Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-4_03-cv-01431/USCOURTS-cand-4_03-cv-01431-17/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

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United States District Court

For the Northern District of California

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United States District Court

For the Northern District of California

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

FRESENIUS MEDICAL CARE

HOLDINGS, INC., et al.,

Plaintiffs,

 v.

BAXTER INTERNATIONAL, INC., et al.,

Defendants. _______________________________________

No. C 03-1431 SBA

 

ORDER

[Docket No. 477]

This matter comes before the Court on Defendants Baxter International, Inc. and Baxter

Healthcare Corporation's (collectively, "Defendants" or "Baxter") Motion to Bar the Expert Testimony

of Jeff Riley. Having read and considered the arguments presented by the parties in the papers

submitted to the Court, the Court finds this matter appropriate for resolution without a hearing. The

Court hereby DENIES Baxter's Motion to Bar the Expert Testimony of Jeff Riley [Docket No. 477]. 

BACKGROUND

Plaintiffs and counter-defendants Fresenius USA, Inc. and Fresenius Medical Care Holdings,

Inc. (collectively "Fresenius") initiated this patent suit on April 4, 2003 by filing a Complaint for

Declaratory Judgment of Non-infringement and Invalidity against defendants and counter-plaintiffs

Baxter International, Inc. and Baxter Healthcare Corporation (collectively "Baxter"). Fresenius cited

five patents in its complaint: (1) U.S. Patent No. 5,247,434 ("'434 Patent"); (2) U.S. Patent No.

5,326,476 ("'476 Patent"); (3) U.S. Patent No. 6,284,131 B1 ("'131 Patent"); (4) U.S. Patent No.

5,486,286 ("'286 Patent"); and (5) U.S. Patent No. 5,744,027 ("'027 Patent") (collectively

"patents-in-suit"). 

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On May 14, 2003, Baxter answered and counterclaimed that Fresenius' 2008H and/or 2008K

hemodialysis machines infringe four of the five patents. On October 20, 2003, Baxter amended its

answer and counterclaims to assert infringement of the '286 Patent. 

 On December 22, 2005, the Court-ordered deadline for filing expert reports, Fresenius submitted

the Opening Expert Witness Report of Jeff Riley. See Sitrick Decl. at Ex. A (Riley Expert Report). Jeff

Riley graduated from Kent State University and began his formal training as a perfusionist in 1972 at

Ohio State University. Id. He graduated from Ohio State University and was recognized as an

outstanding student in the School of Allied Medical Professions in 1974. Id. During his career as a

perfusionist, Mr. Riley has used and studied a variety of different heart and lung machines, including

models from Sarns, Cobe, Baxter, Medtronic, CINCO, PemCo, and Jostra. Id. He is also currently

writing a chapter on computerized cardiopulmonary bypass for Gravlee's next edition of his textbook

on cardiopulmonary bypass. Id.

Mr. Riley teaches and directs the perfusion education program at the Circulation Technology

Division in the School of Allied Medical Professions at the College of Medicine of Ohio State

University. Id. Additionally, he holds an adjunct faculty position in the Midwestern University

graduate perfusion education program in Glendale, Arizona. Id. Mr. Riley served on the faculty of

Midwestern University prior to his employment at Ohio State University. He also currently serves as

the Director of Continuing Medical Education for the American Society of Extra-Corporeal Technology

and is a special section editor in the Journal of Extra Corporeal Technology. Id.

Mr. Riley's personal experience with hemodialysis includes: (1) coursework and laboratory study

in hemodialysis as a perfusion student; (2) an eleven-week clinical rotation where he performed

hemodialysis as a student; (3) performing simultaneous hemodialysis and/or hemofiltration with

cardiopulmonary bypass during clinical practice on numerous occasions; (4) writing protocols for

perfusionists to conduct hemodialysis during cardiopulmonary bypass; (5) co-authoring and helping to

generate data for peer-reviewed articles on the topic of hemodialysis and cardiopulmonary bypass; and

(6) teaching the principles of concurrent hemodialysis and cardiopulmonary bypass in Ohio State

University's perfusion education program. Id. 

In his report, Mr. Riley sets forth his background and qualifications, provides a background and

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history of extracorporeal circulation, provides a tutorial on cardiopulmonary bypass and heart/lung

machines, compares cardiopulmonary bypass and hemodialysis, and details the use of heart/lung

machines to perform hemodialysis. Id. Mr. Riley does not specifically address the patents-in-suit or

provide an expert opinion with regard to the validity of any of the patents-in-suit. 

On March 2, 2006, Baxter deposed Mr. Riley. On March 7, 2006, Baxter filed the instant

Motion to Bar the Expert Testimony of Jeff Riley ("Motion to Bar Expert Testimony"). Baxter's Motion

to Bar Expert Testimony is premised on Federal Rules of Evidence 403 and 702 and Federal Rule of

Civil Procedure 26(a)(2)(B).

