Sci.Ev rjm Week 7 1 Today  4:15 pm: Daubert – in the Supreme Court, in patent cases (liability issues only), on remand  5:20 pm: UCBerkeley Transcripts: What can we learn?  5:55 pm:  Choosing patents, teams, roles.  Ordering file histories.  Scheduling conferences for next week.  When to get to:  Finishing instant patent law and instant civil procedure with grad students.  Looking at the patents the grad students found.  6:05 pm: Midterm Evaluations  Next Week: No class, just meetings, but claim charts (at least left hand column) due Friday (?)

Sci.Ev rjm Week 7 2 DAUBERT the name everyone* associates with the phrase “scientific expert testimony” * law universe, expert witness universe Daubert in the Supreme Court Questions from the class Science Experts for the class Lawyers (from week 4) Daubert on Remand Your Best/Worst Facts Daubert in Patent Cases (Liability Issues) What you learned (from weeks 4 [law] and 6 [grad])

Sci.Ev rjm Week 7 3 Daubert in the Supreme Court -The Petition for Cert QUESTIONS PRESENTED 1. Whether, in light of the Federal Rules of Evidence, federal courts may apply the rule of Frye v. United States, 293 F (D.C. Cir. 1923), and hold expert scientific testimony inadmissible unless it has attained general acceptance in the relevant scientific field. 2. Whether the Frye rule (assuming its applicability) is properly construed to make the admissibility of expert scientific testimony depend upon prior publication in a peer-reviewed journal. -The Interesting, Interested AMICI

Sci.Ev rjm Week 7 4 Daubert in the Supreme Court - go to slide 13 Where are they (plaintiffs’ experts) now? Shanna Helen SwanShanna Helen Swan (1999 NRC/NAS 4-year study) Stuart A. NewmanStuart A. Newman – still at NYMC Why do Rehnquist and Stevens (not a likely pair) refuse to join in part of the decision? - Questions from the class Science Experts for the class Lawyers (from week 4)

Sci.Ev rjm Week 7 5 If - scientific, - technical, or - other specialized knowledge will assist the trier of fact - to understand the evidence or - to determine a fact in issue, a witness qualified as an expert by - knowledge, - skill, - experience, - training, or - education, Daubert in the Supreme Court Rule 702. TESTIMONY BY EXPERTS Federal Rules of Evidence may testify thereto in the form of an opinion or otherwise, if(1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable - principles and - methods, and (3) the witness has applied the - principles and - methods reliably to the facts of the case.

Sci.Ev rjm Week 7 6 Daubert Decision’s Version of Rule 702 (See part C) Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a), {n10} whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. {n11} This entails a preliminary assessment - of whether the reasoning or methodology underlying the testimony is scientifically valid and - of whether that reasoning or methodology properly can be applied to the facts in issue. --- {n10} Rule 104(a) provides: "Preliminary questions concerning the qualification of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court, subject to the provisions of subdivision (b) [pertaining to conditional admissions]. In making its determination it is not bound by the rules of evidence except those with respect to privileges." These matters should be established by a preponderance of proof. See Bourjaily v. United States, 483 U.S. 171, 175 ‑ 176, 97 L. Ed. 2d 144, 107 S. Ct (1987). Daubert in the Supreme Court Rule 702. TESTIMONY BY EXPERTS Federal Rules of Evidence

Sci.Ev rjm Week 7 7 Daubert Decision’s Version of Rule 702 (See part C) Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a), {n10} whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue. {n11} This entails a preliminary assessment - of whether the reasoning or methodology underlying the testimony is scientifically valid and - of whether that reasoning or methodology properly can be applied to the facts in issue. --- {n10} Rule 104(a) provides: "Preliminary questions concerning the qualification of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court, subject to the provisions of subdivision (b) [pertaining to conditional admissions]. In making its determination it is not bound by the rules of evidence except those with respect to privileges." These matters should be established by a preponderance of proof. See Bourjaily v. United States, 483 U.S. 171, 175 ‑ 176, 97 L. Ed. 2d 144, 107 S. Ct (1987). Daubert in the Supreme Court Rule 702. TESTIMONY BY EXPERTS Federal Rules of Evidence -Has the theory or technique been TESTED -Has it been published in a PEER REVIEWED journal - Rates of error; standardization of technique -GENERAL ACCEPTANCE

