S C UPREME

No. 2016-0123
IN THE
SUPREME COURT OF CINCINNATIA
MARCH TERM 2016
BRANDON B. TAFT,
PETITIONER
V.
LUCKY HOSPITAL SUPPLY, INC.,
RESPONDENT
On Writ of Certiorari to the
First Appellate Circuit Court of
Cincinnatia
BRIEF ON PETITIONER
TEAM NO. 7,
Attorneys for Petitioner
ORAL ARGUMENT REQUESTED
QUESTIONS PRESENTED
I.
Does a state lack personal jurisdiction over a foreign defendant who knowingly sells
hundreds of dangerous products into the forum state when the foreign company’s only
customer in the United States is an independent distributor hired to serve the U.S. market
as a whole?
II.
Are state-law negligence claims preempted under the Food, Drug, and Cosmetics Act
against a manufacturer for a dangerous medical device which was not given pre-market
approval but which contains a component part which passed the pre-market approval
process as part of another device which is for another use?
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
ii
TABLE OF CONTENTS
QUESTIONS PRESENTED ....................................................................................... ii
TABLE OF CONTENTS .......................................................................................... iii
TABLE OF AUTHORITIES ..................................................................................... iv
OPINIONS BELOW ................................................................................................ 1
CONSTITUTIONAL AND STATUTORY PROVISIONS .................................................. 1
STATEMENT OF THE CASE .................................................................................... 1
Statement of the Facts ..........................................................................................................1
Procedural History ...............................................................................................................4
SUMMARY OF THE ARGUMENT ............................................................................. 6
ARGUMENT ......................................................................................................... 9
I. LUCKY HOSPITAL IS SUBJECT TO THE J URISDICTION OF C INCINNATIA ............................... 9
a. Lucky Hospital has Sufficient Contacts with Cincinnatia Because
Substantial Amounts of Its Products Have Been Purposefully Directed
Towards the State ...................................................................................................10
i. A Brief History of the Stream of Commerce Doctrine ...............................11
ii. Lucky Hospital is Subject to Jurisdiction Because It Was
Aware Its Products Were Heading Towards Cincinnatia
and Its Contacts Were Not an Isolated Occurrence ..................................15
iii. Lucky Hospital Not Only Puts Goods into the Stream
of Commerce But Purposefully Directs Them Towards
Cincinnatia.................................................................................................18
iv. This Court Should Not Apply the Test Manifested by
the Kennedy Plurality ................................................................................22
b. The Exercise of Jurisdiction Over Lucky Hospital is Reasonable .........................23
II. TAFT’S C LAIMS ARE NOT PREEMPTED BY THE PRE-MARKET APPROVAL
PROCESS, BECAUSE THE DEVICE USED ON HIM WAS NEVER APPROVED ............................ 24
a. The Product Should be Characterized as the Hipflex System Only ......................26
b. Even if the Component Part Carries with it PMA Approval,
Taft’s Negligence Claims Do Not Conflict with Any
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
iii
Federal Requirements Because the Lucky Liner is Being
Used for a Non-PMA Use ......................................................................................30
CONCLUSION ..................................................................................................... 35
APPENDIX A ..................................................................................................... A1
APPENDIX B ..................................................................................................... A2
APPENDIX C ..................................................................................................... A9
APPENDIX D ................................................................................................... A10
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
iv
TABLE OF AUTHORITIES
UNITED STATES SUPREME COURT CASES:
Asahi Metal Indus. Co. v. Superior Court of California, Solano Cnty.,
480 U.S. 102 (1987) ................................................................................................... passim
Ashcroft v. Iqbal,
556 U.S. 662 (2009) ...........................................................................................................34
Burger King Corp. v. Rudzewicz,
471 U.S. 462 (1985) ...........................................................................................................10
Goodyear Dunlop Tires Operations, S.A. v. Brown,
131 S. Ct. 2846 (2011) .........................................................................................................9
International Shoe Co. v. Washington,
326 U.S. 310 (1945) .............................................................................................................9
J. McIntyre Mach., Ltd. v. Nicastro,
131 S. Ct. 2780 (2011) ............................................................................................... passim
Marks v. United States,
430 U.S. 188 (1977) ...........................................................................................................15
Medtronic, Inc. v. Lohr,
518 U.S. 470 (1996) ...................................................................................21, 25, 29, 31, 35
Riegel v. Medtronic, Inc.,
552 U.S. 312 (2008) .....................................................................................................25, 29
Walden v. Fiore,
134 S. Ct. 1115 (2014) .........................................................................................................9
World-Wide Volkswagen Corp. v. Woodson,
444 U.S. 286 (1980) ...............................................................................7, 10–12, 14–18, 22
UNITED STATES COURT OF APPEALS CASES:
AFTG-TG, LLC v. Nuvoton Tech. Corp.,
689 F.3d 1358 (Fed. Cir. 2012)...................................................................................................... 14
Ainsworth v. Moffett Eng'g, Ltd.,
716 F.3d 174 (5th Cir. 2013) ............................................................................................. 14, 16, 17
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
v
Barone v. Rich Brothers Interstate Display Fireworks Co.,
25 F.3d 610 (8th Cir. 1994) ...............................................................................................18
Causey v. Sewell Cadillac-Chevrolet, Inc.,
394 F.3d 285 (5th Cir. 2004) ...............................................................................................9
Irving v. Owens-Corning Fiberglas Corp.,
864 F.2d 383 (5th Cir. 1989) .............................................................................................15
LeMay v. U.S. Postal Serv.,
450 F.3d 797 (8th Cir. 2006) ...............................................................................................9
Renner v. Lanard Toys Ltd.,
33 F.3d 277 (3d Cir. 1994).................................................................................................18
Tobin v. Astra Pharm. Products, Inc.,
993 F.2d 528 (6th Cir. 1993) .............................................................................................24
Williams v. Romarm, SA,
756 F.3d 777 (D.C. Cir. 2014) ....................................................................................................... 14
UNITED STATES DISTRICT COURT CASES:
Allianz Glob. Corp. & Specialty Marine Ins. Co. v. Watts Regulator Co.,
92 F. Supp. 3d 910 (S.D. Iowa 2015) ................................................................................10
Bertini v. Smith & Nephew, Inc.,
8 F. Supp. 3d 246 (E.D.N.Y. 2014) ...................................................................3, 27, 29, 32
Blankenship v. Medtronic, Inc.,
6 F. Supp. 3d 979 (E.D. Mo. 2014)....................................................................................33
Johnson v. Chrysler Canada Inc.,
24 F. Supp. 3d 1118 (N.D. Ala. 2014) ...............................................................................14
Hornbeck v. Medtronic, Inc.,
2014 WL 2510817 (N.D. Ill. June 2, 2014) .................................................................32, 33
Lewis v. Johnson & Johnson,
991 F. Supp. 2d 748 (S.D.W. Va. 2014) ......................................................................28, 29
Monje v. Spin Master Inc.,
2013 WL 2369888 (D. Ariz. May 29, 2013) ...............................................................19–22
Ramirez v. Medtronic Inc.,
961 F. Supp. 2d 977 (D. Ariz. 2013) .................................................................................30
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
vi
Riley v. Cordis Corp.,
625 F. Supp. 2d 769 (D. Minn. 2009) ................................................................................31
Rockwell Int’l Corp. v. Costruzioni Aeronautiche Giovanni Agusta,
553 F. Supp. 328 (E.D. Pa. 1982) .................................................................................................. 19
Simon v. Smith & Nephew, Inc.,
18 F. Supp. 3d 423 (S.D.N.Y. 2014)..................................................................................30
Smith v. Teledyne Cont’l Motors, Inc.,
840 F. Supp. 2d 927 (D.S.C. 2012) ..............................................................................14, 18
Zippo Manufacturing Co. v. Zippo Dot Com, Inc.,
952 F.Supp. 1119 (W.D.Pa.1997) .................................................................................................. 21
FEDERAL STATUTES:
21 U.S.C. § 360e ............................................................................................................................33
21 U.S.C. § 360c ............................................................................................................................26
21 U.S.C. § 360k ................................................................................................................25, 29, 31
Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976)
21 U.S.C. §§ 360–360n .................................................................................................................. 25
SECONDARY SOURCES:
Bertrand, Olivier, M.D., Biocompatibility aspects of new stent technology,
Journal of the American College of Cardiology, 562–71 (Sept. 1998) .............................28
Jeffrey, Jessica, The Stream of Commerce Flows on,
46 Suffolk U.L. Rev. 137, 146 (2013) ...............................................................................13
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
vii
OPINIONS BELOW
The opinion and order of the Court of Common Pleas, Cliffton County is unreported, but
can be found using its case number 2013-CV-9100, or in the record at R. 2–18. The opinion of
the First Appellate Circuit Court is also unreported, and can be found under the case number: 149600, or in the record at R. 19–32.
CONSTITUTIONAL AND STATUTORY PROVISIONS
The following statutory and constitutional provisions were used in this brief and are set
out in the Appendices as follows:
1. APPENDIX A: FEDERAL FOOD, DRUGS, AND COSMETICS ACT, 21 U.S.C. § 360k
2. APPENDIX B: FEDERAL FOOD, DRUGS, AND COSMETICS ACT, 21 U.S.C. § 360e
3. APPENDIX C: UNITED S TATES CONSTITUTIONAL PROVISIONS
STATEMENT OF THE CASE
I.
Statement of the Facts
Appellant Brandon Taft (“Taft”) is a resident of Clifton County, Cincinnatia where he has
worked at his self-owned storefront as a carpenter for more than 25 years. R. at 21. In March of
2012, Taft’s life of hard-labor began to take its toll on him as he began feeling debilitating pain
in his hip. R. at 22. As a result, Taft met with Dr. Kelly Puma who diagnosed him with
osteoarthritis in his left hip and recommended total hip replacement surgery. R. at 22.
The Surgery. Total hip replacement is a surgical procedure which entails going into the
hip to replace worn out cartilage and bone to make the “ball and socket” joint move smoothly
and to prevent pain. R. at 16. In Taft’s case, Dr. Puma stated his surgery would involve “surgical
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
1
removal of the head of the femur [the ball] and acetabulum [the socket] and replacement of these
components with metallic versions.” R. at 16.
