Niazi Licensing Corp. v. St. Jude Med. S.C., Inc.

Niazi Licensing Corporation, Plaintiff, v. St. Jude Medical S.C., Inc., Defendant.

Case No. 17-cv-5096 (WMW/BRT)

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

September 14, 2020

ORDER

Plaintiff Niazi Licensing Corporation (NLC) and Defendant St. Jude Medical S.C., Inc. (St. Jude), cross-move to exclude expert testimony. (Dkts. 164, 196.) For the reasons addressed below, NLC's motion to exclude Dr. Arthur Erdman is denied, St. Jude's motion to exclude Dr. Martin Burke is denied, St. Jude's motion exclude Brad Carlson is granted in part and denied in part, and St. Jude's improper request for reconsideration is denied.

BACKGROUND

NLC owns United States Patent No. 6,638,268 (the '268 Patent), which issued on October 28, 2003. The '268 Patent is directed to a catheter system that can be inserted into the coronary sinus of the heart. This catheter system allows medical professionals to administer fluids and introduce pacing leads to the coronary sinus. Although the use of catheters in general was well established by 2003, the '268 Patent describes an invention that, based on its structure and shape, purportedly is better suited for "use in the coronary sinus, especially in patients suffering from congestive heart failure." The '268 Patent claims a double catheter system with an "outer, resilient catheter having shape memory and a hook-shaped distal end" and an "inner, pliable catheter slidably disposed in the outer catheter." The '268 Patent also claims methods of using the catheter system.

NLC initiated this patent infringement lawsuit against St. Jude on November 13, 2017. NLC alleges that St. Jude infringed the '268 Patent either literally or through the doctrine of equivalents. According to NLC, St. Jude directly infringes the '268 Patent by using, manufacturing, selling, or offering to sell infringing catheter systems. NLC also alleges that St. Jude indirectly infringes the '268 Patent by inducing its customers—namely, medical professionals—to infringe the '268 Patent.

The '268 Patent includes 27 claims, some of which are directed to configurations of the catheter and some of which are directed to the method of using the catheter system. NLC alleges that St. Jude infringes independent Claims 1, 11, 13, 18 and 24 and dependent Claims 10, 14, 15, 19, 23, 25, 26, and 27. The Court determined that Claims 1, 13, 18, and 24 are invalid as indefinite and that because Claims 10, 14, 15, 19, 23, 25, 26, and 27 depend on Claims 1, 13, 18, and 24, they also are indefinite. Only a single method claim remains: Claim 11, which relates to a series of steps for "using a double catheter." On October 21, 2019, the Court issued a claim construction order as to Claim 11, construing "the catheter" to mean "the double catheter" and concluding that "Claim 11 is infringed only when the steps are performed in the order listed."

On November 4, 2019, St. Jude moved to strike facts disclosed in the expert reports of NLC's technical expert, Dr. Martin Burke, and NLC's damages expert, Brad Carlson, because those facts were not disclosed before the fact-discovery deadline. OnDecember 2, 2019, United States Magistrate Judge Becky R. Thorson granted St. Jude's motion to strike. NLC appealed, and the Court affirmed the magistrate judge's December 2, 2019 Order. Currently pending before the Court are NLC's motion to exclude the expert testimony of St. Jude's technical expert Dr. Arthur Erdman and St. Jude's motion to exclude the expert testimony of NLC's experts Dr. Burke and Carlson.

ANALYSIS

The admissibility of expert testimony is a question of law for the district court that is governed by Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Rule 702 provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. "An expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed. If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted." Fed. R. Evid. 703.

The proponent of expert testimony must prove its admissibility by a preponderance of the evidence. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.2001). "Rule 702 reflects an attempt to liberalize the rules governing the admission of expert testimony" and favors admissibility over exclusion. Id. (internal quotation marks omitted). Determinations as to the admissibility of expert testimony are within the district court's discretion. See Arkwright Mut. Ins. Co. v. Gwinner Oil, Inc., 125 F.3d 1176, 1182 (8th Cir. 1997) (reviewing for an abuse of discretion).

