Goldsmith v. Mentor Corp. CV-94-651-JD 12/04/95 P UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE
R. Gardner Goldsmith
v. Civil No. 94-651-JD
Mentor Corporation
O R D E R
The plaintiff, Gardner Goldsmith, filed this products
liability action against the defendant. Mentor Corporation, to
recover for injuries resulting from the implantation and
subseguent removal of a testicular prosthesis. Before the court
is the defendant's motion for summary judgment (document no. 5).
Background1
In April 1990, the plaintiff underwent surgery to correct a
testicular abnormality he had since birth. The surgery included
the implantation of a silicone testicular prosthesis designed,
manufactured, and marketed by the defendant as the Mentor Large
Testicular Prosthesis.
During late 1991 and early 1992 the plaintiff, who was
otherwise healthy, began to suffer a variety of pain, swelling.
1The court's recitation of the facts relevant to the instant motion are either not in dispute or have been alleged by the plaintiff. and other symptoms in many areas of his body. The plaintiff's
physicians concluded that the prosthesis was causing or
exacerbating many of his ailments. The prosthesis was removed on
June 14, 1994, and many of the plaintiff's symptoms have subsided
since then. However, the plaintiff continues to suffer from
other impairments related to the prosthesis.
The instant action was filed on December 19, 1994. The
complaint alleges eleven separate causes of action: strict
liability (count one) ; negligent design, manufacture, sale, and
distribution (count two); failure to warn (count three); breach
of express and implied warranties of merchantability and fitness
for a particular purpose (count four); statutory breach of
warranty under the Uniform Commercial Code (count five);
misrepresentation (count seven); unfair business practices (count
eight); false advertising (count nine) ; violation of the
Magnuson-Moss Act, 15 U.S.C. § 2301 (count ten); and punitive,
enhanced and exemplary damages (count twelve). See Complaint;
Plaintiff's Motion in Objection to Summary Judgment at 3. The
plaintiff has withdraw count six, see Motion for Voluntary
Nonsuit, and has never identified a cause of action as count
eleven.
The court incorporates other facts, infra, as necessary for
its analysis of the legal issues presented by the instant motion.
2 Discussion
The role of summary judgment is "to pierce the boilerplate
of the pleadings and assay the parties' proof in order to
determine whether trial is actually reguired." Snow v.
Harnischfeger Corp., 12 F.3d 1154, 1157 (1st Cir. 1993) (guoting
Wynne v. Tufts Univ. Sch. of Medicine, 976 F.2d 791, 794 (1st
Cir. 1992), cert. denied, 113 S. C t . 1845 (1993)), cert, denied,
115 S. C t . 56 (1994). The court may only grant a motion for
summary judgment where the "pleadings, depositions, answers to
interrogatories, and admissions on file, together with the
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." Fed. R. Civ. P. 56(c).
The party seeking summary judgment bears the initial burden
of establishing the lack of a genuine issue of material fact.
Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986); Quintero de
Quintero v. Aponte-Rogue, 974 F.2d 226, 227-28 (1st Cir. 1992).
The court must view the entire record in the light most favorable
to the non-moving party, "'indulging all reasonable inferences in
that party's favor.'" Mesnick v. General Elec. Co., 950 F.2d
816, 822 (1st Cir. 1991) (guoting Griqqs-Ryan v. Smith, 904 F.2d
112, 115 (1st Cir. 1990)), cert, denied, 112 S. C t . 2965 (1992).
However, once the moving party has submitted a properly supported
3 motion for summary judgment, the non-moving party "may not rest
upon mere allegation or denials of [its] pleading, but must set
forth specific facts showing that there is a genuine issue for
trial." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256
(1986) (citing Fed. R. Civ. P. 56(e)).
I. PREEMPTION
Congress' intent, as "explicitly stated in the statute's
language or implicitly contained in its structure and purpose,"
Cipollone v. Liggett Group, 112 S. C t . 2608, 2617 (1992), is the
"touchstone of preemption analysis," Mendes v. Medtronic, Inc.,
18 F.3d 13, 16 (1st Cir. 1994). The First Circuit has made clear
that where Congress has included an express preemption clause in
a statute, the court "ought to limit [its inguiry] to the
preemptive reach of that provision without essaying any further
analysis under the various theories of implied preemption." Id.