LEGAL STANDARD

A. Federal Rule of Civil Procedure 26

Pursuant to Rule 26(a)(2), a party is required to "disclose to other parties the identity of any

person who may be used at trial to present evidence under Rules 702, 703, or 705 of the Federal Rules

of Evidence." Fed. R. Civ. P. 26(a)(2). Further, under Rule 26(a)(2)(B):

[The] disclosure shall, with respect to a witness who is retained or specially

employed to provide expert testimony in the case or whose duties as an

employee of the party regularly involve giving expert testimony, be

accompanied by a written report prepared and signed by the witness. The report

shall contain a complete statement of all opinions to be expressed and the basis

and reasons therefor; the data or other information considered by the witness

in forming the opinions; any exhibits to be used as a summary of or support for

the opinions; the qualifications of the witness, including a list of all

publications authored by the witness within the preceding ten years; the

compensation to be paid for the study and testimony; and a listing of any other

cases in which the witness has testified as an expert at trial or by deposition

within the preceding four years.

Fed. R. Civ. P. 26(a)(2)(B). 

B. Federal Rule of Evidence 702

The admissibility of expert testimony is governed by the Federal Rule of Evidence, primarily

Rule 702. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589 (1993). Pursuant to Rule 702:

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,

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.

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Fed. R. Evid. 702.

Under Daubert, the district court acts as a "gatekeeper," excluding "junk science" that does not

meet the standards of reliability required under Rule 702. Gen. Elec. Co. v. Joiner, 522 U.S. 136, 142

(1997); Kennedy v. Collagen Corp., 161 F.3d 1226, 1229-30 (9th Cir. 1998). The court accomplishes

this goal through a preliminary determination that the proffered evidence is both relevant and reliable.

Daubert, 509 U.S. at 589-95. Scientific evidence is deemed reliable if the principles and methodology

used by the expert proffering it are grounded in the methods of science. Daubert, 509 U.S. at 592 ("The

proponent need not prove that the expert's testimony is correct, but that the methodology used by the

expert was proper."). The Supreme Court has provided five non-exclusive factors to consider when

assessing whether the methodology upon which an expert rests his opinion is scientifically reliable.

These factors are: (1) whether the expert's theory can be or has been tested; (2) whether the theory has

been subject to peer review and publication; (3) the known or potential rate of error of a technique or

theory when applied; (4) the existence and maintenance of standards and controls; and (5) the degree

to which the technique or theory has been generally accepted in the scientific community. Daubert, 509

U.S. at 593-94. The test for determining reliability is flexible and can adapt to the particular

circumstances underlying the testimony at issue. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137,

150-51 (1999). 

A trial court has broad latitude in determining whether an expert's testimony is reliable and also

in deciding how to determine the testimony's reliability. United States v. Hankey, 203 F.3d 1160, 1167

(9th Cir.2000). However, the Court's inquiry must "focus[] solely on [the] principles and methodology,

not on the conclusions that they generate." United States v. Prime, 431 F.3d 1147, 1153 (9th Cir. 2005).

"Only if the expert's opinion is so fundamentally unsupported that it can offer no assistance to the jury

must such testimony be excluded." Children's Broad. Corp. v. Walt Disney Co., 357 F.3d 860, 865 (8th

Cir.2004) (citations omitted).

C. Federal Rule of Evidence 403

Under Federal Rule of Evidence 403, relevant evidence may be excluded if "its probative value

is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the

jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative

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evidence." Fed. R. Evid. 403. 

ANALYSIS

In its Motion to Bar Expert, Baxter argues that Mr. Riley's testimony must be excluded because:

(1) Mr. Riley did not read the patents-in-suit, and therefore his testimony is neither relevant nor reliable

under Federal Rule of Evidence 702; (2) Mr. Riley's testimony would unfairly prejudice the jury, and

therefore should be barred under Federal Rule of Evidence 403; and (3) Mr. Riley's expert report does

not disclose his opinions, in violation of Federal Rule of Civil Procedure 26.

A. Reliability and Admissibility Under Rule 702

Baxter's assertion that Mr. Riley's testimony must be excluded because he failed to read the

patents-in-suit is without merit. Although Baxter argues that Mr. Riley's report directly opines on issues

of validity and therefore "usurps the jury's role in assessing and making determinations regarding critical

facts about Fresenius' anticipation and obviousness defenses," it is clear that Mr. Riley's report does not

purport to reach the ultimate issues of invalidity in this case. 

