Tobin v. Astra Pharmaceutical Products, Inc.

• Citation: 993 F.2d 528
• Decision Date: 16 April 1993
• Docket Number: Nos. 91-6413,91-6478,s. 91-6413
• Parties: 36 Fed. R. Evid. Serv. 1338, Prod.Liab.Rep. (CCH) P 13,478 Kathy D. TOBIN, Plaintiff-Appellee (91-6413), Plaintiff-Appellant (91-6478), v. ASTRA PHARMACEUTICAL PRODUCTS, INC., Defendant-Appellant (91-6413), Duphar B.V., Defendant-Appellee (91-6478).
• Court: United States Courts of Appeals. United States Court of Appeals (6th Circuit)

Page 528

993 F.2d 528

36 Fed. R. Evid. Serv. 1338, Prod.Liab.Rep. (CCH) P 13,478

Kathy D. TOBIN, Plaintiff-Appellee (91-6413) Plaintiff-Appellant (91-6478), v. ASTRA PHARMACEUTICAL PRODUCTS, INC., Defendant-Appellant (91-6413) Duphar B.V., Defendant-Appellee (91-6478).

Nos. 91-6413, 91-6478.

United States Court of Appeals Sixth Circuit.

Argued Dec. 1, 1992.

Decided April 16, 1993.

Rehearing Denied in No. 91-6413 May 13, 1993.

Douglas H. Morris, II (argued and briefed), William F. McMurray, Oldfather & Morris, Louisville, KY, for plaintiff-appellee.

Winfrey P. Blackburn (briefed), W. Kennedy Simpson (argued and briefed), Stites & Harbison, Louisville, KY, for Astra Pharmaceutical Products, Inc., defendant-appellant.

Donald W. Darby, Jacobson, Maynard, Tuschman & Kalur, Louisville, KY, James E. Akers (argued and briefed), Sullivan & Cromwell, Washington, DC, for Duphar B.V., defendant-appellee.

Before: GUY and RYAN, Circuit Judges; and CHURCHILL, Senior District Judge. ^*

RALPH B. GUY, Jr., Circuit Judge.

Defendant Astra Pharmaceutical Products, Inc., appeals the denial of its motion for judgment not withstanding the verdict, or in the alternative for a new trial, in this diversity products liability action. On appeal, Astra argues that its motion for a j.n.o.v. should have been granted, because the causation hypothesis of plaintiff's expert does not have a generally accepted scientific basis and the risk/benefit theory and failure to warn theory proposed by the plaintiff cannot establish liability under Kentucky law. Astra also argues that its motion for a new trial should have been granted for two reasons: first, because two of the plaintiff's experts either expressed opinions not disclosed prior to trial or relied on more reports than were disclosed and, second, because the verdict was against the clear weight of the evidence. We reject defendant's arguments and affirm.

Plaintiff appeals the dismissal of defendant Duphar B.V., the manufacturer of the drug at issue based in the Netherlands, for lack of personal jurisdiction. We find dismissal was inappropriate because Duphar B.V. purposefully availed itself of the United States market.

I.

In 1986, Kathy Tobin was 19 years old and pregnant with twins. Her expected date of delivery was in early April 1987. Other than a mitral valve prolapse, or heart murmur, ¹ a rather common finding in reproductive-age women, Tobin was a healthy young woman. In mid-October 1986, Tobin was hospitalized for dehydration. She was having difficulty keeping down food and fluids and required hydration. Her condition was diagnosed as viral in origin. She was released after a few days and her pregnancy progressed. In January 1987, Tobin was admitted to the hospital for management of preterm labor. She was given an injection of magnesium sulphate and then was placed on an oral maintenance dose of ritodrine. ² Dosage levels varied, being increased when contractions returned.

Tobin testified that after each dose of ritodrine her pulse would race and her heart felt as if "it was going to jump out of my skin"; her face would also flush and her hands and legs would swell. She was advised that these symptoms were normal side effects of ritodrine. On March 9, 1987, Tobin's obstetricians reduced the dosage because of her rapid heart rate. On March 16, 1987, Tobin informed her doctors that she could not breathe when lying down, and she was told to further reduce the ritodrine dosage. At 1:30 a.m. on March 17, she was admitted to the hospital with symptoms of tachypnea (rapid breathing), dyspnea (shortness of breath), and a gallop rhythm of the heart. At this time, it also was noted that Tobin had a grade I/IV systolic murmur of the heart. X-rays revealed that she had pulmonary edema (fluid in the lungs) and cardiomegaly (enlargement of the heart) caused by congestive heart failure. An electrocardiogram revealed advanced dilated cardiomyopathy. ³ Ritodrine was discontinued, and that afternoon plaintiff delivered healthy twins having a gestational age of 37 weeks.

On March 20, Tobin was discharged from the hospital with instructions to follow up with a cardiologist. The next day she was readmitted for treatment of congestive heart failure, cardiomyopathy, and pulmonary edema. After five days in the hospital, she was again released. She was readmitted on April 10, and on April 15 a mechanical heart, or ventricular assist device, was inserted until a donated heart for a heart transplant could be found. On April 16, Tobin underwent a heart transplant.

