1995 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

2-7-1995

Michael v Shiley, Inc.

Precedential or Non-Precedential:

Docket 94-1496

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Recommended Citation

"Michael v Shiley, Inc." (1995). 1995 Decisions. Paper 35.

http://digitalcommons.law.villanova.edu/thirdcircuit_1995/35
 UNITED STATES COURT OF APPEALS 

 FOR THE THIRD CIRCUIT 

 

 ---------- 

 

 No. 94-1496 

 

 ---------- 

 NINA MICHAEL, 

 Appellant

v. 

 SHILEY, INC.; 

 HOSPITAL PRODUCTS GROUP, INC., 

 (FORMERLY HOWMEDICA, INC.); 

 PFIZER, INC. 

 ---------- 

 On Appeal from the United States District Court 

 for the Eastern District of Pennsylvania 

 (D.C. Civil No. 93-1729) 

 

 ---------- 

 Argued Monday, October 24, 1994 

 BEFORE: STAPLETON, HUTCHINSON and GARTH, Circuit Judges

 ---------- 

 (Opinion filed February 7, l995) 

 

 ---------- 

 

 Gary Green (Argued) 

 Sidkoff, Pincus & Green 

 530 Walnut Street 

 Philadelphia, Pennsylvania 19106 

 Morton B. Wapner 

 David Kuritz 

 Wapner, Newman & Wigrizer 

 115 South 21st Street 

 Philadelphia, Pennsylvania 19103 
 Attorneys for Appellant 
 David Klingsberg (Argued) 

 Maris Veidemanis 

 Kaye, Scholer, Fierman, Hays & 

 Handler 

 425 Park Avenue 

 New York, New York 10022 

 John W. Frazier, IV 

 James A. Willhite, Jr. 

 Montgomery, McCracken, Walker & 

 Rhoads 

 Three Parkway, 20th Floor 

 Philadelphia, Pennsylvania 19102 

 Attorneys for Appellees 

 

 ---------- 

 

 OPINION OF THE COURT 

 

 ---------- 

 

GARTH, Circuit Judge: 

 This appeal requires that we determine how the Medical 

Devices Amendments of 1976 which amended the Food, Drug and 

Cosmetics Act of 1938, 21 U.S.C. § 360-360rr, allocates authority 

between the states and the Food and Drug Administration. To be 

precise, we must decide whether 21 U.S.C. § 360k pre-empts Nina 

Michael's state law causes of action for negligent manufacture 

and design, strict product liability, breach of the implied 

warranty of merchantability, breach of an express warranty, and 

common law fraud against Shiley Inc., the manufacturer of the 

Bjork-Shiley Heart Valve. 

 Applying the express pre-emption analysis defined by 

Cipollone v. Liggett Group Inc., 112 S. Ct. 2608 (1992), we 

conclude that § 360k pre-empts Michael's cause of action for 

negligence (both manufacturing and design), strict product 
liability, and breach of the implied warranty of merchantability. 

We also hold that Michael's complaint to the extent that it 

relies on fraud perpetrated by Shiley on the FDA is pre-empted. 

Finally, we hold that § 360k does not preclude Michael from 

pursuing common law causes of action for express warranty and for 

fraud to the extent that the fraud arises from Shiley's efforts 

to promote its product through letters to doctors and 

advertisements in medical journals. 

 Accordingly, while we will affirm the district court's preemption rulings as to Michael's negligence, strict product 

liability, and implied warranty claims, we will reverse the 

district court's summary judgment to the extent that it entered 

judgment against Michael on her express warranty and fraud 

claims. 

I 

A. 

 Nina Michael's claims arise from the discovery in the past 

fifteen years that the outlet strut of the Bjork-Shiley 60 Degree 

Convexo-Concave Disc Heart Valve ("Shiley valve"), which was 

designed and manufactured by Shiley Inc., fractures in 

approximately one percent of the patients who received a Shiley 

implant. App. 200. These failures result from a weak strut 

mechanism and from poor manufacturing standards at Shiley's 

facilities. A strut failure leads inevitably to death or serious 

injury. 
B. 

 The Shiley valve was one of the first medical devices to be 

approved under the 1976 Medical Device Amendments to the Food 

Drug and Cosmetics Act of 1938 (the "MDA"), a comprehensive 

extension of the FDA's authority beyond medical drug 

manufacturers to medical device manufacturers. Pub. L. No. 94-

295, 90 Stat. 539 (1976). Congress passed the Amendments in 

response to the harm caused by the Dalkon Shield, an unregulated 

medical device which resulted in serious injury to a large number 

of women.1 Sen. Rep. No. 33, 94th Cong., 1st Sess. 2 reprinted 

in 1976 U.S. Code Cong. & Admin. News 1070, 1071. Through the 

MDA, Congress hoped "to assure the reasonable safety and 

effectiveness of medical devices intended for human use." H. 

Conf. Rep. No. 1090, 94th Cong., 1st Sess. 51 reprinted in 1976 

U.S. Code Cong. & Admin. News 1103, 1103. To do so, it granted 

the FDA new broad powers to regulate medical devices, which 

powers are based on three statutory classifications. 

 Class I devices, such as tongue depressors, are devices 

which generally pose little or no threat to public health and are 

subject only to general controls on manufacturing. See 21 U.S.C. 

§ 360c(a)(1)(A). Class II devices, such as oxygen masks, pose a 

slightly greater risk of injury to patients, and accordingly, the 

MDA subjects them to performance standards, post market 

 

1. For a history of the harm which resulted from the Dalkon 

Shield, see In re A.H. Robins Co., 880 F.2d 709, 710-12 (4th 

Cir.), cert. denied sub nom, Anderson v. Aetna Casualty and 

Surety Co., 493 U.S. 959 (1989). 
surveillance, guidelines for use and other appropriate controls. 

See id § 360c(a)(1)(B). Class III devices, such as the Shiley 

valve, include all devices which are to be implanted into people, 

which are used to sustain life, or which pose a potentially 

unreasonable risk of injury. See id. § 360c(a)(1)(C). 

 Class III devices may not be marketed or sold until the 

sponsoring company obtains Premarket Approval (PMA) from the FDA. 

Id. § 360e. To obtain a PMA, the sponsor must submit "all 

information, published or known to or which should reasonably be 

known to the applicant, concerning investigations which have been 

made to show whether or not such device is safe and effective," 

id. § 360e(c)(1)(A), a statement of the intended use of the 

product, a description of the expected manufacturing processes 

for the device, and any other information requested by the FDA. 

Id. § 360e(c)(1)(B)-(G). After review by a panel of medical 

experts, the FDA may approve the PMA. 

 The FDA retains continuing oversight over approved Class III 

devices. It requires manufacturers to report any deaths or 

serious injuries which result from the use of the product. See

21 C.F.R. § 803.24(c). It may require warning or instructions on 

the labels which accompany the product. 21 C.F.R. § 814.82. 

Finally, the FDA regulates the manufacture of the devices through 

the imposition of good manufacturing processes. 21 C.F.R. 

§ 820.100-820.101. The only remedial power granted to the FDA is 

the power to require the sponsor of the product to notify the 

public of a newly discovered danger posed by the product, order 

the company to replace the device, or order the company to refund 
the purchase price to the patient. The FDA can take these 

actions only if it determines that the device presents an 

unreasonable risk of substantial harm to the public. 21 U.S.C. 

§ 360h(a). The act does not permit the FDA to require companies 

to compensate victims for their medical expenses or for the pain 

and suffering resulting from a device failure. 

C. 

 Shortly after the passage of the MDA, Shiley applied for 

Premarket Approval (PMA) to market the Shiley valve. At the 

time, the FDA's procedures for PMA applications had not been 

finalized, see 51 Fed. Reg. 26364 (July 22, 1986) (defining PMA 

procedures), and thus the Shiley application did not receive the 

same organized and comprehensive evaluation that might be 

expected today. Sen. Comm. on Energy & Commerce, 101st Cong., 2d 

Sess., The Bjork-Shiley Valve: Earn as You Learn 20-22 (Comm. 

Print 1990) [hereinafter Energy & Commerce Report]. For example, 

evidence of the first strut fracture was belatedly brought to the 

FDA's attention and explained as an "isolated incident" even 

though it was unexplained at the time of the application. Id. at 

21. Further, Shiley made claims, based on unsubstantiated data, 

that reduced heart complications would result from Shiley valve 

implants.2 Id. at 22-24. Despite these deficiencies, the FDA 

 

2. Specifically, Shiley claimed a reduction in the rate of 

thromboembolism, the development of potentially dangerous blood 

clots at the valve's location. The FDA later determined that 

there was no improvement in the rates of thromboembolism with the 

new valve and that this information, if known at the time the PMA 
approved the PMA on April 27, 1979, without a recorded vote. Id.

at 22. 