(guoting Greenwood Trust Co. v. Massachusetts, 971 F.2d 818, 823
(1st Cir. 1992), cert. denied, 113 S. C t . 974 (1993)). Express
preemption may extend to state common law claims along with state
statutes, regulations, and ordinances. E.g., id. (citing cases).
Finally, the court's construction of preemption clauses must
reflect the traditional presumption against preemption. See id.
at 16.
4 Mentor argues that the plaintiff's claims are preempted by
the Medical Device Amendments ("MDA") to the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. § 360k(a). The MDA contains the
following express preemption provision:
[N]o State or political subdivision may establish or continue in effect with respect to a device intended for human use any reguirement -- (1) which is different from, or in addition to, any reguirement applicable under [the Federal Food, Drug, and Cosmetic Act] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a reguirement applicable to the device under [the Federal Food, Drug, and Cosmetic Act].
21 U.S.C. § 360k(a). The First Circuit has ruled on at least
three occasions that § 360k(a) expressly preempts any claim the
resolution of which would establish a state "reguirement"
different from or in addition to that established under the MDA.
E.g., Talbott v. C.R. Bard, Inc., 63 F.3d 25, 27 (1st Cir. 1995);
Mendes, 18 F.3d at 16; King v. Collagen Corp., 983 F.2d 1130,
1135-36 (1st Cir.), cert. denied, 114 S. Ct. 84 (1993). The
scope of such preemption necessarily extends to common law claims
because
[t]he common law, no less than agency regulations and statutes, can impose 'reguirements' on a manufacturer. The tort and implied warranty theories of products liability are regulatory in that the "obligation to pay compensation can be . . . a potent method of governing conduct and controlling policy." Cipollone, 112 S. C t . at 2620. . . . Products liability "regulation" under the common law imposes reguirements by case law precedent.
5 Mendes, 18 F.3d at 18 (citations and internal quotation marks
omitted); see Wilson v. Bradlees, 93-47-JD, slip op. at 5 (D.N.H.
Nov. 8, 1995) .
The controlling question, then, is whether the plaintiff's
statutory and common law claims fall in the "broad, but limited"
path of the § 360k(a) express preemption provision. See King,
983 F.2d at 1134. This inquiry requires the resolution of two
related issues. The court first must determine if and to what
extent the prosthesis at issue was regulated under the MDA for
preemption purposes. If the court determines that the prosthesis
was regulated, it then must examine each of the plaintiff's
claims to determine whether their litigation would yield a state
law standard or requirement different from or in addition to that
prescribed by the federal government. See 21 U.S.C. §
360k(a)(1); Mendes, 18 F.3d at 16.
I. The Mentor Prosthesis is Regulated Under the MDA
A. The Prosthesis is a Class III Device
Under the MDA, the Food and Drug Administration ("FDA")
classifies all medical devices intended for human use into three
categories according to the degree of regulation necessary to
assure safety and effectiveness. See 21 U.S.C. § 360c. The FDA
lists "testicular prosthesis" as a "Class III" medical device.
6 21 C.F.R. § 876.3750 (1995), the designation given to those
devices subject to the most stringent MDA controls, see Duvall v.
Bristol-Mvers-Sguibb Co., 65 F.3d 392, 396 (4th Cir. 1995); 21
U.S.C. § 360c(a)(1)(C).
In support of its motion the defendant has submitted two
brief affidavits from its regulatory affairs manager, Lynn
Breckenridge, to establish that the prosthesis is regulated under
the MDA. Breckenridge testified that, based on her personal
knowledge of the federal regulations applicable to her company's
products, "[p]ursuant to the [MDA] . . . the testicular
("prosthesis") is a Class III medical device." Breckenridge
Affidavit at 55 1-3. In her supplemental affidavit Breckenridge
testified that the "Mentor Testicular Prosthesis is an implanted
device that contains reinforced, molded silicone elastomer and is
implanted surgically to resemble a testicle." Breckenridge
Supplemental Affidavit at 5 4.
