Lewis v. Intermedics Intraoc

• Court: Court of Appeals for the Fifth Circuit
• Decided: July 6, 1995
• Docket: 94-30668
• Status: Published

Opinion

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,

Joseph FERRARA, Plaintiff-Appellee,

Joseph CARONIA, etc., Plaintiff-Appellee,

Christopher BORDENAVE, Jr., etc., et al., Plaintiffs-Appellees,

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.

1 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

2 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

4 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

5 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.