1994 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

5-3-1994

Gile v. Optical Radiation Corporation, et al.

Precedential or Non-Precedential:

Docket 93-5555

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Recommended Citation

"Gile v. Optical Radiation Corporation, et al." (1994). 1994 Decisions. Paper 6.

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1 

UNITED STATES COURT OF APPEALS 

FOR THE THIRD CIRCUIT 

____________ 

 NO. 93-5555 

____________ 

HELEN GILE, 

 Appellant 

v. 

OPTICAL RADIATION CORPORATION; 

XYZ COMPANIES, #1 through #5; 

JOHN DOES, #1 through #5 

____________ 

Appeal from the United States District Court 

for the District of New Jersey 

D.C. No. 92-cv-02957 

____________ 

Argued March 24, 1994 

Before: HUTCHINSON, ROTH, and ROSENN, Circuit Judges

 Opinion Filed May 3, 1994 

____________ 

RICHARD GALEX, ESQUIRE (Argued) 

Galex, Tortoreti & Tomes 

150 Tices Lane 

East Brunswick, NJ 08816 

 Attorney for Appellant 

JOHN F. BRENNER, ESQUIRE (Argued) 

McCarter & English 

100 Mulberry Street 

Four Gateway Center 

Newark, NJ 07101-0652 

 Attorney for Appellees 

____________ 

OPINION OF THE COURT 

ROSENN, Circuit Judge. 

 This case raises an interesting question of liability 

which has its origin in the coordinated efforts of the Government 
2 

and manufacturers of optical medical devices to advance the cause 

of medical treatment through research, experimentation, and 

optimum freedom for scientific investigation in the pursuit of 

that purpose. 

 In 1981, the Food and Drug Administration (FDA) 

approved for clinical investigation an intraocular lens 

manufactured by defendant Optical Radiation Corporation (ORC). An 

intraocular lens (IOL) is a lens intended to replace surgically 

the natural lens of the human eye. In December 1985, Dr. Henry 

Scimeca, an investigator approved by the FDA, implanted in the 

eye of plaintiff Helen Gile, who suffered from cataracts, an ORC 

model UV11H intraocular lens. Prior to the surgery, Gile signed 

an informed consent form, which she claims that she did not read 

before signing. Gile subsequently had the ORC lens surgically 

removed from her left eye, and is now legally blind in that eye. 

 In May of 1992, Gile commenced this products liability 

and negligence action against ORC in the Superior Court of New 

Jersey. ORC removed the case to the United States District Court 

for the District of New Jersey.1 Thereafter, ORC moved for 

summary judgment on the ground that Gile's claims were expressly 

preempted under the Federal Food, Drug and Cosmetic Act (FDCA or 

the Act), 21 U.S.C. § 301 et seq. The district court entered 

summary judgment in favor of ORC and dismissed the complaint with 

prejudice. Gile timely appealed to this court. We affirm. 

 

1

The district court exercised diversity jurisdiction over this 

case pursuant to 28 U.S.C. § 1332. This court has jurisdiction 

over this appeal from a final order pursuant to 28 U.S.C. § 1291. 
3 

I. 

 This court exercises plenary review over a grant of 

summary judgment, and we apply the same test the district court 

should have utilized initially. Oritani Sav. and Loan Ass'n v. 

Fidelity and Deposit Co., 989 F.2d 635, 637 (3d Cir. 1993). 

Summary judgment is appropriate only when it is demonstrated that 

there is no genuine issue as to any material fact and the moving 

party is entitled to judgment as a matter of law. Celotex Corp. 

v. Catrett, 477 U.S. 317, 322-32 (1986); Fed.R.Civ.P. 56(c). An 

issue of material fact is genuine "if the evidence is such that a 

reasonable jury could return a verdict for the nonmoving party." 

Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In 

deciding a motion for summary judgment, all reasonable inferences 

must be drawn in favor of the non-movant. Oritani, 989 F.2d at 

638. 

