                                                                                                                           Opinions of the United
1995 Decisions                                                                                                             States Court of Appeals
                                                                                                                              for the Third Circuit


9-29-1995

English v Mentor Corp
Precedential or Non-Precedential:

Docket 94-1714




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                  UNITED STATES COURT OF APPEALS
                        FOR THE THIRD COURT


                           No. 94-1714


          HUGH EDWARD ENGLISH, III; LORRAINE ENGLISH,
                                          Appellants

                                v.

                        MENTOR CORPORATION


         ON APPEAL FROM THE UNITED STATES DISTRICT COURT
            FOR THE EASTERN DISTRICT OF PENNSYLVANIA
                 (D.C. Civil Action No. 93-02725)


                     Argued January 12, 1995

        Before:   COWEN, NYGAARD and ALITO, Circuit Judges

              (Opinion Filed:   September 29, 1995)

BARBARA M. DALY, ESQUIRE (Argued)
Jaffe & Hough
15th & J.F.K. Boulevard
1907 Two Penn Center Plaza
Philadelphia, PA 19102
Attorney for Appellants

HOWARD M. CYR, III, ESQUIRE (Argued)
DAVID J. GRIFFITH, ESQUIRE
Harvey, Pennington, Herting & Renneisen
1835 Market Street
Eleven Penn Center, 29th Floor
Philadelphia, PA 19103
Attorney for Appellee

JEFFREY R. WHITE, ESQUIRE
Association of Trial Lawyers of America
1050 31st Street, N.W.


                                1
Washington, DC 20007-4499
Attorney for Amicus-Appellant

RICHARD A. SAMP, ESQUIRE
Washington Legal Foundation
2009 Massachusetts Avenue, N.W.
Washington, DC 20036
Attorney for Amicus-Appellee


                       OPINION OF THE COURT




PER CURIAM.

           Hugh and Lorraine English sued Mentor Corporation,

alleging claims based upon strict product liability, negligence,

breach of express and implied warranty, loss of consortium by

Mrs. English, and punitive damages.   Mr. English had a Mentor

inflatable penile prosthesis implanted.   The device malfunctioned

and appellants sued Mentor in the Pennsylvania Court of Common

Pleas.   Mentor removed the case to the federal district court,

which granted summary judgment in its favor, holding that

appellants' claims were preempted by the Medical Device

Amendments to the Food, Drug, and Cosmetic Act of 1938, 21 U.S.C.

§§ 360c-360rr.

           Appellants raise two issues on appeal:   (1) whether the

 Medical Device Amendments of 1976 preempt their state law tort

   and contract claims against the manufacturer of a Class III

medical device; and (2) whether the Amendments also preempt these

   claims for a medical device cleared for marketing under the

"substantial equivalence" exception to the general rule requiring




                                  2
    a full Premarket Approval process.    We will affirm in part,

            reverse in part, and remand the cause. I.

          The Medical Device Amendments classify medical devices

as Class I, II or III devices, depending upon their potential

danger to the public.   Class III devices are the most dangerous,

the most heavily regulated, and include the prosthesis implanted

in Mr. English.    Generally with Class III devices, the

manufacturer must submit a detailed "Premarket Approval"

application to the FDA, 21 U.S.C. § 360e(c)(1), and obtain

Premarket Approval before they can be marketed to the public. Id.

§ 360c(a)(1)(C).

          There are two exceptions to this requirement.     First,

Class III devices may receive an "Investigational Device

Exemption" (or "IDE") from the FDA, id. § 360j(g), which permits

the device to be tested on human subjects without obtaining

Premarket Approval.   Id. § 360e(a).     Second, absent formal

premarket approval, the FDA has permitted manufacturers to market

new inflatable penile implants by completing the "510(k)

procedure," which requires a demonstration that the new device is

"substantially equivalent" to other penile implants already on

the market before the passage of the MDA.1     21 U.S.C.