 Between 1979 and 1983, the struts which hold the mechanical 

valves in place in 73 Shiley valves fractured, id at 28, leading 

to the death of most of the implanted individuals. These 

fractures were the result of both the valve's design and poor 

manufacturing processes. In particular, the valves suffered from 

poor welding and poor quality control. See id. at 5-14; App. 

461, 615-16, 623-25. During this period, Shiley sent a set of 

letters to doctors and to the FDA reassuring them that these 

incidents did not compromise the integrity, safety, or 

effectiveness of the device. Energy & Commerce Report at 14-17. 

Despite a redesign of the manufacturing process, continuing strut 

fractures forced Shiley to recall those valves which had not been 

implanted in 1980, 1982, and 1983. Because of continuing 

problems with valve failures, Shiley recalled its larger size 

valves and ceased production of those sizes in October 1985. 

Finally, on November 24, 1986, Shiley withdrew all its remaining 

valves from the market and ceased production of any heart valves. 

On March 21, 1990, Shiley asked the FDA to withdraw its Premarket 

Approval. To date, approximately 501 Shiley valves have 

fractured, resulting in 347 deaths. App. 691. 

D. 

(..continued) 

was filed, would likely have prevented FDA approval. App. 766-

68. 
 These events first affected Nina Michael in 1981. In that 

year, Michael was diagnosed with a congenital defect with her 

mitral heart valve, which controls of the flow of blood between 

the left atrium and the left ventricle. Because the defect was 

potentially fatal, Michael underwent surgery to have her natural 

heart valve replaced with the Shiley valve on November 24, 1982. 

 The surgery was successful and the valve functioned 

properly. The valve implanted in Michael came with the following 

disclosure under the heading "Disclaimer of Warranties": 

 Shiley warrants that reasonable care has been used in 

the manufacture of this device. This warranty is 

exclusive and in lieu of all other warranties, whether 

express, implied, written or oral. 

App. 680. 

 In the late 1980s and early 1990s, Michael became aware of 

the strut fracture problem through media sources and her doctor. 

Research disclosed that her class of valves was among the Shiley 

valves with the highest rate of failure. It was estimated that 

there was a two percent chance per year that a catastrophic valve 

failure would occur in the Shiley valve implanted in Michael. 

These disclosures caused Michael significant anxiety, which 

resulted in sleeplessness and other emotional and physical 

symptoms. 

 After consultations with her physicians, Michael had the 

Shiley valve surgically removed and replaced with a different 

valve in June 1992. The surgeon visually examined her explanted 
valve and found no visible defects. The valve was later 

discarded. 

 In March 1993, Michael filed a complaint in the Philadelphia 

Court of Common Pleas, alleging state law claims of negligence, 

strict product liability, breach of implied warranties, breach of 

express warranties, and fraud. App. 10-29. Her complaint named 

Shiley Inc., the maker of the Shiley valve; Pfizer Inc., Shiley's 

corporate parent; and Hospital Products Group Inc., another 

corporate owner of Shiley. Shiley removed the case to the 

Eastern District of Pennsylvania on the basis of diversity 

jurisdiction. App. 31. On August 16, 1993, Shiley filed two 

summary judgment motions. One motion alleged that all claims 

except the express warranty claim were pre-empted. The second 

motion alleged that Michael had failed to raise a genuine issue 

of material fact to support her claims. 

 Through orders dated February 25, 1994, March 31, 1994, and 

April 7, 1994, the district court granted judgment on all the 

claims against Michael and in favor of Shiley. It granted 

judgment on the negligence, strict product liability, and implied 

warranty claims on both pre-emption and traditional Rule 56 

grounds. See Fed. R. Civ. P. 56(c). It granted judgment on the 

express warranty claim for failure to raise a genuine issue of 

material fact. Finally, it granted judgment on the fraud claim 

solely because it was pre-empted. 

 Michael filed a timely notice of appeal. 

II. 
 We exercise plenary review of the district court's grant of 

summary judgment and apply the same test that the district court 

should have applied initially. Goodman v. Mead Johnson & Co., 

534 F.2d 566, 573 (3d Cir. 1976), cert. denied, 429 U.S. 1038 

(1977). Thus, we will affirm only if Michael has failed to raise 

a genuine issue of material fact and Shiley is entitled to a 

judgment as a matter of law. Id. In examining the record, we 

give the nonmoving party the benefit of all reasonable inferences 

from the record. Gray v. York Newspapers, Inc., 957 F.2d 1070, 

1078 (3d Cir. 1992). We exercise plenary review over the 

district court's pre-emption determination, as it is a question 

of law. Travitz v. Northeast Dep't ILGWU Health & Welfare Fund, 

13 F.3d 704, 708 (3d Cir.), cert. denied, 114 S. Ct. 2165 (1994). 

We also exercise plenary review over the district court's 

application of state law. Salve Regina College v. Russell, 499 

U.S. 225, 231 (1991). 

III 

A. 

 The parties' core dispute is whether, or to what extent, the 

MDA pre-empts Michael's state common law causes of action. 

Article VI of the Constitution provides that the laws of the 

United States "shall be the supreme Law of the Land; . . . any 

Thing in the Constitution or Laws of any State to the Contrary 

notwithstanding." U.S. Const. art. VI, cl. 2. By virtue of this 

grant of federal power, Congress can through a sufficiently clear 

expression of its intent displace state law. Cipollone v. 
Liggett Group, Inc., 112 S. Ct. 2608, 2617 (1992);3 CSX Transp. 

Inc. v. Easterwood, 113 S. Ct. 1732, 1737 (1993) ("[P]re-emption 

will not lie unless it is `the clear and manifest purpose of 

Congress.'") (quoting Rice v. Sante Fe Elevator Corp., 331 U.S. 

218, 230 (1947)). "In the interest of avoiding unintended 

encroachment on the authority of the States, however, a court 

interpreting a federal statute pertaining to a subject 

traditionally governed by state law will be reluctant to find 

pre-emption." CSX Transp. Inc., 113 S. Ct. at 1737. 

 Pre-emption may arise explicitly from the statute's language 

or implicitly from the statute's structure and purpose. Morales 

v. Trans World Airlines, Inc., 112 S. Ct. 2031, 2036 (1992). 

Nonetheless, "[w]hen Congress has considered the issue of preemption and has included in the enacted legislation a provision 

explicitly addressing that issue, and when that provision 

provides a reliable indicium of congressional intent with respect 

to state authority, there is no need to infer congressional 

intent to pre-empt state laws from the substantive provisions of 

legislation." Cipollone, 112 S. Ct. at 2618 (quotations and 

citations omitted). 

 

3. We recognize that Cipollone was decided by a plurality of the 

Supreme Court. We are satisfied that the pre-emption discussion 

and holding represents the Court's current pre-emption analysis. 

See, e.g., American Airlines, Inc. v. Wolens, 1995 WL 15047 (U.S. 

1995); Gile v. Optical Radiation Corp., 22 F.3d 540, 542 (3d Cir. 

1994); Weber v. Heaney, 995 F.2d 872, 875 (8th Cir. 1993); 

Cleveland v. Piper Aircraft Corp., 985 F.2d 1438, 1443 (10th 

Cir.), cert. denied, 114 S. Ct. 291 (1993). 
 Because Shiley relies upon the express pre-emptive scope of 

21 U.S.C. § 360k, our task is primarily one of statutory 

construction. Id. at 2621. We must give the language of § 360k 

"a fair but narrow reading" which will give effect to Congress' 

purpose without undermining "the strong presumption against preemption." Id. 

 Cipollone illustrates the manner in which we are to apply 

these doctrines. In Cipollone, the Supreme Court considered 

whether the Cigarette Labeling and Advertising Act of 1965 or the 

Public Health Cigarette Smoking Act of 1969 pre-empted Rose 

Cipollone's state common law causes of action for failure to 

warn, breach of express warranty, fraudulent misrepresentation, 

and conspiracy claims. The Court concluded that the limited 

language of the 1965 act did not prevent a state claimant from 

recovering damages in a state common law cause of action not 

otherwise pre-empted. 112 S. Ct. at 2619. 

 The Court turned to the broader pre-emption provision of the 

1965 Act which stated "[n]o requirement or prohibition based on 

smoking and health shall be imposed under State law with respect 

to the advertising or promotion of cigarettes . . . ." Id. at 

2617. Applying a "fair but narrow" reading of this provision, 

the Court held that Cipollone could not maintain a failure to 

warn claim because the statute prevented states from requiring 

any warning beyond the federally mandated statement "CAUTION: 

CIGARETTE SMOKING IS DANGEROUS TO YOUR HEALTH." Id. at 2621-22. 

