Stahl v. Novartis Pharmaceuticals Corp.

Revised March 15, 2002

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

_____________________

No. 00-31440
_____________________

JOSEPH B. STAHL

Plaintiff-Appellant

v.

NOVARTIS PHARMACEUTICALS CORP.

Defendant-Appellee

_________________________________________________________________

Appeal from the United States District Court
for the Eastern District of Louisiana
_________________________________________________________________

February 13, 2002

Before KING, Chief Judge, and DUHÉ and BENAVIDES, Circuit Judges.

KING, Chief Judge:

Plaintiff-Appellant Joseph B. Stahl appeals the district

court’s summary judgment in favor of Defendant-Appellee Novartis

Pharmaceuticals Corporation on his claims under the Louisiana

Products Liability Act. Stahl also appeals the district court’s

prior order dismissing his intentional tort claim. For the

following reasons, we AFFIRM.

I. FACTUAL AND PROCEDURAL BACKGROUND

Lamisil is a prescription drug manufactured by Defendant-

Appellee Novartis Pharmaceuticals Corporation (“Novartis”). The
drug is approved by the FDA for treatment of fungal infections in

the toenails and fingernails. The package insert included with

Lamisil during the time period relevant to this litigation

contained warnings of a number of possible adverse reactions.

The “WARNINGS” section of the insert stated: “Rare cases of

symptomatic hepatobiliary dysfunction including cholestatic

hepatitis have been reported. Treatment with Lamisil . . .

Tablets should be discontinued if hepatobiliary dysfunction

develops.” The “PRECAUTIONS” section of the insert indicated

that “[h]epatic function (hepatic enzyme) tests are recommended

in patients administered Lamisil for more than six weeks or in

those who develop unexplained nausea, anorexia, or fatigue.” The

“ADVERSE REACTIONS” section of the insert stated that “[r]are

adverse events, based on worldwide experience with Lamisil . . .

use include symptomatic hepatobiliary dysfunction, including

cholestatic hepatitis . . . .”

On April 3, 1998 Plaintiff-Appellant Joseph B. Stahl

(“Stahl”) was treated by Dr. Martin Claiborne, a dermatologist,

for chronic fungal infection of the toenails. Dr. Claiborne

prescribed Lamisil to treat Stahl’s condition. Dr. Claiborne

explained that he planned to treat Stahl’s infection with Lamisil

for twelve weeks, but prescribed only a six-week supply of the

drug. Dr. Claiborne instructed Stahl to return to the doctor’s

office after the first six weeks of treatment for a liver

2
(hepatic) function test, due to the risk of liver problems

associated with use of Lamisil.

On April 27, 1998, twenty-four days after he began taking

Lamisil, Stahl developed cholestatic hepatitis. He did not

experience any nausea, anorexia, or fatigue prior to this time.

His treating physicians have diagnosed his cholestatic hepatitis

as drug-induced.

Stahl commenced the instant action against Novartis in

district court on April 5, 1999. Stahl’s initial complaint

alleged negligent and intentional tort claims under the general

tort liability provisions of Louisiana’s Civil Code. See La.

Civ. Code Ann. art. 2315 (West 1997 & Supp. 2002). In a July 14,

1999 order, the district court dismissed these claims on the

ground that the Louisiana Products Liability Act (“LPLA”)

provides the exclusive remedy for products liability actions

against manufacturers under Louisiana law. See La. Rev. Stat.

Ann. § 9:2800.52 et seq. (West 1997). In that order, the

district court gave Stahl leave to file an amended complaint.

Stahl accordingly amended his complaint to allege two claims

under the LPLA: that Lamisil is “unreasonably dangerous in

composition,” see id. § 9:2800.54 (B)(1), and that Lamisil is

“unreasonably dangerous because an adequate warning has not been

provided,” see id. § 9:2800.54(B)(3).

After extensive discovery, Novartis filed a motion for

summary judgment. On November 29, 2000 the district court

3
granted this motion with respect to both of Stahl’s LPLA claims,

finding: (1) that Stahl had adduced no evidence apart from his

own unsubstantiated allegations to support his “unreasonably

dangerous in composition” claim, and (2) that the warnings

contained in the Lamisil package insert were adequate as a matter

of law.

Stahl appeals this summary judgment in favor of Novartis,

arguing that the district court’s conclusions were erroneous and

that the district court improperly considered expert opinion in

its summary judgment determination. Stahl further contends on

appeal that the district court improperly dismissed the

intentional tort claim raised in his original complaint because

there is an “intentional acts” exception to the exclusive remedy

provision of the LPLA.1 We will first address the viability of

Stahl’s intentional tort claim and then discuss the district

court’s summary judgment on his two claims under the LPLA.

Initially, some background information on the LPLA is useful.

II. THE LOUISIANA PRODUCTS LIABILITY ACT

To maintain a successful products liability action under the

LPLA, a plaintiff must establish four elements: (1) that the

1
Stahl purports to raise nine claims of error in his
brief. Most of these claims of error are encompassed within our
review of the district court’s dismissal order and subsequent
summary judgment. Stahl’s remaining “claims of error” appear to
accuse the district court of mischaracterizing testimony in the
record and of failing to consider the entirety of the record.
Our own review of the record reveals that these claims are
without merit.