1
In adopting the MDA, Congress drew a distinction between devices
that were on the market before its passage (and devices
"substantially equivalent" to these devices) and devices marketed
after its passage in 1976. Congress realized that it was
impracticable to require that devices that were already on the
market be withdrawn until they obtained premarket approval from
the FDA. See 21 U.S.C. § 360e. Instead, Congress directed the
FDA to promulgate regulations to allow manufacturers of these
devices to move gradually into compliance with the MDA. Id. This


                                 3
§360c(f)(3); 21 C.F.R. §§ 807.81-807.100.     Absent such a

demonstration, a device may not be marketed until obtaining the

full premarket approval described above.

          Under this 510(k) procedure, the FDA must decide

whether a new device is in fact substantially equivalent to a

device already on the market prior to 1976.    See 21 U.S.C.




authority also extended to new devices "substantially equivalent"
to devices on the market as of 1976. Id.

          The FDA relied on this distinction as authorization for
its 510(k) process. Thus, the FDA has issued regulations, such
as 21 C.F.R. § 876, classifying certain preexisting devices
(including inflatable penile implants) as Class III devices, but
exempting them from immediate premarket approval (by postponing
the date the regulations become effective). The FDA also allows
substantial equivalents of these devices to be marketed before
obtaining final premarket approval--by completing the 510(k)
process. Id. at §§ 807.81-807.100. These devices, however, are
required to obtain premarket approval in the future. See 21
C.F.R. § 870.1-870.3. New devices (i.e. devices not in existence
before 1976 or substantially equivalent to such a device) must
receive premarket approval before they may be marketed. 21
U.S.C. § 360e(a); 21 C.F.R. § 870.3.

          With the passage of the Safe Medical Devices Act
("SMDA") in 1990, Pub. L. No. 101-629, Congress explicitly
codified these 510(k) procedures. See H.Rep. No. 101-808, 101st
Cong., 2d Sess., 1990 U.S.C.C.A.N. 6305, 6319 ("Section 4(b) [of
the SMDA] codifies the FDA's current practice regarding the use
of the 510(k) procedure for entering the market."). The current
approach is found at 26 U.S.C. § 360c(f)(3), which explicitly
allows a manufacturer of a Class III device, for which no final
regulation requiring premarket approval has been promulgated, to
market the device by complying with the FDA's 510(k) notification
process. Similarly, the SMDA codified the FDA's definition of
substantial equivalence. See 21 U.S.C. § 360c(i)(1)(A). Because
Congress in the SMDA codified FDA procedures in place at the time
the device implanted into English was approved by the FDA
pursuant to the 510(k) process, we make reference to its
provisions in determining the extent to which the FDA has
regulated the device.


                               4
§360c(f)(3).   Pursuant to 21 U.S.C. § 360c(i)(1)(A), a device is

considered "substantially equivalent" if the device:
          (i) has the same technological
          characteristics as the predicate device, or

          (ii)(I) has different technological
          characteristics and information submitted
          that the device is substantially equivalent
          to the predicate device contains information,
          including clinical data if deemed necessary
          by the Secretary, that demonstrates that the
          device is as safe and effective as a legally
          marketed device, and (II) does not raise
          different questions of safety and efficacy
          than the predicate device.


This substantial equivalence determination therefore requires the

manufacturer to provide information to the FDA in order to ensure

that "the device is safe, effective and performs as well as or

better than the [predicate] device...."   21 C.F.R. § 807.95; see

21 U.S.C. § 360c(i)(3)(A); 21 C.F.R. § 807.92.

          The FDA, however, views the 510(k) exception as an

intermediate step to obtaining full premarket approval.   The FDA

will eventually require all Class III devices to obtain full
premarket approval.2


2
Congress has directed the FDA to clear up the backlog of devices
that are classified as Class III, but for which the FDA has not
issued a final regulation requiring premarket approval. 21 U.S.C.
§ 360e(i). Congress was concerned that the FDA was using the
510(k) process as a means to avoid having to issue premarket
approval on a wide array of devices. See H.Rep. No. 101-808,
101st Cong., 2d Sess., reprinted in 1990 U.S.C.C.A.N. 6305, 6317-
20. Under § 360e(i), manufacturers of these Class III devices
will have to submit information pertaining to their performance,
including safety and effectiveness data. The FDA will then be
required promptly to re-categorize these devices as Class II
devices or finally issue regulations requiring that they obtain
premarket approval. Id.


