Hollander v. Sandoz Pharmaceuticals Corp.

Decision Date10 May 2002
Docket NumberNo. 00-6135.,00-6135.
Citation289 F.3d 1193
PartiesDee HOLLANDER and Don Hollander, Plaintiffs-Appellants, v. SANDOZ PHARMACEUTICALS CORPORATION, a New Jersey corporation; Sandoz, Ltd., a foreign corporation; and HCA Health Services of Oklahoma, Inc., an Oklahoma corporation, d/b/a/ Presbyterian Hospital, Defendants-Appellees.
CourtU.S. Court of Appeals — Tenth Circuit

Steven R. Hickman (James E. Frasier with him on the briefs), of Frasier, Frasier & Hickman, LLP, Tulsa, OK, for the Plaintiffs-Appellants.

Grant J. Espisito of Mayer, Brown & Platt, New York, NY; Joe G. Hollingsworth (Katherine R. Latimer and Kirby T. Griffiths of Spriggs & Hollingsworth, Washington, DC, for Defendant-Appellee Sandoz Pharmaceuticals Corporation; Richard M. Eldridge and Thomas E. Steichen of Eldridge Cooper Steichen & Leach, P.L.L.C., Tulsa, OK, for Defendants-Appellees Sandoz Pharmaceuticals Corporation and Sandoz, Ltd., with them on the brief).

David A. Branscum (Glenn D. Huff with him on the brief) of Foliart, Huff, Ottaway & Bottom, Oklahoma City, OK, for the Defendant-Appellee HCA Health Services of Oklahoma, Inc.

Before EBEL and HENRY, Circuit Judges, and ROGERS, District Judge.*

HENRY, Circuit Judge.

Dee and Don Hollander filed this products liability action in the District Court for Oklahoma County alleging that Parlodel, a drug manufactured by Sandoz Pharmaceuticals Corporation ("Sandoz"), now known as Novartis Pharmaceuticals Corporation, and distributed by HCA Health Services of Oklahoma, Inc., doing business as Presbyterian Hospital ("Presbyterian Hospital"), caused Ms. Hollander to suffer an intracerebral hemorrhage shortly after she gave birth to the Hollanders' second child. After the Oklahoma County District Court dismissed the Hollanders' claim against Presbyterian Hospital, the remaining defendants removed the case to the federal district court.

The federal district court denied the Hollanders' motion to remand the case to state court. It rejected the Hollanders' arguments that it lacked jurisdiction over the remaining claims and that the defendants' removal petition was untimely. Subsequently, the federal district court dismissed the defendant Sandoz, Ltd. with prejudice, reasoning that the holding company had its principal place of business in Switzerland and that the court lacked personal jurisdiction over it.

Finally, applying Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), the federal district court ruled that the Hollanders' expert testimony regarding the causal connection between Parlodel and intracerebral hemorrhages lacked the necessary reliability and was therefore inadmissible. See Hollander v. Sandoz Pharms. Corp., 95 F.Supp.2d 1230, 1238-39 (W.D.Okla.2000). As a result, the court granted summary judgment to Sandoz.

The Hollanders now appeal those rulings, arguing that: (1) the federal district court lacked subject matter jurisdiction and therefore erred in denying their motion to remand the case to the Oklahoma state court; (2) the court erred in dismissing their claim against the defendant Presbyterian Hospital; (3) the court abused its discretion in ruling that the testimony of their experts was not sufficiently reliable to be admissible; (4) the court erred in granting summary judgment to Sandoz; and (5) the district court erred in dismissing their claim against Sandoz, Ltd., with prejudice.

For the reasons set forth below, we conclude that the federal district court had subject matter jurisdiction. We further hold that the court did not abuse its discretion in finding that the Hollanders' expert testimony was not sufficiently reliable and that the court did not err in granting summary judgment to Sandoz. However, we agree with the Hollanders that the federal district court should have dismissed their claim against Sandoz, Ltd., without prejudice. In light of these conclusions, we do not address the Hollanders' challenge to the dismissal of their claim against Presbyterian Hospital.

Accordingly, we affirm the district court's judgment against the Hollanders and in favor of Presbyterian Hospital and Sandoz. We remand the Hollanders' claim against Sandoz, Ltd., so that it may be dismissed without prejudice.

I. BACKGROUND

On July 23, 1990, Ms. Hollander gave birth by cesarean section to a healthy baby boy at Presbyterian Hospital in Oklahoma City. Because Ms. Hollander did not want to breast feed her son, her obstetrician prescribed a fifteen day course of Parlodel, to be taken in two 2.5 mg doses per day.

