BRANDON B. TAFT, Petitioner v.

No. Rendigs--2016--0123
BRANDON B. TAFT,
Petitioner
v.
LUCKY HOSPITAL SUPPLY, INC.,
Respondent
Writ of Certiorari
BRIEF FOR THE PETITIONER
Team 3
Counsel for the Petitioner
Brandon Taft
February 15, 2016
AUGUST A. RENDIGS, JR. NATIONAL
MOOT COURT COMPETITION
____________________________
Page 1 of 37
ISSUES PRESENTED FOR REVIEW
I.
Does Cincinnatia have specific personal jurisdiction over Lucky Hospital Supply,
Inc.?
II.
Should the Hipflex and Lucky Liner combination be considered a premarket
approved device entitled to preemption of state law negligence claims under the
Medical Device Amendments, or a 510(k) device without such protections?
Page 2 of 37
TABLE OF CONTENTS
ISSUES PRESENTED FOR REVIEW .................................................................................................................. 2
STATEMENT OF THE CASE AND FACTS .......................................................................................................... 6
SUMMARY OF THE ARGUMENT .................................................................................................................. 10
ARGUMENT ................................................................................................................................................. 12
I. CINCINNATIA CAN EXTEND PERSONAL JURISDICTOIN THROUGH THEIR LONG-ARM STATUTE
OVER RESPONDENT. ............................................................................................................................... 12
A. CINCINNATIA HAS PERSONAL JURISDICTION OVER RESPONDENT BECAUSE THE
REQUIREMENTS OF DUE PROCESS HAVE BEEN MET. ......................................................................... 12
B. RESPONDENT HAD SUFFICIENT CONTACTS WITH CINCINNATIA SUCH THAT THE DUE PROCESS
HAS BEEN SATISFIED. .......................................................................................................................... 13
C. MR. TAFT HAS MET THE BURDEN OF SHOWING MININUM CONTACTS VIA THE RESPONDENT’S
WEBSITE. ............................................................................................................................................. 16
D. THE COURT OF APPEALS DID NOT APPLY THE NARROWEST HOLDING OF MCINTYRE IN
APPLYING THE STREAM OF COMMERCE THEORY. THEREFORE, CINCINNATIA CAN APPLY PERSONAL
JURISDICTION OVER RESPONDENT. .................................................................................................... 20
E. RESPONDENT HAS FAILED TO PRESENT ANY CLAIMS WHY CINCINNATIA’S EXERCISE OF
PERSONAL JURISDICTION WOULD BE UNFAIR AND UNJUST. ............................................................. 22
II. MR. TAFTS CLAIMS AGAINST THE HIPFLEX AND LUCKY LINER ARE NOT PREEMPTED BY FEDERAL
LAW 23
A. THE HIPFLEX ONLY RECEIVED §510(K) CLEARANCE UNDER THE MDA AND THEREFORE DOES
NOT TRIGGER PREEMPTION UNDER §360K(A) ................................................................................... 24
B.
RESPONDENT’S FOCUS ON THE LUCKY LINER TO PREEMPT MR. TAFT’S CLAIMS IS MISPLACED.
26
i.
EXPRESS PREEMPTION IS BASED ON THE REVIEW PROCESS THE ENTIRE DEVICE ACTUALLY
WENT THROUGH, NOT ITS INDIVIDUAL COMPONENT PARTS. ....................................................... 26
ii. THE CASES RELIED ON BY RESPONDENT TO DISTINGUISH WELL-ESTABLISHED LEGAL
PRINCIPLES ARE FACTUALLY INAPPLICABLE AND CONTRARY TO THE LAW. .................................. 28
C. PREEMPTING CLAIMS AGAINST A 510(K) CLEARED DEVICE WHICH CONTAINS A PREMARKET
APPROVED COMPONENT IS CONTRARY TO THE INTENT OF CONGRESS ............................................ 32
D. PREEMPTING CLAIMS AGAINST A 510(K) CLEARED DEVICE WHICH CONTAINS A PREMARKET
APPROVED COMPONENT IS CONTRARY TO PUBLIC POLICY ............................................................... 34
Page 3 of 37
TABLE OF AUTHORITIES
Cases
AFTG-TF, LLC v. Nuvoton Tech. Corp., 689 F.3d 1358 (Fed. Cir. 2012) ................................................. 19
Ainsworth v. Moffett Engineering, LTD., 716 F.3d 174 (5th Cir. 2013) ..................................................... 20
Asahi Metal Industry Co. v. Superior Court of Cal., Solano City., 480 U.S. 102 (1987) ........................... 20
Bausch v. Stryker Corp. 630 F.3d. 546 (7th Cir. 2010). .............................................................................. 31
Bellew v. Ethicon Inc. 2-14 WL 6674424, 4 (S.D.W Va. Nov. 24, 2014) ............................................ 25, 26
Bensusan Restaurant Corp v. King, 937 F. Supp. 295 (1996). ................................................................... 17
Bertini v. Smith & Nephew, Inc., 8 F.Supp.3d 246 (2014).......................................................................... 27
Burger King Corp v. Rudzewicz, 471 U.S. 462 (1985) ................................................................... 11, 12, 21
Choice Healthcare v. Kaiser, 615 F.3d 364, 368 (5th Cir. 2010) ................................................................ 11
Compuserve, Inc. v. Patterson, 89 F. 3d. 1265 (3RD Cir. 1996) .................................................................. 16
Cybersell, Inc. v. CyberSsell, Inc., 130 F.3d 414 (9th Cir. 1997) ................................................................ 17
Edwards v. Ethicon, Inc. 30 F. Supp.3d 554 (2014). ................................................................ 25, 26, 28, 29
Felty v. Conaway Processing Equipment Co., 738 F. Supp. 917, 919 (E.D. Pa. 1990).............................. 14
Hanson v. Denckla, 367 U.S. 235 (U.S. 1958) ........................................................................................... 12
Huskey v. Ethicon, Inc. 29 F.Supp. 3d 736 (S.D.W. Va 2014) ............................................................. 25, 30
Inset Systems, Inc. v. Instruction Set, 937 F. Supp. 161 (D. Conn. 1996) .................................................. 16
International Shoe Co. v. State of Washington, 326 U.S. 310 (U.S. 1945) .......................................... 11, 12
Irving v. Owens-Corning Fiberglass Corp, 864 F.2d 383 (5th Cir. 1989) .................................................. 11
J. McIntyre Machinery, Ltd. v. Nicastro, 131 S. Ct. 2780 (U.S. 2011). ............................................... 19, 20
Kernan v. Kurz-Hastings, Inc., 175 F. 3d 236 (2d Cir. 1999)..................................................................... 14
Lewis v. Johnson & Johnson, 991 F.Supp.2d 748 (S.D.W. Va. 2014) ................................................. 25, 26
Lewkut at 656. Duggan v. Medtronic, Inc. 840 F. Supp.2d 466 (D.Mass. 2012).................................. 27, 28
Lewkut v. Stryker Corp. 724 F. Supp.2d 648, 656 (S.D. Tex. 2010) .......................................................... 25
Marks v. United States, 430 U.S. 188 (1977) ............................................................................................. 19
Medtronic Inc. v. Lohr, 518 U.S. 470, (1996)..................................................................................... passim
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ........................................................................ 22, 23, 24, 28
Riley v. Cordis Corp. 625 F.Supp.2d 769, 780 (D. Minn. 2009). ......................................................... 25, 29
Shuker v. Smith & Nephew PLC, Civ. Action No. 13-6158, 2015 WL 1475368 (E.D. Pennsylvania, March
31, 2015) ........................................................................................................................................... 27, 30
Simon v. Smith & Nephew, Inc., 18 F.Supp.3d 423 (2014)................................................................... 27, 28
Stokes v. L. Geismar, S.A., 815 F. Supp. 904 (E.D. Va. 1993) ................................................................... 14
Walden v. Fiore, 134 S. Ct. 1115 (2014). ................................................................................................... 13
World-Wide Volkswagen Corp v. Woodson, 444 U.S. 286 (1980) ....................................................... 13, 18
Zippo Mfg. Co. v. Zippo Dot Com., 952 F. Supp. 1119 (W.D. Pa. 1997) ................................. 15, 16, 17, 18
Page 4 of 37
Statutes
21 C.F.R. 396 .............................................................................................................................................. 30
21 U.S.C. §360(a). ...................................................................................................................................... 23
21 U.S.C. §360c(a)(2) ................................................................................................................................. 27
21 U.S.C. §360e(d)(6)(A)(i) ....................................................................................................................... 30
21 U.S.C. §510(k) ................................................................................................................................ passim
21 U.S.C. 360k(a) ................................................................................................................................. 24, 25
Page 5 of 37
STATEMENT OF THE CASE AND FACTS
Mr. Brandon Taft, a resident of Clifton County, Cincinnatia, is the 55 year old owner and
operator of his self-owned carpentry business. R at 21. Mr. Taft is a carpenter by trade and
specializes in furniture repair, construction and sales. R at 21. The storefront is Mr. Taft’s
livelihood and supplies nearly all of his income. R at 21. Mr. Taft operated the storefront for 25
years before the events at the center of this case began. R at 21. Due to the nature of his
profession, Mr. Taft is required to maintain a standing or crouching position for hours on end
while performing his furniture crafting duties. R at 21. In March of 2012, Mr. Taft’s
physiologically strenuous career finally took its toll on his hips, forcing Mr. Taft to reduce his
hours of work and eventually seek professional medical treatment. R at 22.