Plaintiff filed suit against Duphar B.V., the corporation in the Netherlands that manufactures ritodrine, and against Astra Pharmaceutical, Duphar's United States distributor. After removal to federal court on diversity grounds, the district court granted Duphar's motion to dismiss for lack of personal jurisdiction. Plaintiff proceeded against Astra. After a two-week trial, the jury returned a verdict in favor of the plaintiff. The jury awarded Tobin approximately $4.5 million, finding Astra liable on the basis of defective design and failure to warn for the conditions that led to her heart transplant. The district court denied Astra's motion for j.n.o.v. or in the alternative for a new trial, and Astra timely appealed.

II.

Plaintiff cannot prevail under any theory if ritodrine did not substantially contribute to her heart disease. In other words, plaintiff must prove causation. Astra attacks the testimony of plaintiff's causation expert, Dr. Waller, as based on nothing but opinion and not founded on a generally accepted scientific basis. Plaintiff refutes this claim by pointing not only to Dr. Waller's credentials, ⁴ but also to various studies conducted; Astra's own package inserts; and the testimony of Astra's causation expert, Dr. O'Connell.

Ritodrine belongs to a class of compounds known as betamimetics. These compounds mimic adrenaline, a natural hormone. A betamimetic, or beta-receptor agonist, exerts its effect by stimulating beta-adrenergic receptors. There are at least two sub-groups of beta receptors, beta-1 and beta-2. The heart contains beta-1 receptors, which, when stimulated, result in an increased heart rate and a rise in systolic pressure concomitant with a decrease in diastolic pressure. The force with which the heart contracts also increases. Stimulation of beta-2 receptors inhibits contractility of smooth muscle, such as that contained in the uterus.

Ritodrine, which at low doses preferentially affects beta-2 receptors, is administered to pregnant women to arrest premature labor. The drug, however, may also exert pronounced beta-1 effects. Ritodrine may unmask occult heart conditions and is specifically contraindicated when a patient suffers from cardiac disease.

Both plaintiff's causation expert, Dr. Waller, and defendant's causation expert, Dr. O'Connell, testified that Tobin's viral infection in October 1986 resulted in myocarditis, an inflammation of the heart muscle. Dr. O'Connell testified that approximately 70 percent of us have been infected by a virus that causes myocarditis and that at least 50 percent of us actually have had the virus infect our heart, and therefore, by definition, have had myocarditis. But Dr. O'Connell testified that most people recover without ever having known it. Dr. Waller's main causation theory was that Tobin would have recovered from the myocarditis, just like the vast majority of people, if it had not been for the added strain of the ritodrine. Dr. O'Connell, on the other hand, testified that plaintiff's cardiomyopathy could be explained by the myocarditis and her twin pregnancy which placed additional strain on her heart. Dr. Waller also felt that there was evidence that ritodrine had a direct effect on plaintiff's heart.

Pursuant to Federal Rule of Evidence 702, this circuit has adopted a four-part test for the admission of expert testimony: "(1) a qualified expert (2) testifying on a proper subject (3) which is in conformity to a generally accepted explanatory theory (4) the probative value of which outweighs its prejudicial effect." Sterling v. Velsicol Chem. Corp., 855 F.2d 1188, 1208 (6th Cir.1988). It is the third criteria which Astra claims was not met. ⁵ Defendant argues vigorously before this court that Dr. Waller's testimony was "junk science," a term made popular by Peter Huber in his recent work Galileo's Revenge: Junk Science in the Courtroom (1991), and that Dr. Waller's causation theory does not withstand the "hard look" approach we have adopted in dealing with expert testimony on scientific matters. Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349, 1352 (6th Cir.), cert. denied, --- U.S. ----, 113 S.Ct. 84, 121 L.Ed.2d 47 (1992). Defendant argues that Dr. Waller did not subject the view he expressed at trial to peer review, that he presented no epidemiological evidence, and that the treating physicians did not attribute Tobin's condition to the ritodrine therapy. As for the last claim, Tobin's treating doctors stated that they were not concerned with diagnosing what had caused plaintiff's heart to fail, but only with keeping her alive. Defendant's other complaints ignore the evidence.

While Dr. Waller did not publish any article regarding the view that ritodrine aggravated Kathy Tobin's myocarditis, and thus was a substantial cause of her cardiomyopathy, he did rely on several sources already published. The first step in his theory is that myocarditis can cause cardiomyopathy, but that in the vast majority of cases it does not. This general view was also expressed by Dr. O'Connell, and, while Astra argues against this proposition in its reply brief, it does not seem to be in serious dispute. To illustrate her point, plaintiff cites an authoritative text which states that myocarditis, while generally benign, can lead to congestive cardiomyopathy. II The Heart 1183 (J. Willis Hurst ed., 6th ed. 1986). Other articles, which plaintiff cites to...