4
defendant is a manufacturer of the product; (2) that the

claimant’s damage was proximately caused by a characteristic of

the product; (3) that this characteristic made the product

“unreasonably dangerous”; and (4) that the claimant’s damage

arose from a reasonably anticipated use of the product by the

claimant or someone else. See La. Rev. Stat. Ann. § 9:2800.54(A)

(West 1997). A product is “unreasonably dangerous” under the

LPLA if the product meets at least one of the following criteria:

(1) The product is unreasonably dangerous in
construction or composition as provided in
R.S. 9:2800.55;
(2) The product is unreasonably dangerous in
design as provided in R.S. 9:2800.56;
(3) The product is unreasonably dangerous
because an adequate warning about the product
has not been provided as provided in R.S.
9:2800.57; or
(4) The product is unreasonably dangerous
because it does not conform to an express
warranty of the manufacturer about the
product as provided in R.S. 9:2800.58.

Id. § 9:2800.54(B). These statutory mechanisms for establishing

that a product is unreasonably dangerous “are predicated on

principles of strict liability, negligence, or warranty.”

Jefferson v. Lead Indus. Assoc., 930 F. Supp. 241, 245 (E.D. La.

1996). However, for causes of action arising after the effective

date of the LPLA, negligence, strict liability, and breach of

express warranty are not available as theories of recovery

against a manufacturer, independent from the LPLA. See id.

To maintain a “construction or composition” defect claim

under the LPLA, a plaintiff must establish that, at the time the

5
product left the manufacturer’s control, “the product deviated in

a material way from the manufacturer’s specifications or

performance standards for the product or from otherwise identical

products manufactured by the same manufacturer.” La. Rev. Stat.

Ann. § 9:2800.55 (West 1997). To maintain a failure-to-warn

claim, a plaintiff must demonstrate that “the product possessed a

characteristic that may cause damage and the manufacturer failed

to use reasonable care to provide an adequate warning of such

characteristic and its danger to users and handlers of the

product.” Id. § 9:2800.57 (West 1997). Proving a design defect

or a “construction or composition” defect is not a prerequisite

to establishing a failure-to-warn claim. Even if a product is

not defectively designed or constructed, a manufacturer “may

still have a duty to warn consumers about any characteristic of

the product that unreasonably may cause damage.” Grenier v. Med.

Eng’g Corp., 243 F.3d 200, 205 (5th Cir. 2001).

III. STAHL’S INTENTIONAL TORT CLAIM

The district court dismissed the claims in Stahl’s original

complaint, including his intentional tort claim, because these

claims were not based on theories of liability recognized in the

LPLA. We review the district court’s dismissal of a claim de

novo. Proctor & Gamble Co. v. Amway Co., 242 F.3d 539, 564 (5th

Cir. 2001).

Because Stahl’s cause of action accrued after September 1,

1988, the LPLA governs his claims. See Brown v. R.J. Reynolds

6
Tobacco Co., 52 F.3d 524, 527 (5th Cir. 1995). As the district

court correctly noted, the LPLA contains an exclusive remedy

provision, stating that “[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. Rev.

Stat. Ann. § 9:2800.52 (West 1997). This provision limits a

plaintiff’s theories of recovery against a manufacturer of an

allegedly defective product to those established by the LPLA.

See, e.g., Jefferson, 930 F. Supp. at 244.

Stahl contends that the district court’s dismissal of his

intentional tort claim was nonetheless improper because there

must be an “intentional acts” exception to the exclusive remedy

provision of the LPLA. In support of this contention, Stahl

cites a number of cases recognizing the existence of an

intentional acts exception to the exclusive remedy provision of

the Louisiana Workers’ Compensation Act (the “LWCA”). See, e.g.,

White v. Monsanto Co., 585 So.2d 1205, 1208 (La. 1991); Bazley v.

Tortorich, 397 So.2d 475, 480 (La. 1981). Stahl reads this

provision to suggest that “intentional tort is an exception to

every exclusive remedy.” We disagree.

Stahl is correct that the exclusive remedy provision of the

LWCA contains an express exception for intentional acts. See La.

Rev. Stat. Ann. § 23:1032(B) (West 1998) (“Nothing in this

Chapter shall affect the . . . liability, civil or criminal,

resulting from an intentional act.”). However, the fact that the

7
LWCA contains such a provision does not imply that the LPLA’s

exclusive remedy provision is subject to a similar exception.

There is no language in the LPLA indicating that its exclusive

remedy provision does not preclude intentional tort claims, and

both federal and Louisiana courts have read the Act’s exclusive

remedy provision to prevent plaintiffs from bringing intentional

tort claims. See, e.g., Grenier, 243 F.3d at 203-06 (affirming

the district court’s dismissal of a fraud claim and other tort

claims not among the exclusive theories of liability in the

LPLA); Arabie v. R.J. Reynolds Tobacco Co., 96-0978 (La. App. 5

Cir. 6/30/97), 698 So.2d 423, 424-25 (granting summary judgment

to defendants because plaintiffs’ battery, fraud, and wrongful

death claims were not among the exclusive theories of liability

enumerated in the LPLA). Further, there is no reason to read an

intentional acts exception into the LPLA, as manufacturers are

subject to suit under the Act for both intentional and

unintentional acts.2

2
An “intentional acts” exception, while essential to the
remedial scheme established in the LWCA, would be nonsensical in
the context of the LPLA. The LWCA provides a remedy only for
claims arising out of an “accident.” See La. Rev. Stat. Ann.
§ 23:1031(A) (West 1998). That statute thus extends only to
claims based on unintentional acts. Accordingly, the LWCA’s
exclusive remedy provision contains an exception allowing workers
to bring tort claims based on intentional injuries because
otherwise workers would have no legal remedy against their
employers for such intentional tortious acts.
In contrast, the applicability of the LPLA does not turn on
whether a manufacturer has acted “intentionally” in manufacturing
a defective product. A claimant can bring an action under the
LPLA based on conduct by a manufacturer that was either
intentional or unintentional, presuming that the claim meets the