In June of 2012, Mr. Taft consulted with Dr. Puma, a licensed physician with the state of
Cincinnatia since 1993 with an 8 year surgical residency under his belt. R at 15. Further, Dr.
Puma graduated from Harvard College with a degree in biology and attended the Geisel School
of Medicine at Dartmouth College. R at 15. Dr. Puma subsequently diagnosed Mr. Taft’s
condition as osteoarthritis of the left hip and recommended Mr. Taft undergo a total hip
replacement surgery, to which Mr. Taft agreed. R at 22.
Dr. Puma elected the Hipflex System (hereinafter “Hipflex”) produced by the Defendant,
Lucky Hospital Supply of Hong Kong, for Mr. Taft’s surgery. R at 16. In order to prevent
loosening and instability of the artificial joint, Dr. Puma also elected to combine the Hipflex with
the Lucky Liner, also produced by and advertised by the Defendant as being of significant use
with Hipflex. R at 16, 23 and 24. The Hipflex is often combined with optional lines for such
purposes. R at 23.
Page 6 of 37
Dr. Puma first learned of the Lucky hip replacement product line from a distributor of the
Defendant at a tradeshow whilst on vacation in Florida. R at 16. His decision to use the Hipflex
specifically was further backed by the raving reviews of his colleagues. R at 16. Upon visiting
the Defendant’s website, pop-up advertisements directed Dr. Puma to the exclusive U.S.
distributor of Defendant’s products, Fancy Medical Distributor (hereinafter “FMD”), from which
Dr. Puma ordered the device at issue. R at 16.
Defendant is a foreign international company located in Hong Kong. R at 21. Defendant
specializes in the design and production of a variety of medical devices, specifically hip
replacement and resurfacing products such as those at issue in the case at bar. R at 21. Defendant
has no real property or direct connections in the United States. R at 6. Defendant does engage in
the marketing of its products in all 50 states of the U.S. via an interactive website which
bombards and assaults visitors, such as Mr. Puma, with advertisements and pop-ups regarding
Defendant’s products and links to distributors of Defendant’s products. R at 6 and 7. One such
distributor, FMD, is the distributor through which Mr. Puma acquired Defendant’s device at
issue. R at 16.
FMD is engaged in a sales agreement with the Defendant as its exclusive distributor in
the entire United States, without territorial limit. R at 7 and 12. As the Defendant’s U.S.
distributor, FMD maintains the Defendant’s knowledge of product sales in the United States by
providing quarterly reports of purchasing details, including the specific sale locations. R at 7.
FMD heavily markets Defendant’s products at trade shows, including the Florida show to which
Dr. Puma’s knowledge of Defendant’s products came to be. R at 7. As a result, FMD has
purchased approximately 9,700 medical devices from the Defendant, 2.3% or 223 of which have
Page 7 of 37
been sold in Cincinnatia. R at 7 and 13. FMD is incorporated in Delaware with a principle
place of business in Chicago, Illinois. R at 7.
The Hipflex was the first of the Defendant’s prosthesis at issue to undergo approval by
the Food and Drug Administration (hereinafter the “FDA”). R at 23. The Hiplfex was subjected
to and passed the 510(k) process, which requires a less stringent analysis as compared to other
FDA approval process, i.e. an analysis of the device as being substantially similar to a previously
approved device. R at 23, and 27. Further, the Hipflex was authorized to be used with liners,
including retroactively with the Lucky Liner. R at 23 and 24.
The Lucky Liner, as permanently used as a component with the Lucky Hospital Hip
Resurfacing System, was subsequently produced and approved by the FDA through the PreMarket Approval process (hereinafter PMA). R at 23. Specifically, the Lucky Liner was cleared
to be sold with the Lucky Hospital Resurfacing System through the process of Supplemental
Approval. R at 23 and 24. The PMA process requires a more stringent analysis of the medical
device with respect to Federal health and safety requirements and therefore also pre-empts any
civil actions against such approved devices. R at 26.
After selecting the above described FDA approved hip prosthesis, Dr. Puma performed a
total hip replacement surgery on Mr. Taft. R at 22. The surgery resulted in the removal of Mr.
Taft’s left femoral head and acetabulum, and replacement with the Hipflex and the
optional Lucky Liner. R at 16.
Following the surgery, a liberated Mr. Taft initially returned to his work routine without
issues or signs of complications. R at 22. To his dismay, in October 2012, Mr. Taft began to
endure physical complications with the implanted prosthesis including painful clicking and
Page 8 of 37
popping sensations. R at 22. The complications soon evolved into debilitating pain requiring the
extensive use of painkillers. R at 22. Upon notification of his condition by Mr. Taft, Dr. Puma
diagnosed the post-surgery symptoms as a hiccup in the healing process and prescribed that Mr.
Taft the use of a wheel chair. R at 17. Regrettably, Mr. Taft’s extreme discomfort did not subside
and he was forced to undergo revision surgery. R at 17 and 23. During revision surgery, Dr.
Puma discovered that the Lucky Liner’s locking mechanism had failed to bond with the Hipflex
system and the liner had become extremely loose within the Hipflex artificial joint. R at 23.
