William Sanders v. Advanced Neuromodulation Systems, Inc. ( 2009 )

IN THE SUPREME COURT OF MISSISSIPPI
NO. 2009-CA-00594-SCT
WILLIAM SANDERS
v.
ADVANCED NEUROMODULATION SYSTEMS,
INC.
DATE OF JUDGMENT: 04/03/2009
TRIAL JUDGE: HON. JAMES LAMAR ROBERTS, JR.
COURT FROM WHICH APPEALED: LEE COUNTY CIRCUIT COURT
ATTORNEY FOR APPELLANT: D. L. JONES, JR.
ATTORNEY FOR APPELLEE: LEAH NICHOLS LEDFORD
NATURE OF THE CASE: CIVIL - PERSONAL INJURY
DISPOSITION: AFFIRMED - 09/30/2010
MOTION FOR REHEARING FILED:
MANDATE ISSUED:
BEFORE WALLER, C.J., DICKINSON AND CHANDLER, JJ.
CHANDLER, JUSTICE, FOR THE COURT:
¶1. This case involves whether a trial court erred by granting summary judgment in favor
of Advanced Neuromodulation Systems, Inc. (ANS) on the basis of federal preemption for
a medical device regulated by the United States Food and Drug Administration (FDA). The
case turns on whether a genuine issue of material fact exists as to classification of the device.
A medical device designated as a class II device is subject to state law, whereas a medical
device designated as a class III device is entitled to federal preemption.
¶2. William Sanders (Sanders) filed a complaint against ANS, North Mississippi Medical
Center, Inc. (NMMC), Dr. Benjamin Wiseman, and John Does one through five in the Circuit
Court of Lee County, Mississippi. Sanders alleged that he had an operation on September
14, 2005, at NMMC to remove the left lead of a spinal-cord stimulator. A spinal-cord
stimulator is for treatment of chronic intractable pain of the trunk or limbs. Dr. Wiseman and
NMMC purchased the spinal-cord stimulator from ANS, the manufacturer and distributor of
the medical device used in the procedure. During the operation to remove the left lead of the
spinal-cord stimulator, the product broke, allegedly causing Sanders’s injury and damages.
Sanders’s causes of action included (1) negligent manufacture of the spinal-cord stimulator
by ANS; (2) distribution of a defective and dangerous product in commerce by ANS,
NMMC, and Dr. Wiseman; and (3) strict liability for injuries resulting from the manufacture,
sale, and distribution of a defective product by ANS.1 ANS filed its answer and affirmative
defenses. Thereafter, ANS filed a motion for summary judgment and memorandum in
support of its motion. After conducting a hearing, the trial court granted summary judgment
in favor of ANS, finding that Sanders’s claims against ANS were barred by the Medical
Device Amendments (MDA) preemption clause and that ANS was entitled to judgment as
a matter of law.2 Following this decision, Sanders appealed to this Court.
FACTS
¶3. ANS manufactures a spinal-cord stimulator known as a GenesisXP Implantable Pulse
Generator System (GenesisXP). This device uses low-intensity electrical impulses to
interfere with pain signals sent to the brain to prevent pain to a patient. While these devices
1
The trial court docket indicates that the trial court granted a motion to dismiss in
favor of NMMC and Dr. Wiseman on May 2, 2008.
2
Medical Device Amendments of 1976, 21 U.S.C. § 360k (2006).
2
may be either partially or totally implantable in a patient, the GenesisXP at issue is a totally
implantable device. In February 2005, ANS sent NMMC a GenesisXP, a Quattrode lead, and
a Patient Programmer for the GenesisXP.
