Merrell Dow Pharmaceuticals, Inc. v. Havner Ex Rel. Havner

535 2(e) 37.071, § affirmatively non-statutory special ele of a on the basis of issue or a nullifica- McPherson, possible having bearing considerations no on tion v. instruction. State “the defendant’s moral (Tex.Cr.App.1992). blameworthiness.” S.W.2d 846 Whether Id., 2(f)(4). § not the was to instruc- defendant entitled depended upon tion was whether evidence suggested

We have elsewhere that: presented mitigation having no relevance “categorical opposition penal to the death Id., statutory to special the former issues. at ty can a trial court’s conclusion course, way 850. Of there no for the was impaired’ that a venireman ‘substantially parties a to tell voir dire whether Witt, 412, Wainwright under v. U.S. [469 mitigation instruction of some would kind (1985) 844, ], 105 S.Ct. 83 L.Ed.2d 841 at required Penry Lynaugh, have been under v. opposition least if that cause would supra. It is after all the evidence has invariably special venireman answer the presented been at punishment phase required issue to be submitted subsec the trial court can determine a Pen- whether [2](e) [of tion current 37.071] Article ry necessary. un- instruction Given that way prevent such imposition a as to of the certainty, juror the State is entitled to a who State, penalty. Staley death Cf. v. instruction, would a Penry not use should (venireman (Tex.Cr.App.1994) submitted, way one be as a to vindicate his categorical opposition who maintained his categorical opposition penalty. to the death penalty to death would cause him invari State, Staley supra. might v. The trial court ably to answer nullification instruction challengea- well have concluded Brewer was Penry Lynaugh, satisfaction v. ble for cause on this 302, basis. This is sufficient- 2934, U.S. 109 S.Ct. 106 L.Ed.2d 256 ly in principle upon similar to the basis which (1989),in such way prohibit imposi as to apparently grant the trial court did the chal- tion of death properly sentence was sub lenge ject cause). agree for that I willing cause am challenge to State’s for there was no error. State, Riley 301, v. 889 S.W.2d at n. 4 (Tex.Cr.App.1994) (Opinion on State’s motion For I agree appellant’s this reason rehearing). It within was the trial twenty-third court’s point of error should over- discretion, given the voir dire out in set ruled. I otherwise concur in the Court’s majority opinion 528-529, to conclude judgment.

Brewer was such a venireman. only problem is that current Article

37.071 applicable was not the law trial

of this offense. Otherwise we would not be

vacating appellant’s death sentence and re- PHARMACEUTICALS, MERRELL DOW

manding the cause for a punishment new INC., Appellant, hearing State, authority on of Powell v. (Tex.Cr.App.1994). S.W.2d 307 It is a bit of anomaly, though majori- not noted Marilyn Havner, Ernest HAVNER and ty, that venireman Brewer should have been Child, on Behalf their Minor excluded for cause on inability .the basis of an Kelly Havner, Appellees. phase follow manifestly law that No. 13-92-540-CV. apply does not at least not should have —or applied been Texas, this cause. Appeals Court —in Corpus Christi. Nevertheless, proved Brewer himself to be challengeable on a related basis March 1994. applicable statutory to this cause. The miti- Opinion Rehearing En gation clearly here, instruction did apply Aug. Banc 1995. since the offense was committed 1988. Rehearing Sept. Overruled But even before the advent of current Article 37.071, 2(e), capital § might defendant have Eighth

been entitled under the Amendment instruction,

to a mitigation either in the form

539

ports punitive damages, if award so, whether such award violates Merrell’s process rights due under United States Constitution; Constitution and the Texas Austin, Botts, Dallas, Earl B. Baker & fourth, reversibly court whether the trial Brennan, Powell, Marjorie E. Bruce Pharma- admitting erred in various evi- items into Association, Washing- ceutical Manufacturers Havners, by way points, dence. The of cross ton, DC, for amicus curiae. complain trial court’s reduction in the damage pre- award and the failure to award Hill, Jr., Snell, Liddell, L. John James judgment interest. We reverse render. LaBoon, Houston, Zivley, Hill Sapp, & Gene Williams, Weber, Beaumont, M. Mehaffy & FACTS AND PROCEDURAL HISTORY Marston, Dickson, George Robert L. Hall Dickson, Berry, Kelly Campillo, Carlson & Santa Havner was bom with a limb reduc- Monica, CA, Miller, Essig, consisting missing fingers Russell E. tion defect James Liddell, LaBoon, Sapp, Zivley, right Hill During & thumb on preg- Hous- her hand. ton, Liddell, nancy Bridges, Sapp, Zivley, Kelly, Marilyn Kamela Havner took LaBoon, Austin, medication, Hill appellant. prescription & anti-nausea Bendec- tin, composed doxylamine which is succi- Hilliard, Hilliard, C. Robert & Mu- Grillo (an antihistamine) pyridoxine hy- nate and noz, Nace, Christi, Paulsen, Corpus Barry J. (vitamin B-6). drochloride drug This was Nace, Sellinger, Washington, DC, Norwind & in the manufactured United States from 1956 Grillo, Hilliard, Munoz, Kevin W. Grillo & by to 1983 Merrell. Christi, Allison, Corpus Guy Rebecca E. behalf, Hamilton, On Kelly’s a Huerta, the Havners filed Christi, Allison Corpus & product liability against action as- Merrell appellees. serting by the birth defect was caused Harris, Thomas, James R. J. Norman Har- ingestion Mrs. during Havner’s of Bendectin Thomas, Christi, ris Corpus & for movant. pregnancy. liability The Havners advanced theories on negligence, based de- defective SEERDEN, C.J., Before and KENNEDY sign, marketing. and defective The trial was HINOJOSA, Jr., and FEDERICO G. JJ. liability compensatory bifurcated with damage being by jury issues resolved OPINION prior to presentation evidence on SEERDEN, Chief Justice. punitive damages. phases Both pro- ceeding presented were to the same twelve product a liability This is Appellees, case. jurors. jurors liability Ten ac- assessed Havner, Marilyn and Ernest sued Merrell two, damages phase phase tual In a one. (“Merrell”) Pharmaceuticals, Dow Inc. on be- jurors different ten of the same twelve found half daughter, Kelly. of their minor Kelly grossly negligent Merrell puni- and assessed fingers was bom with no or thumb on her damages. tive judgment Merrell moved for right Appellees alleged, hand. and the verdict, notwithstanding the to set aside the found, that these birth defects were caused jury findings, and for a new trial. Those taking Bendectin, Havner drug, Mrs. motions were denied. The trial re- court morning a sickness manufactured punitive damage duced the award four appellant. appeals judg- Merrell from the compensation times the award and entered exemplary damages ment of actual and en- judgment for the Havners. in favor tered of the Havners. Four issues presented first, are for review: whether POINT “NO EVIDENCE” legally factually there is or sufficient evi- Liability Standard verdict; dence of causation to second, whether accepting product involving the court erred in In cases either al jurors a leged verdict when the same ten did negligence design marketing issues; third, defects, concur on all plaintiff prove material whether a must the defec legally factually sup- product producing sufficient evidence tive a cause of

540 (1951). 660, 662, 244 How injuries Morgan Compugraphic v. Tex. 661 suffered. S.W.2d 729, (Tex.1984); Corp., ever, a prove 675 S.W.2d 732 “when evidence offered Frankson, Cyanamid 732 American Co. v. no fact is so weak as to do more than vital (Tex.App. Corpus 657 Christi S.W.2d suspicion a of its create mere surmise or — n.r.e.). Producing writ ref'd cause has existence, the no more evidence is than efficient, as an properly been defined excit and, effect, legal no scintilla evidence.” contributing which, ing, in a cause natural Browning-Ferris, Reyna, v. Inc. S.W.2d injuries complained sequence, produced the (Tex.1993). n. 3 Garza, of. Rourke S.W.2d Co., (Tex.1975); Cyanamid American Testimony Expert Required at 657. error, The of causation was submitted issue point first Merrell asserts its jury, appellant’s objection. over probative no that there is value producing generally cause. fact is to decide the on the essential element trier of allowed (1) presented by following contends that the case issue of causation cases: fatally there the Havners defective because general common sense experience and when Bendectin, drug, no evidence that fairly layman will determine enable general, causes human birth defects relationship causal between event in particular. limb reduction Fur- defects (2) injury; is a the condition or when there ther, offered, no evidence was asserts Mer- categorical natu principle, sharp scientific rell, ingestion Mrs. of Bendec- Havner’s law, ral which that a result is al theorizes producing pregnancy tin her was the directly particular to a ways traceable back right hand. cause of deformed (3) cause;1 and, proba when the reasonable by

bility relationship a is shown causal of Review Standard Physician’s expert Lenger testimony. v. (Tex. 703, Inc., Hosp., Gen. 455 S.W.2d 706 “no reviewing point In a evidence” Co., 1970); Cyanamid 732 American S.W.2d injury, only concerning producing cause of undisputed majority in a at It was 657. the evidence inferences which tend to defects, isolation of limb reduction birth jury support finding the of the will be consid the has the determined efforts cause eluded contrary to ered. All evidence or inferences brightest minds. the scientific even finding jury disregarded. the be Havner will ease, Therefore, lay jury ill- a is this Stores, Inc., 456, v. E-Z Mart 825 S.W.2d only equipped to causation armed determine (Tex.1992); Alviar, v. 395 458 Garza S.W.2d general experience common sense. (Tex.1965). 821, Transportation also 823 See too, type are the of this So birth defects (1994). Moriel, 10, 20 Ins. v. S.W.2d Co. 879 law, sharp categorical a natural subject of ease, therefore, only In the evidence and this a they usually back to nor are traceable jury’s finding support which the inferences particular is this the usual cause. Neither Kelly Havner’s birth Bendectin caused product liability the is drug case where If there is defect will be considered. produce par certain effects under known probative force to the circumstances, inquiry the is ticular point “no finding jury, of the the evidence” Estate, are merely those circumstances King’s In re 150 whether must be overruled. drug pro- ingestion of "Z" the the traditional use courts have made of circumstances "This is expert testimony." Employers Mutual impaired responses. Parker The duces drowsiness 43, Wis., (Tex. 440 46 Ins. Co. Liab. only underlying expert explain the scientific need 1969). expert telling "The is in effect not of facts jury explain principle under what rules, laws, all, physical natural at or but of uniform particular and im- drowsiness circumstances principles, jury apply general which the must ingestion responses by paired are caused Hand, (quoting 5 "Histor to the facts.” Id. at n. jury may if drug "Z.” decide then facts Regarding ical Considerations Ex and Practical presented particular render it more in a case 40, (1901)). pert Testimony”, Harv.L.R. 50 15 ingestion of "Z" likely than not that cases, underlying dispute such no exists as to impaired responses the drowsiness and caused may example, principle. an For be scientific by plaintiff. particular experienced undisputed "natural law” that under

