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Daubert/Frye Motions in Product Liability Litigation

Bringing or Defending Challenges to Expert Witness Evidence

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Presenting a live 90-minute webinar with interactive Q&A

Sean P . Wajert, Managing Partner, Shook Hardy & Bacon, Philadelphia Tara D. Sutton, Partner, Chair, Mass Tort Group, Robins Kaplan Miller & Ciresi, Minneapolis

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Daubert/Frye Motions in Product Liability Litigation

Sean P. Wajert, Esq. Shook, Hardy & Bacon Philadelphia

215-278-2430 swajert@shb.com

Strafford Publications’ CLE Webinar

www.shb.com swajert@shb.com

Daubert/Frye Motions in Product Liability Litigation

• Mr. Wajert is the managing partner of Shook, Hardy & Bacon’s office in Philadelphia,
• PA. He has represented clients in the chemical, consumer product, pharmaceutical,

medical device, food and fragrance, and industrial products sectors when they face significant product liability and mass tort claims. Since 2003, Sean has been ranked annually among the top product liability lawyers by Chambers USA, a referral guide to leading lawyers in the United States based on the opinions of their peers and

• clients. Chambers has praised Sean as a “calm and organized” lawyer who “continues

to deliver high quality work in the pharmaceutical area.” The Best Lawyers in America has also recognized Sean for product liability and mass tort litigation; The Legal 500 (U.S.) recommended his work in product liability and mass tort defense in the areas of toxic tort and consumer products; and Who's Who Legal: The International Who’s Who of Product Liability Defense Lawyers in 2013 named him a leading product liability defense attorney. Sean is an American Bar Foundation fellow and an elected member of the American Law Institute, the leading independent organization in the United States producing scholarly work to clarify, modernize, and otherwise improve the law. He previously chaired the Mass Torts and Class Actions Subcommittee of DRI. He is the author of the widely read law blog masstortdefense.com. www.shb.com swajert@shb.com

Overview of Frye

• Frye v. United States, 293 F. 1013 (D.C. Cir. 1923)

– Criminal (murder) case – Systolic blood test showed defendant was telling the truth; early polygraph – Court excluded

• just when a scientific principal or discovery crosses the line

between the experimental and the demonstrable, is difficult to define

• it must be sufficiently established to have gained general

acceptance in the particular field in which it belongs

• focus on relevant field’s view of its own members work;

seeks to assure that reliability is determined by those most qualified to assess the validity of a scientific method

7

Overview of Frye

• Doctrine lay dormant for almost a decade
• and even after 25 years, only 8 federal and 5

state cases relied on it

• citations exploded in 1970’s but mostly cited

in criminal cases until 1980’s

• the vast majority of courts then adopted Frye

as the standard of admission for scientific evidence – until Daubert

8

Overview of Frye

• Established a method of ensuring the reliability of certain scientific

evidence

• Does Frye apply to all scientific evidence or just novel scientific evidence,

i.e. literal application?

– E.g., Anderson v. Akzo Nobel Coatings, Inc., 260 P.3d 857 (Wash. 2011) (Frye test is implicated only if opinion is based upon novel science). – some state courts have thus suggested the vast majority of expert opinion is not subject to Frye because it only applies when an expert attempts to offer an opinion based on new or novel scientific techniques

• Others apply more broadly, with expanded definition of “novel”
• Some apply when theories are subject to reconsideration
• Note: some states adopted the “pure opinion” exception, if the opinion

rests solely on the expert’s own experience and training, it need not be subject to Frye analysis

9

Overview of Frye

• Issues Arising From Frye
• How does the court define the relevant scientific community?

– Especially when the theory or technique involves several scientific principles – Influence outcome by narrowing or expanding the pertinent group

• What quantum of acceptance means general acceptance?

– Most courts hold general acceptance does not mean universal acceptance of methodology

10

Overview of Frye

• Issues Arising From Frye
• Must there be acceptance of underlying theory and the methodology and

the application of the theory -- one version of “fit”? – E.g., Anderson v. Akzo Nobel Coatings, Inc., 260 P.3d 857 (Wash. 2011)(both underlying theory and technique or methodology used to implement it must be generally accepted). – E.g., Blackwell v. Wyeth, 971 A.2d 235 (Md. 2009)(method was generally accepted but applied to a novel theory; differential diagnosis to prove general causation)

11

Overview of Frye

Issues arising from Frye

• How does one prove general acceptance? Counting noses?