                                5
          Before Mr. English's prosthesis was inserted, the FDA

determined that Mentor's prosthesis was substantially equivalent

to other Class III devices marketed before the Amendments, and

allowed Mentor to market its prosthesis to the public without

Premarket Approval.   The FDA had initially granted an

Investigational Device Exemption to Mentor, permitting it to test

its prosthesis on human subjects; English, however, did not

receive a device as part of an IDE test study and thus Mentor

cannot rely on IDE regulations in support of its argument that

English's state tort claims are preempted.

                               II.

          Appellants argue first that Congress never intended the

Amendments to preempt state law claims.   We rejected that

argument in Gile v. Optical Radiation Corp., 22 F.3d 540 (3d

Cir.), cert. denied, 115 S. Ct. 429 (1994); see also Michael v.

Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995).   The preemption

provision provides:
          (a) Except as provided in subsection (b)3 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


3
Subsection (b) permits a state to apply for an exemption from
the preemption of subsection (a) for certain state laws. No such
application was made in this case, thus subsection (b) is not at
issue.


                                6
            matter included in a requirement applicable
            to the device under this chapter.


21 U.S.C. § 360k(a).

            We opined in Gile that Congress' use of the word
"requirement" in § 360k(a) adequately expresses its intent to

preempt state law claims that would impose different or

additional requirements from those under federal law.       22 F.2d at

542-43.     We held that § 360k(a) preempted state law strict

liability and negligence claims as impermissible attempts to

impose additional safety or effectiveness requirements on medical

device manufacturers.     Id. at 545.   In Michael, we held that

§ 360k(a) also preempts breach of implied warranty claims because

they too arise under state law.       46 F.3d at 1324-25.

            Applying Gile and Michael, we hold that the district

court correctly adjudged appellants' strict liability,

negligence, and breach of implied warranty claims preempted by

§ 360k(a) of the Medical Device Amendments.       Because Gile and

Michael explain our rationale with respect to these claims, we
need not.

             In Michael, we held that breach of express warranty

claims are not preempted by § 360k(a) because they are created by

the parties and not by state law.       46 F.3d at 1325-26; see also

Cipollone v. Liggett Group, Inc., -- U.S. --, 112 S. Ct. 2608,

2622 (1992) ("[R]equirements imposed by an express warranty are

not 'imposed under state law,' but rather imposed by the
warrantor.").     Again, we are satisfied that our opinion in




                                  7
Michael fully sets forth our analysis.    We will reverse the

district court's summary judgment on this claim.

          The remaining claims are for loss of consortium by Mrs.

English and punitive damages.    We will uphold summary judgment

with respect to the latter, inasmuch as the Pennsylvania courts

have held that, absent fraud, punitive damages cannot be awarded

for a breach of warranty.   See e.g., AM/PM Franchise Ass'n v.

Atlantic Richfield, 526 Pa. 110, 584 A.2d 915, 927 (1992).

           We have found no Pennsylvania case, however, deciding

whether a loss of consortium award can be premised upon a breach

of warranty.   Pennsylvania has made clear that loss of consortium

cannot be based on pure breach of contract.    E.g., Thorsen v.

