Kathleen Ziliak v. ASTRA ZENECA LP and ASTRA ZENECA AB

1 The other appellee, AstraZeneca AB, distributes Pulmicort in
the United States; we will refer to the two appellees simply as
“AstraZeneca.”
In the
United States Court of Appeals
For the Seventh Circuit
____________
No. 02-3446
K ATHLEEN Z ILIAK ,
Plaintiff-Appellant,
v.
A STRA Z ENECA LP and A STRA Z ENECA AB,
Defendants-Appellees.
____________
Appeal from the United States District Court
for the Southern District of Indiana, Evansville Division.
No. 00 C 249—Richard L. Young, Judge.
____________
A RGUED F EBRUARY 28, 2003—D ECIDED M ARCH 31, 2003
____________
Before P OSNER , M ANION , and R OVNER , Circuit Judges.
R OVNER , Circuit Judge. Kathleen Ziliak suffers from
bronchial asthma. To treat her disease, her physician,
Dr. Frank Amodio, prescribed Pulmicort Turbuhaler
(“Pulmicort”), an inhaled corticosteroid manufactured by
AstraZeneca LP. 1 Following clinical studies conducted in
1996 and 1997, AstraZeneca determined that on rare
occasions Pulmicort users developed glaucoma, cata-
racts, and increased intraocular pressure. As a result,

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2 No. 02-3446
AstraZeneca issued package inserts warning that “rare
instances of glaucoma, increased intraocular pressure, and
cataracts have been reported following the inhaled admin-
istration of corticosteriods.” Although he was aware of
AstraZeneca’s warnings and of the risks of using Pulmicort
to treat asthma, Dr. Amodio decided to prescribe Pulmicort
to Ziliak because, in his view, the benefits of using the drug
outweighed the risks. Ziliak began using Pulmicort in
January 1998. The following month, she informed to Dr.
Amodio that she was “doing great” and had stopped cough-
ing as a result of her asthma. In July, Ziliak saw Dr.
Amodio again and reported that she had run out of
Pulmicort and that she had started wheezing and having
difficulty breathing again. Dr. Amodio decided that Ziliak
should continue taking Pulmicort, and gave her a refill for
her inhaler. Ziliak did not see Dr. Amodio again.
In November 1998, after a routine eye exam, Ziliak re-
ceived the unfortunate news that she had developed severe
glaucoma, cataracts, and high intraocular pressure. Follow-
ing this diagnosis, Ziliak brought this products liability
action against AstraZeneca in state court, alleging that
AstraZeneca had failed to adequately warn of the risks of
developing glaucoma, cataracts, and high intraocular pres-
sure after using Pulmicort, and that the lack of adequate
warnings rendered Pulmicort a defective or unreasonably
dangerous product. Because the parties are diverse (Ziliak
is a citizen of Indiana; AstraZeneca AB is incorporated and
has its principal place of business in Sweden; AstraZeneca
LP is a limited partnership with citizenship in Sweden,
Delaware, and New York) and the amount in controversy
exceeds $75,000, AstraZeneca removed the action to feder-
al court. It then moved for summary judgment, arguing,
among other things, that the firm could not be held liable
for Ziliak’s injuries under Indiana’s “learned intermediary
doctrine,” and that the warning accompanying Pulmicort
was adequate as a matter of law.

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No. 02-3446 3
After receiving several extensions of time to respond to
AstraZeneca’s motion for summary judgment, Ziliak filed
a response in which she argued that genuine issues of
material fact existed concerning whether the warnings were
adequate. In support, she tendered an affidavit from her
medical expert witness, Dr. Donald Marks. Dr. Marks
asserted that he was “aware of case reports and also two
small studies of the incidence of glaucoma and cataracts
with inhaled steroids, indicating a small, but not what I
would try to minimize and dismiss as a rare risk,” but
opined that the studies were neither adequate in size nor in
design to reasonably estimate the risk of developing the
adverse side effects. These observations led him to conclude
that “the information made available [to a prescribing
physician] about the side effects of glaucoma and cataracts
related to the use of inhaled corticosteroids was insufficient
to warn him adequately of the risk of those side effects.” He
further concluded that “the information provided to the
prescribing physician needs to state that there is a causal
relationship between the use of Pulmicort and development
of cataracts and glaucoma, that monitoring is necessary for
development of these problems, and that cessation of in-
haled steroid use needs to be considered, as part of any
changing therapeutic regimen.”
The district court found that Dr. Marks’ testimony was
inadequate because he had not sufficiently established his
expertise. The court noted that in discussing the “case
reports” and “two small studies,” Dr. Marks had failed to
mention when the reports and studies were made or
published, and that he had failed to mention the results of
the studies. But instead of rejecting Dr. Marks’ testimony
outright, the district court gave Ziliak 30 days to submit
additional affidavits establishing his qualifications. The
order was dated June 5, 2002. Ziliak tendered the supple-
mental affidavit on July 9. AstraZeneca then objected to
Ziliak’s submission on timeliness grounds and asked the