In contrast, the Court concluded that Cipollone's express 

warranty and fraud claims could proceed. The contract claim was 
not "imposed under State law" and the fraud claim did not impose 

a requirement "with respect to the advertising or promotion of 

cigarettes." Id. at 2622-24. 

B. 

 Statutory interpretation begins with an analysis of the 

statute's language. Section 360k(a) provides: 

 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. 

This section pre-empts only state imposed requirements. Further, 

it pre-empts those requirements only when they differ from or add 

to a previously established FDA requirement and relate to the 

safety or efficacy of the regulated device. When a state law 

differs from or adds to a FDA requirement and when a state law 

relates to the safety or effectiveness of a device approved by 

the FDA, the state law is pre-empted. Conversely, when a state 

law neither imposes requirements nor differs from or adds to a 

FDA requirement nor relates to the safety or effectiveness of the 

device or to any other matter included in a FDA requirement, the 

state law is not pre-empted by § 360k. 
C. 

 We first consider Michael's two threshold arguments: (1) 

that state common law does not impose "requirements" and (2) that 

the FDA imposed no "requirements" on Shiley. Either would 

prevent the MDA from pre-empting any of her claims. 

 An extended discussion of whether the state common law 

imposes requirements under the MDA is unnecessary.4 We have 

already determined that the term "requirements" as used in § 360k 

encompasses state common law claims. Gile v. Optical Radiation 

Corp., 22 F.3d 540, 541-42 (3d Cir.), cert denied, 115 S. Ct. 429 

(1994). In Gile, we followed the Supreme Court in its 

interpretation of the term "requirement" as used in § 5(b) of the 

Public Health Cigarette Smoking Act of 1969. There the Court 

"reject[ed Cipollone's] argument that the phrase `requirement or 

 

4. Michael points in particular to the FDA regulations which 

interpret § 360k. See 21 C.F.R. § 808.1. 21 C.F.R. 

§ 808.1(d)(1) states: 

 [Section 360k(a)] does not preempt State or local 

requirements of general applicability where the purpose 

of the requirement relates either to other products in 

addition to devices (e.g. requirements such as general 

electrical codes, and the Uniform Commercial Code 

(warranty of fitness)), or to unfair trade practices in 

which the requirements are not limited to devices. 

Despite the reference in 21 C.F.R. § 808.1(d)(1) to laws of 

general applicability, we hold that the statutory language of 

§ 360k preempts Michael's claims for breach of the implied 

warranties of merchantability and fitness as explained in section 

IV. A. infra. 

 We express no view on the validity of § 808.1(d)(1) 

because Shiley disclaimed all implied warranties as it was 

entitled to do under the Code. 
prohibition' limits the 1969 Act's pre-emptive scope to positive 

enactments by legislatures and agencies." Cipollone, 112 S. Ct. 

at 2620. 

D. 

 Michael next argues that, while we could normally conclude 

that the FDA had imposed requirements on a manufacturer, the 

unique facts of this case preclude such a determination. 

Michael's argument is based on failings in the Premarket Approval 

and oversight process which arose because Shiley's heart valve 

was among the first mechanical devices approved under the MDA. 

According to Michael, these failings kept the FDA from imposing 

any requirements on Shiley. 

 Michael claims that the lack of FDA requirements is proved 

by the absence of any specific regulations which govern heart 

valves as compared with the other medical devices. Cf. 21 C.F.R. 

§ 813.1 - 813.170 (regulating the testing and manufacture of 

intraocular lenses); 21 C.F.R. § 870.1025 - 870.5925 (classifying 

and imposing requirements on various cardiovascular devices). To 

support this claim, Michael points to the FDA's statement that 

the MDA pre-empts state requirements only when the FDA "has 

established specific counterpart regulations or there are other 

specific requirements applicable to a particular device under the 

act . . . ." 21 C.F.R. § 808.1(d). 

 The absence of regulations relating specifically to heart 

valves is not dispositive as long as the Shiley valve was subject 

to "any requirement applicable under [the MDA] to the device." 
21 U.S.C. § 360k(a)(1). While Shiley's premarket application may 

indeed have been flawed, there is ample evidence that the Shiley 

valve was subject to requirements under the MDA. First, it is 

clear that Shiley had to and did obtain a PMA prior to marketing 

the device. See 21 U.S.C. § 360e. After Premarket Approval was 

obtained, Shiley was subject to the labeling requirements of 21 

C.F.R. § 801.1 - 801.16, which became effective February 13, 

1976, and of 21 C.F.R. § 820.1 - 820.198, which defined the 

general "good manufacturing practices" ("GMP") required of 

medical device manufacturers after July 21, 1978. See 41 Fed. 

Reg. 6896 (1976); 43 Fed. Reg. 31508 (1978). The FDA had the 

power to force notification of a previously unknown risk under 21 

U.S.C. § 360h(a)5 and at least once threatened to use this power. 

 

5. 21 U.S.C. § 360h(a) reads in relevant part as follows: 

 (a) Notification

 If the Secretary determines that-- 

 (1) a device intended for human use which is 

introduced or delivered for introduction into 

interstate commerce for commercial distribution 

presents an unreasonable risk of substantial harm to 

the public health, and 

 (2) notification under this subsection is 

necessary to eliminate the unreasonable risk of such 

harm and no more practicable means is available under 

the provisions of this chapter (other than this 

section) to eliminate such risk, 

 the Secretary may issue such order as may be necessary 

to assure that adequate notification is provided in an 

appropriate form, by the persons and means best suited 

under the circumstances involved, to all health 

professionals who prescribe or use the device and to 

any other person (including manufacturer, importers, 

distributors, retailers, and device users) who should 
See app. 766-69. Even though these generally applicable 

regulations do not rise to the level of specificity present in 

the case of some other devices regulated by the FDA, we conclude 

that they present "specific requirements applicable to a 

particular device under the act." 21 C.F.R. § 808.1(d). They 

therefore constitute proper bases for pre-emption under § 360k. 

IV 

 Having disposed of Michael's general allegations, we 

consider whether § 360k pre-empts the separate theories of 

recovery that Michael alleges. See Cipollone, 112 S. Ct. at 2621 

(considering each of Cipollone's theories of recovery to 

determine if they are pre-empted). Because Gile has already 

determined that state law negligence and strict product liability 

claims are pre-empted under § 360k on account of the potential 

conflict with FDA labeling, design, and manufacturing 

requirements, we will not discuss those claims further than to 

restate that they are pre-empted. See Gile, 22 F.3d at 543-44. 

(..continued) 

properly receive such notification in order to 

eliminate such risk. 
A. 

 Breach of Implied Warranties -- Pre-empted

 Michael brings a claim for breach of the implied warranties 

of merchantability and fitness for a particular purpose. 13 

Penn. Con. Stat. Ann. §§ 2314, 2315. These Uniform Commercial 

Code causes of action meet the first requirement of pre-emption 

under § 360k; they are state imposed. They "arise by operation 

of law" in any transaction in goods in Pennsylvania. Altronics 

of Bethlehem, Inc. v. Repco, Inc., 957 F.2d 1102, 1105 (3d Cir. 

1992). The requirements imposed by §§ 2314 and 2315 also 

potentially differ from or exceed the FDA's requirements. To 

decide Michael's implied warranty claims, the jury would have to 

decide whether the Shiley valve was defective. Id.; see also 13 

Penn. Cons. Stat. Ann. § 2314 (Goods must be "fit for the 

ordinary purpose for which such goods are used."). In Michael's 

case, this determination would require a finding that the heart 

valve's design was flawed, unreasonably dangerous, or poorly 

manufactured. Id. 

 This conclusion by necessity depends upon the accepted 

standards for the design and manufacture of products in the state 

of Pennsylvania. These standards may deviate from the FDA's 

determinations in the PMA process or from the FDA's "good 

manufacturing practices," which represent the agency's expert 

evaluation regarding the design and production of the Shiley 

valve. Section 360k does not permit this conflict. Accord King 

v. Collagen Corp., 983 F.2d 1130, 1135 (1st Cir.), cert. denied, 

114 S. Ct. 84 (1993). 
B. 

 Express Warranty Based on Shiley's Label -- Not Pre-empted

 Michael also brought an express warranty claim based on 

Shiley's statement on its packaging that it "warrants that 

reasonable care has been used in the manufacture of this device." 

App. 680. 

 Before we address this issue, we must consider, as a 

threshold issue, whether the district court ruled that this claim 

was pre-empted. The district court's February 25, 1994 order 

granted Shiley's motion for partial summary judgment based on 

pre-emption. Shiley's motion had sought the entry of summary 

judgment on Michael's claims of negligence, strict product 

liability, breach of implied warranties, and fraud claims, but 

not on Michael's breach of express warranty claim. App. 48. 