Iron and Glass Bank, 328 Pa. Super. 135, 476 A.2d 928, 932

(1984).   Other courts, however, have looked to the substance of

the breach of warranty claim in deciding whether it will support

a loss of consortium award.     See, e.g., Scarzella v. Saxon, 436

A.2d 358, 363 (D.C. App. 1981) (allowing loss of consortium

premised upon breach of warranty and citing W. Prosser, Law of

Torts § 95, at 635 (4th ed. 1971) for the proposition that

warranty actions have historically sounded in tort as well as

contract); Fernandez v. Union Bookbinding Co., Inc., 400 Mass.
27, 507 N.E.2d 728, 735 (1987) (same); Klein v. Sears, Roebuck

and & Co., 92 Md. App. 477, 608 A.2d 1276, 1284, cert. denied,

328 Md. 447, 614 A.2d 973 (1992) (same); Henningsen v. Bloomfield

Motors, Inc., 32 N.J. 358, 161 A.2d 69, 100-102 (1960) (same).

          Appellants' breach of express warranty claim seeks

damages for personal injuries, which are recoverable in


                                  8
Pennsylvania as consequential damages for breach of warranty.      13

Pa.C.S.A. § 2715(b)(2).   Given the substance of appellants'

warranty claim and that "a consortium claim is inextricably

intertwined with the underlying action for personal injury...[,]"

Novelli v. Johns-Manville Corp., 395 Pa. Super. 144, 576 A.2d

1085, 1088 (1990), appeal denied, 527 Pa. 625, 592 A.2d 45

(1991), we think the Pennsylvania Supreme Court would permit Mrs.

English to maintain her loss of consortium claim.

          Finally, appellants argue that the Amendments do not

preempt their claim that Mentor failed to comply with FDA

requirements in the design and manufacture of the device.    The

district court rejected this argument because appellants did not

properly allege that Mentor failed to comply with FDA regulations

concerning the manufacturing process.   Appellants point to no

evidence that would support or create an issue of fact with

respect to such a claim, even if properly alleged.   We find no

error in the district court's determination.   See also Mendes v.

Medtronic, 18 F.3d 13, 20 (1st Cir. 1994) (refusing to consider

the same argument where plaintiff's complaint contained no

allegations of manufacturer's failure to comply with FDA

requirements).

                               III.

          The second issue raised by appellants is whether

§ 360k(a) preemption also applies to a Class III medical device

without Premarket Approval, but cleared for marketing by a

"substantial equivalence" determination.   To reiterate, a

manufacturer can bypass the full-blown Premarket Approval process


                                9
if the FDA determines that the device is substantially equivalent

to devices on the market before the Amendment became effective in

1976.   21 U.S.C. § 360e(b)(1); see discussion supra part II.

           FDA regulations require that a manufacturer seeking a

substantial equivalence determination submit a 510(k) Premarket

Notification containing "an adequate summary of any information

respecting [the] safety and effectiveness [of the device] or

state that such information will be made available upon request

by any person."   21 U.S.C. § 360c(i)(3)(A).   The actual summary

regarding the safety and effectiveness of the device must contain

"detailed information regarding data concerning adverse health

effects and shall be made available to the public by the [FDA]

within 30 days of the issuance of a determination that such

device is substantially equivalent to another device."   Id.

§360c(i)(3)(B).

           Moreover, the FDA regulates both the format and content

of a 510(k) Notification.   The Notification must include, among

other things:   any action taken by the manufacturer to comply

with the Amendment's requirements for performance standards;

proposed labels, labeling, and advertisements sufficient to

describe the device, its intended use, and the directions for its

use; where applicable, photos or engineering drawings of the

device; a statement that the device is similar to and/or

different from other products of comparable type, accompanied by

data to support the statement that may include an identification

of similar products, materials, design considerations, and a

description of the operational principles of the device; and any


                                10
additional information requested by the FDA that is necessary for

it to make a finding of substantial equivalency.    21 C.F.R.

§807.87.

