Lewis v. Intermedics Intraoc ( 1995 )

United States Court of Appeals,
Fifth Circuit.
No. 94-30668
Summary Calendar.
Edward A. LEWIS, Plaintiff-Appellee,
v.
INTERMEDICS INTRAOCULAR, INC., Defendant-Appellant.
Louis ANGELLE, Plaintiff-Appellee,
v.
INTERMEDICS INTRAOCULAR, INC., Defendant-Appellant.
Joseph FERRARA, Plaintiff-Appellee,
v.
INTERMEDICS INTRAOCULAR, INC., Defendant-Appellant.
Joseph CARONIA, etc., Plaintiff-Appellee,
v.
INTERMEDICS INTRAOCULAR, INC., Defendant-Appellant.
Christopher BORDENAVE, Jr., etc., et al., Plaintiffs-Appellees,
v.
INTERMEDICS INTRAOCULAR, INC., Defendant-Appellant.
July 6, 1995.
Appeal from United States District Court for the Eastern District
of Louisiana.
Before DUHÉ, WIENER and STEWART, Circuit Judges.
STEWART, Circuit Judge:
This appeal encompasses five consolidated personal injury
actions which were originally filed in Louisiana state court but
were removed to federal district court on the basis of diversity.
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The suits arose because of problems plaintiffs allegedly suffered
from intraocular lenses which had been surgically implanted into
their eyes as treatment for their cataracts. The lenses were all
manufactured by Intraocular Intermedics, defendant-appellant.
Congress enacted the Medical Device Amendments of 1976 (MDA)
in order to vest regulatory power over medical devices in the Food
and Drug Administration (FDA). The MDA established three
categories of medical devices, each with different pre-marketing
requirements, based upon the degree of risk to the public health
and safety. The intraocular lenses in question are classified as
Class III devices under the MDA. Class III devices receive the
most rigorous level of scrutiny by the FDA. Usually, manufacturers
of Class III devices must submit an extensive application for
pre-market approval before such devices can be marketed. However,
the Investigational Device Exemption (IDE), 21 U.S.C. § 360j(g),
allows the FDA to exempt qualified devices from the requirements of
the MDA. Thus, under the IDE a device may be marketed even though
its safety and effectiveness have not been proven to the FDA. The
FDA granted such an IDE to intraocular lenses and adopted federal
regulations governing their clinical investigation. Pursuant to
the federal regulations, intraocular lenses were to be tested on
cataract patients who gave their informed consent for the lenses to
be tested.
Each of the plaintiffs had intraocular lenses surgically
implanted into their eyes. They all have allegedly encountered
problems with them. Plaintiffs' suits allege that the lenses are
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defective in design and manufacture and that Intermedics failed to
properly warn them of alleged design and manufacturing defects and
failed to inform them that the lenses were experimental and that
there were alternative choices for cataract treatment. They allege
that Intermedics is liable both under a theory of strict liability
and for breach of warranty, either express or implied. Plaintiffs
seek compensatory and punitive damages. In addition to asserting
the state products liability-type causes of action described above,
plaintiffs also state claims based upon various federal
regulations.
Intermedics filed a motion for summary judgment, contending
that all of plaintiffs' state tort claims regarding the safety and
effectiveness of the lenses are preempted by the MDA. See 21
U.S.C. § 360k(a) and 21 C.F.R. § 808.1(b). Plaintiffs opposed the
motion, arguing that Congressional intent with respect to the IDE
was not to preempt state tort law claims, but to encourage
discovery and development of useful medical devices and to protect
the public health. The FDA did not provide remedies for the public
in the event of injury; therefore, plaintiff contends there is no
federal preemption of remedies for damages caused by intraocular
lenses.
The district court dismissed all of plaintiffs' state tort
claims except those relating to the duty to obtain informed
consent, because it concluded that federal law preempts any state
law claim relating to the safety and effectiveness of the lenses.