However, in ruling on Shiley' motion, the district court stated, 

"[w]e have held that the MDA has wholly pre-empted plaintiff's 

state law claims against defendants." App. 1362. On appeal, 

Shiley has argued that we can reach the question of pre-emption 

because the district court granted summary judgment on Michael's 

express warranty claim for failure to raise a genuine issue of 

material fact and we can affirm on any appropriate ground. 

Shiley's Br. at 28. Because "[t]he prevailing party may, of 

course, assert in a reviewing court any ground in support of his 

judgment, whether or not that ground was relied upon or even 

considered by the trial court," we will address that issue. 

Dandridge v. Williams, 397 U.S. 471, 475 n.6 (1970). 
 Section 360k only pre-empts requirements which the state 

"establish[es]" or "continue[s] in force." The focus of § 360k 

is on preventing the States from imposing on medical device 

manufacturers normative policy choices which conflict with FDA 

requirements. See Gile, 22 F.3d at 546. This focus is 

consistent with the limited purpose for which Congress displaced 

the states' coordinate regulatory role -- to permit efficient and 

effective FDA regulation of medical devices. The FDA itself has 

recognized the MDA's limited focus by interpreting § 360k to preempt only state requirements "having the force and effect of 

law," a term normally reserved for binding standards of conduct 

that operate irrespective of private agreement. 21 C.F.R. 

§ 808.1(d). 

1. 

 Express warranties arise from the representations of the 

parties which are made the basis of the bargain and do not result 

from the independent operation of state law. See 13 Penn. Cons. 

Stat. Ann. § 2313. Implied warranties, on the other hand, "arise 

by operation of [state] law." Altronics of Bethlehem v. Repco, 

Inc., 957 F.2d 1102, 1105 (3d Cir. 1992). The parties to a 

contract, not the state, define the substantive obligations of 

the contract and hence any express warranties. While the state 

provides for the enforcement of the parties' bargain, it does not 

define each party's duties.6 

 

6. The conceptual difficulty with determining whether, to what 

extent, and for what purposes contractual obligations arise by 
 The underlying foundation of contract law is the objectively 

manifested intentions of the parties. E. Allan Farnsworth, 

Contracts §§ 1.1 - 1.3 (2d ed. 1990). Shiley, in the 

representation which appears on the Shiley valve label, clearly 

manifested an intent to be bound by its one unequivocal promise 

and to disclaim any other implied warranties. Shiley 

represented: 

 Shiley warrants that reasonable care has been used in 

the manufacture of this device. This warranty is 

exclusive and in lieu of all other warranties, whether 

express, implied, written or oral. 

App. 680. 

2. 

 The Supreme Court has twice recognized this same distinction 

between state-imposed and state-enforced common law remedies. In 

American Airlines, Inc. v. Wolens, 1995 WL 15047 (U.S. 1995), the 

(..continued) 

virtue of state action, on the one hand, or the autonomous 

actions of the parties, on the other, has been addressed time and 

again in the literature on the common law. See, e.g., Jay M 

Feinman & Peter Gabel, Contract Law as Ideology in The Politics 

of Law 373, 378 (David Kairys ed. 1990); Charles Fried, Contract 

as Promise 7-27 (1981). Ultimately, contractual obligations 

result from the confluence of state authority and private 

actions. While the "binding force" of a properly executed 

contract derives from state authority, the content of the 

commitment is determined (absent mandatory or impermissible 

terms) by the parties themselves. In this way, contractual 

obligations differ fundamentally from state imposed regulatory 

requirements, such as the FDA requirement that medical devices 

meet certain design parameters. Both the content and the effect 

of these regulations flow from governmental authority. 
Court held that the Airline Deregulation Act of 1978, 49 U.S.C. 

§ 1305(a)(1), did not preempt Wolen's common law contract claims, 

writing: 

 We do not read the ADA's preemption clause, however, to 

shelter airlines from suits alleging no violation of 

state-imposed obligations, but seeking recovery solely 

for the airline's alleged breach of its own, selfimposed undertakings. As persuasively argued by the 

United States, terms and conditions airlines offer and 

passengers accept are privately ordered obligations 

"and thus do not amount to a state's enact[ment] or 

enforce[ment] [of] any law rule, regulation, standard, 

or other provision having the force and effect of law' 

within the meaning of § 1305(a)(1)." Brief for the 

United States as Amicus Curiae 9. . . . A remedy 

confined to a contract's terms simply holds the parties 

to their agreements -- in this instance to business 

judgments an airline made public about its rates and 

services. 

1995 WL 15047 at *6. 

 Previously, in Cipollone, the Court concluded that § 5(b) of 

the Public Health Cigarette Smoking Act of 1969 did not pre-empt 

state contract law claims. 

 A manufacturer's liability for breach of an 

express warranty derives from, and is measured by, the 

terms of that warranty. Accordingly, the 

"requirements" imposed by an express warranty claim are 

not "imposed under State law," but rather imposed by 

the warrantor. . . . In short, a common law remedy for 

a contractual commitment voluntarily undertaken should 

not be regarded as a "requirement . . . imposed under 

State law" within the meaning of § 5(b). 

Cipollone, 112 S. Ct. at 2622 (emphasis in original). 

 Moreover, our conclusion complies with the Supreme Court's 

admonition that courts should be "reluctant" to find pre-emption 

when "interpreting a federal statute pertaining to a subject 

traditionally governed by state law." CSX Trans. Inc. v. 
Easterwood, 113 S. Ct. 1732, 1737 (1993). This is especially 

true here where Congress remained silent as to whether the MDA 

pre-empted common law contract claims. The elimination of those 

claims might result in the elimination of all legal remedies to 

the purchaser. "It is difficult to believe that Congress would, 

without comment, remove all means of judicial recourse for those 

injured by illegal conduct." Silkwood v. Kerr-McGee Corp., 464 

U.S. 238, 251 (1984). 

 In this case, Congress has not only remained silent as to 

whether it intended to prevent states from enforcing the 

contractual representations of medical device manufacturers, it 

gave indications in 21 U.S.C. § 360h that at least some common 

law remedies would remain in conjunction with FDA regulation. 

Section 360h(d) defines the effect that a manufacturer's 

compliance with an FDA notification, reimbursement, or recall 

order should have: 

 Compliance with an order issued under this section 

shall not relieve any person of liability under Federal 

or State law. In awarding damages for economic loss in 

an action brought for the enforcement of any such 

liability, the value to the plaintiff in such action of 

any remedy provided him under such order shall be taken 

into account. 

While this provision does not delineate the scope of the state 

law remedies that remain after the MDA's passage, it contemplates 

that injured persons will be able to pursue a category of claims 

for economic loss under some circumstances. We conclude that 

express warranty claims are included in that category. 
3. 

 Shiley points to previous cases that have concluded that the 

same or similar federal regulatory schemes do pre-empt contract 

claims because the contract claims conflict with the FDA's 

supervision over medical device labeling. Worm v. American 

Cyanamid Co., 5 F.3d 744, 747 (4th Cir. 1993)7; King v. Collagen 

Corp., 983 F.2d 1130 (1st Cir.), cert. denied, 114 S. Ct. 84 

(1993)8; Kemp v. Pfizer, Inc., 851 F. Supp. 269 (E.D. Mich. 

1994).9 These courts have held that pre-emption was appropriate 

because the state law causes of action arose from representations 

made by manufacturers on labels approved by the FDA or EPA. The 

courts reasoned that because these labels were approved by the 

relevant regulatory authority, they could not give rise to 

voluntary obligations undertaken by agreement and so would 

conflict with federal regulation. 

 

7. In Worm v. Cyanamid Co, the Fourth Circuit decided that the 

pre-emption provision of the Federal Insecticide Fungicide and 

Rodenticide Act (FIFRA), 7 U.S.C. § 136v(b), pre-empted the 

plaintiff's contract claims because the claims were based on 

instructions for use found on the product label which were 

required and approved by EPA regulations. 5 F.3d at 749. 

Because the Fourth Circuit found that these instructions were 

mandated by the Environmental Protection Agency, the court 

concluded that the express warranty claims were pre-empted. Id.

8. In King v. Collagen Corp., the First Circuit concluded that 

§ 360k pre-empted King's express warranty claims because those 

claims arose from the language on the packaging approved by the 

FDA. 983 F.2d at 1135. "Allowing appellant's express warranty 

claims effectively would impose additional or different 

requirements on Zyderm's labeling and packaging." Id.

