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REVISED, FEBRUARY 8, 1999
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
_____________________
No. 97-40591
_____________________
In Re: NORPLANT CONTRACEPTIVE PRODUCTS LIABILITY LITIGATION
------------------------------------------
THERESA HARRISON, ET AL.,
Plaintiffs,
THERESA HARRISON; ANDREA ELAINE HAUGHT,
Plaintiffs-Appellants,
versus
AMERICAN HOME PRODUCTS CORPORATION, doing
business as Wyeth-Ayerst Laboratories, a
Delaware Corporation; WYETH LABORATORIES
INCORPORATED,
Defendants-Appellees.
------------------------------------------
BARBARA WOODS, ET AL.,
Plaintiffs,
KRISTY YOUNGBLOOD,
Plaintiff-Appellant,
versus
AMERICAN HOME PRODUCTS CORPORATION, doing
business as Wyeth-Ayerst Laboratories, a
Delaware Corporation; WYETH LABORATORIES
INCORPORATED,
Defendants-Appellees.

-------------------------------------------
CRYSTAL McDONALD, ET AL.,
Plaintiffs,
BEVERLY McDANIEL,
Plaintiff-Appellant
versus
AMERICAN HOME PRODUCTS CORPORATION, doing
business as Wyeth-Ayerst Laboratories, a
Delaware Corporation; WYETH LABORATORIES,
INCORPORATED,
Defendants-Appellees.
------------------------------------------
WENDY BOEHM, ET AL.,
Plaintiffs,
JENNIFER L. BURTON,
Plaintiff-Appellant,
versus
AMERICAN HOME PRODUCTS CORPORATION, doing
business as Wyeth-Ayerst Laboratories, a
Delaware Corporation; WYETH LABORATORIES
INCORPORATED,
Defendants-Appellees.
_________________________________________________________________
Appeal from the United States District Court for the
Eastern District of Texas, Beaumont
_________________________________________________________________
January 29, 1999
Before JOLLY, DAVIS, and DUHÉ, Circuit Judges.
E. GRADY JOLLY, Circuit Judge:
2

The appellants in this matter (collectively referred to as
"Harrison") are five plaintiffs who each suffered side effects from
their use of the prescription contraceptive Norplant, manufactured
by Wyeth Laboratories Incorporated, a company owned by American
Home Products ("AHP"). They appeal a district court ruling for
summary judgment in favor of AHP. The primary question presented
on appeal is whether the learned intermediary doctrine should apply
to the plaintiffs' claims. Because we find no error in the
district court's ruling, we affirm. AHP cross-appeals the district
court's denial of its motion for partial summary judgment based on
the statute of limitations bar. Because we find that AHP is
entitled to summary judgment, we need not address this issue on
appeal.
I
This case involves litigation over the side effects of the
contraceptive Norplant. Norplant is a long-term birth control
method whereby the recipient has six thin capsules of the hormone
progestin inserted just below the skin of her upper arm. Harrison
claims that Norplant can also have significant, unwanted side
effects.1
1These effects include severe headaches, mood swings,
depression, nausea, acne, arm pain, numbness, breast tenderness,
weight gain, hair loss, cramps, and bleeding irregularities,
including amenorrhea.
3

In this case, all five plaintiffs received Norplant from their
personal physicians and each suffered side effects. On July 22,
1994, a class action was filed against AHP, as the parent entity of
Wyeth Laboratories--the manufacturer of Norplant, on behalf of "all
adult women who have had Norplant inserted in their bodies and who
have sustained damages." On December 8, 1994, the Judicial Panel
on Multidistrict Litigation transferred all federal Norplant
actions to the Eastern District of Texas for consolidated pretrial
proceedings before Judge Richard Schell. Each of the plaintiffs in
this matter subsequently filed individual actions in the Eastern
District of Texas. On August 5, 1996, the court denied the
plaintiffs' motion for class certification, deciding that class
certification was premature and that bellwether trials were
appropriate to determine whether the class should be certified
under rule 23(c)(4). The plaintiffs in this case were selected for
the first of three bellwether trials.
At the close of discovery, AHP moved for summary judgment and
the district court granted the motion. The district court held
that the learned intermediary doctrine applied to all of the claims
filed by Harrison. Under that doctrine "when a drug manufacturer
properly warns a prescribing physician of the dangerous
propensities of its product, the manufacturer is excused from
warning each patient who receives the drug. The doctor stands as
a learned intermediary between the manufacturer and the ultimate
4

