Merrell Dow Pharmaceuticals, Inc. v. Havner
| Decision Date | 13 November 1997 |
| Docket Number | No. 95-1036,95-1036 |
| Parties | Prod.Liab.Rep. (CCH) P 15,015, 40 Tex. Sup. Ct. J. 846 MERRELL DOW PHARMACEUTICALS, INC., Petitioner, v. Ernest HAVNER and Marilyn Havner on Behalf of their minor child Kelly HAVNER, Respondents. |
| Court | Texas Supreme Court |
John L. Hill, Austin, Russell W. Miller, Dallas, James E. Essig, Kamela Bridges, Houston, Robert L. Dickson, Hall R. Marston, George E. Berry, Santa Monica, CA, Gene M. Williams, Beaumont, Rob L. Wiley, Steven Goode, Austin, for Petitioner.
Guy H. Allison, Kevin W. Grillo, Corpus Christi, Barry J. Nace, Washington, DC, Roberrt C. Hilliard, Corpus Christi, Rebecca E. Hamilton, Rockwall, John T. Flood, Corpus Christi, for Respondents.
The issue in this case is whether there is any evidence that the drug Bendectin caused Kelly Havner to be born with a birth defect. We hold that the evidence offered is legally insufficient to establish causation. Accordingly, we reverse the judgment of the court of appeals. 907 S.W.2d 535.
Kelly Havner was born with a limb reduction birth defect. The fingers on her right hand were not formed. Kelly's mother had taken the prescription drug Bendectin in 1981 during her pregnancy to relieve nausea and other symptoms associated with morning sickness. Bendectin was formulated by Merrell Dow and its predecessors and marketed in the United States from 1957 to 1983. It was sold in other countries as well, but was called Debendox in the British Commonwealth, Ireland, and Australia and Lenotan in West Germany. The Bendectin Marilyn Havner ingested had two components: doxylamine succinate, which is an antihistamine, and pyridoxine hydrochloride, which is vitamin B-6. Prior to 1977, Bendectin had contained a third component, dicylomine hydrochloride, which is an anticholergenic. Approximately thirty million women took Bendectin in either the two- or three-ingredient form.
More than twenty years ago, questions were raised about Bendectin and its possible association with birth defects. The FDA investigated the concerns, but failed to conclude that Bendectin increased the risk of birth defects. More than thirty studies on Bendectin and birth defects have been conducted and published in peer-reviewed scientific and medical journals since questions were first raised. None of these studies concludes that children of women who took Bendectin during pregnancy had an increased risk of limb reduction birth defects. Some of these studies affirmatively conclude that there is no association between Bendectin and birth defects and that Bendectin is a safe drug. Although FDA approval of Bendectin has never been revoked, Merrell Dow withdrew the drug from the market in 1983, a little over a year after Kelly Havner was born.
The Havners' suit is based on theories of negligence, defective design, and defective marketing. It is one of thousands brought against Merrell Dow and its predecessors for the manufacture and distribution of Bendectin. In virtually all the Bendectin litigation, the central issue has been the scientific reliability of the expert testimony offered to establish causation. Merrell Dow challenged the Havners' causation evidence at several junctures in these proceedings. It filed a motion for summary judgment, contending that there is no scientifically reliable evidence that Bendectin causes limb reduction birth defects or that it caused Kelly Havner's birth defect. Before denying the motion, the trial court held a hearing at which the scientific Just before trial, the scientific reliability of the Havners' evidence was again raised by Merrell Dow in motions in limine that sought to exclude the testimony of certain of the Havners' experts and other causation evidence. One of these motions requested that testimony about causation be excluded until a prima facie case had been established that there was a statistically significant elevated risk that a child would be born with limb reduction birth defects if the child's mother ingested Bendectin. Another motion sought to preclude the Havners' witnesses from relying on in vitro and in vivo animal studies. Other motions sought to exclude entirely the testimony of three of the Havners' causation witnesses. The issues were fully briefed, and after a lengthy hearing, the trial court denied each of the motions.
reliability of the Havners' summary judgment evidence was extensively aired.
A bifurcated jury trial ensued. In the liability phase, the Havners called five experts on the causation question. Merrell Dow objected to the admission of some, but not all, of this evidence. Merrell Dow also unsuccessfully moved for a directed verdict on the issue of causation at the close of the Havners' evidence. As can be seen from the record, the question of scientific reliability was raised repeatedly.
At the conclusion of the liability phase, the jury found in favor of the Havners and awarded $3.75 million. In the punitive damages stage, the jury awarded $30 million, but that amount was reduced by the trial court to $15 million pursuant to former TEX. CIV. PRAC. & REM.CODE § 41.007. Merrell Dow appealed.
The panel of the court of appeals that originally heard the case reversed and rendered judgment that the Havners take nothing, holding that the evidence of causation was legally insufficient. 907 S.W.2d at 548. The panel concluded that "[t]he Havners have failed to bring forward anything more than suspicion on the essential element of causation." Id. On rehearing en banc, a divided court disagreed. It affirmed the trial court's award of actual damages, but reversed and rendered the award of punitive damages. Id. at 564. We granted Merrell Dow's application for writ of error.