The following image from the National Library of Medicine1 shows how the two pieces
interact in a typical hip surgery:
While performing the surgery, Dr. Puma had significant difficulties attempting to
stabilize the ball and socket components and used an optional metal liner to affix the two
components and to help remedy the problem. R. at 16. This liner is attached between the ball and
socket components of the hip replacement system and is used to prevent looseness or separation.2
R. at 16. The hip replacement system used on Taft is the “Hipflex” system and is marketed as
being compatible with the optional metal liner also used by Dr. Puma—the “Lucky Liner.” R. at
16. Both of these components were manufactured by the Respondent, Lucky Hospital Supply,
Inc. (“Lucky Hospital”), a Hong Kong corporation. R. at 16.
The surgery was initially a success, but after a few months Taft returned because of pain
and an audible clicking noise from his hip. R. at 17. Dr. Puma decided it was best to perform
1
Hip Replacement, U.S. National Library of Medicine (last accessed on February 5, 2016) (The following is not
meant to be a re-enactment of the hip replacement in this case, but is merely used as a demonstrative of hip
replacement surgery generally.) , available at: https://www.nlm.nih.gov/medlineplus/hipreplacement.html.
2
See Appendix D for a visual of how the liner works with the other components to make up the entire device.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
2
revision surgery to find the source of the problem. R. at 17. During the revision surgery, Dr.
Puma saw that the ball and socket joint were “very loose” and that “the Lucky Liner was
grinding against the locking mechanism of the Hipflex system.” R. at 17. The result of this was
metal chips embedded into Taft’s tissue, and muscles which were lacerated and inflamed. R. at
17. Dr. Puma immediately removed both the Hiplex system and the Lucky Liner and Taft has
been in a wheelchair ever since.
The Products. Both the Hipflex system and the Lucky Liner are classified by the FDA as
Class III devices—those having an unreasonable risk of injury during use. R. at 8. Because the
devices fell into this category, they needed to be approved by the FDA by either going through
the rigorous Pre-Market Approval (“PMA”) process or through the 510(k) process. R. at 8.
Congress has decided that if a product can pass the PMA process then it will be exempt from
most state torts, but if a manufacturer decides to take the easy route—510(k)—than causes of
action against the products will not be. R. at 8. The Lucky Liner has only received PMA for its
use as a component part in a hip resurfacing system, but not for use in any hip replacement
system, such as the Hipflex.3 R. at 24. The hip resurfacing system first received PMA without the
Lucky Liner, but Lucky Hospital wanted to sell the liner as an additional piece to the hip
resurfacing system so it was required to file a supplemental PMA. R. at 23–24. The Lucky Liner
was then PMA approved for its use as a component part in the overall hip resurfacing system.
The Hipflex system has not received PMA for any use at all. R. at 23.
The Contacts. Dr. Puma initially learned about the Lucky Liner and Hipflex systems
while visiting a trade show in Florida, and learned more about the product by going to Lucky
3
In contrast with total hip replacement surgery, during hip resurfacing, the femoral head is trimmed and capped
with a covering, rather than replaced. Bertini v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 250 (E.D.N.Y. 2014). A
visual of the difference between the two surgeries is provided in Appendix D.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
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Hospital’s website upon returning home. R. at 16. Lucky Hospital’s website invited Dr. Puma to
visit a distributor’s site to purchase the products through a pop-up which contained a clickable
link which would redirect to the distributor. R. at 7 & 16. Dr. Kelly did visit this distributor’s
website, purchased the product on the distributor’s website, and then had it shipped to her in
Cincinnatia. R. at 16.
Lucky Hospital “wanted to sell [its] devices in the United States” and “never attempted to
limit the scope of [where.]” R. at 11–12 (Aff. of Han, Lucky Hospital Dir. Operations). To this
end, it hired an independent distributor named Fancy Medical Distributors, Inc. (“Fancy
Distributors”) and signed an exclusive sales agreement making Fancy Distributors the sole
customer of Lucky Hospital in the United States. R. at 12. As part of this agreement, at the end
of each financial quarter Fancy Distributors sends an itemized list of sales with the location of
each sale. R. at 13. To date, Lucky Hospital has sold approximately 9,700 medical devices to
Fancy Distributors all of which have made their way to the United States including 223 hip
replacement systems which were sold to medical providers in Cincinnatia. R. at 12–13.
II.
Procedural History
The Complaint. Taft brought a negligence claim against Lucky Hospital in the Court of
Common Pleas, Clifton County, alleging that when the Hipflex system is used with the optional
Lucky Liner it is unsafe. R. at 3. The complaint was accompanied by an affidavit of Taft’s
doctor, Dr. Puma. R. at 15–18. Dr. Puma indicated that the Lucky Liner should have worked
within the Hipflex device but because of a defect—which he could not identify as solely being
the fault of one of the components—the Hipflex system when combined with the Lucky Liner
became dangerous and caused Taft’s personal injuries. R. at 17.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
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Lucky Hospital challenged the complaint by moving for a motion to dismiss under
Federal Rules of Procedure 12(b)(2) (personal jurisdiction) and 12(b)(6) (failure to state a claim).
Lucky Hospital argued that it did not have sufficient contacts with Cincinnatia so as to be subject
to its jurisdiction and that Taft’s state law cause of action was preempted because of the FDA’s
approval of the Lucky Liner.
The trial court. As to the 12(b)(2) motion, the trial court held that “minimum contacts
are met if the defendant delivers a substantial number of products into the stream of commerce
with the expectation that it would be purchased by or used by consumers in the forum state.” R.
at 4–5. The court found that Lucky Hospital intended for products to be sold to the entire United
States without limitation, knew that its products were being carried into Cincinnatia, and that the
products moved into the state in such large numbers so as not to be the result of merely fortuitous
or attenuated circumstances. R. at 6–7. Based on these facts, the court held Lucky Hospital
should have “reasonably anticipated being haled into court” in Cincinnatia. R. at 6.
On the 12(b)(6) motion, the trial court held that Taft’s state-law negligence claim was
preempted and dismissed the action. The trial court ultimately held that if a component part of a
device has been PMA approved then “preemption applies if the plaintiff does not or cannot plead
that the 510(k) component of the device was the sole cause of the injury.” R. at 9. Because Taft’s
claims centered around the interaction of the Lucky Liner with the Hipflex system—and did not
focus on the Hipflex system alone—the trial court ruled that all state-law claims were preempted
and dismissed Taft’s complaint. R. at 9–10.
The appellate court. Taft appealed to the First Appellate Circuit where the court held
that Taft’s negligence claims were not preempted, but that Lucky Hospital was not subject to the
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
5
jurisdiction of Cincinnatia courts. R. at 21. The appellate court held that the trial court erred in its
approach to defining the device, and instead held that for preemption purposes, the proper scope
was limited to the looking at federal requirements applicable to the device as a whole device
rather than its components. R. at 28. The appellate court continued that it was not proper to
participate in “piecemeal preemption” and that a device which is not preempted cannot change
its status by simply adding a single PMA approved component piece to it. R. at 28.
The complaint was still ordered dismissed however, because the appellate court held that
personal jurisdiction could not be maintained over Lucky Hospital. The court decided to follow
the reasoning of the plurality in J. McIntyre, requiring proof that a foreign defendant
demonstrated intent to submit to the state as an individual sovereign rather than looking at
marketing targeted towards the United States as a whole. R. at 32. It then held that it was
irrelevant that Lucky Hospital “consciously chose to market to the United States” because there
was no evidence that the foreign company “deliberately targeted Cincinnatia.” R. at 31.
SUMMARY OF THE ARGUMENT
A. Personal Jurisdiction
This case is about a manufacturer who wishes to direct hundreds of dangerous of
products into this state through a stream of commerce it created with absolute impunity. This
Court should hold that Lucky Hospital is subject to the jurisdiction of Cincinnatia because it
purposefully availed itself of the benefits and privileges of the state and as such should
reasonably anticipate being haled into court here. The proper stream of commerce test to use is
the one followed by the trial court which is based on foreseeability, instead of a test based on
vague notions of state sovereignty. Jurisdiction should be based on a company’s knowledge and
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Taft v. Lucky Hospital Supply, Inc.
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conduct, not on their ability to structure particular marketing arrangements. However, under any
of the three major tests, Lucky Hospital is subject to jurisdiction.
First, under World-Wide Volkswagen, Lucky Hospital is subject to jurisdiction because it
knew for a fact that its products were arriving into Cincinnatia regularly through the stream of
commerce. Cincinnatia had an exclusive distributorship relationship with Fancy Distributors,
Fancy Distributors’ area was listed as the United States, and Fancy Distributor reported all sales
it made back to Lucky Hospital with pertinent facts, including location. Despite having the
knowledge of where its exclusive distributor was sending products, Lucky Hospital continued to
sell products to that distributor and will continue to do so in the future. Under these facts, it
should be no surprise to a manufacturer when it is asked to defend itself in the states it knows its
products are being delivered into.
Second, under the O’Connor plurality, Lucky Hospital directed its contacts to the forum
itself by making a U.S. specific design (as shown by going through the FDA’s rigorous PMA
process), using an exclusive distributor to sell to the state, and by selling such large quantities to
the United States as a whole so as to show an intent to serve every single state. When Lucky
Hospital delivered almost 10,000 medical devices to the U.S.’s doors without limit to where they
would sell (and with knowledge of where sales had occurred before) it was more than a mere
likelihood that its products would arrive in the forum state, it was certain.
Third, this Court should not follow the plurality in in J.McIntyre, because it does not take
into consideration modern commercial concerns and leads to absurd results in cases which are
outside of its facts. J.McIntyre, should be limited to cases involving one or a few sales into the
forum, not cases where almost 10,000 products were sold to the United States. However, for all
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Taft v. Lucky Hospital Supply, Inc.