¶4. The FDA regulates drugs and devices pursuant to the Federal Food, Drug, and
Cosmetic Act (the FDCA). See 21 U.S.C. §§ 301 to 399 (2006). In 1976, the FDCA was
amended with the Medical Device Act (MDA). See (Pub. Law 94-295); 21 U.S.C. § 360c
(2006). The MDA classified medical devices into three categories, class I, II, and III. See
21 U.S.C. § 360c (2006). The classes are distinguished as class I general controls, class II
special controls, and class III premarket approval. See U.S.C. § 360c(a)(1)(A), (B), and, (C)
(2006). The MDA automatically classifies a device as a class III device if it has been
introduced into the market after May 28, 1976. See 21 U.S.C. § 360c(f)(1) (2006).3
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21 U.S.C. § 360c states, in part:
(f) Initial classification and reclassification of certain devices
(1) Any device intended for human use which was not introduced or delivered
for introduction into interstate commerce for commercial distribution before
May 28, 1976, is classified in class III unless--
(A) the device--
(i) is within a type of device (I) which was
introduced or delivered for introduction into
interstate commerce for commercial distribution
before such date and which is to be classified
pursuant to subsection (b) of this section, or (II)
which was not so introduced or delivered before
such date and has been classified in class I or II,
and
(ii) is substantially equivalent to another device
within such type, or
3
However, a manufacturer may petition the FDA to reclassify a device from class III to class
I or II. See 21 U.S.C. § 360c(f)(1)(B) (2006).
¶5. The GenesisXP was placed on the market after May 28, 1976. In June 1999, ANS
petitioned the FDA to reclassify the totally implanted spinal-cord stimulator for pain relief
from a class III device to a class II device. However, the FDA denied ANS’ petition to
reclassify the device from a class III to a class II device in February 2001. In its letter, the
FDA described the history and classification process, as follows:
In accordance with sections 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial
distribution prior to May 28, 1976 (the date of enactment of the Medical
Device Amendments of 1976 (the amendments)), generally referred to as
postamendments devices, are classified automatically by statute into class III
without any FDA rulemaking. Those devices remain in class III and require
premarket approval, unless and until: (1) the device is reclassified into class
I or II; (2) FDA issues an order classifying the device into class I or II in
accordance with new section 513(f)(2) of the act (21 U.S.C. 360c(f)(2)), as
amended by the Food and Drug Administration Modernization Act of 1997
(FDAMA); or (3) FDA issues an order finding the device to be substantially
equivalent, in accordance with section 513(I) of the act (21 U.S.C. 360c(I)),
to a predicate device that does not require premarket approval. The agency
determines whether new devices are substantially equivalent to previously
marketed devices by means of premarket notification procedures in section
510(k) of the act (21 U.S.C. 360(k)) and Part 807 of the regulations (21 CFR
Part 807).
As you know, on June 16, 1999, you submitted a petition requesting
(B) the Secretary in response to a petition submitted under
paragraph (3) has classified such device in class I or II.
A device classified in class III under this paragraph shall be classified in that
class until the effective date of an order of the Secretary under paragraph (2)
or (3) classifying the device in class I or II.
21 U.S.C. § 360c (2006).
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reclassificiation of the Totally Implanted Spinal Cord Stimulator for Pain
Relief from a class III into class II. The petition was submitted under section
513(f)(2) of the act, now section 513(f)(3) of the act, as amended by FDAMA,
and 21 CFR 860.134 of the agency’s regulations. In accordance with section
513(f)(1) of the act, the Totally Implanted Spinal Cord Stimulator for Pain
Relief was automatically classified into class III because the device was not
within a type of device introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976,
and had not been found to be substantially equivalent to a device placed
in commercial distribution after May 28, 1976, that had been reclassified
into class II or class I.
(Emphasis added.) By way of the February 2001 FDA letter to ANS’ director of regulatory
affairs, Drew Johnson, the FDA acknowledged that pursuant to the FDCA, ANS’ spinal-cord
stimulator was categorized as a class III device automatically. This was because the device
had not been introduced into interstate commerce for commercial distribution prior to May
28, 1976, and it had not been determined to be substantially equivalent to a similar device
placed into commercial distribution after that date which had been designated as a class I or
class II device.
¶6. In its later-published notice of ANS’ petition to reclassify the totally implanted
spinal-cord stimulator, the FDA announced that it had denied the petition. In so doing, the
FDA stated that it was “announcing that it has denied a petition submitted by Advanced
Neuromodulation Systems, Inc. (ANS), to reclassify the totally implanted spinal-cord
stimulator (SCS) for treatment of chronic intractable pain of the trunk or limbs from class III
into class II . . . . After considering all the available information, including the public
comments of the Panel’s recommendation, FDA denied the reclassification petition by order
in a letter to the petitioner.” Further, the FDA’s supplementary information included with
the notice described the regulatory history of the device, in part, as follows:
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The totally implanted SCS [spinal cord stimulator] intended for
treatment of chronic intractable pain of the trunk or limbs is a postamendments
device classified into class III under section 513(f)(2) of the act. Therefore,
this device cannot be placed in commercial distribution for treatment of
chronic intractable pain of the trunk or limbs unless it is reclassified under
section 513(f)(2) of the act, or subject to an approved PMA under section 515
of the act.