consumer." Alm v. Aluminum Co. of America, 717 S.W.2d 588, 592
(Tex. 1986) (citations omitted). The district court concluded
that, under the doctrine, AHP had no obligation to warn the end
user of the potential side effects of Norplant. The district court
then concluded that Harrison had failed to produce evidence that
AHP had not properly notified the prescribing physicians of
Norplant's potential side effects. Harrison now timely appeals.
II
Summary judgment is proper if "the pleadings, depositions,
answers to interrogatories and admissions on file, together with
affidavits, if any, show that there is no genuine dispute as to any
material fact and that the moving party is entitled to judgment as
a matter of law." Fed.R.Civ.P. 56(c). A summary judgment ruling
is reviewed de novo, applying the same criteria employed by the
district court. Conkling v. Turner, 18 F.3d 1285, 1295 (5th Cir.
1994).
Harrison raises a number of objections to the district court's
application of the learned intermediary doctrine. First, Harrison
argues that the learned intermediary doctrine cannot be applied to
claims under the Texas Deceptive Trade Practices Act ("DTPA") as
the doctrine is a common law defense and cannot be applied to a
statute like the DTPA. Second, Harrison urges that even if the
doctrine could be applied to the claims in this case, it should not
as AHP marketed Norplant directly to the end users and that the end
5

users relied on warnings (and the absence of warnings) provided by
AHP's marketing rather than warnings provided by their physicians.
Finally, Harrison argues that the doctrine should not apply because
Norplant was required by the Food and Drug Administration ("FDA")
to provide warnings about the side effects.
A
Harrison argues that the learned intermediary doctrine is
inapplicable to the claims made under the DTPA.2 The district
court did not address this issue below, apparently concluding that,
because the DTPA claim was equivalent to the other common law
claims, the learned intermediary doctrine should apply to it.
On appeal, Harrison argues that the learned intermediary
doctrine is a common law defense, and that common law defenses may
not be applied to the DTPA. Harrison's support for this argument
comes from a line of cases spawned by the Texas Supreme Court's
decision in Smith v. Baldwin, where that court stated: "The DTPA
2Harrison alleges violations of TEX. BUS. & COM. CODE
§ 17.46(b)(5) ("representing that goods or services have
sponsorship, approval, characteristics, ingredients, uses,
benefits, or quantities which they do not have or that a person has
a sponsorship, approval, status, affiliation, or connection which
he does not"); (b)(7) ("representing that goods or services are of
a particular standard, quality, or grade, or that goods are of a
particular style or model, if they are of another"); and (b)(23)
("the failure to disclose information concerning goods or services
which was known at the time of the transaction if such failure to
disclose such information was intended to induce the consumer into
a transaction into which the consumer would not have entered had
the information been disclosed"). Harrison also alleges violations
of implied and express warranties under § 17.45(5) of the Act.
6

does not represent a codification of the common law. A primary
purpose of the enactment of the DTPA was to provide consumers a
cause of action for deceptive practices without the burden of proof
and numerous defenses encountered in a common law fraud or breach
of warranty suit." 611 S.W.2d 611, 616 (Tex. 1980).
Subsequent Texas cases have applied Baldwin to generally
disallow the use in DTPA claims of both common law defenses and
common law doctrines that affect the burden of proof. Alvarado v.
Bolton, 749 S.W.2d 47, 48 (Tex. 1988)(barring use of doctrine of
merger); Weitzel v. Barnes, 691 S.W.2d 598, 600 (Tex. 1985)(barring
use of parole evidence rule and common law burden of proof); O'Hern
v. Hogard, 841 S.W.2d 135, 137 (Tex. App.--Hous. 1992) (barring
common law doctrine of new and independent cause); Shenandoah
Associates v. J & K Properties, Inc., 741 S.W.2d 470, 496 (Tex.
App.--Dallas 1987, writ denied) (barring defense based on waiver
and ratification); Home Savings Association v. Guerra, 720 S.W.2d
636, 644 (Tex. App.--San Antonio 1986) (barring estoppel defense),
aff'd in part, rev'd in part, 733 S.W.2d 134 (Tex. 1987); Roy E.
Thomas Const. Co. v. Arbs, 692 S.W.2d 926, 932 (Tex. App.--Fort
Worth 1985) (barring defense of impossibility), writ rev'd n.r.e.
per curiam,700 S.W.2d 919 (Tex. 1985); Joseph v. PPG Indus., Inc.,
674 S.W.2d 862, 865-66 (Tex. App.--Austin 1984, writ rev'd n.r.e.)
(barring defense of failure of consideration).
7

