Trach v. Fellin

pros being of non en- prior judgment averred Appellant

tered. also brief was not Appellee prejudiced

her delay. pre-judgment

¶ 14 offered reasons for Appellant While entry delay preceding judgment pros,

of non she made no indication that motion/petition promptly

her was filed or there facts which supported were such, As Ap-

meritorious action. cause of for reconsideration is not

pellant’s motion equivalent petition

the functional judgment pros, of non find

open we Appellant’s

all of the brief issues raised Sahutsky. waived

to be under

¶ 15 Affirmed. TRACH, Appellant

Allen

v. Drug/Eckerd

J. FELLIN Thrift

Store, Drug, Inc. Thrift Drug

Eckerd Co. Trach

Allen (J. Fellin, Drug,

Thrift Thrift Inc.

Drug/Eckerd Drug Store, and Eckerd

Drug Co.), Appellants Pennsylvania.

Superior Court of

Argued June 11, 2003.

Filed Feb. by a

edge beyond possessed layperson fact to understand will assist the trier of determine a the evidence or to fact issue, qualified expert by witness skill, experience, training or knowledge, in may testify education thereto the form ]”). of an See also otherwise! (noting id. Comment—-1998 Rule Pennsylvania’s 702 does adoption not alter standard; noting also that the Rule the rule for change qualify- does not ing expert a an enunciated in witness as Tavern, Inc., Pa. Miller v. Brass Rail 541 (1995) 474, 480-481, 664 A.2d 528 ... (holding, applied test to be “The any whether has reasonable the witness pretension on the specialized knowledge to does, subject If investigation. he he under may weight to testify given and the be to Allentown, Karoly, John P. for Trach. the trier fact to such is for Cotier, Philadelphia, Thrift Alan K. for determine.”)). Drug/Eckerd Store. 2 In the trial court vacated this jury’s granted verdict of million and $5 P.J., SOLE, DEL Before: FORD Thrift Inc. a new to dam- Drug, as JOYCE, ELLIOTT, STEVENS, ages, having determined it erred MUSMANNO, MELVIN, ORIE LALLY- it Trach’s when allowed Allen scientific GREEN, KLEIN, BENDER, JJ. Drug Thrift expert testify. challenged to ELLIOTT, Opinion by FORD J. expert’s methodologies and conclu- sions, had claiming neither been en granted 1 banc review Af- accepted community. in the scientific this case order to reevaluate the circum thorough analysis ter a of the circum- a party seeking stances under which party may invoke stances under which test expert exclude evidence testimony, howev- exclude admissibility of that pursuant evidence er, we to conclude that the are constrained States, F. 1013 United it vacated jury’s trial court erred when (D.C.Cir.1923). process, we are allegedly Trach failed to verdict because required panel to revisit several recent connection establish a causal between decisions of this court determine wheth problems Trach’s medical long-term Frye beyond er we have extended negligence. Thrift Drug’s supreme parameters our court has estab lished, in mind an 3 The facts of case are not keeping (“Trach”), such, dispute. healthy, Trach exclusionary rule of evidence. As Mien man, narrowly 47-year-old to his must as not to went dentist be construed so 11, 1995, pain in his impede admissibility July complaining evidence will dentist, infection, an jaw. suspecting aid trier of fact the search for truth. (“If gave prescription forty Trach 250- See Pa.C.S.A. scienti Pa.R.E. Amoxil, antibiotic, fic, mg. capsules of specialized or other knowl- technical (Shane’s five-day Drug Doxepin period. which Trach then took to a Thrift over 1.) A pharmacy pharmacy Store fill. assis- expert report mistakenly tant gave capsules Trach 29 Thrift July 6 On Trach returned to antidepressant him Doxepin, and told Drug pick up the remainder of the remaining to return for the capsules that the prescription, and his wife noticed days, a few pharmacy did not have origi- pills new were different from capsules in stock. pharmacy, nal called the 29. She ¶ 4 Doxepin potential has the to cause investigation, the stated upon pharmacist serious adverse reactions individuals that Trach given wrong had been med- who take it in the dosage. recommended initially, ication an antidepressant called Trach, however, Doxepin took the accord Doxepin. hospital Trach then went to the ing dosage to the prescribed his dentist for (Trial for at testing. opinion, 5/18/00 Amoxil, for which dosage approp was 5.) While most Trach’s reactions to the According expert’s to Trach’s re riate.1 month, Doxepin subsided within a he con- 1,800 port, Trach took milligrams (“mg.”) difficulties, experience cognitive tinues to of Doxepin day. on the first (Expert re headaches, cluster problems. and vision (“Shane’s Shane, port of John J. M.D. eight In March of months after expert report”), citing Physician’s Desk Doxepin following overdose and re- (“PDR”) Reference R. Doxepin, at 31 peated efforts to determine the nature of A.) Exhibit The optimal recommended vision, problems Trach’s with his Trach range dose for Doxepin mg. is between 75 (Notes diagnosed glaucoma. was with per day, and 150 while the maximum rec 138.) testimony, at Mark E. Mor- 6/17/99 ommended mg. per day. Phy dose is 300 an, D.O., the who ophthalmologist treated (“PDR”) sicians’ Desk Reference at 2408 glaucoma, Trach’s described as “chronic (53rd ed.1999).2 open-angle glaucoma specifi- or even more ¶ 5 immediately When Trach experi- (Id. 116.) cally pigmentary glaucoma.” at effects, enced including side symp- visual Additionally, crescent-shaped Trach has a toms, he consulted physician, diag- his who scotoma, an spot, blind known as arcuate problem nosed the trigeminal neuralgia, as right eye optic his as a result of nerve but did not believe it was a side effect of damage glaucoma. damage from the The (Plaintiffs the antibiotic. complaint at 3 eyesight permanent to his and affects 7.) 12, R. at Trach subsequently devel- ability engage his to read and to throat, and, oped a sore believing the sinus photography hunting hobbies it, infection caused took an additional ten previously enjoyed. he He is also con- capsules Doxepin over the next cerned that he not be able to retain (Id.) Despite hours. hallucina- suffering job cognitive his because of his vision and tions, heartburn, confusion, and extreme problems. difficulty concentrating, Trach continued ¶8 until, PDR, to take according According the medication adverse re- Shane, 4,800 Dr. mg. Doxepin he had consumed of actions to when taken the rec- prescription slight discrepancies 1. The called for take existed between Trach to While mg. capsules two 250 four antibiotic report at trial Dr. Shane's and his 2,000 day, per mg. per day. times took, Testi- Doxepin Trach as to the exact amount of mony presented at trial indicated that disputed no that it was a massive over- one Doxepin capsules pharmacy gave assistant dose. (Notes mg. capsules. Trach were 150 of testi- 184.) mony, at 6/16/99 adopted supreme our may include blurred which dosage ommended disorientation, Phar- vision, confusion, and hal- Blum v. Merrell Dow test. See also (Pa.Su- maceuticals, Inc., PDR indicates A.2d 1314 lucinations. The also an may result from over- death or coma Pa. 764 A.2d affirmed, 564 per.1997), confusion, Doxepin, (2000). as well dose court denied Thrift The trial concentration, visual transient disturbed Drug’s motion. hallucination, and other pupils, dilated only expert was Trach’s 10 Dr. Shane Additionally, one consequences. serious of causation. witness on the issue experts, Michael Drug’s of Thrift medical court in its summarized Naidoff, ac- M.D., ophthalmologist, testimony as follows: can cause nar- knowledged Doxepin tricyclic antidepressant... Doxepin is suscepti- closed-angle glaucoma

row or blocking the amine works A. (Deposition of Michael ble individuals. impulses nerve transmits pump (“Naidoff Naidoff, deposition”), M.D. junction points synapses, across 4.) For Defendant’s Exhibit with each up cells hook which nerve however, reasons, no one has obvious im- The transmission of nerve other. the ef- conducted studies to determine an synapses depends on pulses across Doxepin a massive overdose of fects of Doxepin environment. intact chemical therefore, took; as the dose Trach such by with this environment interferes that a massive indicating exist no studies of the chemi- blocking the transmission open angle pig- or overdose can cause blocking This action acetylcholine. cal glaucoma mentary glaucoma, the form of n anticholinergic an effect. as known to suffer. from which Trach continues reactions or side may There be adverse indicating exist Similarly, no studies of therapeutic even a dose effects from of Doxe- usually transient side-effects are contraindica- Doxepin. There also unsteadiness, confusion, poor pin, such as i.e., con- Doxepin, symptoms for headaches, tions inability and memory, cluster may by be exacerbated concentrate, ditions that Trach still com- of which effects and con- drug. The known side permanent can when plains, become determined massive overdose of have been individual takes a traindications approval Doxepin. prior clinical trials through Federal Food and of drug his claim that the Doxe- 9 To ‘FDA’) (the and Drug Administration cognitive and vi- pin overdose caused experience clinical since also from experience, problems he continues sion on the market. The side drug has been testimony from proffered expert Trach for a thera- effects and contraindications toxicologist, pathologist and board-certified in Doxepin are identified peutic dose trial, Prior to Thrift Dr. John Shane. insert and the manufacturer’s limine to preclude filed a motion in Drug ‘PDR’). (the Physician’s Desk Reference testimony, claiming did Dr. Shane’s is included The manufacturer’s insert requirements for scientific meet that has package drug of a with each and its Frye, supra, forth in evidence set marketing by the test). for (the approved been Pennsylvania in progeny compilation PDR is a FDA. The Blasioli, See, v. e.g., Commonwealth the treat- that are drugs available (1998); Common- A.2d 1117 Pa. au- It is considered Crews, patients. ment of A.2d 395 Pa. wealth v. regularly relied on thoritative (1994); Topa, 471 and Commonwealth drugs pa- prescribing in physicians in the case Pa. 369 A.2d

