Wade-Greaux v. Whitehall Laboratories, Inc.

• Citation: 874 F. Supp. 1441
• Decision Date: 03 March 1994
• Docket Number: Civ. No. 30/1988.
• Parties: Jacqueline WADE-GREAUX, As Next of Kin and friend of TiaNicole V. Greaux, and Jacqueline Wade-Greaux, Individually, Plaintiff, v. WHITEHALL LABORATORIES, INC., Defendant.
• Court: U.S. District Court — Virgin Islands

874 F. Supp. 1441

Jacqueline WADE-GREAUX, As Next of Kin and friend of TiaNicole V. Greaux, and Jacqueline Wade-Greaux, Individually, Plaintiff, v. WHITEHALL LABORATORIES, INC., Defendant.

Civ. No. 30/1988.

District Court, Virgin Islands, D. St. Thomas and St. John.

March 3, 1994.

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Robert L. King, St. Thomas, V. Islands, for plaintiff.

Peter Coll, Christopher P. Johnson, Donovan Leisure Newton & Irvine, New York City, for defendant.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

GILES, District Judge, Sitting by Designation.

INTRODUCTION

Plaintiff Jacqueline Wade-Greaux commenced this product liability action on her own behalf and on behalf of her daughter, TiaNicole Greaux, on January 21, 1988. Plaintiff alleges that her use during pregnancy of Primatene? Tablets and Primatene? Mist, over-the-counter asthma medications sold by the defendant, Whitehall Laboratories, Inc. ("Whitehall"), caused TiaNicole to be born with true malformation of her upper limbs and other skeletal defects. She has asserted, on behalf of herself and her daughter, claims of strict liability, breach of warranty, negligence and misrepresentation. On October 21, 1991, this court granted Whitehall's motion for summary judgment against the claims asserted by the plaintiff's mother on her own behalf because they were barred by the applicable statute of limitations.¹

On August 6, 1992, Whitehall moved for summary judgment as to the remainder of plaintiff's claims on the grounds that plaintiff's experts' opinions were inadmissible at trial or insufficient as a matter of law on the issue of causation. Whitehall's motion was predicated upon the curricula vitae, written reports and deposition testimony obtained from plaintiff's five causation witnesses: Alan K. Done, M.D.; Enid F. Gilbert-Barness, M.D.; John A. Tilelli, M.D.; Stuart A. Newman, Ph.D.; and John D. Palmer, M.D., Ph.D. The motion was vigorously opposed by plaintiff. After consideration of competing paper submissions of experts' opinions, the court denied Whitehall's motion without prejudice² and scheduled a "Downing hearing"³ to determine finally the admissibility and/or sufficiency of plaintiff's expert opinion evidence on causation. It was agreed that the plaintiff minor's case was totally dependent upon expert opinion.

Following the criteria set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., ___ U.S. ___, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), DeLuca by DeLuca v. Merrell Dow Pharmaceuticals, Inc., 911 F.2d 941 (3d Cir. 1990), on remand to 791 F.Supp. 1042 (D.N.J.1992), aff'd, 6 F.3d 778 (3d Cir.1993), and Downing, this court conducted a hearing spanning seven separate days. Testimony was adduced from each of the plaintiff's expert witnesses listed above, with the exception of Dr. Palmer, whose deposition testimony was submitted by plaintiff because he was on a teaching sabbatical in New Zealand and could not attend.

Plaintiff's witnesses were required to address both general causation and specific causation. "General causation" concerns whether the agent at issue is capable of causing birth defects in humans at therapeutic dose levels, while "specific causation" concerns whether that agent caused the particular malformations found in this particular plaintiff. Plaintiff also offered testimony from Warren E. Cohen, M.D., a geneticist who offered no opinion as to either general or specific causation, but provided opinion testimony purporting to exclude genetic origins of TiaNicole's malformations, an opinion upon which plaintiff's causation witnesses relied. Plaintiff withdrew Alan K. Done, M.D. as an expert witness following defendants' cross-examination of the witness. However, the court refused to exclude the testimony already received from him.

Testimony was also received from four expert witnesses offered by Whitehall: Lewis B. Holmes, M.D.; Ellice S. Lieberman, M.D.; Mildred S. Christian, Ph.D.; and Paul A. Greenberger, M.D. The testimony addressed the subjects of teratology, epidemiology, mammalian experimentation, fetal development, genetics, and asthma and its treatment.

FINDINGS OF FACT

I. Incidence and Causes of Birth Defects

1. TiaNicole Greaux has malformed upper limbs. Each of plaintiff's expert witnesses has reviewed TiaNicole's medical records, including X-rays, and some have performed physical examinations of her. Plaintiff's experts have attempted to exclude certain possible causes of the malformations. Having done so to their own satisfaction, they have assigned causation to defendant's products because the drugs in question were allegedly ingested during a critical period of gestation.

2. Defendants, on the other hand, argue that not only have all other possible causes not been excluded but plaintiff's theory of general causation is speculative and inadmissible. Birth defects have existed throughout human history. Palmer Dep. (6/12/92) at 14. Limb deformities, in particular, are as old as recorded history. Cohen Test., Tr. 11/10/93 at 28-29.