9. In Kemp v. Pfizer, Inc., the district court followed the 

reasoning of King and Worm to hold that § 360k pre-empted a 

contract claim against Pfizer, Hospital Products Group, and 

Shiley, the defendants in this case. 
 If for no other reason, Worm is distinguishable from this 

case because it deals with a separate statutory scheme. Worm

dealt with Federal Insecticide Fungicide and Rodenticide Act 

(FIFRA), not the MDA. Second, the plaintiff in Worm complained 

that Cyanamid had provided improper instructions for the use of 

the insecticide on its label, giving rise to a contract claim. 5 

F.3d at 748-49. Michael is not challenging the instructions for 

the use or the implantation of the Shiley valve. Rather she 

seeks to enforce the company's explicit warranty which guarantees 

the product. 

 King and Kemp are less easily distinguished. The court in 

King did not indicate the type of language or warning upon which 

the plaintiff relied in the case before it and so we cannot know 

if it is distinguishable from Michael's claims. Kemp dealt with 

the same product and the same warranty as is at issue in the 

present case. 

 Neither King nor Kemp are binding on this court and we 

conclude that the concern expressed in those cases, that warranty 

obligations would arise from and therefore be in conflict with 

statements that are required on a regulated label, does not make 

pre-emption appropriate. First, the fact that third parties 

dictate or define the terms of a contract does not undermine the 

doctrine that contractual duties arise from the mutual assent of 

parties to agreed upon language. For example, organizations that 

receive government grants to operate social programs frequently 

agree to include specified language in agreements with 

contractors and beneficiaries. See, e.g., 24 C.F.R. § 85.36(i) 
(1994) (mandating the inclusion of specified terms in contracts 

between Housing and Urban Development grant recipients and local 

parties); Ayers v. Philadelphia Housing Authority, 908 F.2d 1184 

(3d Cir. 1990) (discussing HUD mandates for contracts between the 

local housing authority and the local authority's 

tenants/purchasers). Government contractors must agree to 

specified compensation and wage terms in their contracts with 

employees who work on the government projects. See, e.g., 40 

U.S.C. §§ 328-29, 323; 41 U.S.C. § 351; 29 C.F.R. §§ 4.1 to 4.51; 

29 C.F.R § 5.5. Courts do not thereby conclude that these 

requirements cause the immediate parties' contractual 

relationships to arise from the federal mandate. Regardless of 

the economic and legal pressures that dictate the final terms, 

the contract still results from the parties' mutual agreement to 

those terms. 

 Further, King and Kemp did not adequately consider the 

extent to which Shiley's label was ultimately a product of its 

voluntary actions. The FDA does not devise a label of its own 

making. Rather, Shiley submitted its proposed label to the FDA, 

which label was then reviewed with the company. Shiley itself 

drafted the initial language of the label. If Shiley disagreed 

with FDA recommendations, it could have engaged in negotiation 

over what statement was proper or, if it did not wish to be bound 

by the required statement, it could have chosen not to market its 

device. Despite indications in King and Kemp to the contrary, we 

believe that Shiley participated actively and meaningfully in the 
FDA regulatory process that resulted in the label which we review 

here. 

4. 

 Even if this were not the case, the enforcement of an 

express warranty that arises from approved packaging does not 

establish a requirement that "is different from, or in addition 

to, . . . any requirement applicable under this chapter to the 

device." 21 U.S.C. § 360k. Through her express warranty claim, 

Michael seeks to enforce the very language which the FDA approved 

on the Shiley valve label. Given the clarity with which that 

language speaks of warranties, neither the FDA, Shiley, nor 

Michael could have mistaken this language as creating anything 

other than an explicit contractual obligation. Thus, it is the 

FDA's own requirement that Michael would have the state enforce. 

 If any person, other than Shiley, "established" the 

warranty, it was the FDA, not the state. Because the obligations 

imposed arise directly from the FDA's own approved language, the 

resulting liability does not differ from or add to FDA 

regulation. Rather it supports the FDA's approval regulation by 

giving it effect. 

 Michael's contract claim is not a product of state action; 

hence, it is not state imposed -- the sine qua non of pre-emption 

under § 360k. Michael's express warranty claim is not pre-empted 

and can be prosecuted. 

V 
 Michael also brought fraud claims relying on two theories of 

recovery. First, she alleges that Shiley fraudulently misled the 

FDA to her eventual, but foreseeable, detriment. Second, she 

alleges that Shiley's unregulated promotional and advertising 

materials fraudulently misrepresented that the Shiley valve was 

safe and would produce fewer complications than other valves when 

the company knew that these claims were not supportable. We 

consider whether § 360k pre-empts each of these claims. 

A. 

 Fraud on the FDA -- Pre-empted

 Michael produced substantial evidence that Shiley misled the 

FDA with false or misleading information when it applied for 

Premarket Approval. She claims that these fraudulent submissions 

led to the FDA's approval of the Shiley valve and thus led 

eventually to the necessity of removing the heart valve implanted 

in her. Alternatively, she argues that these fraudulent 

submissions estop Shiley from claiming that the MDA pre-empts its 

common law claims. Because of the conflict with the FDA's own 

efforts to monitor and control its PMA application process, we 

conclude that Michael's claims for Shiley's knowing 

misrepresentation to the FDA, even if provable, are pre-empted. 

 A state law cause of action for fraud is a state imposed 

requirement. By means of its recognized cause of action in 

fraud, the Commonwealth of Pennsylvania imposes a duty on anyone 

who sells products. That duty requires the seller to avoid any 
material misrepresentation that could induce purchasers to buy 

its product. See Moser v. DeSetta, 589 A.2d 679, 682 (Pa. 1991) 

 Michael seeks to use this general prohibition on deception 

to encourage the district court to review the PMA application 

Shiley submitted to the FDA. This inquiry could ultimately 

require that a court determine whether the information Shiley 

submitted was truthful, whether it was complete, whether FDA 

procedures sufficed to avoid a material misrepresentation, and 

whether the FDA should have or would have approved the device 

despite the misrepresentations. In sum, this claim requires a 

court, applying state law, to perform the same functions 

initially entrusted to the FDA. 

 Section 360k does not permit such a searching state inquiry 

into the inner workings of FDA procedures. Congress allocated 

the FDA responsibility to design and manage a process which would 

result in approval of the safest and most effective medical 

devices possible. See 21 U.S.C. § 360e (creating the PMA 

requirement). Congress also assigned the FDA the responsibility 

to approve or disapprove of applications to market medical 

devices. Under § 360k, states may not impose different 

requirements and thereby reach a different conclusion than the 

FDA. "[W]here the FDA was authorized to render the expert 

decision . . ., it, and not some jury or judge, is best suited to 

determine the factual issues and what their effect could have 

been on its original conclusions." King, 983 F.2d at 1140 

(Aldrich & Campbell, J.J. concurring). Under the MDA, states 

have no authority to police Shiley's compliance with the FDA's 
procedures. If Shiley knowingly misled the FDA in its PMA 

application, it is for the FDA to remedy that situation using the 

authority Congress gave it in the MDA. 

 Further, permitting a fraud claim based on false 

representations to the FDA would conflict with our precedent that 

plaintiffs may not bring implied causes of action for violations 

of the Food, Drug and Cosmetic Act. Gile v. Optical Radiation 

Corp., 22 F.3d 540, 544 (3d Cir.), cert. denied, 115 S. Ct. 429 

(1994). Plaintiffs cannot circumvent this bar by characterizing 

their cause as a claim for state law fraud. 

 Nor can Michael revive the pre-empted fraud claim by 

characterizing it as a defense to pre-emption. Michael argues 

that, though her fraud claim might be pre-empted, her allegations 

of Shiley's fraud in obtaining its PMA, if proven, should deprive 

Shiley of the defense of pre-emption. In essence, Michael argues 

that we should not permit Shiley to invoke the cloak of federal 

pre-emption when it obtained that cloak through the fraudulent 

manipulation of the regulatory process. 

 While we do not condone misconduct by medical device 

manufacturers, we cannot agree with Michael's theory. If a 

medical device manufacturer's claim that the MDA pre-empts a 

plaintiff's cause of action depends in the first instance upon 

proof that its Premarket Approval was not fraudulently obtained, 

courts would have to engage in the intrusive inquiry, which we 

have just demonstrated is forbidden. Only the timing, and not 

the inquiry itself, would differ from a claim for fraud on the 

FDA. This argument thus presents not less, but greater 
interference with the FDA's decisions. An attempt to reexamine 

the FDA's approval under state law standards, however pleaded, is 

pre-empted by § 360k. 

B. 