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the reasons above, this Court should still find that Lucky Hospital submitted to Cincinnatia as an
individual sovereign and not just to the United States as a whole, because the over 200 products
it sent into the state with knowledge thereof shows Lucky Hospital intended to serve the state’s
market and thus purposefully availed itself of the benefits and protections of Cincinnatia laws.
B. Preemption
This Court should also hold that Taft’s state-law negligence claims are not preempted
because it was never the intent of Congress to take away a remedy from an entire class of injured
person’s who were hurt by a medical device which was never inspected by the FDA for its
safety. This Court should hold that Taft’s claims are not preempted for two reasons. First,
because the Hipflex device does not have any safety regulations attached to it and the Court
should not break the device apart to find which components do. Second, even if the Court does
break apart the device to find the PMA pieces, any state-law claim is not contrary to federal
requirements because the Lucky Liner was never approved for use in hip replacement systems.
The only device at issue here is the Hipflex system, and this Court should not impute to
Congress an intent to create a scheme where a court is required to look at every single
component piece of a complex medical device to determine which parts of it a plaintiff may or
may not allege a cause of action against. A component piece which has gained PMA approval
because of its use in a larger PMA device cannot take that PMA approval with it everywhere it
goes, and does not automatically grant PMA approval to any and all devices and designs to
which it is incorporated into. Allowing a component part to be used for any purpose and in any
design without evaluation of its safety by the FDA and then granting that entire device
preemption rights makes no since and should not be followed by this Court.
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Taft v. Lucky Hospital Supply, Inc.
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STANDARD OF REVIEW
Motions for failure to state a claim under 12(b)(6) are reviewed de novo. Causey v.
Sewell Cadillac-Chevrolet, Inc., 394 F.3d 285, 288 (5th Cir. 2004). Whether or not a court has
jurisdiction implicates due process and is to be reviewed de novo. LeMay v. U.S. Postal Serv.,
450 F.3d 797, 799 (8th Cir. 2006).
ARGUMENT
III.
LUCKY H OSPITAL IS SUBJECT TO THE JURISDICTION OF CINCINNATIA
Cincinnatia’s long-arm statute extends to the full extent allowed by the U.S. Constitution.
R. at 3. The Due Process Clause of the Fourteenth Amendment “constrains a State’s authority to
bind a nonresident defendant to a judgment of its courts.” Walden v. Fiore, 134 S. Ct. 1115, 1121
(2014). Generally, it must be proven that the defendant has “certain minimum contacts... such
that the maintenance of the suit does not offend traditional notions of fair play and substantial
justice.” International Shoe Co. v. Washington, 326 U.S. 310, 316 (1945).
Jurisdiction can be either general or specific. Goodyear Dunlop Tires Operations, S.A. v.
Brown, 131 S. Ct. 2846, 2851 (2011). General jurisdiction allows a defendant to be brought into
a state court for its conduct anywhere, and requires contacts so “continuous and systematic” that
the company is “essentially at home” where suit is brought. Id. General jurisdiction is not an
issue in this case
Specific jurisdiction, in contrast, requires an “affiliation between the forum and the
underlying controversy.” Id. In this case, Taft’s injuries happened in Cincinnatia and arose out of
the sale of Lucky Hospital’s product into the state. R. at 16–17. As such, it is not in dispute that
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Taft v. Lucky Hospital Supply, Inc.
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there is a proper nexus between the defendant, the forum, and the litigation.4 See generally,
Allianz Glob. Corp. & Specialty Marine Ins. Co. v. Watts Regulator Co., 92 F. Supp. 3d 910, 919
(S.D. Iowa 2015) (Holding that there was a proper nexus where the product “was installed in an
Iowa building, by an Iowa corporation, [and by a defendant that] has a sales distribution network
in Iowa”).
Under a specific jurisdiction analysis, there must be certain minimum contacts between
the defendant and the forum state and the exercise of jurisdiction must be fair and reasonable
under the circumstances. Burger King Corp. v. Rudzewicz, 471 U.S. 462, 476 (1985). The
minimum contacts analysis is meant to ensure defendants have “fair warning” that their activities
may subject them to jurisdiction. Id. at 472. In products liability cases, this requires more than
“the mere likelihood that a product will find its way into the forum state.” World-Wide
Volkswagen Corp. v. Woodson, 444 U.S. 286, 297 (1980). However, whether or not a defendant
has ever stepped foot in a state, when a corporation “purposefully avails itself” of the privileges
of conducting business within the forum state “it has clear notice that it is subject to suit there.”
Id.
a. Lucky Hospital has Sufficient Contacts with Cincinnatia Because Substantial Amounts
of Its Products Have Been Purposefully Directed Towards the State
Lucky Hospital is subject to the jurisdiction of Cincinnatia courts because it directed its
products into the stream of commerce towards the forum state with the intent that they would be
used by persons in the forum state and as such, has purposefully availed itself of the benefits and
protections of the laws of this state. Lucky Hospital and foreign companies which send
4
R. at 30 (“This Court agrees with the trial court that a specific jurisdiction analysis is appropriate…”).
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Taft v. Lucky Hospital Supply, Inc.
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thousands of their products into the United States cannot simply use a distributor or creative
marketing to avoid liability but should be held to reasonably anticipate being haled into court in
those states where it has shipped substantial amounts of products.
i. A Brief History of the Stream of Commerce Doctrine
While it was almost 140 years ago that the Supreme Court held that the Fourteenth
Amendment provides out-of-state defendants certain safeguards before being brought into court,5
there is still confusion at the Supreme Court level as to how expansive these safeguards should
be—especially in products liability cases where the defendants primary connection to the forum
is through a product arriving into the forum through the “stream of commerce.” While all cases
agree that a defendant must “purposefully avail” itself of the benefits and privileges of the forum
state and cannot be held liable based on mere “fortuitous” circumstances, the Supreme Court has
split over how purposeful availment can be reached.
The first Supreme Court case to look to the “stream of commerce” to analyze minimum
contacts was World-Wide Volkswagen Corp. v. Woodson, (WWVW). 444 U.S. at 297. There, the
plaintiffs brought a products liability suit claiming a defect in design of a vehicle and sued the
automobile’s German manufacturer (Audi), its American subsidiary (Volkswagen of America),
the regional distributor (World-Wide), and the dealer (Seaway) from which the plaintiff bought
the car. Id. at 288. The plaintiffs were residents of New York when they bought the car in New
York from Seaway. Id. While driving the car to Arizona from New York, the plaintiffs were
injured in Oklahoma and attempted to bring suit in Oklahoma. Id.
5
Pennoyer v. Neff, 95 U.S. 714 (1878).
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The Supreme Court held that there could be no jurisdiction over World-Wide or Seaway
because the unilateral actions of the plaintiffs in taking the car from New York into Oklahoma
created their only contact with the forum state and thus in no way did they “avail themselves…
of the benefits and protections of Oklahoma law.” Id. at 294 & 298. The exercise of personal
jurisdiction over Audi or Volkswagen of America was not before the court, but the court
compared the contacts of the four defendants in the context of the stream of commerce argument:
[I]f the sale of a product of a manufacturer or distributor such as Audi or
Volkswagen is not simply an isolated occurrence, but arises from the efforts of the
manufacturer or distributor to serve directly or indirectly, the market for its
product in other States, it is not unreasonable to subject it to suit in one of those
States… The forum State does not exceed its powers under the Due Process
Clause if it asserts personal jurisdiction over a corporation that delivers its
products into the stream of commerce with the expectation that they will be
purchased by consumers in the forum State. But there is no such or similar basis
for Oklahoma jurisdiction over World-Wide or Seaway…
Id. at 297–98 (internal citations omitted).
A few years later, the Supreme Court did confront the issue of the liability of a
manufacturer in Asahi Metal Indus. Co. v. Superior Court of California, Solano Cnty., 480 U.S.
102 (1987) but the court split into three concurrences with different theories on how to apply the
stream of commerce theory.
Asahi dealt with a Japanese manufacturer of a component part which manufactured the
component part in Japan, sold it to a Taiwanese company which assembled it into a tire in
Taiwan, and then the Taiwanese manufacturer sold the tire all over the world. Asahi, 480 U.S. at
106. The Brennan Concurrence held that placing a product into the stream of commerce with
foreseeability that the product would reach the forum state was enough to establish purposeful
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
12
availment and sustain jurisdiction. Id. at 117 (“The stream of commerce refers not to
unpredictable currents or eddies, but to the regular and anticipated flow of products from
manufacture to distribution to retail sale. As long as a participant in this process is aware that the
final product is being marketed in the forum State, the possibility of a lawsuit there cannot come
as a surprise.”).
In contrast, the O’Connor Concurrence required proof of both placing an item into the
stream of commerce plus an action on the part of the defendant showing that contacts with the
state were purposefully directed to serve the market of the forum state. Id. at 112. The O’Connor
Concurrence gave a non-exclusive list of how something more may be shown,6 the premise of
which were that contacts must “proximately result from actions by the defendant himself that
create a substantial connection with the forum State.” Id. at 109 (emphasis in original).
The Stevens Concurrence also held that something more was needed than just “mere
awareness,” but believed that whatever the something more was, it was satisfied due to the
volume of sales which flowed into the state of California.7 Id. at 122. The Stevens Concurrence
held that to determine purposeful availment it would require “a constitutional determination that
is affected by the volume, the value, and the hazardous character of the components.” Id.
Not surprisingly, the lack of a majority opinion left the lower courts confused and led to
circuits divided amongst their favorite concurrence. See generally Jessica Jeffrey, The Stream of
Commerce Flows on, 46 Suffolk U.L. Rev. 137, 146 (2013).
6
“designing the product for the market in the forum State, advertising in the forum State, establishing channels for
providing regular advice to customers in the forum State, or marketing the product through a distributor who has
agreed to serve as the sales agent in the forum State.”
7
“In most circumstances I would be inclined to conclude that a regular course of dealing that results in deliveries of
over 100,000 units annually over a period of several years would constitute ‘purposeful availment.’” Id. at 122.
(Stevens Concurring).
