Ziliak v. Astrazeneca Lp

• Court: U.S. Court of Appeals — Seventh Circuit
• Writing for the Court: Rovner
• Citation: Ziliak v. Astrazeneca Lp, 324 F.3d 518 (7th Cir. 2003)
• Decision Date: 31 March 2003
• Docket Number: No. 02-3446.,02-3446.
• Parties: Kathleen ZILIAK, Plaintiff-Appellant, v. ASTRAZENECA LP and ASTRAZENECA AB, Defendants-Appellees.

Page 518

324 F.3d 518

Kathleen ZILIAK, Plaintiff-Appellant, v. ASTRAZENECA LP and ASTRAZENECA AB, Defendants-Appellees.

No. 02-3446.

United States Court of Appeals, Seventh Circuit.

Argued February 28, 2003.

Decided March 31, 2003.

C. Richard Martin (argued), Martin & Martin, Boonville, IN, for Plaintiff-Appellant.

Bonnie L. Gallivan, L.A. Whaley (argued), Ice Miller, Indianapolis, IN, for Defendant-Appellee.

Before POSNER, MANION, and ROVNER, Circuit Judges.

ROVNER, 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, cataracts, and increased intraocular pressure. As a result, AstraZeneca issued package inserts warning that "rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration 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 Dr. Amodio that she was "doing great" and had stopped coughing 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 received the unfortunate news that she had developed severe glaucoma, cataracts, and high intraocular pressure. Following 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 pressure 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 federal 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.

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 inhaled 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 supplemental affidavit on July 9. AstraZeneca then objected to Ziliak's submission on timeliness grounds and asked the 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...