Further, the loose components had grinded against one another causing metal shards from both
prosthesis to embed, lacerate, and inflame the tissue and muscles surrounding and surrounding
Mr. Taft’s joint. R at 17 and 22. Mr. Taft has been permanently wheelchair bound and is
devastatingly no longer able to operate his business and source of livelihood ever since. R at 23.
STATEMENT OF THE PROCEEDINGS BELOW
In the court of common pleas the Respondent filed a Federal Rules of Civil Procedure
12(b)(2) motion to dismiss for lack of facts to support jurisdiction, a 12(b)(6) motion for failure
to state a claim that relief can be granted for. Additionally, Respondent argued that Mr. Taft’s
claim was preempted by the MDA, 21 U.S.C. §360(c). This court held that there was personal
jurisdiction, however, the MDA preempted Mr. Taft’s claims. Thus, the court affirmed
Respondent’s motion to dismiss.
The First Circuit Court of Appeals affirmed the Court of Common Pleas, but their
reasoning differed. In the Court of Appeals Mr. Taft’s claims were found to not be preempted
due to the Hipflex not having pre-market approval. Further, that court found the trial court had
not correctly found that there was personal jurisdiction because there were not sufficient
minimum contacts.
Page 9 of 37
SUMMARY OF THE ARGUMENT
The State courts of Cincinnatia have personal jurisdiction over the Respondent, Lucky Hospital,
Inc. in the case at bar.
The court should hold that Mr. Taft has established sufficient minimum contacts between
Respondent and Cincinnatia. Mr. Taft has presented through the affidavits of Dominic Han and
Dr. Puma facts sufficient to support minimum contacts. Moreover, the Court of Appeals did not
correctly apply the stream-of-commerce theory that was relied upon by Respondent to overcome
personal jurisdiction.
When reviewing a case to dismiss, de novo, for lack of personal jurisdiction the
reviewing court looks at is a question of law when the facts below are not disputed. Thus, the
court can determine that the Court of Appeals did not correctly apply the proper stream-ofcommerce theory. Further, the court can review the affidavits of Dominic Han and Dr. Puma to
establish sufficient facts that Respondent has purposefully availed and benefited from the
privileges of doing business in Cincinnatia. Therefore, the court should hold that Cincinnatia can
apply personal jurisdiction without offending the traditional notions of fair-play and substantial
justice.
Mr. Taft’s State law claims against the Hipflex are not preempted under §360k(a).
The court should hold that a determination of preemption is to be based on the actual
review process the device in its entirety was subjected to and therefore Mr. Taft’s only chance at
recourse stands. The precedent relied on by Respondent to argue otherwise is factually
distinguishable and misguidedly applies established principles of law.
Page 10 of 37
Respondent designed the Hipflex with the Lucky Liner as a complete Class III medical
device and subjected it to review under the §510(k) clearance process. At no point did the device
that permanently placed Mr. Taft in a wheelchair undergo safety and effectiveness approval by
the Federal Government. Respondent suggests that a component of the device that was never
individually tested for safety and effectiveness qualifies the Hipflex as a premarket approved
device entitled to preemption. The fact that a component of a Class III medical device was
subsequently incorporated into a different medical device that underwent premarket approval is
irrelevant to whether the Hipflex implanted into Mr. Taft is a §510(k) medical device. To hold
otherwise would (1) affirm the misguided application of established legal principles proposed by
Respondent (2) reward manufacturers’ reckless Class III medical device design with a dangerous
civil liability loophole, (3) provide a result contrary to the intent of Congress in enacting the
federal act and its relevant provision, and (4) unjustly strip injured victims such as Mr. Taft of
remedy at law.
Page 11 of 37
ARGUMENT
I.
CINCINNATIA CAN EXTEND PERSONAL JURISDICTOIN THROUGH
THEIR LONG-ARM STATUTE OVER RESPONDENT.
A. CINCINNATIA HAS PERSONAL JURISDICTION OVER RESPONDENT
BECAUSE THE REQUIREMENTS OF DUE PROCESS HAVE BEEN MET.
Cincinnati’s long-arm statute allows it to extend personal jurisdiction outside of its
territory and apply personal jurisdiction upon foreign actors.
To establish personal jurisdiction over Respondent, a foreign company, Mr. Taft must
show that both the Cincinnatia long-arm statute and the 14th amendment Due Process
requirements are satisfied. Irving v. Owens-Corning Fiberglass Corp, 864 F.2d 383, 384-385 (5th
Cir. 1989). It has been a long standing rule that Due Process requires a nonresident defendant to
have certain minimum contacts with the forum so as not to offend traditional notions of fair play
and substantial justice. International Shoe Co. v. State of Washington, 326 U.S. 310, 316 (U.S.
1945)
The case at bar, as stated below, involves specific personal jurisdiction, “where a
nonresident defendant has purposefully directed its activities at the forum state and the litigation
results from alleged injuries that arise out of or relate to those activities.” Choice Healthcare v.
Kaiser, 615 F.3d 364, 368 (5th Cir. 2010).
The minimum contacts must arise out of actions by which the foreign defendant
purposefully avails itself of the privilege of conducting activities within the forum state, thus
invoking the benefits and protections of its law. Burger King Corp v. Rudzewicz, 471 U.S. 462,
475 (1985). This purposeful availment requirement ensures that a nonresident defendant will not
Page 12 of 37
“be haled into a foreign court…solely as random, fortuitous, or attenuated contacts” or as result
of the “unilateral activity of another person or third party.” Burger King at 475.
The framework set forth by the Supreme Court of the United States for establishing
personal jurisdiction under the Due Process clause is: (1) minimum contacts by the defendant be
purposefully directed at the forum state, (2) a nexus between the defendant’s contacts and the
plaintiff’s claims, and (3) that the exercise of jurisdiction over the defendant be fair and
reasonable. International Shoe Co. at 310. The courts below, however, disagreed upon whether
the first part of this framework had been met.
B. RESPONDENT HAD
SUFFICIENT
MINIMUM
CONTACTS
WITH
CINCINNATIA SUCH THAT THE DUE PROCESS HAS BEEN SATISFIED.
In International Shoe, the Supreme Court reasoned that activities that are carried out in the
forum state that benefit the manufacture, that are neither irregular or causal, but systematic and
continuous make a foreign defendant subject to personal jurisdiction. Int’l Shoe, 326 U.S. at 320.
The court reasoned that the manufacturer had done a “large volume” of interstate business, and
during that course the manufacturer had “received the benefits and protections of the laws of the
state;” those rights included the “right to resort to the courts for the enforcement” of their rights.
Id.
After Int’l Shoe, the Supreme Court in Hanson further explained what constitutes
minimum contacts under Due Process. In that case, the Supreme Court determined that personal
jurisdiction did not apply to a will dispute where the cause of action was not based on anything
that happened or took place in the forum state. The Court stated, “unilateral activity of those
claiming some relationship with a non-resident defendant cannot satisfy the requirement of
contact with the forum state.” Hanson v. Denckla, 367 U.S. 235 (U.S. 1958).
Page 13 of 37
Following Hanson, in World-Wide, the Supreme Court further fleshed out the first prong
of the Int’l Shoe framework. The Supreme Court stated, when a corporation purposefully avails
itself of the “privilege of conducting activities within the forum state, it has clear notice that it is
subject to suit there, and can act to alleviate the risk of burdensome litigation by procuring
insurance, passing the expected costs onto customers, or, if the risk are too great severing its
connection with the state.” World-Wide, 444 U.S. at 298. In World-Wide, a New York resident
bought a Volkswagen car in New York then drove the car to Oklahoma. While in Oklahoma, the
plaintiff was in a car accident, and then brought suit in Oklahoma against the car manufacturer.
