Teresa Ambrosini v. Jorge Labarraque and the Upjohn Company

III. Conclusion already given, we reverse

For the reasons judgment of the District Court and re- Crespin pursue

mand the case so attorneys’

his claim for fees. AMBROSINI, al., Appellants, et LABARRAQUE

Jorge Upjohn and The

Company, Appellees.

No. 95-7270. Appeals,

United States Court

District Columbia Circuit.

Argued Sept.

Decided Dec. 60(b) Crespin's

Court's denial of Rule motion was an abuse of discretion. was upon causation based a valid methodology. They also contend ruling contrary

that the district court’s was Co., to Ferebee v. Chevron Chemical DC, Nace, argued Barry Washington, J. (D.C.Cir.), appellants, with whom Kenneth the cause 1062, 105 (1984), L.Ed.2d 432 Chesebro, MA, Cambridge, on the J. appellees’ expert diagnos used the same briefs. tic as Dr. Goldman and differed vice, Berry, pro argued George E. hac the only in his conclusion as to causation. We cause, appellees. Covey, M. Allen for David conclude that the proper while district court Heeht, City, Roger New York W. M. ly expert’s methodology could review the as Heald, DC, Washington, on the brief. were function, part “gatekeeping” of its Daubert v. Duy- Flynn, F. Jr. and Katherine S. Michael Dow, 579, 597, Merrell Rockville, MD, er, appearances. entered 2786, 2798-99, (1993), 125 L.Ed.2d 469 its EDWARDS, Judge, Chief Before: ultimately distinguish failure to between the ROGERS, Circuit HENDERSON question threshold and the Judges. persuasive weight assigned to be requires reversal and remand. Opinion by for the Court filed Circuit Judge ROGERS. I. Judge.

Dissenting filed Circuit HENDERSON. Teresa Ambrosini'was bom on October

ROGERS, Judge: defects, including Circuit with severe birth fa- malformations, hearing cial and ear loss due appears this court for the This case before abnormalities, eye to middle ear and verte- granted court second time after the district malformations, lip palate. bral and cleft summary judgment appellees, Jorge Dr. parents In Teresa and her sued the Company. Labarraque Upjohn and the drugs manufacturers of the Bendectin and only question Again, address we admissibility, weight, Depo-Provera claiming drugs, Ambro- either combination, expert evidence. The district court individually sinis’ or in caused Tere- initially ruled that the Ambrosinis had failed sa’s birth defects. Ambrosinis also evidence suf present admissible scientific phy- named as a defendant Mrs. Ambrosini’s genuine of material ficient to create a issue sician, Labarraque, prescribed Dr. who drug Depo-Provera fact as to whether the drags during preg- for Mrs. Ambrosini her the birth defects suffered Teresa caused nancy. against The claims the manufacturer Ambrosini, daughter and Mrs. Mr. 1989, leaving of Bendectin were dismissed in summary This Ambrosini. court reversed physician Up- prescribing judgment afford and remanded the ease to john Company as defendants.1 opportunity the district to deter court summary judgment Upjohn moved for opinions expressed by mine whether the ground no reliable scientific evidence adequate Ambrosinis’ medical had support Depo- existed to the contention that legal foundation to them admissible render Provera caused Teresa’s birth defects. Federal Rule of Evidence 703. Am under motion, Upjohn submitted the Labarraque, support its brosini (D.C.Cir.1992) (“Ambrosini I”). Following Leigh Simpson, who dis- affidavit of Joe remand, again granted the district court epidemiological studies, cussed three as well summary judgment appellees. published articles and all as other (the ge- indicating medroxyprogesterone The Ambrosinis contend that the district Depo-Provera) did not cause neric name refusing accept at “face court erred type of birth defects suffered Teresa Dr. Allen uneontrovert- value” S. Goldman’s concerning response, Ambrosinis testimony that conclusion Ambrosini. ed reference, appellees Upjohn. For ease of we refer hereinafter to as reasonably relied on is not of a epidemiologist of an basis the affidavits submitted affidavit, Dr. Bri at 1469. The by experts In his in the field.” Id. teratologist.2 and a a review of judicial that after stated limits an Leslie Strom stated that Rule 703 data, it was his epidemiological the available expert’s opin- inquiry into the basis for degree of medical opinion within a reasonable ion, expert’s conclusion. from the distinct “ teratogen ais certainty, Depo-Provera methodology employed long as the basic ‘As Dr. Goldman’s defects. that causes birth sound, law [the] a conclusion is to reach such opinion to it was his stated that affidavit recovery until preclude a “statisti- does not certainty that degree of medical reasonable cally significant” people have been number of types of birth de causes the injured until science has had the time born, and that fects with which complete sophisticated laborato- resources to of the admin ” were result her birth defects at 1467 ry of the chemical.’ Id. mother. Depo-Provera to her istration of 1536). Ferebee, F.2d at (quoting 736 publica specifically the identified Neither tions, studies, methodology that formed or remand, issued orders the district court On reviewing opinion. Upon the basis of his ex requiring cause the Ambrosinis’ to show alone, district court found the affidavits perts produce the articles and other data “conclusory unsupport experts’ opinions opinions, and that formed the basis of their ed,” noting conclusions were con that their hearing. evidentiary an Thereaf then held peer- in trary to those relevant ter, the district court ruled that the testimo journals, that Dr. reviewed scientific ny of Dr. was inadmissible under Strom, “reinterpret who the court found had Pharmaceuticals, Daubert v. Merrell Dow data, had epidemiological ed” the available 579, 113 2786, 125 469 509 U.S. S.Ct. L.Ed.2d interpretation published his nor sub neither (1993), of Dr. Brian and that jected peer Relying on its it to review. Strom, admissible, if even was insuffi Leslie of the affidavits as well as Rich assessment genuine a issue of material cient to create Richardson-Merrell, Inc., F.2d ardson v. 857 fact because it did not address whether 882, (D.C.Cir.1988), 493 823 U.S. drug had caused Teresa’s birth defects. (1989), 218, 171 110 107 L.Ed.2d S.Ct. granted summary judgment Up court

john. II. reversing grant summary judg- summary grant judg Our review ment, court that Federal Rule this Liberty ment is de novo. v. Lob Anderson prior prac- of Evidence 705 “eliminates the Inc., 248, 2505, 242, by, 106 S.Ct. out, requiring expert specifi- an tice. of set Freeh, (1986); 91 L.Ed.2d Tao cally, underlying opin- the facts and data an (D.C.Cir.1994). Summary testify.” allowing expert ion before when, judgment granted only view should be I, Ambrosini 966 F.2d at 1468-69. The ing light in most favorable the evidence case, holding court remanded the that be- non-movant, genuine are no to the cause the district court had not conducted a moving party issues of material inquiry into the of the Am- sufficient bases judgment a matter law. is entitled to experts’ opinions, summary judg- brosinis’ Anderson, 250, 255, 477 U.S. at premature. Noting ment was Id. at 1469. 2513-14; Tao, 27 F.3d at 638. The Federal Rule Evidence 703 “broadens moreover, appeal, court noted in the first acceptable expert testimony by bases for right to a court denies the have “[w]hen allowing expert opinion an an base issue, jury disputed especially one a decide a hearsay in and other evidence admissible nature, doing so court,” of a scientific its reasons for id. at the court observed that I, strong.” Ambrosini 966 F.2d at an must be “[a] must know the basis for ex- pert’s opinion before it can determine that congenital epidemiologist in animals