541 (Tex.1988). 175, present. Nor this an instance the S.W.2d 176 While reason- is where injurious product per- from the evidence are nature of has become able inferences plaintiffs missible, apparent after use and the

inquiry is the manufacturer knew or whether “probable” possible cause becomes of the earlier should have known risk at an of other reasonable when absence firmly has estab- date. No causal link been explanations likely causal it becomes more birth lished between Bendectin and human injury was a result of its than not Applicable defects. here is the statement action. This is the outer limit of inference Appeals made States Court of United upon which an can be submitted to issue when it affirmed a Second Circuit jury. summary judgment for the manu- herbicide Employers Liab. Ins. Parker v. Mutual Co. Agent Orange litigation: facturer in the (Tex.1969) of Wis., (empha 440 S.W.2d 47 This is not a case which hazard ours) (expert testimony that radiation sis ex hindsight known to and the have existed plaintiffs posure “could have” cancer caused suffi- issue is whether the defendant had causation). to be “no evidence” held knowledge cient it at an earlier time necessary absolutely is “not that an While it trigger obligation an to inform. Existence expert opinion his couch terms of ‘rea unproven of hazard remains to this date. probability,’ sonable medical we still embrace (2d Agent Orange, In re 818 F.2d principle that a issue should not be denied, Cir.1987), cert. merely upon spec U.S. submitted when it is based case, conjecture.” Duff, S.Ct. 101 L.Ed.2d 932. This ulation and S.W.2d at therefore, (evaluation category falls into the third where of causation medical mal- all, action). if proved, causation must be at scienti practice Additionally, even when fic as to the reasonable expert expresses opinion using magic Contrary probability of that to words, causal link. probability,” “reasonable the entire assertions, appellees’ lay testimony legally expert’s testimony must substance insufficient to establish cause in case. this opinion if examined determine based 706; Lenger, See 455 S.W.2d American rely on demonstrable facts and does not sole Co., Cyanamid 732 S.W.2d at 657. ly assumptions, possibility, speculation Schaefer, and surmise. See 612 S.W.2d at Probability

Reasonable (expert exposure 204-05 proof, expert soil, To testi constitute the contaminated to a “reasonable medical mony proba must the establish “reasonable probability,” plaintiffs caused tuberculo the bility” causation). of a causal connection between Mrs. to “no of sis held be evidence” ingestion Havner’s of Bendectin and Myers, at (expert See 411 713 also S.W.2d Employ defect. birth See v. Texas held to that trau be “no evidence” Schaefer (Tex. Ass’n, 199, Ins. ers’ 612 S.W.2d 202 injury producing plain was cause of matic 1980). probability” cancer); been Ralph “Reasonable has from v. Mr. tiffs death “testimony (Tex. predictive Shoes, Inc., 812, as: defined of will what Paul’s 572 814 S.W.2d happen reasonably 1978, ... the future results Civ.App —Corpus writ ref'd Christi . n.r.e.). anticipated.” to be Am. Insurance Co. N. of (Tex.1966). Myers, v. 411 713 S.W.2d is, therefore, Our review confined must, jus probability equity [ T]his only the to a consideration of evidence tice, be more than coincidence there before support jury which tend to the inferences proof can be the deemed sufficient for causation, ignoring contrary; all finding of plaintiff go to the ... In the to supporting must have but the some probability, of in absence reasonable the Stores, Mart probative force. See E-Z ference of more causation amounts to no 458; Schaefer, at S.W.2d at 612 S.W.2d 204- conjecture than speculation. or expert testimony, pos in order to 05. With force, Schaefer, opinion at must probative 612 S.W.2d 202. “Proof of mere sess the specula possibilities suspicion to than will not the submission amount more Yelin, Schaefer, jury.” an issue to at 204-05. of the tion. See Duff par- required, during pregnancy, certainty not an considered for use While trimester, grounded, ticularly Ben- must be at the the first opinion scientific least, only clearly underlying very some demonstrable deetin should be used when on logical there- scientific data or inferences needed. & 705. from. Tex.R.Civ.Evid. testimony of The Havners offered the then proba- phrase When the “reasonable medical experts warning to issued five show that used, bility” is it amount to some evi- -will by Merrell “false” and that causation represents the overall dence when however, experts, The Havners’ existed.3 expert’s and is opinion substance any unable offer demonstrable scien- were purely con- speculative on than based more or even tific data available to Merrell personal opinion ungrounded clusions today, that a available which would indicate reality. Schaefer, 612 scientific See S.W.2d general relationship causal between exists 702, 703, 204-05; at also Tex.R.Civ.Evid. see Bendeetin adminis- human birth defects and probability cannot be & Reasonable therapeutic at the normal human dose.4 tered by magic created the mere utterance of opinions on data Two were based scientific by designated expert. Id.

words someone analysis concerning chemical test-tube which, composition analogies the absence Application to Facts might animal and human raise he physician suspicion Mrs. terato- Havner’s testified Bendeetin was human opinions prescribed gen.5 Havner based of the other three ex- Bendeetin Mrs. As animal provided by perts Merrell. consisted of criticism information information, epidemi- had and the of human proof of the Havners studies multitude that, ologic all indicate at nor- page admitted into evidence studies which (PDR) doses, statistically significant Physician’s no Desk mal there is Reference human following warning listed association between Bendeetin and which revealed the birth defects. for Bendeetin:2 drowsi- potential Precautions: Because human scientific data Without direct ness, prescribed Bendeetin should causation, theory substantiate their who drive auto- patients caution for must attempted experts merely refute Havners’ machinery. operate mobiles or methodology employed and conclu- animal human reached in the live Studies in rats and rabbits have revealed sions drug-induced relied on Merrell. suggestion epidemiologic no fetal abnor- studies up They to 90 inferred of causation malities doses of Bendeetin the existence proof contrary asserting In addi- does times maximum human dose. tion, Havners’ epidemiologic Indulging in wom- several exist. in their claim that all during preg- who outer limits inference

en received Bendeetin epide- all the human nancy incidence the animal studies and have shown miologic wrong, the we can offspring higher no studies are most birth defects their taking has no conclusive drug conclude that Merrell than women the Nevertheless, drugs never causes birth all that Bendeetin pregnancy. like evidence drug, by undisputed every prescription generally It was 2. The PDR is the text referred nature, drugs. physicians provides very capable producing on It by for information available delete- its action, description, drug’s indica- each effects death when administered rious and even greater use, contraindications, warnings, pre- tions quantities human than the determined cautions, reactions, dosage and adminis- adverse here, therapeutic was no dose. There assertion information, and for overdose. tration treatment party, the by Mrs. Havner exceeded either dosage. recommended opinion qualifi- rendering 3. Without an as admissibility the of their cations of the or teratogen agent or factor that causes 5. A is an utilizing testimony analysis evidentiary under an develop- production physical 402, defects in the 104, 401, the Evidence Texas 403, of Civil Rules embryo. ing initially we will admissibility qualifications proper assume testimony merely the admitted review by jury. finding of causation defects in warning humans and that protection is- zens would have no reasoned might speculations juries. sued in the 1981 PDR from the courts and inaccurate. However, fact, absence of a Parker, (citations omitted), 440 S.W.2d at 49 alone, standing does not amount to some record, that, Having scrutinized the we hold evidence of its converse.6 Absence of abso- despite magic use words the Hav- proof lute that Bendectin does not cause experts, ners’ there no evidence of that humans, birth defects in is not some evidence causal link. The substance of the Havners’ that it expert testimony does. is as follows: 1) Jay Dr. Glasser case, proof this operates burden of Merrell, in favor of the defendant below. Glasser, Jay experimental a Ph.D. in (fail- The Havners’ marketing defective claim statistics, confined his to a review warn) ure to does not alter this burden. epidemiologic of the human studies conduct required prove was not lack of ed with Bendectin other researchers. “A causation. manufacturer who knows or Epidemiology measures the statistical rela- potential should know of tionship, any, harm to a if exposure user between to an Bendectin, agent, because of product the nature of a such as is re- and the incidence condition, quired defects, give a such as birth adequate warning in a of such dangers.” scientifically Cyanamid, sample population. selected American 732 S.W.2d Depending on (citing methodology employed, to Bristol-Myers Co. v. Gon- zales, the incidence of the (Tex.1978)). exposed condition in Implicit S.W.2d 801 compared cases is non-exposed with either in this rule is presumption prod- exhibiting condition, cases the same or with uct causes some harm. adequacy Before the exposed cases who do not exhibit the condi- warning evaluated, can even be tion. The result is stated as a risk or odds produce Havners must some evidence that ratio, 1.0, reported which is with reference to Bendectin is harmful ingested by when hu- equal risk. This ratio is then converted to dosage mans at normal Merely levels. show- interval”, a “confidence a measure which ing warning inaccurate, as it compensates for variables and randomness. related to animal is not the same as explained Dr. Glasser concepts these of rela- showing that it inadequately warned of a risk, ratio, interval, tive odds confidence potential for human harm. inaccuracy, Mere significance statistical they as relate to hu- harm, without cannot warning render a tor- that, man epidemiology. He stressed in in- Therefore, tious. prevail any theory vestigating drug the connection between advanced, they even the failure to warn effects, and adverse important there is an claim, the Havners required were to offer at difference between “lack of evidence of an least Bendectin, some evidence that more association” and “evidence of no association.” (to likely than not probability), reasonable He divided the conclusions inferable from caused defect. epidemiologic zones, studies into three de- requirement This [scientific of pending on whether the confidence interval causation to a probability] reasonable does 1.0, equal includes risk. When the entire place some instances extraordinary bur- 1.0, confidence interval falls below the infer- proof dens of on claimants. But once the drug ence is protective has a effect. theory of causation leaves lay the realm of When the entire confidence interval falls knowledge theories, for esoteric scientific 1.0, above inference is that a has an theory scientific must be more than a adverse effect. When confidence interval possibility to the scientists 1.0, who created it. study includes is considered “incon- mind, For to the scientific things clusive,” all are “no anything,” evidence of possible. things possible, And with all citi- “zona obscura.”7 example, proof stop light For absence epidemiologic of that a among 7. While studies are red, green is not some types evidence that it was most relevant of information available to yellow, presumption legal or unless some drugs or establish a human causal link between and principle, reactions, proof, operates such as the burden of adverse we note that these studies will green-yellow in theory. favor of the produce never some evidence of “no effect” or judgment, beyond reach I look what is concerning Dr. Glasser testified then twenty-one epidemiologic on a strictly interpretation than human a statistical more have studies that been conducted with Ben- confidence interval rela- one-at-a-time stating methodologic finding try After faults the di- dectin. tive and to see risk reported mind, to "no or “no effect.” association” in in full harmful tion listed for the 1981 PDR concurrence that effects were Bendeetin only exhibited far in “completely at levels excess the was false.” dose, disagreed. human Dr. Gross On the drug agreed Dr. Gross that when a is study, basis of a of each “data-audit” he only, prescription available there is risk pointed discrepancies out what he considered involved, especially higher than rec- at doses summary between the raw data and the re- dosages that the ommended. He admitted reason, port, any expla- further without utilized in the studies that revealed animal nation, in scientific data his equivalent birth defects would to a human that, position, regardless he concluded taking 1200 to tablets at one 4800 Bendeetin dosage, teratogenic Bendeetin in animals: time. He revealed that: Now, Doctor, Q. just if I can read one of Drug A What the Food and Administra- two, statements, page go those on into requires, policy, tion as a matter is that more, says: it a little bit then. It “In the tests in animals should be carried out at present doxylamine case succinate looks they such until doses become—the teratogen like ... a in clear-cut Wistar clearly toxic. It the animal. kills So per kilogram milligrams per rats of 100 way, it becomes sick in and then to some day Fifty higher. milligrams per kilo- regular back off from that at intervals. gram teratogenic, are to as declare and of Q. Okay. no effect level for rats.” Yes, A. sir. you A. So a that —in which see noth- test Q. Well, all, you agree first of would with all, ing very at is not a on its face useful part being teratogen? about a clear-cut you implication test because the is that Yes, certainly agree gone high enough. A. that I with. haven’t And, Q. Doctor, your then, analysis, Despite requirement, this FDA Dr. Gross it, you you through as went did look ultra-high dosage uses those same animal vast they numbers of animals that used? teratogenicity studies to infer human without A. Yes. any qualification dosage as to level. Even Q. your opinion? And what is reanalysis, under his offered no he Well, My A. highly dosage view is this adverse effects at levels at or even that — significant rats, in teratogenic Wistar but near the human In recommended dose. ar- it’s the that I exception. riving last sentence take opinion, at his indicated that human he milligrams per kilogram “50 epidemiology are to declare studies with Bendeetin were of teratogenic substance, as opinion no effect level for rats.” no concern to him. his they’re words, saying, What grounded other is was demonstrable scien- milligrams per kilogram merely did not tific data. It was based criticism seem to have an multiple effect. That’s what I animal which all substan- agree don’t I say with.... would position. Indulging every it’s tiated Merrell’s teratogen, period. clear-cut higher possible “discrepancy” inference from his gives, theory, the dose that possibly one the more noticea- we are with still left n ble product these effects. precaution regarding inaccurate studies, underlying animal no but with data Based on the same “data-audit” of the same relating either animals at lower to defects studies, animal Dr. Gross then extended his dosages or to causation humans. opinion “My opinion well: humans as teratogenic, period, that Bendeetin is mean- 3) Dr. Stuart Newman ing to animals humans.” On the basis and/or disagreement Newman, chemistry, the conclusions of Dr. Stuart a Ph.D. with testified on the basis of four in vitro9 studies the authors of the various Gross opined product initially informa- done with Bendeetin. He instructed literally glass”, keep 9. The "in them alive. The cells term means but here it nutrient fluids to factors, process agents refers to the scientific in which cells are exposed are then various placed living removed animal from the in a response and the is noted. (a tube) petri controlled dish or environment test 3) being general aspects living of a does not me- the on the human that human (which render development, tabolize the chemical would pre-natal and then focused on inert); partially completely it or and period development. limb the of Dr. New- 4) experiments man of related the results done that the concentrations chemical the limb bud cells of equal others on isolated in at least to human fetal are tissue doxylamine chickens and mice. When succi- in the mother. that found cells, applied directly nate the was attempt to that an establish Bendectin development cartilage of was inhibited.10 placenta, the Dr. Newman testified crosses explain, When to Dr. Newman stated: asked type doxylamine that a of anti- succinate was that, if is What it means this substance histamine, in and that the 1950’s re- studies in present developing embryo in a a such vealed that some antihistamines caused abor- way get it can to the cells that of in resorptions pregnancy tions rats and or of embryo, developing impair- cause will However, mice. he that the anti- admitted I process ment an inhibition that or in histamines studied differed chemical struc- before, chondrogenesis11 described doxylamine ture from succinate. limbs. fetus, Dr. To concentration establish “doxylamine a opined Dr. that Newman showing in mice con- Newman cited studies teratogen He in humans.”12 stated that doxylamine higher in centrations of to by Kelly was consistent with defect exhibited Indulging than in mother. fetal tissue reported type cartilage impairment favor, every we still inference note by a and could have been caused any total that human absence teratogen ingested during period limb cells that a cells react the same as animal development. Dr. that Newman then stated live human would not metabolize the chemi- ingestion Mrs. Havner’s of Bendectin coincid- cal. period for limb ed with the critical all do Newman admitted that animals Dr. development. a her From review of medical chemicals, identically the same not react to any identify po- records he could other and animals humans do not neces- ingested by tentially teratogenic substance way. sarily in the same metabolize chemicals period.13 critical Mrs. Havner this makeup that the He testified chromosomal of Dr. Direct and cross-examination New- widely varies which animals humans following assumptions man that the revealed predispose wide variation reac- would are in order to infer human terato- required al- tions metabolism. He revealed that genicity from in vitro animal cell studies: utilizing in vitro though testing human cells 1) exactly human cells react the same available, performed none has been cells; as animal Neither have metabolism Bendectin.