 At the heart of this action are the Medical Device 

Amendments of 1976 ("MDA"), 21 U.S.C. § 360c et seq., to the 

FDCA. Pursuant to the FDCA, and amendments thereto, including 

the MDA, the FDA strictly regulates the development, marketing, 

and monitoring of medical devices. The MDA sets forth various 

requirements concerning the safety and effectiveness of medical 

devices and the approvals to be obtained from the FDA before 

bringing a device to the market. The MDA also limits entities 

other than the FDA from imposing requirements on the makers of 

medical devices and the process by which those devices are 

discovered, investigated, and manufactured. Section 360k(a), the 

focus of this appeal, provides: 
4 

[N]o State or political subdivision of a 

State may establish or continue in effect 

with respect to a device intended for human 

use any requirement-- 

(1) which is different from, or in 

addition to, any requirement applicable 

under this chapter to the device, and 

(2) which relates to the safety or 

effectiveness of the device or to any 

other matter included in a requirement 

applicable to the device under this 

chapter. 

21 U.S.C. § 360k(a). 

 In enacting the MDA, Congress recognized the need for 

special treatment of investigational devices which, by their very 

nature, could not meet the requirements applicable to marketed 

devices: 

It is the purpose of this subsection to 

encourage, to the extent consistent with the 

protection of the public health and safety 

and with ethical standards, the discovery and 

development of useful devices intended for 

human use and to that end to maintain optimum 

freedom for scientific investigators in their 

pursuit of that purpose. 

21 U.S.C. § 360j(g)(1). Persons seeking an exemption from premarket approval for a particular medical device (an 

"investigational device exemption" or "IDE") must apply to the 

FDA for permission to undertake clinical investigations. Id. at 

§ 360j(g)(2)(A). 

 The FDA issued specific regulations governing the 

development of IOLs. 21 C.F.R. § 813 et seq. (the "IOL 

Regulations"). The regulations require a detailed application, 

describing the device under investigation and setting forth a 

plan for studying its use in human subjects, which is reviewed by 
5 

both the FDA and an institutional review committee. 21 C.F.R. 

§§813.20, 813.30. The device must be described in sufficient 

detail to permit "a knowledgeable judgment about the anticipated 

safety and effectiveness of the lens." Id. at § 813.20(b)(2). 

After approval, the committee has a duty to monitor the clinical 

investigation. Id. at § 813.65. The regulations detail the 

monitoring of the studies and set forth reporting and 

recordkeeping requirements, including evaluation of complaints 

about devices. Id. at §§ 813.46, 813.180 et seq. Under the IOL 

Regulations, the FDA can refuse an exemption if it finds, inter

alia, that the lens may be unsafe or ineffective, that the 

investigational plan is not a reasonable one, or that 

manufacturing, storage, and implantation methods do not assure 

adequate safety and effectiveness. 21 C.F.R. § 813.30(c). In 

sum, the IOL regulations broadly govern nearly all facets of the 

investigational program. See Covey v. Surgidev Corp., 815 F. 

Supp. 1089, 1095 (N.D.Ohio 1993) ("[t]o say that the regulations 

covering intraocular lenses are expansive would be an 

understatement"). 

II. 

 Gile first argues that Congress never intended to 

preempt state common law when it passed the MDA. She contends 

that the word "requirement" in 21 U.S.C. § 360k(a) refers only to 

positive legislative enactments and not to state tort common law 

claims. This argument must be rejected, however, in light of 

Cipollone v. Liggett Group, Inc., 112 S.Ct. 2608, 120 L.Ed.2d 407 

(1992). The Cipollone Court addressed the Public Health 
6 

Cigarette Smoking Act of 1969, which preempted certain 

"requirement[s] or prohibition[s] . . . imposed under state law." 

