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E KIN$ -/t'3601 5 P H.OCI932007
IN THE SUPERIOR COURT OF PENNSYLVANIA
1058 WDA 2006
DIANA K. BETZ, Executrix of the Estate of CHARLES SIMIKIAN, deceased
Appellant,
VS.
PNEUMO ABEX LLC, successor-in-interest to Abex Corporation, ALLIED SIGNAL
INC., in its own right and as successor-in-interest to Allied Corporation, successor-in-
interest to Bendix Corporation, BORG-WARNER CORPORATION, CARLISLE
COMPANIES, INC., OKONITE COMPANY, GENERAL MOTORS CORPORATION,
KELSEY-HAYES COMPANY, METROPOLITAN LIFE INSURANCE COMPANY,
a/k/a Metropolitan Insurance Company, DAIMLERCHRYSLER CORPORATION, f/ida
CHRYSLER CORPORATION, FORD MOTOR COMPANY, VOLKSWAGEN OF
AMERICA, INC., NAPA AUTOMOTIVE PARTS GROUP, ROHRICH CADILLAC,
INC., DYKE MOTOR SUPPLY COMPANY INCORPORATED, SOUTH HILLS AUTO
PARTS CO.,
Appellees.
BRIEF FOR APPELLEE -- DEFINITIVE COPY
Appeal from the Final Order of the Court of Common Pleas of Allegheny County entered on
May 10, 2006, and amended on May 30, 2006, specifically with regard to the Order datedFebruary 27, 2006, granting Defendants' Motion to Preclude Expert Testimony, and the Orders
dated April 3, 2006, Granting Summary Judgment in favor of Defendants DaimlerChrysler
Corporation, Ford Motor Company, General Motors Corporation, and Honeywell International,Inc., docketed at No. GD 05-4662
Alice S. Johnston
Pa. I.D. No. 46637
Jay EvansPa. I.D. No. 82149OBERMAYER REBMANN
MAXWELL & HIPPEL, LLP
One Mellon Bank Center, Suite 5240500 Grant Street
Pittsburgh, PA 15219
(412) 566-1500
Counsel for DaimlerChrysler Corporation
TABLE OF CONTENTS
TABLE OF CONTENTS .............................................................................................................. i
TABLE OF AUTHORITIES ...................................................................................................... iii
COUNTERSTATEMENT OF THE SCOPE AND STANDARD OF REVIEW .................... 1
COUNTERSTATEMENT OF THE QUESTIONS INVOLVED ............................................ 2
COUNTERSTATEMENT OF THE CASE ................................................................................ 3
SUMMARY OF ARGUMENT .................................................................................................. 12
ARGUMENT ............................................................................................................................... 14
B.
III.
THIS CASE PRESENTS A SIGNIFICANT ISSUE FOR PENNSYLVANIA COURTS AND
LITIGANTS ................................................................................................................... 14
A. The Issues Presented in This Case Affect Hundreds of Cases in theCommonwealth ..................................................................................................... 14
B. Consistency of Outcomes on Critical Issues is of Paramount Importance ........... 15
C. The Decision of This Court Should be Published (Rule 3519 Request For
Publication) ........................................................................................................... 17
THE OPINIONS AT ISSUE ARE NOVEL ............................................................................ 17
Novel Does Not Mean New, and Frequency is Not a Surrogate for General
Acceptance ............................................................................................................ 18
Judge Colville Properly Determined the Issue of Novelty ................................... 21
THERE IS NO GENERALLY ACCEPTED METHODOLOGY WHICH SUPPORTS THE OPINION
THAT "EVERY BREATH CONTRIBUTES" IN THE CONTEXT OF FRICTION CLAIMS ........... 22
A. The Methodology At Issue Was Expressly Rejected in Blum .............................. 22
B. The Exposures at Issue are Not High-Dose/Amphibole Occupational Exposures25
C. "Extrapolation Down" is Not Generally Accepted Methodology ......................... 26
D. Allegations of Illcreased Risk Are Insufficient ..................................................... 30
E- Anything Less Than Exclusion of"Every Breath" Testimony as a Matter of Law
Allows Plaintiffs to Impermissibly Shift the Burden of Proof to the Defendants 31
F. Frye Challenges Affect Admissibility, Not Weight, of the Expert Testimony ..... 33
G. TreatingPhysiciansGenerallyDoNotConcernThemselvesWithCausation,Particularlyin theContextof LongLatencyToxicExposureCases....................34
H. Paustenbach's"Concession"Is Anything But ....................................................... 37
IV. THE ESSENTIAL ROLE OF EPIDEMIOLOGY 1NTOXIC TORT LITIGATION CANNOT BE
IGNORED ..................................................................................................................... 39
A. This Court Has Given Weight to Epidemiology in Prior Cases ........................... 39
B. In Toxic Tort Cases Involving Diseases With Long Latency Periods and
Vanishingly Low Exposures, Epidemiology is the Only Method for Properly
Determining General Causation ............................................................................ 42
1. Epidemiological Studies Are the Most Conclusive Evidence to Prove GeneralCausation .......................................................................................................... 42
2. Case Reports Neither Support Nor Establish An Inference Of Causation ....... 44
3. The Epidemiology Offered in this Case is Not "Equivocal" ............................ 46
C. This Court Should Clarify the Proper Role of Epidemiology ............................... 49
V. JUDGE COLVILLE PROPERLY APPLIED THE LAW OF PENNSYLVANIA ............................ 49
A. Chrysler Countered Betz's Expert With Experts in All Appropriate Disciplines. 49
1. The Issue Was Waived ..................................................................................... 50
2. The Medical Malpractice Rules are Inapplicable and Irrelevant ..................... 50
B. Judge Colville Properly Interpreted the Case Law ............................................... 52
1. The Non-Frye Cases Cited by Betz Are Completely Irrelevant and Could NotFetter Judge Colville's Discretion .................................................................... 52
2. Smalls Did Not Limit Judge Colville's Discretion ........................................... 54
3. Rafter Still Requires Plaintiffs to Prove the Exposure Was a ContributingFactor ............................................................................................................... 56
C. The Parties Were Afforded a Full and Fair Opportunity to be Heard .................. 57
CONCLUSION ........................................................................................................................... 59
ii
TABLE OF AUTHORITIES
Federal Cases
Allen v. Pennsylvania Engineering Corp., 102 F.3d 194 (5th Cir. 1996) ......................... 43
Amorgianos v. National Railroad Passenger Corp., 137 F. Supp. 2d 147 (E.D.N.Y.,
March 29, 2001) ......................................................................................................... 43
Bell v. Swift Adhesives, Inc., 804 F. Supp. 1577 (S.D. Ga. 1992) ................................... 43
Bickel v. Pfizer, Inc., 431 F. Supp. 2d 918 (N.D. Ind. 2006) ........................................... 43
Brock v. Merrell Dow Pharm., Inc., 874 F.2d 307 (5th Cir. 1989), modified_ 884 F.2d 166
(5th Cir. 1989), cert. denied, 494 U.S. 1046 (1990) .................................................. 43
Burleson v. Glass, 268 F. Supp. 2d 699 (W.D. Tex. 2003), affd, Burleson v. Tex. Dep't
of Crim. Justice, 2004 U.S. App. LEXIS 25271 (5th Cir. 2004) ............................... 43
Cano v. Everset Minerals Corp., 362 F. Supp. 2d 814 (W.D. Tex. 2005) ........................ 43
Case¥ v. Ohio Medical Products, 877 F. Supp. 1380 ....................................................... 43
Chambers v. Exxon, 81 F. Supp. 2d 661 (M.D.La. 2000) ................................................ 43
Conde v. Velsicol Chem. Corp., 24 F.3d 809 (6th Cir. 1994) .......................................... 43
Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) ................................................. passim
Hall v. Baxter Healthcare Corp., 947 F Supp. 1387 (D. Ore. 1996) ................................. 43
In re: "Agent Orange" Product Liability Litigation, 611 F. Supp. 1223 (E.D.N.Y. 1985).............................................................................................................................. ..... 39
In re: W.R. Grace & Co., No. 01-01139, --- B.R. ---, 2006 WL 390176 (Bankr. D.Del.,
Dec. 14, 2006) ................................................................................................ 25, 43, 44
In re: Breast Implant Litigation, 11 F. Supp. 2d 1217 (D. Colo. 1998) ............................ 43
Lynch v. Merrell-National Laboratories, 830 F.2d 1190 (lst Cir. 1987) ......................... 43
Meister v. Medical Engineering Corp., 267 F.3d 1123 (D.C. Cir. 2001) ................... 43, 44
National Bank of Commerce v. Dow Chemical, 965 F. Supp. 1490 (E.D. Ark.1996) af_._A,fd
133 F.3d 1132 (Sth Cir. 1998) ................................................................................... 43
Norris v. Baxter Healthcare Corp., 397 F.3d 878 (10th Cir. 2005) .................................. 43
iii
Pozefsk¥ v. Baxter Healthcare Corp., No. 92CV0314LEKRWS, 2001 WL 967608
(N.D.N.Y., Aug. 16, 2001) ........................................................................................ 43
Rains v. PPG Indus., Inc., et al., 361 F. Supp. 2d 829 (S.D. Ill. 2004) ............................ 43
Ravnor v. Merrell Pharmaceuticals, Inc., 104 F.3d 1371 (D.C. Cir. 1997) ...................... 43
Renaud v. Martin Marietta Corp., et al., 749 F. Supp 1545 (D. Colo. 1990) ................... 43
Sanderson v. International Flavors & Fragrances, 950 F. Supp. 981 (C.D. Cal. 1996).... 43
Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347 (N.D. Ga. 2001) ...................... 43
Sorenson By & Through Dunbar v. Shaklee Corp., 31 F.3d 638 (8th Cir. 1994) ............ 43
Thomas v. Hoffinan-La Roche, Inc., 731 F. Supp. 224 0g.D. Miss. 1989) ...................... 43
Turpin v. Merrell Dow Phann., Inc., 959 F.2d 1349 (6th Cir. 1992) ............................... 43
Wilson v. Merrell Dow Pharmaceuticals, Inc., 893 F.2d 1149 (10th Cir. 1990) .............. 43
State Cases
Andaloro v. Armstrong World Industries, Inc., 799 A.2d 71 (Pa. Super. Ct. 2002) .. 52, 53
Bedford Downs Management Corp. v. State Horse Racing Comm'n, 901 A.2d 1063 (Pa.
Commw. Ct. 2005) .................................................................................................... 50
Blum v. Me=ell Dow Pharm., Inc., 705 A.2d 1314 (Pa. Super. Ct. 1997), affd, 564 Pa. 3,
764 A.2d 1 (2000), abrogated in part on other grounds b¥ Trach v. Fellin, 817 A.2d
1102 (Pa. Super. Ct. 2003) .................................................................................. passim
Brookshire Brothers, Inc. v. Wesley Smith, 176 S.W.3d 30 (Tex. App. 2004) ................ 43
Cauthom v. Owens Coming Fiberglass Corp., 840 A.2d 1028 (Pa. Super. Ct. 2004) ..... 53
Checchio v. Frankford Hosp., 717 A.2d 1058 (Pa. Super. Ct. 1998) ............................... 30
Com. v. Dengler, 843 A.2d 1241 (Pa. Super. Ct. 2004) ....................................... 18, 19, 34
Commonwealth v. Hall, 867 A.2d 619 (Pa. Super. Ct. 2005) .......................................... 34
Crowhom v. Boyle, 793 A.2d 422 (Del. Super. Ct. 2002) ............................................... 43
Daniels v. L¥ondell-Citgo Refining Co., Ltd., et al., 99 S.W.3d 722 (Tex. App. 2003).. 43
Eckenrod v. GAF, 375 Pa. Super. 187, 544 A.2d 50 (1988) ...................................... 30, 33
Ettinger v. Triangle-Pacific Corporation, 799 A.2d 95 (Pa. Super. Ct. 2002) .................... 1
Farm Bureau Mutual Ins. Co v. Foote, 341 Ark. 105, 14 S.W.3d 512 (Ark. 2000) ......... 43
iv
Goodyear Tire and Rubber Co. v. Thompson, 11 S.W.3d 575 (Kent. 2000) ................... 43
Grad¥ v. Ffito-La¥, Inc., 576 Pa. 546, 839 A.2d 1038 (2003) .......................... 1, 16, 22, 51
Green v. Cessna Aircraft Co.., 673 A.2d 216 (Me. 1996) ................................................. 43
Hammond v. Bedford Great Road CVS, Inc., 1998 Mass. Super. LEXIS 546 (Mass.
Super. Aug. 17, 1998) ................................................................................................ 43
Junge v. Garlock, Inc., 427 Pa. Super. Ct. 592, 629 A.2d 1027 (1993) ............................ 53
Lasley v. Georgetown Univ., 688 A.2d 1381 (D. C. Ct. App.1997) ................................ 33
Lille¥ v. Johns-Manville Corp., 408 Pa. Super. Ct. 83, 596 A.2d 203 (1991) ........... 39, 53
Liunen v. A.H.Robins Co. Inc., 2000 W-L 16769 (Super. Mass. Dec 14, 1999) .............. 43
Lonasco v. A-Best Products Co., 757 A.2d 367 (Pa. Super. Ct. 2000) ............................ 53
M.G. Bancorporation, Inc. v. LeBeau, 737 A.2d 513 (Del. 1999) ................................... 43
Martins v. Interstate Power Co., 2002 Iowa App. LEXIS 586 (Iowa App. 2002) ............ 43
McMahon v. Young, 442 Pa. 484, 276 A.2d 534 (1971) ................................................. 30
Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706 (Tx. 1997) .................................. 43
Minner v. American Mort. & Guaranty Co., 791 A.2d 826 (Del. Super. Ct. 2000) ......... 43
Nelson v. American Sterilizer Co., 566 N.W.2d 671 (Ct. App. Mich. 1997) ................... 43
Orkin Exterminating Co. v. Mclntosh, 215 Ga. App. 587, 452 S.E.2d 159 (Ga. App.
1994) .......................................................................................................................... 43
Paden v. Baker Concrete Construction, Inc., 540 Pa. 409, 412, 658 A.2d 341 (1995) ...... 1
Parker v. Mobil Oil Corp., 877 N.E.2d 114, 824 N.Y.S.2d 584 (N.Y. 2006) .................. 18
Rafter v. Raymark Industries, 429 Pa. Super. 360, 632 A.2d 897 (Pa. Super. Ct.
1993) .................................................................................................................... 56, 57
Samarin v. GAF Corp., 391 Pa. Super. 340, 571 A.2d 398 (1990) .................................. 53
Smalls v. Pittsburgh Coming Corp., 843 A.2d 410 (Pa. Super. Ct. 2004) ..... 54, 55, 56, 57
Summers v. Certainteed Corp., 886 A.2d 240 (Pa. Super. Ct. 2005), appeal granted, 587
Pa. 699, 897 A.2d 460 (2006) .............................................................................. 55, 56
Toledo v. Medical Eng'g Corp., 50 Pa. D. & C.4th 129 (Pa. Com. P1. 2000) .................. 46
Trach v. Fellin, 817 A.2d 1102 (Pa. Super. Ct. 2003) ............................................... passim
v
Vinitski v. Adler., No. 1759 EDA 2004, 2005 WL 984497 at *2 (Pa. Super. Ct., Apr. 22,
2005) .................................................................................................................... 27, 28
Wackv. Farmland Indus. In% 744 A.2d 265 (Pa. Super. Ct. 1999), abrogated in part on
other grounds by Trach v. Fellin, 817 A.2d 1102 (2003) .......................................... 46
State Statutes
40 Pa. C.S. § 1303.512 ...................................................................................................... 50
42 Pa. C.S. § 702(b) .......................................................................................................... 11
State Rules
Pa. R. App. Pro. 2154 (b) .................................................................................................... 8
Pa. R. App. Pro. 2186 (a) (2) .............................................................................................. 8
Pa. R. App. Pro. 3519 (a) .................................................................................................. 17
Pa. R. Cir. Pro. 1042.1 etseq ........................................................................................... 50
Pa. R. Cir. Pro. 207.1 ........................................................................................................ 19
Other Authorities
David E. Bernstein, Keeping Junk Science Out of Asbestos Litigation, 31 Pepp. L. Rev.
