Gile v. Optical Radiation Corporation

Opinions of the United
1994 Decisions 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Precedential or Non-Precedential: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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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
1
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.
2
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:
3
[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 pre-
market 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
4
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
5
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
6
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
7
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
8
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
9
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."
10
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.
11
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
12
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
13
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 non-
efficacious 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).
14
[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,
15
the judgment of the district court in favor of Optical Radiation
Corporation will be affirmed.
16
17