The Court rejected the contention that the act did not extend to 

state tort claims: 

The phrase "[n]o requirement or prohibition" 

sweeps broadly and suggests no distinction 

between positive enactments and common law; 

to the contrary, those words easily encompass 

obligations that take the form of common law 

rules. As we noted in another context, 

"[state] regulation can be as effectively 

exerted through an award of damages as 

through some form of preventive relief. The 

obligation to pay compensation can be, indeed 

is designed to be, a potent method of 

governing conduct and controlling policy." 

 Although portions of the legislative 

history of the 1969 Act suggest that Congress 

was primarily concerned with positive 

enactments by States and localities, the 

language of the Act plainly reaches beyond 

such enactments. 

112 S.Ct. at 2620; 120 L.Ed.2d at 426 (citations and footnote 

omitted). Thus, the Supreme Court has clearly stated that the 

word "requirement," in the context of an express preemption 

provision, includes state law claims. See also Stamps v. 

Collagen Corp., 984 F.2d 1416, 1421 (5th Cir. 1993), cert. 

denied, 114 S.Ct. 86 (1993); King v. Collagen Corp., 983 F.2d 

1130, 1133 (1st Cir. 1993), cert. denied, 114 S. Ct. 84 (1993). 

 Gile contends that there cannot be express preemption 

unless Congress uses "the words 'common law' or something 

analogous" to indicate its intent to preempt such claims. 

However, the MDA, providing "no State or political subdivision of 

a State may establish . . . any requirement . . . different from, 

or in addition to, any requirement applicable under this 
7 

chapter," is indistinguishable from the act at issue in 

Cipollone, which provided, "[n]o requirement or prohibition . . . 

shall be imposed under State law with respect to the advertising 

. . . of any cigarettes." Thus, Gile's argument that Congress 

needs to explicitly provide that common law claims are preempted 

in order to find express preemption is unpersuasive. 

 Gile further argues that even if her tort claims in 

general are preempted under § 360k, her specific claims based on 

lack of informed consent and adulterated products are exempt from 

preemption. First, she relies on 21 C.F.R. §§ 50.20 and 50.25(c) 

as support for her contention that her claim for failure to 

obtain informed consent is not preempted. Section 50.20, which 

addresses general requirements for informed consent, provides in 

part: "No informed consent, whether oral or written, may include 

any exculpatory language through which the subject or the 

representative is made to waive or appear to waive any of the 

subject's legal rights, or releases or appears to release the 

investigator, the sponsor, the institution, or its agents from 

liability for negligence." Section 50.25(c), which addresses 

elements of informed consent, provides: "[t]he informed consent 

requirements in these regulations are not intended to preempt any 

applicable Federal, State, or local laws which require additional 

information to be disclosed for informed consent to be legally 

effective." Gile further notes that the court in Slater v. 

Optical Radiation Corp., 961 F.2d 1330 (7th Cir. 1992), cert. 

denied, 113 S.Ct. 327 (1992), held that not all claims are 
8 

preempted under § 360k, including claims for informed consent. 

Id. at 1334. 

 The Slater court, however, stated that 21 C.F.R. §50.20 

"preserves the patient's common law rights outside of the limited 

scope of the preemption provision. It does not . . . repeal the 

preemption provision itself." Id. Similarly, the court in 

Hunsaker v. Surgidev Corp., 818 F. Supp. 744 (M.D.Pa. 1992) 

concluded that "the consent regulation should be read to prevent 

patients from waiving legal rights which are not preempted under 

federal law. That is, those common law rights which are retained 

by a patient and not preempted by the federal scheme may not be 

waived by the patient." Id. at 750 (emphasis in original). 

Gile, however, ignores that the predicate of a claim for informed 

consent addresses the duty of the physician, not the 

manufacturer, to the patient. See e.g., Largey v. Rothman, 540 

A.2d 504 (N.J. 1988); Kershaw v. Reichert, 445 N.W.2d 16 (N.D. 