H07 system at the Canal of symptoms experienced by tients... The the filter Schlemm, Trach ingesting Doxepin after are con- the filter clogging up further with the sistent adverse reactions identi- causing pressure and also increased in- package fied the manufacturer’s eye. mydriasis The combination of sert and the PDR. These adverse cycloplegia is a mechanism reactions or side effects included ataxia narrow-angle glaucoma, some- leads (unsteadiness feet), dizziness, on his closed-angle glauco- times referred to as blurred vision and disorientation... However, ma. the distinctions between Glaucoma is a condition of increased closed-angle glaucoma narrow or pressure eye ocular that causes open-angle glaucoma are often confused pathologic change to It eye. profession. Consequent- in the medical damage optic result nerve that ly, some authorities have recommended irreversible, cases, and in some loss changed the nomenclature be vision. Both the manufacturer’s insert eliminate the distinction... and the PDR state that is con- Doxepin 7-9, opinion, Trial court citing 5/18/00 glaucoma. traindicated for This is for testimony, notes of at 168-251. First,

two reasons. the anticholinergic Further, Dr. Shane testified effect of pupils causes the to a degree toxicological reasonable eye unequally, to dilate a condition certainty symptoms that all the Trach suf Second, mydriasis. known as the anti- immediately fered after ingesting the cholinergic effect also causes the ciliary Doxepin, continuing and his in symptoms, inactive, eye muscle of the to become cluding glaucoma and scotoma and condition referred to cycloplegia... cognitive problems, various are the direct mydriasis combination of cyclo- and (Notes result of Doxepin. the overdose of plegia leads to blurred vision. It also 208-215.) of testimony, at At changes leads to in eye, specifically 6/16/99 evidence, of all blockage Schlemm, a close Thrift Drug of the Canal of a circulatory testimony channel moved to strike Dr. between the front Shane’s however, chamber entirety; and back its the trial court de eye. chamber of the The result is pressure supra, increased nied the motion.3 As noted Trach addition, eye. Moran, iris, called Dr. ophthalmologist dilation of the also part eye, colored pig- treating eye causes who has been Trach for his mentary pigment deposited loss. The problems and who referred Trach to vari- Nevertheless, argues Drug agree Trach that Thrift waived its we with Trach that it is Frye challenge object when it failed to questionable Drug’s whether Thrift chal- trial, testimony during Shane's instead wait- lenge comports in this case with established ing until the close of all the evidence to move Drug’s procedure because Thrift chal- limited nonsuit, verdict, for a a directed or to .strike lenge expert report to Dr. Shane’s in its mo- note, testimony entirety. Dr. Shane’s in its We tion in limine did not a motion to however, 103(a)(1) provides that Pa.R.E. testimony entirety, strike Dr. Shane's in its litigant challenges when a the admission of especially at all the We the close of evidence. evidence, preserved the issue is if there is "a therefore do not condone the manner timely objection, motion strike or motion in Drug preserved its which Thrift raised and stating specific ground objec- limine of Frye challenge, against and caution counsel tion.” The Comment to the Rule further using procedure such a in the future. We ruling states: "A on a motion in limine on the will, however, the issue this case. address preserve record is sufficient to the issue for appeal, objection without renewal of the offer at trial.” Drug’s Thrift mo- finally The trial court denied diag- one of whom specialists,

ous not testi- a new trial as glaucoma. j.mo.v. granted Dr. Moran did but nosed tion for (Notes causation, of fy as to however. that Dr. only, agreeing Shane’s damages 114-148.) testimony, at testimony long-term as to the 6/17/99 causation not meet the stan- Doxepin effects of did 12 In to Trach’s testi response (Trial opin- by Frye. required dard testimony offered the mony, Drug Thrift 33.) ion, ap- filed parties at Both Naidoff, 5/18/00 experts; ophthal Dr. of two trial court error peals, claiming Trach earlier, regularly who mologist mentioned damages a trial as to ordering new had ex glaucoma patients treats and who testimony that Dr. as had basis Trach’s medical records but amined Trach; Doxepin pass did not long-term Richard I. effects of never examined and Katz, M.D., test; neurologist Drug claiming a board-certified Thrift who, Naidoff, only examined- j.n.o.v. like Dr. had granting trial court error Naidoff, Trach’s medical records. long-term injuries, as to Trach’s and/or testified through videotaped deposition, his damages new trial as to both causation closed-angle that while can cause allegedly inadmissible Dr. Shane’s because in the medical glaucoma, nothing there is (Trach’s Drug. Thrift prejudiced type indicating literature can cause 1.) 4; Drug’s Thrift brief at brief at suffers, Trach of glaucoma from which (Naidoff unknown. de which the cause is first note our standard 14-24.) Dr. Katz testi position, appeal grant in this from the of review 6/8/99 neurological symptoms Where, here, fied that Trach’s the trial court trial. new month, have subsided within specific grant basis for its set forth the medical records indicated no that Trach’s trial, whether the court a new we consider objective neurological damage, in signs or committed an er abused its discretion indicating neurologically that he was stead law in its decision on that stated ror of (Notes testimony, normal. Co., Flickinger only. basis Coker v. S.M. 252-315.) 441, 449-450, 625 A.2d 1185- 533 Pa. (1993). Therefore, only we consider supra, at the close of 13 As noted in a judge ordering trial erred whether the evidence, compul- Thrift moved for a Drug verdict, damages on the basis that a nonsuit, new trial as to or a mo- sory directed evidence did In- of Trach’s causation testimony. portion tion to strike stead, Frye improperly in and was trial directed a verdict not meet the test court negligence and sent at trial.4 Trach’s favor as admitted jury jury damages. the issue of the circum 15 We first consider of Trach in the a verdict favor returned court supreme which our stances under then Drug Thrift amount of million. $5 admissibility of evidence analyzed the has requesting judg- motion post-trial filed with the ob Frye. begin alternative, pursuant We or, a new n.o.v. ment definition, only ap Frye, that trial, servation that the trial court should arguing required. testimony is testimony. plies expert where Dr. Shane’s not have admitted 33; opin- opinion, at trial court Drug challenged recognize 4. We that Thrift 5/18/00 ion, 1-2.) method- Because we find that conclusions and his both Dr. Shane's its ology, court addressed both in and the trial and his Dr. Shane's conclusions Nevertheless, 18, trial May opinion. intertwined, however, 2000 inextricably we will are solely granted a trial on the basis new both. address (See testimony. of Dr. Shane's causation

1109 (“ Pa.C.S.A., 2001, 22, 2001, Frye, question adopted January 293 F. at 1014 “When 1, 2001. July explanatory effective As the range involved does not lie within the states, purpose comment to that Rule “The experience or knowledge, common common provide proce- of new Rule 207.1 is to requires special experience special but or pre-trial concerning dure for motions knowledge, opinions then of witnesses admissibility expert re- which particular skilled in that ... science are Id., lies scientific evidence.” upon novel ’), quoting admissible evidence” brief Comment—2001.5 Explanatory the United States. ¶ 18 are therefore concerned with ¶ 16 A our supreme review of Blum, su pronouncement this court’s over application past court’s pra, panel opined which a of this court twenty-five years also supports propo “whenever en applies science Frye only sition that applies party when courtroom, ters because 'there is the seeks to introduce novel scientific evi danger judge jury the trial will Blasioli, 153, supra dence. See degree certainty ascribe to the testi (“In A.2d at determining whether mony may ... not be ’ ...,

novel scientific evidence is admissible (em Blum, deserved.” 705 A.2d at 1317 Pennsylvania apply courts the test set added), 230, phasis quoting Topa, supra at added). forth in Frye (emphasis 369 A.2d at 1281. See also Commonwealth Topa, supra, See also involving a case 498, Rodgers, Pa.Super. A.2d Thus, novel methodology. (1992) 1228, 1234 scienti (stating, “Before apply every does not time science enters fically adduced evidence be consid the courtroom. admissible, ered it must first be shown that it meets the standard established supreme 17 The court reaffirmed the .”).6 Frye .. proper application of Frye adopted when it 207.1,