The plaintiff responds that the testimony "fails to assert
that the prosthesis at issue, i.e., the defendant's product, is a
Class III medical device and fails to attach, cite to or other
wise reference FDA approval or certification." Plaintiff's
Memorandum in Opposition to Summary Judgment at 6. The argument
is unavailing. Although the affidavits are brief, the court
finds that, fairly read, they establish that the prosthesis at
7 issue is a Class III device. Significantly, Breckenridge's
description of her company's product tracks the language used by
the FDA to describe Class III testicular prostheses in the
regulations. See 21 C.F.R. § 876.3750 ("a testicular prosthesis
is an implanted device that consists of a solid or gel-filled
silicone rubber prosthesis that is implanted surgically to
resemble a testicle."). The plaintiff has not presented evidence
under Rule 56(c) to challenge this conclusion. Finally, as
discussed infra, the fact that this particular prosthesis may not
have received "FDA approval or certification" is irrelevant to
the court's preemption analysis. The court concludes that the
prosthesis is a Class III medical device within the meaning of
the MDA.
B. Class III Devices are Subject to Preemption Regardless of the Route to Market or Actual Compliance with Federal Law
Generally, manufacturers must receive premarket approval
("PMA") from the FDA before they can market a Class III device.
E.g., Mendes, 18 F.3d at 17; 21 U.S.C. § 360c(a)(1)(C). This
process involves, inter alia, the submission of various clinical
and manufacturing data and proposed labeling, see 21 U.S.C.
§ 360e(c), "in order 'to provide reasonable assurance of [the]
safety and effectiveness' of the device." Duvall, 65 F.3d at 396
(guoting 21 U.S.C. § 360c (a) (1) (C)) . However, certain Class III
devices do not reguire PMA and a manufacturer may market such a device by demonstrating that it is "substantially equivalent" to
a device that was on the market prior to 1976. See English v.
Mentor Corp., 1995 WL 573387 * 1-2 (3d Cir. 1995) (citing 21
U.S.C. § 360c(f)(3)). This alternative method requires the
manufacturer to provide the FDA with various information through
a premarket notification process known as 510(k) notification in
order to ensure that "the device is safe, effective and performs
as well as or better than the [predicate] device." Id. (quoting
21 C.F.R. § 807.95 and citing 21 U.S.C. § 360c(i)(3)(A); 21
C.F.R. § 807.92).
The plaintiff asserts that his claims are not preempted
because the prosthesis "was never subjected to the extensive
premarket approval [PMA] process" and, instead, was in all
likelihood marketed pursuant to the less exacting 510(k)
prenotification process. Plaintiff's Supplemental Memorandum in
Opposition to Summary Judgment at 1-2. Consistent with Rule 56,
the court takes as true the assertion by plaintiff's counsel
that, according to FDA officials, "Mentor simply filed a
barebones 510k notification . . . [and] there was never any
comprehensive analysis or review by the FDA." Affidavit of
Joseph Keefe at 5 3.
The plaintiff correctly notes that products cleared for
market under the 510(k) process encounter less scrutiny from the FDA than those requiring PMA. Nonetheless, most courts that have
addressed the issue, including the First Circuit, have ruled that
the 510(k) prenotification process does impose federal
requirements on the product such as to trigger preemption by the
MDA. See English, 1995 WL 573387 at * 4-5 (listing cases) ("We
are satisfied that [the 510(k)]process is sufficiently rigorous
to constitute a 'requirement . . . relating to the safety or
effectiveness' of Class III medical devices"); Duvall, 65 F.3d at
399; Feldt v. Mentor Corp., 61 F.3d 431, 435-36 (5t Cir. 1995)
("Preemption does not depend on the route the product takes to
the market, but on whether there are any specific federal
requirements applicable to the device."); Mendes, 18 F.3d at 18-
19 (finding preemption where pacemaker was marketed under 510(k)
prenotification process). Contra Larsen v. Pacesetter Svs.,
Inc., 74 Haw. 1, 16-17, 837 P.2d 1273, 1282 (1992) (510(k)
process does not preempt state claims because prenotification
does not constitute FDA approval of device). Accordingly, the
court finds that the MDA's express preemption provision, 21
U.S.C. § 360k(a), applies regardless of whether the prosthesis
was subject to PMA.
The plaintiff next asserts that summary judgment is
foreclosed by a factual dispute of whether the particular
prosthesis at issue did, in fact, satisfy the applicable federal
10 standards. Plaintiff's Memorandum in Opposition to Summary
Judgment at 9 ("nowhere in its motion or affidavit does the
defendant even allege that it has received, or even applied for,
FDA approval"), 11, 15-16. The plaintiff argues that state law
claims are preempted only where the device at issue "had been
cleared for marketing by the FDA" under the 510(k) process. Id.
at 19-20 (guoting Mendes, 18 F.3d at 17) .