The Supreme Court reasoned that because World-Wide never sold any cars in Oklahoma, there
were no minimum contacts. Further, the court held that World-Wide did not avail itself of any of
the privileges and benefits of Oklahoma law. Therefore, personal jurisdiction could not be
applied while maintaining the procedural safeguards of the Due Process clause. World-Wide
Volkswagen Corp v. Woodson, 444 U.S. 286 (1980).
The Court in World-Wide stated “if a sale of a product of a manufacturer or
distributor…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 if it allegedly… has been the source of injury to
its owner or others.” World-Wide, 444 U.S. at 298.
Comparatively, the sale of Hipflex system that was implanted into Mr. Taft was delivered
into Cincinnatia via the Distributor. This sale was not an “isolated sale” by the Distributor on
behalf of the Respondent. World-Wide, 444 U.S. at 298. For a court to exercise personal
jurisdiction consistent with Due Process, the defendant’s related conduct must create a
substantial connection with the forum state. Walden v. Fiore, 134 S. Ct. 1115 (2014). The sale of
Page 14 of 37
over two-hundred products to medical providers in Cincinnatia should be found as “substantial”
enough for this court to exercise personal jurisdiction over Respondent.
Further, the sale of the Hipflex in the United States and Cincinnatia was exactly what the
Respondent and Distributor signed their agreement to accomplish. This exclusive agreement
defined the territory of Distributor to be the entire United States. By signing the agreement
Respondent made itself amenable to suit where their exclusive distributor sold their product. See
Kernan v. Kurz-Hastings, Inc., 175 F. 3d 236, 242 (2d Cir. 1999) (holding that distributor’s
exclusive agreement to sell foreign manufacturer’s products within the United States, satisfied
the state long-arm statute and established personal jurisdiction over the foreign manufacturer).
Moreover, Respondent’s exclusive sales agreement required Distributor to make
quarterly reports of amount and location of sales. See Felty v. Conaway Processing Equipment
Co., 738 F. Supp. 917, 919 (E.D. Pa. 1990) (holding that manufacturer “clearly and
purposefully” contracted with the distributor to sell their products in the international market…
and was well aware that its equipment was being sold for use in the United States”). Respondent
could have severed with Cincinnatia or instructed their Distributor to not sell to Cincinnatia if
Respondent did not want to be brought before this court. See Stokes v. L. Geismar, S.A., 815 F.
Supp. 904 (E.D. Va. 1993) (holding that personal jurisdiction could be applied because there was
no evidence of any attempt to limit the US marketing strategy to avoid the forum state or any
other state.)
Therefore, by signing an exclusive agreement with Distributor, not taking any measures
to sever ties with Cincinnatia, knowing that their product was being sold in Cincinnatia, and
Page 15 of 37
receiving the profits associated with those sales, Respondent has purposefully availed itself of
the privileges of conducting business in Cincinnatia.
C. MR. TAFT HAS MET THE BURDEN OF SHOWING SUFFICIENT MININUM
CONTACTS VIA THE RESPONDENT’S WEBSITE.
Courts have adopted a sliding scale test when determining if a defendant has “purposely
availed” itself to a jurisdiction by way of their website. Zippo Mfg. Co. v. Zippo Dot Com., 952
F. Supp. 1119, 1124 (W.D. Pa. 1997). Purposeful availment on this sliding scale test requires the
defendant to “consummate some transaction or perform some act” with the forum. Which is
sufficient to find the defendant has invoked the benefit and protection of the forum’s law and
subjected itself to personal jurisdiction Id at 1126.
Respondent’s Internet website meets the requirements for personal jurisdiction under the
sliding scale test.
In Zippo, the court was asked to determine whether the defendant, Dot Com, conducting
electronic commerce with Pennsylvania (the forum) residents constituted the purposeful
availment of doing business in the forum. The Zippo court developed a sliding scale test to
determine when the purposeful availment prong has been met in allowing states to reach beyond
their borders to establish personal jurisdiction while meeting the safeguards of the Due Process
clause. Id at 1124.
The Zippo court reasoned that there were three different points on the scale: (1) where a
defendant enters into contracts with residents of a foreign jurisdiction that involve the knowing
and repeated transmission of computer files over the internet, personal jurisdiction is proper; (2)
interactive web sites where a user can exchange information with the host computer, in these
Page 16 of 37
cases the exercise of personal jurisdiction is determined by the level of interactivity and
commercial nature of the exchange of information that occurs on the web site; and (3) “Passive
web sites” that do no more than make information available to those who are interested in the
product, and the exercise of personal jurisdiction is not proper. Importantly, the court in Zippo,
stated “when the business of a defendant takes place solely over the internet” the results should
not be any different than if it took place by traditional means. Zippo Mfg., F. Supp. 1124 -1127.
Similarly to the case at bar, the defendant in Zippo attempted to argue that their contacts
with the forum were not numerous enough or of the quality required by Shoe, Hanson, WorldWide, and Burger King. The defendant in Zippo claimed their contacts with the forum state
accounted for only “two percent” of their business. The Court dismissed this argument, stating
the test has always focused on the “nature and quality” of the contacts with the forum and not the
quantity of those contacts. Zippo Mfg., F. Supp. at 1127. See also Compuserve, Inc. v. Patterson,
89 F. 3d at 1265 (3RD Cir. 1996) (holding that contacts were “deliberate and repeated” even if
there was little profit yielded by the foreign manufacturer).
Further, in Inset Systems, personal jurisdiction was exercised over a defendant who had
advertised via the Internet and provided a phone number to call and buy the product. The court
reasoned that advertising on the Internet constituted the purposeful availment of doing business
in the forum because “unlike television and radio advertising,” advertising over the Internet is
constant and having a phone number to call was more than mere advertising. Inset Systems, Inc.
v. Instruction Set, 937 F. Supp. 161, 165 (D. Conn. 1996).
Conversely, in Bensusan, the exercise of personal jurisdiction did not meet the
requirements set forth by the Due Process clause. In Bensusan, the defendant operated a passive
Page 17 of 37
website that gave general information about shows and performances occurring at a nightclub in
Missouri. The court reasoned that the website was passive because it only provided general
information, i.e., dates and times, but a customer would have to call to buy tickets or purchase
tickets at the venue. Thus, the court held, the only contact with the forum state was that the
website could be accessed from the forum. Zippo Mfg. v. Zippo Dot Com, F. Supp. 1119, 1125
(1997) (citing Bensusan Restaurant Corp v. King, 937 F. Supp. 295 (1996)).
Cybersell distinguished the difference between accessing information and soliciting
business. In Cybersell, the defendant’s website advertised its services in the forum state, but did
not allow webpage visitors to transact business via the website. The court concluded personal
jurisdiction was not proper when the foreign defendant had “done no act” and “consummated no
transaction” nor performed any other act to purposefully avail itself of the privilege of
conducting activities in the forum. Cybersell, Inc. v. CyberSsell, Inc., 130 F.3d 414 (9th Cir.
1997).