2. Whereas an studies the distri- ment and malformations popula- bution and determinants of disease in tions, beings. and human teratologist develop- a studies abnormal mony provides Rule of Evidence 702 “will assist the trier of fact Federal to under knowledge ... will assist or “[i]f stand determine a fact in issue.” Id. at of fact to understand the evidence the trier Performing “gate- S.Ct. issue, a fact in a witness keeping” role, or to determine the district court engage must may testify qualified as an ... ... preliminary in “a assessment of whether the opinion of an or otherwise.”3 Rule reasoning the form or underlying the tes explains that if facts or data in the timony “[t]he scientifically valid and of whether upon ease which an bases reasoning methodology properly can or inference” are “of a rea applied to the facts issue.” Id. at 592- sonably upon particu relied 113 S.Ct. at 2796. “gatekeeper,” As forming opinions lar field in instructed, or inferences Daubert Court the district court subject, upon facts or data need “solely must principles focus and method 4 Following- be admissible in evidence.” our ology, not they gener on the conclusions that I, Supreme 595, 113 remand Ambrosini Court ate.” Id. at at 2797.6 case, Supreme decided Daubert. prong analysis, Under the first rigid Court instructed that adherence to the the district court’s focus is on the methodolo requirement Frye announced v. United “ gy reasoning employed. ‘[Scientific’ im States, (D.C.Cir.1923), 293 F. plies grounding proce in the methods and “gen be based on methods “ science,” ‘knowledge’ dures connotes erally accepted]” in the relevant-scientific' subjective more than or unsupported belief community, “would be at odds with the ‘lib 590, speculation.” Id. at 113 S.Ct. at 2795. eral thrust’ of the Federal Rules and their Ruling any requirement out that scientific approach relaxing ‘general of the traditional “ certainty,” must ‘known’ to be Daubert, testimony.’” “opinion” barriers to id., Supreme Court concluded that: (citations 509 at 113 at 2794 U.S. S.Ct. qualify [I]n order to as “scientific knowl- omitted). Frye’s instructing “general In edge,” an inference or assertion must be superseded by acceptance” test had been by derived the scientific method. Pro- Evidence,5 adoption of the Federal Rules of posed testimony supported by ap- must be particular, Supreme Rule i.e., propriate “good grounds,” validation — Court announced a new standard in Daubert. short, based on what is known. 588, 113 at at 2794. U.S. S.Ct. requirement expert’s testimony that an The Daubert standard involves a pertain knowledge” to “scientific estab- two-prong analysis that centers on evidentia- evidentiary reliability. lishes a standard of ry reliability relevancy: the district Id. court must determine whether first the ex pert’s is based on “scientific four The Court discussed factors second, knowledge;” may evaluating whether the testi- the district court consider in admissible, provides: except 3. Federal Rule of Evidence 702 relevant is All technical, scientific, specialized provided by If the Constitution or other otherwise knowledge States, will assist the trier of to under- by Congress, by United Act of these stand issue, evidence or to determine fact in rules, by prescribed by or other rules the Su- expert qualified by a witness as an preme pursuant statutory authority. Court skill, knowledge, experience, training, or edu- Evidence which is not relevant is not admissi- cation, may testify thereto in the form of an ble. opinion or otherwise. Co., provides: Federal Rule of Evidence 6.See also Joiner v. General Electric (11th Cir.1996), particular upon petition The facts or data in the case for expert (U.S. 1996) (No. which an bases an or inference filed, Aug. 65 U.S.L.W. 3110 may perceived by be those or made known to 96-188) ("Trial judges must evaluate scientific hearing.' the type reasonably at or before the of a if* processes they may which and studies with upon by experts relied in the familiar, intimately be careful not to cross be but forming opinions field in or infer- expert’s deciding the line between whether the upon subject, ences the facts or data need princi 'scientifically is based on valid be admissible in evidence. ples’ deciding upon the correctness conclusions.”). provides: expert's Federal Rule of Evidence 402 admissibility expert testimony regard- 593-94, of at validity. Id. scientific concluding that the testi- ing wages. (1) theory lost whether They are: 2796-97. “wholly speculative,” id. at (2) mony was tested; technique be and has been or can was unaf- noted that its conclusion the court technique been theory or has whether Daubert, by Daubert. Under (3) fected courts publication; subjected peer review subjects regulate the and theories must still of potential rate er the method’s known “ testimony, word “knowl- of and ‘the (4) technique ror; theory or and whether subjective than belief or edge” connotes more in the relevant sci general acceptance finds ” speculation.’ Id. at 569-70 unsupported empha community. The Court Id. entific Daubert, 509 U.S. at 113 S.Ct. (quoting sized, however, a “flexible inquiry is 2795). words, analy- the Daubert In other one,” the factors discussed and that none of heightened threshold not establish a sis does every necessarily applicable in case or evidence, for the admission four factors exhaus dispositive; nor are the “gatekeeper” rather focuses on court’s at 2796-98. Id. at 113 S.Ct. tive. “subjective a check on belief’ and role as publication, respect peer review and With speculation.” “unsupported example, “[s]ome noted that the Court at 2795. While “an U.S. at new, particular, ... too too propositions are or assertion must be derived inference published.” of too limited interest id., method,” for ad- the threshold scientific upon examining the will clear Id. As become lowered, missibility both has been because III, testimony, Part experts’ see Ambrosinis’ theory admissibility adopted the liberal infra, limited assistance the four factors offer Rules of Evidence and because the Federal acknowledged the Su here for reasons acceptance” longer is no Frye’s “general test proposition in Daubert: preme Court admissibility. accep- dispositive of General attract highly particular and has not issue is community in the relevant scientific tance because, scrutiny significant ed permit be sufficient to position Drug accord with the the Federal expert testimony, longer but it is no re- (“F.D.A.”), Depo-Provera is Administration quired. pregnant longer prescribed for women. no 593, 113 at Id. at S.Ct. 2796-97. placed Even if the on the burden see, times, heavy “gatekeeper” may at seem analysis prong of the Daubert The second Daubert, 600-01, 113 e.g., at S.Ct. 591, 113 concerns relevance. Id. at primarily J., (Rehnquist, concurring part in 2800 C. The must S.Ct. at 2795-96. district court dissenting part), nothing in in and there is proffered expert whether the tes determine judges suggest to become sci Daubert sufficiently timony “is tied to the facts of the experts, much entific less evaluators jury resolving case that it will aid the persuasiveness expert’s of an conclusion. omitted). (citations dispute.” factual Id. Rather, once an has his or Daubert Court this consider The described methodology, and has withstood cross- her ation as one of “fit.” Id. As the Court suggesting that the examination or evidence “ obvious, cautioned, always ‘Fit’ is not and not derived from the scienti is validity purpose not nec scientific for one is method, expert’s testimony, long fic the so other, essarily validity for unrelated case, it “fits” an issue the is admissible purposes.” Id. weigh. Rule 702 for the trier of fact to under Recognition This court has had one occa of the limited nature of the Dau- inquiry implicit Joy similarly sion to consider Daubert standard. bert and Textron, Inc., Joy Helicopter post F.2d circuits’ -Daubert decis v. Bell 999 reflected other 549, (D.C.Cir.1993), “gatekeeper” light of the limited 567 the court addressed ions.7 See, Joiner, (11th jury's conflicting experts e.g., of for the consid 78 F.3d at 530 Cir. views 1996) ("In eration"); Hopkins CorningCorp., analyzing admissibility v. see also Dow denied, Cir.1994), (9th testimony, important keep cert. 33 it is for trial courts to 1124-25 -, judge L.Ed.2d separate jury, U.S. 130 in mind functions of - Bonds, (1995); 12 F.3d and the intent of Daubert to the strictures 637 United loosen States (6th Cir.1993); present legitimate Frye 556 Porter v. Whitehall Laborato- and make it easier to role that Daubert envisions under the Feder- on remand from Supreme Court’s deci Evidence, treating Frye's al Rules sion in Daubert. Daubert v. Merrell Dow standard, “general acceptance” Pharmaceuticals, Inc., and thus this 43 F.3d — (9th pre-Daubert precedent, circuit’s Cir.), see Mendes- -, U.S. States, (1995) Silva v. United (Daubert F.2d 1482 S.Ct. 133 L.Ed.2d 126 (D.C.Cir.1993); Richardson, 823; law).8 (applying 857 F.2d California tort Because ID Ferebee, as relevant but not Dr. testimony Strom-“offer[ed] no as to the dispositive, we examine the relative risk exposed unexposed proffered by the Ambrosinis. populations of lip palate cleft any