11 (2003) .............................................................................................................. 37, 44
Green et al., Reference Guide on Epidemiology, Reference Manual on Scientific
Evidence (Fed. Judicial Center 2d ed. 2000) ............................................................ 42
J.M. Eggen, Toxic Torts, Causation, and Scientific Evidence after Danbert, 55 U. Pitt. L.
Rev. 889 (1994) ......................................................................................................... 39
R.J. Fierce, Jr., Causation in Government Regulation and Toxic Torts, 76 WashingtonUniversity Law Quarterly 1307 (1998) ..................................................................... 33
RAND Report in Asbestos Litigation, Rand Institute for Civil Justice (2005) .......... 14, 15
Weihrauch and DieM, Artificial Sweeteners - Do They Bear a Carcinogenic Risk, Annals
of Oncology 1460-65 (2004) ..................................................................................... 29
Woitowitz et al., Mesothelioma Among Car Mechanics, Ann. Occup. Hyg. 38(4):635-638(1994) ......................................................................................................................... 45
Woitowitz et al., Pleuramesotheliom Nach Asbeststaubgefahrdung Bei Bremsreparaturen[Pleuramesothelioma after asbestos dust exposure in brake repair work in automobile
repair workshops: Case observations], Prax. Klin. Pneumol. 39:362-366 (1985) .... 45
vi
COUNTERSTATEMENT OF THE SCOPE AND STANDARD OF REVIEW
A trial court's ruling to exclude or admit expert testimony pursuant to Frye v. United
State_.______s,293 F. 1013 (D.C. Cir. 1923) is an "evidentiary matter for the trial court's discretion and
should not be disturbed on appeal unless the trial court abuses its discretion." Gradv v. Frito-
Lag, Inc., 576 Pa. 546, 559, 839 A.2d 1038, 1046 (2003). Any party that challenges a
discretionary ruling bears a heavy burden. Paden v. Baker Concrete Construction, Inc., 540 Pa.
409, 412, 658 A.2d 341,343 (1995). The standard of review is "very narrow. [An appellate
court] may only reverse upon a showing that the trial court clearly abused its discretion or
committed an error of law." Ettinger v. Triangle-Pacific Corporation, 799 A.2d 95, 110 (Pa.
Super. Ct. 2002).
"An abuse of discretion may not be found merely because an appellate court might have
reached a different conclusion." Grad% 576 Pa. at 559, 839 A.2d at 1046. Rather, an abuse of
discretion "requires a result of manifest unreasonableness, or partiality, prejudice, bias, or ill-
will, or such a lack of support as to be clearly erroneous." Id._.at 559, 839 A.2d at 1046.
COUNTERSTATEMENT OF THE QUESTIONS INVOLVED l
1. Whether Judge Colville abused his discretion by granting Chrysler's _ motion.
Suggested Answer: No
2. Whether an expert opinion can propdrly be found to be novel, even though it is
not new, because it is deployed in a new or unusual way or because it has become novel as a
result of scientific advances.
Suggested Answer: Yes
3. Whether an expert's methodology can be found to be generally accepted if it relies
entirely on methodologies expressly rejected by the Superior Court.
Suggested Answer: No
4. Whether an expert's methodology can be considered generally accepted if it fails
to take into consideration the conclusions of consistent, replicated, analytic epidemiology
studies, and instead places undue reliance on case reports.
Suggested Answer: No
5. Whether this Court should make clear that with respect to toxic torts with long
latency periods, epidemiology is required to prove general causation.
Suggested Answer: Yes
Chrysler notes that Appellant stated her Questions Involved in her brief in a fashion inconsistent with theStatement of Issues Complained of on Appeal upon which Judge Colville based his August 17, 2006 Opinion.
COUNTERSTATEMENT OF THE CASE
Appellant Diana K. Betz ("Betz") is the Executrix of the Estate of Charles Simikian
("Simikian"), who was diagnosed with mesothelioma in 2004. 2 On February 24, 2005, Simikian
brought an action in the Court of Common Pleas of Allegheny County, Pennsylvania, against
manufacturers and suppliers of asbestos-containing products to which he was exposed. R. 16a.
These alleged exposures were to asbestos-containing automotive friction products, such as
automotive brakes, and they occurred during the course of Simikian's employment as a
mechanic. R. 19a. Simikian alleged that the inhalation of asbestos from these products caused
his mesothelioma. R. 20a.
On March 18, 2005, Appellee DaimlerChrysler Corporation ("Chrysler") 3 filed a "Global
Motion" seeking to preclude any plaintiff with claims pending against Chrysler in that
Court from offering expert testimony that working with or around automotive friction products
causes or contributes to causing asbestosis, lung cancer, or mesothelioma. R. 36a. The motion
was filed before The Honorable Robert J. Colville. 4 Chrysler's Global Motion asserted that
asbestos plaintiffs' usual experts have no scientifically accepted methodology to support their
opinions that working with and around friction products causes asbestos-related disease. Id.
Judge Colville requested, and on June 3, 2005 Chrysler filed, an Amended Global _ motion.
R. 94a.
2 This case was initiated by Charles Simikian before his death. The Complaint was eventually amended toreflect Ms. Betz's role as Executrix, on October 19, 2005 (after the _ hearing began) but transcripts of theproceedings below typically refer to Mr. Simikian, rather than his executrix, Ms. Betz. R. 528a- 534a.
3Volkswagen of America, Inc., was also a party to the Motion andparticipated in the hearing, but wassubsequently dismissed from Mr. Simikian's case and is not a party to this appeal.
4All asbestos cases in the Allegheny County Court of Common Pleas are assigned to Judge Colville, theToxic Substances Judge, for all pretrial matters, in accordance with local roles. Judge Colville is often assigned astrial judge to preside over trials of asbestos cases, as well.
Attached to the Amended Motion, Chrysler included numerous sample causation
opinions which had been propounded by asbestos plaintiffs in prior cases, and challenged the
methodology used by these experts to reach the conclusion that working with and around friction
products can cause asbestos-related disease. In particular, Chrysler challenged the
methodologies such as utilizing chemical analysis, animal studies, case reports, and
"extrapolation down" from a high dose to a low dose, as such methodologies rely on untested
hypotheses to reach a conclusion. R. 98a-99a. The Amended Motion also included, as an
attachment, a letter to Judge Cotville from several noted scientists calling plaintiffs'
methodologies into question. R. 143a-148a.
Judge Colville entered an Order on June 23, 2005 requiring the parties to designate a
group of representative cases that would become the subject of said "Global F__.._._._._._._._I_Motion." R.
296a. The Order also required the plaintiffs in the selected cases to secure and disclose expert
reports setting forth their causation opinions in these cases, so that Judge Colville could hold a
comprehensive _ heating under Pa.R.Civ. Pro. 207.1. Id.
In support of their claims against Chrysler and other friction defendants, plaintiffs
collectively submitted an expert report of John Maddox, M.D., a pathologist, opining that each
and every exposure to asbestos (without regard to type of exposure, type of asbestos fiber or
circumstances of exposure) contributes to the development of mesothelioma in a cumulative and
dose-related manner. R. 322a. The report was essentially a standard affidavit which is
propounded in every asbestos case in which he testifies. R. 701a. The report did not discuss or
applyanyfactsof anyof thecasesinwhichit waspropounded.R.359a-360a.An opinionof Dr. Laman,a
pulmonologist,wasalsodisclosed.5
A hearingwasheldonAugust17,2005,sothatJudgeColvillecouldhearargumentasto
whethertheopinionsof Plaintiffs' experts were novel. R. 340a-461a.
Judge Colville made an initial determination that the causation opinions were novel and
that a Frye hearing was warranted:
8/17 Hearing:
Where Maddox' opinion becomes, arguably, and I think perhaps
ultimately, novel in that it is new, original or striking is when he
attempts to extrapolate down to the position that each and every
fiber contributes to the disease process.
..o
Without that statement, I have no causation as to any of the
specific plaintiffs. You need that element of Maddox's report to
prove causation to each plaintiff. And the reason I think you need
it is because his report doesn't specifically rely upon or doesn't
reference exposure rates for any specific plaintiff, doesn't
specifically rely upon digestive rates or studies from samples takenfrom the bodies.
°..
And the reason I fmd it to be, perhaps, novel is because it relies
upon purely the idea that mesothelioma caused by asbestos is a
dose-response disease. But all the literature relied upon by
Maddox... deal with where the exposure is of a known quantity,
of a significant quantity. And I say significant, but of a known
value where you can say, look, where we know it is eight hours a
day in this kind of air, I know that it creates a certain dosage. And
at that dosage we expect this increase response... But there are
commonsensical sort of... known examples everything is a
poison at a certain rate. Too much water will kill you. I don't want
to overstate the case. But take arsenic, for example. Obviously
you can be killed by arsenic poison, but we all have a trace ofarsenic. Nitroglycerin. Too much of that will kill you. At certain
5Dr. Laman's opinion appeared to be specific to one of the other cases which were the subject of themotion. See infra. Later, plaintiffs' counsel indicated that Dr. Laman's opinions were offered with respect to all ofthe cases, including Betz. (R.1156a-I 162a). However, Appellant Betz does not appear to be challenging, onappeal, the exclusion of the opinion of Dr. Laman. In any event, the opinions andmethodologies of Maddox andLaman are nearly identical.
dosages it is beneficial. So the question of whether you can
extrapolate down is not, in my judgment at the present moment and
my present understanding of the science or what Dr. Maddox relies
upon, is not an absolute or a given or something that is sort ofcommonsensically understood. I don't see that he relies upon or
references any scientific authority or any medical authority for his
doing so.
9/08:
This is not a perfect example, I understand it is not, but it is similar
to at some point the world accepted the world wasn't flat. At some
point the scientific knowledge advanced that the opinion that theworld was fiat, while accepted by the whole universe of people for
a long, long, long, long time, at some point became novel -- not
new, not different, but novel -- in that it no longer made real sense.
..o
To date no one has changed my mind, notwithstanding the fine
arguments by counsel. I do find adequate novelty to support theneed for a Frye hearing on the general acceptance of the scientific
methodology employed by Dr. Maddox.
R. 443a-451a; R. 488a-492a, 517a-518a.
A Frye hearing regarding Dr. Maddox's causation opinion in automotive friction products
cases was ordered and subsequently held on October 17, 18 and 21, 2005. (R. 465a-466a).
Additional testimony was taken in December 2005 via deposition, and the parties were given the
opportunity to add additional evidence to the record and file post-hearing memoranda.
At the Frye hearing, Dr. Maddox offered the opinion that mesothelioma can be caused by
the inhalation of asbestos shed from automotive brakes, and that every exposure, "the total and
cumulative asbestos exposure," causes mesothelioma. R. 618a-619a. Dr. Maddox's opinion, in
his own words, involved "a matter of small bridges" (R. 641a): 1) all types of asbestos cause the
disease ofmesothelioma; 2) brakes contain asbestos6; 3) asbestos in brakes can be released and
6The evidence presented at the Frye was uncontroverted that for a period of time certain automobilefriction products contained short fiber ehrysotile asbestos (not amphiboles), the least potent form &asbestos. Theehrysotile asbestos in friction produets is encapsulated in a hard resin binder. _ R. 1013a-1015a.
inhaled during service and repair; and therefore 4) exposures from brake repair can cause the
disease ofmesothelioma as part of a "total and cumulative exposure." R. 778a-779a; see also
Plaintiffs' Summary of Evidence, paragraph 17, R. 1614a. Dr. Maddox was not familiar with the
exposure history of Mr. Simikian; he did not know any specifics of the case. R. 778a-779a. Nor
is he, as a pathologist, normally called upon to ascribe causation (rather than a diagnosis). R.
727a-729a. The mechanism by which asbestos causes mesothelioma is still unknown. R. 729a.
Dr. Maddox has conceded that his "each and every breath" hypothesis is unproven, and is instead
an extrapolation. R. 730a. The opinion will not be found in any peer-reviewed medical journal,
and no methodology to reach that opinion has been described in the published scientific
literature. R. 734a-735a. Dr. Maddox states that he doubts a "no disease threshold" level of
exposure to asbestos exists but he cannot say so for certain. R. 787a.
Dr. Laman testified that he utilized similar methodology to Dr. Maddox. He agreed that
ambient air exposure cannot cause disease, and recognized that there are idiopathic
mesotheliomas for which there is no known cause (or causes other than asbestos). R. 1201a,
1231a-1233a. He also agreed that causation is determined by epidemiology (R. 1212a-1214a),
and it is impossible to know with absolute certainty that every breath contributes to the
development of disease. R. 1235a-1236a.
In support of the _ challenge to Dr. Maddox's methodology, through live testimony
and submission of transcripts, Chrysler presented the testimony of two epidemiologists, a
toxicologist, a medical doctor and epidemiologist, and a pathologist. They each testified that Dr.
Maddox's methodologies are not generally accepted in the scientific community.
Dr. Dennis Paustenbach, a toxicologist and risk assessor who follows the methodologies
dictated by the EPA (R. 817a-820a), testified that without knowledge of the mechanism of the
O
disease, one cannot state with certainty that "each and every breath" contributes to that disease
process. R. 822a; see also Paustenbach Report, R. 1992a. 7 Therefore any such assertion can be
no more than an untested hypothesis. The weight of the scientific evidence shows thatasbestos
exposure from working with and around friction products is a very low exposure. This is
because asbestos-containing friction products were composed of, inter _ chrysotile asbestos
encased in a resin binder. The heat generated by the brake and clutch use transforms more than
99% of the original asbestos into nonfibrous material. Further, of the small amounts of
chrysotite asbestos remaining in brake and clutch wear debris, approximately 80-90% of the
fibers are below five microns in length, and there is consensus in the scientific community that
these extremely short fibers are not associated with disease. R. 822a-824a, 836a, 843a-876a; R.
2004a (Panstenbach brake study).
Dr. Paustenbach testified that while case reports are useful to generate a hypothesis, Dr.
Maddox relied on them too much (especially in light of the weight of scientific evidence). R.
823a. There are no studies which prove that each and every exposure contributes. R. 825a.
Exposure to ambient levels of asbestos is accepted to have no effect on disease, and therefore
there must be some threshold -- Dr. Maddox assumes that, because there is no identified
threshold, there is no threshold, without the benefit of any scientific data to support that
conclusion. R. 825a-827a. Further, extrapolation from the high doses experienced by insulators
to the low doses experienced by lifetime auto mechanics is impossible -- such a reliance on
7 Betz elected to proceed with this appeal under Rule 2154 (b) for large records. As a result, Rule 2185 (e)indicates that references in this Brief shall be to the original record, and the Reproduced Record will be finalizedafter service of advance copies of the Brief. Rule 2186 (a) (2). However, despite this designation, Betz served aReproduced Record with her Brief without consulting Chrysler. Therefore, some references in the Advance FormBrief will be to the Reproduced Record, while some will be to the original Record (with "R..._.._" denoting laterreproduction). Chrysler will file a Supplemental Reproduced Record and a definitive copy of its Brief in accordancewith the Rules of Appellate Procedure pertaining to large records.
generic literature showing that "asbestos exposure in sufficient levels can cause disease" cannot
be used to support a thesis that does not include evidence of such a sufficient level of exposure.
R. 837a. Further, the scientific consensus is that short asbestos fibers do not cause disease. R.
865a-871a. Fiber burden studies of mechanics showed increased commercial amphiboles, which
indicates some other form of asbestos exposure. R. 880a-884a. Only case reports have
suggested any link between automotive repair work and asbestos-related disease, and that
hypothesis is disproven by the subsequent epidemiology that has been performed. R. 921a.
Even without the epidemiologic evidence, however, it is Dr. Paustenbach's opinion that Dr.
Maddox's methodology is not generally accepted because his methodology fails to take into
account the vanishingly small nature of the exposure -- epidemiology simply validates the
criticism. R. 944a-949a.
Dr. Jane Teta, an epidemiologist, testified on behalf of Chrysler and issued a report. R.