Pa.R.Civ.P. “Motion to Exclude Ex- Topa, Rodgers, 19 In both supra, pert Testimony however, Which Relies upon Novel supra, upon the cases which a 207.1, Blum, Scientific Evidence.” panel Pa.R.Civ.P. supra, of our court relied 5. Rule 207.1 thermodynamics, prop- did not take effect until after the such as the laws of case; however, clearly erly subject judicial trial in this it indicates are notice under ]”). Pennsylvania. Federal 201[ state of the law in Rules Evidence (emphasis Id. at 592 n. 113 S.Ct. 2786 Thus, added). though even the Daubert court additionally Supreme 6. We note Frye, recognized abandoned was Court in Daubert v. Merrell Dow Pharmaceuti- limited to novel scientific evidence. cals, Inc., 509 U.S. 113 S.Ct. court, supreme has Our which so far (1993), although abandoning L.Ed.2d 469 Frye test in favor of the Dau abandoned the Frye having superseded by test as been the Grady analysis, granted v. bert allocatur in Evidence, Federal Rules of nevertheless ob- Inc., Frito-Lay, (Pa.Super.2001) 789 A.2d 735 served: banc), (en to the issue whether the en address Although Fiye the decision itself correctly applied panel focused of this court the banc exclusively techniques, on ‘novel it the of the trial scientific law when reversed decision requirements we do not read the of Rule preclude [plaintiff’s] expert court to testimo apply specially exclusively 702 to or to un- Inc., Grady Frito-Lay, ny. 569 Pa. 800 course, conventional evidence. Of well-es- (2002) curiam). (per supreme A.2d 294 The propositions likely less tablished are to be parties the address the court also directed novel, Daubert, challenged than those that are and Frye, supra, supra, effect both Indeed, they handily suspect are more defended. analysis of Id. We on the this issue. firmly today ultimately theories that are so established as to here will that our decision law, the the same route. have attained status of scientific travel

1110 necessity Having prerequisites 21 delineated two regarding the for the statements that scientific Frye every applying Frye, time applying the standard nov- and that being the courtroom involved is offered the sci- science enters evidence sense, is, novel, Topa, the in we methodology; el scientific entific evidence some was or voice it that must methodology spectrography, must next ask what is be novel Frye, method- print analysis; the novel note about the science. We recent cases decep- systolic pressure was a blood sister ology this court and from our court from test, was alleged which determine applies tion that standard holding the telling an individual the truth. whether was methodology the the when either scientist Likewise, Rodgers involved DNA/RFLP7 scientist or the conclusion the reaches uses analyses performed on bloodstains found Blum, 705 A.2d at 1322 is novel. See Rodgers’ clothing. on the victim’s and the reading “A relevant (opining, close cases, Thus, in the context of those the analyze two yields ways ques- cases the Frye applied court that because the stated of whether causation tion the Clearly, methodology was novel. scientific Frye/Topa case meets the proffered this however, supreme our court did not intend the standard. One focuses whether apply trial courts be the required that relationship generally accepted causal is experts every standard time scientific community, and other by the scientific the trial, at to render an are called methodology generally is on whether nothing Kafkaesque that is result short ]”). by community[ accepted the scientific contemplate. panel deciding court of this ¶ We, dissent, are aware that like Blum, on McKenzie v. supra, relied West are at the heart of the scien- ebb and flow (Pa. Elec. 674 A.2d 1167 inghouse Corp., relativity theory tific method: is denied, Commw.1996), appeal Pa. it. only disproves valid until someone As A.2d 237 to reach conclu stated, howev- elegantly court so relationship that both the causal sion er, long way in go courts will “While generally accept must be from admitting expert testimony deduced community. ed in the relevant scientific well-recognized principle or dis- Blum, supra, the McKenzie According the deduction covery, thing Topa interpreted Frye to hold sufficiently is must be established to made “ showing, that that ‘there be a must par- gained general acceptance have causal establishing the studies relation Frye, belongs.” in which it ticular field generally accepted methodolo ship follow single, simple 293 F. existence of causal gies, but sentence, recognized accepted relationship general ac- admissibility the essence of ” community.’ Blum, relevant medical discovery can principle ceptance: McKenzie, 674 quoting A.2d at advances wayside fall as science Blum). (emphasis A.2d just way gener- it is not saying another our court affirmed supreme 23 While accepted. therefore conclude ally Blum, supra, Pennsyl- this court’s decision merely stating the law we are the fact that “the its affirmance on Frye applies only we state that based vania when supporting evidence at primary to novel science. Rodgers, signifies “deoxyribonucleic 605 A.2d at 1234-1235. acid 7. DNA/RFLP fragment polymorphism.” length restriction

mi C.J., 9, dissenting). drug (Cappy, at 764 A.2d at 5 conclusion that Bend[e]ctin [the Cappy in continued: appellant’s issue that caused birth As Chief Justice case] ... defect was so flawed as to render [the Superior I to the Specifically, refer expert’s] conclusions unreliable and there that are ‘two statement there Court’s fore inadmissible under either of whether ways analyze question Blum, 8, supra Daubert.” at 764 A.2d at ... testimony proffered the causation majority 4. The did not state that fo- meets the ... standard. One community generally scientific must have relationship cuses on whether the causal accepted relationship the causal about by the scientific generally accepted Rather, expert testify. which the is to in a community, and the other on whether quoting footnote from the Ninth generally accepted methodology Appeals, majority Circuit Court of community.’ by scientific “ stated, rely When a claims to scientist scientists, Noting supreme Id. that the court has “not practiced by on a method most conclusion yet presents by stated reached conclusions that are shared scientist, regarding no scientist causation must also be [trial] other id., wary Cap- should be the method not generally accepted,” has Chief Justice ” 5, been faithfully applied.’ Id. at 7 n. 764 py opined: A.2d at 4 n. quoting Lust v. Merrell Dow to an inqui- standard is limited Pharmaceuticals, Inc., 89 F.3d methodoloyies ry into whether the (9th Cir.1996) added).8 (emphasis con- which the scientist has reached her ¶ 24 Additionally, jus accepted we note that two clusions have been dissents, tices in Blum wrote strong community.... both the scientific It restricts McKenzie, specifically rejecting ad- supra, the scientific evidence which be Justice, its “two analysis. proffered bases” now mitted as it that the ensures Justice, Cappy, Chief research example, observ evidence results ing majority that the had not in a addressed which has been conducted fashion this court’s reasoning generally recognized being its affirmance of Blum, stated, sound, “I believe that and is not the fanciful creations matter Yet, important it is Superior renegade discuss the of a researcher. [sic] Court’s recitation of the it senselessly test as has such a standard is not re- potential testify mislead the lower courts strictive for it allows scientist to Blum, practicing and the bar.” supra at as to new conclusions have Blum, Done, Blum, 8. Judge explained "Epidemiolo- one of the Beck Blums' ex- perts, appeared recalculated data in a gy population samples deals with and seeks published study, results; one of the studies Justice generalize goes spe- those from the dissent, vigorously Castille so criticized in his cific, i.e., i.e., sample, general, infra, discussed because Merrell lead Dow's According population.” Id. at 1323-1324. journal witness was the editor Beck, Judge epidemiologists choose "While appeared, attorneys which it and because engage analysis their data and in statistical representing allegedly Merrell Dow edited the experimental popu- that their order ensure Blum, supra at studies. 14-15 and 15 n. biased, did Id. lations are not Dr. Done not.” (Castille, A.2d at 8 n. 3 J. dissent- Instead, Dr. Done eliminated all the 1324. 67-68, ing), citing slip op. trial court 70- simple and used arithmetic. standardization observed, “Epidemiological Judge Beck Id. As Nevertheless, Dr. re-calcu- Done based his analyses that are not standardized are general- lation on a that was not generally accepted.” Id. Blum, ly accepted. 705 A.2d at 1320. As