other of the birth defects from which [Tere suffers,” III. sa] the district court concluded that Dr. Strom’s Depo-Provera can In response Upjohn’s motion sum- cause the type of birth defects from which mary judgment, which asserted that suffers, adequately “[did] ‘fit’ [the was no reliable supporting scientific evidence Thus, proof.” Ambrosinis’] burden of while Depo-Provera contention causes ruling Dr. Strom’s to be per se type congenital defects with which Teresa inadmissible, the court held it inadmissible born, proffered the Ambrosinis a two- because it failed relevancy the Daubert test. first, pronged response: Strom, Dr. that, The district court further ruled even if epidemiologist, drug show admissible, Dr. Strom’s .in itself Teresa’s; could cause birth defects like would have been gen insufficient to create a second, by Goldman, teratologist, Dr. uine issue of material necessary to de drug, show that opinion, had judgment. feat summary caused Teresa’s birth defects. So under- stood, presented Ambrosinis Daubert, Under Dr. Strom’s evi general both causation meet dence does not warrant exclusion simply be their burden to judgment. defeat summary cause it fails to establish the causal link to a Mendes-Silva, See 980 F.2d at 1487. specified degree probability. The fitness prong of Daubert inquiry A. primarily concerns relevance. disposi- Strom, epidemiologist, offered question tes- tive “ is whether the will timony addressing causal link ‘assist the trier of fact to understand the of birth evidence or to issue,”’ determine a fact in which Teresa was with bóm. With- U.S. addressing out prong the first (quoting the Daubert 702), Federal Rules of Evidence not analysis, reliability the of Dr. Strom’s meth- whether the plaintiffs satisfies the odology, the district court ruled his that tes- burden on the ultimate issue at trial. Con timony was inadmissible trary conclusion, it did not because to the district court’s Dr. meet the prong, relevancy second the or medroxyprogesterone Strom’s that (the testimony. conducting “fitness” generic Depo-Provera) the capa name for is inquiry, relevance the adopted district causing types ble of the of defects suffered by standard articulated the Ninth Circuit Teresa relates to a contested issue and ries, Inc., 607, (7th Cir.1993); 9 F.3d logical proof drag United “more than doubles’’ Cir.1993), Martinez, (8th States epidemiological the risk of birth defects because rt. 510 U.S. 114 S.Ct. ce 126 presents evidence statistical likelihoods rather (1994) (instructing L.Ed.2d that the dis than direct information about the cause of birth trict court must determine not whether the particular plaintiff. defects for the Id. at 1320- expert’s proffered methodology principle or is light disposition, of our we have no valid, scientifically but whether the actual occasion to consider whether the substantive tort ly applied methodology principle the or in the law of District of Columbia California case). adopt are similar and need not decide whether to analysis the Ninth Circuit’s II Daubert when standard, plain- Under Ninth Circuit’s solely by causation is to be established the testi- tiff offer must either evidence that the mony epidemiologist. of an drug actually injuries caused epidemio- conclu- criteria to draw ologieal methods and Ambro- jury’s resolution could aid to determine Daubert, In order at 509 U.S. sions causation.” sinis’ claims. causation, explained, ep- testimo- he epidemiologic That Dr. Strom’s at 2795-96. S.Ct. Ambro- for the insufficient whether ny idemiologist be first determines alone summary judgment does not phenomena, sinis survive between two an “association” is admissibility under the necessarily its statistically sig- defeat is, is a “whether there Dr. Because of Daubert. prong “fitness” percent finding greater than 95 nificant at “sufficiently to the tied” testimony is Strom’s not to random error.” it’s due chance issue, it satisfies conclude that we facts continued, association, he finding an Upon prong. fitness Daubert’s specific criteria apply then epidemiologists is causal. that association whether determine also survives Dr. Strom’s crite- explained these recited and Dr. Strom scrutiny, which re- stage of Daubert first findings ria, consistency in the which include constitute evidence quires studies, biologic plausi- multiple scientific knowledge. U.S. at scientific prospective sequence of the bility, the time Testifying his conclu- at 2795-96. effect, quantitative strength epide- cause on conventional premised were sions association, which methods, specificity forth with Dr. first set miological Strom him to reasoning employed that led After find- phenomenon he correlate. the two finding no causal studies disagree with those ing an association between progestins birth de- relationship defects types of birth suffered explained that an He fects like Teresa’s. also found Teresa, Dr. stated that he Strom on studies epidemiologist evaluates based among consistency the relevant power, power.” Statistical their “statistical exception those negative with continued, ability of a represents he as too small he discounted studies which size, its'sample to detect a study, based Dr. biological plausibility. significant, and Conventionally, in order relationship. causal not recalculate he did Strom testified meaningful, negative stud- to be considered studies,9 is no arid there data from other is, ies, allege the absence of those which suggests his record that an relationship, must have at least a causal improper unconventional detecting a causal chance of percent 80 to 90 in his field. otherwise, the exists;, a link link if such jour- peer-reviewed in a publication considered conclusive. While cannot be evaluating sample dispositive too small to be reli- whether sizes nal is Based issue, able, knowledge, negative studies at Strom based on scientific power lacked sufficient statistical explained, considered conclusive.