The Texas courts have also made clear, however, that at least
some common law common law doctrines are applicable to the DTPA.
Joseph E. Seagram & Sons, Inc. v. McGuire, 814 S.W.2d 385, 387-88
(Tex. 1991) (holding that, under the DTPA, no legal duty exists to
warn of the health risks of alcohol consumption because such risks
are "within the ordinary knowledge common to the community");
Autohaus, Inc. v. Aguilar, 794 S.W.2d 459, 462 (Tex. App.--Dallas
1990) (permitting use of common law doctrine of "puffing" in DTPA
claim), writ denied per curiam, 800 S.W.2d 853 (Tex. 1991); Jenkins
v. Steakley Bros. Chevrolet Co., 712 S.W.2d 587, 590 (Tex.
App.--Waco 1986, no writ) (permitting DTPA suit to be barred by
accord and satisfaction). In both Seagram and Autohaus, Texas
courts therefore permitted a common law doctrine that defined the
degree to which a seller is responsible for a consumer's reliance
on the safety or quality of a sold product.
Harrison asserts, however, that the learned intermediary
doctrine is a common law defense that should not be applicable to
the DTPA under Baldwin. The basis for this conclusion arises from
the following language in Rolen v. Burroughs Wellcome Co., 856
S.W.2d 607, 609 (Tex. App.--Waco 1993 writ denied): "The `learned
intermediary doctrine' is distantly related to the tort concept of
`superseding cause.' Although the doctrine has never been
recognized by the Texas Supreme Court, it has been adopted by
intermediate appellate courts." Based on this language, Harrison
8

argues that the doctrine is a common law defense inapplicable to
the DTPA. To the extent that the learned intermediary doctrine is
comparable to the tort concept of superseding cause, a credible
argument can be made that, under O'Hern, the doctrine should not be
applicable to the DTPA.
AHP responds, however, by arguing that the doctrine is not a
defense but instead is "a rule of law that defines a pharmaceutical
manufacturer's duty to provide adequate warnings with its
products." AHP further supports its contention by noting that in
three cases, the Texas courts, though admittedly not the Texas
Supreme Court, have applied the learned intermediary doctrine to
the DTPA. Rivers v. American Home Products Corp., No.
342-160538-95 (Order dated 4/9/98) (Appellee's Record Excerpt Tab
4); Bean v. Baxter Healthcare Corp., 1998 WL 104944, at *8 (Tex.
App.--Houston [14th Dist.] 1998, no writ h.); Jordan v. Geigy
Pharmaceuticals, 848 S.W.2d 176 (Tex. App.--Fort Worth 1992, no
writ.). The most telling of these cases is Rivers, which applies
the doctrine to the DTPA in the context of the same Norplant
litigation addressed in this case.
While Texas courts have applied the learned intermediary
doctrine to the DTPA, none of them have explicitly addressed the
argument made by Harrison here. That Texas appeal courts have
applied the doctrine in DTPA cases despite the edict not to apply
common law defenses to the DTPA, nevertheless suggests the result
9