 Fraud Based on Shiley's Advertisements -- Not Pre-empted

 Michael's second fraud claim differs from the first in that 

it does not rely on conduct which was directly regulated by the 

FDA. Michael alleges that Shiley sent cardiac surgeons and 

cardiologists a series of letters and other promotional materials 

which knowingly misrepresented the extent of the valve fracture 

problem and knowingly overstated the reduction in serious side 

effects achieved by the Shiley valve. See FDA and the Medical 

Device Industry, Hearing Before the House Committee on Energy and 

Commerce, 101st Cong., 2d Sess. 15-21 (1990) (providing samples 

of these letters); App. 393-95. Michael alleges that the 

company's misinformation resulted in the eventual harm she 

suffered when her valve was explanted. 

1. 

 Having already concluded that state law fraud claims create 

state-imposed requirements and, when combined with other § 360k 

elements, are thus pre-empted, see section V. A. supra, we need 

only consider the other elements of pre-emption under § 360k.10 

 

10. The Supreme Court recently held that the Airline 

Deregulation Act of 1978 ("ADA") pre-empted the enforcement of a 

state consumer fraud statute, the Illinois Consumer Fraud Act, 

815 Ill. Comp. Stat. § 505/2. American Airlines, Inc. v. Wolens, 
The FDA had not imposed specific requirements related to 

advertising and promotion of the Shiley valve. Accordingly, we 

find that, as applied to Michael's circumstances, a state law 

fraud claim based on Shiley's advertising and promotional 

activities does not impose a requirement that "is different from, 

or in addition to" a FDA requirement and "which relates to the 

safety or effectiveness of the device or to any matter included 

in a requirement applicable to the device under this chapter." 

21 U.S.C. § 360k. 

 Unlike Michael's strict liability claims which are based on 

a duty to produce safe products, Michael's fraud claims are based 

"on a more general obligation -- the duty not to deceive." 

Cipollone, 112 S. Ct. at 2624. Thus, Michael's fraud claim does 

not relate to the safety or effectiveness of the Shiley valve. 

Michael argues that because this duty to avoid deceit does not 

"relate to the safety or effectiveness of the [Shiley valve]," 

her claims are not pre-empted. 

 She relies on Cipollone for this argument. In Cipollone, 

the Supreme Court concluded that the Cipollone's fraud claims 

against cigarette manufacturers were only pre-empted to the 

(..continued) 

1995 WL 15047 *5-*6 (U.S. 1995). In Wolens, the Supreme Court 

held that state consumer fraud statute was a state imposed law. 

Id. The Court then found that the Illinois state statute met the 

other element of pre-emption under the ADA, that is, the statute 

"relate[d] to [airline] rates, routes, or services." 49 U.S.C. 

§ 1305(a)(1). 

 Here, of course, the other requirements which dictate 

pre-emption under § 360k of the MDA differ from the requirements 

which dictate pre-emption under § 1305(a)(2) of the ADA. As 

stated in text, we conclude that Michael's common law fraud claim 

is not pre-empted by § 360k. 
extent they sought to impose additional warnings on the cigarette 

packages. The Court permitted Cipollone's fraud claims for 

"claims based on allegedly false statements of material fact made 

in advertisements." Id. at 2623-24. The Court made this 

distinction because Cipollone's second claim based on "the duty 

not to deceive" did not conflict with federal requirements of § 5 

of the Public Health Cigarette Smoking Act of 1969 which only 

pre-empts state law claims "based on smoking and health." Id. at 

2624. 

 If § 360k also limited its pre-emptive scope to state 

requirements "which relate[] to the safety or effectiveness of 

the device," Michael's argument might be compelling, but § 360k 

is not so limited. It extends as well to state requirements 

"which relate[] . . . to any matter included in a requirement 

applicable to the device under this chapter." Thus, we must 

determine not only whether Michael's fraud claim relates to 

"safety and effectiveness" -- which we hold it does not -- but 

also whether it relates to any other FDA requirement. 

2. 

 This latter inquiry turns on whether the FDA imposed any 

requirements on Shiley's efforts to promote its heart valve. The 

record reflects that it did not. Shiley prepared and sent the 

letters which tout the valve's reliability and superiority as 

compared to competitors' valves to doctors without the FDA's 

approval. App. 393-94. The FDA, at that time, was not 

supervising medical device manufacturers' efforts to promote 
their devices outside of a limited category of "restricted 

devices" defined by the MDA and not relevant to this appeal. 

Only in the last few years has the FDA actively sought to control 

the promotional representations which device makers make to the 

medical community. Sandra J.P. Dennis, Promotion of Devices: An 

Extension of FDA Drug Regulation or a New Frontier, 48 Food & 

Drug L.J. 87 (1993). We note, however, that this on-going 

extension of the FDA's authority has been criticized as exceeding 

the FDA's statutory mandate. See id; Jeffrey N. Gibbs, Medical 

Device Promotional Activities and Private Litigation, 47 Food & 

Drug L.J. 295 (1992). 

 To be sure, the FDA did regulate the information Shiley 

placed on its labels. As required by the MDA, Shiley submitted 

its labels to the FDA and the FDA approved them. (See section 

IV. B. supra). A deviation from the content of the label 

approved by the FDA violates the MDA. 21 C.F.R. § 814.39(a)(2). 

Nonetheless, there is a substantial difference between 

supervising label content and supervising advertising. 

 Mindful that the Supreme Court has observed in a slightly 

different context that "Congress offered no sign that it wished 

to insulate . . . manufacturers from longstanding rules governing 

fraud," Cipollone, 112 S. Ct. at 2624, we conclude that Michael's 

second theory of fraud is not precluded by § 360k and is thus not 

pre-empted. 

 Our conclusion does not conflict with First Circuit's 

determination in King that § 360k pre-empted King's fraud claim. 

983 F.2d at 1136. King's fraud claim arose from the absence of 
warnings on the label of the medical device. Id. Because the 

FDA regulates the labeling of medical devices, King's claims were 

pre-empted. Michael's theory does not depend upon Shiley's 

representations on its labeling. Unlike in King where the court 

determined that the plaintiff's fraud claim was, "at bottom, a 

failure to warn claim," id., and thus pre-empted by the MDA, 

Michael's fraud claim is, at bottom, a fraudulent promotion 

claim. As such, it is not pre-empted. 

VI 

 Summary Judgment -- Sufficient Evidence

 Although the district court granted summary judgment on the 

majority of Michael's claims because it believed they were preempted, it also analyzed the claims using the traditional 

standard for summary judgment. We have concluded that Michael's 

express warranty claim and her fraud claim are not pre-empted. 

However, our holding in this regard does not address the district 

court's ruling that Michael had failed to present sufficient 

evidence to proceed to trial. We address that issue here and 

hold that, on this record, it was error to grant summary judgment 

for Shiley. 

A. 

 Our consideration of Michael's contract claims originates 

with an examination of the contract. The label attached to the 

heart valve, which was implanted in Michael, included the 

statement "Shiley warrants that reasonable care has been used in 
the manufacture of this device." App. 680. This language 

clearly created an express warranty with regard to the manner in 

which Shiley manufactured its heart valves. Shiley does not deny 

that the sale created a valid contract with an express warranty. 

See 13 Pa. C.S.A. § 2313. Rather Shiley contends that it never 

breached the warranty because there is no proof that the valve 

implanted in Michael was defective. 

 We agree that there is no evidence in the record that 

Michael's valve was defective. That does not, however, defeat 

Michael's cause of action. Shiley's warranty does not simply 

warrant that the valve which was implanted in Michael was defectfree. The language is less specific, warranting instead that 

"reasonable care has been taken in the manufacture of this 

device." App. 680. 

 We are satisfied that the representation made by the 

language on this label reaches beyond the valve explanted from 

Michael to encompass the manufacture of Shiley valves generally. 

While most consumers of most products have little reason to seek 

assurances in a contract that any device, other than the product 

purchased by them, is safe and effective, heart valve purchasers, 

as perhaps other purchasers of implanted devices, have salient 

and compelling reasons to seek such assurances. 

 Shiley's customers rely on Shiley's mechanical heart valves 

in a manner that differs entirely from the normal buyer's 

reliance on a consumer product. The Shiley valve sustains 

customer's lives. Malfunction will result in serious harm, or 

most likely, death. In this context, the purchaser has reason to 
demand a very high degree of assurance that the implanted product 

presents no substantial risk that it will fail. The existence of 

a significant risk that the device will fail makes the product 

unsuitable for its purpose. Therefore, a patient-purchaser has 

every reason to seek, and Shiley has every reason to give, 

assurances that reasonable care has been taken in the production 

of such life sustaining devices generally. It is only such a 

warranty that can alleviate concerns that an implanted medical 

device will fail without warning. 

 Shiley's warranty afforded its patient-purchasers those 

assurances. Michael proceeded with her implant operation with a 

justifiable belief that the valve implanted in her heart would 

not fracture or fail due to deficiencies in the manufacturing 

process. Because any latent defect in an implanted device may be 

undetectable after it has entered medical supply channels, the 

representations made by the manufacturer, which here form the 

basis of Shiley's warranty, requires an examination, not just of 

the specific heart valve implanted in Michael, but rather of 

Shiley's valve production generally. 