The argument is contrary to the recently clarified law of
this circuit. In Mendes, the First Circuit did state that " [w]e
express no opinion on whether products liability claims are
preempted only if the manufacturer complied with applicable
regulations." 18 F.3d at 19-20. However, in its August 14,
1995, decision in Talbott, the First Circuit sguarely addressed
the issue and ruled that "Congress did not intend to provide for
an exception to the MDA's preemption clause where a manufacturer
fails to comply with the provisions of the MDA by fraudulently
obtaining approval of its device from the FDA." 63 F.3d at 28,
25 (citing cases). The court explained:
The terms of the statute make no distinction based upon whether or not a manufacturer has in fact complied with the federal standard. We find nothing to indicate that preemption is conditional upon satisfactory compliance with the federal standard. Section 360k(a) does not mention compliance at all. . . . [T]he relevant inguiry is simply whether, in the abstract, the state tort law reguirement is "different from, or in addition to" the federal reguirement. If a device manufacturer fails to
11 meet the federal requirements, it will be subject to federal penalties as set forth in the MDA.
Id. at 29; see English, 1995 WL 573387 * 5 ("[MDA's] preemption
provision is triggered not by FDA approval of a device's safety
and effectiveness, but by federal requirements relating to a
device's safety and effectiveness."). Accordingly, the court's
preemption inquiry focuses on the regulations and requirements to
which the prosthesis is subject under federal law without regard
to whether or to what extent the device actually complied with
such regulations and requirements.2
II. The Plaintiff's Claims are Preempted
The court next "scrutinize[s] the plaintiff's claims to
determine whether the successful litigation of any of them would
"establish or continue in effect" a standard or regulation other
than that established by the federal government. Mendes, 18 F.3d
at 16; see 21 C.F.R. § 808.1(d) (requirements imposed by state
law preempted where there are "specific requirements applicable
to a particular device under the act") see Levesque v. Miles,
Inc., 816 F. Supp. 61, 64 (D.N.H. 1993) (when faced with express
preemption, "the only remaining question is whether a particular
2The First Circuit also has ruled that the MDA preempts state law claims even where the claims are based on a violation or breach of the applicable federal standards or requirements. Talbott, 63 F.3d at 29 (listing cases).
12 state statute [or cause of action] intrudes into the federal
pale"))• This inquiry requires an examination of both the scope
and extent of the federal requlations and of the specific claims
asserted by the plaintiff.
The federal requirements fall into two qeneral cateqories,
either of which can triqqer preemption under the MDA. First, the
510(h) process itself imposes requirements on the device:
The FDA mandates that a 510(k) Notification include, inter alia, "proposed labels, labelinq, and advertise ments sufficient to describe the device, its intended use, and the directions for its use"; a statement indicatinq the similarity of the device to currently marketed devices (includinq data to support the statement, such as information on similarity in materials and desiqn); and additional information as requested by the FDA. 21 C.F.R. § 807.87. And, if [the manufacturer] wishes to substantially chanqe the desiqn, components, or manufacturinq processes used in makinq the device, it must submit a new 510(k) Notification. 21 C.F.R. § 807.81(a)(3). . . . We therefore conclude that the 510(k) Notification is a requirement applicable to the device under the MDA.
Duvall, 65 F.3d at 399-401 (citinq Reeves v. AcroMed Corp., 44
F.3d 300, 305 (5th Cir.), cert. denied, 115 S. Ct. 2251 (1995)).
Second, all medical products, reqardless of classification
or the premarket process to which they are subject, are requlated
by the federal qood manufacturinq practices ("GMP"), 21 C.F.R.
§ 820 et sea., and the federal labelinq requirements, 21 C.F.R.
§ 801 et sea. The GMP requlations require, inter alia,
"manufacturers to develop and implement 'appropriate,'
13 'adequate,' or 'sufficient' quality control, quality assurance
personnel traininq, environmental controls, equipment
maintenance, testinq, inspection, and storaqe and distribution
procedures, to assure that devices are safe and effective."