8
 Because there is no “intentional acts” exception to the

exclusive remedy provision of the LPLA, Stahl cannot bring

intentional tort claims against Novartis under the Louisiana

Civil Code for damages allegedly caused by Lamisil. Accordingly,

the district court properly dismissed Stahl’s intentional tort

claim.

IV. STAHL’S “UNREASONABLY DANGEROUS IN CONSTRUCTION OR
COMPOSITION” CLAIM UNDER THE LPLA

The “unreasonably dangerous in construction or composition”

provision of the LPLA provides a remedy for damages caused by a

product that is defective due to a mistake in the manufacturing

process. La. Rev. Stat. Ann. § 9:2800.55 (West 1997). As noted

above, to prevail on a claim under this provision, the plaintiff

must demonstrate that “at the time the product left its

manufacturer’s control, the product deviated in a material way

from the manufacturer’s specifications or performance standards

for the product or from otherwise identical products manufactured

by the same manufacturer.” Id.

The district court granted summary judgment to Novartis on

Stahl’s construction or composition defect claim, finding that

Stahl’s “conclusory and unsubstantiated” assertions that Lamisil

is unreasonably dangerous were insufficient to survive summary

judgment. We review a district court’s grant of summary judgment

statutory criteria outlined above. Thus, there is no need for a
specific exception to the LPLA’s exclusive remedy provision for
“intentional acts,” as intentional acts are encompassed within
the LPLA’s coverage provisions.

9
de novo, applying the same standard as the district court. See

Rivers v. Cent. & S.W. Corp., 186 F.3d 681, 683 (5th Cir. 1999).

Stahl argues on appeal that the district court’s summary

judgment determination was erroneous because the district court

misinterpreted Celotex Corp. v. Catrett, 477 U.S. 317 (1986).

Stahl asserts that the court improperly placed the summary

judgment burden on him, the non-moving party, without first

requiring Novartis to come forward with documentary proof of the

absence of a genuine issue of material fact regarding Stahl’s

claim. Stahl misreads both Rule 56 and the Celotex decision.

Under Rule 56(c), summary judgment is proper “if the pleadings,

depositions, answers to interrogatories, and admissions on file,

together with the affidavits, if any, show that there is no

genuine issue as to any material fact and that the moving party

is entitled to a judgment as a matter of law.” Fed. R. Civ. P.

56(c). The moving party may meet its burden to demonstrate the

absence of a genuine issue of material fact by pointing out that

the record contains no support for the non-moving party’s claim.

In this circumstance, if the non-moving party can point to

nothing in the record supporting its claim, summary judgment is

appropriate. As the Celotex Court explained, “Rule 56(c)

mandates the entry of summary judgment, after adequate time for

discovery and upon motion, against a party who fails to make a

showing sufficient to establish the existence of an element

essential to that party's case, and on which that party will bear

10
the burden of proof at trial.” 477 U.S. at 322. In such a

situation there can be no genuine issue as to any material fact,

since there has been a “complete failure of proof concerning an

essential element of the nonmoving party’s case.” Id. at 323.

In the instant case, Novartis correctly argues that Stahl

has provided no evidence raising a genuine issue of material fact

as to whether Lamisil is unreasonably dangerous in construction

or composition. While Stahl does provide some evidence that

Lamisil’s active ingredient can be dangerous to the liver, this

evidence is not dispositive in a “construction or composition”

claim under the LPLA. Therefore, summary judgment is appropriate

because Stahl has not provided any evidence suggesting that the

particular pills he received deviated in any way from the

manufacturer’s production standards or from the manufacturer’s

otherwise identical products.

V. STAHL’S “INADEQUATE WARNING” CLAIMS UNDER THE LPLA

Stahl claims that Novartis failed to provide adequate

warnings regarding the dangers associated with Lamisil.3 Stahl

primarily contends that: 1) Novartis should have strengthened the

3
Stahl also contends at various points in his brief that
the limited warnings that Novartis provided were diluted by
unfounded assurances of safety offered by its pharmaceutical
sales representatives. However, there is no evidence in the
record supporting this assertion. The only relevant evidence is
Dr. Claiborne’s testimony about his conversations with Novartis’s
drug representatives, and the record reveals that Dr. Claiborne
testified unequivocally that the drug representatives informed
him of the risks of Lamisil and never told him anything that was
inconsistent with the label.