While deciding personal jurisdiction via the sliding scale test, supra, our sister courts
have focused on the interactivity of the website. Our sister courts have distinguished between a
website merely providing information, or actively soliciting the webpage visitors to conduct a
business transaction. As seen above, if a website does something more than presenting
information, i.e., actively solicits business and/or allows one to transact business over the
website, personal jurisdiction can be fairly exercised.
Respondent’s website falls into the second category of the sliding scale test discussed in
Zippo, because of the interactivity and commercial nature of the site. Zippo Mfg., at 1124.
Respondent’s website does not merely present information about the Hipflex, but as the trial
Page 18 of 37
court below stated “would be faced with a garish assault of pop-ups and advertisements hailing
the products of Respondent.” R at 6. Distributor was the sole distributor for Respondent’s
products in the United States. R at 12 (“In the United States, we have hired Fancy Medical
Distributors, Inc., to handle all of our sales and marketing in that region.”) Therefore, redirecting
Dr. Puma from their main website to their sole U.S. distributor constitutes “some act” and
Respondent facilitated “a transaction” between their exclusive United States distributor and
Cincinnatia via the Internet. This redirecting to Distributor’s website is allowing Respondent to
sell their products in the United States and Cincinnatia but at the same time propping up
Distributor as their straw-man to avoid liability.
The Court of Appeals, opined that Respondent’s contacts with Cincinnatia are fortuitous
because Dr. Puma unilaterally found and accessed their website. This opinion “misconstrues the
concept of fortuitous contacts” because there have been 223 other sales by Distributor in
Cincinnatia. Zippo Mfg., at 1126. When a defendant makes a conscious choice to conduct
business with the residents of a forum state, “it has clear notice that [they are] subject to suit
there.” World-Wide Volkswagen, 444 U.S. at 297
Respondent, through their knowledge of sales taking place in Cincinnatia, acknowledge
that someone from Cincinnatia could access the website, that their pop-up advertisements would
redirect the website visitor to a list of distributors in their location, and took no steps to prevent
someone from Cincinnatia from accessing the website. Respondent has “consciously chosen” to
conduct business with Cincinnatia; therefore, this court can exercise personal jurisdiction over
the Respondent.
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D. THE COURT OF APPEALS DID NOT APPLY THE NARROWEST HOLDING
OF MCINTYRE IN APPLYING THE STREAM OF COMMERCE THEORY.
THEREFORE, CINCINNATIA CAN APPLY PERSONAL JURISDICTION OVER
RESPONDENT.
Mr. Taft has established that under the stream of commerce theory and the controlling
holding of McIntyre that Cincinnatia has personal jurisdiction over Respondent.
When a decision by the Supreme Court of the United States 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 the position taken by those members who concurred in the judgments on the narrowest
grounds. Marks v. United States, 430 U.S. 188, 193 (1977). In AFTG-TG, the court stated that a
court should “refrain” from articulating on the stream-of-commerce theory “where the facts of a
particular case mandate exercising or declining to exercise personal jurisdiction under any
articulation of that theory. AFTG-TF, LLC v. Nuvoton Tech. Corp., 689 F.3d 1358 (Fed. Cir.
2012)
In the present case, the Court of Appeals relied heavily on the plurality opinion of
McIntyre, which stated a stream of commerce theory requiring “defendant activities manifest an
intention to submit to the power of a sovereign” forum. R at 32. This opinion, however, was not
the narrowest grounds, as stated above, thus it is not the controlling opinion. Therefore Justice
Breyer’s concurrence, which was joined by Justice Alito, controls in McIntyre. J. McIntyre
Machinery, Ltd. v. Nicastro, 131 S. Ct. 2780 (U.S. 2011).
In McIntyre, a British manufacturer sold their machines through an independent
distributor in the United States. The plaintiff was injured while working in the forum state by a
machine made by the British manufacturer. Importantly, this machine was the only one sold into
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New Jersey via an independent distributor (emphasis added). Therefore, the plurality opinion
held that there were not sufficient contacts between the British manufacturer and New Jersey.
Justice Breyer, however, made clear that in deciding the issue the Supreme Court would require
“no more” than following the precedent of that court and that the decision he made was “based
on the facts” of the case. McInytre, at 2792. Justice Breyer went on to state “none of the
precedents find that a single isolated sale, even if accompanied by the kind of sale effort
indicated here, is sufficient.” McIntyre, at 2792. In support of this precedent, Justice Breyer,
relied on another plurality opinion in Ashai.
In Ashai, a Japanese manufacturer sold tire parts to a Taiwanese manufacturer who then
sold the finished tire to California. The court held that there were no minimum contact between
California and Ashai to establish personal jurisdiction. This case, however, led to a plurality
opinion as well. Justice Brennan’s concurrence stated that “jurisdiction should lie where a sale in
a state is part of the regular and anticipated flow of commerce into the state.” Asahi Metal
Industry Co. v. Superior Court of Cal., Solano City., 480 U.S. 102 (1987)
For example, in Ainsworth, the 5th Circuit Court of Appeals upheld personal jurisdiction
over an Irish manufacturer. Similar to the case at bar, the defendant corporation had an exclusive
sales and distribution agreement with their sole U.S. distributor. The court concluded that
personal jurisdiction could be exercised over the defendant in part because they entered into a
specific agreement that delineated the distributor’s territory as the whole U.S. and the defendant
made no attempt to limit the scope of the distributor’s marketing effort. The 5th Circuit also noted
that since the defendant manufactured a forklift for poultry related use and that the forum was the
4th largest poultry producing state in the U.S., that defendant should have expected that its
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distributor made sales in the forum. Ainsworth v. Moffett Engineering, LTD., 716 F.3d 174 (5th
Cir. 2013)
McIntyre is distinguishable from the present case for the following reasons: (1)
Respondent entered into a detailed exclusive contract with Distributor, unlike the independent
distributor in McIntyre; (2) Respondent was made aware every quarter of the location of sales by
the Distributor, indicating the Distributor was not independent; (3) Distributor sold 223 of
Respondent’s manufactured goods in the forum; (4) Respondent hired Distributor to take care of
all its sales and marketing in the United States and never attempted to limit the scope of those
efforts; and (5) The sale to Dr. Puma was part of a regular flow of Respondent’s products into
Cincinnatia. Not only was it foreseeable that a Hipflex would be sold in Cincinnatia, Respondent
was actually aware of the previous 223 sales in the forum state. Therefore, Mr. Taft has that is
not unreasonable or unfair for this court to exercise personal jurisdiction over the Respondent.
E. RESPONDENT HAS FAILED TO PRESENT ANY CLAIMS WHY
CINCINNATIA’S EXERCISE OF PERSONAL JURISDICTION WOULD BE
UNFAIR AND UNJUST.
The second part of the framework is not at issue in this case. Since Respondent
manufactured the Hipflex and Lucky Liner, there is a “nexus” between the cause of the injury
and the defendant.
As stated at length above, based on the contacts between the Respondent and their
Distributor with the forum state it is not unreasonable to hold them amenable to suit in
Cincinnatia. See Burger King, 471 U.S. at 477 (recognizing that the state’s interest, among other
considerations, “sometimes serve to establish the reasonableness of jurisdiction upon a lesser
showing of minimum contacts that would otherwise be required”). Respondent’s sole argument
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against personal jurisdiction was that there were not minimum contacts. Thus, it would be
substantially unfair and unjust to allow a foreign manufacture who has sold hundreds of products
to this forum to escape liability for the injuries caused to Mr. Taft by simply hiring a distributor.