2023a. She described in detail how she and other researchers have reviewed the scientific
literature carefully, and have reviewed 17 separate epidemiological studies that lead to the
conclusion that automotive repair work does not cause asbestos diseases such as mesothelioma.
R. 990a-1013a. As the epidemiology shows that there is no general causation, there can be no
specific causation. R. 1016a. Dr. Teta also discussed flaws in Dr. Maddox's methodology which
cause it to fall outside generally accepted methodologies: 1) he did not perform a complete
review of literature; 2) he did not weigh the relevant evidence; and 3) he proceeded t_om
hypothesis to conclusion without performing or relying on any studies or other scientific data. R.
1018a-1019a. Dr. Maddox's opinion was grounded on a litany of irrelevant studies and case
reports, that are only useful for generating a hypothesis, not for reaching a verifiable, scientific
conclusion. R. 1023a-1024a. Further, the Helsinki criteria relied upon by Dr. Maddox is only
usefulfor diagnosisandattributionof adiseaseto "asbestos"generally,notto establishgeneral
causationasaresultof exposureto specificproducts•1064a-1066a.Dr. Tetaalsonotedthe
fimdamentalproblemwith theeachandeverybreathmethodology:
•.. thereisnoconsensusonamechanicof carcinogenicityformesothelioma.Youneedto knowthatin orderto knowwhethereverydoseaddsto therisk if thereisathreshold.
R. 1067a-1070a(emphasissupplied).Dr. Tetaalsonotedflawsin thesourcesof Dr. Maddox's
referencedcasereports.R. 1071a-1077.Dr. PatrickHessel,alsoanepidemiologist,testified
similarlyto Dr.Tetaregardingotherasbestos-relateddiseases.8
Chrysleralsopresentedvia transcriptthetestimonyof anepidemiologistandphysician,
Dr. Goodman,andapathologist,Dr.Roggli.R. 2165a-2269a,2347a-2443a.Dr. Roggli,who
testifiesmoreoftenfor asbestosplaintiffsthanhedoesfor defendants,describedin detailwhy
thereisnomethodologywhichsupportsthenotionthatasbestosexposurefromautomotive
productscausesdisease.First,Dr.Rogglitestifiedthathisowndetailedpathologyresearch
showsthatalthoughautomechanicsdonotoftenhaveaboveaverageasbestoscontentin their
lungs,whenautomechanicsdo have elevated asbestos levels in their lungs, it is elevated levels
of commercial amphiboles not found in brakes. R. 2190a-2192a, 2223a-2224a; see also R. 880a-
884a (Paustenbach)). Further, the time-weighted exposure to asbestos in automobile service is
vanishingly small. R. 2192a. During the braking process, the bulk of the asbestos in brake
debris is converted into inert nonfibrous substances such as forsterite. R. 2193a. There is no
credible evidence that short fibers cause disease. R. 2207a-2209a; see also Teta 12/28/2005, R.
s Other cases which were also the subject of the F_e hearing below involved asbestosis and lung cancer.Those cases are not at issue here.
10
2496a-2500a.Finally,Dr.Rogglirecognizedthattherelevantepidemiologyshowsnoincreased
riskof asbestos-relateddiseasefor mechanics.R.2183a-2184a,2189a-2191a.
Dr.GoodmanfoundthesamemethodologicalflawsasdidDrs.Paustenbach,Teta,and
Hessel.Healsonotedthattheveryfabricationof frictionproductschangesthechemical
structureof theasbestoswithin,andreiteratedthelow exposuresidentifiedbyDr. Paustenbach
andRoggli.R.2425a.
ByOrderdatedFebruary27,2006,JudgeColvillegrantedChrysler'sFrye Motion. R.
171 la. 9 Plaintiff filed a Motion for Reconsideration, which was argued on March 10, 2006. R.
1773a, 1823a. This Motion was denied on March 30, 2006. R. 1930a. In April, 2006, Judge
Colville entered summary judgment in favor of Chrysler based on the February 27, 2006 Frye
Order. R. 1934a. Final judgment was subsequently entered on May 10, 2006, as amended
on June 1, 2006. R. 1935-1940a.
After receiving the Issues Complained of on Appeal, on August 17, 2006, Judge Colville
issued a 34-page opinion in support of his February 27, 2006 Order. R. 1941a. Judge Colville
reiterated his finding (as explained in the hearings) that Dr. Maddox's methodology was novel.
R. 1945a. Judge Colville also held that Dr. Maddox's methodology was "fimdamentally flawed
and not generally accepted by the relevant scientific community." R. 1969a. In deference to his
broad view of this Court's opinion in Trach v. Fellin, 817 A.2d 1102 (Pa. Super. Ct. 2003), Judge
Colville declined to base his opinion on Chrysler's epidemiology evidence, instead relying solely
upon the analytical gaps in Dr. Maddox's methodology. R. 1970a.
9 The Order included a certification for immediate appeal pursuant to 42 Pa. C.S. § 702(b). All fourplaintiffs filed Petitions for Permission to Bring Interlocutory Appeal at Superior Court docket numbers 56 WDM2006 and 57 WDM 2006. Those Petitions were denied on May 3, 2006. Betz then obtained a final order in heraction and is the only plaintiffpartieipating in this appeal.
11
SUMMARY OF ARGUMENT
Betz supports this appeal with the flawed premise that Chrysler failed to demonstrate that
the causation opinions and underlying methodology of her expert are flawed under Frye. She
ignores the reality that the trial court properly found that the opinions were novel, and thereafter
Betz had the burden to prove that the expert used a generally accepted methodology in reaching
that opinion. Instead of demonstrating general acceptance of the methodology with sound and
reliable scientific evidence, Betz assumed that the mere fact that the opinion has been often
repeated in other cases would win the day. It did not.
Judge Colville, after extensive legal arguments, a comprehensive evidentiary hearing, and
review of a voluminous record, properly found that there is no generally accepted methodology
supporting the generic opinion that "each and every breath" of asbestos causes mesothelioma.
He exercised his discretion properly and correctly applied Pennsylvania law, and his ruling
should not be disturbed by this Court.
The methodology at issue here is strikingly similar to methodologies previously rejected
by this Court in Blum v. Merrell Dow, including reliance on animal studies, re-calculation of
data from other studies to reach conclusions contrary to those studies, and elevation of case
reports over epidemiological studies. Additionally, insofar as the methodology does not involve
consideration of any facts, and completely disregards case-specific details such as the nature,
duration and intensity of exposures, it is unquestionably nothing more than a biased guess.
At its core, the methodology behind the opinion at issue involves untested hypotheses,
unverifiable assertions, and unreliable supposition in the form of extrapolation from high dose
causation to low dose causation. No valid methodology was alleged or proven. Skipping steps
in the scientific method cannot be a generally accepted methodology in the scientific community.
12
Thefailureof themethodologybecomesevenmoreclearwhenoneconsidersthe
existenceof uncontroverted,replicatedepidemiologicalstudiesshowingnoassociationbetween
automotiverepairworkandasbestos-relateddiseases.A methodologywhichreliesonlesser
formsof evidenceandignoresepidemiology,themostreliableformof evidence,isnotgenerally
accepted.Opinionsbasedonsuchmethodologycannotbepermittedintoevidence.ThisCourt
shouldclarify theessentialroleof epidemiologyincasesof thistype.
Becauseof thesignificanceof thisissueandtheimportanceofuniformityand
predictabilitythroughouttheCommonwealth,thisCourt'sopinionshouldbepublished.
13
ARGUMENT
I. THIS CASE PRESENTS A SIGNIFICANT ISSUE FOR PENNSYLVANIA
COURTS AND LITIGANTS
A. The Issues Presented in This Case Affect Hundreds of Cases in the
Commonwealth
This case is emblematic of the issues presented by the "new wave" of asbestos litigation
in recent years. At the outset of asbestos litigation, most claims were filed by "asbestos workers"
from asbestos mining and manufacturing, shipyards, railroads and construction, where they
worked with high concentrations of airborne amphibole asbestos fibers in close quarters. Many
traditional asbestos defendants are now gone or have declared bankruptcy. In their place,
plaintiffs have begun suing non-traditional defendants.10
In particular, asbestos plaintiffs now sometimes sue manufacturers and distributors of
automobiles and automotive parts (collectively, the "friction defendants"), alleging that fi'iction
applied during, for example, the clutch or braking process, causes encapsulated chrysotile
asbestos fibers in those parts to be emitted. Thus, they claim that working with or around
automobiles or automotive parts caused or contributed to their asbestos-related illnesses. The
basis for this opinion, and the only proof of specific causation ever offered at trial, is the
contention of plaintiffs' experts that each and every exposure to asbestos over a lifetime plays a
causal role in the development of asbestos-related disease.
10The RAND Report in Asbestos Litigation, published by the RAND Institute for Civil Justice in 2005,described the revolution in asbestos litigation: "When increasing asbestos claims rates encouraged scores ofdefendants to file Chapter 11 petitions in the late 1990's, the resulting stays in litigation against those defendantsdrove plaintiff attorneys to press peripheral non-bankrupt defendants to shoulder a larger share of the value ofasbestos claims and to widen their search for other corporations that might be held liable for the costs of asbestosexposure and disease." RAND Report in Asbestos Litigation, Summary, xiii, Rand Institute for Civil Justice(2005). "Corporations that were perceived to have little or no exposure to asbestos-related liability have foundthemselves at the center of the litigation." Id. at 21-22.
14
However,unlikeinsulatorsandshipyardworkers,inhighlyexposedoccupationswidely
documentedandprovenin thescientificandmedicalliteraturetobe"atrisk" for asbestos-related
diseases,thereisnosound,scientificevidencethatpeopleworkingwithor aroundautomotive
frictionproductswill faceanyincreasedriskof asbestos-relateddisease.Therearesignificant
questionsasto whetherexposureevenoccursfor peopleworkingwithor aroundautomotive
products.
Therefore,thereisasignificantquestionof factinhundredsof casesthroughoutthe
Commonwealthasto whetherexposuretoasbestosby individualsworkingwithoraround
automotivefi'ictionproductsiscapableof causingasbestos-relateddisease.Nevertheless,
millionsof dollarsarespentbythepublicandthepartiesonasbestoslitigationinPennsylvania.n
JudgeColvilleagreedwith Chryslerthattheseclaimsagainstautomotivefrictionproductscannot
beproven,becauseplaintiffs'causationevidenceis of akind andqualityinadmissiblein the
courtsof Pennsylvania.JudgeColville'srulingcallsintoquestionthelegitimacyof all friction
claimspendingin theCommonwealth.Theimpactof this issueonthecourtsandasbestos
frictiondefendantsinPennsylvaniacannotbeignored.
B. Consistency of Outcomes on Critical Issues is of Paramount Importance
Chrysler believes that the Allegheny County Court of Common Pleas is the only court in
Pennsylvania (and the nation) which has conducted a complete Frye analysis and conducted an
evidentiary hearing under the Five standard, with respect to causation opinions as to asbestos-
n The RAND Report estimated that through the end of 2002 defendants alone had spent approximately $70billion to defend asbestos litigation. Id. at 92. For much of that time, Pennsylvania was one of a handful of stateswith the majority of the pending asbestos claims in the nation. Id.._._.
15
containingautomotivefrictionproducts.12OtherCommonPleasjudgeshavebeenpresented
with_ challenges-- somejudgeshavesummarilydeniedthemotionswithoutsubstantive
consideration,andothershaveorderedFrye hearings, which did not proceed. As a result, there
is currently no possibility of a consistent outcome in Pennsylvania asbestos litigation until this
Court can give the various trial courts appropriate guidance.
As discussed below, the "each and every breath" causation opinion is a uniform, generic
expert opinion offered in support of every asbestos friction claim. 13 It is the linchpin, without
which plaintiffs' friction claims cannot be proven. If that same "one size, fits all" opinion will be
considered admissible in some counties and not in others, Pennsylvania litigants will not be
assured consistent outcomes in every court. Tiffs will inevitably lead to the worst kind of forum-
shopping and judge-shopping.
If this Court concludes that Judge Colville is correct, and the "each and every breath"
opinion is inadmissible in the context of automotive friction claims, that decision will not turn on
the facts of any particular case, but on the generic methodology underlying this generic opinion.
As such, the ruling must be applied to all cases throughout Pennsylvania. _, Gra_Q_N_d_d839
A.2d at 1045 (holding that F_e will provide "uniform, objective, and predictable results among
the courts").
12In Texas, an evidentiary heating was held under the Texas Havner standard. Se___e.eExhibit A to Chrysler'sBrief in Support of Amended Global F_e Motion, R. 2544a-2549a.
13Dr. Maddox admitted at the F_ hearing that his affidavit which was submitted in this ease regarding themethodology used to reach his causation opinion is a "form" which he has been using "for about five years." R.701a. Moreover, Dr. Maddox admitted that his methodology did not involve consideration of the facts surroundingany particular exposure (R. 698a-700a) and he was not conversant with any facts relating to any of the plaintiffs whowere the subject of the hearing (R. 708a-709a), thus his methodology clearly did not entail anything other thangenetic considerations.
16
C. The Decision of This Court Should be Published (Rule 3519 Request For
Publication)
Based on the foregoing, as well as the numerous issues raised in this Brief, Chrysler
refers this Court to Rule 3519 (a) of the Pennsylvania Rules of Appellate Procedure:
Briefs of the Parties. The brief of... appellee may include ... a
request for the publication of the Superior Court's disposition with
respect to the issues on appeal. The request shall be separately and
distinctly entitled and shall set forth the reasons why publication as
an opinion is being sought. Such reasons may include (1) that the
Court of Common Pleas has decided a question of substance not
previously determined by the Superior Court or the Supreme
Court; (2) the Court of Common Pleas has rendered a decision inconflict with the decision of another Court of Common Pleas on
the same question; or (3) the question involves an issue of
substantial public importance.
All of the bases for publication of this Court's ruling are implicated by Judge Colville's
decision, and publication of this Court's opinion is warranted. The viability of the "each and
every exposure" opinion, based on the current state of the science of asbestos-related disease as it
relates to friction products, has never been squarely addressed by this Court. Further, other trial
courts throughout the years have allowed such testimony to go forward in friction cases, in
conflict with the ruling sub judice. Finally, the nature and sufficiency of the evidence presented
by plaintiffs in the largest mass tort in Pennsylvania history is, of course, of substantial public
importance, for the individual litigants, and for the integrity of Pennsylvania law.
II. THE OPINIONS AT ISSUE ARE NOVEL
Betz argues that Judge Colville could never properly have found the "each and every
breath" opinion to be novel, because it has been so frequently espoused and admitted into
17
evidenceduringthehistoryof asbestoslitigation.14Thisargumentispremisedupontwo
fallacies.First,thispositionassumesthatscienceis immutableandcanneverchange,aposition
alreadyrejectedbytheappellatecourtsof Permsylvania.SeeTrach,817A.2dat 1110. Second,
Betzfailsto takeintoconsiderationthatthevalidityof herexpert'sgenericcausationopinion
mightdependuponthecircumstancesin whichit is applied.Thus,it isbeyondthescopeof this
appealtoconsidertheappropriateness,in acaseinvolvingrawasbestosfibers,oracaseagainst
"traditional"asbestosdefendants,of anexpertopiniontotheeffectthateverybreathof friable
amphiboleasbestosfibersinhaledcontributedto mesothelioma.However,it cannotbeassumed
thatthesameopinionwhichmighthavebeenproperlyadmittedin acasebroughtby an
"asbestosworker"wouldbevalidwith referencetoadifferentplaintiffs exposuretoautomotive
frictionproducts,containingalimitedquantityof chrysotileasbestosencapsulatedin rock-hard
resin.15
A* Novel Does Not Mean New, and Frequency is Not a Surrogate for General
Acceptance
A Free analysis is not triggered every time science enters the courtroom; it only applies
when an expert seeks to introduce novel scientific evidence. Com. v. Dengler, 843 A.2d 1241,
14In support of this argument, plaintiffs submitted to Judge Colville transcripts from more than 20 asbestostrials at which "each and every breath" opinions of a variety of different experts were admitted into evidence, over aperiod of years. _ R. 1532a-1603a. Appellee Chrysler was not a party to most of those proceedings, butbelieves that few of them actually involved friction products.