First, nowhere in Mr. Riley's report does he opine on whether or not "the Sarns 9000 meets each

limitation of the asserted patent" as Baxter claims he does. Instead, the Report discusses the Sarns 9000

in very general terms. The report also does not directly opine on whether or not cardiopulmonary

bypass "is the same field of the inventors' endeavor or reasonably pertinent to the problem with which

the inventors were involved." Instead, the report gives a brief overview of the two fields and provides

a historical background of their development as well as the overlap and similarities involved in the two

fields. As Fresenius points out, the closest Mr. Riley comes to opining on an ultimate issue is the

generalized statement that "[t]here is significant overlap in the basic operative principles of CPB and

dialysis and heart lung machines and hemodialysis machines have components and operating principles

that are identical or similar." Based on the fact that Mr. Riley has had over thirty years worth of

experience with these particular technologies, it is beyond dispute that Mr. Riley is qualified to make

a statement of this nature. The report also does not purport to identify specific time periods for Mr.

Riley's comparison between cardiopulmonary bypass and hemodialysis procedures, but rather focuses

on the relevant body of knowledge Mr. Riley has developed over his career as a perfusionist and

educator. Although Baxter contends that this lack of specificity with regard to time is fatal to the

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Also due to Fresenius' representations, the Court has not considered Mr. Riley's testimony as

providing an opinion on validity.

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reliability of Mr. Riley's opinions, there is no need for the report to have such specificity unless Mr.

Riley is providing an opinion on anticipation. Since he is not, Baxter's argument does not apply. 

Further, Baxter's argument that Mr. Riley is attempting to "define" certain patent claims is not

persuasive. Although Mr. Riley discusses general principles related to perfusion and hemodialysis

procedures in his report, and uses and describes certain terms such as "hemodialysis," "hemodialysis

machine," and "ultrafiltration," his report does not purport to define or redefine these terms as they relate

to the specific patents-in-suit. Instead, the terms are discussed in a manner that gives the trier of fact

a basic understanding of the general principles upon which the report is based. Moreover, the

"definitions" used in Mr. Riley's report do not conflict with the Court's construction of the claims. 

In sum, Fresenius has established that Mr. Riley's report is not intended to provide an opinion

on patent validity but instead is intended to provide the jury with a more generalized overview of

cardiopulmonary bypass and hemodialysis procedures. Fresenius has also established that Mr. Riley's

testimony will be used to help the jury better understand the evidence that will be presented at trial,

including the basic principles of cardiopulmonary bypass and hemodialysis, thereby allowing the jury

to make its own inferences. Based on Fresenius' representations, the Court finds that Mr. Riley's

testimony is admissible.1

 

Contrary to Baxter's assertion, the practice of allowing an expert to educate the jury without

necessarily expressing an opinion on the specific facts of the case, or even reaching an opinion at all,

is regularly upheld. See, e.g., U.S. v. Rahm, 993 F.2d 1405, 1411 (9th Cir. 1993) ("[N]ot every expert

need express, nor even hold, an opinion with regard to the issues involved in a trial. . . . [T]he key

concern is whether expert testimony will assist the trier of fact in drawing its own conclusion as to a 'fact

in issue.'"); see also Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000) ("When analyzing the

relevance of proposed testimony, the district court must consider whether the testimony will assist the

trier of fact with its analysis of any of the issues involved in the case. The expert need not have an

opinion on the ultimate question to be resolved by the trier of fact in order to satisfy this requirement.");

Erickson v. Baxter Healthcare, Inc., 151 F. Supp. 2d 952, 968 (N.D. Ill. 2001) ("an expert may explain

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principles without applying them or offering an opinion on the ultimate issue").

In fact, the Advisory Committee notes to Rule 702 specifically address the use of expert

testimony for such purposes. See Fed. R. Evid. 702 Advisory Committee Notes to the 2000

Amendments ("[I]t might also be important in some cases for an expert to educate the factfinder about

general principles, without ever attempting to apply those principles to the specific facts of the case.

For example, experts might instruct the factfinder on the principles of thermodynamics, or bloodclotting

. . . without ever knowing about or trying to tie their testimony into the facts of the case."). The standard

that should be applied to determine the admissibility of such expert testimony is also set forth in the

Advisory Committee notes:

For this kind of generalized testimony, Rule 702 simply requires that: (1) the

expert be qualified; (2) the testimony address a subject matter on which the

factfinder can be assisted by an expert; (3) the testimony be reliable; and (4) the

testimony ''fit'' the facts of the case.

Fed. R. Evid. 702 (advisory committee notes). 

Each of the requirements for admissibility is met here. Specifically: (1) Baxter does not

challenge the qualifications of Mr. Riley as a skilled perfusionist, scholar, and educator; (2) the subject

matter of the litigation is beyond the general understanding of the average layperson, and therefore, a

tutorial on the basic technologies involved will assist the factfinder in making its determinations; and

(3) Mr. Riley's testimony "fits" the facts of the case because it provides background contextual

information about cardiopulmonary bypass and its relation to hemodialysis as well as providing the jury

with a tutorial on the use and functionality of the Sarns 9000 heart/lung machine – a device that

Fresenius contends is prior art. 