11
wording of existing warnings to explicitly acknowledge the causal

relationship between Lamisil use and liver

dysfunction/cholestatic hepatitis; 2) Novartis should have added

language to the package insert indicating that use of Lamisil can

cause liver failure and death; and 3) Novartis should have

recommended or mandated pre-administration blood testing and

weekly or biweekly blood testing for all patients taking Lamisil

or, at a minimum, should have recommended blood testing for

patients who experienced early warning signs of liver damage,

including jaundice, dark urine, and pale stools.4

To successfully maintain a failure-to-warn claim under the

LPLA, a plaintiff must demonstrate that the product in question

has a potentially damage-causing characteristic and that the

manufacturer failed to use reasonable care to provide an adequate

warning about this characteristic. See Grenier, 243 F.3d at 205

(“To prevail on her failure to warn claim, Grenier would need to

show only that ‘gel bleed’ is a potentially damage-causing

characteristic of MEC’s breast implants and that MEC failed to

use reasonable care to provide an adequate warning.”); see also

La. Rev. Stat. Ann. § 9:2800.57(A) (West 1997). To meet the

first prong of this test, we have indicated that a plaintiff must

provide evidence about the “cause, frequency, severity, or

consequences” of the dangerous characteristic in question.

4
Stahl claims to have experienced these symptoms prior
to the onset of his cholestatic hepatitis.

12
Grenier, 243 F.3d at 205; see also Krummel v. Bombardier Corp.,

206 F.3d 548, 552 (5th Cir. 2000) (finding that liability for

failure-to-warn requires a plaintiff to provide evidence of the

probability or risk of injury from the allegedly damaging

characteristic of the product). However, in the instant case,

neither party contests that Lamisil tablets have a potentially

damage-causing characteristic (i.e., hepatoxicity). The parties

only dispute whether Novartis used reasonable care to provide

adequate warnings regarding this characteristic. Accordingly, we

focus our attention on this inquiry.

The district court determined that the warnings contained in

the Lamisil package insert were adequate as a matter of law. The

court relied primarily on the testimony of Stahl’s treating

physician, Dr. Claiborne, who indicated that the warnings

contained in the Lamisil package insert were clear, unambiguous,

and reasonably adequate to inform him of the risk of liver damage

associated with the use of the drug. Stahl argues that summary

judgment on this issue was inappropriate because the adequacy of

a warning is an issue of fact for the jury to decide.

This court has previously rejected the notion that a claim

of inadequate warning always presents a jury issue. See Anderson

v. McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987). A “mere

allegation of inadequacy” is insufficient for a plaintiff to

survive summary judgment on a failure-to-warn claim. Id. Stahl

must “go beyond the pleadings and designate specific facts in the

13
record showing that there is a genuine issue for trial” to defeat

summary judgment. Wallace v. Texas Tech Univ., 80 F.3d 1042,

1047 (5th Cir. 1996).

Stahl further contends that the district court erred in

basing its summary judgment determination on Dr. Claiborne’s

testimony. Stahl argues that because Dr. Claiborne is an expert

in dermatology, not liver disease or the adequacy of drug

warnings, the district court should not have considered his

“expert” testimony regarding the adequacy of the warning without

requiring a hearing under Daubert v. Merrell Dow Pharmaceuticals,

Inc., 509 U.S. 579 (1993). Stahl further contends that, even if

Dr. Claiborne’s expertise in liver disease and the adequacy of

drug warnings were established, such expert testimony cannot form

the basis of a summary judgment determination.

We reject these contentions. When Dr. Claiborne testified

as to the adequacy of the warning contained in the Lamisil

package insert, he was not providing an expert opinion. While

Dr. Claiborne was offered as an expert in the field of

dermatology and fielded some questions in his deposition that

called upon his expertise as a dermatologist, the portion of his

testimony that was relevant to the district court’s summary

judgment determination involved his own understanding and

perception of the warning label as Stahl’s treating physician.

In that capacity, Dr. Claiborne was testifying as to whether the

Lamisil package insert made him aware of the risks involved in

14
prescribing Lamisil at the time that he treated Stahl. This

portion of Dr. Claiborne’s testimony does not constitute an

expert assessment and is related to matters within the scope of

Dr. Claiborne’s personal knowledge.5 It is appropriate for a

district court to consider such testimony in evaluating a motion

for summary judgment. See Fed. R. Civ. P. 56(e).

We turn now to the substance of Stahl’s inadequate warning

claims. Louisiana applies the “learned intermediary doctrine” to

products liability claims involving prescription drugs. Under

5
This court has previously recognized that a treating
physician does not necessarily testify in an expert capacity when
he or she testifies as to the adequacy of the warning contained
in a drug label. Indeed, no expertise outside the treating
physician’s field is required for such an assessment. See
Mauldin v. Upjohn Co., 697 F.2d 644, 648 (5th Cir. 1983). As we
reasoned in Mauldin:
Upjohn insists that only an expert in the
preparation or construction of medical
product warning statements can testify
properly as to the issue of adequacy. We
cannot accept this argument, for it belies
the essential purpose of the warning.
Package inserts and PDR references are not
written for medical experts schooled and
skilled in the writing of warnings. They are
written to inform fully and adequately the
medical practitioner who is called upon . . .
to prescribe the medication. The
understanding and perception of [the
prescribing physicians] is entirely relevant,
for the sufficiency of the warning is
dependent upon their reasonably anticipated
comprehension.

Id.; see also Zachary v. Dow Corning Corp., 884 F. Supp. 1061,
1065 (M.D. La. 1995) (noting that in the learned intermediary
context, a manufacturer’s duty to warn requires adequate warning
of inherent dangers not within the knowledge of or obvious to the
average learned intermediary).