1112 community gen has

emerged during properly- the course of the relevant scientific and erally accepted principles the method conducted research. ology employs, the scientist not the conclu 9-10, C.J., (Cappy, at 764 at Id. A.2d 5 reaches, the before sions scientist Hence, dissenting) (emphasis original). in may testify. allow court See that Cappy Chief Justice concluded he Blasioli, 153, A.2d at supra at 713 1119. “squarely reject portion would that this court To the extent decisions of Superior holding Court’s re- Blum, Co., supra; Bend Thomas West conclusions, that a as quire scientist’s well Inc., 760 A.2d (Pa.Super.2000), ap 1174 methodologies as the in reaching utilized denied, 647, 566 A.2d peal Pa. 781 147 conclusions, generally accepted those are (2001); Industries, and Wack v. Farmland 10, community.” in the medical Id. at Inc., appeal 744 A.2d 265 (Pa.Super.1999), (Cappy, C.J., A.2d at 5 dissenting). denied, 649, Pa. 771 A.2d 1287 Castille, Similarly, Justice McKenzie, on have relying supra, followed dissent, provocative rejected and lengthy analysis, or referenced the two-bases we . opin- novel Commonwealth court’s “rather support so in doing can find no for our ion” that “the as to expert’s opinion Rather, supreme Frye analysis. court’s it issue, just relationship causal at not and analysis if appears as arose two-bases expert’s methodology, gener- must find confusing with “conclu “principles” acceptance al relevant scientific McKenzie, 1172, A.2d at sions.” See community before it even be heard.” quoting Rodgers, (opining 605 A.2d at 1234 (Castille, J., Id. at 764 A.2d at 7 dis- “ Frye/Topa standard ‘assures senting).9 most qualified those to assess the validity of method will general a scientific Finally, that the we note Su by requiring have the voice determinative Daubert, Court in preme supra, discussing principle discovery forming F.R.E. that “the explicitly stated fo the basis for evidence at presented trial ... must be on solely principles cus and gained general acceptance must have methodology, on the conclusions that ”) belongs[ it particular ]’ field to which Daubert, they generate.” 509 U.S. McKenzie). (emphasis in Thus, having 113 S.Ct. 2786. reviewed the history case law and the “two behind bas 27 In this trial relied on analysis, supreme however, es” we that our conclude two-bases analysis; inter- it, court has never and therefore conclusion adopted methodology twined such Frye only way hold that to determine if that we must discuss both.10 applies dissent, vigorously 'The case 9. In his Justice Castille it: in this demonstrates can be objected to the which Merrell Dow how "scientific created manner in consensus” through purchased manip- acceptance” research and allegedly "general obtained literature, of a funded ulation "scientific” in the rele- its and conclusions defense, part litigation as choreo- community. As Justice vant scientific Castille graphed by counsel.' observed: (Cas Blum, 13-14, supra at A.2d at 7-8 disagreed The trial court Merrell [with tille, J., dissenting), slip quoting op. Dow’s assertion the scientific commu- 46. experts' nity did not the Blums’ first, dissent, although pur- appears as for two because It if the conclusions] reasons: Frye's porting agree with us as to limita- it did not believe that conclusions causa- tions, fact, court, applies separate methodology needing like are a the trial tion second, ...; methodology. acceptance general be- to conclusions well as See succinctly put discussion [a]s cause ... the trial court infra.

1H3 from other fields of distinguishes science observing ques that there is no begin by ” Daubert, at 509 U.S. inquiry.’ human community gen that the scientific has tion Green, Expert 2786, 593, quoting 113 erally principle the basic Dr. S.Ct. accepted Sufficiency of Evidence and “Dose-Response” The Witnesses employed, Shane Litigation: The old as in Toxic Substances principle. principle This is not as Legacy Agent Orange Bendectin and by an en of pyramids panel cited banc Inc., Litigation, 645 Nw. U.L.Rev. Grady Frito-Lay, court in 789 86 this (en (1992). differently, the scientific Stated (Pa.Super.2001) A.2d 742-743 banc), in which “a method of research granted, allocatur 569 Pa. 800 method is identified, are a relevant data referring problem A.2d 294 when to crush is formulated from compression strength gathered, hypothesis and calculations. Nevertheless, data, hypothesis empirical- and the dose-response principle these century ly Encyclopedic when tested.” Una- originated the sixteenth Webster’s Paracelsus, Lan- bridged Dictionary English and alchem of the physician Swiss (1989). (“Webster’s”) and 1279 Within guage ist born 1493 considered some Toxicology,” meaning be the “Father of revolution of the definition of the scienti- method, “empirical” “provable fic or disciplines chemistry ized the and medi means “ statement, by experience experiment.” verifiable Ding cine with his ‘Alie sind Gift; of the Key aspects Gift und nichts ohn alein die Dosis Id. 468. verify Ding ability

macht das ein kein ist” method include the to test or [all Gift things poison experiment by parallel exper- are and not without a scientific poison; only thing poi comparison the dose makes a not a iment or other standard of (control) Krieger, replicate experiment C. Foreword on and to son’].” William 318-319, Response, 1217. Paracelsus —Dose or reduce error. Id. expose Academic Handbook of Toxicology, Press: Pesticide In accepted this court (2d ed.2002).11 at xxvii-xxxiv According as it related to “methodology” Dr. Shane’s = me2, Krieger, exception E “With Trach’s immediate adverse reactions perhaps no' other single statement has PDR and Doxepin overdose based on the establishing pop wielded such force in other studies un epidemiological ular notoriety professional and the stature (Trial findings. opinion, its derlying history of an individual in the of science 21.) rejected Dr. The trial ....” Id. atxxvii.12 “methodology” long-term as to the ¶ Next, however, Dr. meaning Doxepin, we address the effects of because texts, studies, “methodology” purposes Shane did not refer accep indicating general Supreme test. As Court observed other sources Daubert, as to those effects. supra, methodology “‘Scientific tance of his (Id. 30.) “Dr. opined, trial court today generating hypotheses is based on As the were opinions if on these issues testing they them to see can be Shane’s falsified; indeed, reasoning general on his own is what based Blum, recognized has the ven- experts, 12. At least one court In one of Blums’ Gross, erability principle. States v. applied dose-response principle to of this United 2,116 Weighing Approxi- Boxes Boned determine the effect of Bendectin on humans Beef 154,121 Pounds, al., studies, F.Supp. mately et solely relationship based on animal (U.S.D.C. 1981), quoted widely acknowledge Kansas the court is not which scientists " 'the dose proposition corroborating data. Paracelsus for reliable without human ” Blum, poison.’ Id. at 327. A.2d at 1320. determines

toxicological principles. There is no evi- where medical literature is silent with any regard techniques dence that other of the med- to certain or members treat ments," community ical lack1 written share his conclusions of materials (Id.) reasoning necessarily concur in his fatal to the process.” [propo be claim. nent’s] ¶ particular 30 The trial court relied in Hamilton, 466, 472, Pa. 715 Gala analysis on this court’s Checchio v. (1998).13 1108, 1111 A.2d Division, Hospital-Torresdale Frankford A.2d (Pa.Super.1998), appeal de ¶ thought 32 As with the two schools of nied, 633, 566 Pa. 781 A.2d 137 doctrine, Frye’s general acceptance stan- support expert’s its conclusion that an tes requires only dard that the scientific com- timony must be based on more than his or munity generally accept principles her own observations and experience proceeding from which the scientist is field, without reference outside is employing scientist (Trial opinion, sources. 29- Assuming to reach his or her conclusions. 1062.) Checchio, citing 717 A.2d at properly qualified testify, analysis find error in court’s her as Shane was his or two reasons. expertise, appropriately brought to bear on the ac- through issue use of expert testimony 31 As noted supra, cepted principles scientific and methodolo- required only knowledge where the is “be- gy, pass Frye. should also muster under yond that possessed by layperson” a only by be offered a witness with Furthermore, clear pretension specialized “reasonable method, definition of the scientific set forth knowledge subject on the investiga- under supra, extrapolation, one of the meth- tion.” Pa.R.E. 702 and Comment—1998. odologies Dr. Shane used to conclude that supreme recently As our observed a massive overdose could result thought” the context of the “two schools of in permanent exacerbated adverse and/or doctrine: effects documented at the recommended dose, fact,