1989). She is unable to provide any support for her contention 

that she is entitled to bring such a claim against the 

manufacturer of an experimental product. Moreover, despite the 

completion of discovery in this action, Gile has not offered any 

proof to support her vague allegation that ORC failed to provide 

her physician with the proper forms and information necessary to 

obtain informed consent. 

 Gile next quotes the first sentence of section 

808.1(d)(6)(ii) of the FDA Regulations, which states: 

"[g]enerally, [§ 360k(a)] does not preempt a State or local 

requirement prohibiting the manufacture of adulterated or 
9 

misbranded devices." 21 C.F.R. § 808.1(d)(6)(ii).2 But the next 

sentence, not quoted by Gile, provides: 

Where, however, such a prohibition has the 

effect of establishing a substantive 

requirement for a specific device, e.g., a 

specific labeling requirement, then the 

prohibition will be preempted if the 

requirement is different from, or in addition 

to, a Federal requirement established under 

the act. 

Id. This action by Gile challenging the design of the Stableflex 

lens and the warnings and instructions that accompanied it, if 

successful, would impermissibly result in new common law 

standards for lens design and warnings. See e.g., Stamps, 984 

F.2d at 1421-22; King, 983 F.2d at 1135-36; Slater, 961 F.2d at 

1333. Thus, it is preempted. Moreover, read in its entirety, 

section 808.1 prohibits, not supports, challenges such as Gile's 

to FDA requirements affecting the safety and effectiveness of 

investigational devices under the guise of product liability 

actions by reflecting the FDA's determination that the word 

"requirement," as used in § 360k, includes "court decisions."3 

 

2

21 C.F.R. § 808.1(d) sets forth examples of state or local 

requirements that are not preempted by § 360k. Significantly, 

the list of requirements exempted from § 360k does not include 

state tort or common law claims. 

3

Section 808.1(b) states: 

[Section 360k provides that] no State or 

political subdivision of a State may 

establish or continue in effect any 

requirement with respect to a medical device 

intended for human use having the force and 

effect of law (whether established by 

statute, ordinance, regulation, or court 

decision), which is different from, or in 

addition to, any requirement applicable to 

such device under any provision of the act 

and which relates to the safety or 
10 

 Similarly, Gile's argument that her claims are not 

preempted because the IOL was "adulterated" within the meaning of 

21 U.S.C. § 351(i) must fail.4 The FDA can determine an 

investigational device to be adulterated if requirements under 

the IDE are not complied with. Here, the FDA made no findings of 

adulteration and the record does not contain any facts to support 

such a claim. Moreover, violations of the FDCA do not create 

private rights of action. See e.g., Pacific Trading Co. v. 

Wilson & Co., Inc., 547 F.2d 367, 370 (7th Cir. 1976); Kemp v. 

Pfizer, Inc., 835 F. Supp. 1015, 1022 (E.D.Mich. 1993); Brinkman 

v. Shiley, Inc., 732 F. Supp. 33, 35 (M.D.Pa.), aff'd, 902 F.2d 

1558 (3d Cir. 1989). Thus, only the government has a right to 

take action with respect to adulterated products. Additionally, 

as noted by the district court, to the extent Gile's adulteration 

claim is derivative of her other claims for inadequate design, 

manufacture, and warnings, she cannot overcome a finding of 

preemption merely by claiming that the product was adulterated. 

III. 

 Every court that has considered the issue of the 

preemptive effect of § 360k in the context of ORC's product, has 

 

effectiveness of the device or to any other 

matter included in a requirement applicable 

to the device under the act. 

21 C.F.R. § 808.1(b) (emphasis added). See Stamps, 984 F.2d at 

1421 n.1.; King, 983 F.2d at 1134; Slater, 961 F.2d at 1331. 

4

21 U.S.C. § 351(i) provides that a device shall be deemed to be 

adulterated "[i]f it is a device for which an exemption has been 

granted under section 360j(g) of this title for investigational 

use and the person who was granted such exemption or any 

investigator who uses such device under such exemption fails to 

comply with a requirement prescribed by or under such section." 
11 

ruled in favor of ORC. See Slater, 961 F.2d 1330; Hinners v. 