to be explained the reasons persuasively Dr. Strom findings. why he had proceeded explain how he Dr. Strom First, nothing novel he that there was stated positive causal opinion that a at his arrived subject, he on this his work Depo-Provera and exists between connection “absolutely employed an conventional simply Teresa. of birth suffered very reviewing a detailed litera- approach to epidemiologists that evaluate Emphasizing Second, explained that he ture.” data,” Dr. “totality of the stated Strom publish in world” to reason would be “no search of [an] “conducted extensive he no Depo-Provera is findings because in literature the entire medical terms during pregnancy. The longer prescribed progestins the link epidemiology of stated, F.D.A., prohibits Provera Dr. Strom defects, paper every reviewed and birth pregnancy literature, being in “because from used to this in the medical is relevant exposed offspring on when absolutely, epidemi- known effects applied conventional tion, present degree the relevant calcula- that to the did 9. Dr. Strom clarified calculation, tions, did Never study did Dr. Strom do them himself. a did the he the author of on the author's own calculations he preferred and used the author's calculations. recalculate presented ques- an Only on a issue. when the author data útero.”10 This second rationale one of the may no other factors have caused [her] birth contemplated by Supreme factors Court defects.” suggested Daubert when it that courts The district court miseharacterized Dr. scientifically should bear mind that some Goldman’s testimony causation may

valid studies not be because of it when stated only description of his “too interest.” limited 509 U.S. at methodology was that he reviewed data and then performed a balancing analysis. reaching conclusion, this the court “relied B. heavily an isolated comment” about bal- The district court also ruled inadmissible ancing than, rather as this circuit requires, that, Dr. Goldman’s within a rea- “a reading fair of [Dr. Goldman’s] entire degree sonable certainty, Depo- medical Mendes-Silva, [statement].” 980 F.2d at Provera can and did fact cause Teresa’s 1487. The record reveals that Dr. Goldman birth defects. noting While that Dr. Gold- specifically animal, identified the pharmaco- testimony passed man’s prong relevance logical, and human studies that he relied on test, of the Daubert the district court con- to reach that Depo-Provera cluded that it qualify failed to as scientific caused type Teresa’s of birth defects. While knowledge. The essentially district court he acknowledged that none of the studies found fault with Dr. Goldman’s testimony for specifically concluded that Depo-Provera First, two general causation, reasons. caused the of birth defects suffered the court took issue with Dr. Goldman’s con- Teresa, explained that, he by following the Depo-Provera clusion that can cause birth methodology traditional in his Reviewing defects. presented by the studies field, after considering all the data and evi- Upjohn suggest the absence of a causal dence, he arrived at the conclusion that relationship, the court stated that Dr. Gold- Depo-Provera can cause birth defects like specified man “has never the basis for his Teresa’s. Upon considering range disagreement.” While Dr. rejects Goldman find:, that the studies Dr. Gold- negative showing no causal rela- man concluded that all together there was tionship, continued, the court he offered no sufficient data to conclude progestins basis for his conclusion that causation did in produced significant malformation rate. fact exist. The court also faulted him questioned When chapter about table in a founding his conclusion on a balaneing-of-the- book, he wrote for the Pharmacol- Pediatric competing-arguments methodology, ap- an ogy, Dr. table, proach the court concluded was not based on which did any not describe correlation be- knowledge. Second, as to tween estrogen-progestin drugs and causation, cranio- the court emphasized that Dr. deformities, facial intended to illus- Goldman failed to elaborate the was. trate timing the effect of on the he used to causal rela- move from the conclusion that tionship drugs malformations, Depo-Provera can cause birth defects to the not to provide conclusion teratogen- exhaustive list of actually ic drugs caused Teresa’s birth malformations they defects. regard With to excluding potential causes, other cause. the court

stated, gave “Dr. Goldman no recitation of took, steps he reviewing other than Under precedent the relevant records, Ambrosini’s medical circuit, to ensure that this Goldman’s is ad- originally granting summary judgment, (Jan. 12, Fed.Reg. 1989). However, gave district court "significant stated it that testified, both Drs. Strom and Goldman and it weight” expressed to the view the in F.D.A. undisputed by was Upjohn, that 1989 before the 1989 that relationship there is no causal between placed X, Depo-Provera category had F.D.A. in a progestational agents defects, non-urogenital and drugs prohibited of classification that are from previously required and that package label warn- during pregnancy use because of known effects ings possible congenital about heart and defects offspring exposed on in útero. longer limb necessary. reduction defects were no 138 cases, as as well the two In Fere distinctions knowledge.11 scientific as