Merrell Dow challenges the legal sufficiency of the Havners' causation evidence and the admissibility of some of that evidence and further contends that its due process rights under the United States Constitution and its due course rights under the Texas Constitution were denied. Because of our disposition of this case, we reach only the no evidence point of error.
All the expert witnesses on causation have appeared in other cases in which Bendectin was claimed to have caused limb reduction birth defects. The Sixth Circuit commented that the Bendectin suits are "variations on a theme, somewhat like an orchestra which travels to different music halls, substituting musicians from time to time but playing essentially the same repertoire." Turpin v. Merrell Dow Pharms., Inc., 959 F.2d 1349, 1351 (6th Cir.1992).
The federal courts have dealt extensively with Bendectin litigation. To date, no plaintiff has ultimately prevailed in federal court. The evidence in those cases has been similar to that offered by the Havners. The federal decisions have discussed the substance of the evidence in detail, and often the testimony under scrutiny included that of Drs. Palmer, Newman, Glasser, Gross, and Swan, the Havners' witnesses. These decisions are not binding on our Court, but they do provide extensive consideration of the scientific reliability of the causation evidence.
Some federal courts have concluded that the expert evidence of causation is legally insufficient. See Elkins v. Richardson-Merrell, Inc., 8 F.3d 1068 (6th Cir.1993); Turpin, 959 F.2d 1349; Brock v. Merrell Dow Pharms., Inc., 874 F.2d 307 (5th Cir.), modified on reh'g, 884 F.2d 166 (5th Cir.1989); Richardson v. Richardson-Merrell, Inc., 857 F.2d 823 (D.C.Cir.1988); LeBlanc v. Merrell Dow Pharms., Inc., 932 F.Supp. 782 (E.D.La.1996); Hull v. Merrell Dow Pharms., Inc., 700 F.Supp. 28 (S.D.Fla.1988); Monahan v. Merrell-National Labs., No. 83-3108-WD, 1987 WL 90269 (D.Mass. Dec.18, 1987).
Other federal courts have found the expert evidence to be inadmissible. See Raynor v. Merrell Pharms., Inc., 104 F.3d 1371 (D.C.Cir.1997); Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311 (9th Cir.) (on remand), cert. denied, --- U.S. ----, 116 S.Ct. 189, 133 L.Ed.2d 126 (1995); Ealy v. Richardson-Merrell, Inc., 897 F.2d 1159 (D.C.Cir.1990); Lynch v. Merrell-National Labs., 830 F.2d 1190 (1st Cir.1987); DeLuca v. Merrell Dow Pharms., Inc., 791 F.Supp. 1042 (D.N.J.1992), aff'd, 6 F.3d 778 (3d Cir.1993); Lee v. Richardson-Merrell, Inc., 772 F.Supp. 1027 (W.D.Tenn.1991), aff'd, 961 F.2d 1577 (6th Cir.1992); Cadarian v. Merrell Dow Pharms., Inc., 745 F.Supp. 409 (E.D.Mich.1989); Ambrosini v. Richardson-Merrell, Inc., No. 86-278, 1989 WL 298429 (D.D.C. June 30, 1989), aff'd, 946 F.2d 1563 (D.C.Cir.1991); Will v. Richardson-Merrell, Inc., 647 F.Supp. 544 (S.D.Ga.1986).
One federal circuit court initially found the expert testimony admissible and reversed a summary judgment for Merrell Dow. DeLuca v. Merrell Dow Pharms., Inc., 911 F.2d 941, 952-59 (3d Cir.1990). However, on remand the trial court once again found the evidence inadmissible and, after entering extensive findings of fact and conclusions of law, granted summary judgment for Merrell Dow. The Third Circuit affirmed that judgment with an unpublished opinion. DeLuca v. Merrell Dow Pharms., Inc., 791 F.Supp. 1042 (D.N.J.1992), aff'd, 6 F.3d 778 (3d Cir.1993).
A few federal district courts have denied summary judgment for Merrell Dow on the basis that the evidence raised a fact question. Longmore v. Merrell Dow Pharms., Inc., 737 F.Supp. 1117 (D.Idaho 1990); In re Bendectin Prods. Liab. Litig., 732 F.Supp. 744 (E.D.Mich.1990); Hagen v. Richardson-Merrell, Inc., 697 F.Supp. 334 (N.D.Ill.1988); see also Lanzilotti v. Merrell Dow Pharms., Inc., No. 82-0183, 1986 WL 7832 (E.D.Pa. July 10, 1986) ().
Decisions in which Merrell Dow obtained a jury verdict in its favor include Wilson v. Merrell Dow Pharmaceuticals, Inc., 893 F.2d 1149 (10th Cir.1990), and In re...
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