15In a comparable situation, New York's highest appellate court has ruled that, where it was undisputed thathigh exposures to benzene over a long period could cause acute myelogenous leukemia ("AML") it was neverthelessappropriate to undertake a _ analysis and ultimately preclude the causation opinions of plaintift's experts, whosemethodologies were found not to be generally accepted. The Court noted that the relationship between benzene andAML was not at issue, but that plaintiffs' experts had failed to make a connection "between exposure to gasolinecontaining benzene as a component and AML." Parker v. Mobil Oil Corp., 877 N.E.2d 114, 824 N.Y.S.2d 584, 591(N.Y. 2006) (emphasis in original). The context of the exposure matters in science, and therefore it must matter inthe courtroom.
18
1243(Pa.Super.Ct. 2004);Trach v. Fellin, 817 A.2d 1102 (Pa. Super. Ct. 2003). See also Pa.
R. Cir. Pro. 207.1.
However, and importantly for the framework of this Court's analysis, the meaning of the
word "novel" is not restricted to "new." "Novel" can also mean "original," "striking," "having no
precedent" or "unusual." Den_ler, 843 A.2d at 1243; Trach, 817 A.2d at 1110. Despite Betz's
protestations to the contrary, in Trach this Court held that the mere fact that a scientific principle
has been repeated frequently in the past does no___Atmean that it cannot later be determined to be
novel:
We... are aware that ebb and flow are at the heart of the
scientific method: the theory of relativity is only valid until
someone disproves it. As the Frye court so elegantly stated,however, "While courts will go a long way in admitting expert
testimony deduced from a well-recognized scientific principle or
discovery, the thing from which the deduction is made must besufficiently established to have gained general acceptance in the
particular field in which it belongs." In this single, simple
sentence, the _ court recognized that the essence ofadmissibility is general acceptance: that a principle or discovery
can fall by the wayside as science advances is just another way
of saying it is not generally accepted. We therefore concludethat we are merely stating the law in Pennsylvania when we state
that _F_.w_e.applies only to novel science.
Trach, 817 A.2d at 1110 (citations omitted) (emphasis supplied). This concept is discussed in
even more detail in Judge Klein's dissent:
Pennsylvania law often states that the _F__.W_9.standard applies to
"novel" science. As noted in the majority's opinion, "novel" does
not necessarily mean "new." A careful consideration of the
purpose of the Frye rationale shows that the Courts are referring to
the second meaning of "novel," not the first. While the term"novel" can mean "new;" it can also mean "having no precedent"or "unusual."
o..
The methodology need not be "new" or involve cutting-edge
technology .... Moreover, a temporal or technological view of
19
"novelty"wouldunreasonablyhamperthetrialjudge'sgate-keepingfunctionto ensurethatall scientificmethodologyisgenerallyacceptedbeforeit ispresentedto thejury.
WhileI wouldhopethatin thefutllrewewoulduseatermotherthan "novel"whentalkingaboutwhenFrye applies, if"novel" isdefined as "having no precedent or unusual," this fits with the law
as it has developed. I believe that the proper standard, which I
think is adopted by the majority, is that Five properly governs
the admissibility of expert testimony, new or old; whether
there is a le_itimate dispute as to whether it is generally
accepted.
Trach, 817 A.2d at 1123, 1124-25 (Klein, J., dissenting) (citations omitted)(emphasis supplied).
Trach makes clear that Betz cannot attack the novelty determination based only on
litigation history or past repetition of testimony. Even if the principle that "every exposure
contributes" is a view that has been widely held in the past, 16Trach clearly would permit a trial
court in its discretion to re-examine novelty if the challenging party demonstrates a current,
legitimate dispute regarding the general acceptance of the expert's proffered methodology. The
Trach majority's reference to the theory of relativity makes it quite clear that any scientific
principle presently held sacred, could someday be found to have become "novel" and without
general acceptance. This is the very essence of Frye -- the fluid distinction "between the
experimental and demonstrable stages" should be the focus of the trial court's analysis, not
whether the alleged principle has been propounded in the past. _ 293 F. at 1014.
_6Curiously, this view seems to only be held in the courtroom. Certainly Dr. Maddox did not refer to anyliterature which holds this view; only literature that supports the notion that arguably states that there is no knownsafe level of exposure to asbestos above "background" levels, which most if not all scientists and researchers wouldagree do not contribute to the development of an asbestos-related disease (thus demonstrating an arguably safe levelof exposure). R. 769a, lines 18-19 (describing his method of analysis as "forensic").
2O
B. Judge Colville Properly Determined the Issue of Novelty
Betz argues that Judge Colville has not explained his finding of novelty, and had no basis
for doing so on the record. This contention is wrong. First, Judge Colville addressed the basis
for novelty numerous times in open court. R. 443a-451 a, 488-492a, 517a-518a. To summarize,
Judge Colville explicitly found that:
• Dr. Maddox's opinion relies on "extrapolation down" from proven results at high
exposures to hypothesize causation at low exposures;
• "Extrapolating down" causation from a high dose to a low dose is not supported
by any scientific authority or any medical authority;
• While scientific data and literature may argue that there is no known safe level of
exposure to asbestos, that is not equivalent to saying that there is no safe level of
exposure to asbestos; and
• As a result, there is a legitimate question as to whether "extrapolating down" inthis fashion in the absence of other concrete exposure data is a generally accepted
methodology in the context of the low-dose exposures from friction products.
Procedurally, Judge Colville offered to file a formal order on the subject of novelty, but
the plaintiffs, including Betz, did not request he do so. R.489a-490a. The basis for Judge
Colville's position on novelty is clear: he was concerned with Dr. Maddex's intellectual "leap of
faith" from the literature regarding high amphibole or mixed fiber exposures to his "guess"
regarding the very low exposures associated with friction products, without any scientific data to
support that leap.
Additionally, the August 17, 2006 opinion speaks to novelty --- as indicated, he found a
legitimate dispute as to the opinions and methodology because they are based upon the logical
fallacy he described at the various _ hearings. R. 1941a-1976a. Therefore, his detailed
description of that logical fallacy in his 34-page opinion also demonstrates the novelty of Dr.
Maddox's opinion.
21
III. THERE IS NO GENERALLY ACCEPTED METHODOLOGY WHICH
SUPPORTS THE OPINION THAT "EVERY BREATH CONTRIBUTES" IN THE
CONTEXT OF FRICTION CLAIMS
As the proponent of Dr. Maddox's testimony, Betz had the burden to prove that his
methodology "is generally accepted by scientists in the relevant field 17as a method for arriving
at the conclusion." Grady_, 839 A.2d at 1045. Betz did not meet that burden.
The focus of a Frye analysis in Pennsylvania is the methodology on which the opinion is
based. The seientific method must be at the heart of a valid methodology: "[k]ey aspects of the
scientifc method include the ability to test or verify a scientific experiment by a parallel
experiment or other standard of comparison (control) and to replicate the experiment to expose
or reduce error." Tra._T_ch817 A.2d at 1113. Thus, in order for a methodology to be generally
accepted, it must follow the scientific method. Experts cannot merely state a hypothesis as fact;
a hypothesis must be tested empirically. Id. ("Scientific methodology today is based on
generating hypotheses and testing them to see if they can be falsified; indeed, this methodology
is what distinguishes science from other fields of human inquiry"). The thrust of Chrysler's
challenge and Judge Colville's resulting exclusion of Dr. Maddox is based on the failure of Dr.
Maddox's methodology to move past hypothesis and into empirically verified results.
A. The Methodology At Issue Was Expressly Reieeted in Blum
Chrysler maintains, and will discuss in Part IV below, that epidemiology is crucial to
determining causation of disease, especially with respect to long latency toxic exposures such as
17Betz complains bitterly about the relevance and/or hierarchy of disciplines, and suggests that the onlyscientific community at issue is "pathology and etiology." Etiology is not a distinct field, per se. There is noetiology specialty within the American Medical Association. Scientists do not hold themselves out as "etiologists"in the same way that there are "pathologists," "epidemiologists,"and "toxicologists" (all of which, incidentally,Chrysler offered to challenge Maddox's methodology). Nonetheless, Chrysler's experts opined that epidemiology isthe gold standard in determining causation, but it is appropriate to obtain evidence and input from multipledisciplines before assigning causation. _ R. 819a-820a.
22
asbestos.However,evensettingasideDr. Maddox'sfailureto cometo termswith theconsistent,
analyticepidemiologyshowingnoassociationbetweenautomotiverepairworkandasbestos-
relateddiseases,Dr.Maddox'smethodologyfailsonitsfaceunderthesettledlawof thisCourt,
asdiscussedin Blum v. Merrell Dow Pharm., Inc., 705 A.2d 1314 (Pa. Super. Ct. 1997) affd,
564 Pa. 3,764 A.2d 1 (2000), abrogated in part on other _rounds by Trach v. Fellin, 817 A.2d
1102 (2003).
In _ this Court considered expert testimony regarding the role of Bendectin in the
development of birth defects. In that case, plaintiffs' experts opined that Bendeetin causes birth
defects such as club feet, and that Bendectin ingested by the mother during pregnancy had
caused the birth defects of the minor plaintiff, despite the fact that no published epidemiological
studies demonstrated an association between Bendectin and limb defects. One of plaintiffs'
experts, Dr. Done, testified about the methodology supporting his opinion. His methodology
included reliance on chemical structure analysis, animal studies, case reports, recalculation of the
data in one of the published epidemiological studies to reach a conclusion contrary to the
conclusion reached in that study, and the use of unreported preliminary data generated by
another researcher. Blum, 705 A.2d at 1320. The parallels between the methodology used in
Blum and in this case are striking:
Blum experts used the following
methodologies (rejected by this Court):
1. Chemical structure analysis - Blum,705 A.2d at 1319;
. In vitro and in vivo animal studies -
Blum, 705 A.2d at 1320;
Maddox used the same methodologies:
Reliance on the potential of all chemical typesof asbestos to cause disease and the chemical
analysis done by Dodson, R. 602a, 613a-615a;
Reliance on animal studies showing "increasingincidence of tumors at higher doses of asbestos
[not friction products]," R. 623a, 779a-780a;
23
.
.
.
.
Re-calculation of data from a published
epidemiological study, to reach a
conclusion contrary to the conclusion
of the published study-Blum, 705
A.2d at 1320 -use of"simple
arithmetic" to perform a crude relative
risk calculation without eliminating
bias and prejudice;
Analysis of preliminary data, the
legitimacy of which has beenquestioned by the researcher who
gathered that data - Blum, 705 A.2d at
1320;
Reliance on a case report of a pregnant
woman exposed to Bendectin early in
gestation giving birth to malformed
child- Bhim_ 705 A.2d at 1321;
Elevation of case reports over the
published epidemiological studies -Blum, 705 A.2d at 1320; and
Testifying expert had never published
his opinions to allow peer review of
opinions and methodology underlying
opinions -Blum, 705 A.2d at 1320.
Re-calculation of data from reports of other
researchers and reliance on the use of "simple
arithmetic" to reach a preliminary conclusions
about risks - conclusions which are contrary to
the conclusions reached by those researchers,
R. 677a-678a, 754a-760a;
Analysis of the data contained in the Australian
Mesothelioma Registry, despite the fact that its
author Dr. Leigh has testified that there are
flaws in the data collection and interpretation,
R. 750a-754a. Reliance on the preliminary 1970
McDonald data later repudiated by the 1980
McDonald study, R. 326a n.20, 645a-646a,
764a-765a;
Reliance on case reports of mesothelioma
among auto mechanics, R. 641a-643a;
Treating case reports as more persuasive than
published epidemiological studies, R. 660a-661a, 745a-746a, 796a-797a and failing to take
into account the conclusions of published
epidemiological studies, R. 705a-707a; and
The opinion that "each and every inhalation [of
asbestos] causes or contributes to causing
asbestos-related disease" is not published in thescientific literature, R. 733a-735a.
This Court expressly criticized the methodology relied upon by the plaintiffs in Blum
(which mirrors Maddox's methodology):
The Blums simply did not meet their burden of proving that their
experts' reasoning and methodology.., were generally accepted
by the relevant scientific communities. Dr. Done's own testimony
that his opinions were based on generally accepted methods was
not sufficient to carry this burden.
24
Blum,705A.2dat 1321.
Resultsderivedfromchemicalanalysis,in vitroandin vivostudiesdonotyieldsufficientlyreliableconclusionsasto causationunlesssupportedbyepidemiologicalevidence.Dr.DonewhowastheonlywitnesstotestifyspecificallythatJeffreyBlum'sclubfeetwerecausedbyBendectin,reliedonepidemiologicalevidence.Buthiseliminationof standardizationfromtheepidemiologicalanalysismadetheepidemiologicalmethodologynotgenerallyaccepted.Tobemorespecific,hisepidemiologicalanalysiswassoflawedasto renderhisconclusionsunreliableandthereforeinadmissible.
BecauseDr. Done'sconclusionsweretooinlaerentlyunreliabletobesubmittedto thejury andnootherwitnessprofferedby theBtumswouldhavetestifiedthatBendectincausedJeffrey'sclubfeet,theconclusionin inescapablethattheBlumsfailedtopresentproperlyadmissibleevidenceraisingajury questionastocausation.
Id. at 1325.See also In re: W.R. Grace & Co., No. 01-01139, --- B.R. ---, 2006 WL 390176
(Bankr. D. Del., Dec. 14, 2006) (rejecting argument suggesting that release of a single asbestos
fiber increases the risk of disease and therefore creates an unreasonable risk of harm). Without
any reference to the validity of the conclusions he reaches, Dr. Maddox's methodology cannot be
considered generally accepted, as this Court has previously ruled that it is not.
B. The Exposures at Issue are Not High-Dose/Amphibole Occupational
Exposures
There is no serious dispute that any arguable asbestos exposures from working with and
around automotive friction products are low exposures, especially when compared to
occupational exposures in demonstrated high-risk occupations. As noted by Judge Colville and
amply supported by the record, dose-response curves have been widely studied for high-dose
exposures to asbestos. 18
18For example, insulators have a relative risk of46.0. R. 2554a (McDonald 1980).
25
Theseexposuresof traditional"asbestosworkers"arein starkcontrasttotheexposures
connectedwithautomobilerepairworkandautomotivefrictionproducts.No establisheddose-
responsecurvesexistfor theseoccupationalexposuresand,thus,Dr.Maddoxisunabletorely
uponsuchacurveto supporthisopinion.Instead,heassumes,withoutproof,thattheeffectis
equivalent.
In evaluatingexposureswhereexactdosesmaynotbeknownbutexposuresoccur
stereotypicallyin anoccupationalsetting,timespentin theoccupationbecomesasurrogatefor
"dose"andthe"dose-response curve" charts years in the occupation against observed
occurrences of disease. Although Dr. Laman conceded that evaluation of exposure by
occupation makes sense (R.1202a, lines 11-21), in fact Dr. Maddox's methodology ignores
occupational differences. R. 729a-730a. Dr. Maddox utilized an unreliable and unaceepted
methodology because he used studies and observations from traditional high-dose asbestos
occupations to draw conclusions about the unique kinds of"vanishingly low" exposures which
occur in connection with automotive work. Without a tested, verified dose-response curve
relating to the specific type and quality of exposures at issue and established in accordance with
the scientific method, no expert can effectively demonstrate a causal relationship between low
exposures to asbestos and disease. To state otherwise is merely to make what may be a well-
intentioned, but ultimately futile, supposition without empirical scientific data to transform that
supposition into scientific fact.
C. "Extrapolation Down" is Not Generally Accepted Methodolog_
Dr. Maddox conceded at the F_e heating, and has testified in the past, that the
methodology on which his causation opinion relies is extrapolating down from studies by others.
R. 729a-732a. In other words, from studies suggesting that there is an increased incidence of
26
mesotheliomaasaresultof highlevelsof occupationalexposuretoamphibole-containing
products,Dr. Maddoxhasused"extrapolationdown"19tojustify hisconclusionthat"it is the
totalandcumulativeexposurethatshouldbeconsideredfor causationpurposes."(R.618a-619a)
or,asstatedinhiswrittenreportin thiscase,eachandeveryexposuretoasbestoscontributes
thedevelopmentof mesotheliomainacumulativeanddose-relatedmanner.R.323a.