15
this doctrine, a drug manufacturer discharges its duty to

consumers by reasonably informing prescribing physicians of the

dangers of harm from a drug. Anderson, 831 F.2d at 93. This

court has acknowledged that there is a two-prong test governing

inadequate-warning claims under the LPLA when the learned

intermediary doctrine is applicable. First, the plaintiff must

show that the defendant failed to warn (or inadequately warned)

the physician of a risk associated with the product that was not

otherwise known to the physician. Willett v. Baxter Int’l Inc.,

929 F.2d 1094, 1098 (5th Cir. 1991). Second, the plaintiff must

show that this failure to warn the physician was both a cause in

fact and the proximate cause of the plaintiff’s injury. Id.

Because we find that Stahl has failed to raise a genuine issue of

material fact regarding the adequacy of the warnings contained in

the Lamisil package insert, we reach only the first of these

questions.

The Adequacy of the Warnings Addressing Liver Dysfunction
and Cholestatic Hepatitis

Stahl’s first inadequate warning claim is that the Lamisil

package insert inadequately informed his treating physician of

the risk of liver dysfunction and hepatitis associated with

Lamisil use. While Stahl acknowledges that the “WARNINGS”

section of the 1997 package insert specifically indicated that

“[r]are cases of symptomatic hepatobiliary dysfunction including

cholestatic hepatitis have been reported” and that “treatment

with Lamisil . . . Tablets should be discontinued if

16
hepatobiliary dysfunction develops,” he contends that the wording

of these warnings was not strong enough. According to Stahl, the

warnings provided in the package insert were inadequate because

they did not acknowledge the causal relationship between Lamisil

use and liver dysfunction or cholestatic hepatitis.

Novartis maintains that the Lamisil insert fulfilled the

company’s duty to warn. Novartis points to a line of cases

decided under Louisiana law finding that a drug warning is

adequate as a matter of law if it clearly and unambiguously

notifies the prescribing physician of the particular adverse

reaction that forms the basis of the plaintiff’s complaint. See

Bealer v. Hoffman-La Roche, Inc., 729 F. Supp. 43, 44-45 (E.D.

La. 1990); Calhoun v. Hoffman-La Roche, Inc., 98-2770, (La. App.

1 Cir. 2/18/00), 768 So.2d 57, 61-62. Indeed, one of those

courts concluded that, if a warning label clearly and

unambiguously states the particular ailment suffered by the

plaintiff, summary judgment on a failure-to-warn claim is

appropriate despite the prescribing physician’s testimony that

the warning did not adequately inform him of the risk involved.

See Calhoun, 768 So.2d at 62 (“The Calhouns have not cited to us,

nor have we found, any jurisprudential support for their

contention that the test of whether a warning is adequate is

subjective, based solely on the opinion of the prescribing

physician.”). Based on this line of authority, Novartis contends

that the language in the insert indicating that “[r]are cases of

17
symptomatic hepatobiliary dysfunction including cholestatic

hepatitis have been reported” and that treatment “should be

discontinued if hepatobiliary dysfunction develops,” constitutes

an adequate warning about the danger of liver dysfunction or

cholestatic hepatitis as a matter of law because these portions

of the warning mention Stahl’s particular ailments.

Novartis is correct that in Calhoun and similar cases courts

apparently interpreted Louisiana law to require summary judgment

in favor of a drug manufacturer whenever the particular ailment

suffered by the plaintiff is mentioned in the warnings section of

the package insert, regardless of the prescribing physician’s

testimony about his or her actual awareness and understanding of

the risks involved. However, this suggestion that any clear and

unambiguous reference to a particular adverse effect is

sufficient to satisfy the manufacturer’s duty to warn is

inconsistent with this court’s jurisprudence interpreting the

LPLA. In applying the learned intermediary doctrine to an

inadequate warning claim under the LPLA in Anderson, for example,

we noted that “[u]nder Louisiana law, a drug manufacturer has

discharged its duty to consumers of its prescription drugs when

it has reasonably informed prescribing physicians of the dangers

of harm from such a drug.” Anderson, 831 F.2d at 93 (emphasis

added). Thus, as our language in Anderson indicates, a mere

reference to an adverse effect is not necessarily an “adequate

warning” under the LPLA. The warning must contain language that

18
is adequate to reasonably inform the recipient (i.e., the doctor

in a learned intermediary case) about the nature of the danger

involved. See also Restatement(Third) of Torts: Products

Liability § 6(d) (1997) (noting that a prescription drug or

medical device “is not reasonably safe due to inadequate

instructions or warnings if reasonable instructions or warnings

regarding foreseeable risks of harm are not provided”) (emphasis

added).

An alternate line of Louisiana authority suggests that a

warning regarding a particular adverse drug reaction is adequate

as a matter of law if the package insert clearly and

unambiguously mentions the specific ailment suffered by the

plaintiff AND the plaintiff’s prescribing physician unequivocally

testifies that the information provided in the warning was

adequate to provide that physician with a reasonable

understanding of the risks involved. Compare White v. Slidell

Mem’l Hosp. & Med. Ctr., No. 89-2691, 1990 WL 111447 (E.D. La.

July 26, 1990) (finding summary judgment appropriate when the

particular ailment suffered by the plaintiff was mentioned in the

warning and the plaintiff’s physicians testified that they

considered the manufacturer’s warnings adequate); Mikell v.