2) despite millions placental performed human barrier is not studies been ingested have Bendectin dur- impervious doxylamine; of women who cross-examination, agreed major oversimplification by Dr. Newman this 13.On 10. This is a However, reported. Court the actual results studies have revealed link between recent scientifically explanation more detailed is neither pills prolonged subse- use of birth control helpful nor relevant. explained quent He limb reduction defects. deficiency as a of B vitamins causative factor develop- Chondrogenesis 11. is the formation system. pills birth Use of control mother's cartilage. ment of longer deplete period months for a than six can depletes Pregnancy these same B vitamins. itself the actual re- Dr. Newman admitted the result as vitamins. Dr. Newman described doxylamine concluded searchers ' 'double-whammy.'' inducing genetic damage “potentially capable of systems tested other which should be that Mrs. Hav- further revealed His endpoints.” genetic Additionally, detect pills eight years. taken birth control ner had ignore selectively sub- Newman has continued to that, However, opinion personal be- it was his prior sequent pointed out to him Ben- pills two had discontinued use cause she directly litigation, which refute his theo- dectin conceiving Kelly, prior her vitamin months support- ries. our is confined Because review probably normal. levels were evidence, ing ignore we also them. mg pregnancy. validity actually assuming Even evidence that a causal link exists of the animal in vitro studies upon human which Dr. between Bendeetin and birth defects. relies, Newman his own reveal admissions 5) Dr. John Palmer relating that there is no evidence to two of underlying absolutely assumptions the four principal expert, The Havners’ causation necessary studies, to his inference. The Palmer, degree Dr. John has both a medical therefore, possibility raise no than a more phar- in internal and a doctorate in medicine teratogen. that Bendeetin could a human macology. His scientific area of concentra- opinions rely solely Dr. Because Newman’s study drugs tion a the effectiveness possibilities, testimony on these mere allergies. only Dr. exami- combat Palmer’s probative necessary lacks the force to consid- Kelly’s day nation looked at hand the before er it “some evidence” of causation. identify type trial. He was unable to or defect, pattern Kelly’s could make no ob- Dr. Shanna Swan

tí x-rays, servations from her and admitted Swan, that, Dr. except serving Shanna a Ph.D. in and statistics as an witness Reproductive Epidemiology litigation, chief of the Pro- other Bendeetin he has never California, gram of diagnosed the State of testified as a studied nor the cause of a human rebuttal witness to counter data introduced birth defect. Dr. Palmer was unaware and by Merrell from epide- dosage, timing, the numerous human unconcerned with miologic ingested by studies which all fail to establish number of Bendeetin tablets statistically significant However, link between Bendec- Mrs. Havner. Dr. Palmer testified ingestion tin only and human birth purported expert pharmacol- defects. Her as a Glasser, was similar to ogy, toxicology, teratology, that of Dr. but also clinical probative and lacks in vitro activity analysis, value for the same rea- chemical structure studies, studies, sons. She has never conducted a teratology Bendeetin animal human fe- herself, epidemiologic study development, genetics. nor can she even tal and He advanced testify by to one conducted opinion someone else that the critical Bendeetin not that conclusions; supports defects, generally her but Dr. Swan causes human birth but opines probable teratogenic that there is a specifically that it caused limb reduc- exposure risk to a child born opinion after to Bendec- tion defect. Dr. Palmer based his during gestation tin on the same in vitro probably partially and that “more animal than not analogy [Bendeetin] is associated with limb studies and chemical studies utilized reduction defects.” In hy- by by of her the other called the Havners. pothesis, above, Dr. possible Swan all finding general recounted As outlined of even causation, epidemiologic faults of the human existing in reliance on these stud- ies, hypothesis. which refute her pure specula- She concludes than amounts to no more that all the Additionally, studies are flawed in some man- tion. Dr. Palmer relied on (DERs).14 prove Drug ner and therefore cannot serve to Experience Reports teratogenic Bendeetin is free from human that it Merrell reviewed 96 DERs re- effect. pool- concerning She recites that the methods of ceived birth defects in children of ing meta-analysis and exposed data utilized the millions of Bendeetin mothers. “megasilli- report Merrell to refute causation are DERs the concurrence of effect ness,” although having drug, she admits to used with the use of a and are filed doctors, techniques prod- lawyers same herself with other individuals. Dr. other reports ucts. She does not refute with demonstrable Palmer are volun- admitted data; “unsubstantiated,” merely injects tary they scientific she doubt as to lack controls, methodology the value and conclusiveness of Merrell’s evi- scientific However, Taking they suggest dence. Swan’s do not causation. inference, basis, perhaps despite outer limits of we are left fact this tenuous the admitted is, proof actually to wonder how irrefutable Merrell’s that no scientist who has researched presented relationship but hypothesized we are with not one scintilla of between Ben- hearsay. 14. The actual DERs were found inadmissible as unreliable empow- dectin and birth defects has At the ... are not concluded same time we relationship, a causal suspicion there is Dr. Palmer ered to convert mere surmise opined specific causation in this case. His into there some evidence. Where is real opinion wholly without evidence, foundation or jury verdict, uphold the we must is, underlying support, scientific in es- but in this where cases such as there is sence, personal lay opinion no more than and only suspicion, must real we overturn it. disguised as scientific dogma. surmise Inc., Browning-Ferris, 865 S.W.2d at 928 (reversing jury rendering judg- and a verdict Experts Battle of ment for on a tortious the defendant interfer- argue The Havners that this is a classic claim). ence real suspi- Here there is and, therefore, experts, battle of the our legal cion. insufficiency We sustain Merrell’s Cyanamid holding in American controls point. here. See 732 S.W.2d at 648. note that We Having ground, on this it un- sustained Cyanamid, American drug prod- another necessary points to reach Merrell’s other action, liability uct underlying, there was sci- error, cross-points. or the Havners’ Tex. based, entifically opinion testimony on both R.App.P. 90(a). Id. controversy. sides of the 668. Cyanamid, experts American par- for both We, therefore, judgment REVERSE the principally ties relied on the and research court, trial and RENDER the Hav- others, reports underlying but that re- nothing by ners take this suit. exposed opinions supportive search both Before court en banc. Id. The causation and lack of causation. primary differing researchers had reached OPINION conclusions. Id. at 656-57. Such is not the primary case All here. researchers who DORSEY, Justice. have have studied Bendectin reached but one from a products appeal liability This is an conclusion, support and it does not the theo- against drug company, suit Merrell Dow ry postulated experts. the Havners’ Dow Pharmaceuticals. Merrell manufac- aspersions Casting unsubstantiated on Bendectin, a drug tured and marketed to work of others cannot be a substi- considered pregnancy. relieve the nausea associated with tute for real scientific data. Our deference family The claims that Havner the American jury to determination daughter’s caused their birth defect. The Cyanamid case, experts, a true battle of the plaintiffs jury obtained a favorable verdict inapplicable here. judgment. appealed. and Merrell Dow On bring Havners have failed to forward The original panel of this submission court suspicion anything more than on the essen- causation, support found no evidence to and tial of causation. Dr. Palmer element While judgment.1 reversed rendered the We suspicions attempted piece together banc, en granted rehearing argu- heard oral more, amounting something into a mosaic court,2 ment entire and now AF- before the premise a basic remains that: part judgment FIRM the below and RE- suspicion suspicion some linked to other part in part. VERSE We REVERSE that produces only suspicion, more is not which punitive judgment that awards dam- sys- same as some evidence- Our ages, AFFIRM. but otherwise justice designed tem ensure right by jury our of trial does fundamental History I. Procedural mere game become some Marilyn empowered are not Ernest Havner sued Merrell chance.... We David evidence into Dow Pharmaceuticals and Dr. Bruce convert some no evidence. Pharmaceuticals, Havner, Kennedy 1. Noah Merrell Dow Inc. v. 2. The Court included Justices Hinojosa, Gilberto who left the court Decem- (Tex.App. Corpus March 13-92-540-CV Christi — 1, 1995, January Justices Mel- ber 1994. On 17, 1994). Rodriguez replaced chor and Nelda them Chavez participate decision. in this daughter, Kelly.3 Kelly jury’s finding of causation between Bendeetin on behalf of their hand; Although right Kelly Havner’s birth defect. was bom with a defect of her her fingers fully During put on extensive scientific evi- are not formed. her the Havners claims, pregnancy, Marilyn dence of their Havner took Bendeetin was not contends that the evidence offered prescribed Dr. Bruce. The Havners reliable, helpful jury. and thus not Kelly’s claim that the Bendeetin caused birth challenged if the evidence was admissi- Even defect. ble, “no Merrell contends that it is effect against The case Merrell Dow was tried it is too weak to do more evidence” because September for four weeks suspicion than of causation. Merrell create negligent, found that Merrell Dow was that the Havners’ did no more claims proximately negligence its caused “magic than mouth the words” of reasonable defect, defectively birth that Bendeetin was probability and that medical or scientific marketed, designed and and it awarded $3.75 support is no basis in the evidence to there damages. million actual The verdict was their stated conclusions. signed by jurors. ten things attempted to do two The Havners punitive damages portion The of the trial 1) experts: with their establish Bendee- bifurcated. The was found Merrell Dow 2) Kelly’s tin caused birth defect and defuse grossly negligent to be and awarded $30 not Merrell’s defense that Bendeetin did punitive damages. million in The verdict was cause birth defect because does jurors not unanimous and ten different generally. attempting cause birth defects In signed punitive damages charge. the prove theory, pro- their the Havners first 1, 1992, Judgment was entered June duced evidence that limb reduction defects awarding damages, million in actual $3.75 rare, approximately every 4 are defects for prejudgment interest in the amount of $15 10,000 live births. million, $20,205,821.80 punitive dam- According experts, for Havners’ ages. punitive damages The were reduced Bendeetin to cause a reduction defect it limb pursuant from the verdict amount to section during twenty day ingested period must be 41.007 of the Civil Practice and Remedies within the first trimester when the fetal skel- judgment Code. It is from this that Merrell developing. eton is This window of vulnera- appeals. Dow bility days concep- between 30 after brings categories Merrell four of com- According tion. to her and the plaints: legal sufficiency and factual records, prescribed medical Mrs. Havner was causation; evidence of scientific the pregnancy Bendeetin and took it for her jurors liability same ten did not find both induced nausea. Dr. Newman calculated damages actual gross negligence; that found dining that she took Bendeetin that window challenge punitive to the award of dam- vulnerability. prescribed dosage The was ages; evidentiary challenges. and several pill daily twenty days. one reanalyzed of the Havners’ Several Legal Sufficiency

