244 F.Supp.2d 434 (W.D.Pa. 2003), Civ.A.98-1712, Soldo v. Sandoz Pharmaceuticals Corp.

Docket Nº:CIV.A.98-1712.
Citation:244 F.Supp.2d 434
Party Name:Lisa A. SOLDO, Plaintiff, v. SANDOZ PHARMACEUTICALS CORPORATION, Defendant.
Case Date:January 13, 2003
Court:United States District Courts, 3th Circuit
 
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244 F.Supp.2d 434 (W.D.Pa. 2003)

Lisa A. SOLDO, Plaintiff,

v.

SANDOZ PHARMACEUTICALS CORPORATION, Defendant.

No. CIV.A.98-1712.

United States District Court, W.D. Pennsylvania.

Jan. 13, 2003

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Damon J. Faldowski, Kathleen Smith-Delach, Phillips, Faldowski & McCloskey,

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Washington, PA, Jeffrey A. Lutsky, Stradley, Ronon, Stevens & Young, Philadelphia, PA, Catherine T. Heacox, Ellen Relkin, Denise M. Dunleavy, Weitz & Luxenberg, New York, NY, Jerry M. Kristal, Weitz & Luxenberg, Cherry Hill, NJ, for Lisa A. Soldo, plaintiff.

Mark D. Shepard, Babst, Calland, Clements & Zomnir, Pittsburgh, PA, Joe H. Hollingsworth, Bruce J. Berger, Conrad J. Jacoby, Neil S. Bromberg, William J. Cople, III, Spriggs & Hollingsworth, Washington, DC, for Sandoz Pharmaceuticals Corporation, defendant.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

LEE, District Judge.

Introduction

This pharmaceutical products liability action was originally filed by the plaintiff, Lisa A. Soldo, in the United States District Court for the District of New Jersey which transferred the action to this Court because the plaintiff is a resident of Pennsylvania and also because Pennsylvania is the situs where she allegedly suffered an intracerebral hemorrhage as a result of her ingestion of Parlodel TM, a drug manufactured and marketed by the defendant and also where she received most of her medical treatment.

The Court has jurisdiction based on diversity of citizenship and the amount in controversy pursuant to 28 U.S.C. § 1332.1

The plaintiff is a citizen of the Commonwealth of Pennsylvania, residing at 101 West Lake Road, Transfer, Pennsylvania 16154.

The defendant, Sandoz Pharmaceuticals Corporation, now Novartis Pharmaceutical Corporation ("NPC"), is organized and existing under the laws of the State of Delaware, with its principal place of business located at 59 Route 10, East Hanover, New Jersey 07936.

Procedural Background

Before the Court for disposition is the defendant's Motion for Summary Judgment on Issues of Medical Causation (Document No. 77), to which plaintiff responded in Plaintiff's Memorandum of Law in Opposition to Defendant's Motion for Summary Judgment on Issues of Medical Causation (Document No. 84).

NPC moves the Court to enter judgment in its favor as a matter of law on the basis that plaintiff's evidence of general and specific causation fails to meet the test of scientific reliability set out in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) and followed by the Court of Appeals for the Third Circuit in In re Paoli Railroad Yard PCB Litig., 35 F.3d 717 (3d Cir. 1994) and Heller v. Shaw Indus., Inc., 167 F.3d 146 (3d Cir. 1999).

Pursuant to NPC's Motion for Evidentiary Hearing Regarding NPC's Motion for Summary Judgment on Issues of Medical Causation (Document No. 63), the Court conducted a Daubert hearing during which medical expert witnesses testified on behalf of the parties and exhibits were introduced into the record. At various other times, on motions of the parties, other extensive exhibits, including medical treatises, were also introduced into the record.

Following the Daubert hearing, with the assistance of the Duke University School

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of Law Registry of Independent Scientific and Technical Advisors, the Court appointed three medical experts who were directed to opine as to whether the methodology or technique employed by the plaintiff's medical experts in opining that Parlodel TM can cause stroke and did cause plaintiff's intracerebral hemorrhage is scientifically reliable.

Those three experts are:

(i) David A. Savitz, Ph.D.--Epidemiology

(ii) William J. Powers, M.D.--Neurology/Radiology

(iii) David A. Flockhart, M.D., Ph.D.--Pharmacology

Additionally, both before and after the Daubert hearing, the parties submitted proposed findings of fact and conclusions of law, and, after receipt of the reports of the court-appointed experts, the parties were invited to file and did file supplemental proposed findings of fact and conclusions of law.

Based on the record before it, the Court enters the following Findings of Fact and Conclusions of Law.2

Findings of Fact

A. Findings of Fact Regarding the History of Parlodel TM

1. Parlodel TM is a prescription drug formulated and sold by Novartis Pharmaceutical Corporation f/k/a Sandoz Pharmaceuticals Corporation ("NPC") since 1978. The active ingredient of Parlodel TM is bromocriptine mesylate ("bromocriptine").