Limiting logical evidence to medical literature is not science: in it is a preventing would have the effect of ex used “to estimate the of a method value pert from testifying to the variable outside its tabulated or observed witnesses (that thought range” existence of school of based on or “to infer which is not known) experience practitioners their and on from that which is known.” Web- they during question information obtained their ster’s 505. The then becomes training attending although medical and while lec whether not sci- extrapolation, ence, programs methodology generally accepted tures and other educational is a sponsored by profes institutions and and used scientists within the relevant Furthermore, community.14 sional societies. in cases fact, might reasonably why lidity applying principle of one wonder statistical 13. probability analysis expert testimony at all if the to DNA forensic and then would be needed Blasioli, admitting the into evidence. parties merely results could refer medical texts supra at 713 A.2d at 1119. The Blasioli positions. and treatises to their admissibility court therefore addressed appar- testing Pennsylvania appellate courts have both the results of DNA and certain ently admissibility probabilities testing using not addressed the of scien- derived from that methods, testimony extrapolation. product based on Our two statistical rule tific court, however, supreme recently ceiling principle. 713 A.2d at decided Id. observed, “This case in which the defendant attacked the va- 1118. As the Blasioli court very rare form no Neuroblastoma is 34 While we have found Penn cancer, occurring young chil admissibility usually sylvania discussing cases of nine out of dren and infants a rate extrapola of scientific based on tion, community in which million. Id. The we have found several cases decided one recorded 520 live jurisdictions other which have ad the four children lived Statistically, a small in 1988. such admissibility extrapolation dressed the births record a case of neurob- recog community evidence under the test. however, cases; every years; 29 nize that we are not bound these lastoma once 1991, however, August March 1989 and may guidance we use them for to between community recorded cases of neuroblasto- degree we find them useful and not See, teenager. one Id. Pennsylvania with law. ma three infants and incompatible Services, warned e.g., Gutteridge published v. A.P. scientific research Green While “ Inc., 643, (Pa.Super.2002) ‘among power 804 A.2d 651 tar was the most coal ” exist[,]’ id. at (opining carcinogens that “Federal court decisions do ful known to 319, 68, 854, not control the of the Ill.Dec. 767 N.E.2d at Supe determinations 262 (citations Court[]”) omitted); quoting rior on Manufactured Com the Handbook Santarelli, Gas, Super. community monwealth v. 334 Pa. had been (1984) 589, 895, (observing, 483 A.2d 900 limited the small number of neuroblas- receive to link per ability specifically “We decisions as toma cases its [out-of-state] authority binding development suasive but not tar with prece exposure to coal ]”) (citation omitted), 85, 854, Ill.Dec. cert. denied sub neuroblastoma. Id. at 262 dent nom. Steingraber Pennsylvania, 476 767 at 328. N.E.2d 1116, 1973, U.S. 106 S.Ct. 90 L.Ed.2d 656 Furthermore, plain 37 as one of the (1986). mind, With the foregoing in we experts explained, tiffs’ ethical consider extra-jurisdictional consider these cases. exposing humans to coal prevented ations 87, Donaldson v. tar for Id. at 262 purposes. Central Illinois research Co., 63, 854, Public Service 199 Ill.2d 262 Ill. Ill.Dec. 767 N.E.2d at 330. Addition 854, not exposure Dec. 767 N.E.2d 314 for exam is often ally, environmental illness, ple, thereby the plaintiffs, parents who were of four detected until the onset of study exposed during preventing settings children to coal tar controlled result, clean-up of a gasification plant exposure. former coal effects of Id. As site, the chil brought against experts suit Central Illinois testified on behalf of who (“CIPS”) similar, extrapolated Public Service Co. and three of dren but identical, According its contractors. to conclude parents, to the studies and theories neuroblastoma, chil exposure their children caused the developed that coal tar 88, Ill. form Id. at pe rare of cancer that attacks the dren’s neuroblastomas. 854, These ex ripheral system, nervous as a result of Dec. 767 N.E.2d at 330. specializ by perts epidemiologist or included an various acts omissions committed cancers, toxicologist during ing its in childhood CIPS contractors and/or 65-66, 854, biology, and clean-up. specializing Id. at 262 Ill.Dec. molecular occupational physician specializing 767 N.E.2d at 317-318. li, however, general accep- recognized, generally required that both the court has theory technique underlying require novel scien- una- tance of a does not generally accepted.” 168, (citations be tific evidence must nimity. Id. at 713 A.2d at 1127 1119, Crews, 153, citing Id. at 713 A.2d at omitted). 522, supra at 640 A.2d at 402. As the Blasio- 74, extrapolate weight environmental medicine. Id. at affects the of the testi 854, Ill.Dec. 767 N.E.2d mony admissibility. rather than its Id. at 854, Ill.Dec. 767 N.E.2d jury 38 The returned a verdict favor (citation omitted). plaintiffs against CIPS alone million, the amount of and the inter- $3.2 ¶ 40 and our supreme As this court mediate court affirmed. appellate ap- On have the rationale recognized, behind the court, claimed, peal supreme to the CIPS attempt to measure test alia, inter that the trial court erred when quality prior of scientific evidence to its “ the-extrapolation testimony it admitted be- danger admission because ‘there is the pass cause did not muster under the judge jury that the trial will' ascribe a Frye test. Id. at 262 Ill.Dec. 767 degree certainty N.E.2d at 323. ” ... not be deserved.’ analysis, 39 In its Donaldson court Blum, 1317, quoting Topa, 705 A.2d at out parameters Frye, set of much as 230, supra at 369 A.2d at 1281. The Don we have supra. done The court then ad court, concern, acknowledging aldson admissibility dressed the extrapolation of observed, however, that “the method of evidence, reviewing prior Illinois cases as extrapolation technique does not concern a case, well appellate as federal Fer new to science that instill a sense of Co., v. ebee Chevron Chemical 736 F.2d carry misleading ‘false confidence’ or denied, (D.C.Cir.1984), 1529 cert. ” 469 U.S. 86, ‘infallibility.’ sense of scientific Id. at 1062, 545, (1984), 105 S.Ct. 83 L.Ed.2d 432 (cita 854, 262 Ill.Dec. 767 N.E.2d at 329 upheld which the admissibility extrapo of omitted). tion As the Donaldson court testimony lation under facts similar to the continued, “[Ejxtrapolation by nature ad Donaldson, facts of this case.15 199 Ill.2d fallibility specific sup mits its lack of —the 86, 854, 262 Ill.Dec. 767 N.E.2d at 328- port to establish the existence of a known observed, 329. As the Donaldson court 87, relationship.” cause and effect Id. at “extrapolation commonly used scien (cita 854, 262 Ill.Dec. 767 N.E.2d tists certain limited instances ... omitted). result, tion As a the Donaldson example, inquiry when the medical is new court concluded that the trial court did not opportunities or the to examine a specific admitting testimony plain err in limited; relationship cause and effect are 88, 854, experts. tiffs’ Id. at 262 Ill.Dec. when the number of study cases limits 767 N.E.2d at 330. disease; or, supra, as noted when ethi Ferebee, an supra, employ- involved cal prevent considerations indi exposing to a long-term exposure ee’s chemical her- viduals to a toxic substance for research bicide, manufacturer, paraquat, its 85, 87, 854, Id. at purposes. 262 Ill.Dec. (“Chevron”), ac- Chevron Chemical Co. 328, According 767 N.E.2d at is, “acutely knowledged was toxic—that court, expert Donaldson when an relies any injuries resulting exposure upon discussing scientific literature simi lar, identical, paraquat very occur short time but not cause and effect rela within ... tionships, exposure exposure the fact that must and that when 316, 327, 36, Cal.Rptr.2d P.2d 15. We will discuss Ferebee We are Cal.4th infra. (2000) recognized aware that numerous courts have (collecting finding 371-372 cases Inc., Cipollone Group, Liggett v. 505 U.S. preemption analysis long- is no Ferebee’s 112 S.Ct. 120 L.Ed.2d 407 law). not, however, good Preemption er abrogated analysis. preemption Ferebee's disposition relevant to our of this case. See, Service, Inc., e.g., Etcheverry Tri-Ag

H17 Ferebee, first alert ceases, may have been the injury.” so too does the his doctors Ferebee, case, his recognize 736 F.2d at 1585. and later does enough to such estate, claimed, however, that Ferebee ul- testimony of those not mean that timately pulmonary died from fibrosis doctors, quali- concededly who are well by long-term exposure paraquat caused fields, not have been fied in their should poisoning. Id. at 1533. admitted. theory, 42 In its Ferebee’s (emphasis original). Id. at 1535-1536 presented estate of Fere- Ferebee, scientific ev- substantial treating physicians,