a Texas court would likely reach if presented with this issue.3 We
therefore make an Erie guess that the Texas Supreme Court would
hold that the learned intermediary doctrine is not a common law
defense but instead a common law doctrine, like those in Seagram
and Autohaus, that establishes the degree to which a prescription
drug manufacturer is liable for an end user's reliance on the
effects of a prescription drug. Because we hold that the learned
intermediary doctrine is not a common law defense like those barred
by Baldwin, Harrison's argument that the district court incorrectly
applied it to the DTPA fails.
B
Harrison's other two arguments, each of which have been
thoroughly addressed by the district court below, also lack merit.
We briefly address each in turn.
Harrison argues that the learned intermediary doctrine should
not apply in this instance given AHP's knowledge of Norplant's side
effects and its conduct in marketing Norplant. Harrison argues
that, for reasons of public policy, Norplant should have had a duty
to warn the end user of Norplant's side effects because of the
reduced role physicians play in selecting contraceptives for their
3In U.S. v. Johnson, 160 F.3d 1061, 1063-64 (5th Cir. 1998),
we recently addressed the degree to which we are bound by holdings
of the Texas appeal courts. In this case, where no Texas Supreme
Court case is directly on point, we may look to an appeal court
holding for guidance if it is likely to be adopted by the Texas
Supreme Court.
10

patients. Harrison contends that the physician's reduced role
invalidates the rationale of the learned intermediary doctrine
because the patient cannot rely on the physician to provide an
adequate warning. Although it may be true that physicians may seek
to provide greater freedom to their patients in selecting an
appropriate form of contraception, Norplant is nevertheless a
prescription drug. The record makes it clear that physicians play
a significant role in prescribing Norplant and in educating their
patients about the benefits and disadvantages to using it.
Harrison's argument therefore is unavailing.
Harrison also argues that because AHP engaged in "aggressive"
marketing, AHP should be liable for not providing adequate
warnings in conjunction with that marketing. This argument is
critically weakened by the absence of any evidence on the record
that any of the five plaintiffs actually saw, let alone relied, on
any marketing materials issued to them by AHP.4 Given this
deficiency, even if such an exception to the doctrine should
apply, summary judgment would still be appropriate in this case.
It seems clear, however, that even if the facts were in Harrison's
favor, Harrison would still lose. Two of our cases applying Texas
4Harrison argues that although none of the plaintiffs were
ever exposed to direct marketing, their physicians did show them
videos and other materials prepared by AHP in explaining Norplant
to them. Those materials, however, were entirely within the
control of the physician and AHP had no control over which, if any,
of the materials were shown to the patient.
11

law in this area have concluded that, as long as a physician-
patient relationship exists, the learned intermediary doctrine
applies. Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178 (5th
Cir. 1988); Swayze v. McNeil Laboratories, 807 F.2d 464 (5th Cir.
1987).
Harrison's next argument is that there should be an exception
to the learned intermediary doctrine when the FDA has provided
recommended warnings. To support this argument, Harrison relies
on an Oklahoma Supreme Court case for the proposition that, when
the FDA mandates that labeling information be provided to
patients, the learned intermediary doctrine should not apply.
Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997). The
court reached this somewhat counter-intuitive result by concluding
that, where the potential side effects of a prescription drug are
so serious that the FDA places a requirement on the manufacturer
to warn the end user, the rationale of the learned intermediary
doctrine no longer applies.
At the outset, we find this conclusion to be puzzling. Our
understanding of the rationale of the learned intermediary
doctrine, at least in substantial part, is that it seeks to
encourage the drug manufacturer to make available prescription
drugs despite their potentially harmful side effects, by shielding
the drug manufacturer from liability when the drug is prescribed
by a properly trained physician. Why the learned intermediary
12

doctrine should somehow be less applicable when the severity of
the side effects encourages the FDA to promote additional labeling
escapes us.
Regardless of the merits of the Oklahoma Court's holding,
there are other reasons why it is not applicable to this case.
First, although the state of Oklahoma has created this exception
to the learned intermediary doctrine, there is no evidence that
the Texas Supreme Court would be inclined to follow in that
state's footsteps. In addition, the FDA has explicitly stated
that its regulation should not affect civil tort liability for
drug manufacturers and dispensers. FDA, Prescription Drug
Products; Patient Labeling Requirements, 44 Fed. Reg. 40016, 40023
(July 6, 1979). Finally, even if we were permitted to create such
an exception to the doctrine in Texas law, Harrison's argument in
this case would still fail as the FDA did not mandate any sort of
labeling for Norplant.
III
The only issue Harrison raises on appeal is whether the
learned intermediary doctrine applies to her claims. For the
foregoing reasons, it does. The judgment of the district court is
therefore
A F F I R M E D.
13

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