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Precedential or Non-Precedential: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., 

, 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, 

, 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., 

, 248 (1986).      In

deciding a motion for summary judgment, all reasonable inferences

must be drawn in favor of the non-movant.       

.

           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.    

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."    

813.20(b)(2).

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

investigation.   

813.65.    The regulations detail the

monitoring of the studies and set forth reporting and

recordkeeping requirements, including evaluation of complaints

about devices.   

§ 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., 

, 

(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 

; 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., 

, 1421 (5th Cir. 1993), cert.

denied, 

(1993); King v. Collagen Corp., 

, 1133 (1st Cir. 1993), cert. denied, 

(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., 

(7th Cir. 1992), cert.
denied, 

(1992), held that not all claims are




                                 7
preempted under § 360k, including claims for informed consent.

           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."   

court in

Hunsaker v. Surgidev Corp., 

(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."    

(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, 

(N.J. 1988); Kershaw v. Reichert, 

(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.

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., 

; 

; 

.   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., 

, 370 (7th Cir. 1976); Kemp v.

Pfizer, Inc., 

, 1022 (E.D.Mich. 1993); Brinkman

v. Shiley, Inc., 

, 35 (M.D.Pa.), aff'd, 

(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 

n.1.; 

; 

.
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, 

; Hinners v.

Optical Radiation Corp., 

(11th Cir. 1994) (per

curiam); Rogers v. Optical Radiation Corp., 

(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 

.   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., 

, 371-72 (N.D. Ill.

1991), aff'd, 

(7th Cir. 1992).    The lens in Slater,

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

.

          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.


                                

(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.

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 

.   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.    

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, 

(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, 

(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., 

(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."     

(citation omitted).     The court reasoned that the difference

between experimental devices and those approved for marketing

supports a finding of express preemption under § 360k.     

  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.

-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., 

(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 

.   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., 

(citing

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

, 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 

; 

.   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