bee’s who were both as to the acute adverse ef- idence existed medicine, as specialists pulmonary ex- intense, exposure fects of short-term They pert per- witnesses. relied on their if any but little evidence existed paraquat, of Ferebee and tests sonal observation exposure pro- low-level over a linking him, as well as they performed “upon longed long-term side effects: period which, asserted, they sug- medical studies ex- our substantial scientific evidence gested that absorption paraquat dermal ists as to the acute adverse effects lung can lead to chronic abnormalities of dosage, taken its recommended pulmonary the sort characterized as fibro- if any linking but little evidence exists Finding Id. experts’ opinions sis.” extremely high-level dosage long-term admissible, to causation the Ferebee court issue, Addressing this side effects. opined: Ferebee court observed: Thus, a cause-effect relationship need have Judges, appellate, both trial and no clearly not be established animal or the com- special competence to resolve epidemiological studies before a doctor plex refractory and causal issues raised that, testify opinion, can in a his such attempt exposure to link low-level relationship long exists. As as the basic to toxic chemicals with human disease. methodology employed to reach such these, questions On such as which stand sound, conclusion is such as use of tissue at of current and the frontier medical tests, samples, standard and patient ex- epidemiological inquiry, if are experts amination, products liability law does not exists, willing testify that such a link preclude recovery until a ‘statistically jury it is for the to decide whether to significant’ people number of have been testimony. credit such injured or until science has had the time complete sophisticated and resources to Id. at 1534. laboratory studies of the chemical. In a ¶ 44 find the facts of this case even courtroom, allowing plain- the test for Ferebee, than facts of compelling more tiff in type to recover a tort suit of this Donaldson, on the supra, supra, based certainty legal is not scientific but suffi- that a sub- stronger logical even inference jurors if ciency; reasonable could con- side effects stance known to cause adverse clude from the likely to cause its recommended dose paraquat likely more than not caused of the same or similar heightened level injury, Ferebee’s the fact that another taken in a massive adverse effects when jury might opposite reach the conclusion overdose. require or that science would more evi- court’s set forth the trial We have conclusively considering dence before testimony, summary of Dr. Shane’s question resolved is irrele- causation in minute detail explained which Dr. Shane vant. That Ferebee’s case have chemis- works on the brain’s type, Doxepin been the first of its exact or that how 97, 101, A.2d 496 Pa. and contraindica- try; the adverse effects Frye, (emphasis 293 F. at 1013 quoting doses as Doxepin therapeutic tions for Nazarovitch). trials and clini- through clinical determined description the PDR’s experience; cal agree we with the trial contraindications; those side effects which Dr. Shane thing that the works on the manner that a massive overdose of Doxe- deduced vision, anticholinergic especially its “known symptoms Trach’s acute has pin caused which, even its recommended effect” sufficiently established have been can excessive dilation of dosage, cause particular in the general acceptance gained dilation, in eye. Prolonged pupil of In the case of belongs. field to which loss, turn, thereby pigmentary causes reactions, “the the immediate adverse pigment deposited to be causing of the clinical trials thing” consists Schlemm, system filter at the Canal Doxepin at thera- experience clinical with also clogging up the filter and further in the PDR dosages, documented peutic eye. pressure in the causing increased manufacturer’s inserts. (Trial 7-10, citing at opinion, 5/18/00 court, howev the trial Unlike 198.) testimony, at notes of 6/16/99 er, dose-response we conclude that pigmentary clogging loss and result of ac principle Shane used type glau- pigmentary glaucoma, community. We in the scientific cepted from which Trach suffers and which coma extrapolation, the meth also conclude Naidoff acknowl- Drs. Moran and both used to deduce odology Dr. Shane glaucoma. edged open-angle is a form of including glau symptoms, Trach’s chronic (Notes 116; Nai- testimony, 6/17/99 coma, Doxe were the result of massive 17.) deposition, doff overdose, novel nor “scienti pin is neither ¶46 regard cognitive to Trach’s With has, Extrapolation fic” in strict sense. its difficulties, that Dr. Shane testified however, in the gained general acceptance tests negative neurological results of the limited community under certain scientific Doxepin administered to Trach after circumstances, supra. As the delineated supported the system his further cleared opined, Ferebee courts as Donaldson and a ingestion conclusion that of massive methodology employed long as basic problems. caused his Doxepin overdose of sound, as a conclusion is such reach such Shane, MRI or According to Dr. an EEG tests, and samples, of tissue standard use sys- and some nervous will reflect tumors examinations, may ex the scientist patient diseases, reflect chemical tem but will not scientific basis from this sound trapolate drug aby such as those induced changes, it either or unethical impossible when (Notes at testimony, of overdose. 6/16/99 trials that the sorts of clinical perform 208-215.) Donaldson, definitive results. yield observed, citing at Ill.Dec. 767 N.E.2d supreme 47 As our Ferebee, As the F.2d at 1535-1536. long way go courts will a “‘[W]hile courtroom, continued, “In a testimony deduced from Ferebee admitting expert allowing plaintiff to recover the test for principle or dis- well-recognized type of this is not scientific thing which the deduc- a tort suit covery, Ferebee, sufficiently certainty legal sufficiency!/]” but estab- made must be tion is jury, for the F.2d at 1536. It was gained general acceptance have lished to fallibility extrapolation, it be- aware of particular field in which ” Nazarovitch, testimony was whether Dr. Shane’s decide longs.’ Commonwealth supported It’s Randall Bassault. Drug, through It was for Thrift credible. cross-examination, will Ellenhorn vigorous prove other textbooks. today nothing

it I said. I said was not. what have by medi- jury supported to this that isn’t dissent, agreeing 50 The while cal literature. an extrapolation acceptable methodolo- finds, however, that is neces- gy, remand not in the medical literature What’s sary purportedly because Trach did not that distal end of the how does block opportunity adequately to estab- have synapse? We don’t know.... underlying scientific foundation lish counsel did not Id at 220-221. Defense extrapolated, from which Dr. Shane object to Dr. Shane’s references Drug opportunity Thrift did not have an Dr. challenge accuracy texts or (Klein, J., challenge that foundation. dis- representations of that literature. 17.) fact, at senting agree. We cannot only challenge came dur- Defense counsel’s to this complete

we find the record as examination, with reference to ing direct issue. to which Dr. specific content of text stated, already have 51 As we (Id 206-207.) In re- referred. at Shane extrapolated from the known ad- Shane stated, wit- the trial court sponse, “[T]he Doxepin verse effects recommended give can his which he’s ness doses, documented in the PDR and the into the authoritative taken consideration Trach manufacturer’s inserts. introduced specifics text but he’s not state into evidence a three-column chart show- text. That would be considered ing symptoms taking Trach’s after Doxe- under Penn- hearsay violation of the rule pin, the reflecting manufacturer’s insert (Id 207.) sylvania Rules of Evidence.” possible adverse reactions and contraindi- expresses 53 The dissent also Doxepin, cations and the PDR’s enu- signifi concern that our review has been meration the same adverse reactions trial court’s re cantly hampered by the (Notes and contraindications. of testimo- evidence versing taking any itself without 192-194, ny, and Plaintiffs Ex- (Klein, J., dissenting at on the issue. 10.) information, upon hibit Based as 6.) recognize n. disagree. We following well Trach’s medical records Court, as an error-correct Superior “[t]he overdose, Dr. extrapo- Shane court, to reverse a ing purport lated to reach his ultimate conclusion. only for trial court’s order where the basis ¶ Additionally, 52 our review of the rec- is a claim that the re finding of error ord indicates that defense counsel cross- the trial court sponsible party gave never underlying examined Shane as to the Harber Phil to consider.” opportunity an extrapolation testimony, basis for his to LPCI, City Ltd. v. adelphia Center Office responded: which Dr. Shane 1100, 1105, ap (Pa.Super.2000), 764 A.2d today I have Every opinion given 566 Pa. 782 A.2d peal denied very definitely in the medical supported (2001). things It’s that supported literature. ¶ case, opined, In the trial court every desk this physician’s are available on of a to the effects Physician’s opinions [as Reference. “Dr. Shane’s like the Desk Doxepin] were based overdose of supported It’s the medical literature massive toxico- reasoning general from sup- It on his own by the various textbooks. (Trial opinion, logical principles.” ported the medical literature 30.) trial court contin- As the written toxicology textbook on his supported that the literature ued, any that other testified “There is no evidence have been cross-exam- opinion, he could community medical share members of the While the regarding ined the literature. reasoning or concur his his conclusions (Id.) may have made a tactical decision defense find that the process.” We therefore cross-examination, as the dis- forgo to to opportunity trial court had the first surmises, grant- it should not now be sent community address whether the scientific to do so. opportunity ed a second based generally accepted extrapolation has and erred dose-response principle on the ¶ opportunity did have an 3 The defense in its conclusion. challenge explore the literature ¶ opinion; of Dr. it chose not basis granting new trial as 55 Order to do so. jury’s verdict damages is vacated and denying Order of million is reinstated. $5 KLEIN, J., dissenting. liability

j.n.o.v. or a new trial as is remanded damages is affirmed. Case ¶ majority 1 I with the that a agree Drug’s trial to address Thrift for the Frye16 can meet the stan- expert medical regarding motions the excessive- post-trial by extrapo- in unusual circumstances dard and, turn, Trach’s ness of the verdict theories.17 lating generally accepted from delay damages. Jurisdiction is motion However, judge at no relinquished. Frye hearing, and from point conducted whether record we cannot determine SOLE, J., DEL P. files a testimony did or did not meet Dr. Shane’s Concurring Statement in Therefore, I Frye standard. MUSMANNO, joins. J. If hearing. full it is remand for a was standard determined ¶ KLEIN, Dissenting J. files met, need for a new there would be no LALLY-GREEN, in which J. Opinion met, was not If the standard trial. joins. trial.18 there should be a new then SOLE, P.J., concurring. DEL supports premise itself join opinion my colleague, 1 I extrapolation can make an separately Elliott but write Judge Ford principles. well-recognized scientific dissenting point address a raised Frye the court said: Judge Klein. or dis- principle a scientific Just when the ex- covery the line between majority opinion as crosses 2 I do not view the stages and demonstrable position by failing perimental “takfing] the in this to define. Somewhere that the litera- difficult challenge Dr. Shane’s claim trial, the evidential force twilight zone during theories supported ture his and while recognized, must be principle the litera- has conceded that the defense way admitting go long will Dr. courts supports in fact exist and ture does (Klein, a well- testimony deduced from Op. at 1106 opinion.” Slip Shane’s or discov- Rather, recognized principle scientific once Dr. Shane dissenting). J. States, (D.C.Cir. necessary would be because 18.A new trial Frye v. 293 F. 1013 United 16. not be entered on a judgment n.o.v. should 1923). Treegoob,433 Pa. record. Jones v. diminished (1969); Hughes v. A.2d 352 John Frye objection was agree that the I also Sons, Pa.Super. 144 A.2d & Hanna the in limine. properly preserved in motion (1958). H21 ¶ Therefore, the I would remand case deduction ery, thing from which the Frye a full sufficiently the trial court to conduct is made must be established gained general acceptance testimony passes to have in the If Dr. Shane’s hearing. particular belongs. muster, field in which it is no need for new Frye there muster, pass If it does not trial. 293 F. at 1014. in order. then a new trial would be ¶ go 3 The statement that “courts will testimony long way admitting expert administered to Mr. dosage 7 Since the well-recognized from a deduced Doxepin anti-depressant drug Trach of the long principle” supports extrapolation, so far in excess of the recommended was thing as “the from which the deduction is drug had dosage, prescription sufficiently made established to have [is] (R.R. 339a, discontinued been Id. gained general acceptance.” 6/16/99, 185, 196), there were not p N.T. significant studies deal- any and will not be procedures by conducted receiving this ing with humans massive judge in the instant case had the (R.R. 385a, p. overdose. N.T. 243- given op- result that neither side was 44). portunity put testimony on the kind of that would enable one to determine wheth- Frye, As I view the basic issue er Dr. Shane’s is or is not based on testimony this case is whether Dr. Shane’s generally accepted underlying principles. permanent caused Trach Mr. judge The trial ruled on first a motion in injury sufficiently reliable be admit- healing, limine without ruling that majority, jury. ted to the As noted allowing standard was met and Dr. jurisdictions permitted expert other have Then, testify. post-verdict Shane on extrapolate general- witnesses to based on motions, again without any Frye hearing ly recognized principles. medical There is taken, any and without evidence being why ap- cannot use this no reason we