missible reasoning adopted in Richardson the the 1529, considered bee, the 736 Mendes-Silva, significant are prod testimony explained in a admissibility of Rich- admissibility here. See involving support a chemical. action liability ucts First, ardson, rela Dr. Goldman 823. “á cause-effect 857 F.2d that The court methodology was clearly established that not be conceded tionship need never field, point a studies before a accepted in his epidemiological generally not animal or that, opinion, her] suggested [or in his was testify I court can Ambrosini that the doctor I, Id. at 1536. relationship exists.” Ambrosini 966 dispositive such a in Richardson. liability does law “products that testified re- court noted 1469. F.2d at ‘statistically recovery a until preclude ac- employed generally a that he peatedly in have people been of significant’ number confirmed methodology, a contention cepted science “that would the fact jured,” that peer-re- Teratology, a article from in an conclusively before require evidence more to the presented journal that was viewed question resolved considering the causation of article’s enumeration court.12 The district Thus, experts are when Id. irrelevant.” is by ter- generally followed methodologies the fields,” the in their “concededly qualified well types of including a list of’ the atologists, type, first of its the that a case expla- an teratologists consult and data may have been doctors plaintiff’s the or that weigh of the data teratologists all nation recognize a causal enough” to first “alert com- of an individual the risk to determine admissibility preclude connection, should Dr. Gold- of the soundness pound, supports addition, testimony. Id. experts’ approach. man’s Mendes-Silva, “[w]hen court held Richardson, is no Second, unlike in of an ex or methods underlying basis epide- contradictory body of “overwhelming reasonably relied of a opinion are pert’s conclu- Dr. Goldman’s miological evidence” to field, the court upon by the F.2d at While some by the 857 830. assessed sion. to be opinion allow the must relationship between suggest nov no causal reaches a if the factfinder —even types of at 1485. Even and the birth 980 F.2d conclusion.” el Teresa, positive a suggest no biochemi others admitted party has suffered where pointed out has been done the court test In Richardson epidemiological one. cal subject a link conclusively it had been establish issues can that the before that, on illness, evidence “on drug and an research scientific of extensive Id. inadmissible. subject relationship not rendered is causal claim the oft-asserted defects, drug at 1486. has Bendectin of. and a wealth extensively studied been offered expert evidence It is true has been data epidemiological published case in the instant bears by Dr. Goldman amassed, has concluded none of which proffered Rich- to that some resemblance to this teratogenic. Uniquely drug is ardson, held inadmis- F.2d at which twenty case, has the benefit the law now of a testimony alleging causation sible study, years of But the factual drug defects Case. in a birth testimony expert’s inadmissi- rule the Fireguard, to order reliance The Ambrosinis' Co., ble; expert's proponent of the 864 F.2d Sprinkler Sys. v. Scottsdale Ins. Cir.1988), (9th conjecture. DeCintio v. present Westches than mere n. 2 more must Cf. (2d Cir.), Ctr., County 821 F.2d Entrust- ter Med. at 2798-99. 509 U.S. at 108 S.Ct. U.S. gatekeeper, ing with the role district court (1987), for contention that L.Ed.2d court to en- simply the district directs Daubert accept true required was district court the scientific preliminary assessment of gage ain by Upjohn under was not struck methodology. reasoning expert’s validity 56(e) misplaced. case Neither Fed.R.Civ.P. at 2796-97. Id. proposition than the stands more object when submitted failure to independent suggest that an We do not Moreover, (cid:127) appeal. objections waives later support necessary to source Mendes-Silva, Dau- nor neither testimony. of Dr. Goldman’s point require the district court affirma bert expert's disproving tive given just results must their due.” 857 Goldman explained that those studies did not added). (emphasis F.2d at 832 instant enough have lip cases cleft palate or cleft is more ease similar to the situation in any render conclusive determination con- Mendes-Silva, where in an cerning relationship drug between the area where “no epidemiological conclusive and those defects.13 studies was held exist[ed]” admissible. Consistent with the Daubert at Court’s in Particularly F.2d inqui- because the struction that ry admissibility concerning Depo-Provera inquiry is and pregnant flexible one and women has become moot as a include result of consideration of action, beyond F.D.A. factors the fact that a those Court, cause-effect discussed relationship conclusively has not been see estab- 593-94, U.S. at S.Ct. at lished epidemiological 2796-97, animal studies additional reliability indicia of sup does not Dr. render Goldman’s port of Dr. Goldman’s testi Ferebee, inadmissible. See at F.2d 1536. mony general causation. In early 1980’s, request F.D.A., at