 The evidence in the record suggests that Shiley did not 

exercise due care in the fabrication of the Bjork-Shiley valve. 

A number of Shiley valves failed as a result of welding cracks 

that were not prevented or eliminated at Shiley's factories. 

Michael also submitted to the court the findings of a House 

Committee report on the manufacture of Shiley's valves. That 

report stated that Shiley trained welders inadequately, repaired 

valves which had previously been deemed not repairable by 
inspectors, and masked cracked welds to pass quality inspections. 

She also produced a letter to Shiley from a medical researcher, 

stating that "[y]our statement re. strut fracture that I just 

received only tells me that your manufacturing procedure is not 

acceptable." App. 461. Former welders stated in affidavits that 

Shiley trained welders poorly and told welders to force badly 

welded valves past quality control personnel. App 615-16, App. 

623-25. This record could amply support a jury determination 

that Shiley did not exercise reasonable care in the manufacture 

of its heart valves. 

 Michael has also shown that Shiley's alleged manufacturing 

breaches caused her damage. Shiley's failure to manufacture its 

heart valves using proper care resulted in a risk that any of its 

heart valves could fail. Indeed, the weak or improper strut 

construction has resulted in over 500 documented strut failures. 

Nor, as we have pointed out, could it be determined without 

explantation whether the valve implanted in Michael suffered from 

any of the same defects that affected other valves. Accordingly, 

Michael's doctors concluded that it was reasonable to explant her 

Shiley valve and replace it surgically. App. 499-501, 526-29; 

see also app. 471 (Shiley document sent to doctors noting an 

investigative article which recommended replacement of heart 

valves in young patients). Michael understandably took the 

advice of her medical advisors. The cost, inconvenience, risk, 

and pain of the surgery to explant and replace the valve occurred 

because of Shiley's alleged general manufacturing deficiencies 
which led to Shiley's alleged breach of its warranty of 

reasonable care. 

 Contrary to Shiley's arguments, our conclusion does not 

conflict with our recent decision in Angus v. Shiley, Inc., 989 

F.2d 142 (3d Cir. 1993).11 In Angus, we concluded that a 

recipient of a Shiley valve could not recover for intentional 

infliction of emotional distress and a failure to warn claim 

where the implanted valve had neither failed nor been explanted. 

Id. at 147 & n.5. Angus had failed to allege that the valve 

implanted in Angus was defective. Id. In the absence of a valve 

failure or explantation surgery, she could not maintain a product 

liability action. Id. In footnote 5, we explicitly held open 

the question of whether relief would be appropriate following 

surgery to explant the valve. Id. at 147 n.5. 

 Unlike the plaintiff in Angus, Michael has suffered a 

tangible injury on account of the risks, pain, and emotional 

trauma associated with explantation of the Shiley valve. 

Michael's case presents the issue left open in Angus -- what 

relief may be accorded for physical and emotional trauma 

occasioned by the need for actual explantation surgery. We 

conclude that, under the terms of Shiley's express warranty, 

 

11. Shiley claims we had earlier determined that a plaintiff 

whose valve had not failed could not recover for emotional 

distress on any product liability theory in Brinkman v. Shiley, 

Inc., 732 F. Supp. 33 (M.D. Pa.), aff'd without opinion, 902 F.2d 

1558 (3d Cir. 1989); see Shiley Brief at 41. We, of course, are 

not bound by an unpublished disposition of our court. See Third 

Circuit Internal Operating Procedures § 5.8. Moreover, the 

plaintiff in Brinkman, unlike the plaintiff here, had not 

undergone explantation surgery. 
sufficient evidence has been shown by Michael to withstand entry 

of summary judgment for Shiley. Our conclusion is consistent 

with Pennsylvania's rule that emotional harm may be recovered 

when it accompanies a physical injury. Houston v. Texaco, Inc., 

538 A.2d 502, 504 (Pa. Super. 1988). 

B. 

 Finally, we consider whether Michael produced sufficient 

evidence to proceed to trial on her fraud claim.12 In 

Pennsylvania, the elements of fraud are: (1) a material 

misrepresentation of fact, (2) which is false and (3) made with 

knowledge of its falsity, (4) which is intended to induce the 

receiver to act, and (5) upon which a party justifiably relies. 

Mellon Bank Corp. v. First Union Real Estate, 951 F.2d 1399, 1409 

(3d Cir. 1991). 

 It is well established that fraud consists of anything 

calculated to deceive, whether by single act or 

combination, or by suppression of truth, or suggestion 

of what is false, whether it be by direct falsehood or 

by innuendo, by speech or silence, word of mouth, or 

look or gesture. We have held that "fraud is composed 

of a misrepresentation fraudulently uttered with the 

intent to induce the action undertaken in reliance upon 

 

12. The somewhat confusing nature of the district court's orders 

makes it uncertain that the district court determined that 

Michael did not raise a genuine issue of material fact on her 

fraud claim. While the court granted a judgment on her fraud 

claim on the belief that it was pre-empted, a conclusion which we 

now reverse, the court granted Shiley's motion for summary 

judgment for failure to produce sufficient evidence on all claims 

"except plaintiff's fraud claim." Nonetheless, because we 

exercise the same review as the district court did in the first 

instance, we will consider the merits of Shiley's motion, 

particularly since the two district court orders appear on their 

face to conflict with one another. 
it, to the damage of its victim." The concealment of a 

material fact can amount to a culpable 

misrepresentation no less than does an intentional 

false statement. 

Moser v. DeSetta, 589 A.2d 679, 682 (Pa. 1991) (quoting Thomas v. 

Seman, 304 A.2d 134, 137 (Pa. 1973)) (other citations omitted). 

 In support of her claim, Michael points to two sources of 

fraudulent information: (1) letters written by Shiley to doctors 

between 1978 and 1983 which attempt to minimize the significance 

of the prior valve fractures and (2) advertisements and other 

promotional materials which emphasize a reduction in 

complications with the Shiley valve that never materialized. 

 Michael claims that Shiley's representations to doctors in 

letters, which accompanied its recalls and which Shiley otherwise 

disseminated to boost the Shiley valve's image following the 

disclosure of the outlet strut fractures, misrepresented the 

extent of the strut fracture problem. These letters state that 

some fractures had occurred but purportedly withheld information 

on the actual number of strut fractures known to Shiley. 

Further, the letters asserted that the Shiley valve's original 

design and the then current manufacturing practices confirm the 

structural integrity of the Shiley valve. 

 In contrast to Shiley's reports, the record discloses that 

Shiley had ample reasons to believe both the heart valve's design 

and the manufacturing process rendered the heart valve unsafe. 

Just a month prior to Shiley's distribution of a set of letters 

to doctors in May 1982, Dr. Bjork, one of the original designers 

of the Shiley valve, wrote Shiley, "You're circling around with 
other solutions is probably a waste of time. At this stage, 

welding will not be acceptable any more [sic]. . . . Your 

statement re. strut fractures that I just received only tells me 

that your manufacturing procedure is not acceptable. You have 

provided me with absolutely no facts and truthworthy [sic] data 

for the future." App. 461. 

 In a prior letter to Dr. Bjork, Shiley had written, "We 

would prefer that you did not publish the data relative to strut 

fractures. We expect a few more and until the problem has been 

corrected, we do not feel comfortable." App. 548. This 

disclosure contrasts with Shiley's assurances in the letters to 

doctors that new fractures were very unlikely to occur. 

 Moreover, Michael has produced affidavits and deposition 

testimony from employees who worked for Shiley in the late 1970s 

and early 1980s that state that Shiley supervisors and management 

ordered them to reweld valves which could not pass inspection, to 

polish or cover defects in outlet strut welds, and to rework 

previously scrapped valves in an attempt to hide any defects in 

the outlet strut welds. App. 555-57, 613-17, 625-29, 635-36. 

These manufacturing practices likely undermined the structural 

integrity of the valves and thereby rendered Shiley's 

representations false. 

 Michael has also produced samples of advertisements, which 

Shiley placed in medical journals that circulate to cardiac 

surgeons, claiming a fifty percent reduction in complications 

with the Shiley valve over prior valves. App. 678. In prior 

testimony, Dr. Bjork disagreed that this claim fully represented 
the scientific findings. App. 812. By 1984, the FDA, through 

independent investigation, concluded that scientific tests could 

not confirm these reductions. App. 766. In fact, the FDA 

determined that the Shiley valve's design "d[id] not result in 

meaningful differences in thromboembolic complications in 

clinical experience . . . . After nearly eight years of clinical 

use, there is no statistically significant difference between 

[the Shiley valve and its predecessor] when thromboembolic 

complication rates are compared." Id.

