252 F.3d 986 (8th Cir. 2001), 00-3087, Glastetter v Novartis Pharmaceuticals Corp.

Docket Nº:00-3087, 00-3467
Citation:252 F.3d 986
Party Name:TINA M. GLASTETTER, STEVEN J. GLASTETTER, APPELLANTS, v. NOVARTIS PHARMACEUTICALS CORPORATION, FORMERLY KNOWN AS SUSAN LANDERS, NOVARTIS AG, FORMERLY KNOWN AS SANDOZ AG, APPELLEES.
Case Date:June 08, 2001
Court:United States Courts of Appeals, Court of Appeals for the Eighth Circuit
 
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252 F.3d 986 (8th Cir. 2001)

TINA M. GLASTETTER, STEVEN J. GLASTETTER, APPELLANTS,

v.

NOVARTIS PHARMACEUTICALS CORPORATION, FORMERLY KNOWN AS SUSAN LANDERS, NOVARTIS AG, FORMERLY KNOWN AS SANDOZ AG, APPELLEES.

No. 00-3087, 00-3467

United States Court of Appeals, Eighth Circuit

June 8, 2001

Submitted: April 9, 2001

Appeal from the United States District Court for the Eastern District of Missouri

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Before Hansen and Bye, Circuit Judges, and Melloy,1 District Judge.

Per Curiam.

Tina Glastetter suffered a stroke two weeks after she gave birth to her third child. She blamed her stroke on medication called Parlodel, which she had taken to suppress postpartum lactation. Glastetter sued Parlodel's manufacturer, Novartis Pharmaceuticals Corporation, in federal court under a state-law products liability theory. The district court2 excluded Glastetter's expert medical testimony that Parlodel caused her stroke, holding that it lacked scientific reliability. Glastetter v. Novartis Pharms. Corp., 107 F.Supp.2d 1015 (E.D. Mo. 2000). Because the court's ruling was fatal to Glastetter's proof of causation, the court granted Novartis summary judgment and assessed costs. Glastetter now appeals, and we affirm.

I.

Glastetter suffered from occasional migraines, she was overweight, and she had smoked heavily for several years. At age 36, she delivered her third child by caesarean section on August 2, 1993. Her pregnancy and delivery were uneventful. After childbirth, Glastetter chose not to breast-feed her child. Her doctor prescribed a two-week dose of Parlodel to suppress lactation. Glastetter had taken Parlodel for the same reason following a

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prior pregnancy. On August 16, Glastetter complained of a severe headache. The pain became intense, and she was later taken to a local hospital. At the hospital, doctors performed a CT scan, which revealed an intracerebral hemorrhage (ICH)3 in the right frontoparietal area of Glastetter's brain. She experienced left-side paralysis and slurred speech. Doctors were unable to identify the cause of Glastetter's stroke.

Novartis introduced Parlodel in 1978. In 1980, the Food & Drug Administration approved Parlodel for use in preventing postpartum lactation. Parlodel blocks the body's production of the hormone prolactin, which acts upon the breasts to induce secretion of milk in postpartum women. Parlodel's active ingredient is a chemical substance called "bromocriptine mesylate" (bromocriptine).4 About six months after Glastetter suffered her stroke, the FDA proposed to revoke its earlier approval of Parlodel for inhibiting postpartum lactation. The FDA concluded that the possible harm from using Parlodel (including the possibility of seizures and strokes in certain at-risk women) outweighed its limited benefit as a lactation suppressant. 59 Fed. Reg. 43,347 (Aug. 23, 1994). The FDA later revoked its approval of Parlodel after Novartis waived a formal hearing. 60 Fed. Reg. 3404, 3404-3405 (Jan. 17, 1995).

Glastetter brought an action against Novartis in 1997. She alleged that her ingestion of Parlodel caused her ICH. Glastetter's husband, Steven, joined a claim for loss of consortium. Following extensive discovery, Novartis moved in limine to exclude Glastetter's two expert witnesses on medical causation, Dr. Kenneth Kulig and Dr. Denis Petro. The district court received testimony from Drs. Kulig and Petro, and from Novartis's own medical experts, during a four-day evidentiary hearing in March 2000. On August 14, 2000, the district court excluded Glastetter's proposed expert testimony, holding that it was not scientifically valid, a prerequisite for admission under Fed. R. Evid. 702. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). Because Glastetter relied upon her experts to prove causation, and because causation was an essential element of her state-law products liability theory, the district court granted Novartis summary judgment. The district court later awarded Novartis some of its costs in conducting the Daubert hearing. Glastetter then filed the instant appeal challenging both the district court's Daubert ruling as well as its award of costs to Novartis.

II.

A party may present expert medical testimony if the expert's opinion is scientifically valid and it will assist the jury. Daubert, 509 U.S. at 589-93. Daubert described the district court as a gatekeeper. In exercising its gatekeeping function, a district court must make "a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue." Id. at 592-593. An expert opinion "must be supported by appropriate validation--i.e., 'good grounds,' based on what is known." Id. at 590.

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In sum, the district court's gatekeeping role separates expert opinion evidence based on "good grounds" from subjective speculation that masquerades as scientific knowledge. See...

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