Mendes, 18 F.3d at 19 (citinq 21 C.F.R. §§ 820.1, 820.5, 820.20,
820.25); see Duvall, 65 F.3d at 399 (citinq 21 C.F.R. p t . 820)
(GMP include "standards for production facilities, quality
assurance, monitorinq of packaqe labels, and device failure
reportinq" obliqations). For example, the quality assurance
requirements compel manufacturers to desiqn and implement a
protocol "to ensure, amonq other thinqs, that all components,
labels, packaqinq, and finished devices are inspected, and either
approved or rejected." Mendes, 18 F.3d at 19 (citinq 21 C.F.R. §
820.20(a)). The labelinq requirements, which are independent of
those imposed by the GMP requlations, specify the content and
prominence of the required lanquaqe. Duvall, 65 F.3d at 399
(citinq C.F.R. p t . 801).
The court will consider the plaintiff's claims seriatim.
The common law claims asserted in counts one and two are, by
definition, performance-based claims in that they concern the
safety of the prosthesis. Under New Hampshire law, the viability
of each claim, whether soundinq in strict liability or
neqliqence, hinqes on the plaintiff's ability to prove that the
14 prosthesis was defective or otherwise did not satisfy applicable
performance standards. See generally Wilson v. Bradlees, 93-47-
JD, slip op. at 8. As discussed supra, both the 510(h)
notification process and the GMP regulations address the design,
manufacture, marketing, sale, and distribution of the Mentor
prothesis. Litigation of the negligence and strict liability
claims necessarily would be based on a state standard or
reguirement "different from or in addition to" these federal
reguirements. See 21 U.S.C. § 360k(a) (1) . Thus, counts one and
two are preempted by the MDA.
Count three asserts liability for the defendant's failure to
"furnish adeguate warnings and instructions of the risks
associated with the use of the testicular impact." Complaint at
5 14. The 510(h) notification process, the GMP reguirements, and
the labeling regulations address and relate to the nature and
form of the prosthesis' labeling and instructions. Thus,
litigation of a failure to warn claim would be based on warning
or labeling reguirements "different from or in addition to" these
federal reguirements. See 21 U.S.C. § 360k(a)(1). Count three
is preempted.
Counts seven, eight, and nine are variations of the
plaintiff's failure to warn claim and are preempted for the same
reasons. Count seven asserts that the defendant "made
15 misrepresentations to the plaintiff regarding its product that
induced him to act to his detriment and is liable for fraud and
misrepresentation." Complaint at 5 18. Count eight asserts that
"the defendant misled the plaintiff as to the safety and guality
of the testicular implant" in violation of N.H. Rev. Stat. Ann.
("RSA") § 358-A. Id. at 5 19. Count nine asserts that the
"defendant falsely advertised the safety and guality of the
testicular implant." Id. at 5 20. Each of these claims,
although advanced under different legal theories, essentially
alleges that the defendant mislabeled, misadvertised, or
otherwise failed to warn or provide necessary information about
its product. The litigation of such a claim would saddle the
defendant with labeling, packaging, disclosure, or other warning-
related duties "different from or in addition to" those imposed
by both the 510 (k) process and the GMP and labeling regulations.
See 21 U.S.C. § 360k(a)(1). Thus, the court finds that counts
seven, eight, and nine are preempted for the reasons discussed in
connection with count three. See also Talbott, 865 F. Supp. 37,
52 (D. Mass. 1994) (claim under state consumer protection statute
preempted where its resolution "has the potential to impose state
reguirements in addition to, or different from, the FDA's
reguirements"), aff'd 63 F.3d 25 (1st Cir. 1995).
16 Count four asserts that the "defendant breached express and
implied warranties of merchantability and fitness for a
particular purpose." Complaint at 5 15. The plaintiff argues
that breach of warranty claims cannot be preempted because they
"arise[] from the manufacturer -- not from state law or
regulation." Plaintiff's Memorandum in Opposition to Summary
Judgment at 23 (citing Cipollone, 112 S. C t . at 2622).
The warranty claims are analogous to the strict liability
and negligence claims to the extent that each focuses sguarely on
the safety or "fitness" of the prosthesis. As discussed supra,
such performance-based claims are preempted because their
litigation necessarily would rest on reguirements different from
or in addition to those imposed by under the 510(k) process or
the GMP regulations. The plaintiff cannot skirt the preemptive
reach of § 360k(a) by re-casting these performance-based product
liability claims as claims based on a breach of an express or
implied warranty. Specifically, "[a]s an implied warranty is a
reguirement upon a product that arises exclusively from the
operation of state contract law, this claim is preempted
expressly by the MDA. Otherwise, it would impose a reguirement
additional to those imposed under the MDA." Talbott, 865 F.