– E.g., Anderson v. Akzo Nobel Coatings, Inc., 260 P.3d 857 (Wash. 2011)(if there is a “significant dispute” among qualified scientists, evidence should not be admitted) – testimony of experts?

• Most courts seem convinced by testifying experts

– Review of literature?

• Few courts will undertake

– Other judicial opinions

• some states find once it is deemed by a court accepted in the particular community,

its general acceptance is presumed in subsequent litigation

• Although, generally accepted in the courts may or may not mean acceptance in

science

12

Overview of Frye

Status of Frye?

• Do your local homework!
• Approximately 30 states have adopted Daubert or something akin to federal

standard

– Alabama, Wisconsin, Florida (by statute in 2013) recently

• Approximately 12 states retain Frye in a quasi-traditional form

– Including Pennsylvania, Minnesota

• Many holdover courts view Frye as a higher standard of reliability

– some novel scientific evidence may seem admissible under Daubert even if not generally accepted yet – but otherwise, most commentators disagree

• Several states employ a unique or individual or hybrid approach

– Maine (Rule 403-sounding) – Nevada (calling Daubert a work in progress)

• Some states will apply Frye in criminal and Daubert in civil

13

Overview of Frye

Brief word on mechanism

• Proponent of evidence has burden of establishing that it satisfies, in most

Frye states

• Courts typically have discretion whether to hold Frye hearing

– Court may conclude it can decide general acceptance on paper or based on prior judicial decisions – Failure to timely request hearing may constitute waiver

• Frye decisions usually seen as interlocutory
• Standard of appellate review varies from de novo to clearly erroneous

– Again check your jurisdiction

• Focus will be

– is it novel or experimental – if so has it gained general acceptance

14

DAUBERT OVERVIEW

Tara D. Sutton, Esq. Robins, Kaplan, Miller & Ciresi LLP Minneapolis, MN

612.349.8500 tdsutton@rkmc.com

Daubert/Frye Motions in Product Liability Litigation

Tara Sutton is a partner and chair of the Robins, Kaplan, Miller & Ciresi mass tort litigation group. Ms. Sutton has a trial practice focusing on representing individuals who have been injured by defective drugs and medical devices. She was lead counsel in the Mirapex Products Liability MDL No. 1836 and obtained a verdict in the first bellwether trial for $8.3 million, including $7.8 million in punitive damages. She was trial counsel in the historic Minnesota tobacco litigation, which settled in May 1998, after a four month trial when the tobacco companies agreed to pay the State of Minnesota & Blue Cross more than $6.6 billion. More recently, she served on the Executive Committee and chaired the Science & Expert Committee in Chantix Products Liability MDL No. 2092. She was lead trial counsel in the first bellwether Chantix MDL trial, which settled shortly before jury selection. Ms. Sutton currently serves in the plaintiffs’ leadership of the Stryker Rejuvenate modular hip litigation consolidated in New Jersey state court.

• Ms. Sutton frequently lectures and publishes on the topics of trial

advocacy and products liability. She was named “Plaintiff Top 150 Women in Litigation,” by Benchmark Litigation in 2013 and has been a named a “Minnesota Super Lawyer,” since 2009. She is a member of the Executive Committee and serves as Secretary of Public Justice Foundation, a non-profit law firm dedicated to access to justice and individual consumer rights.

16

Overview of Daubert

• Daubert v. Merrell Dow Pharmaceuticals, Inc.,

509 U.S. 579 (1992)

• Products liability case
• Plaintiffs’ experts sought to testify on basis of in vitro, animal and

unpublished re-analysis of epidemiological data that drug Bendectin, taken during pregnancy, could cause birth defects

• District court and 9th Circuit found that experts’ methodologies were

“not generally accepted as reliable in the scientific community”

• Justice Blackmun wrote majority opinion, reversed and remanded
• Ushered in a new test for admissibility of expert

evidence

• Concluded that Frye (or “general acceptance”)

test did not survive adoption of Federal Rule of Evidence 702

17

Overview of Daubert

• Major Themes
• Trial court as “gatekeeper”
• Expert testimony must be “not only relevant, but

reliable”

• Daubert is satisfied where expert is qualified

and the proffered testimony is shown to be relevant and reliable.