In so doing, the court relied upon a case from the Seventh Circuit
3
involving the issue of such federal pre-emption in the field of
intraocular lenses, Slater v. Optical Radiation Corp., 961 F.2d
1330 (7th Cir.), cert. denied, --- U.S. ----, 113 S.Ct. 327, 121
L.Ed.2d 246 (1992). In Slater, the plaintiff alleged injury to his
eye caused by the implantation and removal of a defective
anterior-chamber intraocular lens. The plaintiff alleged
negligence relating to the testing, safety, and effectiveness of
the lens, inadequate clinical testing, defective design, failure to
warn, strict products liability, and breach of implied warranty.
The Seventh Circuit held that all of plaintiff's claims were
state law claims relating to the safety or effectiveness of the
lens, which claims were different from or in addition to federal
law claims. Thus, the appellate court held that plaintiff's state
law claims were preempted by federal law. Id. at 1333. However,
the Seventh Circuit clearly stated that pre-emption of state claims
is not unlimited:
[Pre-emption] does not affect cases charging negligence in the
implantation or removal of a lens, or complaining of
contamination of the lens by bacteria or fungi or of failure
to obtain the patient's informed consent to the procedure.
Id. at 1334 (emphasis added).
The district court in the instant cases viewed the above
language from the Seventh Circuit in Slater as persuasive and
accordingly held that all of plaintiffs' claims except those
relating to informed consent are preempted. The court based its
determination on its finding that Congress clearly intended the
federal government to be the sole governmental body regulating the
safety and effectiveness of intraocular lenses, as evidenced by its
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passage of the MDA. Because the products liability-type claims
clearly related to the safety and effectiveness of the intraocular
lenses themselves, those claims are preempted. However, the court
concluded that failure to obtain informed consent does not relate
directly to the safety and effectiveness of the lenses; thus, the
district court excepted the informed consent claims from dismissal.
Intermedics subsequently urged the court to reconsider its
ruling as to the informed consent claim in light of the Third
Circuit's decision in Gile v. Optical Radiation Corp., 22 F.3d 540(3d Cir.), cert. denied, --- U.S. ----, 115 S.Ct. 429, 130 L.Ed.2d
342 (1994). In Gile, the court addressed the question of whether
a patient who had received an intraocular lens had a cause of
action against the manufacturer based on an alleged failure to
obtain informed consent. Our colleagues of the Third Circuit
disallowed the claim because the plaintiff could not provide any
support for her contention that she was entitled to bring an
informed consent claim against the manufacturer under state law.
The district court in the case at bar distinguished Gile and
refused to dismiss the informed consent claim because it found that
authority for plaintiffs' informed consent claims could be found in
Louisiana Civil Code art. 2315. The district court allowed
Intermedics to take an interlocutory appeal pertaining to the issue
of whether federal law preempts plaintiffs' state law informed
consent claims. See 28 U.S.C. § 1292(b).
We have reviewed Slater and Gile closely and have carefully
considered whether plaintiffs can make out any state law cause of
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action against a manufacturer for failure to obtain informed
consent. We note at the outset that the above-cited language from
Slater relating to informed consent is mere dicta because the
plaintiff there did not argue that he did not give informed
consent. Moreover, we believe that, in the above passage from
Slater which refers to informed consent, the Court was merely
pointing out that any claim which a plaintiff might have against a
health care provider for malpractice or battery would not be
preempted. The types of cases cited by the court which would not
be preempted were predominantly claims that necessarily would be
filed against the physician, not the manufacturer. For example,
"cases charging negligence in the implantation or removal of a
lens," Id., clearly refers to malpractice actions, which can only
be filed against a physician or health care provider, not a
manufacturer. The court also noted that the tort of medical
battery would not appear to be preempted by the MDA if a surgeon
were to implant a lens without the patient's consent. However,
such a claim clearly would be one against the physician, not a
manufacturer of the product. Gile made this same observation.