Additionally, and importantly, Mr. Riley's testimony is also reliable under the standard Daubert

analysis. In Daubert, the Supreme Court articulated a set of non-exclusive factors to assist the trial

court's determination of the reliability of expert testimony. Daubert, 509 U.S. at 593 ("Many factors

will bear on the inquiry, and we do not presume to set out a definitive checklist or test."). The three

factors that are relevant and applicable in this case favor the admissibility of Mr. Riley's testimony by

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The other two factors, which relate to known or potential error rate and the maintenance of

standards and controls, are not applicable under the facts of this case.

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demonstrating its reliability.2 

First, the assertions made by Mr. Riley can be or have been tested. In fact, counsel for Baxter

deposed Mr. Riley on March 2, 2006 and therefore had the opportunity to test or challenge Mr. Riley's

factual and contextual assertions regarding cardiopulmonary bypass procedures, his knowledge of

hemodialysis procedures, and also his experience with the concurrent application of cardiopulmonary

bypass procedures and hemodialysis under certain circumstances. 

Second, as demonstrated by the directory of publications listed on Mr. Riley's curriculum vitae,

Mr. Riley's knowledge of perfusion as well as his understanding of hemodialysis has been tested through

the process of publication and peer review. Third, it appears that Mr. Riley's assertions have been

generally accepted in the scientific community. Indeed, as demonstrated by Mr. Riley's report, the

concurrent use of cardiopulmonary and hemodialysis procedures is a practice that has been documented

and explained in published scholarly journals. 

Accordingly, Fresenius has met its burden in establishing that Mr. Riley's testimony is relevant,

reliable, and admissible. 

B. Unfair Prejudice and Compliance with Federal Rule of Civil Procedure 26

Finally, the Court declines to exclude Mr. Riley's testimony based on Baxter's assertion that it

is unduly prejudicial. "'Undue prejudice' within [the context of Rule 403] means an undue tendency to

suggest decision on an improper basis, commonly, though not necessarily, an emotional one." Fed. R.

Evid. 403 Advisory Committee Notes to 1972 Proposed Rules. As the Advisory Committee notes to

Rule 403 state, "[i]n reaching a decision whether to exclude on grounds of unfair prejudice,

consideration should be given to the probable effectiveness or lack of effectiveness of a limiting

instruction." Id. Here, neither party disputes that Mr. Riley has not read the patents-in-suit and is not

providing expert testimony on obviousness or anticipation. To the extent that there is any danger that

the jury might be mislead that Mr. Riley is nevertheless expressing an opinion on these matters, this can

be addressed by effective cross-examination and appropriate jury instructions. See Daubert, 509 U.S.

at 595 ("Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the

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Since Baxter concedes that Dr. Bruner has prepared a report fully addressing Mr. Riley's

conclusions, Baxter's assertion that Fresenius has violated Federal Rule of Civil Procedure 26 because

his report does not specifically state "what [his] opinions are" is totally disingenuous. In fact, Fresenius

produced Riley's expert report by the Court-ordered deadline and the report conforms, in all respects,

with the requirements of Rule 26. Baxter's argument that the report must be excluded because Riley has

not used the phrases "my opinions" and "the opinions expressed in this report" borders on frivolous. 

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burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.").

Further, Baxter has admitted that it intends to introduce its own expert, Dr. J. Dennis Bruner ("Bruner"),

to address Mr. Riley's conclusions.3

 Thus, precluding Mr. Riley from testifying on the grounds that he

would unfairly "confuse" or "mislead" the jury is unnecessary.

In fact, the heart of Baxter's concern appears to be Fresenius' reliance on Mr. Riley's testimony

in support of its summary judgment motion and in opposition to Baxter's cross-motion. However, the

Court has been clearly apprised of the fact that Mr. Riley has not read the patents-in-suit and is not

purporting to express an opinion on patent validity. To the extent that Fresenius is relying on Mr.

Riley's testimony to establish anticipation or obviousness, Baxter's arguments go to the weight of

Fresenius' evidence and will be addressed in the context of the summary judgment motions, when

relevant. Baxter has, not, however, provided the Court with a valid basis for excluding Mr. Riley's

testimony in its entirety. As such, Baxter's Motion is DENIED. 

CONCLUSION

IT IS HEREBY ORDERED THAT Baxter's Motion to Bar the Expert Testimony of Jeff Riley

[Docket No. 477] is DENIED.

IT IS SO ORDERED.

 Dated: 5/15/06 SAUNDRA BROWN ARMSTRONG

United States District Judge

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