• Daubert inquiry is a “flexible one”

18

Overview of Daubert

• Is the Expert Qualified?
• Rule 702: an expert must be qualified “by knowledge, skill,

experience, training or education”

• Fact specific inquiry as there is no perfect recipe to follow
• An expert may have great credentials, but if collateral to

subject at hand, the expert may be deemed unqualified.

• After determining qualifications, second step is whether

expert’s opinion exceeds those qualifications.

• Challenges to qualifications most likely come out in cross-

examination, not at Daubert phase

• 19

Overview of Daubert

• Is expert’s testimony reliable?
• Daubert’s Non-Exhaustive Factors for

Considering Reliability

• 1. Whether the theory can and has been tested;
• 2. Whether it has been subjected to peer review;
• 3. The known or expected rate of error; and
• 4. Whether the theory and methodology employed is

generally accepted in the scientific community.

20

Overview of Daubert

• Is expert’s testimony relevant?
• Does it “fit” the facts of the case?
• Will it assist the trier of fact in understanding and

reaching a conclusion?

• Specialized understanding required
• Mirror testimony of fact witness?
• Legal conclusions

21

Overview of Daubert

• Post-Daubert Gloss
• General Electric v. Joiner, 522 U.S. 1997
• Abuse of discretion standard of review
• Examined methodology and conclusions
• Affirmed exclusion of testimony based on pooling of

studies to demonstrate link between PCB’s and cancer

• “ipse dixit” of the expert
• “too great an analytical gap” between data and

conclusion

22

Overview of Daubert

• More post-Daubert Gloss
• Kuhmo Tire Co. v. Carmichael, 526 U.S. 137 (1999)
• Tire blow out case; 11th Circuit found improper to apply

Daubert to “non-scientific” testimony of plaintiffs’ failure analysis expert

• Extended Daubert factors to all expert testimony,

including “soft” sciences such as economics and psychology

• Objective of Daubert was:
• “to ensure the reliability and relevancy of expert testimony. It is

to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”

23

Overview of Daubert

• Additional Daubert Factors
• Advisory Committee Minutes to the 2000 Amendments to Rule

702

• Whether the opinion grows naturally out of research they have

conducted independent of litigation or whether opinion developed expressly for purposes of testifying

• Whether the expert has unjustifiably extrapolated from an accepted

premise to an unfounded conclusion

• Whether the expert has adequately accounted for alternative

explanations

• Cherry picking the data?
• Whether the expert is being as careful in his/her litigation work as in

his/her professional work

• Consistently apply methodology?
• Whether the field of expertise claimed by the expert is known to reach

reliable results for the type of opinion the expert would offer.

24

Overview of Daubert

• Additional Daubert Factors
• Advisory Committee Minutes to the 2000 Amendments to Rule

702

• Whether the opinion grows naturally out of research they have

conducted independent of litigation or whether opinion developed expressly for purposes of testifying

• Whether the expert has unjustifiably extrapolated from an accepted

premise to an unfounded conclusion

• Whether the expert has adequately accounted for alternative

explanations

• Cherry picking the data?
• Whether the expert is being as careful in his/her litigation work as in

his/her professional work

• Consistently apply methodology?
• Whether the field of expertise claimed by the expert is known to reach

reliable results for the type of opinion the expert would offer.

25

Bringing a Daubert Challenge

• Daubert Motion Ingredients
• Summary of opinion challenged
• Explanation of methodology and reasoning

employed

• Description of basis for challenge; what’s wrong

with it?

– Reflecting criteria from case law; qualitative factors – Including affidavit or other source material supporting challenge

• Know local rules/customs. E.g., D.Colo.

26

Mechanics

• Expert issues have been raised in multiple ways:
• Motion to strike under FRCP 37
• Motion in limine/request for Rule 104 hearing
• Motion for summary judgment

– where the exclusion of expert evidence will leave proponent without sufficient evidence to raise a genuine issue of fact on an element of a claim where it has burden

• f proof
• Objections to admissibility at trial
• Motions for directed verdict
• Post-trial motions

27

Mechanics

• Timing of raising the challenge…
• Often dictated by CMO or discovery order.
• How important is it to educate the judge?