BetzclaimsthatthisCourtinTrachpermittedextrapolation,andthatthereforeDr.
Maddox'sextrapolationhasalreadybeenfoundtobegenerallyacceptedmethodology.
However,the"extrapolationdown"utilizedbyDr. Maddoxdoesnotcomparetothe
"extrapolationup"permittedin Trach.
The expert in Trach extrapolated "up" from a small dose to a larger dose. Dr. Maddox, in
this case, utilized a methodology which involved extrapolation "down" from conclusions about a
large dose to hypothesize conclusions about a smaller dose. This is in direct contradiction to the
generally accepted dose-response principle the Trach Court regarded as compelling, and simply
cannot be established as a proper methodological analysis.
In fact, this Court has clarified its opinion in Trach by noting that "F_e demands that the
scientist begin from generally accepted scientific principles and then employ the scientific
method each and every step of the way before reaching his or her conclusion." Vinitsld v. Adler,
No. 1759 EDA 2004, 2005 WL 984497 at *2 (Pa. Super. Ct., Apr. 22, 2005). 20 Further, in
Vinitski, this Court made it clear that the extrapolation in Trach was proper only because the
19Although Dr. Maddox doesn't know the precise shape of a dose response curve for chrysotile andmesothelioma or amphiboles and mesothelioma (R. 620a-621 a), he nevertheless used "simple arithmetic" to re-calculate data from other studies to hypothesize a dose response curve, on which his methodology relies. R. 676a-678a.
20Chrysler is aware of the rules governing the citation of memorandum opinions to this Court. However,because the trial court referenced Vinitski in its Opinion below, Chrysler feels constrained to discuss it, especiallysince the principles elucidated therein are logical extensions of the principles set forth in Trach.
27
druginquestionhadbeenprovento causeharmin recommendeddoses,andthereforeit was
consistentwith thescientificmethodtohypothesizethatthedrugwaslikely to causeharmin
largerdoses.In Vinitski bycontrast,theexpertopinedthatValinmcausedpermanentbrain
damagebasedonlyonextrapolationfromevidencethatthedrugcausedshorttermcognitive
changes.ThisCourtruledthatsortof extrapolationtobeimproper,andnotagenerally-accepted
methodology:
Thecurrentappealis afarcryfromTrach.Here,Dr. Bregginwishesto startattheprinciplethatValinmcausesshort-termandacutedementiaandarrive,somehow,attheconclusionthatlong-termValiumusecausespermanentfrontallobebraindamage.Yet,thisisnotlogical;onecannotjustviewthetemporaryeffectsadrughasonthebrainandthenleapto theconclusionthatthesetemporaryeffectsbecomepermanentand,indeedmuch worse,
with repeated exposures. This is not extrapolation, it is merely abiased guess.
Thus, we agree with the trial judge: Dr. Breggin's methodologies
do not proceed scientifically to his stated conclusion. As such, Frye
prohibits his testimony as an expert.
Vinits_, 2005 WL 984497 at *4 (emphasis supplied). In fact, this clarification of the appropriate
use of extrapolation is crucial to any analysis of Dr. Maddox -- because his methodology consists
almost entirely of improperly extrapolating down. Dr. Maddox ignores the settled and
scientifically sound principles of a proper analysis, therefore he can do no more than make a
"biased guess." That is not scientific evidence, and Judge Colville properly precluded it.
Dr. Maddox knows nothing about Mr. Simikian's alleged exposure to asbestos - only that
he was exposed. R. 699a-700a, 709a-710a. Further, he has made no attempt to quantify his
exposure or to create an applicable does-response curve. Dr. Maddox does not quantify what
exposures he believes are necessary to cause disease, over any period of time. For Dr. Maddox,
28
thefactthathighdosesof asbestosleadtodiseaseisenough;onemustsimplyacceptthatsmaller
doseswill achievethesameeffect.Id____.
However,substancesthatcauselittle (orno)harminsmalldosescanbefound
throughoutindustryandin thehome.JudgeColville'sopinionlistsseveralexamples.R. 1956a.
Saccharinwasresearchedin the1970sto ensureits safetyfor consumption- theresulting
"cancerstudies"(thatarealsocontradictedby laterstudiesshowingnorisk)in factinvolved
dosageshundredsof timeshigherthanthoseconsumerswouldeverencounter.
WeihrauchandDiehl,Artificial Sweeteners- DoTheyBeara CarcinogenicRisk,Annalsof
Oncology1460-65(2004).Regardlessof theproduct,if thedosemakesthepoison,thesizeof
thedose(andthedurationof exposure)mustbeconsideredasrelevantfactors.
Nevertheless,BetzwishesthisCourtto endorseamethodologythatignoresdose-
response,_nores settled science, and instead makes the counter-initiative leap from high to low
without any stated basis. As Judge Colville explained:
Trach tells us what we understand common-sensibly, that when
science knows that a certain deviation from a body's chemical
norm causes harm, then a greater deviation from a body's chemical
norm can be reasonably expected to cause increased harm (i.e."extrapolation up").
What Trach does not say is that where it is known that a certain
deviation from a body's chemical norm causes harm, a lesser
deviation from a body's chemical harm can be similarly presumedto cause harm (i.e. "extrapolation down").
R. 1956a - 1957a. Certainly Dr. Maddox must reasonably be required to use a consistent
methodology that does not rely on such an assertion. This is particularly true since, as Dr.
Maddox himself acknowledges, the human body can tolerate asbestos at certain levels. Certainly
Dr. Maddox acceots that the human body can tolerate asbestos at certain levels, such as
background. R. 802a-803a. Therefore, vanishingly small exposures cannot be logically linked to
29
highexposures:theremustbeathreshold,andthereforeextrapolationcannotbeutilizedin this
fashion.
D. Allegations of Increased Risk Are Insufficient
Dr. Maddox testified generally that, based on his questionable methodologies, it is his
contention that each and every exposure to asbestos increases the risk of disease, and therefore
contributes to the development of disease. R. 625a. To the extent that this opinion expresses
itself in terms of "increased risk" of injury, the opinion is not permissible under Pennsylvania
law.
Pennsylvania law requires proof of actual causation, not increase of risk. Eckenrod v.
GAF, 375 Pa. Super. 187, 544 A.2d 50 (1988). As Judge Colville noted in his opinion (R.
1961a-64a), probabilities are insufficient. "[T]he expert has to testify, not that the condition of
claimant might have, or even probably did, come from the accident, but that in his professional
opinion the result in question came from the cause alleged." McMahon v. Young, 442 Pa. 484,
276 A.2d 534, 535 (1971). The premise that a purported cause may result in an effect is
insufficient under Pennsylvania law. Checchio v. Frankford Hosp., 717 A.2d 1058, 1061 (Pa.
Super. Ct. 1998). An opinion that an exposure may have increased the probability of injury is
similarly deficient. 21
2_Betz agrees with this view, as her counsel made the same argument (purportedly against Chrysler'sexperts) in his opening statement to the Court. R. 587a-588a ("the defendants are subtly re-packaging this questionof risk to make it cause.., it is a case specific causation question that is being tested here, not general causation oran opinion about risk").
30
E° Anything Less Than Exclusion of "Every Breath" Testimony as a Matter of
Law Allows Plaintiffs to Impermissibly Shift the Burden of Proof to theDefendants
Judge Colville has expressed concern that Dr. Maddox's opinion is part of an effort to
establish causation through mere proof of disease coupled with proof of exposure. R. 1964a-
1965a. This is an apt concern in light of his testimony:
Q: Doctor, I want to put a couple ofhypotheticals to you. I
want you to assume for the purpose of this question that you see a
patient ... who was exposed to both amphiboles and chrysotile.
Let's say, for instance, he worked in a shipyard near your facility.
But also in addition to the work in a shipyard, he also did his brake
changes on his family car, as well as friends' cars every year for
twenty years. Given that, let's say that you believe that that
mesothelioma is related to asbestos exposure. Assume for
purposes of this question that it meets your criteria for that, okay?
A: Yes, sir.
Q: Is there any reason why you would say that those brake
exposures should not be included as contributing to hismesothelioma?
A: No.
Q: When we talked about the total and cumulative effect, do
you add on the chrysotile exposures to the other exposures,
amphibole exposures?
A: Yes.
Q: Can you explain why?
A: They are all exposures to asbestos. No matter what the
source, the individual still ends up with asbestos fibers in his lungs.
Now, individual exposures differ in the potency of the fiber to
which an individual is exposed, to the concentration or
intensity of the fibers to which one is exposed, and to theduration of the exposure to that particular material. So thoseare the three factors that need to be considered in trying to estimate
the relative effects of different exposures. But all exposures havesome effect.
R. 684a-685a (emphasis supplied).
31
In effect,althoughDr.Maddoxhasadmittedthatall exposuresarenotcreated
equal,andtheycandiffer in fibertype,concentration,intensityandduration,neverthelesshe
irrationallyinsiststhatwithoutknowinganyof thedetailsof anindividual'sexposures,his
methodologyallowshimto attributecausationof themesotheliomatoall exposures.Judge
ColvilleobservedthatDr.Maddox'smethodologydidnotincluderelianceonbiological"fiber
load"findingsorquantitativeevidenceof occupationalhighdoseexposure,andhecorrectly
notedthatit iswithoutmeritto arguethatmereproofof anasbestos-relateddisease,alongwith
proofthattheplaintiffwasexposedto asbestosinhislifetime,is sufficientto carryplaintiff's
burden.R. 1964a-1965a.WhatJudgeColvilledidnotdo,however,wastopointout thewaythat
thisconstructturnsthelegalsystemonits head,confusesgeneralcausationwithspecific
causation,andunfairlyshiftstheburdenof proofto defendants.
Therearemultiplelayersof deficientlogicin thereasoningthat"chrysotileasbestoscan
causedisease"(generalcausation),thisplaintiff wasexposedto chrysotileasbestosinbrakes
(proofof exposure),thereforethebrakesdidcausethisplaintiffs disease(specificcausation)."
Here,Dr.Maddoxhasofferedtestimonyonbothgeneralandspecificcausationasto friction
products,bothofwhicharecontested.However,evenwhengeneralcausationisestablished,
mereproofof exposureisnotsufficientto establishspecificcausation.
Additionally,if the_ dixit of experts such as Dr. Maddox is considered adequate to
meet plaintiff's burden to make out a prima facie case, defendants are then forced to disprove
causation by bringing forth evidence regarding all of the particular plaintiff's exposures to
asbestos in various contexts, as well as the fiber types, concentrations, intensities and durations
of those exposures, in order to establish that exposure to defendant's product was not the cause
of the disease. This is exactly backwards. "In order liability to attach in a products liability
32
action... plaintiff must establish that the injuries were caused by a product of the particular
manufacturer or supplier." Eckertrod v. GAF Corp., 375 Pa. Super. 187, 190-191,544 A.2d 50,
52 (1998) (emphasis supplied).
The agenda advocated by Betz would mean that liability can be assumed in all cases, and
the burden shifts to the defendant to prove that there is causation. Following the logic and
methodology of Dr. Maddox, then, there will be no bar to any lawsuit alleging diseases caused
by exposure to the trace amounts of toxins which are ubiquitous in our environment 22because
plaintiffs will only need to establish disease and exposure to the toxin, and present a medical
expert to testify that the toxin can cause disease at some level of exposure, so the toxin must
have caused the disease in this case. Just because a toxin can cause disease at some level of
exposure, it is not necessarily true that the toxin caused disease in every instance.
If Pennsylvania courts will allow such cases to go to a jury without reliable expert
causation testimony premised on generally accepted methodology, we would be inappropriately
shifting the plaintiffs' burden to the defendants. Instead of requiring the plaintiff to prove each
element of her case, including causation, "we would in effect be forcing defendants to disprove
causality." Lasley v. Georgetown Univ., 688 A.2d 1381, 1387 (D. C. Ct. App.1997). As Judge
Colville properly recognized, our legal system requires more - "proof of causation of the actual
injury is necessary." R. 1976a.
F. Frye Challenges Affect Admissibilitv_ Not Weight, of the Expert Testimony
Pennsylvania appellate courts have made it clear that, while the legitimacy of an expert's
opinions are a matter of weight, the novelty and general acceptance of their methodologies are a
22_ R.J. Pierce, Jr., Causation in Government Regulation and Toxic Torts, 76 WashingtonUniversity Law Quarterly 1307, 1313-1318 (1998) (discussing prevalence of trace amounts of known carcinogensand teratogens in common products and foods).
33
fundamentalmatterof admissibility._, Commonwealthv. Hall,867A.2d619,633(Pa.
Super.Ct.2005);see also Commonwealth v. Dengler, 586 Pa. 54, 78-79, 890 A.2d 372, 387
(2005) (Baer, J., concurring).
This ease does not represent a simple "battle of the experts." This is not a ease that
concerns, for example, two accountants differing on the valuation of a business in a contractual
dispute, or two engineers disagreeing on the level of structural strain that caused a bridge to
collapse. In those cases, the experts will likely be using the same methodologies, or two
different, generally accepted, methodologies to reach their opposing conclusions.
Here, Dr. Maddox did not base his causation opinion on any acceptable methodology. As
demonstrated at the Frye hearing and as determined by Judge Colville, Dr. Maddox's causation
opinion is nothing more than a "best estimate." No jury can accept Dr. Maddox's conclusions
without also accepting what amounts to speculation. That is not weight- any methodology that
results in speculation cannot be presented to a jury as expert testimony, and Judge Colville was
right to restrict it.
G. Treating Physicians Generally Do Not Concern Themselves With Causation_
Particularly in the Context of Long Latency Toxic Exposure Cases
Proving causation in an asbestos case requires consideration of two questions: (i) general
causation - does the alleged exposure at issue (i.e., working with or around automotive friction
products) cause the disease alleged, e.g., mesothelioma; and (ii) specific causation - did the
alleged exposure cause the disease in a particular plaintiff. See Blum, 705 A.2d at 1316. Thus,
in this case, Betz had the burden of proving that Chrysler's automotive products are capable of
causing mesothelioma and that exposures to those products caused or contributed to causing the
alleged injury to Mr. Simikian. A treating physician presented with the diagnosis or care of a
specific patient does not set out to conduct primary research on the cause of the disease. Rather,
34
epidemiologyandotherscientificdisciplinesprovidethe"menu"of knowngeneralcausesof the
diseasefromwhichthelikely causein aparticularcasecanbeselected.R. 1212a-1214a(Dr.
Lamanre:smokingandlungcancer;smokingandmesothelioma)
Betzmaintainsthatthe"realissue"in thiscaseis oneofpatient-specificdiseaseetiology.
Generalcausation,sheargues,is establishedbytheirpathologistattributingthediseaseatissue
to asbestos.Populationstudieswhichmightshedsomelightonwhetherthespecificproductcan
causediseaseandananalysisoftheactualexposurearethereforeirrelevant.Sheclaimsher
expertsaresufficientbecausetheyhavetiedthediseaseto "asbestos,"andnothingfurtheris
required.Thischaracterizationof theissuesof amodernasbestoscasemissesthemarkand
improperlyreducesacomplexissue.
Stereotypically,anasbestosplaimiffbeginswithaverysimplecase.A pulmonologist,
pathologist,or othermedicalprofessionalseesapatient(or reviewsothermedicalevidence)and
ahistoryof exposurethatdemonstratesthatthepatientwas,atsomepoint,exposedto asbestos.
Basedonthis,thedoctordeterminesthat:1) thepatienthasanasbestos-relateddisease;and2)
asbestoscausedthedisease.Thatisall a treatingphysicianisultimatelyconcernedwith -- a
diagnosisandappropriatetreatment.Certainly,apracticingphysicianmaybecorrectin
ascribingthe"cause"of apatient'smesotheliomato asbestosexposure,givenacrediblehistory
of significantexposure.