           In addition to the requirements pertaining specifically

to substantially equivalent devices, the devices are also subject

to the FDA's "General Controls," which include labeling

requirements and good manufacturing practices.     Mendes, 18 F.3d

at 14 (citing 21 U.S.C. §§ 360i, 360j).   The parallel FDA

regulations on labeling govern the content and appearance of

prescription medical device labels.    21 C.F.R. §§ 801.1, 801.15,

801.109.   As the Mendes court noted, these regulations exempt

such devices from the requirement that there be directions to a

layperson on how to use the product safely, if the package

describes, inter alia, "any relevant hazards, contraindications,

side effects, and precautions" for the prescribing physician. Id.

at 18 (quoting 21 C.F.R. § 801.109).    Furthermore, the FDA has

promulgated extensive regulations interpreting the Amendment's

good manufacturing practices requirements.   21 C.F.R. §§ 820.1-

820.198.

           Only a handful of federal courts have considered

whether the 510(k) process is a "requirement" that preempts state

law tort claims under 21 U.S.C. § 360k(a).   The majority of them

hold that it is a requirement.   For example, in Mendes, supra,
the court held that a FDA determination of substantial

equivalence carries with it sufficient federal requirements

relating to safety and effectiveness to preempt state tort

claims.    Accord Duvall v. Bristol-Myers Squibb Co., No. S-93-


                                 11
1072, 1994 WL 591534 (D. Md. Mar. 30, 1994); Bollier v.

Medtronic, Inc., No. H-92-2439, 1993 WL 734843 (S.D. Tex. Oct.

28, 1993); Rutland v. Mentor Corp., No. 20235, 1994 WL 454741

(Miss. Cir. Feb. 23, 1994).

           With respect to Mentor's penile implants, the Rutland

court stated:
          The application procedure under 510(k)
          includes extensive qualification criteria
          based upon clinical studies, drawings and
          procedures in the manufacture of the device,
          proposed labelings and warnings, extensive
          product sterility information and documen-
          tation, a comparison to other devices on the
          market and safety and effectiveness status
          based upon ten (10) years of another similar
          device. Mentor not only complied with the
          510(k) requirements, it continues to comply
          with post-510(k) requirements imposed by law.


Id. at *3.

           Among the few cases suggesting that the 510(k) process

does not invoke preemption is Larsen v. Pacesetter Systems, Inc.,

74 Haw. 1, 837 P.2d 1273 (1992) (involving pacemaker).    Larsen

held that the 510(k) process does not preempt state law claims

because it does not constitute FDA approval of a device.    Id. at

1282.   The court cited 21 C.F.R. § 807.97, which states that an

FDA determination of substantial equivalence "does not in any way

denote official approval of the device.    Any representation that

creates an impression of official approval of a device because of

complying with the [510(k) Notification] regulations is

misleading and constitutes misbranding."   Id.

           Nevertheless, we agree with the district court's well-

reasoned rationale that the Amendment's preemption provision is


                                12
triggered not by FDA approval of a device's safety and

effectiveness, but by federal requirements relating to a device's

safety and effectiveness.    See 21 U.S.C. § 360k(a).   Those

regulations include the 510(k) process with which a manufacturer

must comply to obtain a determination of substantial equivalence.

We are satisfied that this process is sufficiently rigorous to

constitute a "requirement...relating to the safety or

effectiveness" of Class III medical devices, pursuant to

§360k(a).

            Implicitly conceding that the FDA regulations discussed

above do establish safety requirements, English nevertheless

maintains that only regulations specifically covering inflatable

penile prostheses have preemptive effect.     In support of this

argument, English asserts that the FDA has determined that

preemption only applies when:
          [T]he [FDA] has established specific
          counterpart regulations or there are other
          specific requirements applicable to a
          particular device under the act, thereby
          making any existing divergent State or local
          requirements applicable to the device
          different from, or in addition to, the
          specific [FDA] requirements. There are other
          State or local requirements that affect
          devices that are not preempted by section
          [360k(a)] of the act because they are "not
          requirements applicable to a device" within
          the meaning of section [360k(a)] of the act.


21 C.F.R. § 808.1(d) (emphasis added).     Indeed, two district

courts have followed this logic and ruled that preemption occurs

only when there are specific, but not general, regulations

pertaining to a device.     Ginochio v. Surgikos, Inc., 864 F. Supp.