judge testimony held that Dr. Shane’s did proach Pennsylvania. not meet the standard. 9 To boil the down its ¶ 5 Dr. Although extrapolations elements, pres- when glaucoma caused reasonable, seem the record is not clear eye. in the This occurs up sure builds enough to underlying demonstrate that the eye when fluid in the is not drained upon basis which Dr. Shane relies for his through of Schlemm. The de- Canal extrapolation meets the standard. said that the side effects experts fense At stage, the motion in limine without a Doxepin only “closed-angle” cause hearing, the was unable to chal- defense entry glaucoma, when the Canal lenge underlying basis of the literature and for this reason Schlemm is narrowed say which Dr. Shane relied to that the up eye. According pressure builds drug Doxepin pigmentary “open- caused or defense, suf- type glaucoma angle” glaucoma. post-verdict At the mo- “open-angle” fered Mr. Trach is stage, hearing plaintiff tion without a essentially re- pigmentary glaucoma, which was unable to refer to the literature that lost from the iris pigment sults when extrapolations. his When system the filter up and blocks did refer to literature in the Shane Canal of Schlemm. trial, course of the the references were ¶ the mas- Pennsylvania 10 Dr. testified as to precluded because under Shane Trach law, subject that Mr. hearsay, textbooks are not to sive overdose testified that addition any received. He exception. definitely in medical lit- very the ported the Canal closed-angle compression of n Schlemm, pigmentary there would be that supported things It’s erature. pupil dilation of the loss from the excessive every desk physician’s are available on the filter of eye, clog which would Reference. Physician’s like the Desk causing pres- the Canal of Schlemm in the medical literature supported It’s That would result sure to build. toxicology written textbook from which permanent glaucoma kind of by oth- supported Randall Bassault. It’s (R.R. 340a, 347a, 349a, Mr. Traeh suffers. support textbooks—Ellenhorn will er 225.) 205, 207, 367a; pp. N.T. 6/16/99. nothing today I I said have said. what Shane, Dr. extrapolation by is an This by medi- supported that isn’t jury to this Doxepin, therapeutic since with doses cal literature. usually closed-angle glaucoma. the result is not in the medical literature What’s makes sense if 11 The extrapolation end of the it block the distal how does premise if Dr. basic only Shane’s And we We don’t know. synapse? correct, is, Doxepin causes loss of that that history on massive don’t have a lot of this, about Dr. pigment. When asked drug has been out several textbooks. overdoses because Shane referred However, already had testimony since his have sufficiently long favor that folks admissible, background these been ruled popu- It has not been a not overdosed. were inadmissible hearsay under texts or pop- lar—it has not been an available Pennsylvania Rules of Evidence.19 drug. ular street attempted to minimize 12 Dr. Shane trial, explore did not 13 At the defense open-angle and the distinction between Therefore, of the literature. the contents he re closed-angle glaucoma, but when presented literature was not because the literature, using published ferred to the trial, the record neither by either side Eye New York and Ear as an example, Dr. nor contradicts the bases of supports objection and the defense raised rule opinion. improper It is literature is inadmis judge ruled such un- discarded opinions that his should be Pennsylvania state courts. hearsay sible (R.R. 6/16/99, ex- 347a-349a, 366a; when the trial court never pp. der N.T. 224). 205-207, chal the defense When the literature to see whether or plored Shane, saying there is lenged Dr. from extrapolation for his there is a basis his nothing in the literature therapeutic doses the results found that the results replied Dr. opinion, Shane Doxepin. Doxe why although literature were Likewise, not have did defense unknown. these results was causes pin literature explore opportunity (R.R. 362a-363a, N.T. opinion Dr. Shane’s challenge the bases of 220-221) as follows: pp. reads no hearing. There was post-verdict at a medical nothing Q. But there’s limine, litera- hearing at the motion literature states trial, during not at issue ture was to- the courtroom you’re giving here in at the hearing post-verdict there, there was no day. Is sir? could be evalu- where the literature stage Oh, absolutely. Ev- [By Shane] A. underlying premise. to examine this today sup- ated given I ery opinion have exception hearsay adopted the federal has not to Section 19. See Pa.R.E. comment treatises). learned (noting Pennsylvania Learned Treatises func- “gatekeeper” approach sense majority position takes the 15 The comes to claim court when it failing challenge Dr. Shane’s tion of the trial theories supported that the literature his scientific evidence. trial, during the defense has conceded that analy- this I we can conduct 18 believe and sup-

the literature does fact exist simple principles. four by following sis However, ports opinion. Dr. Shane’s the Frye applies to scientific 1. might fact that it majority overlooks the legitimate dis- whenever there is strategically not have been wise for the expert’s con- pute as to whether the at trial. explore defense to the literature general- clusions or are trial, By the time Dr. testified at Shane ly accepted. already the defense had lost the issue general- If conclusion is expert’s 2. stage. During at the motion limine no need to ly then there is accepted, trial, the defense had to be concerned methodology. or her evaluate his case, not about estab- winning about lishing challenge ruling a record to on gen- If conclusion is not expert’s 3. major the motion in limine. In a mal- then must de- erally accepted, courts practice lawyers legitimately underlying termine whether challenge not want to focus on a detailed methodology is rehable. jury to distract literature challenger 4. The bears the burdens of they points other make on cross-examina- production proof. issue, Having already tion. lost the the motion with- deny court should it is unfair to hold the defense conceded hearing out a unless the movant has point simply they put because did not supported prima presented enough evidence at trial to support their that the is not case evidence facie Frye arguments. The time to establish a generally accepted. Frye hearing, record is at a outside the analysis A detailed follows. presence jury. If this does not take limine, place on a motion in it should take Frye applies to scientific testimo-

place a ruling post-verdict before on mo- legitimate ny whenever there is (both problem tions. The in this case expert’s dispute as to whether us as an appellate par- court and for the methodology are ties) conclusions or is that neither side ever had the generally accepted. proper opportunity develop a record to position Frye. their Pennsylvania law often states ¶ Therefore, appellate we as an sci- applies standard “novel” cannot determine whether or not the basic See, 207.1, Explana- e.g., Pa.R.C.P. ence. premise upon extrapolat- which Dr. Shane As noted tory Comment—2001.

ed to reach his conclusion is does not neces- majority’s opinion, “novel” is, If it then the accepted extrap- science. A consider- sarily mean “new.” careful not, justified. If it then the olation is rationale purpose ation of fails the basis of the extrapolation because referring that the are shows Courts extrapolation supported. is not “novel,” not the first. meaning of second “new;” can mean the term “novel” of While interpretation have made the We precedent” no “having can also mean Frye principle complex. far too “unusual.”20 up with a common- should be able come (1966). nary Dictio-

20. Webster’s Third New International ¶ majority many years, 20 The states that the evi- in existence for and are cer- dence “in tainly being must some sense” be novel. Id. in the sense of “novel” Supreme Our Court’s decision Blum “cutting-edge.” today new or Yet even does not Frye applies address whether technology generally is still not ac- science, only to novel and therefore does community. cepted the scientific More- not concern itself with a definition of “nov- over, a or view of temporal technological Supreme opinion el.” The Court’s dealt “novelty” unreasonably hamper'the would controlled, with whether Daubert or trial judge’s gate-keeping function to en- majority and for that reason the of the methodology gen- sure that all scientific Supreme Court did not that ques- address erally accepted presented before it is to it, Only tion. the dissenters raised which jury. obviously does not inquiry. end our Nor time, At a reading the same broad any

have I found other controlling prece- phrase that Frye applies “whenever dent. may conjure science enters the courtroom” Judge 21 As Beck noted Blum up Frye hearings a vision of in every case. Pharmaceuticals, Blum v. Merrell Dow That also is not true. One should not Inc., 1314, 705 A.2d 1317 (Pa.Super.1997), confuse the issue of the standard deter- aff'd, 564 Pa. 764 A.2d 1 Frye is admissibility mine and the issue wheth- designed to ascertain whether the scienti er trial court should hold a hear- fic reliability evidence is of sufficient to be ing. expert’s opinion Sometimes the presented jury. Judge Beck said: clearly accepted by the communi- scientific