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
13
After almost two decades, the Supreme Court had the opportunity to provide some clarity
to the problem with the case of J. McIntyre Mach., Ltd. v. Nicastro, 131 S. Ct. 2780 (2011), but
the plurality authored by Kennedy decided to take an entirely different route in an otherwise easy
case (only one product was ever sold in the forum state) by making two broad holdings: 1) That
placing products into the stream of commerce alone is never enough to establish jurisdiction, 131
S. Ct. at 2785–86; and 2) that contacts should be split into two categories, contacts with the
United States generally and contacts with individual states, 131 S. Ct. at 2789–90.
This strict position has been largely ignored, with the exception of the court of appeals
below. Instead, looking at the federal level, the three circuit court of appeals which have actually
confronted the issue have held that the concurrence of Breyer and Alito from J. McIntyre,
controls.8 However, even this has been made difficult because “like one of Dr. Rorschach's
amorphous ink blots, Justice Breyer’s opinion is susceptible to multiple interpretations.” Johnson
v. Chrysler Canada Inc., 24 F. Supp. 3d 1118, 1133 (N.D. Ala. 2014) (internal citations omitted).
Courts have split primarily into three camps which will be analyzed in the following
order: 1) ignoring both Asahi and J. McIntyre and instead reverting to the last majority opinion
on the subject—World-Wide Volkswagen;9 2) Stream of commerce plus “something more”; or 3)
a strict submission to the sovereignty approach as advocated by the Kennedy plurality and
followed the appellate court below. Lucky Hospital should be subject to the jurisdiction of
Cincinnatia under all of these theories.
8
Ainsworth v. Moffett Eng'g, Ltd., 716 F.3d 174 (5th Cir. 2013); AFTG-TG, LLC v. Nuvoton Tech. Corp., 689 F.3d
1358 (Fed. Cir. 2012); Williams v. Romarm, SA, 756 F.3d 777, 784–85 (D.C. Cir. 2014).
Additionally, the large majority of district courts have also said the same. See Johnson v. Chrysler Canada Inc., 24
F. Supp. 3d 1118 (N.D. Ala. 2014) (and cases cited therein); Smith v. Teledyne Cont'l Motors, Inc., 840 F. Supp. 2d
927 (D.S.C. 2012) (and cases cited therein).
9
This also includes the Brennan Concurrence from Asahi for the most part as both rely on knowledge of where your
product is going through the stream of commerce rather than some additional conduct.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
14
ii. Lucky Hospital is Subject to Jurisdiction Because It Was Aware Its Products Were
Heading Towards Cincinnatia and Its Contacts Were Not an Isolated Occurrence
The Supreme Court holds that, “When a fragmented Court decides a case and no single
rationale explaining the result enjoys the assent of five Justices, the holding of the Court may be
viewed as that position taken by those Members who concurred in the judgments on the
narrowest grounds.” Marks v. United States, 430 U.S. 188, 193 (1977). This Court should find
that Justice Breyer’s concurrence in J. Mcintyre, was based upon the narrowest grounds.
Breyer’s Concurrence held that the New Jersey Supreme Court was overruled not
because of any new rule, but instead because “None of our precedents finds that a single isolated
sale… is sufficient.”10 J. McIntyre, 131 S. Ct. at 2792 (Breyer J., Concurring). Breyer then went
on to explain why J. McIntyre would not be susceptible to jurisdiction under WWVW or any of
the three Asahi Concurrences. Id. Breyer held that because solving the issue of jurisdiction did
not require choosing between the tests in that case, the choice of which test to use should be
saved until a case was presented which actually presented “modern concerns.” Id. at 2793. Thus,
the concurrence of Breyer is the most limited grounds upon which a divided court issued an
opinion because it was premised on not crafting any change in the law. This Court should thus
only look to the Supreme Court’s precedent when deciding this case, the most clear of which is
that of the Supreme Court’s only majority opinion on stream of commerce, World-Wide
Volkswagen.
The Fifth Circuit is one of the circuits which has continuously chosen to follow WorldWide Volkswagen. See Irving v. Owens-Corning Fiberglas Corp., 864 F.2d 383 (5th Cir. 1989)
10
The New Jersey Supreme Court articulated a test which allowed jurisdiction over a foreign manufacturer if it
“knows or reasonably should know that its products are distributed through a nationwide distribution system that
might lead to those products being sold in any of the fifty states.” Id. at 2793 (emphasis in original).
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
15
(Holding that the Circuit will follow WWVW after no majority was reached in Asahi); see also,
Ainsworth v. Moffett Eng'g, Ltd., 716 F.3d 174 (5th Cir. 2013) (Same, after McIntyre).
The Fifth Circuit uses the following test crafted from World-Wide Volkswagen:
In cases involving a product sold or manufactured by a foreign defendant… the
minimum contacts requirement is met so long as the court ‘finds that the
defendant delivered the product into the stream of commerce with the expectation
that it would be purchased by or used by consumers in the forum state.’ Under
that test, mere foreseeability or awareness is a constitutionally sufficient basis for
personal jurisdiction if the defendant's product made its way into the forum state
while still in the stream of commerce, but ‘the defendant's contacts must be more
than random, fortuitous, or attenuated, or of the unilateral activity of another party
or third person.’ ”
Ainsworth, 716 F.3d at 177. This rule is most in line with the rule followed by the trial court
below. See R. at 6–7; see also infra p. 5.
In Ainsworth, the Fifth Circuit found the sale of 203 forklifts (1.55% of U.S. sales) by a
foreign manufacturer to customers in the forum state through an exclusive distribution agreement
to be “a far cry from the single sale in McIntyre” and held that there was personal jurisdiction.
Ainsworth, 716 F.3d at 178. The court held that the quantum of conduct was much higher than
the New Jersey test Breyer overruled and which was based on a distribution system that only
“might” lead to products being sold in any of the fifty states. Id. at 178–79. The foreign
manufacturer’s actions went beyond just the likelihood of a product making its way into the
forum state, such that “it reasonably could have expected that such sales would be made.” Id.
The court found that the defendant reasonably could have expected the sales because it only sold
to one distributor whose territory was marked as the United States, it was aware the distributor
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
16
marketed to the United States and it placed no limits on the distributor’s territory, and based on
the large number of sales to the United States as a whole.11
Lucky Hospital should be subject to the jurisdiction of this Court because it not only
“reasonably could have expected that such sales would be made,” it knew for a fact they were
being made. See R. at 12–13 (Aff. of Han) (“At the end of each financial quarter, Fancy Medical
Distributors’ sends Lucky Hospital Supply an itemized account of sales made in the quarter,
including location”). Additionally, these sales were not “simply isolated occurrences” such as
one VW or one saw, but were over 200. Despite knowing for a fact that its product was arriving
in and be marketed to Cincinnatia through an exclusive distributorship, Lucky Hospital
continued to sell only to the one distributor who put its products into the market in the forum
state and never told the distributor to keep its products away. Under World-Wide, when a
manufacturer serves “directly or indirectly, the market for its product in other States, it is not
unreasonable to subject it to suit” there. World-Wide, 444 U.S. at 297–98.
The arrival of the product into the forum state with the awareness of Lucky Hospital was
not merely fortuitous or an isolated occurrence and under such circumstances Lucky Hospital
should reasonably anticipate being haled into court into Cincinnatia as the trial court held below.
This Court should not allow foreign manufacturers to knowingly dump defective products into
the market of our state with impunity so long as they use an independent distributor. If a
manufacturer is aware of the destination of his product and it continues to direct its products
11
The court also looked at the particular applicability of the product to the forum state, noting that one of the
products sold was a tractor for use in poultry and that Miss. was one of the top poultry producing states. The
importance of this is that the defendant should have known at least a product would arrive in the forum state, as
opposed to if a tractor arrived in Alaska. The relative number of sales between states was not the purpose as Miss.
was only 1.5% of the U.S. market. Given the mix of people among all states and Cincinnatia, it is not fortuitous that
a hip replacement device marketed nationally would arrive here if sold in large numbers to the U.S., it is expected.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
17
towards the state, that is all that should be required under the minimum contacts analysis of the
test and such a test is clearly satisfied by the actions of Lucky Hospital.
iii. Lucky Hospital Not Only Puts Goods into the Stream of Commerce But
Purposefully Directs Them Towards Cincinnatia
Some courts have held that Breyer’s concurrence does more than just stick to precedent,
but by overruling the New Jersey Supreme Court’s broad stream of commerce test it endorsed
O’Connor’s stream of commerce plus test from Asahi. See e.g. Smith v. Teledyne Cont’l Motors,
Inc., 840 F. Supp. 2d 927, 931 (D.S.C. 2012). If the Court decides to follow the Breyer
Concurrence but does not adopt the World-Wide Volkswagen test used by the Fifth Circuit, this
court should look to the O’Connor test with an additional focus on the “the volume, the value,
and the hazardous character” of the product at issue here. See Asahi Metal Indus. Co., 480 U.S.
at 122 (Stevens J., Concurring).
When looking for “something more” courts have often looked to the concurrence of
Stevens in Asahi. See e.g. Barone v. Rich Brothers Interstate Display Fireworks Co., 25 F.3d
610, 614 (1994) (“it appears that five justices [in Asahi] agreed that continuous placement of a
significant number of products into the stream of commerce with knowledge that the product
would be distributed into the forum state represents sufficient minimum contacts to satisfy due
process.”); Renner v. Lanard Toys Ltd., 33 F.3d 277, 283 (3d Cir. 1994) (Holding that the
Stevens and O’Connor opinions “meld… because it is likely that if a significant amount of the
defendant’s products are sold to customers in any given state, the plaintiff will be able to show
an intentional marketing toward that state”). In addition to this, courts have looked to the list of
was to show something more given by O’Connor, three of which are relevant here:
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
18

designing the product for the market in the forum state;12

advertising in the forum State;

marketing the product through a distributor who has agreed to serve as the sales agent in
the forum State.
Asahi Metal Indus. Co., 480 U.S. at 109.
Since Lucky Hospital has done all three of the above and has put a large number of
dangerous products into Cincinnatia, this court should find that the stream of commerce plus test
is satisfied and thus Lucky Hospital is subject to jurisdiction in Cincinnatia.
