with prejudice pursuant to 21 U.S.C. § 1605(e); and
IT IS FURTHER ORDERED that Defendant DiSanto Technology
Inc. be and the same is hereby DISMISSED from this action.
Dated at Milwaukee, Wisconsin, this 21st day of June, 2018.
BY THE COURT:

__________________
J. P. Stadtmueller
U.S. District Judge

This request must be denied, as Plaintiffs have not identified any alleged
deviation from any specification or other contractual requirement that could be
established with the benefit of further discovery. (Docket #54 at 11). The mere
mention of a need for discovery, without some minimal explanation of what
benefit it might provide, is insufficient to delay the expeditious dismissal of
biomaterials suppliers that the BAAA is designed to facilitate. 21 U.S.C. §
1601(15)(B).

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