– What other opportunities will you have?

• Even absent CMO, will judge have expected it sooner?

– Some courts view motion at trial as almost per se untimely. E.g., Felicano-Hill v. Principi, 439 F.3d 18 (1st Cir. 2006).

• Typically after close of expert discovery; but not too close to trial.

– If you can and do wait until trial to assert Daubert challenge, objection must be specific. E.g., McKnight v. Johnson Controls Inc., 36 F.3d 1396 (8th Cir. 1994)(objection at trial did not preserve issues for appeal); Alfred v. Caterpillar, Inc., 262 F.3d 1083 (10th Cir. 2003) (Daubert is gatekeeper not “gotcha”).

• To be safe, renew objections at trial!

28

Mechanics

• Other timing considerations?
• Can it be fixed? When and how easily?

– E.g., Viterbo v. Dow Chem. Co., 826 F.2d 420 (5th

• Cir. 1987)(oral history taken by expert was

incomplete)

• No peer reviewed studies; presumably can’t

be immediately fixed.

– E.g., Valentine v. Pioneer Chlor Alkali Co., 921 F.Supp. 666 (D. Nev. 1996)(discussing peer review)

29

Mechanics

• How is challenge decided?
• Courts have employed a variety of procedures:

– Rulings on written record – Oral argument – Pre-trial hearings – Trial hearings outside presence of jury

• Daubert hearing not required by all courts, but increasingly common. E.g.,

U.S. v. John, 597 F.3d 263 (5th Cir. 2010)(not required).

– Some courts say hearing not required in order to exclude, Target Market Publishing, Inc. v. Advo, Inc., 136 F3d 1139 (7th Cir. 1998); but risk abuse of discretion in complex cases, Barabin v. Astenjohnson, Inc., 700 F.3d 428 (9th

• Cir. 2012) (trial court abused discretion in not holding hearing)(en banc

rehearing pending). – Courts vary; some judges like live testimony and opportunity to ask the expert

30

Mechanics

• Moving party may view as opportunity to

educate judge

• Creates thorough record for appeal
• Responding party may want hearing if motion,
• n paper, is strong
• Costly to both sides
• May tip hand and offer dry run of cross at trial

if unsuccessful

31

Strategic Considerations

• Whether to ever by-pass Daubert and save

argument/evidence for trial?

– Risks if you lose, and sometimes if you win – Assess chances of success

• Know your judge
• Know the witness
• Know your jurisdiction

– Relevant legal standard » E.g., relative risk in epidemiology » E.g., differential diagnosis

32

Strategic Considerations

• Whether to ever by-pass Daubert and save

evidence for trial?

– Snowball effect? – Mass tort implications?

• Importance of favorable precedent
• Need to avoid bad rulings if judges in subsequent cases

are likely to be guided by court’s initial ruling

33

Strategic Considerations

• Whether to ever by-pass Daubert and save

evidence for trial?

– Is the challenge to all or part of the opinion? – If some part of opinions likely will survive, is summary judgment available? – Do you want the weaker opinions to remain to discredit the expert’s stronger opinion? – Will exclusion of weak opinion make expert seem more credible at trial?

34

Strategic Considerations

• Whether to ever by-pass Daubert and save

evidence for trial?

– Some issues more appropriate for judge than jury?

• E.g., errors in complex statistical analysis vs. offered
• pinion is inconsistent with witness’ clinical practice
• E.g., In re Rezulin Prods. Liab. Litig., 309 F.Supp.2d 531

(S.D.N.Y. 2004)(expert opinion on ethical obligations of pharma companies excluded)

35

Strategic Considerations

• Whether to ever by-pass Daubert and save

evidence for trial?

– Showing your hand too soon?

• Is it an argument they have seen and expect?

– Loss of surprise=loss of effectiveness?

• Is it an issue on which you can lock the expert in?
• Or a lack of current knowledge issue to be repaired

– Chance to cure?