Supp. at 51; see Mendes, 18 F.3d at 18 (successful implied
warranty claim would supplant federal GMP). Likewise, the
17 plaintiff's "suggestion that Cipollone indicates that [his]
express warranty claims are not preempted has been rejected by
the Court of Appeals for the First Circuit." Talbott, 865 F.
Supp. at 51. The First Circuit has observed that
[t]he FDA retains rigid control over the labeling and packaging of Class III products, largely displacing the ability of manufacturers to make additional claims. This high level of control contrasts with the low level of control in Cipollone, and ensures that manufacturers will not be held liable for packaging and labeling imposed by the FDA.
Id. at 51-52 (guoting King, 938 F.2d at 1135). In any event, the
plaintiff, like those in Talbott, has not even alleged that the
defendant provided express warranties or claims beyond whatever
information was communicated through the federally regulated
packaging, labels, and advertising. See id. at 52; Complaint.
For the foregoing reasons, as well as those discussed in
connection with counts one and two, the court finds that the
claims stated in count four are preempted.
Count five asserts that "[a]s a result of its breach of the
Uniform Commercial Code and N.H. R.S.A. 382-A, the defendant is
liable to the plaintiff." Complaint 5 16. The court's analysis
of this claim is constrained by the plaintiff's failure to
specify which articles and sections of the Uniform Commercial
Code ("UCC") he believes the defendant violated. See id.
However, based on its review of the pleadings and its familiarity
18 with the UCC as codified in New Hampshire, the court understands
the plaintiff to allege a violation of the various warranty
provisions of Article 2 (Sales), RSA § 382-A:2-312 to 2-317.
The court finds that for purposes of preemption an implied
or express warranty action under the UCC is indistinguishable
from an implied or express warranty action arising under common
law. Both species are creatures of state law and, if litigated,
would yield reguirements "different from or in addition to" those
established by either the 510(k) notification process or the GMP
and labeling reguirements. See 21 U.S.C. § 360k(c)(1).
Accordingly, the court finds that the UCC claims alleged in count
five are preempted for the reasons announced in its consideration
of the common law warranty claims alleged in count four.
Finally, count twelve reguests punitive, enhanced, and
exemplary damages as these remedies are available under New
Hampshire law. The preemption of each of the plaintiff's state
law claims, supra, dispenses with any related claims for
additional damages. The court finds that count twelve fails as
a matter of law.
II. MAGNUSON-MOSS ACT
Count ten asserts that defendant violated the Magnuson-Moss
Act ("MMA"), 15 U.S.C. § 2301 et sea.. Complaint 5 21. The
19 defendant argues that it is entitled to summary judgment because
the prosthesis is not considered a "consumer product" within the
meaning of the MMA. The plaintiff has not addressed the
argument.
The MMA only applies to "consumer products," a term defined
as "any tangible personal property which is normally used for
personal, family, or household purposes." 15 U.S.C. § 2301(1);
see Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1024 (E.D. Mich.
1993). Beyond this definition, the MMA does not catalogue the
products which fall within its protection. However, the Consumer
Product Safety Act ("CSPA") explicitly states that "devices"
regulated under the Federal Food, Drug, and Cosmetic Act, of
which the MDA is part, are not "consumer products." 15 U.S.C.
§ 2052(a)(1)(H). The Eastern District of Michigan has adopted
the CSPA definition and ruled that a prosthetic heart valve is
not a consumer product under the MMA because it is regulated by
the MDA. Kemp, 835 F. Supp. at 1024-25. The court is persuaded
that the Kemp court properly construed the applicable statutes
and, for the same reasons, finds that the plaintiff's injuries
are not actionable under the MMA because the prosthesis, a
medical device regulated under the MDA, is not a consumer
product. In the alternative, the court finds that a testicular
prosthesis is not a consumer product under the MMA because it is
20 not "tangible personal property . . . normally used for personal,
family, or household purposes." See 15 U.S.C. § 2301(1).
Accordingly, the defendant is entitled to summary judgment on
count ten.
Conclusion
The defendant's motion for summary judgment (document no. 5)
is granted. The clerk is ordered to close the case.
SO ORDERED.
Joseph A. DiClerico, Jr, Chief Judge December 4, 1995
cc: Joseph F. Keefe, Esguire Michael A. Pignatelli, Esguire