However,theprocedurefollowedbytheclinicalphysicianisnotadequatefor assignment
of legalliability. Of course,asJudgeColvillenoted,Dr.Maddoxcanprobablystatethat"all
asbestosfiberscanpotentiallycausedisease"asaprerequisiteto generalcausation.Colville
Opinion,R.1950a.However,suchanopinion,withoutmore,doesnotcreateapermissible
inferencethatasbestosexposurefromfrictionproductscausedMr. Simikian'sdisease.Id.
35
Dr. Maddoxexplainedhis"bridges"ofmethodologyfordeterminingcausationin detail,
butatnopointdidheeverexplainhowto bridgethegapfrom'"asbestoscanpotentiallycause
• " "asbestosfromChrysler'sproductscausedMr. Simikian'sdiseasein certainconcentrationsto
disease." Nor can he -- he admits his extrapolation is an untested theory. R. 729a-730a. That
bridge cannot be crossed without a methodology that actually considers fiber type, case-specific
exposure data, epidemiology, and the ability to quantify an asbestos exposure threshold that, in a
particular case, has been exceeded. Without such a methodology, Dr. Maddox is, in fact,
making a "biased guess" based on a hypothesis that "every breath counts." He is making a leap
as a physician that no physician can make, and that is not supported by the evidence.
This issue was discussed in detail by Professor David E. Bernstein in a recent article:
Until recently, courts were much too liberal about allowing
doctors, especially treating physicians, to testify with respect tocausation evidence. Courts have had a mistaken notion that if a
doctor examines a patient in his office, this means that the doctor
has some special insight into what caused the patient's disease. In
fact, clinical physicians (as opposed to doctors who engage in
research) are trained to diagnose and treat medical problems, not todetermine whether an injury was caused by exposure to a particular
substance. Therefore, unless a particular treating physician is
actually immersed in the literature discussing the possible external
causes of a plaintiffs health problems, he should generally not be
permitted to testify regarding causation.
Physicians who are not trained researchers are vulnerable just like
laypeople to the 'post hoe ergo propter hoe'--after which, therefore,because of which-- fallacy• Post hoe evidence is based solely on a
temporal sequence of events• For example, if an infant develops abrain tumor after getting a measles vaccine, the baby's physician
may conclude that there is a problem with measles vaccines• In
fact, however, there are several million babies getting measles
vaccine every year and every now and again one of them will get abrain tumor. The fact that these babies happen to get the braintumor after the measles vaccine does not mean the measles vaccine
caused the brain tumor.
Nevertheless, this is the kind of reasoning that physicians often use
in all sorts of medical causation contexts including asbestos. A
36
physicianmaythink,"I'vebeentoldthatmypatientwasexposedto occasionalasbestosfrominsulation.Henewhassomelungdiseaseorsomeformof cancer,it mustberelated."Physicianswhoare sufficiently disengaged from the scientific process that
they use such reasoning should not be permitted to testify as
qualified experts in causation cases.
David E. Bemstein, Keeping Junk Science Out of Asbestos Litigation, 31 Pepp. L. Rev. 11, 20-
21 (2003) (emphasis added).
A pathologist or treating physician may be an important part of an asbestos plaintiffs
case, and is certainly essential to confirm diagnosis. However, proof of general and specific
causation requires a more detailed, multi-disciplinary approach.
H. Paustenbach's "Concession" Is Anything But
In his report in this matter, Dr. Paustenbach made the following statement regarding Dr.
Hammar's 23 contention that each exposure to asbestos during the appropriate time period is
considered to be causal:
For his statement to be true, he would need to have evidence that
the cumulative dose had reached a level which was already
sufficient to cause disease. Had such dose occurred, one can
sometimes opine that further doses of a genotoxic carcinogen
increase the risk but failing that such evidence exists, this opinioncannot be offered.
Paustenbach Report at pp. 6-7, R. 2001a-2002a. Betz attempts to find some sort of"smoking
gun" in support of her appeal by referencing this isolated quote by Dr. Paustenbach. However,
this language does nothing to support Betz's claims, especially when its true context is analyzed.
Dr. Paustenbach's opinion makes perfect sense in the larger context: in traditional high-
dose chemical/toxic exposures, a scientist evaluating causation may be able to demonstrate that
23Dr. Hammar is not a subject of this appeal, but his opinions are nearly identical to Dr. Maddox's andwere made a part of the record below by submission of reports and transcripts.
37
eachsubsequentexposureaftera "satuxationpoint"couldhaveplayedarole. Thisisafarcry,
however,fromthepresentsituation.
First,of course,Dr. Maddoxknewnothingabouttheexposurehistoryof Simikian,and
did notconsideranysuchfactsin reachinghiscausationopinion.R.699a-700a.In fact,Dr.
MaddoxhadtoberemindedwhichdiseaseMr. Simikianhad.R.709a.Hehadnoevidenceof a
historyof exposureto asbestos,andnoevidencequantifyingthetypeanddurationof exposure.
Hehadnoevidencefromwhichcumulativedosecouldbeestimated.Therefore,evenifa
sufficientcumulativedosecouldbeestablishedandquantifiedhere,Dr.Maddoxmadeno
attemptto doso.
Further,Dr. Panstenbach'sstatementin isolationcontainsthemostimportantof
modifiers:"sometimes."Betzdidnot inquireof Dr. Paustenbachwhat"sometimes"meantin
thiscontext.BetzdidnotascertainwhetherDr. Panstenbachwouldapplythatprinciplein the
contextof asbestosexposureatall, letaloneatlow-levelexposuresfromworkingwithand
aroundautomotivefrictionproducts.Indeed,themajorityof Dr. Panstenbach'sopiniondescribes
in detailwhatthescientificmethoddemandstomakesuchastatement,andhowDr.Maddox
failedto followproperscientificprinciples:
• Dr. Maddox focused only on "peak exposures" and did not consider time-
weighted averages;
• Dr. Maddox disregarded the epidemiological studies in favor of case
reports, as well as ignoring the industrial hygiene and pathology
concerning low-exposure friction products; and
• Dr. Maddox assumed that there is no safe level of asbestos exposure when
in fact, the most that can be said is that there is no known safe level of
exposure. 24
24In fact, the consensus opinion that ambient air exposure cannot cause mesothelioma shows that thethreshold for causation of mesothelioma or any asbestos-related disease is at least higher than ambient air exposures.Further, the epidemiologieal studies regarding mechanics would also suggest that the vanishingly low levels ofexposures of automobile mechanics are also below whatever disease threshold does exist.
38
R. 2192etseq.;R. 819a-885a.In light of thesemethodologicalflawshighlightedbyDr.
Panstenbach,his "concession"mustin factbeviewedthroughthelensof whatDr.Maddox
failed to do.
IV. THE ESSENTIAL ROLE OF EPIDEMIOLOGY IN TOXIC TORT LITIGATIONCANNOT BE IGNORED
Although Betz failed to carry her burden of proof, Chrysler offered an additional basis for
Judge Colville's decision: epidemiological studies showing no relationship between friction
products and asbestos-related disease. While Judge Colville elected not to rely on the
epidemiology in making his decision, discussion of this important issue is warranted.
In a routine tort case (such as a car striking a pedestrian), cause-and-effect relationships
between the actions of a defendant and the injuries to a plaintiffmay be so obvious that expert
testimony regarding causation is not required. In tort cases alleging harm from toxic exposures,
however, the causal determination can be complicated by the nature of the causation mechanism,
the latency period between toxic exposure and manifestation of symptoms, and alternative
possible causes. See generally, J.M. Eggen, Toxic Torts, Causation, and Scientific Evidence
after Daubert, 55 U. Pitt. L. Rev. 889 (1994). For that reason, it is generally recognized that a
toxic tort plaintiff requires expert testimony to carry her burden to prove causation. Lillev v.
Johns-Manville Corp., 408 Pa. Super. 83, 92, 596 A.2d 203,207 (1991); see also In re: "Agent
Orange" Product Liability Litigation, 611 F. Supp. 1223 (E.D.N.Y. 1985).
A. This Court Has Given Weight to Epidemiologv in Prior Cases
This Court considered the proper role of epidemiological studies in Blum v. Merrell Dow
Pharm., Inc., 705 A.2d 1314 (Pa. Super. Ct. 1997) affd, 564 Pa. 3,764 A.2d 1 (2000), and noted
the significance of epidemiological studies as the best scientific methodological tool:
39
Replicated epidemiological studies consistently fmding a strongassociation are necessary to establish causation; chemical structure
analysis and in vitro testing can confirm the biological plausibility
of a causal relationship suggested by epidemiology, but without an
epidemiologically demonstrated association, they contribute
nothing to the demonstration of causation.
Animal studies can also provide evidence suggestive of causation.
However, animal studies without epidemiological studies cannot
prove causation in humans because drugs do not have the sameeffect on humans as they do on animals; the doses given to
animals in animal studies are very different from those given to
humans .... No epidemiological study of Bendectin concludes that
there is a statistically significant relative risk high enough to
support a claim of general causation of clubfeet.
Id. at 1323-24 (citations omitted) (emphasis added). Blum was affirmed by the Pennsylvania
Supreme Court on other grounds, and this Court's disapproval of a methodology that relies on
case reports and ignores settled epidemiology was not disturbed by the Supreme Court in its
analysis. The principles enunciated in Blum are equally applicable in this circumstance - as will
be discussed below, consistent, replicated epidemiological studies have established that there is
no association between working with or around automotive fi-iction products and mesothelioma.
As in Blum, in the face of this epidemiological evidence, there is no methodology that can
properly establish causation.
Betz argues, based on Trach, that Pennsylvania law does not require a plaintiff to use
epidemiology to establish causation. Judge Colville expressly did not rely on Chrysler's
references to epidemiology based on his own reading of Trach. 25 However, a fair reading of
2sJudge Colville stated that he did not rely on epidemiology "based on my interpretation of Trach's cleardirective that plaintiffs are not required to advance epidemiological evidence to prove causation. IfI am mistaken inthat regard, guidance from the appellate courts regarding the appropriate, required, or allowableconsideration of epidemiologieal evidence countering the plaintiff's proffered methodologies within thecontext of a Frye hearing would be welcomed." R. 1970a n.28 (emphasis added).
40
Trachdoesnotcompeltheconclusionthatepidemiologyisnotvaluedasaprincipalmethodof
establishingcausation.
In Trach,plaintiff sufferedamassive,accidentaloverdoseof apharmaceuticalproduct,
andexperiencedimmediate,acutesideeffects.Afterjustaweek,plaintiff experiencedcognitive
difficulties.Aftereightmonths,hewasdiagnosedwithglaucomaandarcuatescotomafrom
opticnervedamage.Trach,817A.2dat 1104-1105.At trial,plaintiffs causationexpertused
extrapolationashismethodologytoopinethat,if harmwasknownto resultfromasmalldoseof
apharmaceutical,extrapolationcouldbeusedto determinethatmassiveoverdosescouldresult
in greaterharm.In otherwords,if thedose-responseprinciplecreatedaresultin asmallamount,
it couldbeinferredthatagreaterquantityof theallegedlyharmfulagentcouldcausegreater
harm.Trach,817A.2dat 1117-1119.Defendants'experttestifiedthattherewereno
epidemiologicalstudiesshowinganassociationbetweenmassiveoverdosesof thesortseenin
thiscaseandthekindof harmplaintiffsuffered. On appeal, this Court upheld the admissibility
of the expert causation opinion, suggesting (though not saying) that epidemiology was not
required.
This Court's opinion in Trach should not be read as narrowly as Betz contends. First, the
Trach opinion never explicitly states that epidemiology is unnecessary (or can be ignored). The
opinion does not turn on epidemiological evidence, or the lack thereof. Further, in Trach., there
was no pre-existing epidemiological support for the causal relationship alleged, and because of
the massiveness of the overdose and the rarity of such occurrences it would have been
impossible and/or unrealistic to expect there to be any epidemiological evidence. Thus, and most
importantly, the plaintiffs expert opinion on causation relied on a methodology which did not
involve disregarding the contrary conclusions of consistent, published epidemiological studies.
41
Id__.at 1118.At best,Trachstandsfor thepropositionthat,in theabsenceof analytic
epidemiologyonaparticularsubject,whereepidemiologyhasnotyetbeendevelopedorcannot
bedeveloped,justifiableextrapolationfromlow dosetohighdosemight be acceptable. It does
not legitimize a methodology which disregards unequivocal epidemiological evidence, nor does
it contradict Blum regarding the importance of epidemiology.
B. In Toxic Tort Cases Involving Diseases With Long Latency Periods and
Vanishingly Low Exposures, Epidemiology is the Only Method for ProperlyDetermining General Causation
1. Epidemiological Studies Are the Most Conclusive Evidence to ProveGeneral Causation
In toxic tort cases, there is frequently a considerable length of time between exposure and
manifestation of disease (the latency period), possible alternative causes besides the exposure in
question, and other factors dealing with the mechanism of the disease process which have been
and continue to be either unknown or undiscovered by science. This is particularly true with
respect to asbestos. Despite decades of research, science still does not understand how asbestos
results in cancer, or what a "safe" dose might be (other than background exposure). As a result
of this scientific uncertainty, epidemiological studies are the most useful and conclusive type of
evidence to prove that an exposure to a particular product caused disease. See generally Bhim at
1323-24; See also Green et al., Reference Guide on Epidemiology, Reference Manual on
Scientific Evidence (Fed. Judicial Center 2d ed. 2000).
Epidemiologists use statistical analyses to compare carefully selected groups of exposed
or diseased individuals with control groups to determine whether there is an increased risk of
developing disease as compared with the control group. Without a control group for comparison
purposes, there is no way to determine whether the cases of disease occurred simply by chance
or because of the alleged exposure or risk factor. Because of its value, courts generally require
42
thatepidemiologicalevidencebeconsidered._ In re: W.R. Grace & Co., No. 01-01139,
--- B.R. ---, 2006 WL 369017613 (Bankr. D. Del., Dec. 14, 2006) (epidemiology is primary
generally accepted method of demonstrating causal relationship between a chemical compound
and a disease). In many jurisdictions, courts have ruled that causation issues will not be
permitted to go to the jury unless epidemiological studies exist on the issue, often requiring a
relative risk of greater than 2.0. 26 Courts have accepted this reasoning because a relative risk of
2.0 generally implies a 50% likelihood that an exposed individual's disease was caused by his
exposure to the chemical agent in questions as opposed to other causes.