                                  13
948, 951-53 (N.D. Cal. 1994); Oja v. Howmedica, Inc., 848 F.

Supp. 905, 906 (D. Colo. 1994).

          We find this argument unconvincing.    First, English

attempts to read the phrase "other specific requirements

applicable to a particular device" out of the statute.    This

phrase suggests that a general regulation that is binding on a

particular device has preemptive effect.   See Hodgon v. Mentor

Corp., No. 92-1429, slip. op. at 5 (S.D. Ind. Aug. 8, 1994)

(finding premarket approval regulations are "specific

requirements" within meaning of § 808.1(d)); Tucker v. Collagen

Corp., 1994 U.S. Dist. LEXIS 3101, at *9 (N.D. Ill. Mar. 16,

1994) (rejecting narrow reading of § 808.1(d)).    Indeed, other

circuits have relied on FDA regulations generally applicable to

Class III devices in order to find preemption.    See Mendes, 18

F.3d at 17-18 (good manufacturing practice and labeling

requirements); Stamps v. Collagen Corp, 984 F.2d 1416, 1422 n.5

(5th Cir.) (good manufacturing practice requirements), cert.

denied, -- U.S. --, 114 S. Ct. 86 (1993); King v. Collagen Corp.,

983 F.2d 1130, 1131 (1st Cir.) (premarket approval application

requirements), cert. denied, -- U.S. --, 114 S.Ct. 84 (1993).
          Second, even assuming that the FDA's regulations should

be interpreted as English suggests, we believe no deference is

owed to that interpretation because it conflicts with the text of

the statute.   See Chevron U.S.A., Inc. v. Natural Resources

Defense Council, Inc., 467 U.S. 837, 842-43, 104 S. Ct. 2778,

2781 (1984).   Here, Congress directed that state requirements are

preempted "which are different from, or in addition to, any


                                  14
requirement under [the FDCA]."   21 U.S.C. § 360k(a) (emphasis

added).   Thus, the mere fact that the FDA has promulgated

regulations affecting groups of devices, rather than a specific

type of device, should not alter whether or not there is

preemption.   See   Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 49

(D. Mass. 1994) (rejecting FDA's interpretation of preemption

provision as contrary to statute); Ministry of Health, Province

of Ontario, Canada v. Shirley Inc., 858 F. Supp. 1426, 1436 (C.D.

Cal. 1994) (same); see also Stamps, 984 F.2d at 1421 n.2

(interpreting § 360k(a) and § 808.1(d) as announcing "essentially

the same test"); King, 983 F.2d at 1130 (ruling that § 360k(a)

provides "maximum protection and express preemption....").

           Finally, since promulgating § 808.1(d), the FDA has

issued an interpretation of § 808.1(d) contradictory to the one

advanced by English.   The FDA has stated:   "[P]reemption is not

restricted to State requirements that directly conflict with

Federal law, but rather extends to requirements that are

different from, or in addition to, any requirement applicable to

the device under the act."   45 Fed. Reg. 67,326, 67,328 (1980)

(emphasis added).   Thus, we conclude that the FDA's labeling and

good manufacturing practices regulations establish requirements

within the meaning of § 360k(a).

                                 IV.

           In conclusion, based on our decisions in Gile and
Michael, we hold that appellants' strict product liability,

negligence and breach of implied warranty claims are preempted by

the Medical Device Amendments of 1976.   Furthermore, we hold that


                                 15
preemption applies even where, as here, a Class III medical

device is cleared for marketing under the "substantial

equivalence" exception to the MDA Premarket Approval process.      We

hold, nonetheless, that the district court erred by granting

summary judgment in Mentor's favor on appellants' breach of

express warranty claim.   Under our holding in Michael, such a

claim is not preempted by the MDA.4   We will reverse and remand

the cause for further proceedings on this claim.




4
For the reasons stated, we also remand Mrs. English's loss of
consortium claim; however, we affirm summary judgment on
appellants' claim for punitive damages.

                                16