Optical Radiation Corp., 15 F.3d 1096 (11th Cir. 1994) (per 

curiam); Rogers v. Optical Radiation Corp., 12 F.3d 194 (11th 

Cir. 1994). In Slater, as here, the plaintiff alleged that 

following implantation of a Stableflex lens, his vision 

deteriorated and the implant had to be removed, leaving him with 

permanent damage. 961 F.2d at 1332. The plaintiff in Slater

advanced causes of actions for strict liability, breach of 

warranty, failure to provide adequate warnings, negligent design, 

and failure to conduct proper clinical testing. Slater v. 

Optical Radiation Corp., 756 F. Supp. 370, 371-72 (N.D. Ill. 

1991), aff'd, 961 F.2d 1330 (7th Cir. 1992). The lens in Slater, 

like the one in this case, was governed by the IOL Regulations. 

961 F.2d at 1331. 

 The district court in Slater found that all of the 

plaintiff's claims were expressly preempted by § 360k, and 

granted the defendant's motion to dismiss the entire complaint. 

The Seventh Circuit affirmed, emphasizing that § 360k(a) forbids 

states to subject a medical device to requirements "different 

from, or in addition to" requirements that relate to the safety 

and effectiveness of the device. The Slater court noted that 

although the regulations imposed no requirement concerning the 

specific design of intraocular lenses, 

[t]he FDA can hardly be expected to specify 

the safe and effective design of a device 

when it is still experimental. If there were 

a known safe and effective design, the device 

would no longer be experimental. The point 

of the experiment is to find out whether it 

is safe and effective. 
12 

961 F.2d at 1333 (citation omitted). The court concluded: 

The theory underlying the complaint is that 

the design of the Stableflex was not 

sufficiently safe and effective to allow it 

to be used on human beings. This theory sets 

up a direct collision with federal policy. 

The FDA decided, whether rightly or wrongly, 

but pursuant to regulations the validity of 

which the plaintiff does not question, that 

the Stableflex could be sold, subject only to 

requirements, procedural in character and, so 

far as appears, fully complied with, designed 

to assure that this experimental distribution 

was in fact a worthwhile experiment. The 

plaintiff wishes in the name of state tort 

law to impose additional requirements--namely 

that the Stableflex have had design 

characteristics that it lacked--and this 

engrafting of additional requirements 

relating to safety or effectiveness is 

forbidden by the preemption provision in the 

Medical Devices Amendments. 

Id. 

 Gile argues that Slater is not persuasive because the 

court noted that preemption "is limited to efforts by states to 

impose sanctions for compliance with federal regulations relating 

to the safety or efficacy of the experimental lenses." 961 F.2d 

at 1334. Gile submits that she is not seeking to impose 

sanctions for compliance with regulations, but rather is seeking 

damages for injury received and for the failure to warn of the 

danger of the experiment. The quoted dicta from Slater, however, 

preceded the court's observation that preemption under § 360k 

would not affect claims based on negligence in the implantation 

of a lens, negligence in the removal of a lens, contamination of 

the lens by bacteria or fungi, or medical battery resulting from 
13 

failure to obtain the patient's informed consent to the 

procedure. Id. 

 Notably, all of these claims might be brought against a 

physician, not against the lens manufacturer. The dicta does not 

detract from Slater's holding that the plaintiff's claims for 

negligence, strict liability, and breach of warranty against the 

manufacturer were preempted under § 360k as impermissible 

attempts to impose additional safety and effectiveness 

requirements on the manufacturer. See also Rogers, 12 F.3d 194 

(11th Cir. 1994) (affirming entry of summary judgment in favor of 

ORC on plaintiff's causes of action for design defect, inadequate 

warning, breach of warranty, and inadequate testing on express 

preemption grounds); Hinners, 15 F.3d 1096 (11th Cir. 1994) 

(affirming dismissal of plaintiff's claims regarding safety and 

effectiveness of intraocular lenses on preemption grounds). 