The test an represents attempt to ty challenge, and there is no and therefore quality measure the of scientific evi- hearing no will occur. For no example, admission, prior jurors dence so that Frye hearing one would ask for a if an are not misled unreliable evidence. expert testify that antibiotics are Our courts have considered this to be helpful treating infections. An example necessary whenever science enters the opinion in this case is the that if pressure courtroom danger because “there is the eye, builds in the glaucoma may result. judge jury that the trial or will ascribe Although theoretically Frye apply could degree certainty testimony testimony all from every expert, ... which not be de- opponent in most cases the will raise no served.” challenge. general For medical widely accepted, responsible that is no law- (quoting 705 A.2d at 1317 Commonwealth yer Frye hearing would ask for Pa. Topa, 471 369 A.2d irresponsible lawyers would be sanctioned. (1977)). Also, if petition and answer show term, a confusing Just as “novel” is real question expert’s there is no that the it confusing say also applies is. ac- or “whenever science enters the courtroom.” cepted, the matter can be decided without way better phrase say The is to summary akin to hearing on standard Frye applies party whenever a claims that judgments. opposing expert’s theory meth- and/or odology generally accepted. hope is not I While would than methodology need not be “new” or involve future we would use a term other technology. talking Frye ap- a definition “novel” when about when cutting-edge Such unreasonably plies, narrow. if defined as no “having of “novel” would be “novel” is unusual,” example, precedent For lie detector tests have been this fits with the

H25 step. The second move to a second I that the must developed. law as it has believe standard, meth adopted underlying I think is on the step would focus proper by majority, Frye properly the is that the step would arise where odology. This testi- governs admissibility expert the gener not reached conclusion has expert’s old; a mony, new or whether there is is based the acceptance, al but legitimate gen- as whether it is dispute to As the accepted procedures. generally If then erally accepted. that is the it, phrased Jersey Supreme Court New a challenge the trial court will need hear yet that has not theory of causation “[A] probably hearing. hold a But the may found general acceptance be reached Frye need for a determination will be rela- if it on a sufficiently rehable is based to be tively rare. sound, meth adequately-founded scientific and information of odology involving data gener- expert’s 2. If the conclusion is experts in reasonably relied on type the ally accepted, then there is no Landrigan v. Celotex the scientific field.” need evaluate his her meth- to or 1079, A.2d Corp., 127 N.J. odology. (1992) (quoting Rubanick v. Witco Chem. ¶ 25 As for how the court should conduct Corp., 125 593 A.2d 747-48 N.J. propose two-step the I a sensible inquiry, (1991)). approach. step The first would to de- be opinion expert the of the 28 When general- termine whether the conclusion is accepted, the trial court generally not ly accepted, as discussed above. Some a to examine the hearing should hold (including relating conclusions some and information. The methodology, data causation) generally accepted: e.g., are examine the basis of the court should symptoms. botulism causes certain If the methods, whether the data was the general can acceptance conclusion reasonably in the field experts sort that established, why be should courts delve so, should be admitted. opinion use. If the theory into methods? Once the causa- tion has been admitted the court above and the meth- 29 Both the conclusion generally accepted, usually that will be at different odology may important, but be inquiry the end of the and the evidence analysis. points in the will be admitted. ¶ However, where there is a claim challenger bears the burdens 4.The body opinion changed, that the has production proof. The trial uncertain, opponent has become needs deny the motion should tes- opportunity prevent expert’s hearing the mov- a unless without timony going jury unless it has supported presented and ant has situation, reasonable basis. such prima that the evidence facie case hearing the trial should conduct accepted. generally is not using admissibility determine stan- legal principles substantive 30 These dards. procedural on the significant impact have a expert’s If the conclusion is not hearings and how issue of when generally accepted, then courts First, party should be conducted. the un- must determine whether under must to bar evidence seeking derlying reliable. arguably what identify precisely opin- expert’s ¶27 accepted about generally is not expert’s When 207.1(a)(1). See, More- ion. Pa.R.Civ.P. accepted, then courts generally considered over, following principles apply would 2. The trial court could a Frye hold hearing. motion. After the if hearing, expert’s court determines that If moving party concedes that generally conclusion is indeed ac- expert’s generally accept- conclusion is cepted, the court would allow the ed, inquiry would end. The trial court (It testify. often be deny the motion and allow the ex- the case that a trial court does not if pert testify. Similarly, moving know if a ac- conclusion is party argues expert’s the conclusion is cepted until the court evidence takes generally accepted, but concedes that issue.) If this the court finds methodology generally the is the accepted, that the conclusion not generally is inquiry end. The court would accepted, that finding would not end deny the motion expert and allow the to Rather, inquiry. the the court testify. Majority As the cogently explains, proceed would then to if determine established, if expert the accepted used expert’s the methodology general- is newly- methods to come to a so, ly If accepted. the court would conclusion, recognized opinion the should not, expert testify. allow the If Frye. not be excluded under The matter is testimony the would be barred un- left for jury to resolve. Frye. der Thus, party seeking to exclude event, any 33 In trial courts are to evidence under has the initial burden 207.1, comply pro- with which Pa.R.Civ.P. presenting a prima case that the facie that, party vides where a files a expert’s methodology conclusion and have court, court, motion with the trial in its generally not been accepted. Upon receiv- discretion, can hold a hearing before motion, ing such a the trial court has two trial or defer it to trial.21 Pa.R.C.P. options: 207.1(a)(3). a party Where does not raise admissibility the issue of the of the testi- plead- The court could rule on the trial, mony expert of an prior witness

ings that expert’s either the conclu- and is not ordered the trial court to do generally sion or is ac- so, nothing in precludes raising the Rule situation, In cepted. such a See, generally, during the issue trial. deny court would the motion and 207.1(b). Rule See, testify. allow the Majority Opinion (“general at 1110 ‡ ‡ acceptance” standard can be incor- judicial In I that it porated concept into the do not believe notice). generally accepted Doxepin Because trial courts retain is causes power summarily reject pigmentary open-angle glaucoma. re- However, there I with the that it quests Frye hearings, agree majority is no danger being possible extrapolation of our trial courts that Dr. is Shane’s Frye requests every theory Doxepin flooded with from the causes can single flaking eye’s pigment time that “science enters the of the be extend- courtroom.” ed to find that under such a massive over- so, 207.1, doing limiting our re- 21. The wisdom of Rule evidence on the issue. In timing Frye hearings, apparent significantly view of the matter has been ham- Here, summarily instant case. the trial court pered. taking any reversed itself after trial without

H27 dose, ability challenge pigment can obstruct the flow would have had Dr. underlying theory upon I do not be- Shane into Canal Schlemm. nearly ev- procedure extrapolation. lieve the followed the trial relied for his challenge Dr. court enables us to determine whether in which a ery case extrapolation generally raised, is based on to assess hearing Shane’s will be needed there accepted theory. accepted. medical Since nev- whether Frye hearing, un- er was a the record is result hearing Failure will often to hold general acceptance clear whether there is error, in this case. as did any flaking causes vacate the trial 37 I would therefore pigment. oppor- court’s decision and remand for ¶ Here, questioned when the defense proce- to follow the tunity parties for the admissibility above, with the trial court dures outlined pre-trial, the trial court denied motion opportunity pres- giving both sides the in limine without a hearing. Dr. When evidence, desired, and make fur- ent if supporting Shane referred to his literature argument following presentation ther testimony, body in his trial of litera- of evidence. ture was excluded for the reason that in Pennsylvania, learned treatises are hear-

say. When defendants re-raised the issue motions, post-trial grant- the trial court

ed the motion testimony based on the trial specific Frye hearing,

without holding explored could have the literature. I believe the at trial was insuffi- KUHLMEIER, Appellant, Sandra cient admission of Dr. Shane’s Doxepin conclusion that this case caused (and permanent loss of vision cogni- some KUHLMEIER, Appellee. John functions)

tive because the failure to Pennsylvania. Superior Court support Dr. Shane’s statement even therapeutic flaking doses of cause 1, 2002. Argued Oct. However, pigment. Trach was not Filed Feb. triggered put on more definitive evi- dence because the motion in limine had

already been denied. 36 The court should have held a

Frye hearing, preferably at the motion

limine stage, reversing or at least before Frye. If jury’s decision on basis of done,

that had been then the record would fully Trach developed.

have been opportunity

have had the to establish the

general acceptance of the basis of expert’s opinion,22 and the defense misapplied Frye. hearing hold a 22. The failure to is contained argument within Trach’s that the trial court

Case Details

Case Name: Trach v. Fellin

Court Name: Superior Court of Pennsylvania

Date Published: Feb 11, 2003

Citation: 817 A.2d 1102

Court Abbreviation: Pa. Super. Ct.