Again, the FDA described ANS’ spinal-cord stimulator as a class III device.
¶7. ANS then sought premarket approval of the spinal-cord stimulator in accordance with
the FDA premarket process. On July 16, 2002, the FDA notified ANS that it had completed
its evaluation for the premarket approval application (PMA) for the GenesisXP. The FDA
approved the PMA application by order and required ANS to comply with required MDA
conditions.
¶8. In February 2005, ANS shipped a GenesisXP, a Quattrode lead, and a Patient
Programmer of the GenesisXP to NMMC for Sanders. After surgery, Sanders filed suit
against ANS on September 7, 2007. In his complaint, Sanders alleged that, on or about
September 14, 2005, he was a patient at NMMC. During the surgery, the left lead of the
spinal-cord stimulator broke, allegedly causing Sanders’s injury and damages.
¶9. On January 14, 2009, the trial court heard arguments on ANS’ motion for summary
judgment. Following the arguments, the trial court determined that Sanders’s claims were
barred by the MDA’s preemption clause and issued an order granting summary judgment in
favor of ANS. Sanders appealed, raising three issues, which have been condensed into one:
Whether the trial court erred by granting summary judgment to ANS. We find that the trial
court did not err and affirm the judgment of the Circuit Court of Lee County.
DISCUSSION
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¶10. On appellate review, a trial court’s grant or denial of summary judgment is reviewed
de novo. Moss v. Batesville Casket Co., Inc., 935 So. 2d 393, 398-399 (Miss. 2006).
Mississippi Rule of Civil Procedure 56(c) provides that summary judgment shall be rendered
by a court “if the pleadings, depositions, answers to interrogatories and admissions on file,
together with affidavits, if any, show that there is no genuine issue as to any material fact and
that the moving party is entitled to a judgment as a matter of law.” Miss. R. Civ. P. 56(c).
¶11. The court reviews the record before it, taking “all the evidence in the light most
favorable to the non-moving party.” United States Fid. and Guar. Co. of Miss. v. Martin,
998 So. 2d 956, 962 (Miss. 2008). Affirmance is required where the record before the trial
court demonstrates no genuine issue of material fact, and where the movant is entitled to a
judgment as a matter of law. Id. While the movant has the burden of showing that no
genuine issues of material fact exist, diligence is required of the party opposing the motion
and “may not rest upon the mere allegations or denials of the pleadings, but instead the
response must set forth specific facts showing that there is a genuine issue of material fact
for trial.” Harmon v. Regions Bank, 961 So. 2d 693, 697 (Miss. 2007) (quoting Harrison
v. Chandler-Sampson Ins., Inc., 891 So. 2d 224, 228 (Miss. 2005)). A material fact is one
that “tends to resolve any of the issues properly raised by the parties.” Palmer v. Anderson
Infirmary Benevolent Ass'n, 656 So. 2d 790, 794 (Miss. 1995). “The presence of fact issues
in the record does not per se entitle a party to avoid summary judgment.” Moss, 935 So. 2d
at 398-99. “[T]he existence of a hundred contested issues of fact will not thwart summary
judgment where there is no genuine dispute regarding the material issues of fact.” Id. (citing
Simmons v. Thompson Mach. of Miss., Inc., 631 So. 2d 798, 801 (Miss. 1994)).
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¶12. In Harmon, this Court stated that preemption is proper: “(1) where Congress
explicitly preempts state law; (2) where preemption is implied because Congress has
occupied the entire field; or (3) where preemption is implied because there is an actual
conflict between federal and state law.” Harmon, 961 So. 2d at 697-98 (citing Cooper v.
GMC, 702 So. 2d 428, 434 (Miss. 1997)); see also English v. General Elec. Co., 496 U.S.
72, 78-9, 110 S. Ct. 2270, 110 L. Ed. 2d 65 (1990)).
Whether Sanders’s claims against ANS are barred by the MDA’s
preemption clause.