II. of the Evidence by performed data from studies other scien- A. Standard of Review epidemi- tists and concluded that animal and reviewing point ological In a “no was evidence” studies demonstrated there error, relationship exposure we consider the evidence and reason between Bendeetin light able inferences therefrom in the most and limb reduction and other birth defects. jury’s finding favorable to the from that of the and we disre These conclusions differed cases, gard contrary the all evidence and inferences. authors of the studies. In some Stores, Inc., por- reanalysis performed Havner v. E-Z Mart to focus on a 825 S.W.2d (Tex.1992); Alviar, study 395 tion of the that dealt with Bendeetin Garza (Tex.1965). although other data did not. Merrell claims much the instances, reanalysis the focused on there no evidence to other against 3. The claims Dr. Bruce were dismissed before trial. discrepancies expert’s testimony must

claimed between author’s be relevant DuPont, data Tex.Sup.Ct.J. own raw and his conclusions. rehable. - -. re S.W.2d at trial court’s prophylactical- To rebut Merrell’s defense preliminary sponsibility is make the deter extensively ly, Havners’ experts criticized mination of whether meets prove the studies contends that Merrell standards set out the court in DuPont. Bendectin safe. Some criticism was lev- part The factors established the court as objectivity at the in- eled of some Merrell’s include, inquiry the reliability but are not house researchers or other researchers who limited to: funding received from Merrell or other (1) theory extent to which the has companies. sample Other criticisms involved tested; been can be size, inappropriate groups, use of control fail- (2) properly classify participants ure to as ex- technique the extent to which relies posed nonexposed, methodologi- other upon subjective interpretation epidemi- ...; cal concerns the animal and both ological studies. (3) theory subjected has whether been peer publication; review existing that criticism of contends and/or which link find no between Bendectin (4) error; technique’s potential rate of equal and birth defects does not causation (5) underlying theory or tech- whether agree. and we But Merrell also claims that nique generally accepted valid has been as reanalysis of resulting opinion data and the by community; and relevant scientific of a scientist on an of the based evaluation (6) non-judicial uses which have been is, existing reanalysis data and that as a theory technique. made or law, matter of to a find- insufficient may Id. factors Trial courts consider other ing any of case. causation With helpful determining to which are the reliabili conclusion we differ. ty of the evidence those factors scientific and potential will differ with each case. Id. The Admissibility B. Evidence Scientific DuPont that an testi court notes who testimony The trial court admitted primary fies based on his own research con plaintiffs’ experts at trial after ob- numerous litigation independent “‘provides ducted by jections filed Merrell. Merrell numerous important, objective proof research that the pretrial seeking plaintiffs to exclude motions ” comports of good the dictates science.’ with objected and to the admission 2, at 2 (quoting Id. 858 n. at - n. Daubert testimony Additionally, their at trial. Mer- Inc., Pharmaceuticals, v. Merrell Dow rell filed motion for a directed verdict on (9th Cir.1995)). 1311, F.3d judg- the issue of and a motion for causation Once the trial court determines ment nonobstante veredicto on same is- rehable, court evidence is relevant and January through judgment sue. From must decide whether to exclude the then had in June the trial court numerous probative evidence because its value is out opportunities to consider and reconsider the weighed by danger prejudice, unfair admissibility experts’ testimony. of plaintiffs’ issues, potential mis confusion of the its to jury, other lead issues addressed Admissibility 1. Standards (citing Tex. Rule Id. at at - 403. Expert testimony is if it is admissible 403). R.Civ.Evid. scientific, helpful jury, technical or specialized knowledge, and other if the ex Application skill, knowledge, pert qualified by expe rience, court Merrell’s training, or education. Tex.R.Civ. The trial considered 702; ex pretrial De motions to exclude the Havners’ E.I. du Pont Nemours Evid. Co., Robinson, Tex.Sup.Ct.J. perts separate hearings on the and held two Inc. 858, - S.W.2d -, - [1995 moving WL issue. are mindful 359024] We 1995). (June 15, rule, summary judgment seeking to exclude interpreting In experts pretrial, the burden supreme also determined that the Havners’ our court has experts was ei appellees’ Each of from the bur was on Merrell. This differs in a or held a doctorate in DuPont which is on ther a medical doctor den established admissibility specialized proponent to demonstrate the area and had other scientific DuPont, proffered 38 Tex. its evidence. Each met the crite training experience. - at -. training. Mer- specialized S.Ct.J. education or ria of appeEees’ experts aE had complains reE conjunction hearing first was in backgrounds testify about Ben- wrong summary judgment. motion for MerreE’s they primary re were not deetin because motion, MerreE contended that there field, individuaEy had not searchers in the proof of a causal connection between was no Bendeetin, and did conducted tests ingestion of Havner’s Bendeetin re patients treat with birth defects. This urged MerreE the court birth defect. encompassed in our strictive standard is not reject plaintiffs’ experts’ reanalysis of rules, interpreting law those nor the case studies,4 existing epidemiological and to re- appeEees’ experts worked rules. Each of ject of animal5 and in vitro studies.6 analysis, develop fetal the area of statistical hearing motion The court held a on MerreE’s ment, epide teratology, pharmacology, or it. denied taught subjects related to miology, and most case, MerreE filed motions Later Each inquiry at medical schools. here seeking limine to exclude the part testify under the second qualified Swan, Ph.D., Gross, Shanna estabEshed Rule 702. of the test other evidence of causation based on the experts’ Again, Havners’ conclusions. requires 702 also that ex Rule hearing during court held a which counsel pert testimony helpful to the trier of fact. be offered, Mer- discussed disputes that in cases such as this No one thereto, objections reE’s and the Havners’ specialized knowledge necessary to assist basis for its admission. There was no evi- juryA cannot determine the fact-finder. hearing, parties dence taken at that but the type of or medical causation in this scientific testimony discussed in detaE the to be ehcit- experts. the assistance of See case without During hearing, ed. that same counsel Inc., Lenger Physician’s Hosp., Gen. hearing MerreE referred back to the on its (Tex.1970) (medical 703, 708 testimo S.W.2d summary judgment motion for which covered in ny required to establish causation medical some of the same issues. readüy as malpractice case where cause not trial, AdditionaEy, during court held the general experience and certainable from mini-hearings, jury’s presence, outside the on sense); Em common Hernandez v. Texas qualifica- the issue the various witnesses’ (Tex. Ass’n, 250, ployers Ins. 783 S.W.2d opinions. tions and basis for their writ) (revers App. Corpus no Christi — jury finding of causation in absence of deciding testimony ap- to admit the es? peEees’ experts, ini- the trial court made an asthma). medical as causation experts tial determination that were the helpful, To scientific evidence must also be qualified purposes for the of Rule 702. Tex. DuPont, 38 be relevant and reliable. See requires R.Civ.Evid. 702. The rule both that - at -; Tex.Sup.Ct.J. at see S.W.2d expert testimony helpful jury be to the v. Merrell Dow Pharmaceuti qualified by knowledge, that an also Daubert be - cals, Inc., -, -, skiE, 113 S.Ct. experience, training or education. U.S. animals, laboratory 4.Epidemiological often studies in this context mea- 5. Animal studies use rabbits, mammals, rats, explore relationship, any, or other sure the statistical if between experimental animal to the reaction of exposure agent to an and the incidence of a being investigated. or other substance example, exposure to Bendeetin condition. For and the incidence of birth defects. Such studies popula- compare laboratory the incidence of birth defects in are conducted in a 6. In vitro studies exposed samples, generally tions to bendeetin with the incidence animal and involve tissue also tissue, populations were not ex- cells react to the substance birth defects who to see how investigated. posed being to it. (1993) 2786, 2797, 125 (interpret epidemiological that is L.Ed.2d 469 studies is Bendeetin Evidence). teratogen ing parallel Federal Rules of not a human and does not cause However, defects. even Mer- limb reduction as We review the trial court’s experts agreed biological causation rell’s reliability of the sessment relevance epi- inherently difficult on to assess based admit scientific evidence and its decision to they demiological They agree studies. an of dis or exclude evidence for abuse say that caused limb could not thalidomide DuPont, Tex.Sup.Ct.J. cretion. solely epidemio- reduction defects based on - at -. com- logical although the scientific munity accepts that does. a. Relevance expert’s techniques to which The extent an First, proffered we consider whether rely subjective part of interpretation on his testimony was The Havners’ ex- relevant. inquiry. at -. the DuPont Id. at perts process testified about of limb de- techniques Hav The statistical used velopment, during gestation the time when epidemiologi experts examining ners’ development interrupted, can what rely subjective not inter cal data does interrupt- development can cause limb to be expert. pretation Experts of the for both ed, why experts believed techniques. the same sides used statistical Kelly Havner’s case caused her Bendeetin of the effect and its Evaluation of Bendeetin directly All of birth defect. this not components laboratory studies does Havners’ related to determination subjective interpretation of depend on the action. cause of See Tex.R.Civ.Evid. although experts, dispute there is relevancy The evidence satisfies the test. community proper classifi scientific over the cation of some of the animal observations Reliability b. autopsy. fetuses at urges appellees’ experts could opin- helpful not be their because espoused Publication theories prin- not based ions were on sound scientific expert at trial is another factor to consider ciples, “junk instead but were science” determining expert opinion. admissibility of thus unreliable. pub- generally The Havners’ are subject and its lished on of Bendeetin inquiry in DuPont re established are role in limb reduction defects. Neither we now the trial quires that consider whether Newman, experts. a Havner Merrell’s reasonably court could found the evidence published general area of expert, has reliable under the DuPont standards. be experts development. Havner limb Other - DuPont, Tex.Sup.Ct.J. develop- published in the of fetal have areas at -. analysis epidemiologi- ment and statistical theory development occurs The limb Swan, expert, Another Havner Dr. cal data. concep- during period during a short time involving an abstract published of research accepted by ex- tion is well established and Bendeetin. theory sides. that limb perts for both The Greenberg has by exposure experts, development impaired can be Of Merrell’s during generally subject of birth teratogens7 period published is also well on the defects, teratology; genetic is a disorders and accepted. denies Bendeetin humans, published clini- in testified has articles on teratogen but Dr. Gross Dr. Friedman summary teratology, published and has appears on the United States cal that Bendeetin teratogens. published Bendeetin con- list of human of the studies on Government’s teratogen. teratogen cluding has it is not a human Bendeetin is a human Whether published subject inquiry for sev- of Merrell’s witness have scientific None been sum- general Bendeetin than the The consensus from studies on other eral decades. exposure. teratogen agent may that causes have an environmental 7. A chemical mother agent ingested may or the defects. The birth they they get the industries reports prepared in connection with raary Friedman analyze the data teratogens. They separately operates regulate. the database he regulatory func- part of their submitted as error of the Another factor is the rate of experts all testified tion. The Havners’ by experts. con- techniques used When they expertise. These had areas which sidering potential rate of error of the admissibility. weigh in favor of considerations studies, vari- epidemiological there is a wide experts among But all the ance the studies. distinguish the search for critical to It is material rely on the same universe of use purpose The science. truth law meaning although interpretations of the their dispute any legal inquiry is to resolve of the data differ. The studies themselves body is a parties. The law between the wheth- indicate their confidence intervals and issue, applied to settle the rules that are statistically significant. er their results are pro- they be rules of substantive whether likewise indi- The animal and in vitro studies may impede The rules well cedural law. applicability limit of cate the scientific their truth, such as the statute of evidence of the on the size of the studies and the based testimony of an oral prohibiting frauds significance statistical of the results. parties. But these agreement between the theory underlying The that Bendectin ac- shortcomings compromises have been investigated for causes birth defects has been cepted put in balance with other con- when many years by scientists all over the world. siderations.