Third, Dr. Richardson, unlike the doctor Goldman testified at its opinions whose Public Board of In were based on his own unre- quiry Depo-Provera viewed causes birth gathered by recalculations of data de fects. others, That Dr. Goldman at Dr. Goldman testified to exam- studies, general ined causation public relevant noted in a their limita- hear tions, ing, any and without methodology accepted followed a connection to the Ambrosin- by teratologists litigation, is’ to reach his conclusion. reduces concerns that Dr. Gold response to simply gun studies failed to a man is reveal “a for hire.” That he was significant risk of types of upon by called the F.D.A testify on causa Depo-Provera, defects associated with Dr. tion of suggests birth defects that he is rec- dismissing "they Dr. Strom’s and Dr. Gold- enough lip didn’t have cases of cleft and causation, opinions general man’s palate say "But,” cleft way the dissent one or the other." misinterprets continued, testimony, ignoring their Dr. “they their dis- enough Goldman have did power they grouped altogether cussion of statistical if appropriate- say and the the data that ... progestins data, produced evaluating totality significant ness of see malformation rate in the total amount [of defects].” Dr. Strom and In like 141-143. Dr. Goldman infra manner, not, contrary asserts, to the suggestion oth- as the dissent's dissent infra erwise, see Dr. Strom did not con- largely base independent on two infra cede study Heinonen found no associa- by Greenberg studies Matsunaga. and Dr. tion types between -the and Strom testified that he relied on those studies birth defects from which Teresa suffers. After “among many” that he and examined the "totali- noting that Heinonen found “associations be- data,” ty simply papers.” “a few Dr. progestins tween all and defects and Greenberg Goldman’s reference to the and Mat- progestins [an] congeni- association between sunaga response question was in to a tal heart "specifically defects” and was able to regarding studies that had been in a identify an association Provera and peer-reviewed journal where found authors birth defects which it did not with some of see statistically significant proges- increased risks for progestins,” the other Dr. clarified that Strom tin lip palate; alone and cleft he did not "the that it didn't see an association between purport enumerating important to be the most Provera one defect” was inconclu- studies or the primarily on which he ones relied. you're getting sive because "then down to such Dr. Strom Greenberg study testified you're fine going any divisions to have progestagens found a “trend" between power.” Similarly, discussing statistical Lam- defects, increased of birth incidence but lacked study, mer's although Dr. Strom noted it power sufficient statistically statistical to find a found relationship progestins no causal significant Moreover, association. Dr. Strom lip palate, and cleft it did increased find risk Matsunaga conceded study concluded of other malformations. As to the review articles that, the it found association between hormone Brent, published by Warkany, Wilson and therapy and birth defects could not been have Schardein, simply for which the authors re- causal because hormones were administered viewed conducting the literature rather than organs already after the developed; defective had their own scientific Dr. Strom noted that not, however, he did study concede that epidemiologists, none were therapy concluded hormone does not cause birth. pointed out these studies "there concluded discussing defects. In studies Heinonen and progestins wasn’t data sufficient to establish Newman, Dr. they Goldman clarified that nongenital humans,” did not cause defects in not that specifically lip palate discuss cleft because relationship. "no evidence” of a causal birth known cause viruses” dozen employs half that he and field ognized in his that, responsible were defects, if a virus and methodologies. scientifically valid had the defects, would have the mother signif- expert with Also, is an Dr. Goldman consulting mother’s the After viral disease. in the area expertise and stature icant the clinical that found history, Dr. Goldman current director the He is birth defects. was that a virus indicate did not picture University of at the Center The Craniofacial responsible. the former and Medicine College of Illinois teratology section of the director Dr. Goldman’s efforts to discredit Upjohn’s Philadelphia, has Hospital of Children’s of the by pointing to the limits methodology a consultant as occasions on numerous served genetic possible into undertook he research of Health in Institute to the National de- of Teresa’s causes chromosomal has toxicology, and teratology and fields of a done namely, he had neither fects— articles in the hundred two published over more a family history nor ordered critical usually goes to such evidence field. While study goes to chromosomal state-of-the-art — qualifica- has sufficient expert whether admissibility of than the weight rather have treated circuits testify, several tions Mendes-Silva, where testimony. In his as to whether it as circumstantial alterna- had ruled out he expert testified that scientifically valid employed a expert injury plaintiffs for the causes non-viral tive reasoning. See mode of methodology lab tests consulting examinations and by (11th Cir.); Hopkins, Joiner, at 532 F.3d she was plaintiff while on the conducted Cir.); (9th United States at 1125 33 F.3d fault with found no hospital, this court Cir.1985). (3d 1224, 1239 F.2d Downing, 753 methodology. a such reliance on partial mischaracterized Mendes-Silva, The fact court also at 1487. The district 980 F.2d specific testimony on causa- might remain possible Dr. causes Goldman’s that several ” “ conclu- court’s Contrary ‘uneliminated,’ explained, to the district court tion. conclusion, Dr. Goldman sion, accuracy shows the record goes to the used that he upon the Id. Dr. methodology. elaborate the soundness Depo-Prov- the conclusion literatures get from the various review of Goldman’s of birth defects and Teresa’s era can cause medical records as the relevant as well de- did cause that it her conclusion mother constituted to the her of Teresa and that he consid- admissibility of fects. Goldman for the Dr. a foundation sufficient causes for Teresa’s possible other causation. ered the on condition, abnormali- including chromosomal instructs Daubert Rule viruses, by Under defects, ties, and genetic on inquiry focuses mother’s medical and her reviewing Teresa’s n the rec conclusions, approaches, and records, He eliminated ruled them out. he Goldman Drs. Strom and that both by consulting a ord shows chromosomal abnormalities methodologies. , scientifically valid employed study done was chromosomal comfortably cleared Both doctors’ 1970’s; genetic a and ruled out defect in the by admissibility established history, family the hurdle examining the Ambrosinis’ by con precedents circuit’s literature, this reviewing Daubert consulting genetic Their evidence. expert cerning scientific history physical ex- general medical “subjective be were neither conclusions medical records'of set out aminations Dau- speculation” that reviewing “unsupported mother, lief’ or her Teresa and a preclude Rules would Dr. bert the Federal this case. malformations individual admittedly hearing, nor from single fact finder eliminated Goldman added he by this excluded deficient possible a cause because gene mutations Richardson, gene no described “there are Porter, at 614- virus, Circuit the Seventh ruling out produce this.” asserts dissenting colleague our 15.14 While are explained that there “about Goldman for a having support Porter, no admitted the excluded causation; admit- doctors, another one of whom "curbside” a series of offered employed Dr. Strom and Dr. as this testimony must both “be ‘sci- ” “ “wispish methodologies,” p. see knowledge’ entific ... and ‘assist the trier infra provide does not record a basis for this char- of fact to understand the evidence or to ” summarily acterization. dismissing Dr. determine a fact in issue.’ 509 U.S. at 590- Strom’s, Goldman’s, opinion as well as Dr. 91, 113 S.Ct. at (quoting 2795 Fed.R.Evid. that, despite positive the lack of 702). on The Court that specific relationship Depo-Prov- in qualify order to as “scientific knowl- era and the of birth defects from which edge,” an inference or assertion must be suffers, scientifically it is permissible derived the scientific method. Pro- to reach a conclusion of causation on based posed testimony must supported by ap- be human, animal, related pharmacological propriate i.e., “good grounds,” validation — studies, colleague simply points our stud- to based on short, what is known. contrary ies with conclusions on causation. requirement that an expert’s testimony error, contrast, The district court’s did pertain to “scientific knowledge” estab- not lie in its mischaracterization of the ex- lishes a standard of evidentiary reliability. perts’ methodologies but instead in its mis- 509 at U.S. at conception 2795. “gatekeeper” limited role assigned Court to the trial court Joiner, in the task envisioned Daubert. of See 78 F.3d “determining] outset, 530; at Mendes-Silva, pursuant at see also to 104(a), Rule expert whether By is attempting proposing to evaluate the credibil- (1) to testify to (2) scientific ity knowledge opposing persuasive- and the will assist trier of fact to competing understand or ness of the dis- determine a fact Id. at questions trict court issue.” conflated S.Ct. at 2796. The court’s testimony determination preliminary “entails a weight assessment of appropriately to whether be such accorded reasoning or methodology testimony by underlying a fact finder. The aggregate of testimony scientifically valid and of epidemiology Strom’s wheth gen- on er that reasoning or causation, methodology properly eral Depo-Provera can cause can applied to the Teresa’s, facts birth issue.” Id. defects like Dr. Gold- 592-93, 113 S.Ct. at 2796. The teratology district man’s court here made such an causation, assessment on remand. Depo-Provera, to a conducting After inquiry detailed re certainty, reasonable medical can quired by this court Ambrosini v. Labar injuries, cause Teresa’s other known causes raque, 1468- out, birth having pro- defects been ruled (D.C.Cir.1992), the district found vide sufficient both question raise a Strom’s and Goldman’s inadmissi material as to the cause of Teresa’s ble. And little wonder. Neither defects. of anything fered resembling scientifically val Accordingly, we grant reverse the of sum- id opinion basis for ingestion his mary judgment Upjohn and remand the Depo-Provera, or of progestins general, case the district proceed- court for further has a relationship lip, causal to cleft cleft ings. palate or the other birth defects Teresa Am- brosini suffered. The district court therefore HENDERSON, KAREN LeCRAFT properly experts’ held the testimony inadmis Judge, dissenting: Circuit panel sible and this should affirm the court’s In Daubert v. Merrell Dow Pharmaceuti holding. cals, Inc., (1993), L.Ed.2d 469 Supreme Court held Both purported Strom order to be admissible in a such ease base largely indepen- on two ted that he opinion could not render an cau- greater dosage sation was based on a far than degree sation to a reasonable of medical certain- received; plaintiff which had and a fifth ty; a third conceded that his was a theory doctor admitted that his lay of causation "hypothesis, proof of which to be remains of'expertise. outside field 9 F.3d at 614-15. made;” theory a fourth that his admitted of cau- lip-cleft palate cleft cause progestins do Greenberg and conducted dent studies Ambrosini that Teresa 352-54, 245; any of App. Matsunaga. See not “re- he did and that has,” App. evi- lengthy during the conceded Yet each associa- ... shows an study “any article that neither call” hearing below dentiary pro- Provera or link tion between significant causal found hu- palate in lip of-cleft incidence of cleft incidence an increased increased gestins and (Strom agreeing mans,” 420.2 See, App. e.g., App. palate. study “looked Greenberg that when acknowledged, but Further, each they support, hormonal issue, and progestins discounted, published studies of the existence significant statistically find a unable to were (Lammer study) and Provera progestins of defects”); 360 of birth incidence increased study) that (Katz study Yovich and study Greenberg (Goldman that agreeing those relationship between found no causal excess statistically significant find a not “did App. palate, lip or and cleft substances to mothers born lip-palate in children of cleft (Goldman), and (Strom); App. 350-51 255-56 only progestin”); received who (Warkany published studies three other study “said Matsunaga (Strom agreeing that study, & Brent Sehardein study, Wilson association no “causal” there was in fact” progestins that found no evidence study) that therapy and birth defects hormone between App. birth defects. nongenital cause established, satisfac- to they “because (Goldman). (Strom); App. 402-04 the de- given after tion, drug that (Goldman occurred”); 431 already fects had end, no basis Thus, left with we are in the study “concluded Matsunaga admitting that except their experts’ opinions for the two increased statistically there was an that while that he study. testified Strom own individual lip- and cleft Provera between association totality “look[ing] at the opinions his formed tim- given importance ... palate cleft studies without published in the of the data” concep- they when knew ing and the larger literature of much “looking they to estab- place, were able taken tion had opinions in the literature.” expressing people the defects given after drug was that the lish “methodology” produced con- This App. 260. occurred; associa- therefore the already had stud- those of the with clusions inconsistent causal”). not tion was appellants’ supportive of but ies’ authors opinions on base his claimed to case. Strom rely stud- on two claimed also Goldman only, reject- “positive” studies the data App 346. Newman. and Heinonen ies Small,” as “too data ing negative studies’ questions, specific responding to again, But he “positive” studies the two App. study a sta- but “found that neither he conceded relation- support a causal not identified do for Prov- risk tistically significant increased any of the ship type of birth defects causing the era suf- Ambrosini defects Teresa lip specific birth has,” “cleft neither of Ambrosini (Heinonen study 300, 293 App. fered. See of what picture nor of “the entire palate” “heart progestins with association found App. 347-48.1 has.” Teresa Ambrosini be- an association “didn’t defects” but see not ultimately he was fact, conceded he defect”); specific and one any tween Provera any article review “aware of an in- (Lammer study “didn’t find App. 257 journal ... said has peer-reviewed " Maj. Op. (quoting Goldman n.13 regarding other.' testify the birth defects 1. Goldman 348). App. "like cardiac two found in the that were defects, others,” several limb defects and grouped enough they if "did have researchers data all to the editor cited a 2. also letter Goldman no, together say no— Provera — apparently Journal of Australia” “Medical significant progestins produced a malformation between"progestogen-es- association found some App. This 348^-9. in the total amount.” rate palate. lip trogen” cleft combinations nothing, us rate” tells "significant malformation however, testified, App. See 362-68. however, progestins relationship on an "uncontrolled was based that the letter which, majority lip palate, as the or and cleft concedes, you give idea” study" "might some as such specifically discuss the studies "did "significant yield a result but would enough cases of 'they have ... because didn’t App. statistically.” say way palate one lip and cleft cleft creased lip, incidence of cleft palate cleft the area of birth defects” shows that he any of the other malformations that Teresa “employed a scientifically valid methodology respect Ambrosini has with progestin use” or mode of reasoning.” Maj. Op. at 139-140. only malformations”). Thus, “other Daubert, however, requires that expert’s opinions not, his claimed, are supported as he testimony in satisfy case “a stan- nor, those studies’ judging data from his dard of evidentiary reliability,” 509 U.S. at .by testimony, any “appropriate validation.” 590, 113 S.Ct. at expert’s 2795—the Daubert, 509 U.S. at 113 S.Ct. at 2795. reputation does not meet requirement. And Goldman’s fare no better. II, (“We’ve Daubert 43 F.3d at 1319 been Cf. Goldman described methodology as fol- presented with experts’ qualifica- else, lows: anything “[L]ike prepon- it’s the tions, their conclusions and their assurances argument. of an derance argument It’s the reliability. Under that’s not against favor argument against, enough.”). everyone this is what else App. does.” The majority problem acknowledges concluded: “The district “resem with methodology this is that blance” of it does not Goldman’s to prof “that satisfy App. Daubert.” agree 89. I ap- fered Richardson [v.Richardson-Merrell, —as parently majority. does the Maj. Inc., Op. See at 823, 857 F.2d (D.C.Cir.1988), 832 882, 493 U.S. 110 S.Ct. 107 (1989)], L.Ed.2d 171 which majority The held attempts nevertheless inadmissible to de- expert testimony alleging fend opinion Goldman’s causation drug baseless of a on several First, in a grounds. birth defects Maj. the case.” majority Op. at accuses the 138. I district find of both “‘reifying] heavily Goldman’s and Strom’s isolated strikingly comment’ balancing.” Maj. about similar to expert’s the in Richard Op. at 137 (quoting Mendes-Silva v. son. At United issue Richardson was whether States, (D.C.Cir.1993)). 980 F.2d 1487 “Bendeetin,” an drug ingested anti-nausea The choice, district court however, had no Mrs. during Richardson her pregnancy, had given (such the lack of any support other caused her child’s defects. This court the studies and their data on which Goldman upheld the trial ruling court’s plain purported rely), to to focus on Goldman’s expert’s tiffs’ opinion genuine “lacked ‘a ba own characterization of his methodology— sis, in or record,’ out of the and that his and, given the characterization, nature of his speculations’ ‘theoretical could not sustain reject methodology. the Richardsons’- burden proving causa

