Glaser v. Thompson Medical Co.

Merritt, Chief Judge.

Plaintiffs appeal the district court’s grant of summary judgment for the defendant on the single issue of causation in this product liability action. Plaintiffs allege negligence and breach of warranty in defendant-pharmaceutical company’s manufacture and distribution of the diet pill "Dexatrim." Specifically, the complaint alleges that plaintiff Bryan Glaser’s ingestion of one capsule of Dexatrim caused him to suffer acute hypertension which in turn caused him to suffer a stroke or intracranial bleed. That stroke caused him to fall, hit his head, and suffer further severe injuries. In granting defendant’s motion for summary judgment on this single issue, the district court ruled that the evidence proffered by plaintiffs on causation was insufficient to go to the jury. The issue before us is essentially a factual one: Is the evidence offered below consisting primarily of the deposition testimony of plaintiffs’ expert sufficient to create a dispute of material fact? We believe there is a genuine dispute of material fact regarding causation and therefore reverse. This holding carries no implications regarding the other facets of plaintiffs’ claims of negligence and breach of warranty.

I

The evidence offered by plaintiff on summary judgment is as follows: Twenty-year-old Bryan Glaser began daily ingestion of one or two extra-strength Dexatrim diet pills around Thanksgiving, 1987. On Sunday, January 3, 1988, Bryan complained that he felt ill: his ears were ringing, and he experienced hot and cold flashes and other flue-like symptoms. He cancelled plans for that evening in order to rest. Early the next morning while Bryan was still asleep, Bryan’s sister Jodi noticed an unopened foil package containing one capsule of Dexatrim on Bryan’s dresser in his bedroom along with a glass of water and other vitamin pills. Although no one ever observed Bryan ingest the capsule, Jodi testified that the package had been opened and the capsule and other vitamins were no longer on the dresser later that morning. Bryan left home around noon on Monday and went to the Medstop walk-in medical clinic. Medical records indicate that he complained of hot and cold flashes, ringing in his ears and fatigue. His blood pressure was within normal range (128/82) and the treating physician, Dr. Baubie, diagnosed Bryan with post-viral syndrome and fatigue. Dr. Baubie did not know that Bryan was taking Dexatrim.

After leaving the clinic, Bryan went to the bank, where he stood in line for approximately 20 minutes before reaching teller Jaqueline Kulchycki’s window. Kulchycki’s testimony is important. She testified that it was obvious to her that Bryan was not feeling well: he was squinting, holding his head as if he had a severe headache, and was flushed and sweating. As she turned away from her station, Bryan collapsed to the floor and hit his head. Emergency medical personnel were called and they transported Bryan to Detroit Macomb Hospital for treatment. He was diagnosed with an intracerebral bleed on the left frontal lobe of his brain, a skull fracture and a subdural hematoma. Emergency room doctors never attempted to diagnose the cause of his fall, but rather assumed that all of his injuries resulted from the fall.

The plaintiffs filed this lawsuit asserting that the fall was caused by the intracranial bleed found on the left frontal lobe of Bryan’s brain, and that this bleed had been caused by ingestion of Dexatrim. After extensive discovery, the defendant filed motions for summary judgment, arguing that the scientific literature did not support a conclusion that one capsule of Dexatrim could cause an acute hypertensive reaction, that there was no evidence that an intracranial bleed preceded the fall, and that there was no evidence that Dexatrim caused such a reaction in Bryan. The district court assumed in its opinion that the scientific evidence was sufficient to support the conclusion that one capsule of Dexatrim can cause an acute hypertensive reaction serious enough to induce intracranial bleeding. The district court held, however, that the opinion of Dr. Zaloga, plaintiff’s medical expert, was merely consistent with the known facts and conditions of the case, but was not based on a logical sequence of cause and effect. On that basis, the court granted summary judgment in favor of the defendants. . . .

The propriety of summary judgment in this case hinges on three causation questions:

1. Whether one capsule of Dexatrim is capable of causing hypertension severe enough to cause an intracranial bleed.

2. Whether Bryan suffered the intracranial bleed on the left frontal lobe of his brain prior to his fall.

3. Whether the bleed was caused by ingestion of Dexatrim. . . .

A

The defendant first challenges the scientific basis for Dr. Zaloga’s conclusion that Dexatrim can cause severe hypertension. It argues that the medical studies proffered by the plaintiffs as support for Zaloga’s conclusions actually support the defendant’s position that Dexatrim cannot cause significant elevations in blood pressure and further that because there is no basis for the expert’s opinion, the court should not allow a jury to decide the causation issue.