Sci.Ev rjm Week 7 8 Daubert on Remand - Your Best/Worst Facts Preliminaries: the FINAL JUDGMENT rule US Births (per UNICEF, for 2004): 4,134, (per CDC): 4,065, (per CDC, 1992 report): 4, 158,212 Birth defects: 1 out of 33 babies. Limb reduction defects: ?? Can’t find any data. 1:1000? I know 2, have encountered 2 more. How many people have I, a former resident of NYC, encountered in my life of X years? Well over 4000.

Sci.Ev rjm Week 7 9 Daubert on Remand - Your Best/Worst Facts Best & Counter – DaubertMerrell Dow MD answerDaubert Answer Henry: Multiple TheoriesInitial Victory Fernando: Method hidden E/WRespect for Supremes (H/W) Adam: Deformed BabiesFDA Approval Jeremy: Multiple Causes E/WFDA is a given (E/?) Ann Marie: Augment Affts OptionP Experts: no indep. res. Angela: Palmer has -0- to say E/WFDA approval is old E/L Angela: Frye friedD has no BOP Chrissy: FR702 E/WP meets BOP D/L Fernando: COULD AugmentP Experts method unexplained Ann Marie: Could but no ‘fit’ E/LP fails “fit” E/W

Sci.Ev rjm Week 7 10 Daubert on Remand - Your Best/Worst Facts Best & Counter – DaubertMerrell Dow MD answerDaubert Answer Jason: Frye fried6 th Cir rejected Palmer Lisa: Lousy science anyway E/WThat was under Frye E/L Jeremy: Teratogenic in animalsNo peer reviewed pub Jason: No peer rev pub E/WReal babies E/L Lisa:Deformed babiesBOP on P Alvin: M/Exclude photos E/WLet P supplement affts. H/L Chrissy: Great ReputationsGen.Acc. still lives Adam: Legal Standard E/WP’s Methods are gen.acc.E/L Alvin: FR702FDA Henry:P lacks PROOF H/WPeer rev trumps FDA H/W

Sci.Ev rjm Week 7 11 Daubert on Remand – My Best Fact, but for whom? It’s Bendectin was available from 1957 to Where’s the data on NATIONAL limb reduction defects (annual totals) for the years, say, , , ? Maybe that data is neutral or ambiguous, and maybe or so is affected by women who had Bendectin from a previous pregnancy or a friend. But what if the data is DRAMATIC? Even a 2-fold difference in annual average rate during the Bendectin years? Why doesn’t either party gather this information? Is it just not available? Are they BOTH scared?

Sci.Ev rjm Week 7 12 Daubert in Patent Cases (Liability Issues) What you learned (from weeks 4 [law] and 6 [grad]) Carnegie Mellon: - The most Daubert-like: BrownBrown - Methodology or Substance? Is Carnegie Mellon so dumb? Why did they bring this case, and fight it? [Biology experts please help!] - The experts aside from Brown Sorkin: Why proffer such a lame declaration as Trejo’s? Pharmastem: Ditto on Hendrix? (But the answer will be different, I think.)

Sci.Ev rjm Week 7 13 UCBerkeley v Genentech Transcripts Siegel – Tutorial Expert Campbell – Genentech’s Infringement Expert What you learn from reading these transcripts Order of Testimony Preparing Objecting Cross-Examining

Sci.Ev rjm Week 7 14

Sci.Ev rjm Week rd.edu/~rjmorris/s ciev/READINGS/ A.pdf

Sci.Ev rjm Week 7 16 … … Goodman Patent (UCBerkeley v Genentech) 4,363,877, col

Sci.Ev rjm Week 7 17 … to?

Sci.Ev rjm Week 7 18 Leftovers from past weeks - Looking at other patents collected by the grad students - Instant Patent Law & Instant Civil Procedure Feedback: On this set of comments and comment^2s MEETINGS NEXT WEEK? Evaluations