1995 Decisions

Opinions of the United

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Precedential or Non-Precedential: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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Recommended Citation

"English v Mentor Corp" (1995). 1995 Decisions. Paper 261.

http://digitalcommons.law.villanova.edu/thirdcircuit_1995/261
1 

 

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. 
2 

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 
3 

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. 

 

1In 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 
4 

§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. 
5 

§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 

 

2Congress 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.
6 

 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 

 

3Subsection (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. 
7 

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 
8 

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 
9 

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 
10 

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 
11 

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-
12 

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 documentation, 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 wellreasoned rationale that the Amendment's preemption provision is 
13 

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. 
14 

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 
15 

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 
16 

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. 

 

4For the reasons stated, we also remand Mrs. English's loss of 

consortium claim; however, we affirm summary judgment on 

appellants' claim for punitive damages.