Hoffman-LaRoche, Inc., 94-0242, (La. App. 1 Cir. 12/22/94), 649

So.2d 75, 80 (affirming the trial court’s summary judgment in

favor of the defendant manufacturer when the particular ailment

suffered by the plaintiff was specifically mentioned in the

19
warning and the plaintiff’s physicians testified that they

considered the manufacturer’s warnings adequate); and Cobb v.

Syntex Labs., Inc., 444 So.2d 203, 205-06 (La. Ct. App. 1984)

(same) with Timm v. Upjohn Co., 624 F.2d 536, 539 (5th Cir. 1980)

(finding that when a prescribing physician’s testimony that a

warning was adequate was not unequivocal, a jury is “entitled to

weigh the conflicting statements made by [the prescribing

physician] . . . along with all the other evidence presented in

the case”).

We find this second line of authority, represented by White,

Mikell, and Cobb, to be a more persuasive reading of Louisiana

law. Contrary to the holding of the Calhoun court, a

prescription drug warning is not adequate as a matter of law

simply because the warning label contains a clear and unambiguous

reference to the adverse reaction suffered by the plaintiff. For

summary adjudication of an inadequate warning claim to be

appropriate, the plaintiff’s prescribing physician must also

unequivocally testify that the warning was adequate to inform him

or her of the risks involved in prescribing the drug. The

doctor’s testimony provides added assurance that the language in

the package insert was worded strongly enough to adequately

inform him or her of the actual level of risk involved.

This reading of Louisiana law is consistent with the

principles underlying the learned intermediary doctrine. Under

Louisiana law, “[t]he obligation to the consumer is fulfilled

20
when the prescribing or treating physician is informed of any

potential side effects or risks from the drug’s use so that they

may intelligently decide on its use and advise the patient.”

McCarthy v. Danek Med., Inc., 65 F. Supp. 2d 410, 413 (E.D. La.

1999) (citing Mikell, 649 So.2d at 80). The premise underlying a

failure-to-warn claim in the learned intermediary context is that

the patient is claiming that the manufacturer failed to

adequately warn the treating physician. The treating physician’s

knowledge is thus the focus of the inquiry. Accordingly, when a

particular adverse effect is clearly and unambiguously mentioned

in a warning label and the prescribing physician unequivocally

states that he or she was adequately informed of that risk by the

warning, the manufacturer has satisfied its duty to warn under

the learned intermediary doctrine.

In the instant case, we agree with the district court that

Dr. Claiborne unequivocally testified that the Lamisil package

insert’s warning was clear, unambiguous, and adequate to inform

him of the risks of cholestatic hepatitis associated with

prescribing Lamisil. Accordingly, the district court correctly

determined that under Louisiana law, this warning is adequate as

a matter of law. Summary judgment is appropriate on this claim.

The Failure to Warn of Liver Failure and Death

Stahl’s second contention is that the Lamisil package insert

was inadequate because it failed to warn prescribing physicians

21
that liver failure and death could result from Lamisil use.6 In

considering this claim, the district court found that because

Stahl had not yet suffered liver failure or death, he could not

bring a failure-to-warn claim based on these dangers.7 This

logic is questionable. Because liver failure and death are

widely recognized to be possible outcomes in a serious case of

hepatitis (a condition that Stahl unquestionably suffered), it

makes little sense to suggest that the plaintiff must wait until

he dies to complain that the company failed to warn him of the

risk of hepatitis-induced death. However, in the same vein,

because liver failure and resulting death are widely recognized

to be possible outcomes in a severe case of hepatitis, those

risks are adequately addressed by the warnings already provided

in the Lamisil insert.

Under Louisiana law, there is no duty to warn of obvious

risks. See La. Rev. Stat. Ann. § 9:2800.57(B). In the context

of warnings addressed to a physician acting as learned

intermediary, this court has interpreted this “obvious risk”

exception to exclude any duty to warn of risks that are “within

6
The two-part test described above, governing when a
warning can be deemed “adequate as a matter of law” under the
LPLA, is not applicable to this claim because the adverse effects
that are the subject of this claim were not specifically
mentioned in the warning label.
7
In reaching this holding, the district court relied on
Grenier v. Med. Eng’g Corp., 99 F. Supp. 2d 759, 766 (W.D. La.
2000), aff’d, 243 F.3d 200 (5th Cir. 2001), which held that a
claimant cannot seek to impose a duty to warn on a product
manufacturer with respect to a damage not sustained.

22
the knowledge of or obvious to the average learned intermediate.”