Although have none of the studies concluded try justice through ap- We to achieve does, problem that it of limb reduction justice, plication quest law. In the for occurring by and not defects themselves as truth, engaged in saywe we are a search for part of another cluster of birth abnormalities accept jury’s as true and we verdict very change To detect a in the rate rare. very circumstances. This except limited requires very of such defects studies on a by crucial facts determination citizens of the large very specific information as scale jurispru- of our of the case is the bedrock pregnancy to when Bendectin ex- dence, wrong conclusion is in the however its posure occurred. None of the even eye objective reality. accept of God or We them, using techniques group statistical legitimacy of the verdict if the rules of requisite specific has the size or detail as to procedure have been followed evidence and exposure. way history ac- is the our has because this by parties The various studies used both way determining truth cepted as the best for litigation generally prepared this were courtroom, especially when contrasted litigation. reanalysis for of the raw data oath, with the earlier methods of ordeal pre- performed the Havners’ jury may not be combat. What the finds pared litigation analysis as was the true, really accept it as true in but we will existing performed Merrell’s ex- dispute. order to resolve perts. component of an That one finds that a determining consideration in reli Another negligently designed or man- automobile was ability expert has been whether the relies on ufactured is not universal declaration things typically by experts those relied on of components negligent- all of those same were type, whether he used methodolo the same plain- ly designed manufactured. Other by type, gies experts used other of the same complaint put to the same will be tiffs with testimony and whether the is within his area juries may proof different which their before - Daubert, expertise. at of See U.S. contrary jurisprudence reach results. Our ---, at The Hav- S.Ct. 2796-98. the accepts results and restricts inconsistent by experts developed relied on data ners’ particular to that case law of the case scientists, experts. other as did Merrell’s plaintiffs those and defendants. reanalysis of Havners’ The that several truths in for universal experts methodology did is a that the Food Science searches workings and com- Drug Environ order to understand and Administration and the verify Its Agency position of our world and ourselves. mental Protection use to testing, probing, continuous ex- 1. Adrian methods are Gross data; re-examining always com- amining, and currently for En- Adrian Gross works paring empirical findings given hypothe- to a Agency. vironmental Protection He worked Many hypothesis sis to if see correct. Drug Administration fif- for the Federal years accepted as theories were true years. that in his teen He testified work he ago changed scarcely as to have been so routinely by supplied the raw data examined recognizable, from our ideas about the cul- it, drug companies, analyzed pesticide and Mayas particle physics. ture of the This compared analysis and of his own the results search revision and constant will continue reports by generated to the and into the future as the scientific method is pesticide companies in order to determine applied by researchers. reliability validity of the conclusions separated into Science is not two worlds: primary drawn researchers. Gross junk. experts may true and Reasonable ar- Veterinary holds a Doctorate Medicine given differing rive at conclusions the same pathology. and a He Masters of Science this, always data. The law has dealt with post-graduate training has in statistics and Scopes the trials Galileo training microbiology and has had additional ordinary pain low-back collision case. The biometry. He has statistics and testified purpose dispute, resolve of the trial is to regarding safety Congress before not to truths. find universal drugs published has pesticides and pathology areas of and statistics. animal 3. Conclusion solely EPA animal relies studies to trial court’s We review the decision chemicals; FDA determine the effects of admit for an of dis abuse early studies in heavily relies on animal DuPont, Tex.Sup.Ct.J. cretion. at stages of Animal drug approval. responses - reviewing -. “A court pesticides) (drugs are consid- chemicals cannot that a trial court abused its conclude predictive response. ered of human if, circumstances, discretion in the same differently or would have ruled if the trial analysis that in his Gross testified judgment.” court a mere error in committed compo- animal studies on Bendectin its Id. Only a trial court without when acts doxylamine succinate,8 he used nent the same guiding principles, rules or references to do methodology throughout he has used his we conclude that it abused its discretion. Id. methodology generally career and that the Considering all the factors enumerated accepted. opinions testified that his He also DuPont, say cannot the court in we degree of were based on a reasonable scienti- trial its in decid court here abused discretion Additionally, certainty. fic he noted that ing to admit the the Havners’ governmental Bendectin on a 1987 list experts. developmental Developmental toxicants. teratogens. toxicants Gross’s use are

C. Scientific Evidence to reanalyzed was not attacked the testi- data Support Causation mony experts, nor was it demon- the other techniques unaccepta- his were strated that The Havners’ testified conclusions, His disapproved. ble or kinds of studies: stud based on three animal teratogen animal and human ies, Bendectin is an in vitro epidemiological defects, reduction were chal- causes limb investigated studies. All of the studies lenged by experts, but Mer- Merrell’s teratogen. whether Bendectin is a Teratolo- methodology. rell’s attacked gy study teratogens, are counsel is the which background, say we cannot agents summary With that cause birth defects. A from animal stud- Gross’s conclusions drawn follows. relevant ingredients: ingredients. manu- doxylamine three 8. two had Bendectin had antihistamine) (an pyridoxine hy- United succinate factured States Bendectin B-6) (vitamin at the was time it drochloride 1983. prescribed Havner. versions of for Mrs. Earlier testify qualified to about are without foundation Glasser ies on Bendectin interpretation techniques and the trial court did not statistical are no evidence. The admitting epidemiological in studies based on statistical its discretion his testimo- of abuse some ev- analysis. constitutes ny and his conclusions. His with limb that Bendectin is associated idence in defects humans. reduction Jay Howard Glasser in Jay holds a doctorate Howard Glasser Newman 3. Stewart University of experimental statistics from Carolina, a Master of in bios- North Science in holds a doctorate Stewart Newman tatistics, degree zoology. in and a Bachelor’s chemistry professor full at New and is a trial, profes- of he was an associate At time College where he teaches em- York Medical University of Texas sor at the School bryology students. He has also to medical in Public Health at the Texas Medical Center anatomy. cell biolo- taught His field includes taught epidemiology, Houston. He has sta- gy, developmental biology, embryology, and tistics, biometry, and biostatistics. He has has done research general biology. Newman published thirty peer-re- articles in over genetics, genetics, molecular in the areas of journals epidemiology, viewed the areas development. published has and limb He biostatisties, trial, biometry. At Glasser development and has written the area of limb epidemiological involv- reviewed the studies fifty developmen- papers over the areas ing exposure. explained Bendectin He chemistry. biology biologic He con- tal researchers, terminology statistical used experimental teratologist. siders himself an problems epidemio- the kinds inherent is in vitro primary His research interest inability logical epidemio- and the development. initial- of cell Newman logical studies to do more than track associa- development. ly about human fetal testified Epidemiological tions. studies cannot be twenty-five days conception, At after the fe- prove disprove biologic used to or to causa- beginning tus’s limbs are to form. Between tion. One of Glasser’s concerns about the concep- after the fourth and seventh week majority of the studies and their authors’ tion, develop very the limb and skeleton on a timing conclusions had to do bone, initial is not small scale. The skeleton ingestion Bendectin as described the stud- cartilage. process turning cells but ies. The relative risk of limb reduction de- chondrogenesis. cartilage into is called significantly greater exposure if oc- fects is fifth Chondrogenesis begins at about merely curs in the first trimester rather than disrupted, limb week and if will effect devel- during pregnancy expo- as a whole.9 If may opment. Chondrogenesis be inhibited trimester, sure occurred the first stopped altogether exposure to a tera- relative risk was 2.18 rather than .97 if the succeeding togen. happens, When exposure anytime during pregnan- occurred properly. develop structures do not cy. study Glasser’s examination of the data reanalysis pregnan- Havner’s included a of the relative risk Newman reviewed Mrs. cy Depending on whether exposure when could be broken out of the medical records. data, conception if was based on her last author’s raw even the author did date particular analysis period fashion. or whether was counted do that menstrual birth, concluded that to a reasonable de- backwards from the date of Glasser epidemiological certainty, estimated that Havner took Ben- gree of Bendectin Newman days concep- teratogen, congenital dectin 30 and after is a is connected with between disorders, developmental is an association tion. Based on fetal timeta- there bles, days present if between between Bendectin and limb reduction de- Bendectin was develop- expect hand exposure if the occurs within the first 42 and he would fects disrupted. pregnancy. ment to be trimester of greater protective between effect. If the relative risk 9. Relative risk measures the connection one, agent given than there is an association between studied and a result. A relative agent and the result. one no connection or a studied risk of less than indicates cology teratology to medical students. performed on and Newman reviewed studies pharma- doxylamine published chapters and other antihista- He book on succinate10 has jour- thirty papers major animal in type. cology mines of the same Some of the and over implicated type antihistamines of that studies nals. resorptions in abortions or of fetal mice. He in- laboratory research work His current also reviewed in vitro studies of mouse and in animal studies. volves antihistamines doxyla- embryos. Even low doses of chicken succinate, Doxylamine component a of Ben- impaired inhibited or ehon- mine succinate dectin, H-l antihistamine. Studies of is an embryos. drogenesis in the animal teratogenic H-l antihistamines show other doxylamine succi- Newman testified Doxylamine in succi- effects animal studies. placenta11 in vertebrate ani- nate crosses the placenta in animal studies nate crosses that it mal studies. From that he concludes likely so in and he thinks it does In vitro studies are in