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4 No. 02-3446
district court to rule on its summary judgment motion. The
district court rejected Dr. Marks’ supplemental affidavit as
“clearly late.” The court then entered summary judgment in
favor of AstraZeneca, concluding that the firm was shielded
by Indiana’s learned intermediary doctrine, that without
Dr. Marks’ testimony Ziliak had identified no evidence
suggesting that AstraZeneca’s warnings were inadequate,
and that even if Dr. Marks’ testimony was considered, the
warning accompanying Pulmicort was consistent with his
opinion of what the warning should have said.
Ziliak appeals, contending that the district court abused
its discretion in rejecting her evidentiary submission as
untimely, that genuine issues of material fact exist concern-
ing whether the warnings accompanying Pulmicort were
inadequate, and that the district court misapplied the law.
We review de novo the district court’s order granting sum-
mary judgment, viewing the facts and making all rea-
sonable inferences that flow from them in the light most
favorable to the non-moving parties. Nelson v. Sandoz
Pharm. Corp., 288 F.3d 954, 962 (7th Cir. 2002). Summary
judgment is appropriate where the pleadings, depositions,
answers to interrogatories, and admissions on file, together
with any affidavits, show that there is no genuine issue of
material fact for trial and that the moving parties are
entitled to judgment as a matter of law. Fed. R. Civ. P.
56(c). We review the district court’s decision to disregard an
affidavit submitted in support of summary judgment for
abuse of discretion. Abioye v. Sundstrand Corp., 164 F.3d
364, 368 (7th Cir. 1998).
At the outset, we think it worth noting that a party’s
failure to comply with summary judgment evidentiary
requirements is traditionally remedied not by dismissing
the case, but by excluding the non-conforming submission
and deeming the opposing party’s proposed findings of fact
admitted and then determining whether those facts entitle
the moving party to judgment as a matter of law. E.g.,

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No. 02-3446 5
Salvadori v. Franklin Sch. Dist., 293 F.3d 989, 992 (7th Cir.
2002); Hedrich v. Bd. of Regents of Univ. of Wis. Sys., 274
F.3d 1174, 1178 (7th Cir. 2001); Waldridge v. American
Hoechst Corp., 24 F.3d 918, 922 (7th Cir. 1994). That said,
even if we ignore the untimeliness of Ziliak’s submission
and consider Dr. Marks’ testimony, we can discern no gen-
uine issue of material fact for trial.
Under Indiana law, manufacturers are strictly liable to
consumers for injuries caused by defective or unreasonably
dangerous products placed in the stream of commerce. Ind.
Code § 34-20-2-1; Moss v. Crossman Corp., 136 F.3d 1169,
1171 (7th Cir. 1998). Indiana recognizes, however, that
some products such as pharmaceuticals are “unavoidably
unsafe” in that they are incapable of being made completely
safe for their intended or ordinary use. “Such a product,
properly prepared, and accompanied by proper directions
and warning, is not defective, nor is it unreasonably danger-
ous.” Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 545-
46 (Ind. Ct. App. 1979) (quoting Restatement (Second) of
Torts § 402A cmt. K (1965)). The duty to provide adequate
warnings arises only when the manufacturer knows or
should know of a risk posed by the product, and, in cases
involving drugs available only by prescription, extends only
to the medical profession, not the consumer. See id. at 548.
Accordingly, AstraZeneca is absolved of strict liability so
long as it has imparted adequate warnings to treating
physicians. See Phelps v. Sherwood Medical Indus., 836
F.2d 296, 299 (7th Cir. 1987). A warning is adequate if it is
reasonable under the circumstances. Ortho, 388 N.E.2d at
549.
The warning accompanying Pulmicort stated that “rare
instances of glaucoma, increased intraocular pressure, and
cataracts have been reported following the inhaled adminis-
tration of corticosteriods.” Dr. Marks opined that, at a
minimum, AstraZeneca should have warned that there
exists a “causal relationship between use of Pulmicort and

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6 No. 02-3446
development of cataracts and glaucoma, that monitoring is
necessary for development of these problems, and that
cessation of inhaled steroid use needs to be considered, as
part of any changing therapeutic regimen.” We fail to see
any inconsistency between what Dr. Marks believes that
AstraZeneca should have said and what AstraZeneca actu-
ally said. If a pharmaceutical manufacturer warns doctors
that specific adverse side effects are associated with the use
of a drug, then a causal relationship between use of the
drug and development of potential side effects is implicit in
the warning, as is the doctor’s need to monitor the patient
and to consider alternative therapies. Here Ziliak does not
dispute that Dr. Amodio was aware of AstraZeneca’s
warnings, and that he took the risks that Ziliak would
develop adverse side effects into account when prescribing
Pulmicort. Ziliak therefore has not identified any evidence
demonstrating the existence of a triable question of fact
whether the warnings accompanying Pulmicort were in-
adequate.
The judgment of the district court is A FFIRMED .
A true Copy:
Teste:
________________________________
Clerk of the United States Court of
Appeals for the Seventh Circuit
USCA-02-C-0072—3-31-03

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