3. Roughly 3% of all children born in the United States are born with malformations. Done Test., Tr. 11/16/93 (Mid-Morning) at 32. Data, collected by the Centers for Disease Control in Atlanta, Georgia, show that 1.5 of every 10,000 children born in the United States has a deformity of the upper limbs. Def.Ex. M; Cohen Test., Tr. 11/10/93 at 27-28.

4. Birth defects can be caused by a variety of factors, including genetic and chromosomal abnormalities and environmental agents. Gilbert-Barness Test., Tr. 11/9/93 (Morning) at 22; Done Test., Tr. 11/16/93 (Mid-Morning) at 32. Environmental agents may include bacterial or viral infections, chemicals, radiation and drugs, and may account for between 10% and 20% of human malformations. Gilbert-Barness Test., Tr. 11/9/93 (Morning) at 22, 27; see Palmer Dep. (6/12/92) at 15. The majority of birth defects, as many as 65%, are of unknown origin. Cohen Test., Tr. 11/10/93 at 25; Done Test., Tr. 11/16/93 (Mid-Morning) at 32; Palmer Dep. (6/12/92) at 14-15.

5. Family history is not dispositive in assessing whether a birth defect has a genetic etiology. There can, for example, be a spontaneous mutation of genes in a child. Cohen Test., Tr. 11/10/93 at 21, 32. Alternatively, a child may suffer from a recessive genetic disorder, in which case each parent passes on a defective gene although neither parent is affected. Holmes Test., Tr. 11/16/93 (Late Afternoon) at 10-12.⁴

II. Drugs at Issue

6. Primatene? Mist is an over-the-counter asthma medication that is distributed in a metered-dose inhaler that delivers 0.2 milligrams ("mg") of epinephrine with each administration. Greenberger Test., Tr. 11/19/93 (Vol. I) at 22-23.⁵ Of that amount, only about 10%, or 20 micrograms, of epinephrine gets to the bronchial tubes, with the other 90% being metabolized and deactivated by enzymes in the stomach. Greenberger Test., Tr. 11/19/93 (Vol. I) at 22-23. The 20 micrograms that go to the bronchial tubes are metabolized there. Greenberger Test., Tr. 11/19/93 (Vol. I) at 23. Only about 1 microgram, or .001 mg, of epinephrine gets to the bloodstream per administration of Primatene? Mist. Greenberger Test., Tr. 11/19/93 (Vol. I) at 23. In the bloodstream, that 1 microgram gets diluted in the entire blood volume. Greenberger Test., Tr. 11/19/93 (Vol. I) at 23.

7. Epinephrine, also known as adrenaline, is a substance produced endogenously by the adrenal glands. Gilbert-Barness Test., Tr. 11/9/93 (Afternoon) at 18; Tilelli Test., Tr. 11/15/93 (Vol. II) at 67. There is no difference pharmacologically between endogenous and exogenous epinephrine, such that the same blood level of each should produce the same effects. Tilelli Test., Tr. 11/15/93 (Vol. II) at 68; Done Test., Tr. 11/16/93 (Mid-Morning) at 31.

8. Primatene? "P Formula" Tablets are an over-the-counter medication sold for the treatment of asthma; each tablet contains 130 mg of theophylline, 24 mg of ephedrine and 8 mg of phenobarbital.⁶ Jacobs Aff. at ¦ 4.

9. Epinephrine and ephedrine are classified as sympathomimetic drugs. The sympathomimetic class of drugs includes, among others, pseudoephedrine, phenylpropanolamine, phenylephrine and isoproterenol. Theophylline is classified as a methylxanthine drug. The xanthine class includes caffeine and aminophylline.

III. Causation

A. Teratology

10. The science dealing with the causes of birth defects and their prevention is called teratology. Holmes Test., Tr. 11/16/93 (Vol. II) at 9-15; Tilelli, Tr. 11/15/93 (Vol. II) at 22-23; Newman Test., Tr. 11/12/93 at 48-49. An agent that causes birth defects is known as a teratogen. See, e.g., Holmes Test., Tr. 11/16/93 (Vol. II) at 15.

11. Whitehall called Lewis B. Holmes, M.D., to testify about the science of teratology and the methodology employed by teratologists. Dr. Holmes is a well-recognized teratologist/geneticist. See Tilelli Test., Tr. 11/15/93 (Vol. II) at 23 (recognizing Dr. Holmes as an eminent teratologist); Newman Test., Tr. 11/12/93 at 14-15. He is a member and past-president of the Teratology Society, the professional organization of teratologists. Holmes Test., Tr. 11/16/93 (Vol. II) at 11-12. Dr. Holmes is on the faculty of Harvard Medical School and has been affiliated for 30 years with Massachusetts General Hospital, where he is Chief of the Embryology/Teratology Unit. Holmes Test., Tr. 11/16/93 (Vol. II) at 7-9.

12. Persons who study teratology may come from different medical or scientific disciplines, including pediatrics, obstetrics, embryology, epidemiology and genetics. Holmes Test., Tr. 11/16/93 (Vol. II) at 31-32. Nevertheless, physicians and scientists who study the causes of birth defects, regardless of their specific training and experience, comprise a single medical/scientific community and are known as teratologists. Holmes Test., Tr. 11/16/93 (Vol. II) at 14. The...