Willett, 929 F.2d at 1098 n.16. Consequently, because any

prescribing physician who is forewarned of a risk of systematic

liver dysfunction and cholestatic hepatitis would find it obvious

that there is an attendant possibility of liver failure and

death, Novartis fulfilled its duty under the LPLA to warn

physicians specifically of that possible outcome. Summary

judgment is therefore appropriate.8

The Adequacy of the Medical Monitoring Instructions

Stahl’s final failure-to-warn claim is that Novartis’s

recommended medical testing regime, indicating that “[h]epatic

function (hepatic enzyme) tests are recommended in patients

administered Lamisil for more than six weeks or in those who

develop unexplained nausea, anorexia, or fatigue,” was

inadequate.9 According to Stahl, Novartis should have

8
This court has determined that “obviousness” can be
appropriately evaluated as a matter of law in a summary judgment
proceeding. See, e.g., Scallan v. Duriron, 11 F.3d 1249, 1252
(5th Cir. 1994) (determining that because “[t]he danger inherent
in pumping chlorine through a hydraulic pump is obvious to an
ordinary user of hydraulic pumps . . . . no genuine issue of
material fact exist[ed] as to whether [the defendant] had a duty
to warn”); see also Grenier, 99 F. Supp. 2d at 766 (determining
in a summary judgment proceeding that “Defendants had no duty to
warn against additional scarring that would result from
additional surgery as scarring to some degree is an obvious
consequence of surgery”).
9
Stahl and Novartis dispute the exact meaning of this
language. Novartis contends that this warning recommends that
physicians perform blood testing on the subset of Lamisil
patients that will be taking the drug for more than six weeks
(i.e., those patients who take a twelve-week course of Lamisil to
treat fungal infections of the toenails, rather than a six-week

23
recommended or mandated pre-administration blood testing and

weekly or biweekly blood testing for all patients taking Lamisil

or, at a minimum, should have recommended blood testing for

patients who experienced early warning signs of liver damage,

including jaundice, dark urine, and pale stools. Novartis

contends that that this claim is not appropriately classified as

a failure-to-warn claim because the blood testing recommendations

contained in the package insert do not actually constitute

“warnings.” Novartis’s position is that it is inappropriate to

consider recommended medical monitoring schedules contained in a

drug insert when evaluating the adequacy of a manufacturer’s

warnings. According to Novartis, such monitoring recommendations

are mere suggestions — the actual determination of when and how

to monitor the patient is left to the discretion of the treating

physician.

We find Novartis’s characterization of the recommended

medical monitoring scheme unpersuasive. An inadequate warning

claim under the LPLA can appropriately be based on alleged

inadequacies in a recommended medical monitoring or testing

course to treat fungal infection of the fingernails). Novartis
maintains that this language does not purport to provide any
particular instruction regarding the appropriate timing of this
blood testing. Stahl, however, reads this recommendation to
suggest that no blood testing is necessary until and unless a
patient has been taking Lamisil for more than six weeks. To the
extent that this distinction makes any difference as a practical
matter, for the purposes of reviewing Novartis’s motion for
summary judgment we shall construe the warning consistent with
Stahl’s interpretation.

24
regime. The LPLA provision defining an “adequate warning”

encompasses “instructions” as well as “warnings.” See La. Rev.

Stat. Ann. § 9:2800.53(9) (West 1997) (defining an “adequate

warning” as a “warning or instruction that would lead an ordinary

reasonable user or handler of a product to contemplate the danger

in using or handling the product and either to decline to use or

handle the product or, if possible, to use or handle the product

in such a manner as to avoid the damage for which the claim is

made”); see also Restatement(Third) of Torts: Products Liability

§ 6(b) (1997) (noting that a prescription drug or medical device

is defective if it “is not reasonably safe due to inadequate

instructions or warnings”) (emphasis added). Indeed, it is an

accepted tenet of Louisiana products liability law that a

manufacturer’s duty to warn includes a duty to provide adequate

instructions for safe use of a product. See Hines v. Remington

Arms Co., Inc., 648 So. 2d 331, 337 (La. 1994). There appears to

be no compelling reason to exempt recommended medical monitoring

schemes — which are, in essence, instructions for safe use of

prescription drugs — from a drug manufacturer’s duty to warn.

Louisiana courts have not specifically addressed whether a

recommended medical monitoring program constitutes a “warning.”

However, many courts applying the law of other states have

implicitly assumed that medical monitoring recommendations

contained in package inserts are “warnings” by evaluating such

recommendations (or the absence of such recommendations) in

25
determining whether a drug manufacturer has fulfilled its duty to

warn. See, e.g., Salmon v. Parke, Davis & Co., 520 F.2d 1359,

1362 (4th Cir. 1975) (applying North Carolina law) (finding that

the plaintiff established a jury question precluding summary

judgment by providing evidence that the blood studies recommended

in a drug’s warning label were inadequate); Fornoff v. Parke,

Davis & Co., 434 N.E.2d 793, 802 (Ill. App. 1982)(applying

Illinois law) (indicating that the plaintiff’s inadequate warning

claim created a jury issue as to whether a drug “was so

unpredictable in its rate of absorption so as to require

monitoring, and therefore a warning” to that effect); Formella

v. Ciba-Geigy Corp., 300 N.W.2d 356, 359 (Mich. App. 1980)

(applying Michigan law) (citing medical monitoring language in a

warning label in support of the court’s finding that a warning

was adequate); Cooper v. Bowser, 610 S.W.2d 825, 831-32 (Tex.

Civ. App. 1980) (applying Texas law) (same).

In support of his inadequate warning claim, Stahl relies

primarily on an expert report from Dr. William George, the

Director of the Toxicology Center at the Tulane University School

of Medicine.10 In this report, Dr. George opines (based on a

10
Stahl points to two other sources of support for his
inadequate instruction claim. Initially, Stahl argues that
Novartis’s alteration of the Lamisil package insert in the years
following his injury provides evidence that the 1997 version of
the insert was inadequate. Specifically, he points out that the
current version of the Lamisil package insert includes a warning
that patients should undergo liver testing if they develop
jaundice, dark urine, or pale stools. Such evidence of
subsequent remedial measures cannot be considered in evaluating

26
literature review and review of Stahl’s medical records) that

Lamisil can cause symptomatic hepatobiliary dysfunction as early

as two to three weeks following initiation of treatment. Dr.