will do so humans. important Animal are be- humans. studies teratogenicity in verte- done determine performed cannot be on cause similar studies in brate animals and the results are useful Animal studies can be used with humans. humans. He predicting what will occur with teratogenici- information to determine other had noted that four different laboratories ty. doxylamine succinate is a terato- found contrast, gen experimental systems. familiar with in vitro studies and Palmer is epidemiology is consid- Newman notes pharmacologists useful to be- considers them ered to be a “soft” science because the re- ability to isolate the effects of cause of the variables, all searcher does not control agent complications on tissue without compared to the “hard” science which the body system. He has in an entire inherent years control all the variables in labo- performed in vitro studies researchers ratory testing. pharmaceutical researcher. as a medical and involving He has reviewed in vitro concluded that Bendectin and Newman doxylamine succinate. Bendectin and doxylamine teratogens succinate are based degree certainty. on a reasonable of scientific epidemiologi- Palmer is also familiar with ingested that Mrs. Havner He also concluded Pharmacology epidemiolog- cal studies. uses Kelly’s Bendectin at the time when limbs techniques although personal- he has not ical developing that her defect is a loss were epidemiological study. Epi- ly conducted an portion of her skeleton which is based on although he demiological studies are useful teratogen during the late 30 exposure to a rely solely epidemiological stud- would not day early days gestational her teratology. Epidemiological ies to determine testify qualified to development. Newman is causation, although they prove studies do development of cell vitro the areas may show association. qualified to draw conclu- studies. He is also His is some sions in those areas. In order to determine whether vulnerability” on of the “window of all the data teratogenic, Palmer considers in vitro plaintiffs experi- based their claims. important including which the to be ments, epidemiological stud- animal 4. Palmer John reviewing ies, After and human studies. records, pregnancy exam- Havner’s medical Palmer is a medical doctor and holds John hand, reviewing all ining Kelly’s pharmacology. He is a full a doctorate data, animal, vitro epidemiological, University professor pharmacology at the concluded, de- based on a reasonable part of his Palmer medical school. As of Arizona certainty, that limb gree taught toxi- of medical teaching responsibilities, he has antihistamine, succinate, placenta inside the uterus is the structure Doxylamine 11. The through nourishment which the fetus receives ingredients as it two active in Bendectin one of circulatory waste into the mother’s and excretes prescribed it was was formulated at the time protective bar- system. considered It has been Mrs. Havner. agents the fetus from harm rier that shields system. mother’s did not become red after by mother’s was that her foot reduction defect was caused her assumptions pe- applied spray. she Both ingestion of Bendectin the critical by Cryes’ directly tes- Kelly’s development. were contradicted riod of limb introduced timony. No other evidence was qualifications are Dr. Palmer’s sufficient Burroughs court in on those two issues. The testify phar- him about the action of expert’s testimony, held that the developing product maceutical on a fetus. product] that [the constitutes no evidence performed involving He has studies both ani- injury. Crye caused to sustain frostbite techniques, mals and in vitro he works with expert’s opinion is based on as- When data, epidemiological patients, he treats vary materially facts that from sumed is familiar with medical records and their facts, actual, undisputed opinion interpretation. evi- His is some sup- cannot probative without value and Kelly dence that Bendectin caused Havner’s judgment. port a verdict or limb reduction defect. His ade- quately supports scientific causation. That not ease here. Id. at 499. produced evidence that Ben- The Havners

D. Conclusion it teratogen is a human and that dectin caused birth defect.12 We overrule cases, Appellant cites us to a multitude of sufficiency appellant’s challenge legal including Employers’ v. Texas Ins. Schaefer of the evidence of causation. Ass’n, (Tex.1980), 612 S.W.2d 199 for the may proposition qualified expert that even a Sufficiency the Evidence III. Factual merely by saying not create “some evidence” magic Burroughs words. See Wellcome reviewing In factual sufficien (Tex.1995). Crye, Co. S.W.2d 497 We evidence, cy weigh all we consider disagree proposition. do not with that evidence, may only we exercise our but sufficiency pre jurisdiction factual over expert opinion For an to constitute evi- may manifestly unjust result. We not vent a dence causation must rest reasonable reweigh the evidence and set aside probability. medical Id. Reasonable judges “merely because the feel that verdict probability is determined the substance Pool a different result is more reasonable.” opinion, and context of the not turn does (Tex. Co., 629, 634 v. Ford Motor 715 S.W.2d “magic on semantics or on the use of words.” Estate, 1986); King’s In 150 Tex. re Id. (1951). 660, 661 S.W.2d specific laboratory In there was a Schaefer sufficiency legal In our discussion of conclusively test that could have demonstrat- outlined the evidence the evidence we presence ed the of the bacteria which was jury’s finding supporting the of causation. particular claimed to cause form Schaefer’s competing evidence was also substantial. per- of tuberculosis. That test was not physician formed. Schaefer’s believed Evidence A. Havners’ was infected other evidence Schaefer particular and rare strain. The admitted All of the Havners’ witnesses supreme disagreed. court In this case there authors of the animal or that none of the possible. are no such conclusive tests Ben- epidemiological concluded that All of limb reduction defects. dectin caused Burroughs, Cryes’ expert hypothe- agreed they at trial were the witnesses product frostbite to sized that caused primary researchers into Bendectin opinion Crye’s Mrs. foot and relied for his developing fetuses. its effect on assumptions. assump- several One of those admitted that birth control Crye apply spray Dr. Newman tions was that did not defects and pills can cause limb reduction packaging and another as directed appears Sup.Ct.J. at 12. The evidence here to differ somewhat - at - (citing Daubert,1322). after from the evidence considered in Daubert 43 F.3d at DuPont, Tex. to the Ninth Circuit. remand pills up but that Mrs. Havner took birth control tients as a consultant areas epidemiology occupational health. prior pregnancy months to her until two Nevertheless, Kelly. Newman did not be- epidemiological Lamm first reviewed Kelly’s that defect was attributable to lieve primary in His literature on Bendeetin 1984. taking contraceptives. her mother’s oral data, epidemiological focus is on but he ad- agreed doxylamine that Newman succinate others, animal and in mitted that for vitro listing generally was on a of substances con- may important. studies teratogenic to be not in rats and sidered Lamm limb agreed that fetal formation Several of the rabbits. Havners’ days concep- occurs 26 to 56 after between agreed many are that there more substances timing exposure to tion and Ben- teratogenic in in that are animals than hu- looking at the important deetin is in studies. mans. Reviewing study by of a unpublished draft an Dr. Palmer admitted cross-examination Jick which calculations of Ben- reconsidered women, exposed that not board in deetin some of whom were he was certified internal exposed spermicides, medicine and that he has his boards also Jick found a faded statistically relationship agreed significant that one between twice. He cannot conclude expo- teratogen limb reduction defects and Bendeetin epide- that Bendeetin is a could sure. Lamm testified that he make miological data. He admitted he did not reported in calculations from the raw data Bendeetin know how mueh Mrs. Havner took specific questions the studies to answer not long. nor for how and had addressed the researchers done in The Havners testified no one their so with but not all. some They has a birth defect. also testi- families analysis pooling using Lamm conducted a genetic they gone screening for fied that had data from studies and concluded all of the Kelly after was born were told after birth that Bendeetin does not cause defects unlikely they lengthy interview that it was in humans nor does it cause limb reduction another child with It would have this defect. opinion defects. that his He stated was not clear from the whether certainty. based on medical reasonable any laboratory testing performed had been screening. analysis, part as of that Lamm conducting pooling his ration calcula-

used the odds Mantel-Haeszel not been tions which admits had used he B. Merrell Dow’s Evidence before context of birth defects. He five Merrell called witnesses: Ste- technique published in had never seen Lamm, M.D., phen Henry Lee God- James although connection defect studies with birth M.D., M.D., dard, Greenberg, Frank Jan cancer published it has been for studies. Friedman, M.D./Ph.D., Ray- 'Marshall cohort studies and the Lamm combined the Harbison, Ph.D. All mond testified pooling analysis. in his case-control studies did not cause birth defect. Bendeetin other scientists He did not know whether pooling. types combined of studies the two Stephen Lamm had not Lamm testified that he submitted analysis although he epidemiologist pri- publication claims Lamm is a medical presented Society Epidemio- holds have it to the practice. vate He also a master’s de- analysis of his gree logic The result biophysics and is board certified Research. of 1.09. He did consid- pediatric Lamm worked for the was odds ratio medicine. significant because at the for Dis- er that odds ratio to be Public Health Service Center range puts the part Epidemic the confidence interval below ease as Intelli- Control .08, relationship. no gence His work indicates Service. there involved which inconclusive of a analysis data. as Lamm’s results are epidemiologic use of He served relationship and limb re- epidemiologist to the Health Bendeetin senior Child between admits over the intermittently taught has duction defects. Lamm Institute. Lamm only drug that has past years, been epidemiology Lamm’s to medical students. teratogenic through conclusively to be practice treating pa- is not shown private current Accutane, 5.Raymond Harbison an acne epidemiological medication. pharmacolo- holds a doctorate Harbison teratology. in animal specializes