The majority tion.” also 857 observes that at 829 (quoting Richardson himself Richardson-Merrell, Inc., that he used the “tradition F.Supp. al methodology (D.D.C.1986)). Maj. the field.” holding the ex Op. at pert’s 138-139. Indeed he so inadmissible, stated par we noted in repeatedly ever identifying (1) or de ticular that he had “admitted that no —without one scribing the methodology except as noted who published has work on Bendeetin has above. If such conclusory statements must concluded statistically that there is a signifi accepted value, be at face majority as the cant association between Bendeetin and limb suggests,' the Daubert standard becomes (2) defects of case,” in this issue meaningless. Daubert v. Merrell Dow Cf. reached “a statistically significant result” Pharmaceuticals, Inc., 1319 “[o]nly by recalculating pub data” from (9th Cir.) (Daubert II) (summarily dismissing (3) rejected lished and studies that “experts’ unadorned assertions published “had been peer-reviewed scienti methodology they employed comports with journals,” fic while he pub himself “neither standard procedures”), cert. de his lished recalculations nor offered them for —nied, -, U.S. 133 peer review.” Id. at 831. As is clear from (1995). L.Ed.2d 126 the foregoing discussion, Goldman’s and The majority similarly suggests subject Gold- Strom’s are to the same sort man’s “significant stature expertise Nevertheless, of criticisms. majority at very alter reluctant be should courts on sever cases the two distinguish