¶13. The trial court granted summary judgment in ANS’ favor. In so doing, the trial court
distinguished the GenesisXP from the spinal-cord-stimulator definition provided by the
regulations on the basis of its characteristics. The trial court stated in part:
Under the authority granted to it under the Federal Food, Drug, and
Cosmetic Act, the FDA has promulgated certain regulations designed to
implement the Act. Relevant to the present cause of action, 21 C.F.R. §
882.5880 classifies an “implanted spinal cord stimulator for pain relief” as a
class II device. However, this regulation specifically identifies an “implanted
spinal cord stimulator for pain relief” as a device consisting of “an implanted
receiver . . . and an external transmitter . . .” Id. at (a)(emphasis added). No
regulation has been issued regarding a fully implantable spinal cord stimulator.
Coupled with the fact that the GenesisXP was introduced after May 28, 1976, and thus, was
automatically classified as a class III device, and that the FDA denied ANS’ request to
reclassify the device, which prompted ANS to start the premarket approval process, the trial
court barred Sanders’s claims. The trial court barred the claims because (1) the FDA
regarded the spinal-cord stimulator as a class III device, and (2) Riegel v. Medtronic, Inc.,
552 U.S. 312, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008), preempted state-law claims
challenging the safety and effectiveness of class III devices.
8
¶14. On appeal, Sanders argues that the trial court erred by granting summary judgment
in favor of ANS. Sanders claims that the GenesisXP is a class II device as defined by federal
regulations. Further, he claims that the trial court erred by basing its decision on a FDA
order which was inconsistent with the FDA’s own regulations. That order effectively
designated the GenesisXP as a class III device. Consequently, Sanders asserts that the trial
court erred by finding that the device had a class III designation, because that classification
subjected the state-court causes of action to preemption under federal law. See Riegel v.
Medtronic, Inc., 552 U.S. 312, 128 S. Ct. 999, 169 L. Ed. 2d 892 (2008).
¶15. On the other hand, ANS argues that the trial court correctly found that the GenesisXP
was a class III device. ANS argues that federal regulations have not addressed a totally
implantable spinal-cord stimulator. Nevertheless, ANS maintains that, because the device
had been introduced into the market after May 28, 1976, pursuant to the FDCA, it
automatically received a class III designation. In further support of its position, ANS relies
on the FDA’s denial of ANS’ request to reclassify the GenesisXP from a class III to class II
status, the FDA’s premarket approval of the device, and the United States Supreme Court
holding in Riegel, 552 U.S. 312.
1. Regulations
¶16. Sanders argues that Code of Federal Regulations Section 882.5880 is controlling
authority for the classification of the GenesisXP, an implanted spinal-cord stimulator.
¶17. The Code of Federal Regulations defines an implanted spinal-cord stimulator for pain
relief. See 21 C.F.R. § 882.5880 (2010). The regulation states:
(a) Identification. An implanted spinal cord stimulator for pain relief is a
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device that is used to stimulate electronically a patient’s spinal cord to relieve
severe intractable pain. The stimulator consists of an implanted receiver with
electrodes that are placed on the patient’s spinal cord and an external
transmitter for transmitting the stimulating pulse across the patient’s skin to the
implanted receiver.
(b) Classification. Class II (performance standards).
21 C.F.R. § 882.5880 (2010). The federal regulation also defines an implanted spinal-cord
stimulator as a class II device. 21 C.F.R. § 882.5880 (2010).
¶18. ANS concedes that no regulation exists for a totally implantable spinal-cord
stimulator. However, ANS argues that its device is distinguishable from the implanted
spinal-cord stimulator defined in Section 882.5880 because the GenesisXP is totally
implantable, meaning that the receiver and transmitter are both implanted, whereas the
spinal-cord stimulator described in the regulation has an implanted receiver and an external
transmitter for transmitting the stimulating pulse. Thus, the two devices are distinguishable.
2. FDA Order
¶19. Sanders argues that the trial court incorrectly relied on a FDA order to grant summary
judgment to ANS. The FDA issued an order to ANS in February 2001, in which it denied
ANS’ request to reclassify the spinal-cord stimulator from a class III to a class II device.
Sanders contends that the FDA order is inconsistent with the FDA regulations, which clearly
define the spinal-cord stimulator as a class II device. In support of his position, Sanders cites
Thomas Jefferson University v. Shalala, 512 U.S. 504, 520, 114 S. Ct. 2381, 2391, 129 L.