In Monje v. Spin Master Inc., the plaintiff was attempting to hold a foreign corporation
liable for a manufacturing defect in a children’s toy. 2013 WL 2369888 at *1 (D. Ariz. May 29,
2013). The foreign defendant (Moose) had no offices within the United States, and did not
conduct any direct retail or wholesale operations within the United States but instead contracted
with a distributor to have the product sold throughout the United States. Id. Moose attempted to
argue that in light of J. McIntyre the direction of a product towards the United States was not
enough to show that the company directed their products towards the forum state specifically. Id.
at 8. The district court held that the Breyer Concurrence endorsed the O’Connor plurality but
with a special focus on the quantity of goods. Id. at 7–8. The court held that because the
manufacturer sold such a large quantity of products to the United States as a whole (over 4
12
Even though O’Connor used the phrase “designing a product for market in the forum state,” the Justice indicated
that this meant more than designing it for one individual state and not towards the U.S. as a whole. Asahi Metal
Indus. Co., 480 U.S. at 112. In fact, the case O’Connor cited to as an example of a product designed for market in
the state was Rockwell Int’l Corp. v. Costruzioni Aeronautiche Giovanni Agusta, 553 F. Supp. 328 (E.D. Pa. 1982),
a case involving a component part to a helicopter which was to be marketed to the U.S. and Europe, but not to any
particular state. Rockwell, 553 F. Supp. at 331–32 (“While [the defendant’s] involvement in the sale and distribution
of the ball bearing may be once or twice removed from [the] final sale… [defendant’s] purposeful availment, critical
in the minimum contacts analysis, actually took place at an earlier point. That occurred when [defendant] decided to
enter and exploit the international “executive corporate transport market,” and toward that end, began to work
closely with Agusta's engineers to develop the ball bearings for the A–109 with the knowledge that the A–109 was
to be marketed throughout the continental United States.”).
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
19
million) and did not limit its territory, it must have directed it towards the individual states which
make up the U.S. Id. at 8.
Additionally, the court found the manufacturer to have not just “passively launched its
product into the stream of commerce” but that the company was intimately involved in directing
the product “downstream” to the United States. Id. at 7. The court found that a “prime example”
of this was a website which not only advertised the product but which also “invited those
‘Stateside’ to ‘find [their] closest store’ ”. Id. Additionally, the Court found relevant that the
product was registered with U.S. Patent and Trademark Office, was designed to pass United
States testing, and that Moose used a distributor through which it intended to sell to the United
States as a whole. Id. at 7–8. The court held that “Moose cannot plan to have its product shipped
into all of the United States, work closely with another entity to execute that plan, and then
object when a federal court13 located in one of those states attempts to exercise personal
jurisdiction over it.” Id. at 9.
Lucky Hospital is subject to the jurisdiction of Cincinnatia because it intended to market
to the United States as a whole and sent such a quantity of products as to avail itself of the
markets of each state. First, Lucky Hospital did not passively place its products into the stream of
commerce but directly manifested its intent to do business with the United States. See R. at 11–
12 (Aff. of Han) (“As part of this expansion, Lucky Hospital wanted to sell our devices in the
United States”). Additionally, Lucky Hospital has shown its intent to do business with the United
States by making sure its products were approved by the FDA through the grueling and
13
While J. McIntyre focused on the difference between contacts with the federal government and the individual
states, the fact that it was a federal court here is not relevant because the court called the idea of treating contacts
towards the United States as a whole as separate “absurd” under the facts of the case. Id. at 8.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
20
expensive14 PMA process. See R. at 23–24. Lucky Hospital would never have gone through such
an expensive and long process if it only planned to sell a few products to the United States.
Second, the company has “never attempted to limit the scope of Fancy Medical
Distributors’ marketing efforts to any specific state or region.” R. at 12. Instead, it has shipped
such a large quantity of products into the United States that it manifested an intent to do business
with each state, even though it decided to do so indirectly. Over the last few years, the company
has sold almost 10,000 complex medical devices to the United States through a website15 which
invites Cincinnatia consumers to find a distributor whom they set-up an exclusive sales
agreement with—an agreement which set the United States as a whole as the sales territory.
Lucky Hospital cannot reap the benefits of its efforts to serve the United States market as
a whole and then shirk its responsibilities because it hired an independent distributor to do the
dirty work. Instead, this Court should find that by selling nearly 10,000 medical devices with no
geographic limit, Lucky Hospital knew it was sending hundreds of devices into each state. Lucky
Hospital purposefully availed itself of the benefits of the United States market through FDA
approval and the profits it made off advertising on the internet which reached residents of
Cincinnatia. Cincinnatia is one of those states that Lucky Hospital has shown an intent to serve
and has made profits off of; as such, this Court should find that the company has purposefully
availed itself of the benefits and protections of Cincinnatia’s laws and that its actions constitute
“something more” than just passively putting the product into the stream of commerce.
14
Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996).
15
Lucky Hospital’s website is not completely interactive as it does not allow customers foreign customers to
purchase from the website but is not merely passively providing information as illustrated by its barrage of
advertisements containing clickable links directing users where to buy its products. Instead, the website most likely
fits into the “middle ground” of the Zippo sliding scale. Zippo Manufacturing Co. v. Zippo Dot Com, Inc., 952
F.Supp. 1119, 1124 (W.D.Pa.1997). As such, the website is a relevant contact with the forum, though not itself
sufficient to establish jurisdiction.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
21
iv. This Court Should Not Apply the Test Manifested by the Kennedy Plurality
This Court should not apply the test espoused by the Plurality in McIntyre because it is
factually different from the case at hand and because the reasoning does not take into
consideration modern commercial circumstances. However, if this court were to follow the
Plurality, this Court should still maintain jurisdiction because Lucky Hospital’s conduct targeted
towards the forum state manifests an intent by Lucky Hospital to submit to the sovereign.
First, Breyer and Alito explained the reason that they could not join “without a better
understanding of the relevant contemporary commercial circumstances”:16
The plurality seems to state strict rules… but what do those standards mean when
a company targets the world by selling products from its Web site? And does it
matter if, instead of shipping the products directly, a company consigns the
products through an intermediary (say, Amazon.com) who then receives and
fulfills the orders? And what if the company markets its products through popup
advertisements that it knows will be viewed in a forum? Those issues have serious
commercial consequences but are totally absent in this case.
J. McIntyre, 131 S.Ct. at 2793. These are the same problems that the district court faced in
Monje, when confronted with a manufacturer who supposedly only had an intent to serve the
United States market as a whole, but had sold millions of products to the United States making it
virtually statistically impossible that thousands of these products would not wind up in every
single state. Monje, 2013 WL 2369888 at *8–9. This Court should hold the same as the court in
Monje, that outside the limited facts of J. McIntyre—the sale of only one product into the forum
16
131 S.Ct. at 2794.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
22
state—that a strict separation of contacts with the United States as a whole and the individual
states leads to “absurd practical results.” Id. at 8.
If this Court does decide to follow the Plurality of J. McIntyre though, there is still
jurisdiction over Lucky Hospital. More than the stream of commerce has been proven in this case
because Lucky Hospital has purposefully availed itself of the benefits and protections of
Cincinnatia in ways that J. McIntyre never did. First, if only one product has been sold into the
forum after a defendant has never advertised there, then that truly has the possibility to be
fortuitous. However, if like Lucky Hospital you know for a fact that your product is continuously
being sold into the forum state (and not just generally towards the United States), you advertise
in a manner which directs people in the forum state to buy your product (even if it is sold
indirectly), and you continue to change nothing, than the fact that your product is in the forum is
not fortuitous—it is planned. Lucky Hospital has shown an intent to benefit from the laws of
Cincinnatia and to make money off of its citizens and as such, has consented to the jurisdiction
of the sovereign. The court of appeals erred in its application of J. McIntyre to the facts of this
case, and it should be overruled.
B. The Exercise of Jurisdiction Over Lucky Hospital is Reasonable
Last, jurisdiction must be proven to comply with “traditional notions of fair play and
substantial justice.” Asahi, 480 U.S. at 113. To determine this, the court is to weigh the burden
on the defendant versus: the forum state’s interest in adjudicating the suit; the plaintiff’s interest
in obtaining convenient and effective relief; the interstate judicial system’s interest in obtaining
the most efficient resolution of controversies; and the shared interest of the several states in
furthering fundamental substantive policies. Id. When the defendant is foreign to the United
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
23
States, the Court must take into considerations “the unique burdens placed upon one who must
defend oneself in a foreign legal system.” Id. at 114.
However, the analysis of minimum contacts and reasonableness of the exercise of
jurisdiction often overlap, which is why “When minimum contacts have been established, often
the interests of the plaintiff and the forum in the exercise of jurisdiction will justify even the
serious burdens placed on the alien defendant.” Id.
Courts have held that when a foreign defendant has proven its familiarity with the U.S.
legal system and has sufficient contacts with the United States, than the burden is slight in
comparison to the interests of an injured plaintiff and the forum state. See e.g. Tobin v. Astra
Pharm. Products, Inc., 993 F.2d 528, 545 (6th Cir. 1993) (“Duphar has shown its familiarity
with the United States administrative and legal process by undergoing the formidable task of
obtaining FDA approval... indicat[ing] that Duphar will not be lost in our complex legal system).
Lucky Hospital has taken advantage of the complex Pre-Market Approval process so that
it could market its Lucky Liner in the United with preemption rights, as such, it should not be
assumed to be lost in the U.S. legal system. Further, the forum state in this case has an interest
because a resident of this state has been injured by Lucky Hospital’s product. See Id. The now
immobile Plaintiff will face a much larger burden in attempting to litigate in Hong Kong than the
international corporation will have in attempting to litigate here. Lastly, efficiency is best served
if the suit is brought in Cincinnatia at the location of the product, the doctor, the surgery, and the
patient. As such, the exercise of jurisdiction over Lucky Hospital comports with traditional
notions of fair play and substantial justice and should be allowed.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
24
IV.