gy and He testing. He thinks teratology and animal Lee Goddard 2. James to deter- important animal studies are former for the is a Commissioner Goddard teratogenicity. not think the mine He does medicine; longer practices he FDA. He no reliability in vitro has been estab- studies He gave up his medical license in 1973. prove teratogenicity. human He lished to degree a Master’s in Public Health holds placenta, that Bendectin crosses the admits sole he obtained the 1950’s. His which not think Bendectin is but he does training in occurred epidemiology academic teratogen therapeutic doses. human during program. master’s has Goddard forty times the thirteen testified C. Conclusion trial, years prior usually pharmaceuti- to evaluating presented, evidence companies. epidemio- cal He reviewed the jury judge credibility of the is sole animal, data, ma- logical published and other weight their given and the to be to witnesses Bendectin that Ben- terials on and concludes 226a(III); testimony. Tex.R.Civ.P. Jaffe not cause in hu- dectin does birth defects Carr, 27, Corp. v. 867 S.W.2d Aircraft mans. (Tex.1993); Salazar, Lopez v. 878 S.W.2d no (Tex.App. Corpus Christi — Greenberg Frank 3. writ). weight and a determination of Such credibility applies to as Greenberg practicing physician is a and is Employers Texas Ins. Ass’n v. Cam well. Birth Director of the Defects Genetics Clinic pos, (Tex.App. — Houston Hospital. at Texas Children’s He also teach- writ). 1984, no Each of the [14th Dist.] Baylor College es at the of Medicine cross-examined; extensively witnesses was genetics, pediatrics, fields of molecular credentials, methodological dis flaws their gynecology. obstetrics and the Hav- He saw agreements, and in their errors of omission ners and reviewed the medical records. He explored by opposing were coun Kelly’s genetically concludes defect is Moreover, experts’ each of the work sel. caused rather than induced. Green- opposing an expert was criticized for the berg Kelly’s found hands to be father’s party. constitutional mandate13 autho Our average. than smaller Mrs. Havner’s hands reweigh the to presented rizes us to According Greenberg, are normal. a de- to jury in order to if is determine its verdict genetic makeup father’s fect her caused contrary greater weight of the so defect, exposure birth not tera- manifestly unjust. This evidence so as togen. the verdict we have done conclude that supported sufficient as to causation 4. Jan Marshall Friedman Appellant’s challenge factu evidence. to the sufficiency al evidence is overruled. ge- board Friedman is certified in medical entirety. Point one is overruled in its is a netics and teaches that area. He teratologist clinical children with and treats Agree Ten Did IV. Same Jurors Not Teratogen developed defects. He birth two, System. By appellant opinion point Information His error jurors agreed ten on complains Bendectin does not cause birth defects who extremely damages agrees liability agree He on humans. did damages bi teratogenicity punitive to determine based on verdict. The trial was difficult Only liability epidemiological primary thalido- after was and that even furcated. teratogen punitive damages submit mide would not be as a determined were established jury. epidemiological contends that based on studies. ted to the same "Provided, brought appeal them error.” Tex. 13. decision of said courts before or § questions fact V shall be conclusive on all Art. Const. charge liability Initially consider the found must have we the same ten who jury. punitive damages in order for the was asked: agreed on punitive damages portion of the verdict to be Question 1No. disagree. valid. We addressed a similar We Dow negligence of Merrell Was the Transp. circumstance Greater Houston “gross negligence”? Pharmaceutical Inc. Zrubeck, (Tex.App.— 850 S.W.2d 579 Co. negligence” than “Gross means more denied). Corpus writ This situ Christi momentary thoughtlessness, inadver- infrequently ation arisen and we find no has tence, judgment. It means or error of authority. Supreme Court We will follow such an entire want of care as analysis. previous Point two is over our act omission in establish that the ruled. question the result of actual con- rights, wel- scious indifference to the Damages V. Punitive fare, safety person affected three, By appel Point of error by it. punitive damages. lants attack the award of Although question does not contain the this 1) plain three-pronged: attack is that Their the Moriel court detailed instructions which establish that Merrell acted with tiffs’ had to requires trials which occur after that 2) indifference; there is no conscious opinion, this case was tried October 3) support finding; a and evidence to such long Moriel was handed down. We before damages in punitive that an award of this decision to do not understand the Moriel ease would violate both the state and federal charge require on a automatic reversal based guarantees process. of due constitutional trial but is no acceptable at time of was adequate. longer considered Due A. Constitutional Process However, sufficiency of will review the we Moriel, Transportation In v. Ins. Co. gross finding the of the evidence to (Tex.1994), supreme 27-33 the S.W.2d heightened negligence against review changes imposed procedural to address court by mandated Moriel. We will consider by very process due concerns raised light Kraus factors. The evidence in of the changes Among the are Merrell Dow here. expanded post-judgment review established damages portion punitive of the bifurcation process appellant’s due Moriel satisfies trial, analysis of the Alamo Nat’l of the appel- complaints. Accordingly, we overrule factors, of Kraus14 articulation Bank v. challenge to the award lant’s constitutional reviewing sup- by the court punitive damages. damages, ports finding punitive legal sufficiency of the standard refinement Sufficiency Evidence to B. of the changes, supreme our of review. With these Damages Support Punitive system the Texas will court considers that pass muster and will federal constitutional appellant’s consider first We Moriel, satisfy constitution. See our own together. The Havners challenges second Although Moriel was de- S.W.2d at 27-33. indif required prove actual conscious were applies case it cided after the trial of this gross negli A part. Merrell’s ference on Keever, County it. Ellis State Bank may upheld on-appeal gence finding (Tex.1994). 790, 799 that the legally if sufficient evidence there is risk trial, created an extreme protection of defendant’s conduct procedural this was aware damage of harm and that defendant punitive issues was bifurcation of Moriel, 21. Ex 879 S.W.2d at liability the risk. first considered observed. magni of both the risk is a function damages, to consid- treme and actual then returned anticipated probability and the damage tude punitive issues. er the concerned; (Tex.1981). to which parties and the extent The factors 14. 616 S.W.2d justice wrong; public the character of sense are: the nature of such conduct offends involved; culpability degree propriety. the conduct Id. at 910. wrongdoer; the situation and sensibilities debate. squarely within the falls The ex- ular data plaintiff. Id. at 22. injury to the raw data Merrell’s The FDA reexamined inquiry is not satis- portion risk of the treme report as submitted. support the found it to injury by a possibility of by a remote fied conclu- disagrees the audit Dr. Gross harm. Id. We high probability of minor perspec- from Merrell’s Nevertheless sions. involves the act or omission consider whether charges tive, cleared it of the FDA audit examining events and all the extreme risk the data. misrepresented that it the de- viewpoint of circumstances from the Id. at the time the events occurred. fendant FDA’s also contend The Havners 23. Dow data scrutiny of Merrell heightened for the the motivation period very injury. Kelly has a serious Havner of the the raw data discrepancies between one’s functional hand limits The lack of a report submitted. study and the Staples partici- simple tasks and ability perform scrutiny from data resulted heightened This many pleasures of life. Her pate in FDA on MER to the Merrell Dow submitted great magnitude. injury one of false. to be That data was determined high proba- Merrell knew of the Whether by the Justice was indicted Merrell Dow bility born with such that a child would be Department pled nolo contendere took Bendectin is a more defect if the mother false data a result of Merrell’s charges.15 As justify dam- question. punitive To difficult FDA issued a memo regarding MER known of the ages, must both have submit- employees requiring data to its consciously disregarded it. We re- risk and scrutiny subject special ted Merrell be questions together. evidence on both view the proce- under normal processed and not be so, Merrell Dow doing In we consider what specifically des- to two dures but be directed See id. at knew at the time manufacture. The Havners ignated persons for review. plea indictment and claim that Merrell’s taken Mrs. Havner was The Bendectin falsifying pattern of there was a prove that 1981; in manufactured sometime data, in the which was continued research had been on the market since formulation Staples’ report. produced evidence 1975. The defendants Dr. Additionally, produced Havners rate of limb reduction defects has Hillman, physician, a Canadian Elizabeth substantially periods not varied when Merrell that when she called who testified heavily prescribed all over the Bendectin was reported to ask about in the late 1960’s Dow compared periods Bendectin world before mothers who in children born to birth defects periods after Bendec-

was ever marketed and Bendectin, was told there were took she off the market. tin was taken cross-examina- Hillman admitted on none. recall mak- specifically not In that Merrell was tion that she did support of their claim call, others, no inde- telephone that she had consciously rights ing indifferent to the man at Mer- pendent of what the charge that Merrell did not recollection the Havners her, away an although she came with FDA that rell told complete report a to the submit de- no cases of birth study impression that other Staples in the 1960’s. summarized the reported. Dr. Hillman was bony had been particular, report fects In Merrell did Director at Montreal Poison Control that had been abnormalities rabbit fetuses an Associate Hospital and also from the Children’s The Havners conclude found. was not the of Pediatrics. She to mislead Professor that Merrell intended omissions or chil- attending physician for the mothers develop- Bendectin’s effect on the FDA about pa- Gross, reports from the But, had received criticized dren but ing fetuses. who fur- that she omissions, physician. recalls an tients’ She there was admitted Merrell her physician’s name to nished the ongoing within the scientific commu- debate Later, aware Dr. Hillman became contact. as a nity what should be classified about and birth de- linking Bendectin reports as should be classified variation versus what question hypothetical response to a partic- fects. In anomaly. also admits that this an He error, admissibility challenges of this evidence. point fourth Merrell 15. In its M.D., Hoekenga, physician a who assuming reports linking Mark that Merrell had 60’s, defects, testified Hillman charac- worked for Merrell Dow Bendectin to birth providing with mislead- Merrell he was re- terizes Merrell’s her his time at ing sponsible regulatory data as willful and wanton contacts and incorrect for Merrell’s point Drug During drugs. misconduct. The Havners and other for Bendectin (DERs) there, Experience Reports regularly which Merrell he testified that he time proof for began to receive the late 1950s literature searched the medical and scientific Hill- reports that Merrell received before Dr. to Bendectin that linked references inquired. man congenital August abnormalities. published compiled he a booklet put on that it submitted a and submit- studies and DERs on Bendectin FDA, analysis of DERs to the collection FDA, regulato- ted it to the to the Canadian required to do although it was not so. AMA, ry generally agency, the made the period DERs from 1957 to 1972. Of cover interested scientists. booklet available to defects, reports the 96 of birth 46 involve Hoekenga personal had a interest birth variety examined of limb defects. Merrell several, defects; his father he was bom with reports and concluded a memo dated condition, congenital from a heart died September that some could not infancy from con- one of his children died have resulted from Bendectin because defects; genital his other child’s defects were forma- mother took the Bendectin after limb surgically Hoekenga testified corrected. occurred, pattern tion had that there was no group that Merrell convened defects, that some were associated organization called from an outside Bio/Ba- defects, finally, birth with other to review the Bendectin sics International study performed in Bir- defects resemble a grew group in 1975. out of a data Bio/Basics mingham, England, between 1950 who reviewed professors at Harvard was marketed. Additional- before Bendectin purpose was to have situations. Merrell’s ly, prescriptions million were written over 7 infor- group all the Bendectin outside review through proba- for Bendectin June 1969 and mation, animal to human studies and bly by July 1971. Based more than 9 million safe and whether Bendectin was determine figures Birming- on the birth defect from the vomiting dur- to relieve nausea and effective study, that ham Merrell’s scientists estimate group that ing pregnancy. The concluded they reports should have received over therapy starts and 1973 there were million with Ben- of defects claimed to be associated congenital of malformations the occurrence they had not. dectin use and change not in the incidents of does indicate during punitive the Dr. Goddard testified congenital be- pattern of malformations damages phase that Merrell Dow submitted populations and exposed Bendectin tween the showing animal studies additional human and population. group The also con- the normal and ingredient Bendectin to be safe the two testing, Bendec- cluded that in rat and rabbit effective, company revised its label- not component doxylamine were tin and its available, ing became and as new information group teratogenic. Overall the found to be labeling of was in con- that the Bendectin and animal data found that the clinical data agency requirements. God- formance with tendency in teratogenic Ben- fail to reveal pri- Merrell funded a dard also recalls that dectin. study Bendectin mate to determine whether Hoekenga that he submitted findings also testified teratogenic presented the was for DERs to two outside researchers Advisory Committee. the the Maternal Health to found the DERs indicative FDA review. Neither study required by the nor That was not by Bendectin for agreed teratogenic of effect governmental agency. He any other that the Merrell researchers drug companies same reasons that on cross-examination until correct, Hoekenga at Merrell complete, not. remained duty provide did have a to was His conclusion 1982 when he retired. to doctors about their accurate information causally linked to not that Bendectin was irresponsible be products and that it would birth defects. drug company to mislead doctors. for a cross-examination, MER 29 Hoekenga ad- A. During groups mitted that the outside and reviewers in- part appellant’s complaint The first of reviewing paid time in had been for their separate of re- pieces three evidence volves provided by materials Merrell. All were dur- lated to MER 29. introduced damages phase. ing punitive Because The that Merrell Dow knew evidence three, disposition point of error we our consciously disregarded de- the risk of birth this issue. need address exposure Bendectin before fects caused DERs, the 1980 and 1981 consists of the 96 Program B. Television of Dr. Hillman that Merrell reports, Appellant complains told her it did not know of other next of the admission that program of a in which alleged falsification of data from of evidence television raw Staples study, plea and Merrell’s of no con- was linked to birth defects. Coun- Bendectin alleging to an asked Mr. Havner when and how he came test indictment falsification sel daugh- caused regarding suspect data the cholesterol MER to that Bendectin his objected hearsay. early injury. Appellant This is too weak ’60s. ter’s to support suspected conclusion that Merrell Dow that he first that Havner answered injury in consciously August indifferent to an extreme caused the Bendectin watching could also risk Bendectin cause limb reduc- while he was television. He period tion if taken critical on the a hand defects testified he saw screen Having daughter’s. pregnancy. Appellant found the evidence looked like support punitive damages, objected again be too weak to before Havner answered the analysis. question. we do not We he saw reach Kraus Havner testified after appellant’s challenge legal suf- sustain the hand on television that he asked his wife ficiency jury’s the evidence whether she took Bendectin.

finding gross negligence. objected requested Appellant again, instructed, for a moved objection, Evidentiary Challenges mistrial. court overruled the