Ed. 2d 405 (1994), and Wyoming Outdoor Council v. U.S. Forest Service, 165 F.3d 43, 45
(U.S. App. D.C. 1999), both of which concern an agency’s interpretation of its regulations.
¶20. In Thomas Jefferson, the United States Supreme Court considered whether the
10
Secretary of Health and Human Services' interpretation of medicare regulatory language was
reasonable. Thomas Jefferson, 512 U.S. at 506, 114 S. Ct. at 2384. A hospital sought
reimbursement for graduate medical-education costs. Id. at 507. The Secretary denied some
of the expenses as an impermissible redistribution of costs, and the hospital sought review.
Id. at 511.
¶21. The United States Supreme Court held that substantial deference must be given to an
agency's interpretation of its own regulations. Thomas Jefferson, 512 U.S. at 512, 114 S.
Ct. at 2386. The Court noted that deferral to the Secretary’s interpretation was warranted
unless an “alternative reading is compelled by the regulation's plain language or by other
indications of the Secretary's intent at the time of the regulation's promulgation.” Id. (quoting
Gardebring v. Jenkins, 485 U.S. 415, 430, 108 S. Ct. 1306, 1314, 99 L. Ed. 2d 515 (1988)).
This principle is more justifiable when “the regulation concerns ‘a complex and highly
technical regulatory program,’ in which the identification and classification of relevant
‘criteria necessarily require significant expertise and entail the exercise of judgment
grounded in policy concerns.’” Id. (quoting Pauley v. Beth Energy Mines, Inc., 501 U.S.
680, 697, 111 S. Ct. 2524, 2534, 115 L. Ed. 2d 604 (1991)). The United States Supreme
Court upheld the Secretary’s interpretation of its own regulations. Id. at 518.
¶22. Likewise, in Wyoming Outdoor Council, the Council appealed a district-court
decision which affirmed the United States Forest Service’s interpretation of its own
regulations. Wyoming Outdoor Council, 165 F.3d at 45. The Council argued that the Forest
Service’s authorization of oil and gas leasing on land located in the Shoshone National Forest
in Wyoming violated its own regulations. Id. The court held that substantial deference is
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given to an agency's interpretation of its own regulations. Id. at 52. The interpretation of an
agency’s regulation is controlling “unless it is plainly erroneous or inconsistent with the
regulation.” Id. (quoting United States v. Larionoff, 431 U.S. 864, 872, 97 S. Ct. 2150, 53
L. Ed. 2d 48 (1977)). Again, the appellate court upheld the agency’s interpretation of its own
regulations. Id. at 54.
¶23. ANS contends that the trial court’s order is not inconsistent with federal regulations.
First, ANS contends that 21 C.F.R. Section 882.5880 defines a stimulator that has both
internal and external components. The GenesisXP, however, is totally implantable. ANS
argues that, when it initially sought reclassification of the GenesisXP from a class III to a
class II medical device, it set forth the specific differences between the stimulator defined
by the regulation and its stimulator. Notwithstanding the regulation’s classification of a
stimulator as a class II device, the FDA’s order denied ANS’ petition to reclassify the
stimulator and stated that, because the stimulator was fully implantable in a human body, the
FDA required the device to remain as a class III device.
3. Preemption, premarket approval, and Riegel
¶24. Sanders claims that the trial court erred by finding that the spinal-cord stimulator was
a class III device. This finding, in turn, provided the trial court with the means to consider
ANS’ argument that, because it is as a class III device, Sanders’s claims are preempted by
federal statute and by federal caselaw in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S. Ct.
999, 169 L. Ed. 2d 892 (2008).
¶25. The federal statute at issue is Section 360k, which provides in part:
(a) General rule
12
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.
21 U.S.C. § 360k (2006).
¶26. In Riegel, the United States Supreme Court considered whether the preemption clause
in the MDA barred common-law claims of safety and effectiveness of a medical device that
had premarket approval by the FDA. Riegel, 552 U.S. at 315; see also 21 U.S.C. § 360k
(2006). Charles Riegel had a coronary angioplasty following a heart attack. Id. at 320.
During the procedure, the Evergreen Balloon Catheter, marketed by Medtronic and
designated as a class III device, ruptured, causing a heart block. Id. Riegel subsequently had
to have emergency coronary bypass surgery. Id. Riegel filed suit in the New York federal
district court, alleging that Medtronic’s catheter violated New York common law. Id.