26_ Federal Circuit Courts: Lynch v. Merrell~National Laboratories, 830 F.2d 1190 (lst Cir.1987); Second Circuit: Amorgianos v. National Railroad Passenger Corp., 137 F. Supp. 2d 147 (E.D.N.Y. 2001),aff__,fd303 F.3d 256 (2d Cir. 2002); Fifth Circuit: Alien v. Pennsylvania Engineering Corp., 102 F.3d 194 (5th Cir.1996) ; Chambers v. Exxon, 81 F. Supp. 2d 661 (M.D. La. 2000), af_d, 247 F.3d 240 (5th Cir. 2001); ._rock v.Merrell Dow Pharm., Inc., 874 F.2d 307 (5th Cir. 1989), modified 884 F.2d 166 (5th Cir. 1989), cert. denied_ 494U.S. 1046 (1990); Sixth Circuit: Turpin v. Men'ell Dow Pharm., Inc., 959 F.2d 1349 (6th Cir. 1992); C__ondev.Velsieol Chem. Corp., 24 F.3d 809 (6th Cir. 1994); Eighth Circuit: National Bank of Commerce v. Dow Chemical,965 F. Supp. 1490 (E.D. Ark. 1996), affd, 133 F.3d 1132 (8th Cir. 1998); Sorenson BV& Through Dunbar v.Shaklee Corp., 31 F.3d 638 (8th Cir. 1994); Tenth Circuit: Wilson v. Men'ell Dow Pharmaceuticals, Inc., 893 F.2d1149 (10th Cir. 1990); Norris v. Baxter Healthcare Corp., 397 F.3d 878 (10th Cir. 2005); Meister v. Medical Eng'gCo_9.._.,267 F.3d 1123 (D.C. Cir. 2001); Ravnor v. Merrell Pharmaceuticals, Inc., 104 F.3d 1371 (D.C. Cir. 1997).Federal District Courts: Pozefskv v. Baxter Healtbeare Corp., No. 92CV0314LEKRWS, 2001 WL 967608(N.D.N.Y., Aug. 16, 2001); Sanderson v. International Flavors & Fragrances, 950 F. Supp. 981 (C.D. Cal. 1996);Hall v. Baxter Healthcare Corp., 947 F Supp. 1387 (D. Or. 1996); In re: Breast Implant Litig., 11 F. Supp. 2d 1217(D. Colo. 1998); Thomas v. Hoffman-La Roche, Inc., 731 F. Supp. 224 (N.D. Miss. 1989); Renaud v. MartinMarietta Corp., et al., 749 F. Supp 1545 (D. Colo. 1990); Cano v. Everset Minerals Corp., 362 F. Supp. 2d 814(W.D. Tex. 2005); Burleson v. Glass, 268 F. Supp. 2d 699 (W.D. Tex. 2003), af_fE_PdBurleson v. Tex. Dep't of Crim.Justice, 2004 U.S. App. LEXIS 25271 (5th Cir. 2004); Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347(N.D. Ga. 2001); Bell v. Swift Adhesives, Inc., 804 F, Supp. 1577 (S,D, Ga. 1992); Bickel v. Pfizer, Inc., 431 F.Supp. 2d 918 (N.D. Ind. 2006); Rains v. PPG Indus., Inc., et al., 361 F. Supp. 2d 829 (S.D. Ill. 2004). State courts:Arkansas: Farm Bureau Mutual Ins. Co. v. Foute, 14 S.W.3d 512 (Ark. 2000); Delaware: In M.G. Baneorporation,Inc. v. LeBeau, 737 A.2d 513 (Del. 1999); Crowhorn v. Boyle, 793 A.2d 422, 431(Del. Super. Ct. 2002); Minner v.American Mort. & Guaranty Co., 791 A.2d 826 (DeI. Super. Ct. 2000); _: CIrkinExterminating Co. v.Melntosh 452 S.E.2d 159 (1994); Iowa: Martins v. Interstate Power Co., 2002 Iowa App. LEXIS 586 (Iowa App.2002); _: Goodyear Tire and Rubber Co. v. Thompson, 11 S.W.3d 575 (Ky. 2000); Maine: Green v..Cessna Aircraft Co, 673 A.2d 216 (Me. 1996); Massachusetts: Hammond v. Bedford Great Road CVS, 9 Mass. L.Rep. 104 (Mass. Super. Ct. 1998) ; Linnen v. A.H. Robins Co., Inc., 11 Mass. L. Rep. 205 (Mass. Super. Ct. 2000)(citing Casev v. Ohio Medical Products, 877 F. Supp. 1380 (N.D. Cal. 1995); _ Nelson v. AmericanSterilizer Co., 566 N.W.2d 671 (Ct. App. Mich. 1997) ; Texas: Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d706 (Tex. 1997); Daniels v. L,/ondell-Citgo Refining Co., Ltd., et al., 99 S.W.3d 722 (Tex. App. 2003); BrookshireBrothers, Inc. v. Wesley Smith, 176 S.W.3d 30 (Tex. App. 2004).
43
2. Case Reports Neither Support Nor Establish An Inference OfCausation
On the contrary, "case reports" and case series are not epidemiology -- they are anecdotal
reports describing clinical events involving one individual or a few individuals, and do not have
control groups for comparison purposes. They report unusual or new disease presentations,
treatments, or manifestations, or raise questions regarding suspected associations, but do not
scientifically establish a causal association. Case reports may be used by scientists to form a
hypothesis for further study, but are not in and of themselves evidence of a causal association.
Unusual occurrences can be reported in a case report but later disproven by epidemiological
research. As Judge Colville commented: "the reason case reports (even multiple case reports)
cannot, alone, support a causal attribution is because they only report associations - not causal
correlations." R. 1951a. 27
Courts generally have not permitted plaintiffs to rely on case reports to support an
opinion of causation, especially when the conclusions being reached in reliance on case reports
are contrary to the conclusions reached by epidemiological studies. _ _ 705 A.2d at
1320-21; see also In Re: W.R. Grace & Co., No. 01-01139, --- B.R --- 2006 WL 3690176"12
(Bankr. D. Del., Dec. 14, 2006); (use of individual case studies "was not sound methodology");
Meister v. Medical Engineering Corp., 267 F.3d 1123, 1131 (D.C. Cir. 2001) (case reports
suggesting a connection between exposure and disease, in the face of contrary epidemiological
27See also David E. Bernstein, Keeping Junk Science Out of Asbestos Litigation, 31 Pepp. L. Rev. 11, 20n.40 (2003) ("Recognizing the problem of post hoe clinical evidence, the Food and Drug Administration ("FDA")has promulgated regulations describing the necessary preconditions before it will consider a clinical studypurporting to show the effectiveness of a drug to be valid. These regulations are instructive because proving theeffectiveness of an agent, i.e., that it does good things, involves the same methodology as proving that an agentcauses harm. As the introduction to the regulations note, they are based on principles 'recognized by the scientificcommunity as the essentials of an adequate and well- controlled clinical investigation.' The FDA regulations state
that '[i]solated case reports, random experience, and reports lacking the details which permit scientific evaluationwill not be considered.") (citations omitted).
44
studies,create"ananalyticalgapbetweenthedataand[theexpert's]opinionthat'issimplytoo
great'").
Casereportsmaybeusefulwhencontrolledresearchis lackinginorderto spurfurther
research(andtotesttheresultingassociation).Theyareof little valueoncetherelevant
exposure(i.e.workingwithor aroundautomotivefi'ictionproducts)hasbeenextensivelystudied
andevaluatedin thepeer-reviewedepidemiologicalliterature.Casereportsdonotemploy
controlgroupsorutilizethestatisticalanalysesnecessarytodeveloptheevidenceto conclude
thatanassociativeorcausativeconnectionmayexistbetweenaparticularexposureandacertain
disease.Therefore,casereportscannotsupplantabodyof controlledandconsistent
epidemiologicstudies.28
NoPennsylvaniacourthasallowedanexpert'sopinionintoevidencewhenit isbasedon
casereports29(anecdotalreportswithoutcontrolgroupsfor comparison)andotherevidencethat
2sThis difficulty is best explained in the context of the friction product epidemiology itself. An earlyarticle in the German literature reported four cases ofmesothelioma and from these cases concluded that workingwith or around automotive friction products could cause mesothelioma. Woitowitz et al., Pleuramesotheliom NaehAsbeststaub_efahrdun_ Bei Bremsreparaturen [Pleuramesothelioma after asbestos dust exposure in brake repairwork in automobile repair workshops: Case observations], Prax. Klin. Pneumoh 39:362-366 (1985). R. 2560a etseq. However, a decade later, Woitowitz and Rodelsperger reversed their position and published the final results oftheir research involving a detailed case-control epidemiological study. Woitowitz and Rodelsperger concluded thatthere was "no evidence that car mechanics are exposed to an increased risk of mesothelioma even if they do brakerepairs." Woitowitz et al., Mesothelioma Among Car Mechanics, Ann. Occup. Hyg. 38(4):635-638 (1994). R.2569a et seq. The controlled research by these scientists failed to find any evidence of causation among mechanics,despite their earlier report of four cases.
29The most egregious example of Dr. Maddox's erroneous reliance on case reports as part of hismethodology is his reference to the Australian Mesothelioma Registry. This was thoroughly discussed in the Fivehearing (see R. 1033a-1064a), but to summarize: Dr. Henderson (a pathologist) performed a cursory back-of-the-envelope calculation to say that 58 cases of mesothelioma in Australian "brake lining workers" was too many to becoincidence in a presentation to the World Trade Organization. The Australian Mesothelioma Registry data isnothing more than a collection of case reports without a control group for comparison purposes. To compound theerror, since there is no control group in the Registry data, Dr. Henderson used the world background rate ofmesothelioma as a comparison to the Australian data, even though Australia has the highest national incidence ofmesothelioma in the world due to numerous factors. There is no data regarding how many of the 58 were
manufacturing brakes, or what types of asbestos were present in these manufacturing facilities, versus how manywere engaged in automobile repair. No conclusions can be drawn from the Australian data because, inter alia thereis no control population for comparison purposes, and such reliance on an unsubstantiated case report is improper.
45
contraveneanestablishedbodyof consistentepidemiologicalresearch._, Blum,705
A.2dat 1321;Wackv.FarmlandIndus.Inc., 744 A.2d 265 (Pa. Super. Ct. 1999); Toledo v.
Medical Eng'g Corp., 50 Pa. D. & C.4th 129 (Pa. Com. P1. 2000). Dr. Maddox's reliance on case
reports should therefore be rejected as contrary to settled Pennsylvania law.
3. The Epidemiology Offered in this Case is Not "Equivocal"
Numerous published, peer-reviewed articles have examined the question of whether
exposure to friction products causes asbestos-related disease in vehicle mechanics. Each of these
have consistently reached the conclusion that there is absolutely no association between working
with friction products and the development of mesothelioma, as explained in detail by Dr. Teta
and Dr. Goodman:
Relevant Epidemiology Testimony:
Dr. Teta:
Epidemiology is the best evidence of causation, and the purpose ofepidemiology is to study causation (R. 973a-976a);
Epidemiologists use the scientific method, using observations to test a
hypothesis (in other words, a single study or case report cannot result in ascientifically valid conclusion) (R. 977a-978a);
Even with multiple observations, one cannot skip the testing step of the
scientific method (R. 979a-980a);
She searched all available literature, rated each of 17 studies, and looked at
other disciplines regarding her resulting conclusions (R. 983a-985a)
There is a hierarchy of evidence, with case control studies at the top and
cases reports at the bottom (R. 986a-987a)
The studies must be analyzed for confounding factors (such as other asbestos
exposures encountered in shipyards or by insulators (R. 992a-993a)
The 17 studies came from several different studies and were funded by
various organizations (R. 997a-998a)
The studies were ranked and then tiered -- the studies show no increased risk
of mesothelioma from working with or around automotive friction products
(R. 999a-1003a, 1012a-1013a)
46
TheWoitowitzandMcDonaldresearchersbelievedtheysawanassociation,but after completingtheir studiesdeterminedtherewasno increasedrisk (R.1003a-1004a,1020a-1022a)
Casereports(suchastheAustralianMesotheliomaRegistry,whichalsosufferedfrom numerousmathematicalerrors) aremerelyobservationsandmustbeverifiedempirically(R. 1024a,1033a-1064a)
TheHelsinkicriteria is ausefultool for diagnosis,attribution, andcompensation,but doesnot covercausationby particular products (R.
1064a-R. 1066a)
One must know the mechanism of an agent to determine whether there is an
exposure threshold (R. 1068a-1070a)
Dr. Goodman:
Epidemiology, and all analytic research, must follow the scientific method,including observation, hypothesis, testing of hypothesis, and conclusion (R.
2353a)
In reviewing scientific literature on a topic, one must identify and consider
all relevant studies (R. 2379a, 2386a-2387a)
One cannot reach the conclusion that mechanics exposed to chrysotile from
friction products could be at increased risk of asbestos-related diseases after
close to 50 papers on the subject have been published and concluded there is
no increased risk (R. 2411a)
Human epidemiological studies are the most important tool in identifying
potential risk factors/causes (R. 2352a)
Epidemiology is the universally accepted tool for establishing causation in
humans (R. 2408a)
Persons involved in automobile repair are not at an increased risk of
asbestos-related diseases (R. 2347a-2348a, 2362a, 2377a, 2382a, 2384a, 2387a)
There is no evidence upon which to conclude that friction product exposures
can cause asbestos-related diseases (R. 2349a-2350a)
Human epidemiologic data trumps animal studies or mechanistic studies,
and to a reasonable degree of scientific certainty, based on human
epidemiologic studies, exposure to automotive friction products does notcause mesothelioma (R. 2369a-2370a)
47
Relevant Epidemiology Studies:
McDonald (1980)
Teta (1983)
Hessel (2004)
Tesehke (1997)
Woitowitz (1994)
Agudo (2000)
Relative Risk
RR=.91 (R. 52a, R. 2551a et seq.) 3°
RR=.65 (R. 52a, R. 2573a et seq.)
RR=1.04/.82 (R. 52a, R. 2735a et seq.)
RR=.8/.3/.4 (R. 52a, R. 2611a et seq.)
RR=.87/.89 (R. 52a, R. 2569a et seq.)
RR=.62 (R. 52a, R. 2617a et seq.)
These epidemiological studies, and the testimony smxounding them, are not "equivocal" -
- they represent decades of research into the causation of asbestos-related disease. All of the
studies were created independently, but reach the same conclusion: that working with and
around automotive friction products does not contribute to the development of asbestos-related
disease. 31
This epidemiologieal data makes sense in the larger scientific context. Brake linings are
composed of, inter alia, chrysotile asbestos encased in a resin binder. The heat generated by the
friction during fabrication and use, however, transforms almost all of the asbestos originally
contained in the friction product into nonfibrous material. Studies have consistently shown that
more than 99% of the asbestos in the brake and clutch lining is so converted, and this nonfibrous
material indisputably does not cause "asbestos-related diseases." Of the small amounts of
chrysotile asbestos remaining in brake and clutch wear debris, the vast majority of the fibers are
below five microns in length -- the scientific community generally agrees that these extremely
short fibers are not associated with disease. Research has found both the peak exposures during
a brake job and the 8-hour time-weighted averages were vanishingly small, and below the
30Relevant epidemiologieal and exposure studies have been made part of the reproduced record.R. 2004a-2022a, 2551 a-2792a.
31Betz did incorporate by reference testimony of Dr. Richard Lemen, an epidemiologist. Dr. Lemen,however, is unable to point to any epidemiology that contradicts what Chrysler presented to Judge Colville (R.2870a). Dr. Lemen can only say that it is his belief that the epidemiology is "equivocal." R. 2851a, 2861a.
48
contemporaneousapplicableOSHApermissibleexposurelevels.Finally,researchershave
studiedthelevelsof asbestosin thelungsof brakerepairworkers,whichwerenormalorshowed
elevatedcommercialamphibolesnotfoundinbrakes.32
C. This Court Should Clarify the Proper Role of Epidemiology
Judge Colville requested appellate guidance on the proper role of epidemiology. R.
1970a n.28. Blum stands for the proposition that epidemiology is necessary to establish
causation. Blum, 705 A.2d at 1323-24. Numerous other courts require epidemiology to prove
causation in comparable situations. It is therefore important for this Court to speak with finality
on epidemiology. If case reports and "simple arithmetic" are the standard, and pointing merely
to an alleged association is sufficient, the floodgates of unreliable science will open. This is
precisely what Trach, _ and the other E_._Le.opinions in this Commonwealth are designed to
avoid.
V. JUDGE COLVILLE PROPERLY APPLIED THE LAW OF PENNSYLVANIA
A. Chrysler Countered Betz's Expert With Experts in All Appropriate
Disciplines
For the first time in a Motion for Reconsideration of Judge Colville's _ order, Betz
challenged the way in which Chrysler countered Dr. Maddox. She claims that Dr. Maddox's
opinions could only be challenged by pathologists or other medical professionals under the
medical malpractice standards in Pennsylvania. The argument is without merit.
32The relevant testimony regarding friction products is referenced and summarized in more detail inChryslers'Counterstatementof the Case.
49
1. TheIssueWasWaived
Betzhadampleopportunitytomakeacompleterecord.JudgeColvilleallowedBetzto
file anOppositionto Chrysler'sFrye motion prior to any hearing taking place. The Frye hearing
itself lasted several days, after which the parties supplemented the record with transcripts, briefs,
and other information. Despite these opportunities to create a full record, a post-hearing, post-
ruling Motion for Reconsideration was the first time that Betz raised the contention that medical
malpractice legal standards should be applied to the expert testimony submitted in the Five
challenge. Even if this contention was valid (and it was not), it was waived. See e.g:,. Bedford
Downs Management Corp. v. State Horse Racing Comm'n, 901 A.2d 1063, 1071 (Pa. Commw.
Ct. 2005).
