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Reese v. Stroh6/13/1994
AGID, J. -- William Foster Reese and Frances Reese (the Reeses) brought this medical malpractice action against Dr. James E. Stroh, Jr., alleging that he negligently failed to treat Mr. Reese's emphysema condition with a protein replacement therapy called Prolastin. The Reeses contend that the trial court erred in excluding their expert medical witness testimony on the basis that it lacked sufficient foundation to go to the jury. We reverse.
I. FACTS
William Reese (Reese) was born in 1938. In 1984, Reese began seeing Dr. Stephen Aprill for treatment of asthma. One year later, Dr. Aprill referred Reese to Dr. Stroh because he was concerned that "something else" was going on with Reese's condition. Dr. Stroh diagnosed Reese with asthma, chronic obstructive pulmonary disease and alpha-1 antitrypsin (AAT) deficiency. AAT is a blood-borne protein which prevents the enzyme, neutrophil elastase, from destroying the alveoli in the lungs. National Institutes of Health, Intravenous Replacement Therapy for Patients With Severe Alpha-1 Antitrypsin Deficiency, 248 JAMA 1693 (1982). A person with severe AAT has very little antitrypsin in his or her blood, i.e., 25 to 40 milligrams per hundred. When Dr. Stroh tested Reese's serum level in May 1985, it was 35.5. Experts believe that, in patients with AAT deficiency, the unchecked action of neutrophil elastase or "proteases" on lung tissue causes development of emphysema. Mark D. Wewers et al., Replacement Therapy for Alpha-l Antitrypsin Deficiency Associated with Emphysema, 316 New Eng. J. Med. 1055, 1060 (1987).
When Dr. Stroh diagnosed Reese with AAT deficiency in 1985, AAT therapy, marketed under the name Prolastin, was not available. Dr. Stroh prescribed bronchodilator medications, steroids, and antibiotics, and urged Reese to stop smoking and avoid allergens and environmental irritants. Dr. Stroh told Reese that he should "not worry" about his emphysema and that it was "not serious". Dr. Stroh estimated that Reese would lose approximately one percent of his lung capacity per year more than the average person.
In November 1989, Reese learned that his brother had been diagnosed with AAT deficiency and was going to begin Prolastin therapy. According to the plaintiffs' expert witness, Dr. Robert Fallat, Prolastin was first released on the market in 1987. It is a preparation of the natural protein AAT drawn from pooled human serum. An injection of Prolastin into the blood of patients with AAT deficiency raises their blood protein levels from 25-35 milligrams to 150 milligrams and maintains the serum level above the critical 80 milligram level for about 1 week. This is the level thought to prevent patients from developing lung disease as a result of AAT deficiency. After learning about Prolastin from his brother, Reese went to see his brother's doctor, Dr. Michael D. Eulburg. Dr. Eulburg began Reese on Prolastin therapy in March 1990, as soon as arrangements could be made to pay for the drug.
In October 1990, the Reeses filed this action against Dr. Stroh, alleging that his failure to prescribe Prolastin resulted in a worsening of Reese's lung function. At trial, the defense moved to exclude Dr. Fallat's testimony on the ground that it lacked adequate foundation. The plaintiffs presented Dr. Fallat's testimony as an offer of proof. Dr. Fallat is a pulmonary physician and chief of the pulmonary division at California pacific Medical Center in San Francisco. He is board qualified in internal and pulmonary medicine. He has been doing research on AAT deficiency since 1966. Dr. Fallat testified that in 1987, the Food and Drug Administration (FDA) met with a large working group of physicians from the National Institutes of He
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