II.
MR. TAFTS CLAIMS AGAINST THE HIPFLEX AND LUCKY LINER ARE
NOT PREEMPTED BY FEDERAL LAW
In 1976, Congress addressed its concerns for consumer protection and the regulatory scheme
of complex medical devices by enacting the Medical Device Amendments (MDA) to the Food,
Drug, and Cosmetic Act. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). In the wake of a
surge of severe injuries related to medical devices, the MDA was designed to provide a national
form of regulation for the medical device industry. 21 U.S.C. §360(a).
In addition to the uniform regulatory scheme set forth, the MDA also contains an expresspreemption clause, 21 U.S.C. §360k(a), which forbids the recovery of injured parties under State
law claims that maintain safety and effectiveness requirements that are different from or in
addition to those imposed on medical devices by the FDA under the MDA. 21 U.S.C. §360k(a).
In response to the increasingly common question of whether state tort claims with respect to
an MDA medical device are preempted under §360k(a), the Supreme Court has established a
two-step test:
(1) Whether the Federal Government has established requirements applicable to the device at
issue; and
(2) If the Federal Government has established applicable requirements, whether the state law
claims are based on state safety and effectiveness requirements on the device which differ
or are in addition to the Federal requirements.
Riegel, 552 U.S. at 321-22; 21 U.S.C. §360k(a).
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The Supreme Court has been clear, under part one of the two-part preemption inquiry,
that the rigorous FDA PMA process for the approval of Class III medical devices invokes the
express preemption clause, whereas the more lenient §510k process for the clearance of Class III
medical devices does not. Riegel at 323; Medtronic Inc. v. Lohr, 518 U.S. 470, 513 (1996).
Under part two of the preemption inquiry, it is undisputed that the state claims in the case at bar
are different or in addition to federal requirements imposed under the MDA. Therefore, the
question which remains is whether the Federal Government has established requirements to the
device issue, the Hipflex.
The Hipflex device that injured Mr. Taft in the case at bar was only cleared under the
510(k) process for substantial similarity to a pre-1976 device and therefore fails under part one
of the inquiry to trigger preemption under §360k(a) of the MDA. Respondent, in an attempt to
circumvent liability and strip Mr. Taft of recourse, misguidedly focuses on the separate and
subsequent supplemental premarket approval of a component of the Hipflex, the Lucky Liner.
Mr. Taft respectfully asks the court to dismiss Respondent’s arguments as contrary to wellestablished law, the intent of congress, and public policy.
A. THE HIPFLEX ONLY RECEIVED §510(K) CLEARANCE UNDER THE MDA
AND THEREFORE DOES NOT TRIGGER PREEMPTION UNDER §360K(A)
Under the first step in the Riegel preemption test, it is undisputed that premarket approval
imposes requirements on a medical device with respect to safety and effectiveness under the
MDA, while the §510(k) process does not. Riegel at 323; Lohr at 513.
The distinction drawn by the Supreme Court is based on the focus and extensiveness of
the review processes. The premarket approval process is a rigorous process, approximately 1,200
hours in length, which focuses on the safety and effectiveness of the device under review. Lohr
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at 477. The process also subjects the device to a risk-benefit analysis to determine whether the
societal benefits of the device outweigh the societal risks posed. Riegel at 318. The §510(k)
clearance process on the other hand, is a less stringent process, approximately 20 hours in
length, which focuses only on the equivalence or “substantial similarity” of the device under
review with respect to pre-MDA devices. Id at 323. As a result, devices reviewed under the
premarket approval process are subject to device-specific safety and effectiveness requirements,
while 510(k) cleared devices are subject only to the same general regulations as most other
devices. Id at 322-23
“If a device is subject only to general federal regulations and not federal requirements,
§360k(a) does not preempt state law requirements or duties with respect to that device.” 21
U.S.C. 360k(a). Riegel, at 324. Thus, as held by the Supreme Court, the MDA does not preempt
product liability claims against a medical device cleared only through the §510(k) process. Lohr
at 513.
Here, Mr. Taft’s state law claims are aimed at the interaction of the components of the
Hipflex device. The Hipflex only received §510(k) clearance and was therefore never subject to
federal safety and effectiveness requirements so as to invoke preemption under §360k(a).
Respondent designed the Hipflex and Lucky Liner as a single, complete Class III medical device.
The FDA only reviewed the Hipflex with a variety of liners, including the Lucky Liner, for
substantial similarity to a pre-MDA device. At no point did the device which was implanted into
Mr. Taft undergo the detailed, rigorous 1,200 hour safety and effectiveness review of premarket
approval. The Lucky Liner was established as a component of the Hipflex device and was never
individually cleared for safety and effectiveness with any other device besides the Hip Resurface
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System. Therefore, there are no federal requirements on the Hipflex to preempt state law claims
under §360k(a).
B. RESPONDENT’S FOCUS ON THE LUCKY LINER TO PREEMPT MR. TAFT’S
CLAIMS IS MISPLACED.
Respondent attempts to circumvent the lack of Federal device-specific safety and
effectiveness requirements on the Hipflex, by changing the focus to the Lucky Liner component
of the device. Specifically, Respondent argues that because the Lucky Liner was subsequently
added as a component to a different device which was reviewed under premarket approval for
safety and effectiveness, the requirements placed on the other device should apply to the Lucky
Liner and carry with it to the Hipflex so as to preempt claims against the Hipflex. For the
following reasons, Respondent’s arguments are misguided.
i.
EXPRESS PREEMPTION IS BASED ON THE REVIEW PROCESS THE ENTIRE
DEVICE ACTUALLY WENT THROUGH, NOT ITS INDIVIDUAL
COMPONENT PARTS.
Respondent, in focusing on the review of the Lucky Liner is asking the court to break down
the Hipflex device into its component parts for purposes of preemption analysis. To do so would
be contrary to established principles of law.
Persuasive authority has held that a device regulated by the MDA “should not be broken
down into its component parts in order to apply preemption analysis.” Edwards v. Ethicon, Inc.
30 F. Supp.3d 554, 559 (2014). Doing so adds a level of complication not anticipated by the
FDA, Congress or medical device manufacturers. Lewkut v. Stryker Corp. 724 F. Supp.2d 648,
656 (S.D. Tex. 2010).; Edwards at 561. Specifically the court in Riley v. Cordis Corp. stated:
“It makes no sense – indeed, it would probably be impossible – to pick apart the
components of a medical device and apply different preemption analysis to different
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components . . . [b]ecause the FDA regulated [the device] as a medical device, the Court
applies the express preemption analysis of §360k(a) to the entire device.”
Riley v. Cordis Corp. 625 F.Supp.2d 769, 780 (D. Minn. 2009).
Although the above rationale has more commonly been applied in cases involving a PMA
approved device that contains a §510(k) cleared component, it carries through to the inverse
scenario, as in the case at bar. Edwards at 560; Huskey v. Ethicon, Inc. 29 F.Supp. 3d 736, 748
(S.D.W. Va 2014); Lewis v. Johnson & Johnson, 991 F.Supp.2d 748, 760 (S.D.W. Va. 2014);
Bellew v. Ethicon Inc. 2-14 WL 6674424, at 4 (S.D.W Va. Nov. 24, 2014). For example, the
reasons a component was approved under premarket approval in one device may not carry over
to a new device. Lewis at 758. When the FDA reviews a device for premarket approval or
supplemental premarket approval, the safety and effectiveness of the device’s components are
only examined within the bounds of the device under review. See 21 U.S.C. §360c(a)(2) (for
purposes of premarket approval, “the safety and effectiveness of a device are to be determined . .
