Glastetter v. Novartis Pharmaceuticals Corp.

Decision Date09 April 2001
Docket Number00-3467,No. 00-3087,00-3087
Citation252 F.3d 986
CourtU.S. Court of Appeals — Eighth Circuit

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

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.


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 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.


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. 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 Globetti v. Sandoz Pharms. Corp., 111 F. Supp. 2d 1174, 1177 (N.D. Ala. 2000). We review a district court's decision to exclude expert testimony for an abuse of discretion. General Elec. Co. v. Joiner, 522 U.S. 136, 141-43 (1997).


Each of Glastetter's experts conducted a "differential diagnosis," which concluded that Parlodel caused her ICH. In performing a differential diagnosis, a physician begins by "ruling in" all scientifically plausible causes of the plaintiff's injury. The physician then "rules out" the least plausible causes of injury until the most likely cause remains. The final result of a differential diagnosis is the expert's conclusion that a defendant's product caused (or did not cause) the plaintiff's injury. See generally Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262-66 (4th Cir. 1999).

In Turner v. Iowa Fire Equip. Co., we held that "a medical opinion about causation, based upon a proper differential diagnosis, is sufficiently reliable to satisfy Daubert." 229 F.3d 1202, 1208 (8th Cir. 2000). Because a differential diagnosis is presumptively admissible, see id., a district court may exercise its gatekeeping function to exclude only those diagnoses that are scientifically invalid. In the present case, the district court excluded the differential diagnoses performed by Glastetter's expert physicians because they lacked a proper basis for "ruling in" Parlodel as a potential cause of ICH in the first place. Glastetter, 107 F. Supp. 2d at 1045 & nn.28-29 ("[T]he data and methods of plaintiffs' experts are not scientifically valid bases for the conclusion that Parlodel can cause an ICH in a human."). We agree with the district court's conclusion.


Glastetter's experts articulated a theory to explain how Parlodel might cause an ICH. They theorized that Parlodel causes arteries to constrict (vasoconstriction), resulting in elevated blood pressure. High blood pressure is itself a recognized risk factor for ICHs. Thus the experts opined that Parlodel's vasoconstrictive properties likely caused Glastetter's ICH. Although this chain of medical reasoning appears sound, its major premise remains unproven. Glastetter's experts failed to produce scientifically convincing evidence that Parlodel causes vasoconstriction. Her experts relied on various types of scientific data--published case reports; medical treatises; human rechallenge/dechallenge data; animal studies; internal Novartis documents; and the FDA's revocation of Parlodel's indication for suppressing lactation--to establish that Parlodel acts as a vasoconstrictor. We agree with the district court's conclusion that this data does not demonstrate to an acceptable degree of medical certainty that Parlodel can cause an ICH. See Daubert, 509 U.S. at 590 n.9 ("In a case involving scientific evidence, evidentiary reliability will be based upon scientific validity.") (emphases in original).

Much of the evidence relied upon by Drs. Kulig and Petro has been culled from case reports in which doctors reported patient strokes following their ingestion of Parlodel. A case report is simply a doctor's account of a particular patient's reaction to a drug or other stimulus, accompanied by a description of the relevant surrounding circumstances. Case reports make little attempt to screen out alternative causes for a patient's condition. They frequently lack analysis. And they often omit relevant facts about the patient's condition. Hence, "[c]ausal attribution based on case studies must be regarded with caution." Reference Manual on Scientific Evidence 475 (Fed. Judicial Ctr. 2000); see Turner, 229 F.3d at 1209 n.5 (collecting cases). Though case reports demonstrate a temporal association between Parlodel and stroke, or stroke-precursors, that association is not scientifically valid proof of causation.

Glastetter's experts referred to several medical texts that suggest that bromocriptine acts as a vasoconstrictor. Each of these texts suffers from one or more infirmities that prevented the district court from accepting its conclusions. Some of the texts were largely grounded upon case reports and other anecdotal information. One text reported Parlodel's propensity to cause diseases other than ICH, such as coronary vasospasm and heart attack. Still other texts relied upon generic comparisons between bromocriptine and related chemical compounds. At least one text ventured a hesitant conclusion that Parlodel causes vasoconstriction, but the explanation made clear that more research was needed before causation could be firmly established.

Like the district court, Glastetter, 107 F. Supp. 2d at 1032-35, we find that these texts do not present persuasive scientific evidence that Parlodel causes vasoconstriction. Indeed, we regard the experts' claims with some suspicion since one leading treatise on medical toxicology concludes that bromocriptine has no vasoconstrictive properties. See Matthew J. Ellenhorn, Ellenhorn's Medical Toxicology:...

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