 This record reveals a sufficient pattern of affirmative 

statements that are contrary to the true information known to 

Shiley, which, when combined with the withholding of material 

information as to the integrity and properties of the Shiley 

valve, is more than sufficient to permit a jury to conclude that 

Shiley intentionally misrepresented the Shiley valve's 

performance and the importance of the strut fractures. 

 Having adduced evidence of the first three elements of a 

cause of action sounding in fraud, we turn to a consideration of 

the remaining two elements: inducement and justifiable reliance. 

We conclude that Shiley had ample reason to expect that its 

advertisements and letters, although directed to physicians, 

would induce action by heart patients to accept Shiley's implants 

on the basis of their physicians' recommendations. We also 

conclude that the patients' reliance on these recommendations was 

justifiable. 

 Pennsylvania has held that "the persons or class of persons 

whom [a fraudulent declarant] intends or has reason to expect to 
act or refrain from action in reliance upon the 

misrepresentation" may sue in fraud for the damage which results 

from the declarant's fraudulent statement. Woodward v. Dietrich, 

548 A.2d 301, 309, 315 (Pa. Super. 1988) (quoting Restatement 

(Second) of Torts § 531 (1976)). 

 In Woodward, the Pennsylvania Superior Court held that a 

subsequent transferee of a home could sue the prior owner's 

plumbing contractor, when the plumber had fraudulently 

misrepresented to the prior owner that his work met the relevant 

municipal codes. The plumber fraudulently concealed an improper 

link to the city's sewer system after being hired by the 

Dietrichs, the former owners of the house, to bring the house up 

to code. After the Dietrichs sold the home to the Woodwards, the 

sewer line backed up into the house's basement. The Woodwards 

brought a cause of action sounding in fraud against the plumber. 

 The Pennsylvania Superior Court adopted the rule of the 

Restatement (Second) of Torts § 531 (1976), which reads: 

 One who makes a fraudulent misrepresentation is subject 

to liability to the persons or class of persons whom he 

intends or has reason to expect to act or refrain from 

action in reliance upon the misrepresentation, for 

pecuniary loss suffered by them through their 

justifiable reliance in the type of transaction in 

which he intends or has reason to expect their conduct 

to be influenced. 

This provision extends liability beyond those to whom the 

declarant directs his fraudulent misrepresentation to those whom 

the declarant has special reason to anticipate will be induced to 

act. Woodward, 548 F.2d at 313, 315. As comment "e" of the 

Restatement makes clear, the declarant need not know the identity 
of the eventual plaintiff if the plaintiff is a member of a class 

of persons whom the declarant has reason to expect will act in 

reliance upon his fraud. Restatement (Second) of Torts § 531 

comment e (1976) ("The maker may have reason to expect that his 

misrepresentation will reach any of a class of persons, although 

he does not know the identity of the person whom it will reach or 

indeed of any individual in the class."); Woodward, 548 F.2d at 

309 n.9. 

 After adopting this standard, the court found that the 

plumber had reason to expect that any subsequent purchaser, such 

as the Woodwards, would rely on his fraudulent statement that the 

sewer connection was acceptable, and thus, the court permitted 

the Woodwards to proceed with their fraud action.13

 The Superior Court's decision mirrors § 533 of the 

Restatement (Second) of Torts. Section 533 makes a declarant 

liable when the declarant "has reason to expect that [the 

 

13. More recently, the Pennsylvania Superior Court relied 

upon its opinion in Woodward to decide that plaintiffs need not 

have been in privity with a product manufacturer to bring a claim 

under Pennsylvania's consumer fraud statute, the Pennsylvania 

Unfair Trade Practices and Consumer Protection Law, 73 Pa. Con. 

Stat. Ann. § 209-9.2(a). Valley Forge Towers South Condominium 

v. Ron-IKE Foam Insulators, Inc., 574 A.2d 641, 646-47 (Pa. 

Super. 1990), aff'd without opinion, 605 A.2d 798 (Pa. 1992). As 

a result, a condominium association could sue their roofing 

contractor's supplier for the supplier's unlawful business 

practices despite the fact that the association never purchased 

materials from the supplier. Rather it had only received a 

warranty from the supplier. "[A]s the materials were intended to 

become part of a fixture to realty, [the supplier] knew or should 

have known that its warranty would be relied upon by [the 

condominium association] covered by the roof it warranted." Id.

at 646. 
misrepresentation's] terms will be repeated or its substance 

communicated to the other, and that [the misrepresentation] will 

influence his conduct in the transaction or type of transaction 

involved." See Ostano Commerzanstalt v. Telewide Systems, Inc., 

794 F.2d 763, 766 (2d Cir. 1986) (holding licensor liable to 

sublicensee for representations made to licensee with reason to 

expect that they would influence sublicensee's behavior). As 

with § 531, the comments to § 533 make it clear that the 

declarant (here, Shiley) need not be able to identify the party 

(here, Michael) who eventually relies if the party (here, 

Michael) who relies is a member of a class of people that the 

declarant (here, Shiley) would expect to rely on the 

representation. Restatement (Second) of Torts § 533 comment g 

(1976). 

 Michael fits within the rule of Woodward and Restatement 

§ 533. Shiley had ample reason to expect that the patients and 

eventual recipients of the Shiley valve implants would be 

affected by the information it published and distributed to 

doctors. Indeed, that was Shiley's intent. Shiley had to 

anticipate that its letters and advertisements would lead doctors 

to recommend, and the physician's patients to choose, the Shiley 

valve. As § 533 makes clear, the fact that Shiley initially made 

its representations to Michael's doctors, rather than directly to 

Michael, does not undermine Michael's claim. 

 By the same token, Michael's doctors were justified in 

relying on the medical claims Shiley provided in its promotional 

materials to determine the proper course of treatment for 
Michael.14 Shiley held a tremendous advantage over the doctors 

in its knowledge of the facts surrounding the strut fractures and 

the scientific literature on thromboembolism. The doctors were 

justified in relying on Shiley to restate honestly the facts and 

findings pertaining to the valves which Shiley produced. See

Aaron Ferer & Sons, Ltd v. Chase Manhattan Bank, 731 F.2d 112, 

123 (2d Cir. 1984) (where "one party possesses superior 

knowledge, not readily available to the other, and knows that the 

other is acting on the basis of the mistaken information," the 

second party can justifiably rely on the first party's 

representations); Daughtrey v. Ashe, 413 S.E.2d 336, 338 (Va. 

1992) ("[I]f one who has superior knowledge makes a statement 

about the goods sold and does not qualify the statement as his 

opinion, the statement will be treated as a statement of fact."); 

Restatement (Second) of Torts § 542(a) & comment f (1976). 

 The information provided by Shiley was intended to affect a 

doctor's choice of a heart valve for Michael. Shiley distributed 

its literature containing heart valve information for that very 

purpose -- to encourage doctors to continue implanting the Shiley 

valve. The record, read in the light most favorable to Michael, 

 

14. Both her doctors testified that they received letters from 

Shiley regarding the Shiley valve. App. 495, 524. While they 

did not retain those letters, it is reasonable to assume, given 

Shiley's nationwide distribution of the letters, that these 

letters include the communications discussed above. Both doctors 

stated that they read standard cardiac journals in which Shiley's 

advertisements and claims appeared in order to stay current with 

developments in the field of cardiology and cardiac surgery. 

App. 500, 535. 
suggests that the doctors, who advised Michael, relied on 

Shiley's disclosures. Accordingly, Shiley's letters and 

promotional materials likely affected the choice to implant the 

Shiley valve in Michael. 

 We conclude that Michael has produced sufficient evidence to 

raise a genuine issue of fact on her claim of fraud and we will 

reverse the district court's February 25, 1994 orders of summary 

judgment on that claim. 
VII 

 Having considered the record and the arguments of the 

parties, we will affirm the district court's grant of summary 

judgment on Michael's claims of negligence (both manufacturing 

and design), strict product liability, and breach of implied 

warranties -- all of which we hold are pre-empted by 21 U.S.C. 

§ 360k. (See section IV. A. supra). We also hold that Michael's 

complaint to the extent it relies on fraud perpetrated by Shiley 

on the FDA is pre-empted. (See section V. A. supra). 

 We will reverse the district court's February 25, 1994 order 

granting summary judgment to Shiley on Michael's breach of 

express warranty claim (see section IV. B. & VI. A. supra) and 

her fraud claim insofar as she proceeds on the basis of Shiley's 

representations in its advertising and promotional materials. 

(See section V. B. & VI. B. supra). 

 We will remand the case to the district court for further 

proceedings consistent with the foregoing opinion.