The testimony of plaintiff’s expert is admissible. The Supreme Court, in Daubert v. Merrell Dow Pharmaceuticals, Inc., set forth the standard for admission of expert scientific testimony, holding that Rule 702 of the Federal Rules of Evidence governs the admissibility of such expert testimony. Rule 702 admits expert testimony if the evidence will assist the trier of fact and if the witness is qualified as an expert. . . . Daubert explained that Rule 702 must be read in the context of the liberal thrust of the Federal Rules of Evidence and must be interpreted consistently with the "general approach of relaxing the traditional barriers to ‘opinion’ testimony." The Court also cautioned in its opinion that even under these liberal requirements, trial judges must ensure that scientific testimony is not only relevant, but reliable. A court must determine:

whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. This entails 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.

In assessing scientific validity, the Court provided a non-exclusive list of factors to assist the trial courts: (1) whether a theory or technique can be (and has been) tested, (2) whether the theory or technique has been subjected to peer review and publication, (3) the known or potential rate of error in using a particular scientific technique and the existence and maintenance of standards controlling the technique’s operation, and (4) whether the theory or technique has been generally accepted in the particular scientific field. The inquiry must be a flexible one whose "overarching subject is the scientific validity—and thus the evidentiary relevance and reliability—of the principles that underlie a proposed submission."

If a court concludes that the evidence supporting the expert’s position is insufficient to allow a reasonable juror to conclude that the position more likely than not is true, then the court remains free to prohibit the case from proceeding to the jury. "[A]lthough judges should respect scientific opinion and recognize their own limited scientific knowledge, nevertheless courts have a duty to inspect the reasoning of qualified scientific experts to determine whether a case should go to a jury." Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349 (6th Cir. 1992) (calling for a "hard look" by courts at the basis of scientific opinion).

A thorough review of all of the literature submitted by both parties and of Dr. Zaloga’s testimony convinces us that sufficient, valid, peer-reviewed scientific evidence, along with Dr. Zaloga’s own clinical and research experience, provide a solid foundation upon which Dr. Zaloga bases his conclusion that the 75 milligrams of phenylpropanolamine (PPA), the active ingredient in one capsule of Dexatrim, caused acute hypertension. Dr. Zaloga testified during his deposition that his opinion was based on the five studies he published on the topic, the published articles of other medical researchers, case reports, his experience treating patients who had ingested PPA-containing compounds, his clinical experience with PPA in other studies, and his experience directing endocrine and obesity clinics.

The medical literature upon which Dr. Zaloga relies includes five studies which he coauthored and two other published research papers on the subject of PPA’s effect on blood pressure. . . .

Zaloga also relies on at least two other studies to support his conclusion. . . .

Finally, Zaloga relies to a lesser extent on the Horowitz paper. It summarizes a study done on the effects of single doses of PPA-containing compounds. . . .

These studies, together with Dr. Zaloga’s extensive experience and work in this area, provide sufficient, reliable scientific data upon which Dr. Zaloga may base his conclusion. All of these papers have clearly explained, solid scientific methodologies upon which they have tested their theories, and all have been peer-reviewed and published in reputable medical journals, including The American Journal of Medicine, the Lancet, The Journal of Clinical Pharmacology, and Neuropsychopharmacology. The error rates are published and their impact on the studies explained. These factors, as outlined in Daubert and Bonds, indicate the reliability of the foundation upon which Dr. Zaloga rests his opinion.

Finally, Dr. Zaloga and the plaintiffs concede readily that there are other studies that disagree with Dr. Zaloga’s conclusion. Dr. Zaloga distinguishes many of them and points to flaws in their methods and data reporting techniques which led him to rely on the above-outlined works in reaching his conclusions. Such differences in opinions among medical experts do not invalidate Dr. Zaloga’s opinion, but rather create material issues of fact which must be resolved by the jury. . . . In sum, we believe that sufficient, reliable evidence exists upon which Dr. Zaloga may testify that one capsule of Dexatrim (75 mg PPA) is capable of causing acute hypertension. Such testimony creates material issues of fact and precludes summary judgment on the question. . . .

We therefore reverse the district court’s grant of summary judgment in favor of the defendant and remand the case for further proceedings.

[Dissenting opinion by Boggs, Circuit Judge, omitted.]