George concludes that hepatic function testing would be more

likely to identify the onset of hepatoxicity in a more timely way

if such testing was performed on patients taking Lamisil within

three weeks of initial dosing.

whether the 1997 warning was adequate. See Fed. R. Evid. 407
(indicating that evidence of subsequent remedial measures is not
admissible to show a defect in a warning or instruction).
Stahl also attached to his memorandum opposing summary
judgment a collection of lists of medical journal articles,
paragraph-long summaries of medical journal articles (apparently
obtained from an unidentified computerized database), and
photocopied passages from medical journal articles purportedly
discussing the relationship between terbinafine (the active
ingredient in Lamisil) and liver problems. Stahl argues that
these written materials demonstrate that Novartis had notice that
earlier blood testing of Lamisil patients was necessary. While
the district court does not appear to have addressed the
admissibility of this evidence, we shall undertake this inquiry
pursuant to our de novo review.
With the exception of two photocopied passages from medical
journals where the title and date of the journal are identified
in the photocopy, Stahl has presented insufficient indicia as to
the authenticity of these resources to satisfy the requirements
of Rule 901 of the Federal Rules of Evidence. See Fed. R. Evid.
901(a) (“The requirement of authentication or identification as a
condition precedent to admissibility is satisfied by evidence
sufficient to support a finding that the matter in question is
what its proponent claims.”). With respect to the two
photocopied passages of medical journal articles, we find that
the portions excerpted by Stahl are insufficient to create a
genuine issue of material fact regarding the adequacy of the
monitoring regime recommended in the Lamisil package insert,
particularly in light of the fact that the excerpted passages
present in full only the factual circumstances of the adverse
incident(s) discussed in the articles. The portions of these
articles analyzing and drawing implications from these adverse
incidents are not included in full in the photocopies that Stahl
has submitted.

27
 At oral argument, Novartis argued that Dr. George’s

testimony was insufficient to create a genuine issue of material

fact with respect to the adequacy of the medical monitoring

instruction. Novartis also questioned the relevancy of Dr.

George’s testimony, pointing out that he is not an expert in the

adequacy of warnings. We disagree with Novartis’s suggestion

that Dr. George’s testimony is irrelevant because he is a

toxicologist rather than an expert on warning labels. However,

we agree with Novartis that Dr. George’s testimony is

insufficient to create a genuine issue of material fact with

respect to the adequacy of the medical monitoring instructions.

The statutory definition of an “adequate warning” provides

insight into the appropriate standard to govern inadequate

instruction claims. As one commentator has aptly noted, the LPLA

definition of an adequate warning contains two components, one

component apparently addressing warnings, and one component

apparently addressing instructions: “the warning must both lead

the ordinary user or handler to contemplate the danger in using

the product (the warning component) and to either use it safely

(the instruction component) or decline to use it.” See Thomas C.

Galligan, Jr., The Louisiana Products Liability Act: Making Sense

of it All, 49 La. L. Rev. 629, 677 (1989). Interpreting the

statute in this manner, in order to prevail on an inadequate

instruction claim for a prescription drug, a plaintiff must

demonstrate that the instructions provided did not enable the

28
treating physician to “use or handle the [drug] . . . in such a

manner as to avoid the damage for which the claim is made.” La.

Rev. Stat. Ann. § 9:2800.53(9) (West 1997).

Dr. George’s vague suggestion that “a number of reports in

the literature indicate that hepatoxicity associated with

terbinafine has occurred as early as weeks following initiation

of treatment,” coupled with his tenuous conclusion that testing

“would be expected to be more effective” if conducted around two

to three weeks following initiation of dosing, is inadequate to

create a genuine issue of material fact as to whether the

instructional language in the Lamisil package insert enabled

treating physicians to use the drug safely. This assessment of

Dr. George’s testimony is bolstered by the fact that many of the

reports upon which Dr. George relies were published after Stahl’s

injury in 1998.11 Indeed, within the text of his report Dr.

George specifically cites only one pre-1998 study, which details

only one reported case where symptoms of liver dysfunction

11
While a manufacturer has a duty to update warnings as
new information about the risks of a product is discovered, see
La. Rev. Stat. Ann. § 9:2800.57(C) (1997), a manufacturer’s duty
to warn a particular plaintiff is measured by the state of
scientific and/or technical knowledge at the time the product
left the manufacturer’s control. See La. Rev. Stat. Ann. §
9:2800.59(B) (1997) (“[A] manufacturer of a product shall not be
liable for damage proximately caused by a characteristic of the
product if the manufacturer proves that, at the time the product
left his control, he did not know and, in light of then-existing
reasonably available scientific and technological knowledge,
could not have known of the characteristic that caused the damage
or the danger of such characteristic.”).

29
occurred as early as two to three weeks following initiation of

treatment with terbinafine. Such equivocal and ill-supported

testimony is simply insufficient to preclude summary judgment on

this inadequate warning claim.

VI. CONCLUSION

For the foregoing reasons, we AFFIRM both the district

court’s summary judgment in favor of Novartis on Stahl’s LPLA

claims and that court’s prior order dismissing Stahl’s

intentional tort claim.

30