2. In November 1976, NPC submitted a New Drug Application ("NDA") for Parlodel TM for treatment of amenorrhea/galactorrhea. [Summary for Basis of Approval: Amenorrhea/Galactorrhea] (Att.61).

3. Parlodel TM has been approved by the Food and Drug Administration ("FDA") since 1977 for treatment of amenorrhea/galactorrhea associated with hyperprolactinemia. [Summary for Basis of Approval: Amenorrhea/Galactorrhea] (Att.61).

4. In 1980, after reviewing extensive submissions from NPC's predecessor Sandoz Pharmaceuticals Corporation ("SPC"), the FDA approved Parlodel TM for the indication prevention of physiological lactation ("PPL"). Parlodel TM was found to be "both effective and safe" for the prevention of lactation. [Summary for Basis for Approval of Parlodel TM: Prevention of Physiological Lactation, at 9] (Att.62).

5. The FDA approved the use of Parlodel TM to treat individuals with Parkinson's Disease and also to treat infertility associated with hyperprolactinemia in 1981. [Summary for Basis for Approval of Parlodel TM: Parkinson's Disease] (Att.63); [Summary for Basis for Approval of Parlodel TM: Agromegaly] (Att.64).

6. The FDA approved Parlodel TM for the treatment of acromegaly in 1984. [Summary for Basis for Approval of Parlodel TM: Female Infertility] (Att.65).

7. The FDA approved Parlodel TM for the treatment of Prolactin-Secreting Adenomas. [Summary Basis of Approval of Parlodel TM: Prolactin-Secreting Adenomas] (Att.66).

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8. In 1990, an approved indication for Parlodel TM was the PPL.1990 PDR, (Att.68).

9. At all times relevant to this case, Parlodel TM was FDA-approved for the indication PPL. [Summary for Basis for Approval of Parlodel TM: Prevention of Physiological Lactation] (Att.63).

10. In its 1984 FDA Drug Bulletin, FDA noted that though the labeling of Parlodel TM was being revised to reflect reports of adverse reactions, "[a] cause and effect relationship has not been established." FDA Drug Bulletin, April, 1984 (Ex. 19). The 1984 Drug Bulletin expressly referenced dechallenge and rechallenge data.

11. The 1988 FDA Advisory Committee concluded that there was insufficient "evidence to indicate a causal relationship between the use of Parlodel TM and postpartum stroke/seizure." See 1988 Summary Minutes (Ex. 20).

12. The 1989 FDA Advisory Committee concluded that there was no "need" for pharmaceutical treatment of postpartum breast engorgement, but did not present or review any new data on safety, did not review any new data on efficacy, and did not vote on the safety and efficacy of Parlodel TM for the PPL. See 1989 Summary Minutes (Ex. 21).

13. Subsequent to the 1989 Advisory Committee meeting, Dr. Solomon Sobel prepared an internal memorandum to the Commissioner of the FDA concerning the Advisory Committee's recommendation that notes, inter alia, that "Ms. Ann Witt in the General Counsel's office reports that we have a case for a NOOH [Notice of Opportunity for a Hearing] based on updated perceptions of efficacy and safety, 'but it won't be easy' since we can raise doubts about safety but we cannot prove that risks exist. " See Memorandum from Solomon Sobel to The Commissioner, June 27, 1989 at 4 (Ex. 22) (emphasis added.)

14. SPC voluntarily withdrew the Parlodel TM indication for PPL on August 18, 1994. [Letter from Thomas Koestler to Solomon Sobel, 8/18/94] (Att.89).

15. FDA's August 1994 Notice of Opportunity for Hearing ("NOOH")--which was a proposal to withdraw the indication PPA--did not conclude that there was a causal connection between Parlodel TM and stroke in general, or ICH in particular. See 59 Fed.Reg. 43347 (August 23, 1994).

16. FDA's August 1994 NOOH states only that the information on adverse events raises safety questions, and seeks consideration of those issues. See 59 Fed.Reg. 43347, 43351 (August 23, 1994).

17. The FDA Notice of Opportunity for Hearing was based on FDA's receipt of reports of adverse experiences, and the Notice articulated the FDA's perception that no pharmaceutical intervention was needed, though it confirmed that FDA could not prove that Parlodel TM was not both "effective and safe," as it had determined in 1980. The Notice, in this regard, also confirmed the FDA's internal assessment in 1989 (when the FDA requested voluntary withdrawal of all lactation prevention drugs) that FDA could "raise doubts about safety but [FDA] cannot prove that risks exist." Memorandum from Solomon Sobel to The Commissioner, June 27, 1989, at 4 (Att.90).

18. SPC's voluntary withdrawal of the indication PPL from Parlodel TM mooted the administrative hearing process, and thus no hearing or formal proceeding was held.

19. Notwithstanding SPC's withdrawal of the indication PPL from Parlodel TM, on January 17, 1995, the FDA formally withdrew the indication PPL from Parlodel TM. 60 Fed.Reg. 3404-03 (January 17, 1995), (Att.94).

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20. At least 10,000,000 (ten million) women in the United States...

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