The parties have briefed extensively the issue of whether the
MDA preempts plaintiffs' state informed consent claims. However,
before reaching the pre-emption issue we have to determine that, in
the first instance, Louisiana law provides plaintiffs with a cause
of action against a manufacturer for failure to obtain informed
consent. In other words, the question of pre-emption is irrelevant
if there is no otherwise applicable state informed consent claim
6
which could be preempted by the MDA. Thus, we conclude that if
Louisiana does not recognize a cause of action for failure to
obtain informed consent against a manufacturer, then Intermedics is
entitled to summary judgment on these claims.
Does Louisiana recognize a cause of action for informed consent
against a manufacturer?
Plaintiffs have sued under both the Louisiana Products
Liability Act and La.Civ.C. art. 2315. However, on appeal
plaintiffs argue that the Louisiana Products Liability Act is not
applicable because the intraocular lenses were implanted in
plaintiffs' eyes prior to the effective date of the Act, September
1, 1988.
The Louisiana Products Liability Act (LPLA), La.R.S.
9:2800.51, et seq., "... establishes the exclusive theories of
liability for manufacturers for damage caused by their products.
A claimant may not recover from a manufacturer for damage caused by
a product on the basis of any theory of liability that is not set
forth in [the LPLA]." La.R.S. 9:2800.52. Thus, if the LPLA were
applicable to this case, the text of La.R.S. 9:2800.52 would
clearly preclude plaintiffs' cause of action against Intermedics
for failure to obtain informed consent, because the LPLA contains
no provision for such a cause of action. See 9:2800.51, et seq.
However, we cannot take such an easy path in our resolution
of this pre-LPLA case. The LPLA does not apply retroactively to
causes of action which accrued prior to the effective date of the
Act. Brown v. R.J. Reynolds Tobacco Co., 52 F.3d 524, 527 (5th
Cir.1995); Cates v. Sears, Roebuck & Co., 928 F.2d 679, 683 (5th
7
Cir.1991). The plaintiffs' claims for failure to obtain informed
consent would have "accrued" at the time the manufacturer allegedly
failed to obtain informed consent. In this case, that appears to
have been prior to 1988 for all plaintiffs. Thus, the LPLA does
not appear to be applicable.
Prior to the passage of the LPLA, legislative authority for
all product liability-type claims flowed from Louisiana Civil Code
Article 2315, Louisiana's general tort liability statutory
provision. Article 2315 provides, in relevant part:
Every act whatever of man that causes damage to another
obliges him by whose fault it happened to repair it.
The very general wording of art. 2315 provides very little
instruction as to whether a cause of action may be maintained under
it for a manufacturer's failure to obtain informed consent. We
have found no Louisiana cases which would support such a claim
against a manufacturer. Thus, at first it seems unclear whether a
manufacturer has a tort duty under Louisiana state law to obtain
informed consent. However, for elaboration we do not resort to the
common law in other states. Louisiana, being a Civil Law state,
would not recognize a common law duty on the part of a manufacturer
to obtain informed consent.1 Thus, even if under the common law in
other states such a duty exists, Louisiana would not necessarily
1
In Louisiana, case law is not considered positive law. See
La.Civ.C. art. 1. Even jurisprudence from within this civilian
jurisdiction is not considered binding authority on other
Louisiana courts, because Louisiana does not recognize stare
decisis. A fortiori, common law concepts developed through the
case law in other jurisdictions would not be binding on Louisiana
courts. See Principal Health Care of La., Inc. v. Lewer, 38 F.3d
240, 245, n. 5 (5th Cir.1984).
8
allow it.
However, notwithstanding the very general language in art.
2315, the Louisiana legislature has spoken specifically on the
issue of informed consent in another statute. Louisiana Revised
Statutes 40:1299.40 outlines the procedures by which patients in
Louisiana are to be informed of the risks of medical treatment and
also governs tort suits against a "physician or other health care
provider" for failure to obtain informed consent. The Louisiana
Uniform Consent Law, La.R.S. 40:1299.40 clearly does not apply to
manufacturers. Although plaintiffs might argue that Intermedics
might qualify as some "other health care provider" under the
statute, the 1990 amendments to the statute and the case law do not
support such a view. The statute was amended in 1990 to make it
clear that only a physician or health care provider who will
actually perform the procedure is required to obtain informed
consent. Davis v. St. Charles Gen. Hosp., 598 So.2d 1244 (La.App.