However, the district court held that Riegel’s claims of strict liability; breach of implied
warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing,
and sale of the device were preempted by the MDA. Id. at 320-21.
¶27. The United States Court of Appeals for the Second Circuit affirmed the district court,
holding that the Riegels’ claims were preempted by federal law. Riegel, 552 U.S. at 321.
The basis of the appellate court’s decision was that if the Riegels’ claims were successful,
they would impose state requirements that differ from, or added to the device-specific federal
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requirements. Id. at 321. See 21 U.S.C. § 360k (2006).
¶28. The United States Supreme Court granted certiorari. Riegel, 552 U.S. at 321. The
Court held that the FDA premarket approval process imposes requirements, and it is specific
to individual devices. Id. at 323. The premarket approval is considered the federal safety
review of the device, with safety, as opposed to equivalence, being the key consideration.
Id. Once premarket approval is granted, the device has “almost no deviations from the
specifications in its approval application, for the reason that the FDA has determined that the
approved form provides a reasonable assurance of safety and effectiveness.” Id. When
analyzing whether the claims relied on a requirement that was “different from, or in addition
to, any requirement” pursuant to the federal law for the device and that “relate[d] to the
safety or effectiveness” of the device, the United States Supreme Court determined that
safety and effectiveness were the essence of the Riegels’ claims. Id. Further, the Court
determined that “the common-law causes of action for negligence and strict liability do
impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a
medical device.” Id. at 323-24. The United States Supreme Court affirmed the Court of
Appeal, which had determined that the MDA preempted the Riegels’ claims. Id. at 330.
¶29. We find that the trial court did not err by finding that the GenesisXP was a class III
medical device, and as such, Sanders’s claims were barred, because the claims were subject
to federal preemption. The record shows that the FDA regulates medical devices pursuant
to the FDCA. The federal government amended the FDCA in regard to medical devices with
the MDA. This act provided that devices introduced after May 28, 1976, automatically
received a class III designation. It was undisputed that the GenesisXP was introduced after
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May 28, 1976. The GenesisXP, pursuant to the MDA, was classified as a class III device.
¶30. In an attempt to have the GenesisXP reclassified from a class III device to a class II
device, ANS petitioned the FDA in 1999. The record contains the FDA’s denial of ANS’
request at reclassification. In its 2001 denial letter, the FDA unequivocally stated that the
stimulator was “automatically classified into class III.” The record also has a FDA public
notice. The FDA again designated ANS’ stimulator as a class III device in its public notice
of denial of petition to reclassify the device. The FDA stated that ANS could not place the
device into commercial distribution unless it was reclassified or subjected to premarket
approval. ANS sought premarket approval. In 2002, the FDA approved ANS’ application
for premarket approval.
¶31. Sanders does not dispute the FDA documentation; rather he relies on the definition
of the stimulator as described in the regulations. See 21 C.F.R §882.5880 (2010). The
regulation does provide a class II designation for spinal-cord stimulators that have an internal
and external component. However, as the evidence shows and as the FDA was aware, the
GenesisXP is a fully implantable device. Further, the FDA order, the notice of denial of
petition, and the premarket approval correspondence all make clear that the FDA itself
considered ANS’ GenesisXP stimulator to be a class III device. Consequently, while other
stimulators that may have an internal and external component are generally considered class
II devices, the FDA did not view the GenesisXP in the same light, so much so that ANS
sought the arduous premarket approval process for the device.
¶32. Viewing the evidence in the light most favorable to Sanders, we find that no genuine
issue to any material fact as to whether the GeneisXP is a class III device. Further, Sanders’s
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claims are similar in nature to the claims asserted by the Riegels in Riegel, 552 U.S. at 320.
Like the Riegels’ claims, Sanders’s claims challenge the safety and effectiveness of a class
III device that has received premarket approval by the FDA, imposing requirements that are
different or in addition to MDA federal requirements. Therefore, the trial court did not err
by barring Sanders’s claims under the MDA.
CONCLUSION
¶33. For the above-stated reasons, this Court affirms the judgment of the Circuit Court of
Lee County.
¶34. AFFIRMED.
WALLER, C.J., CARLSON, P.J., DICKINSON, RANDOLPH, LAMAR,
KITCHENS AND PIERCE, JJ., CONCUR. GRAVES, P.J., NOT PARTICIPATING.
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