TAFT’S CLAIMS
ARE NOT
PREEMPTED
BY THE
PRE-MARKET APPROVAL PROCESS,
BECAUSE THE DEVICE USED ON HIM WAS NEVER APPROVED
The device used to perform the total hip replacement was the Hipflex system with the
addition of an optional liner. R. at 16. The Hipflex system has never been given pre-market
approval, and that fact cannot be changed by simply inserting a PMA component part which was
never approved for use in the Hipflex system. The trial court was incorrect in attempting to
participate in “piecemeal preemption” by holding that Taft must prove with 100% certainty the
fault of each component piece entered into him during surgery to state a viable claim. This court
should not go farther than Congress intended, but instead hold that preemption only applies to
those devices which are actually approved.
The Constitution’s Supremacy Clause allows Congress to preempt actions of the
individual states. U.S. Const. art. VI, cl. 2. The key to preemption is to determine the intent of
Congress in the effect and scope of any preemptive scheme. Medtronic, Inc. v. Lohr, 518 U.S.
470, 485 (1996). This analysis starts “with the assumption that the historic police powers of the
States were not to be superseded by the Federal Act unless that was the clear and manifest
purpose of Congress.” Id.
As part of the Medical Device Amendments of 1976,17 Congress expressed its intent to
preempt certain state safety regulations on medical devices by prohibiting any state law which
enacts requirements which are “(1) different from, or in addition to, any requirement applicable
under this chapter to the device, and (2) which relates to the safety or effectiveness of the device
or to any other matter included in a requirement applicable to the device under this chapter.” 21
17
Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (21 U.S.C. §§ 360–360n).
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
25
U.S.C. § 360k(a). A state tort claim is thus preempted if the federal government has issued
federal safety standards relating to the device and if the state tort action puts different or
additional requirements on the device. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
How a device is defined is important because devices which do not go through the PMA
process are not given a federal government safety standard and thus are not preempted. Lohr,
518 U.S. at 493. In fact, a majority of products are not evaluated for their safety but for whether
or not they are a “substantial equivalent” to a device already in existence. 21 U.S.C. §
360c(f)(1)(A). The Hipflex system which was used on Taft was brought in through the 510(k)
process and thus no federal safety standards were set as to it. R. at 23. Additionally, the Lucky
Liner received safety standards only for its use as a component in an unrelated hip resurfacing
system and not in a hip replacement system such as the Hipflex.18 As a result, what was put into
Taft’s body was a device and a component part, neither of which had federal safety standards
relating to hip replacement.
The trial court erred in two fundamental ways when it came to the conclusion that Taft’s
claims were preempted. First, the trial court held that if you were to take a PMA approved
component pieces and put it into a 510(k) device as a component part, that the 510(k) device
would now be entirely preempted unless the plaintiff could show with absolute certainty the fault
of each component piece within the device. Second, the trial court held that PMA component
pieces can preempt causes of action brought against them for any and all uses without looking
into whether or not such causes of action would actually be counter to any federal requirements.
This logic is flawed and should not be followed by this Court. Instead of taking large leaps, this
18
The difference between a hip resurfacing device and a hip replacement device is illustrated in Appendix E.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
26
Court should move cautiously in interpreting the scope of preemption Congress intended in an
area historically governed by the states.
A. The Product Should be Characterized as the Hipflex System Only
Even if this Court accepts that the component part maintains its PMA preemption status
when removed out of the larger device for which it was approved, this Court should still find that
Taft’s claims are not preempted because his cause of action is against the device as a whole and
fault cannot be divided amongst the device’s component parts.
The trial court erred when it held that Taft’s claims must be dismissed “if the plaintiff
does not or cannot plead that the 510(k) component of the device was the sole cause of the
injury.” R. at 9. The trial court was persuaded so by a series of federal district court cases which
also evaluated similar hip replacement/resurfacing devices and accompanying liners which were
PMA components inserted into 510(k) devices. R. at 9. According to these cases “there should
not be a separate preemption analysis for each component of a medical device.” See e.g. Bertini
v. Smith & Nephew, Inc., 8 F. Supp. 3d 246, 253 (E.D.N.Y. 2014).19 Taft agrees with this
premise, but the trial court’s conclusion that a component piece which is PMA approved
automatically grants PMA preemption to the entire device when claims are asserted against the
entire device does not logically flow from it. Instead, the conclusion which should be drawn
from such a premise is the one drawn by the appellate court below, that “Preemption is based on
premarket approval of an entire device, not its component parts… [thus,] it is frankly irrelevant
19
Oddly however, these courts then assert plaintiffs can either choose to assert defects against the device as a whole
(which will typically fail) or solely against the 510(k) device. Bertini, 8 F. Supp. 3d at 255. The court never explains
how it can preempt some claims and not others and stay in line with its statement that “preemption analysis should
focus on the hip replacement device implanted in Mr. Bertini as a whole, rather than individual components within
that device.” Id. at 253. Taft has no interest in dividing up his claims against the components, so all that matters is
the court’s eventual conclusion that claims against a whole device which includes a PMA approved component are
preempted.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
27
that the Lucky Liner went through premarket approval because a 510(k) device [the Hipflex
system] is at issue.” R. at 29.
District courts have held that because a court is not supposed to look to the component
parts of a device and participate in piecemeal preemption when a claim is asserted against a
device as a whole, that if the device is not PMA approved the insertion of a PMA component
will not save it. See e.g. Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 753–54 (S.D.W. Va.
2014). In Lewis, the device at issue was 510(k) approved transvaginal mesh and the defendants
asserted that all claims against the device should be preempted to the extent they relied on
Prolene polypropylene filaments (“Prolene”) creating any part of the defect. Id. at 757–58.
Prolene is the material which was used to make the mesh and was considered to be a component
part of the mesh by the trial court. Id. at 757. The defendants in Lewis, attempted to argue that
because “Prolene sutures” were approved through the PMA process that each of the suture’s
components was approved by the FDA process, including the material it was made of, Prolene.
Id. From there the defendants attempted to make an even bigger leap, arguing that because the
component piece Prolene was preempted, that any other medical device which was made from
the substance Prolene would have all state tort claims preempted against it to the extent the
plaintiff relied at all on a contention the Prolene material contributed to the harm. Id.
The court rightly rejected the argument and showed the absurdity of such a contention
with the example of a bone screw which was approved through the PMA process, it simply does
not make sense that the metal which made up the screw would per se be approved by the FDA as
“safe in all medical devices, no matter what their function in the human body.” Id. In fact, such a
contention would be clearly not true. See e.g. Bertrand, Olivier M.D., Biocompatibility aspects of
new stent technology, Journal of the American College of Cardiology, 562–71 (Sept. 1998)
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
28
(evaluating the “stringent” requirements which must be met for a material to be suitable as a
heart stent). The court held that Congress intended for there to be a bright-line rule of preemption
for the device at issue or no preemption at all, not a complex system of piecemeal preemption.
Id. The court held there was never a safety evaluation of the design of the mesh by the FDA as
§360k and Riegel require, and the introduction of the component part of another PMA approved
device did not change that and therefore state-law claims would not be preempted. Id.
The Supreme Court has already rejected the argument that courts can impute onto
Congress an intent to preempt design defect claims against a design which itself was never
actually evaluated for safety. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 487.20 Even if Congress
intended that every component of a PMA device would also have PMA approval, it is a large
leap to say that Congress intended every possible design which incorporated that component part
would never be defective—especially when that secondary device was never evaluated for its
safety. This Court should not give such intent to Congress when the rule of preemption starts
“with the assumption that the historic police powers of the States were not to be superseded by
the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 485.
Instead, this Court should follow the line of cases Bertini and others claimed to follow,
which continuously state that “distinguishing between different components within a single
system would add a level of complication to the medical device approval process not anticipated
by Congress, the FDA, or medical device manufacturers.” Bertini, 8 F. Supp. 3d 246 (internal
20
“Medtronic’s construction of § 360k would therefore have the perverse effect of granting complete immunity
from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation
in order ‘to provide for the safety and effectiveness of medical devices intended for human use,’ 90 Stat. 539
(preamble to Act). It is, to say the least, “difficult to believe that Congress would, without comment, remove all
means of judicial recourse for those injured by illegal conduct,” Silkwood v. Kerr–McGee Corp., 464 U.S. 238, 251,
104 S.Ct. 615, 623, 78 L.Ed.2d 443 (1984), and it would take language much plainer than the text of § 360k to
convince us that Congress intended that result.”
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
29
quotations omitted). The device at issue here is solely that of the Hipflex system—a 510(k)
approved device and this Court should look no further. Instead, the Court should hold that Taft’s
negligence claims against Lucky Hospital for the unsafe nature of the Hipflex system when the
optional Lucky Liner is incorporated into it, are not preempted because there was never a safety
evaluation of the device inserted into him.
B. Even if the Component Part Carries with it PMA Approval, Taft’s Negligence
Claims Do Not Conflict with Any Federal Requirements Because the Lucky
Liner is Being Used for a Non-PMA Use
Even if this Court finds that it should look at all of the compnents of a device when
deciding preemption, it should still allow Taft’s negligence claims because it does not conflict
with any federal law requirements. When the FDA gives PMA approval to a device, it does not
automatically give PMA approval to all component pieces thereof for any and all purposes.
District courts split on the issue of whether or not off-label21 uses of PMA component
parts have applicable federal requirements related to the device which run contrary to state law
claims based on those off-label uses. Compare Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977,
991 (D. Ariz. 2013) (Holding that FDA requirements for a device would not preempt causes of
action against a manufacturer when manufacturer promoted off-label use); with Simon v. Smith
& Nephew, Inc., 18 F. Supp. 3d 423, 428 (S.D.N.Y. 2014) (“the question is not whether there are
federal requirements applicable to a particular use of a device; the question is whether there are
federal requirements applicable to the device.”).
21
Taft does not use the term “off-label” to denote any illegal conduct, just to show that the PMA device was
promoted for non-PMA uses. R. at 26 (“After the success of the Lucky Liner with the PMA approved resurfacing
system, Lucky Hospital began marketing that it may be of significant use with the Section 510(k) approved Hipflex
system as well.”). Since Taft is not asserting a parallel claim, whether or not it is illegal is not relevant.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
30
The trial court decided to follow the line of cases which ignore how a device is being
used when understanding requirements. Such cases stem from the following reading of the
preemption language of the statute:
[The] argument must fail because it is inconsistent with the text of the statute.