2. The Medical Malpractice Rules are Inapplicable and Irrelevant
The Pennsylvania medical malpractice statutory scheme has no relevance outside the
limited area of medical malpractice, as indicated by the Rules and the statute themselves. See,
e.__., 40 Pa. C.S. § 1303.512; Pennsylvania Rules of Civil Procedure 1042.1 et seq. They have
nothing to do with a challenge lodged under F__uLe.by defendants in asbestos actions.
Further, the relevant field of inquiry cannot be simply limited to pathologists. Judge
Colville considered testimony from numerous witnesses on both sides, including medical
doctors, pathologists, epidemiologists, and toxicologists. His inquiry was not a matter merely for
pathology alone; the proper methodology regarding causation of disease must necessarily
embrace and consider a number of scientific fields of inquiry, including pathology,
epidemiology, and industrial hygiene. Late attempts by Betz to "re-draw" the boundaries of the
trial court's analysis to artificially constrain the court's discretion should not be condoned. No
Pennsylvania Five cases hold that testimony must be rebutted by similar testimony in the same
50
O
"field" (especially since it was Betz's burden to prove general acceptance, not Chrysler's). See,
e.__., Grady v. Ffito-Lay, Inc., 576 Pa. 546, 839 A.2d 1038 (2003) (chemical engineering
professor v. food processing expert); Trach v. Fellin, 817 A.2d 1102 (Pa. Super. Ct. 2003)
(pathologist v. ophthalmologist and neurologist).
Finally, Betz ignores Dr. Roggli's testimony, submitted by transcript, to rebut the
methodologies of Dr. Maddox. Dr. Roggli (a pathologist in Dr. Maddox's "field") does not agree
with the methodologies put forth by plaintiffs' experts. Dr. Roggli noted that his methodology
necessarily recognizes the importance of epidemiology in the study of disease, including the
epidemiological studies involving automotive repair work (R. 2183a-2184a, 2189a-2191 a) as
well as pathology and industrial hygiene (R. 2190a-2192a, 2223a-2224a). Additionally, in other
testimony, Dr. Roggli has expressly stated that he _ with and did not accept Dr.
Hammar's methodologies (which Dr. Maddox would accept) regarding causation of
mesothelioma and could not say that those methodologies were generally accepted by the
scientific community. R 1815a-1817a.
Chrysler also proffered the testimony of Dr. Goodman by transcript. He is a medical
doctor who specializes in preventative medicine and epidemiology. (R. 2347a-2349a).
Thus, even if Betz were correct in her assertion that the medical malpractice rules should
apply, Chrysler offered a sufficient amount of testimony from medical doctors to support its F.__r_
challenge.
51
B. Judge Colville Properly Interpreted the Case Law
1. The Non-Frye Cases Cited by Betz Are Completely Irrelevant and
Could Not Fetter Judge Colville's Discretion
Betz cites several cases 33in support of her nebulous argument that the "each and every
breath" opinion has been "sanctioned" by this Court, and therefore Judge Colville was not free to
make a finding of novelty or a lack of general acceptance. This argument is also without merit.
Andaloro v. Armstrong World Industries, Inc., 799 A.2d 71 (Pa. Super. Ct. 2002),
involved a defendant's appeal from jury verdicts in favor of plaintiffs suffering fi'om asbestosis
and mesothelioma. Plaintiffs' experts testified at trial that each and every breath of asbestos was
a substantial factor contributing to plaintiffs' asbestos-related diseases. The defendant argued on
appeal that those expert opinions exceeded the scope of their reports, had no basis in fact, and
did not enjoy general acceptance in the scientific community under F_e. This Court held that
the opinions expressed by the experts did not improperly exceed the scope of their reports i(i(_,at
85) and that the experts' unfamiliarity with the products did not prevent them from offering an
opinion on asbestos exposure generally, as the record demonstrated that the plaintiff was exposed
to asbestos from those products. Id. at 85-86.
Importantly, though, this Court held that "Crane has failed to preserve for appellate
review its claim that the causation theories advanced by Plaintiffs' experts were not
generally accepted in the scientific community" because it was not properly raised before
the trial court. Id. at 84 (emphasis supplied). Therefore, while the "each and every breath of
asbestos is a substantial contributing factor" opinion was not disturbed on appeal, the ruling was
no__tmade in the context of a substantive analysis under Frye.
33As an initial matter, it must be noted that none of the cases cited by Betz involved discussion of a Fryeanalysis, or involved automotive friction products.
52
Further,noneof thecasescitedin Andaloroaddress_ issues.See Lillev v. Johns-
Manville Corp., 408 Pa. Super. 83, 596 A.2d 203, 207-10 (1991) (whether a defendant should
have been granted judgment n.o.v.); Samarin v. GAF Corp., 391 Pa. Super. 340, 571 A.2d 398
(1990) (appeal of summary judgment ruling); Junge v. Garlock, Inc., 427 Pa. Super. 592, 629
A.2d 1027, 1029-30 (1993) (whether an experts' opinion was sufficient to create an issue of
material fact).
None of the other cases cited by Betz further her argument. Lonasco v. A-Best Products
Co_____.,757 A.2d 367 (Pa. Super. Ct. 2000) involved an appeal from a jury verdict and Cauthorn v.
Owens Coming Fiberglass Corp., 840 A.2d 1028 (Pa. Super. Ct. 2004) merely cites the standard
recited by Lonasco in reference to a request for judgment n.o.v. At no point does this Court or
the trial court recite or refer to a Frye challenge or evaluate expert opinions under Frye. Instead,
Cauthom and Lonasco stand for the proposition that, once expert testimony is presented to a
jury, the jury is free to believe all or part of it. Id. at 1039; Lonasco, 757 A.2d at 374. Therefore,
Canthom and Lonasco implicitly highlight the need for trial courts to exercise their important
gate-keeping fimction.
None of these cases provide guidance on the ultimate question here -- whether Dr.
Maddox's methodologies actually comport with the standards laid out in F_e and its progeny.
While these cases make reference to the fact that "each and every breath" opinions came into
evidence at trial, they do not consider whether those opinions would withstand a Frye challenge.
These cases confirm that Judge Colville was free to receive evidence on the issues presented and
use his discretion to consider whether or not the challenged opinions were admissible.
53
2. Smalls Did Not Limit Judge Colville's Discretion
Smalls v. Pittsburgh Coming Corp., 843 A.2d 410 (Pa. Super. Ct. 2004) also did not
involve asbestos-containing automotive friction products. At trial, plaintiffs' expert opined that
each and every breath of asbestos was a substantial contributing factor to Mr. Smalls' asbestosis,
and the jury awarded damages. Id. at 414. The award case was reversed and remanded for a
new trial on the issue of damages. As part of that appeal, this Court also considered other legal
arguments raised at trial, including a challenge to the causation testimony.
This Court rejected defendant's appellate argument that the opinion had no basis in fact
and did not have general acceptance in the scientific community. Id. at 414. However, this
Court did not discuss general acceptance of the methodology underlying the opinion, instead
citing _ for the proposition that the opinion was admissible, and that its admission was not
an abuse of discretion. This Court also noted that the challenged expert was certified in
pulmonary medicine, even though competence/qualifications are not a substitute for a Frye
analysis. At no point were the elements of_ mentioned, discussed, or analyzed. As the
Smalls case dealt with an opinion rather than methodology, it is not authoritative regarding F___.1_.
Judge Colville correctly noted that the Smalls. trial court had not conducted a
hearing, but instead merely overruled oral objections at trial. R. 1972a. Further, it does not
appear that the E_ryg issues were briefed, nor were any motions filed regarding the experts'
anticipated testimony. R. 2958a-2989a. There was no evidentiary record created by the trial
court for this Court to consider, and the trial court did not file an opinion regarding its dismissal
of post-trial motions. Id.; R. 2990a. There also is no fimher record on remand. Therefore,
Smalls clearly did not offer this Court an opportunity to evaluate a F_Ef_gruling by the trial court.
The decision contains no discussion of the general acceptance of the expert's methodologies.
This Court only noted that Dr. Katz had experience in the field. That reference to his
54
"experience"isnotaFrye analysis -- how, then, could Judge Colville have been bound by the
Smalls opinion?
Finally, a recent opinion authored by a member of this Court on asbestos-related issues
demonstrates that this Court has no____!"rubber stamped" the theory that "each and every breath is a
substantial contributing factor." In Summers v. Certainteed Corp., 886 A.2d 244 (Pa. Super. Ct.
2005), appeal granted, 587 Pa. 699, 897 A.2d 460 (2006), as part of the plurality opinion
affirming summary judgment, there appears an important statement regarding expert testimony
that is directly on point with the issues presented here:
Dr. Gelfand's report in this case uses legal terminology to attempt
to reach the ultimate issue to be decided by a jury at trial and, on
summary judgment, by the court. He uses the "magic words" asfollows:
In my opinion, to a reasonable degree of medical
certainty, exposure to asbestos in the workplace is
the cause of the asbestos pleural disease and is asubstantial contributing factor to his diffusion
abnormality and to his dyspnea on exertion. Each
and every exposure to asbestos has been asubstantial contributing factor to the abnormalitiesnoted.
Id. at 3.
Just because a hired expert makes a legal conclusion does not
mean that a trial judge has to adopt it if it is not supported by
the record and is devoid of common sense. For example, Dr.
Gelfand used the phrase, "Each and every exposure to asbestos has
been a substantial contributing factor to the abnormalities noted."
However, suppose an expert said that if one took a bucket of water
and dumped it in the ocean, that was a "substantial contributingfactor" to the size of the ocean. Dr. Gelfand's statement saying
every breath is a "substantial contributing factor" is not
accurate. If someone walks past a mechanic changing brakes, he
or she is exposed to asbestos. If that person worked for thirty yearsat an asbestos factory making lagging, it can hardly be said that theone whiffofthe asbestos from the brakes is a "substantial" factor
in causing disease.
55
Id. at 244 (emphasis supplied).
This Court does not mandate the conclusion Betz wished Judge Colville to reach. The
trial court, as the gatekeeper of scientific evidence, is required to go beyond the "magic words"
of hired experts, and exercise sound discretion and common sense. This Court has recognized
the trial court's duty to carefully scrutinize such evidence, and Smalls recognizes the trial court's
discretion to make such a determination. R. 1973a-1974a.
3. Rafter Still Requires Plaintiffs to Prove the Exposure Was a
Contributing Factor
Judge Colville noted in his opinion that the case of Rafter v. Ragmark Industries, 429 Pa.
Super. 360, 632 A.2d 897 (Pa. Super. Ct. 1993) runs counter to Betz's contention that this Court
has "ratified" the "each and every breath" opinion in the past, The trial court in Rafter instructed
the jury as follows:
Plaintiffs must prove it is more likely than not that they have been
injured by asbestos exposure. Asbestos exposure need not be theonly factor.
A substantial contributing factor is an actual, real factor. It is not
an imaginary, fanciful or irrelevant factor having little or no
connection with the disease. It is a cause which, in a continuous
and unbroken sequence, produces harm that would not have
occurred without it. Accordingly, the plaintiffs must establish
more than asbestos presence in the workplace. They must prove
they worked near the produce [sic] and inhaled the dust of thismaterial called asbestos.
I__d.at 901. On appeal from a verdict for the plaintiff, the defendant argued that the instruction
suggested that if the jury found that the plaintiff was exposed to asbestos from defendant's
products, plaintiff had met his burden for the jury to fred liability. This Court disagreed:
In the instant action, the trial court never stated that inhalation of
asbestos was sufficient but, rather, stated that it was necessary to
establish that asbestos exposure was a substantial factor in causing
56
Tuzi'sinjuries. Moreover,thetrial court'sinstructionclearlyprovidedthatappelleeswererequiredto showthattheyhadbeeninjuredbyasbestosexposureandthatthisexposurewasasubstantialcontributingfactortotheirinjuries. After reviewing
the instruction in its entirety, we fmd no abuse of discretion or
error of law regarding the trial court's charge on causation.
Id. at 902 (citations omitted) (emphasis added). In other words, asbestos plaintiffs must do more
than simply allege exposure to asbestos -- they must set forth competent expert testimony that
creates a nexus between the asbestos exposure at issue and their disease. It is clear that this
Court does not blindly hold to the notions that the "each and every breath" opinion is supported
by generally accepted methodologies, or that asbestos plaintiffs have carte blanche to offer
expert causation opinions without challenge.
While the Rafter case predates Smalls, there is no evidence that Smalls was meant to
overrule its holdings. First, of course, there is no expression of the abrogation anywhere within
Smalls. In fact, this Court cited to Rafter numerous times in its Smalls opinion, but only to
distinguish it regarding the remittitur claims of the defendants in that case. If this Court wished
to change course from Rafter in the Smalls opinion, it could have done so. This Court's opinions
in Rafter and Smalls are not inconsistent when read in their proper context, and reflect the
willingness of this Court to respect the discretion of a trial court's analysis of the evidence before
it. 34
C. The Parties Were Afforded a Full and Fair Opportunity to be Heard
Judge Colville's deliberate process is further evidence that he engaged in a valid exercise
of his discretion. Judge Colville heard argument on novelty and set forth appropriate procedures
to govern the undertaking. He gave the parties months to prepare for the eventual F___U_hearing
34Rafter is never discussed in the other opinions.
57
andprovidedfor theexchangeof detailedexpertreports.JudgeColvilleheldathree-day
hearing,acceptedadditionaltestimonyfromwitnesses,andallowedthepartiesto supplementthe
recordandmakepost-hearingsubmissionsin anyfashiontheychose.Finally,heaskedthe
partiestoprovidehimwith full copiesof all scientificliteratureonwhichtheexpertsrelied,so
hecouldreviewit for himself.Farfromthe"judicialdabblings"of whichBetzcomplains,the
recordbespeaksathoroughandmethodicalscrutiny.
58
CONCLUSION
For all the reasons set forth herein, Appellee DaimlerChrysler Corporation respectfully
requests this Honorable Court to affirm the decision of Judge Colville excluding the causation
testimony of Dr. Maddox under Frye, and to publish its decision in accordance with Rule 3519.
Dated: February 20, 2007
Respectfully submitted,
OBERMAYER REBMANN
MAXWELL & HIPPEL LLP
I.D.No. Jay EvansPa. l.D. No. 82149
One Mellon Bank Center, Suite 5240500 Grant Street
Pittsburgh, PA 15219(412) 566-1500
Counsel for DaimlerChrysler Corporation
59
CERTIFICATE OF SERVICE
I hereby certify that a true and correct copy of the tbregoing Brief For Appellee
DaimlerChrysler Corporation -- Definitive Copy is being served upon the following
counsel of record via first-class, U.S. mail, postage prepaid, on this 20 thday of February,
2007,
David B. Rodes, Esquire
Jason To Shipp, Esquire
Goldberg, Persky & White, P.C.1030 Fifth Avenue
Pittsburgh, PA 15219
(Counsel for Appellant Diana 1_ Betz)
Eric Falk, Esquire
Davies, MeFarland & CarrollOne Gateway Center, 10m Floor
Pittsburgh, PA 15222
(CounselJbr Defendant/Appellee Allied Signal, lnc.)
Eric Home, Esquire
DanieI J. Sinclair, Esquire
Eckert, Seaman, Cherin & Mellott600 Grant Street, 44 m Floor
Pittsburgh, PA 15219
(Counsel for Defendants/Appellees Ford Motor Company and General Mototw
Corporation)
Peter J. Neeson, EsquireCarl D. Buchholz. III, Esquire
Angela Mo Hein, Esquire
Rawle & Henderson, LLP
One South Petal SquareThe Widener Building
Philadelphia, PA 19107
(Counsel jbr Defendant/Appellee Allied Signal, Inc.)
James M. Beck
Deehert LLPCira Centre
2929 Arch Street
Philadelphia, PA 19104-2808
(Counseljbr Amicus Curiae Pro&tct Liability Advisory Cotmeil, Inc.)
Daniel B. Donahoe, EsquireIra L. Podheiser
Burns White & Hiekton, LLCFour Northshore Center
106 Isabella Street
Pittsburgh, PA 15212
(CounselJbr Amici Curiae Caterpillar, Inc., Chamber of Commerce of the United States
of America, American Tort Reform Association, CoalitionJbr Litigation.htstice, Inc. and
Property Casualty Insurers Association of America)