. with respect to the persons for whose use the device is presented or intended [and] with respect
to the conditions of use prescribed, recommended, or suggested in the labeling of the device”). In
other words, the components of a device undergoing premarket approval are not individually
reviewed for their safety and effectiveness as a component for use with other devices.
Therefore, “Just as a device receiving premarket approval cannot be separated into its
component parts to avoid application of express preemption . . . a device receiving §510(k)
[clearance] . . . cannot be separated into its component parts to create express preemption.”
Lewis at 760; Bellew at 4; Huskey at 748; Edwards at 560.
Here, the Respondent focuses on the Lucky Liner component of the Hipflex in its preemption
analysis. The fact that the Lucky Liner, merely a component of the Hipflex device, underwent
supplemental premarket approval as the component of another device is irrelevant to the
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preemption analysis of the Hipflex. The Hipflex, as a completed device, was only cleared by the
FDA through the §510(k) process. The device was never subject to or approved through the
premarket approval process. Further, the Lucky Liner, as a component of the Resurface System,
was never individually reviewed by the FDA for its safety and effectiveness with other devices.
Therefore, the Federal Government never placed safety and effectiveness requirements on the
Hipflex and Mr. Taft’s claims are not preempted under §360k(a).
ii.
THE CASES RELIED ON BY RESPONDENT TO DISTINGUISH WELLESTABLISHED LEGAL PRINCIPLES ARE FACTUALLY INAPPLICABLE AND
CONTRARY TO THE LAW.
Respondent unpersuasively distinguishes the above precedent by relying on a series of cases
which allegedly held supplemental premarket approval of an optional liner component
preemptive of state law claims against a §510(k) device. These cases – Bertini, Simon, and
Shuker – misguidedly apply the precedent in a way contrary to established legal principles.
Further, Simon and Shuker are factually distinguishable from the case at bar. Bertini v. Smith &
Nephew, Inc., 8 F.Supp.3d 246 (2014); Simon v. Smith & Nephew, Inc., 18 F.Supp.3d 423
(2014); Shuker v. Smith & Nephew PLC, Civ. Action No. 13-6158, 2015 WL 1475368 (E.D.
Pennsylvania, March 31, 2015). If the court were to adopt Respondent’s argument, the court
would not only be applying a series of factually inapplicable cases, but would also misapply the
precedent for a result contrary to the holdings of the Supreme Court.
Of the three cases relied on by the Respondent, the court in Bertini is the closest factually
and legally to the case at issue. The court in Bertini, dealt with an injury caused by a §510(k)
cleared hip replacement device including a component that was subsequently premarket
approved with respect to a different device. Bertini at 250. In addition to the factual similarities,
the court also correctly cited the precedent as requiring that preemption must be applied to a
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device as a whole rather than individually to its component parts, and once preemption is found
for an entire device, all claims related to all components of the device are also preempted.
Lewkut at 656. Duggan v. Medtronic, Inc. 840 F. Supp.2d 466, 471 (D.Mass. 2012). This is
where the applicability of the case stops. As noted by the court in Edwards, after correctly
identifying the applicable legal principles, the Bertini court proceeds to “confuse” its application
by doing the complete opposite and holding preemption of a component supersedes preemption
of the device. Edwards at 562. Not only was the court confused in its application of Lewkut, but
it also created a misguided understanding that the holding in Duggan that the requirements of a
device extend to its components for preemption of claims against the components as part of that
device also extends outside the context of the premarket approved device to §510(k) devices.
The court in Duggan dealt with a premarket approved device which included a formerly §510(k)
approved component that was also approved with the device at issue through supplemental
premarket approval. Duggan at 469-70. The court held that the preemption of claims against the
device as a whole also extended against the individual components in that same case. Duggan at
471. Meaning, that a Plaintiff cannot avoid preemption by bringing a claim against an individual
component of a device in the same case a claim against the entire device is held preempted.
Duggan never held that a §510(k) device could qualify for preemption protection by the
inclusion of a separately premarket approved component. The result in Bertini, is the preemption
of State law claims against a §510(k) device, which is clearly contrary to the holdings of the
Supreme Court in Lohr and Riegel. Lohr at 513. Riegel at 323.
The second case relied on by Respondent – Simon – is not only factually distinguishable
from Mr. Taft’s case, but also misguided in its application of the precedent. The Respondent
correctly recognizes that Simon dealt with a hip replacement device, the R3, implanted with a
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liner that was separately approved through the premarket approval of a different device. Simon
at 426. Respondent fails to point out that approved optional liner implanted with the R3 system
was never part of the R3 system when it was reviewed by the FDA under the §510(k) process. Id
at 426. Therefore, the device that was implanted in the injured plaintiff was never reviewed by
the FDA as a whole device and cannot be analyzed under 360k(a) as a whole. Id. Further, the
plaintiff’s claims in Simon only related to the failure of the liner. Id at 428. The plaintiff never
alleged that components of the R3 device were defective in conjunction with the optional liner.
Id. In the case of Mr. Taft, the Hipflex device which caused his injury was cleared by the FDA as
a whole device through the §510(k) process, including the Lucky Liner. Furthermore, the Lucky
Liner was designed as part of the Hipflex device. Additionally, Mr. Taft’s claims are based on
the interaction of the Hipflex components including the Lucky Liner, not solely on a component
that was never designed or reviewed as part of the implanted device. Finding Simon as involving
a similar situation to the case at bar would require many unsupported leaps.
In addition to the factual gaps between Simon and the case at bar, the court in Simon also
misguidedly applies the holdings of the precedent. The court in Simon takes the leap itself to
apply the precedent as if the liner and R3 system were designed to be used together. Id at 428. In
doing so, the court relied heavily on Riley to find claims against the §510(k) cleared device
preempted based on the separately premarket approved liner component. Id. The court in Riley
held that under §360k(a)(1), the question is not whether there are federal requirements applicable
to a particular use of a device but rather to the device itself, and that the premarket approval
process applied such requirements to a device so as to preempt. Riley at 779. See 21 C.F.R. 396
(premarket approval requires that the device be put on the market in the form it was approved but
does not prevent the use of the device in a different manner). The court in Riley dealt with an offPage 30 of 37
label use of an entire device, and never held that premarket approval of a component part of a
device meant that all claims against a different §510(k) cleared device were preempted. Edwards
at 561. The court in Simon misguidedly applied Riley and the established principle that off-label
use of a device does not render 360k(a) inapplicable, to transfer requirements placed on a
component to a completely different device. Specifically, the premarket approval process under
21 U.S.C. §360e(d)(6)(A)(i) prohibits “any change to a device . . . that affect safety or
effectiveness” outside the supplemental premarket approval process. Removing all components
from the premarket approved device in Simon to leave the optional liner and then replace the
removed components with the §510(k) cleared R3 system is not an “off-label use of a device”,
but rather a “change that affects safety and effectiveness” and removes the requirements from the
device. Applying Simon to the case at bar would require the court to also misguidedly apply the
precedent and well established legal principles. Other courts including Huskey and Edwards have
elected not to apply Simon for this very reason. Huskey at 751. Edwards at 561.