According to Riley, the FDA has not established any requirements with respect to
the off-label use of the Cypher stent, and thus there are no federal requirements
with which his state-law claims will conflict. But under § 360k(a)(1), the question
is not whether there are federal requirements applicable to a particular use of a
device; the question is whether there are federal requirements applicable “to the
device.” If there are… then any state requirements that are different from, or in
addition to, those federal requirements are preempted.
Riley v. Cordis Corp., 625 F. Supp. 2d 769, 778-79 (D. Minn. 2009).
Such a reading of the statute ignores “the statutory framework surrounding it,” and runs
counter to the reasoning used by the Supreme Court in Lohr. First, the statute could have been
written to state that it preempts all state claims related to a medical device approved—but it
wasn’t. Instead, the statute only preempts causes of action against a device when a state puts a
“requirement… which is different from, or in addition to, any requirement applicable under this
chapter to the device.” 21 U.S.C.A. § 360k. Thus, the focus of preemption is not on the device,
but on conflicting requirements applicable to the device and there is no indication that
requirements cannot be use-conscious in light of Lohr.
In Lohr, the defendant argued preemption because the 510(k) device at issue was under a
federal requirement that device be “substantially equivalent to an earlier device.” Lohr, 518 U.S.
at 492. The court held that design defect claims against a device which went through the 510(k)
process would not be preempted because “even though the FDA may well examine § 510(k)
applications… with a concern for the safety and effectiveness of the device, it did not ‘require’
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
31
Medtronics’ pacemaker to take any particular form for any particular reason.” Id. at 493–94.
However, the court also looked at regulations relating to manufacturing and labeling which
involved safety and suggested that these requirements would preempt some claims. Id. at 513
(O’Connor, J. concurring and dissenting). Thus, the Supreme Court looked at a device which had
safety requirements applicable to it (manufacturing and labeling) but did not preempt all causes
of action against it (design).
There is no reason why this Court cannot look at the Lucky Liner as having some safety
standards applicable to it for some uses (hip-resurfacing) and none as to other uses (hip
replacement) when these requirements do not conflict. The reason why design defect claims are
preempted is because they impose an additional requirement on the device that it be made in a
safer way then the FDA said it could be made. See e.g., Bertini v. Smith & Nephew, Inc., 8 F.
Supp. 3d 246, 255 (E.D.N.Y. 2014) (“the design defect claim rests on the alleged ability of Smith
& Nephew to design an even safer device component… Since these additional state requirements
relate to the safety and effectiveness of defendant's devices, the portion of the design defect
claim based on the [PMA approved] R3 metal liner is preempted under the MDA.”). Taft’s
claims do not conflict with any federal safety standards because Taft does not contend that the
Lucky Liner be made safer for use in a hip resurfacing system, or for really any use at all. All
Taft claims is that the Lucky Liner cannot be used with the Hipflex system, a request upon which
no federal requirement has been laid.
In Hornbeck, the Court looked at a similar problem when a medical device which was
made up of two component parts was given PMA but the device was used with only one of the
component parts during surgery. Hornbeck v. Medtronic, Inc., 2014 WL 2510817, at *4 (N.D.
Ill. June 2, 2014). The court held that because two parts were approved to be used together as a
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
32
system, “it follows that the FDA considers the two safe and effective when used together [but
not] that the FDA considered either component as safe and effective when used independent of
the other.” Id. As such, “[i]t is simply disingenuous for the Medtronic Defendants to argue that
the Plaintiffs seek to enforce safety requirements different from or in addition to those imposed
by the FDA when the FDA imposed those requirements on the two components used together.”
Thus, the court held that the plaintiff’s claim that the device was defective outside of its FDA
prescribed use did not require the manufacturer to make it safer than the manner the FDA
allowed, it simply told it to stay within what was already prescribed by the FDA.
The scope of the statute can further be determined from the “statutory framework
surrounding it… [with a] reasoned understanding of the way in which Congress intended the
statute and its surrounding regulatory scheme to affect business, consumers, and the law.” Id. at
486. When a manufacturer submits a premarket approval application for a Class III device, the
FDA evaluates the device’s safety and efficacy for its “intended use” as set forth in the
application. 21 U.S.C. § 360e(d)(1)(B)(iii)(II); 21 U.S.C. § 360e(d)(2)(A) & (B) (secretary shall
deny premarket approval if the device is not shown to be safe and effective under “conditions of
use” in proposed labeling). Further, the purpose of Congress in passing the act to assure safer
devices and compliance with unified standards also supports this understanding. See Blankenship
v. Medtronic, Inc., 6 F. Supp. 3d 979, 988 (E.D. Mo. 2014) (“If medical device manufacturers
were permitted to promote their products for non-approved off-label uses, the regulations
promulgated by the FDA would be meaningless and manufacturers would have little reason to
participate in the supplemental approval process.”). The purpose of the statute is to make sure
devices are safe before the devices hit the market, not for manufacturers to receive preemption
for unauthorized and experimental new uses of an approved device.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
33
For these reasons, this Court should hold that if Lucky Hospital wants to use the Lucky
Liner beyond its PMA approved purpose, then Lucky Hospital will face liability beyond that
point. Taft’s claims which assert problems with the device beyond that point assert no contrary
requirements to the federal governments. The Lucky Liner was only granted supplemental PMA
because of its use inside of a specific device—a device which is not at issue in this case. Since
Taft’s negligence claims are not preempted and because the affidavit accompanying the
complaint allows the trial court to otherwise make a reasonable inference that the defendant is
liable, Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), the complaint should be reinstated in its
entirety.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
34
Conclusion
This case is about whether or not we will grant a foreign manufacturer the right to injure
the citizens of Cincinnatia with impunity. Lucky Hospital has asked for the right to send
hundreds of dangerous products into this state and to never be held to answer when those
products injure persons here.
First, this Court should hold that when a manufacturer knowingly sends hundreds of
complex and potentially dangerous products into a state, then the manufacturer has shown an
intent seeks to serve the citizens of that state and has availed itself of the benefits and protections
of its laws. Foreign manufacturers cannot hide behind distributors when they know where that
distributor is taking its products and when the manufacturer continues to give the product to the
distributor to send to the state. Lucky Hospital has stated that even after this suit it will continue
to sell to its distributor in the exact same way—such an attitude doesn’t show the fortuitous
arrival of products, it shows an intent to serve the sovereign.
Second, Lucky Hospital asks this Court to impute to Congress an intent to take away the
remedies of an entire class of person’s injured by a device which was never evaluated for its
safety. In Lohr, the Supreme Court rejected this exact type of argument and this Court should
continue to do so here.
Lucky Hospital made a choice to send hundreds of products into Cincinnatia and it made
a choice to not have its Hipflex device PMA approved, it is because of these choices that Lucky
Hospital should not be allowed to operate in this state with impunity for its actions and Taft’s claims
should not have been dismissed.
Petitioner’s Brief
Taft v. Lucky Hospital Supply, Inc.
35
APPENDIX A
FEDERAL FOOD, DRUGS, AND COSMETICS ACT, 21 U.S.C. § 360k
[State and local requirements respecting devices]
(a) General rule
Except as provided in subsection (b) of this section, no State or political subdivision of a
State may establish or continue in effect with respect to a device intended for human use any
requirement-(1) which is different from, or in addition to, any requirement applicable under this chapter to
the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in
a requirement applicable to the device under this chapter.
(b) Exempt requirements
Upon application of a State or a political subdivision thereof, the Secretary may, by
regulation promulgated after notice and opportunity for an oral hearing, exempt from
subsection (a) of this section, under such conditions as may be prescribed in such regulation,
a requirement of such State or political subdivision applicable to a device intended for human
use if-(1) the requirement is more stringent than a requirement under this chapter which would be
applicable to the device if an exemption were not in effect under this subsection; or
(2) the requirement-(A) is required by compelling local conditions, and
(B) compliance with the requirement would not cause the device to be in violation of any
applicable requirement under this chapter.
A1
APPENDIX B
FEDERAL FOOD, DRUGS, AND COSMETICS ACT, 21 U.S.C. § 360e
[Premarket approval]
(a) General requirement
A class III device-(1) which is subject to a1 an order issued under subsection (b) (or a regulation promulgated
under such subsection prior to July 9, 2012); or
(2) which is a class III device because of section 360c(f) of this title,
is required to have, unless exempt under section 360j(g) of this title, an approval under this
section of an application for premarket approval or, as applicable, an approval under
subsection (c)(2) of this section of a report seeking premarket approval.
(b) Order to require premarket approval
(1) In the case of a class III device which-(A) was introduced or delivered for introduction into interstate commerce for commercial
distribution before May 28, 1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to
another device within that type,
the Secretary shall by administrative order following publication of a proposed order in the
Federal Register, a meeting of a device classification panel described in section 360c(b) of
this title, and consideration of comments from all affected stakeholders, including patients,
payors, and providers, notwithstanding subchapter II of chapter 5 of Title 5, require that such
device have an approval under this section of an application for premarket approval.
Authority to issue such administrative order shall not be delegated below the Director of the
Center for Devices and Radiological Health, acting in consultation with the Commissioner.
(2) A proposed order required under paragraph (1) shall contain-(A) the proposed order;
(B) proposed findings with respect to the degree of risk of illness or injury designed to be
eliminated or reduced by requiring the device to have an approved application for
premarket approval and the benefit to the public from use of the device;
A2
(C) opportunity for the submission of comments on the proposed order and the proposed
findings; and
(D) opportunity to request a change in the classification of the device based on new
information relevant to the classification of the device.
(3) After the expiration of the period for comment on a proposed order and proposed findings
published under paragraph (2), consideration of comments submitted on such proposed
order and findings, and a meeting of a device classification panel described in section
360c(b) of this title, the Secretary shall (A) issue an administrative order under paragraph
(1) and publish in the Federal Register findings on the matters referred to in paragraph
(2)(B), or (B) publish a notice terminating the proceeding for the issuance of the
administrative order together with the reasons for such termination. If a notice of
termination is published, the Secretary shall (unless such notice is issued because the
device is a banned device under section 360f of this title) initiate a proceeding under
section 360c(e) of this title to reclassify the device subject to the proceeding terminated
by such notice.