VI. rejected request for an instruc- counsel’s four, By point chal appellant in- tion and mistrial. But the court also lenges the admission materials surround away plaintiffs structed counsel move ing falsifying data Merrell’s indictment questioning. that area regarding MER the admission of infor limi- pled defense of statute of regarding program mation television an- Original tation its Answer and in its in to Bendectin which the was linked Original First swer to the Havners’ Amended defects, birth and admission of the Smithells’ of denies that the statute Petition. Merrell prove “purchased” letters to that Merrell The limitations was at issue time of trial. favorable scientific research. We review suspected first that date on which Havner challenges trial of to the court’s admission Kelly’s may have caused defect Bendectin evidence an abuse of stan under discretion prop- information at issue and that was been Ginsberg Appeals, dard. v. Court Fifth the erly admitted. Havner heard on What 105, (Tex.1985); 686 107 Jones v. S.W.2d program hearsay not if it was television Jones, 471, (Tex.App 474 S.W.2d . —Cor to causes prove not offered Bendectin requested). pus writ We re Christi Havner saw hand that defects. That birth only the trial court acts without verse when Kelly’s hearsay, not and that looked like regard guiding principles to rules and investigate him to seeing prompted that hand complained when “the of amounted error she his took Bendectin while whether wife rights appellant a denial of such the Kelly hearsay. pregnant is also not was with reasonably prob was calculated cause and its in court not abuse discretion The trial did ably judg improper did rendition of an cause objection. overruling the case_” Tex.R.App.P. 81(b)(1); ment in the Inc., the Operators, consider whether admission Aquamarine Downer We (Tex.1985). if was harmful its admission testimony damages finding. error. The at issue consumes less The trial court’s evidentia- page consuming ry rulings require trial than a out of a over do not remand. likely pages of statement of facts. It The JUDGMENT is AFFIRMED as to was no more than a few minutes out of a trial damages actual and REVERSED and REN- lasting Although a month. it is not to be punitive damages. DERED as to many place great faith in doubted us television; hear and on what we ourselves see SEERDEN, Justice, dissenting. Chief place it is less clear what value of us on opin- I original panel Because believe the reports second hand of what another saw on case, properly disposed I ion of this cannot clear, given television. It is not at all agree majority opinion rehearing. with testimony, that Havner’s extensive scientific analyses The evidence this case and the provided nudge isolated comments thoroughly the Havners’ have been caused rendition of a verdict different than original opinion discussed in both the and the occur. not what otherwise would We are rehearing. They one on have also been dis- persuaded that admission of the involving cussed the numerous other cases irreparably would have tainted the entire drug, necessary Bendectin.1 It is not proceeding. Simply put, regard due rehash here. Havners, rights impassioned of the Letters C. Smithells lawyers, personal pleas opinions of their During liability damages and actual witnesses, of their and the verdict of the rebuttal, portion of the case its jury, legally I am convinced that there is no the Havners introduced the Smithells letters. competent judgment evidence to Dr. funds from Merrell to Smithells solicited Bendectin, ingestion drug, of the study underwrite the costs of a on Bendectin. producing Kelly was a cause of Havner’s Smithells was British researcher. Merrell birth defect. objected to the admission of the letters on expert for the Havners all witnesses hearsay, lack of several bases: authentica- impressive have credentials. All acknowl tion, probative that the letters had little val- mainly edge the basic fact that it is unknown ue, probative and that the value was substan- Only how birth defects come about. tially outweighed by unfairly prejudicial their that, specifically opin Palmer testified his permitted portions effect. The court ion, Kelly Havner’s condition was caused sus- letters to be read then Bendectin. For all of the reasons set out objection. request tained the Merrell did not original panel opinion, our and based on disregard an instruction to or move to strike admissibility standards for testimo Although from the record. we du ny reasoning set forth and the E.I. disapprove permitting of the court’s the testi- Robinson, 38 Pont de Nemours & Co. v. mony ruling objection, before on the - S.W.2d - (June Tex.Sup.Ct.J. Any requested. received all the relief it 1995), testimony con I believe Dr. Palmer’s complaint further was waived. The trial personal opinion, which is no stitutes four is overruled. court did err. Point scientific evidence the cause correct, problem. Assuming this is the Hav- Conclusion VII. proof. of ners failed to meet their burden legally and We find that the evidence is My reviewing factually support to the verdict on conviction is enhanced after sufficient Pharmaceuticals, damages although v. Merrell Dow the issue of actual it is Daubert (9th Cir.1995) Inc., (upon re- support punitive 43 F.3d 1311 legally insufficient to denied, 1046, Pharmaceuticals, Inc., (5th Cir.1989), cert. 494 U.S. 307 1. Daubert v. Merrell Dow 1511, 2786, (1990); - U.S. -, 110 108 L.Ed.2d 646 Rich S.Ct. 125 L.Ed.2d 469 S.Ct. 113 Richardson-Merrell, Inc., remand, (9th Cir.1995): (1993), v. 857 F.2d 823 43 F.3d 1311 ardson denied, Pharmaceuticals, Inc., (D.C.Cir.1988), Turpin 493 U.S. 110 Merrell Dow cert. v. - denied, (1989); (6th Cir.1992), Lynch v. U.S. S.Ct. 107 L.Ed.2d 171 F.2d 1349 cert. Laboratories, (1st -, (1992); 830 F.2d 1190 Brock Merrell-National 113 S.Ct. L.Ed.2d Pharmaceuticals, Inc., Cir.1987). v. Dow 874 F.2d that, mand). type in this in this case causes me to believe Ninth Circuit Court The experts who case, be inter- affidavits the same 702 should reviewed Tex.R.Civ.Evid. ease. review shows testified in our way. preted the same similar, strikingly only is not the evidence reasons, judgment For I believe these essentially the evidence in is identical to but court should be reversed trial affirming summary judgment our In case. appellant. judgment rendered for Dow, the Ninth Circuit Court for Merrell stated: above, plaintiffs rely entirely on

As noted experts’ unadorned assertions comports they with

methodology employed procedures. In

standard scientific assertions, plaintiffs only offer

of these testimony of these ex- deposition

trial and

perts cases. these materi- in other While plaintiffs’ experts have

als indicate PHARMACEUTICALS, studies, chemical struc- relied on animal DOW MERRELL data, analyses epidemiological INC., ture Appellant, they explain methodology the neither to their conclusions followed reach point nor external source validate Marilyn Havner, Ernest HAVNER and presented methodology. been We’ve Child, of their Minor on Behalf only experts’ their qualifications,

with Kelly HAVNER, Appellees. and their assurances relia- conclusions No. 13-92-540-CV. Daubert, bility. enough. that’s not Under especially This Dr. Palmer —the true of Texas, Appeals of Court only willing testify “that Bendec- Corpus Christi. tin defects each of did cause limb sup- Aff. at 8. children.” Palmer June conclusion, port of Dr. Palmer asserts this teratogen Bendectin is a Botts, Austin, Dallas, Earl B. Baker & plaintiffs’ he medical rec- has examined Powell, Brennan, Marjorie Bruce E. Wash- ords, apparently timing which reveal DC, ington, curiae. for amicus ingestion drug. their mothers’ Jr., Snell, Liddell, Hill, theory offers no or testable L. Palmer tested John James how, LaBoon, Houston, limited explain Sapp, Zivley, this informa- Hill & Gene tion, all Weber, Beaumont, able to other Williams, he was eliminate Mehaffy M. & defects, potential causes birth nor does Dickson, Marston, George L. Hall Robert as explain he how he alone can state a fact Dickson, Campillo, Berry, Carlson & Santa plaintiffs’ injuries. that Bendectin caused Miller, Liddell, CA, Sapp, Monica, Russell agree with the Sixth Circuit’s We therefore LaBoon, Essig, E. Lid- Zivley, Hill & James that “Dr. does tes- observation Palmer not LaBoon, Houston, dell, Zivley, Hill & Sapp, tify basis of collective view of on the Liddell, Zivley, Sapp, Hill & Bridges, Kamela discipline, nor does take this scientific he LaBoon, Austin, appellant. for peers explain the issue Hilliard, Grillo, Hilli- Kevin W. Robert C. Indeed, no grounds for his differences. Munoz, ard, Christi, Barry Corpus & Grillo basis stated. understandable scientific Paulsen, Nace, Sellinger, science, Nace, & testifying Norwind opinion, J. Personal DC, Turpin, appellees. at 1360. For this Washington, here.” F.2d reason, Palmer’s is inadmis- under Rule 702.

sible as a matter law

Daubert, 43 F.3d at 1319. Supreme announcement

Our Court’s

E.I. du de Nemours & Co. Robinson Pont Dr. notes of all the Glasser rection ... one that all but are “inconclusive” virtue orientation, Dr. public health Because of his that of the fact the confidence interval of rejected very ground- principles, Glasser encompasses 1.0. Dr. Glasser admitted each epidemiology, in that he ed statistics and only an study which showed adverse jury. “re- painstakingly explained to the He (the Study) utilized the old effect Rothman data, futed” not with demonstrable scientific Bendeetin, three-component entirely an dif- data, a con- contradictory scientific but with ingested by than ferent that Mrs. Hav- personal feeling that it is clusion on his based ner. safety. Despite better err on the side to of very epidemiologic of studies profession On the basis he termed his own “inconclusive,” opined association,” proof then that: is prove Dr. Glasser are “no unable require. precisely Dr. would not, what Glasser likely is more than Bendeetin an asso- raising ciative factor in birth defects.... best, Dr. Taken its Glasser’s likely is an more than [T]here association might is un- some evidence that Merrell not between and limb reduc- Bendeetin conclusively there is no prove able _I is an tions that there associa- believe link, association, no no Ben- relation between tion between —from the sum substance defects; opin- human birth but his deetin and I from of the literature that reviewed and link ion is that a causal not some evidence point expertise, it has my of an associ- does exist. congenital ation of Bendeetin with disor- 2) Dr. Adrian Gross ders. parameters of His own defines the Gross, a and for- Dr. veterinarian Adrian in this context. Dr. the word “association” Drug mer advisor the Food scientific simply stated: means (FDA), Glasser “Association testified on the basis Administration thing But one is related to the other. early from the animal studies conducted thing claim we cannot that one causes early through by both Mer- 1960’s 1980’s reasoning revealed other.”8 Glasser The stud- independent rell and researchers. finding employed he an association rabbits, rats, monkeys, on ies were conducted his review “inconclusive” studies: baboons, dosages utilized from two equivalent human dose. my background public is to 2400 times the [ B]ecause health, generally say, faculty I of The various researchers concluded being as member recom- being dosages that at of 50 to 100 times the public health and two schools dose, no three, caused mended human Bendeetin trained in that one hallmarks embryos. Dr. developing animal guarding safety effect on public health is why study something each and asserted safe or Gross reviewed decision as whether in de- “inappropriate” at the each was “useless” efficacious. You do look balance was a terato- you always termining whether Bendeetin the data and look the side were gen. all the actual researchers safety. again, trying And While statistically significant, example, is a 8. For there All "no association” cases "no association”. (drug protective within effect summer- would fall zone "association” between demonstrable effect, actually but de- has no adverse by drowning. Summertime time and death naturally occurring ad- creases the incidence of drownings. Howev- increase in "related" to an (no effects) or within the inconclusive zone verse protective studies, er, does not cause the increase summertime effect). adverse These effect and no merely innocent drownings. Summertime is nature, incapable very their are accompa- bystander to the true cause: accidents merely proving a func- "no effect.” It becomes activity. nying an increase water-related time, repetition, and sheer numbers tion of exposed showing a continued individuals before equate, scientific of “inconclusive" will

Case Details

Case Name: Merrell Dow Pharmaceuticals, Inc. v. Havner Ex Rel. Havner

Court Name: Court of Appeals of Texas

Date Published: Sep 28, 1995

Citation: 907 S.W.2d 535

Docket Number: 13-92-540-CV

Court Abbreviation: Tex. App.