• ATLA CLE: ask the court to schedule Daubert motions before

discovery deadline. Ann.2003 ATLA-CLE 851 (July 2003)

36

Tactical Issues

• Treat motion as end of process, educating

judge, developing record with your expert and through discovery

– E.g., treaters to support your exclusion of plaintiff’s experts

• Expert and Fact Discovery
• Independent research

37

Tactical Issues

• Judges who give “lip service” to Daubert?

– Educational process: discovery disputes, trial plan; CMO discussions – Bodyguards: national experts too famous to ignore; local experts well known in community – Use of other cases

• Other rulings by respected courts; argue precedent not

policy; tailor arguments to appellate rulings reversing trial courts

• Strategic sequencing in repeat litigation

38

Class Actions

• Courts had split on whether Daubert applies

to expert opinion at class certification phase

• In Wal-Mart Stores Inc. v. Dukes et al., 131

S.Ct. 2541 (2011), in dicta Supreme Court expressed “doubts” that it did not apply

• Most progeny applied Daubert

– In re Taco Bell Wage and Hour Actions, 2011 WL 4479730 (E.D. Cal. 2011)

39

Class Actions

• But some disagreement about full Daubert analysis

– E.g., In re Aftermarket Auto. Lighting Prods. Litig., 276 F.R.D. 364 (C.D. Cal. 2011)

• or limited, quasi-Daubert, “Daubert-light”?

– E.g., In re Zurn Pex Plumbing Prod. Liab. Litig., 644 F.3d 604 (8th

• Cir. 2011).
• Third Circuit had used limited version in Behrend v.

Comcast, but Supreme Court did not reach issue. 133 S. Ct. 1426 (2013)

– Finding that "arbitrary" or "speculative" expert testimony could not support class certification even if the expert's model would apply on a class-wide basis

• More to come….

40

Defending a Daubert Challenge

• Trial courts enjoy “considerable leeway” in determining

the admissibility of expert testimony. Komho Tire Co. v. Carmichael, 527 U.S. 137, 152 (1999)

• Fed. R. Evid. 702’s admissibility standard “is a liberal
• ne.” United States v. Frazier, 387 F.3d 1244 (11th Cir.

2004).

• Weaknesses in the underpinnings of the expert’s opinions

go to the weight rather than its admissibility

• “Vigorous cross-examination, presentation of contrary evidence

and careful instruction on the burden of proof are the traditional and appropriate means of attacking” expert testimony.” Daubert, 509 at 596.

• The rejection of expert testimony is exception rather than

the rule

41

Criticisms of Daubert

• Most criticism of Daubert comes from the plaintiffs’ bar
• More plaintiff-proffered expert testimony than defendant-

proffered expert testimony is rejected by courts applying Daubert

• Gives trial judges opportunity to prevent a case from

going to a jury

• Pressure to reduce case loads
• Trial judges ill-equipped to be scientific gate keepers
• Can lead to exclusion of evidence that is both peer reviewed and
• therwise accepted in the scientific community
• Lack of ability to understand or judicial economy?

42

Attacks Upon Qualifications

• Qualifications are to be viewed liberally—area for cross,

not basis for exclusion

• Witness not required to have specialized knowledge
• But qualifications and respect in the field do matter:
• Strength of experts qualifications provides circumstantial evidence
• f credibility. Ambrosini v. Labarraque, 101 F.3d 129, 140 (D.C. Cir.

1996); United States v. Downing, 753 F.3d 1224, 1239 (3d Cir. 1985).

• “ The more qualified the expert, the more likely that expert

is using reliable methods in a reliable manner—highly qualified and respected experts don’t get to be so by using unreliable methods or conducting research in an unreliable manner.” Malletier v. Dooney & Bourke, Inc., 525 F. Supp. 2d 558, 616 (S.D.N.Y. 2007).

43

Methodology vs. Conclusion

• Whether testimony is scientifically correct is not the

proper inquiry

• The court’s gatekeeper role “is not intended to supplant

the adversary system or the role of the jury.” Maiz v. Virani, 253 F.3d 641, 666 (11th Cir. 2001).

• A court should not exclude an expert because it believes
• ne expert is more persuasive than another
• Where experts rely on same material, but interpret it

differently and reach different conclusions, testimony of plaintiffs’ expert was admissible. In re Vioxx Products Liability Litigation, 401 F. Supp. 2d 556, 596 (E.D. La. 2005).