(c) Application for premarket approval
(1) Any person may file with the Secretary an application for premarket approval for a class
III device. Such an application for a device shall contain-(A) full reports of all information, published or known to or which should reasonably be
known to the applicant, concerning investigations which have been made to show
whether or not such device is safe and effective;
(B) a full statement of the components, ingredients, and properties and of the principle or
principles of operation, of such device;
(C) a full description of the methods used in, and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing and installation of, such device;
(D) an identifying reference to any performance standard under section 360d of this title
which would be applicable to any aspect of such device if it were a class II device,
and either adequate information to show that such aspect of such device fully meets
such performance standard or adequate information to justify any deviation from such
standard;
(E) such samples of such device and of components thereof as the Secretary may
reasonably require, except that where the submission of such samples is impracticable
A3
or unduly burdensome, the requirement of this subparagraph may be met by the
submission of complete information concerning the location of one or more such
devices readily available for examination and testing;
(F) specimens of the labeling proposed to be used for such device;
(G) the certification required under section 282(j)(5)(B) of Title 42 (which shall not be
considered an element of such application); and
(H) such other information relevant to the subject matter of the application as the
Secretary, with the concurrence of the appropriate panel under section 360c of this
title, may require.
(2)(A) Any person may file with the Secretary a report seeking premarket approval for a
class III device referred to in subsection (a) of this section that is a reprocessed single-use
device. Such a report shall contain the following:
(i) The device name, including both the trade or proprietary name and the common or
usual name.
(ii) The establishment registration number of the owner or operator submitting the report.
(iii) Actions taken to comply with performance standards under section 360d of this title.
(iv) Proposed labels, labeling, and advertising sufficient to describe the device, its
intended use, and directions for use.
(v) Full reports of all information, published or known to or which should be reasonably
known to the applicant, concerning investigations which have been made to show
whether or not the device is safe or effective.
(vi) A description of the device's components, ingredients, and properties.
(vii) A full description of the methods used in, and the facilities and controls used for, the
reprocessing and packing of the device.
(viii) Such samples of the device that the Secretary may reasonably require.
(ix) A financial certification or disclosure statement or both, as required by part 54 of title
21, Code of Federal Regulations.
A4
(x) A statement that the applicant believes to the best of the applicant's knowledge that
all data and information submitted to the Secretary are truthful and accurate and that
no material fact has been omitted in the report.
(xi) Any additional data and information, including information of the type required in
paragraph (1) for an application under such paragraph, that the Secretary determines
is necessary to determine whether there is reasonable assurance of safety and
effectiveness for the reprocessed device.
(xii) Validation data described in section 360(o)(1)(A) of this title that demonstrates
that the reasonable assurance of the safety or effectiveness of the device will remain
after the maximum number of times the device is reprocessed as intended by the
person submitting such report.
(B) In the case of a class III device referred to in subsection (a) of this section that is a
reprocessed single-use device:
(i) Subparagraph (A) of this paragraph applies in lieu of paragraph (1).
(ii) Subject to clause (i), the provisions of this section apply to a report under
subparagraph (A) to the same extent and in the same manner as such provisions
apply to an application under paragraph (1).
(iii) Each reference in other sections of this chapter to an application under this section,
other than such a reference in section 379i or 379j of this title, shall be considered
to be a reference to a report under subparagraph (A).
(iv) Each reference in other sections of this chapter to a device for which an application
under this section has been approved, or has been denied, suspended, or
withdrawn, other than such a reference in section 379i or 379j of this title, shall be
considered to be a reference to a device for which a report under subparagraph
(A) has been approved, or has been denied, suspended, or withdrawn,
respectively.
(3) Upon receipt of an application meeting the requirements set forth in paragraph (1), the
Secretary-(A) may on the Secretary's own initiative, or
A5
(B) shall, upon the request of an applicant unless the Secretary finds that the information in
the application which would be reviewed by a panel substantially duplicates information
which has previously been reviewed by a panel appointed under section 360c of this title,
refer such application to the appropriate panel under section 360c of this title for study and for
submission (within such period as he may establish) of a report and recommendation respecting
approval of the application, together with all underlying data and the reasons or basis for the
recommendation. Where appropriate, the Secretary shall ensure that such panel includes, or
consults with, one or more pediatric experts.
(4)(A) Prior to the submission of an application under this subsection, the Secretary shall accept
and review any portion of the application that the applicant and the Secretary agree is complete,
ready, and appropriate for review, except that such requirement does not apply, and the Secretary
has discretion whether to accept and review such portion, during any period in which, under
section 379j(h) of this title, the Secretary does not have the authority to collect fees under section
379j(a) of this title.
(B) Each portion of a submission reviewed under subparagraph (A) and found acceptable by
the Secretary shall not be further reviewed after receipt of an application that satisfies the
requirements of paragraph (1), unless a significant issue of safety or effectiveness
provides the Secretary reason to review such accepted portion.
(C) Whenever the Secretary determines that a portion of a submission under subparagraph
(A) is unacceptable, the Secretary shall, in writing, provide to the applicant a description
of any deficiencies in such portion and identify the information that is required to correct
these deficiencies, unless the applicant is no longer pursuing the application.
(d) Action on application for premarket approval
(1)(A) As promptly as possible, but in no event later than one hundred and eighty days after
the receipt of an application under subsection (c) of this section (except as provided in
section 360j(l)(3)(D)(ii) of this title or unless, in accordance with subparagraph (B)(i), an
additional period as agreed upon by the Secretary and the applicant), the Secretary, after
considering the report and recommendation submitted under paragraph (2) of such
subsection, shall-(i) issue an order approving the application if he finds that none of the grounds for
denying approval specified in paragraph (2) of this subsection applies; or
A6
(ii) deny approval of the application if he finds (and sets forth the basis for such finding
as part of or accompanying such denial) that one or more grounds for denial
specified in paragraph (2) of this subsection apply.
In making the determination whether to approve or deny the application, the Secretary shall rely
on the conditions of use included in the proposed labeling as the basis for determining whether or
not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither
false nor misleading. In determining whether or not such labeling is false or misleading, the
Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.
(B)(i) The Secretary may not enter into an agreement to extend the period in which to take
action with respect to an application submitted for a device subject to a regulation
promulgated under subsection (b) of this section unless he finds that the continued
availability of the device is necessary for the public health.
(ii) An order approving an application for a device may require as a condition to such
approval that the sale and distribution of the device be restricted but only to the extent
that the sale and distribution of a device may be restricted under a regulation under
section 360j(e) of this title.
(iii) The Secretary shall accept and review statistically valid and reliable data and any
other information from investigations conducted under the authority of regulations
required by section 360j(g) of this title to make a determination of whether there is a
reasonable assurance of safety and effectiveness of a device subject to a pending
application under this section if-(I) the data or information is derived from investigations of an earlier version of
the device, the device has been modified during or after the investigations (but
prior to submission of an application under subsection (c) of this section) and
such a modification of the device does not constitute a significant change in the
design or in the basic principles of operation of the device that would invalidate
the data or information; or
(II) the data or information relates to a device approved under this section, is
available for use under this chapter, and is relevant to the design and intended use
of the device for which the application is pending.
A7
(2) The Secretary shall deny approval of an application for a device if, upon the basis of the
information submitted to the Secretary as part of the application and any other information
before him with respect to such device, the Secretary finds that-(A) there is a lack of a showing of reasonable assurance that such device is safe under the
conditions of use prescribed, recommended, or suggested in the proposed labeling
thereof;
(B) there is a lack of a showing of reasonable assurance that the device is effective under
the conditions of use prescribed, recommended, or suggested in the proposed labeling
thereof;
(C) the methods used in, or the facilities or controls used for, the manufacture,
processing, packing, or installation of such device do not conform to the requirements
of section 360j(f) of this title;
(D) based on a fair evaluation of all material facts, the proposed labeling is false or
misleading in any particular; or
(E) such device is not shown to conform in all respects to a performance standard in
effect under section 360d of this title compliance with which is a condition to
approval of the application and there is a lack of adequate information to justify the
deviation from such standard.
Any denial of an application shall, insofar as the Secretary determines to be practicable, be
accompanied by a statement informing the applicant of the measures required to place such
application in approvable form (which measures may include further research by the applicant in
accordance with one or more protocols prescribed by the Secretary).
(3)(A)(i) The Secretary shall, upon the written request of an applicant, meet with the applicant,
not later than 100 days after the receipt of an application that has been filed as complete under
subsection (c) of this section, to discuss the review status of the application.
(ii) The Secretary shall, in writing and prior to the meeting, provide to the applicant a
description of any deficiencies in the application that, at that point, have been
identified by the Secretary based on an interim review of the entire application and
identify the information that is required to correct those deficiencies.
(iii) The Secretary shall notify the applicant promptly of-(I) any additional deficiency identified in the application, or
A8
APPENDIX C
UNITED S TATES CONSTITUTIONAL PROVISIONS
U.S. Const. art. VI, cl. 2.
This Constitution, and the Laws of the United States which shall be made in Pursuance thereof;
and all Treaties made, or which shall be made, under the Authority of the United States, shall be
the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in
the Constitution or Laws of any State to the Contrary notwithstanding.
U.S. Const. amend. XIV, § 1
All persons born or naturalized in the United States, and subject to the jurisdiction thereof, are
citizens of the United States and of the state wherein they reside. No state shall make or enforce
any law which shall abridge the privileges or immunities of citizens of the United States; nor
shall any state deprive any person of life, liberty, or property, without due process of law; nor
deny to any person within its jurisdiction the equal protection of the laws.
A9
APPENDIX D
Interaction of the liner and the cup within a hip replacement system as demonstrated through the
Depuy, Ultamet metal-on-metal hip replacement system.
Depuy, ULTAMET® Metal-on-Metal Articulation, accessed on (Feb. 6, 2016), available at:
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