Finally, the third case relied on by the Respondent – Shuker – is both factually
distinguishable and expressly states its inapplicability to the factual case at issue. The court did
not reject the holding in Huskey, but rather distinguished its application to the case. Similarly to
the factual scenario in Simon, the court in Shuker dealt with a device that was never reviewed by
the FDA as a complete device under either premarket approval or §510(k) process and therefore
is materially different from the case at bar. Shuker at 9. Specifically, the court in Shuker stated,
with respect to looking at the system implanted as a whole in applying preemption analysis:
“while this approach makes sense in cases in which the FDA has actually reviewed the
system at issue, that is not the case here, as the R3 system the FDA cleared via the
§510(k) process did not include the metal liner. There is thus no basis to characterize the
hip system implanted”
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Shuker at 9. The court in Shuker recognizes that the appropriate preemption analysis in the case
at bar is with respect to the device as a whole, not the individual components. The Shucker
analysis relied on by Respondent is therefore inapplicable to Mr. Taft’s case.
Express preemption analysis under §360k(a) is based on the MDA review process the device as a
whole underwent. The cases relied on by respondent to distinguish this well-established legal
principle are factually distinguishable to the case at bar and are misguided in their application of
the precedent. Here, the Hipflex was only cleared by the FDA though the §510(k) process and is
therefore not entitled to preemption under §360k(a).
C. PREEMPTING CLAIMS AGAINST A 510(K) CLEARED DEVICE WHICH
CONTAINS A PREMARKET APPROVED COMPONENT IS CONTRARY TO
THE INTENT OF CONGRESS
The intent of Congress is the ultimate touchstone in determining the scope of a
preemption provision. Lohr at 485. Applying preemption analysis individually to each
component of a medical device so as to preempt claims against an unapproved device as a whole
is contrary to the intent of Congress in enacting both the Medical Device Amendments and its
preemption provision §360k(a).
In 1976, Congress enacted the Medical Device Amendments to address concerns created
by an influx of severe injuries caused by high risk medical devices. Id at 490. Specifically, the
amendments gave form to federal safety and effectiveness regulations applied through the
premarket approval process. Id. The §510(k) exception to premarket approval was created to
help consumers retain access to pre-MDA devices until the FDA was able to subject them to
premarket approval review, while also ensuring the grandfathered devices did not receive an
unintended monopoly in the industry. Id at 478-79. Finally, the §360k(a) preemption provision of
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the amendments ensured federal regulation without the risk of different or additional State
regulation interference. Id at 489. The provision was intended to protect a manufacturer of a
premarket approved device from civil liability insomuch as it has complied with federal law,
without extending protection from liability where the manufacturer has not complied with federal
law. Bausch v. Stryker Corp. 630 F.3d. 546, 553 (7th Cir. 2010).
Allowing a single component of a complex medical device, that has only been reviewed
under premarket approval as a component of a completely different device to preempt Mr. Taft’s
claims against the device which caused his injury would create an unforeseen loophole, shielding
manufacturers from civil liability for the design of unsafe medical devices. Such a holding uses
the tool Congress created to regulate and prevent the marketing of unsafe medical devices, for
the exact opposite purpose. Specifically, to protect from civil liability unsafe medical devices
based on the very generation of devices which inspired the tools creation. Furthermore, applying
the preemption analysis proposed by Respondent to categorize the Hipflex as a premarket
approved medical device entitled to preemption would strip Mr. Taft and many other plaintiffs of
recourse for the injuries caused by a device that was never itself reviewed for safety and
effectiveness by the FDA. Not only is this not what Congress intended in enacting the Medical
Device Amendments, but it is the exact opposite.
Holding the Hipflex to be a premarket approved medical device entitled to preemption
protection against state law claims is also contrary to the intent of Congress in enacting the
preemption provision of the Medical Device Amendments. Such an application of the provision
would create a loophole through which manufacturers can violate federal law and avoid
premarket approval, while retaining the same preemption protection as premarket approved
devices under §360k(a). Additionally, the application would preempt State law claims regarding
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safety and effectiveness where no federal regulation exists. It is completely contrary to
Congress’s intent to apply §360k(a) in a way which unconstitutionally interferes with State
sovereignty and allows manufacturers to avoid the premarket approval process which is the heart
of the Medical Device Amendments.
Overall, Congress did not intend in enacting both the Medical Device Amendments and
the §360k(a) preemption provision to provide civil liability immunity to a medical device that
was never approved for safety and effectiveness by the mere inclusion of a component that was
itself never approved for safety and effectiveness, but was rather part of a completely different
device that was separately approved. Congress did not intend to give approval and protection by
association.
D. PREEMPTING CLAIMS AGAINST A 510(K) CLEARED DEVICE WHICH
CONTAINS A PREMARKET APPROVED COMPONENT IS CONTRARY TO
PUBLIC POLICY
Applying preemption analysis to the individual components of a medical device so as to
preempt claims against the device as a whole creates an inequity between consumers and
manufacturers, and negatively affects judicial administration.
First, an undue burden would be placed on consumers in selecting which potentially life
threatening medical device to implant into their body. Rather than being able to rely on the
FDA’s premarket approval of the safety and effectiveness of an entire device, consumers will be
required to perform an additional lengthy step to determine whether a device not regulated for
safety and effectiveness is protected from State liability based on its components. Specifically, a
consumer would be required to break apart complex medical devices into their component parts
and research whether each component was reviewed under premarket approval with any device.
Page 34 of 37
This also means that an injured consumer may be stripped of recourse against the responsible
device that was never itself approved by the FDA for safety and effectiveness, but happened to
incorporate a component that was reviewed with a completely different device. Such would be
the case for Mr. Taft who would be unable to recover against the device which permanently
placed him in a wheel chair and forced him to quit the job which was the source of his
livelihood.
Further yet tipping the scales of inequity is the loophole such a holding would create for
manufacturers of medical devices. Manufacturers will be motivated to creatively design, produce
and sell unsafe medical devices with the ability to avoid liability under both Federal and State
law safety and effectiveness regulations. For example, a medical device manufacturer would be
able to subject a single device to the rigorous premarket approval process, and by incorporating a
single component of that device into every other device manufactured avail itself of complete
immunity against State law claims involving safety and effectiveness. It would not be unjust nor
would it hinder innovation to relieve this inequity by placing the burden on the manufacturer to
subject each of its high risk Class III medical devices to strict federal safety and effectiveness
requirements before awarding the protection of preemption. See Lohr at 490 (“nowhere in the
materials relating to the Act’s history have we discovered a reference to fear that product liability
action would hamper the development of medical devices”).
Finally, in addition to the inequity created between consumers and manufacturers,
applying preemption analysis individually to each component of a medical device would
complicate the already chaotic preemption analysis and bog down the courts with a time
consuming analysis just to determine whether a plaintiff’s claims are preempted. Time would be
better spent on the substantive questions of law and fact in such cases. For purposes of judicial
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efficiency, preemption should be determined based on the review process the device as a whole
was reviewed under.
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CONCLUSION
For the forgoing reason, the court should reinstate the Court of Common Pleas’ finding of
personal jurisdiction and the Court of Appeals’ finding that the Hipflex in not entitled to
preemption protection under §360k(a).
Respectfully Submitted,
Team 3
Dated: February 15, 2016
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