44

Atomization

• Frequently Daubert challenges based on a slicing-and-dicing

approach to data relied upon by plaintiffs’ expert

• Some court’s appear to look at each study separately and to

assess reliability of opinion

• Based on Joiner
• But see Justice Stevens concurring and dissenting opinion: “[i]t is not

intrinsically ‘unscientific’ for experienced professionals to arrive at a conclusion by weighing all available scientific evidence—that is not the sort of ‘junk science’ with which Daubert was concerned.

• Approach rejected by Reference Manual on Scientific Evidence
• Prestigious scientific bodies “consider all the relevant available

scientific evidence, taken as a whole, to determine which conclusion or hypothesis regarding a causal claim is best supported by the body of evidence.” p. 20.

45

Toxic Tort Cases and Causation

• Daubert doesn’t necessarily require randomized,

controlled clinical trial showing a statistically significant increase risk as a prerequisite to admissibility.

• Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1199 (11th Cir. 2002)

(citing Eighth, Tenth and Eleventh Circuit decisions holding that epidemiology is not the required to prove causation in toxic tort cases).

• Sometimes impossible/unethical to conduct such tests
• Supreme Court agrees
• “A lack of statistically significant data does not mean that medical

experts have no reliable basis for inferring a causal link between a drug and adverse events. . . Medical professionals and researchers do not limit the data they consider to the results of randomized clinical trials or to statistically significant evidence.” Matrixx Initiatives, Inc. v. Siracusano, 131 S.Ct. 1309, 1319 (U.S. 2001).

46

Practical Guidelines

• Virtually certain defense counsel will file a Daubert

challenge

• Be prepared to argue the reasoning behind Daubert

and Rule 702, i.e., to liberalize the use of expert testimony

• Law of unintended consequences
• Be prepared to meet the burden of admissibility by a

preponderance of the evidence

• The moving party in a Daubert challenge does not bear the burden the
• proof. Daubert, 509 U.S. at 592 n. 10.
• Do not assume that a “Daubert Hearing” will be automatically

granted.

• Check your court’s rules
• Have your affidavits ready

47

Practical Guidelines

• Remember that a Daubert hearing is not an evidentiary

hearing

• Rules of evidence do not apply expect with respect to privilege.
• Fed. R. Evid. 104(a).
• Flawed evidence may be used against your expert
• Consider carefully whether to bring the challenged expert

to the Daubert hearing

• Generally allowed, but not required
• Weigh pros and cons of permitting cross-examination in a setting

where normal rules do not apply

• Remember the opinion of an expert does not have to be

uncontradicted

• The standard of review gives broad discretion to the trial

court

48

Practical Guidelines

• Get it right from the beginning, because you

might not get a chance to fix it up after the Daubert hearing. Weisgram v. Marley, 528 U.S. 440 (2000).

49

Practical Guidelines for Your Expert

• How does your expert’s reasoning and

methodology differ from other theories?

• How does your expert’s reasoning and

methodology differ from opposing experts?

• Best defense is a good offense
• Did you review same material? Vioxx
• Did you apply same methodology?
• What did defense experts do wrong?
• What supporting studies, research or literature

exist to underpin the expert’s opinion?

• Appropriate to consider unpublished data?

50

Practical Guidelines for Your Expert

• Did your expert read the all the relevant literature

pertinent to the subject and his/her theory or methodology?

• Cherry-picking
• Consider the bad stuff too!
• When was the data compiled?
• Expert testimony based upon legitimate, pre-existing research

unrelated to litigation provides the most persuasive basis for reliability.

• Defendants’ control of the studies, including post-litigation
• Did he/she work differently than they do in their

profession?

• Use of assistants

51

Practical Guidelines for Your Expert

• Did your expert reason from known facts to reach

a conclusion and not from an end result in order to hypothesize what needed to be known but what was not?

• Where has the “peer review” occurred. Was it in

an established, unbiased scientific journal?

• Did the expert undertake a hands-on evaluation
• f the think at issue (e.g., the site) or simply

perform a literature and indirect evidence evaluation? How much hands-on experience with the thing at issue has the expert had?

• Interviews/testing

52