 In the only IOL case within this circuit, Hunsaker v. 

Surgidev Corp., 818 F. Supp. 744 (M.D.Pa. 1992), the court agreed 

with Slater that "the standards implicit in the state tort 

actions would be 'different from or in addition to' those 

requirements of both the FDCA and the IDE regulations." Id. at 

752 (citation omitted). The court reasoned that the difference 

between experimental devices and those approved for marketing 

supports a finding of express preemption under § 360k. Id. at 

749. The court concluded: 

A jury determination that the device is not 

sufficiently safe and effective would not 

only be contrary to the experimental purposes 

of the exemption, but, more important, would 

directly conflict with the FDA's contrasting 
14 

judgment. Therefore, state tort law invoked 

to challenge the safety or effectiveness of a 

IOL which is part of an FDA investigation is 

federally preempted. 

Id. at 752-53. Thus, the district court's finding of preemption 

under § 360k is in conformance with the holdings of the vast 

majority of cases which have addressed this issue.5 

IV. 

 Next, Gile argues that public policy favors remedies 

for victims of medical experimentation. Gile erroneously 

contends that if preemption is permitted, medical device 

manufacturers will be granted immunity for all manner of improper 

acts. As explained by ORC, violations of the FDCA and FDA 

regulations are punishable by significant fines, civil penalties, 

and imprisonment. Similarly, Gile's assertion that preemption 

will encourage shoddy clinical investigations and development of 

defective medical devices lack merit. As shown by the detailed 

regulations discussed above, it is unlikely that a nonefficacious or unsafe investigational device would survive FDA 

review. 

 Moreover, Gile ignores the countervailing public policy 

of the discovery and development of new products. See 21 U.S.C. 

§ 360j(g) (one purpose of investigational device exemptions is 

"to maintain optimum freedom for scientific investigators"). As 

explained by the Slater court: 

 

5

In light of our statutory interpretation and the extensive 

authority discussed above, we reject Gile's sole reliance on two 

lower court cases from Louisiana, Lewis v. Intermedics 

Intraocular, No. 93-0007 (E.D.La. Dec. 9, 1993) and Mitchell v. 

IOLAB Corp., 700 F. Supp. 877 (E.D. La. 1988). 
15 

[I]f experimental procedures are subject to 

hindsight evaluation by juries, so that 

failed experiments threaten to impose 

enormous tort liability on the experimenter, 

there will be fewer experimental treatments, 

and patients will suffer. 

961 F.2d at 1334. Thus, state tort claims run counter to the 

important public policy, recognized by Congress, of promoting 

scientific inventions. 

 Finally, Gile argues that the district court's grant of 

summary judgment based on federal preemption encompassed both 

forum and claim preemption, leaving her without a remedy. She 

contends that public policy disfavors preemption of common law 

where no remedies are available to consumers injured by the 

unreasonable conduct of a manufacturer. However, Congress has 

the power to displace state tort law remedies, and clearly did so 

by enacting the MDA. See e.g., Stamps, 984 F.2d at 1421 (citing 

Chicago & N.W. Transp. Co. v. Kalo Brick & Tile, Co., 450 U.S. 

311, 331 (1981)). Moreover, Gile is not precluded from asserting 

a right of redress in the state forum because her claims against 

her physician are not preempted under the MDA. See Slater, 961 

F.2d at 1334; Hunsaker, 818 F. Supp. at 751. Thus, despite her 

arguments to the contrary, Gile is not left without a remedy 

because she may still pursue her claims, if any, against her 

physician in state court. 

V. 

 There being no genuine issues as to any material facts 

in this case, the district court committed no error in rendering 

summary judgment in favor of ORC as a matter of law. Accordingly, 
16 

the judgment of the district court in favor of Optical Radiation 

Corporation will be affirmed. 
17