Parlodel is manufactured by Sandoz. The drug's active ingredient is bromocriptine mesylate, a compound derived from ergot (a naturally occurring substance made from a fungus that attacks cereal grains). The compound blocks the production of prolactin, a hormone that triggers the secretion of milk in postpartum women. The Federal Drug Administration (FDA) approved Parlodel for the suppression of post-partum lactation in 1980, and approximately 9 million women in the United States have taken it for that purpose. See Siharath v. Sandoz Pharms. Corp., 131 F.Supp.2d 1347, 1349 (N.D.Ga. 2001) (discussing the history of Parlodel). Parlodel is also prescribed for several other disorders, including acromegaly (a disease caused by hypersecretion of the pituitary growth hormone), Parkinson's disease, and various diseases involving the excessive production of prolactin.

Ms. Hollander received her first dose of Parlodel at 6:00 p.m. on July 23, 1990. About two hours later, her blood pressure increased sharply to 180/90. On the following day, she received her second and third doses of Parlodel, and her blood pressure returned to the normal range. She continued to take two 2.5 mg doses of the drug each day. Presbyterian Hospital discharged her on July 27, 1990.

On the evening of July 28, 1990, Ms. Hollander complained of a severe headache. By the following morning, she could neither speak nor move her right side. At Presbyterian Hospital, a CT scan revealed that Ms. Hollander had suffered an intracerebral hemorrhage in the left basal ganglia area of her brain. Ms. Hollander's treating physicians were puzzled as to the cause. One of them noted that her stroke resembled those caused by hypertension but added that Ms. Hollander had no history of the disorder. Clinical information revealed no pregnancy-related disorders involving hypertension, such as eclampsia or preeclampsia.1

On August 1, 1990, Ms. Hollander's condition deteriorated. As a result, her physicians performed an emergency left frontal craniotomy and removed an intracerebral hematoma. Ms. Hollander slowly improved. She remained in the hospital for over three weeks and then transferred to a rehabilitation center.

The Hollanders filed this action against Sandoz, Sandoz, Ltd., and Presbyterian Hospital in May 1995 in the District Court for Oklahoma County. They alleged that Ms. Hollander's stroke was caused by Parlodel, that the drug was unreasonably dangerous to the ordinary consumer when used as a lactation suppressant, and that Sandoz, Sandoz, Ltd., and Presbyterian Hospital had failed to warn of the dangers of the drug. They further alleged that Ms. Hollander had suffered permanent injuries.

Presbyterian Hospital filed a motion to dismiss the Hollanders' claims, arguing that a hospital could not be held strictly liable for providing a drug prescribed by a doctor. The Oklahoma County District Court granted Presbyterian Hospital's motion to dismiss in an oral ruling at an August 25, 1995 hearing. It issued a written ruling on May 10, 1996.

Sandoz filed a notice of removal on May 10, 1996. The Hollanders then filed a motion to remand the case to the Oklahoma state court, which the district court denied. See Aplt's App. vol. I, at 116-17 (District Court Order, filed June 12, 1996). Subsequently, the court dismissed the Hollanders' claims against Sandoz, Ltd. reasoning that it was a holding company incorporated in Switzerland with its principal place of business there, that it had no office, manufacturing, distribution, or sales facilities in the United States, and that it did not advertise here. As a result, the court concluded that it lacked personal jurisdiction over Sandoz, Ltd., and it dismissed with prejudice the claims against the company. See id. at 354 (District Court Order, filed Dec. 17, 1996).

The dispute between the Hollanders and Sandoz involves issues that have been raised in other litigation as well as in regulatory proceedings. See Kuhn v. Sandoz Pharms. Corp., 270 Kan. 443, 14 P.3d 1170, 1174 (2001) (describing a "decade — long disagreement between Sandoz and the [FDA] concerning the use of Parlodel for the prevention of physiologic lactation"). In 1984 (four years after first approving the drug as a lactation suppressant), the FDA reported that "the labeling of Parlodel (bromocriptine) is being revised to reflect reports of postpartum hypertension, seizures, and cerebrovascular accidents." Aplt's App. vol. IV-B, at 2401-02 (FDA Drug Bulletin, vol. 14, no. 1, at 3-4). The FDA explained that it had received seven reports of hypertension alone, seven reports of seizures, and three cases of cerebrovascular accidents (including one fatality). Because approximately 500,000 women had used Parlodel to suppress postpartum lactation, however, the significance of those reports was difficult to assess. The FDA expressly acknowledged that "[a] cause and effect relationship has not been established." Id.

Sandoz eventually modified the Parlodel package insert to include information about these cases. However, the company noted that hypertension, seizures, strokes, and myocardial infarctions regularly occur in postpartum women who are not treated with bromocriptine. Thus, it maintained, "the number of cases reported to Sandoz is less that one would expect even in the absence of any drug effect." Id. at 2448 (Letter from Sandoz's Executive Director of Sales, Aug. 20, 1987).

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