4th Cir.1992), was decided based upon the law as it was worded
prior to the 1990 amendment, just as this case will be. Davis held
that a referring physician had no duty to obtain informed consent.
If a referring physician has no duty, a fortiori, a manufacturer
has no duty under state law. Thus, there can be no recovery
against a manufacturer under the Uniform Consent Statute.
Louisiana Revised Statutes 40:1299.40 is a more specific law
than the very general tort provision, La.Civ.C. art. 2315; thus,
we conclude that Louisiana provides no cause of action against a
manufacturer for failure to obtain informed consent. The maxim
9
"lex generalis non derogat speciali" implies that a special law
controls as to the particular matter made the subject of special
legislation. Louisiana Imp. Co. v. Baton Rouge Elec. & Gas Co.,
114 La. 534, 38 So. 444 (1905). The Uniform Consent Law, La.R.S.
40:1299.40, is special legislation aimed specifically at the duty
to obtain informed consent; therefore, it should be applied to
this issue rather than Article 2315, which is very general.
Because "legislation is the solemn expression of legislative will,"
see La.Civ.C. art. 2, we do not find that the legislature intended
for art. 2315 to serve as a catch-all to maintain plaintiffs'
causes of action against the manufacturer when the very specific
informed consent law clearly excludes such claims.
This conclusion also makes sense when considered against the
backdrop of products liability-type claims which plaintiffs have
asserted and which were dismissed by the district court because
they are preempted by federal law. Even if we were to conclude
that plaintiffs' claim that the manufacturer failed to obtain
informed consent could be analogized to a products liability claim
for failure to warn of a product's dangers, plaintiffs still could
not maintain their claims. If plaintiffs' products liability
claims for recovery due to the lenses' dangers are preempted, then
it would seem ridiculous to say that a claim for failure to warn
about these dangers could survive. In other words, if a claim for
damages due to the dangers themselves cannot survive, a fortiori,
a claim for failure to warn of the dangers should not be
cognizable.
10
Moreover, we also note that Gile provides support for our
determination that an informed consent claim does not automatically
flow from an assertion of negligence. In Gile, the plaintiff
asserted both negligence and products liability claims against the
manufacturer, but the court determined that she stated no state law
claim, because the duty to obtain informed consent is imposed upon
the physician, not the manufacturer. Although Gile did not arise
in Louisiana, it is illustrative of the concept that a general tort
duty not to be negligent is not enough to bring a manufacturer
within the purview of an informed consent claim.
Based upon the above, we conclude that Louisiana law does not
recognize plaintiffs' state claims against Intermedics for failure
to obtain informed consent. It is irrelevant to our inquiry
whether Slater is correct in its view that a state law claim for
failure to obtain informed consent is preempted by federal law,
because in the first instance Louisiana does not recognize a cause
of action against a manufacturer for failure to obtain informed
consent which could be preempted by federal law. The district
court erred in denying Intermedics' summary judgment as to the
informed consent claims. The only remaining claims are based upon
the federal regulations which Intermedics allegedly violated in not
obtaining informed consent as required by federal law. These
claims were not the subject of the instant motion for summary
judgment. Although plaintiffs' seemingly conceded in this appeal
that Congress did not provide them with a private right of action
against Intermedics for violation of the federal regulations, we do
11
not deal with the remaining federal law claims because they were
not the subject of this appeal.
Conclusion
Based upon the foregoing, we REVERSE the district court's
denial of Intermedics' motion for summary judgment as to
plaintiffs' state law informed consent claims, we RENDER summary
judgment as to those claims, and REMAND for a determination of
plaintiffs' rights in their remaining claims against Intermedics
under federal law.
Motion to Strike
Plaintiffs have filed a motion to strike portions of
Intermedics' reply brief which relate to the pre-emption issue.
Because our resolution of the case on state law grounds pretermits
a discussion of preemption, the motion to strike is DISMISSED as
moot.
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