tempts to is issue causation when jury’s verdict al grounds. current lstand[s] novel and frontier ’ ” “Dr. Goldman majority states: First, the inquiry pro epidemiological medical and was not conceded never testify to willing are “experts vided that Maj. Op. ...” field in his generally accepted their meth in such situations causation Richard- expert in Neither at 138.3 (quoting F.2d at 832 odology sound.” is is clear it after Daubert son 1534; alteration Ferebee, F.2d at accepted. generally not be methodology need court). The court by Richardson emphasis U.S. at See however, us, before “The case then noted: accepted” stan- (rejecting “generally 2794-95 While is this one. Nor not like Ferebee.’’ and in- from and “absent as “austere” dard contradictory here Evi- Rules the Federal compatible with Richardson, it is sub “overwhelming” as in expert did dence”). Richardson What inquiry “frontier” stantial. necessity aof “acknowledgef ] towas results ago “the long crossed significant association statistically Id. at just due.” given must be popula- in human its effect drug and observed, an event, as any Richardson pub- has who one tions,” that no “admit[ ] always be methodology must expert’s has concluded Bendeetin work on lished That was “frontier.” on the even “sound” significant association statistically is a here. case de- limb reduction Bendeetin majority that “unlike claims and, Finally, the case,” in this type at issue fects Richardson, opinions whose the doctor “[o]nly by recal- concede apparently, to recalcula- his own unreviewed based on were obtain what able [he] was culating the data others, by gathered tions of data significant result.” statistically a he deems the relevant examined Dr. Goldman dispute here no There is 830-31. F.2d at limitations, and followed their noted be) “significantly (nor that some can there by teratologists to accepted a required association” statistical Maj. Op. at 138-139. conclusion.” reach his birth and Teresa’s recal- admit here did not (Strom), witnesses 328 While the See, e.g., App. 210 defects. identify the they data,4 neither above, culating Further, each (Goldman). detailed as explain they nor relied on which specific data associa- no such conceded expert here differ data interpretations why their pp. 141-142. supra shown. had been See tion In studies. published in all of the from those “unlike majority asserts next The spe- addition, ever described neither ‘overwhelming body Richardson, is no reasonably methodology that can be cific contradictory epidemiological “accepted.” characterized as ” Maj. Op. at 138 conclusion.’ Dr. Goldman’s sum, Richardson, appellants’ 830). (quoting 857 F.2d testi like the unfounded very much observation, in Fere here earlier we affirmed our far short and falls 1529, mony in Richardson Co., 736 F.2d Chem. bee v. Chevron “scientifically standard valid” Daubert’s (D.C.Cir.), remand, district admissibility. (1984), On “that L.Ed.2d subject, upon the facts opinions or inferences point that was "a majority that this asserts 3. The evidence.”). admissible in not be or data need dispositive suggested was I court the Ambrosini I, Maj. Op. at 138. Ambrosini Richardson." statistics, he recalculated whether asked When 4. holding however, as Richardson characterized "Generally data—if replied: if the Strom testimony "was expert's inadmissible preferred to paper, I were in calculations acknowledged that he Rule 703 because under only of the author. take the calculations type opinion of a underlying own, was not data and there of our calculations we did time were some did, experts in the reasonably ques- field.” we had relied where where we Richardson, at, added); present- looking data were (emphasis see we were at 1469 tions they do the calcula- reasonably did not ("If relied the authors ed of a F.2d at 829 App. 224. forming tions." particular field in by experts upon in the ordered the witnesses “to produce the articles other data which have formed Jerome D. JACKSON, Appellant, opinions,” basis of their App. sug as

gested panel I,5 in Ambrosini lengthy conducted a hearing part FINNEGAN, HENDERSON, FARABOW, “preliminary required by assessment” Dau GARRETT & DUNNER, al., et bert, see 509 U.S. at 113 S.Ct. at Appellees. end, 2796-97. In the after the two (or ignored) discounted all of No. 96-7014. peer-reviewed opinions, while offering no supporting data a positive statistically signifi United States Court of Appeals, association, cant much less a causal relation District of Columbia Circuit. ship, between Depo-Provera and the specific Argued Oct. suffered, Ambrosini ‘fijases” left experts’ for the opinions two Decided Dec. were “totality Strom’s of the data” and Gold man’s “preponderance argument” of an stan

dards. Based on these wispish methodolo

gies, neither Strom nor Goldman could offer reliable, causat Thus,

ion.6 the district required court was

to hold inadmissible and this

court has no rational alternative but to follow

Richardson and Daubert and to affirm that holding.7 majority Because the opts other

wise, I dissent. panel The Ambrosini I stated: "assist the trier fact to understand the evi- issue,” dence or to determine a fact in propo- —a [T]he required court could have Dr. Strom and sition rejected. 31-33; district court App. See Dr. Goldman to disclose the bases for their see also 509 U.S. at 113 S.Ct. at opinions so that it could determine whether ("study phases moon, for adequate (i.e. had an foundation example, may provide valid scientific 'knowl- they whether were based on information that edge' about night whether certain was dark” experts in the would rely field reasonably on in "evidence the moon was full on a certain determining whether a drug causes night will not assist the trier of fact in determin- defects). Only then could the court de- ing whether an individual unusually likely was termine whether the affidavits were admissible have irrationally behaved night. on that Rule under Rule 703. A court must know the basis 'helpfulness' 702's requires standard a valid sci- expert's opinion for it before can determine entific precondition pertinent connection to the inquiry as a that the basis is type reasonably not of a relied admissibility.”). byon experts in the field. 966 F.2d at 1469. 7.Whether or not the district court "conflated the questions of the admissibility 6. Because there preliminary no showing weight appropriately to be accorded either is irrele- causation — finder,” —it such asserts, a fact majority as the vant adequately whether Goldman eliminated Maj. 141, (and Op. at I do not so con- n causes, possible other maintains, majority as the cede) should, nonetheless, we can and affirm the establish Maj. Op. causation. See court’s decision given. reasons I have observed, 140. As the district court Strom con- Walters, See Haddon qualified ceded he was not testify (“[W]e latter. grounds affirm on judg- different App. See 31. Nor need we consider whether ment of a lower court if it is correct as matter Strom's case, plaintiff's "fit” the law.") (internal quotation and citation omit- is, in the words of rule ted). it whether would

Case Details

Case Name: Teresa Ambrosini v. Jorge Labarraque and the Upjohn Company

Court Name: Court of Appeals for the D.C. Circuit

Date Published: Dec 6, 1996

Citation: 101 F.3d 129

Docket Number: 95-7270

Court Abbreviation: D.C. Cir.