It is a district court's obligation to ensure that testimony admitted under Rule 702 "is not only relevant, but [also] reliable." Daubert, 509 U.S. at 589. When determining reliability, a district court evaluates the expert's method as to (1) whether the method can be (and has been) tested, (2) whether the theory or technique has been subjected to peer review and publication, (3) the method's known or potential rate of error, and (4) the method's general acceptance. Presley v. Lakewood Eng'g & Mfg. Co., 553 F.3d 638, 643 (8th Cir. 2009) (citing Daubert, 509 U.S. at 593-94). These factors are not exhaustive, and the district court must evaluate the reliability of expert testimony based on the facts of the case. Id. A district court also may consider "whether the expertise was developed for litigation or naturally flowed from the expert's research; whether the proposed expert ruled out other alternative explanations; and whether the proposed expert sufficiently connected the proposed testimony with the facts of the case." Sappington v. Skyjack, Inc., 512 F.3d 440, 449 (8th Cir. 2008) (internal quotation marks omitted). When weighing these factors, the district court functions as a gatekeeper to separate "expert opinion evidence based on 'good grounds' from subjective speculation that masquerades as scientific knowledge." Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989 (8th Cir. 2001).

Questions regarding the factual basis of an expert's testimony ordinarily, however, are issues of credibility of the expert's testimony, not issues of admissibility. Sappington, 512 F.3d at 450; see also Minn. Supply Co. v Raymond Corp., 472 F.3d 524, 544 (8th Cir. 2006). "Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Daubert, 509 U.S. at 596.

I. NLC's Motion to Exclude Expert Testimony of Dr. Erdman

NLC moves to exclude the testimony of St. Jude's technical expert, Dr. Erdman. NLC argues that Dr. Erdman does not qualify as an expert under Rule 702 because he is not a medical doctor or electrophysiologist and, therefore, he is unable to testify regarding the medical procedure of implanting permanent pacing leads in a lateral branch of a coronary sinus. NLC also contends that permitting Dr. Erdman to present testimony on the issues of invalidity and non-infringement will unfairly prejudice NLC. St. Jude counters that Dr. Erdman will testify regarding the engineering aspects of non-infringement and invalidity, Dr. Erdman has skill in the art, and his testimony is offered in conjunction with Dr. David Benditt, an electrophysiologist. Moreover, St. Jude contends, NLC fails to challenge any aspect of Dr. Erdman's experience or any specific qualification or opinion of Dr. Erdman.

Rule 702 requires an expert to possess "knowledge, skill, experience, training or education sufficient to assist the trier of fact." Robinson v. GEICO Gen. Ins. Co., 447 F.3d 1096, 1100 (8th Cir. 2006) (internal quotation marks omitted); accord Fed. R. Evid. 702. And such knowledge, skill, experience, training, or education must match "thesubject matter of the witness's testimony." Robinson, 447 F.3d at 1101. When issues of infringement and invalidity are disputed, courts analyze them from the perspective of a person having ordinary skill in the art. Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1361 (Fed. Cir. 2008). To opine on those issues that require the examination of evidence from the perspective of one of ordinary skill in the art, a witness must qualify as an expert in the pertinent art. Id. at 1363. There also must be an "adequate relationship between [the expert's] experience and the claimed invention." SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (distinguishing Sundance and holding that the proffered expert had the "knowledge, skill, experience, training, [and] education" of a "specialized" nature that was likely to "assist the trier of fact to understand the evidence or to determine" infringement for the purposes of Rule 702 (internal quotation marks omitted)).¹ Any gap in an expert witness's qualifications or knowledge generally pertains to the weight of the testimony, not its admissibility. Robinson, 447 F.3d at 1100.

St. Jude offers Dr. Erdman as a technical expert who will opine on the engineering aspects of non-infringement, invalidity, and the "specific aspects of the properties of the materials required to perform claim 11" of the '268 Patent. The parties agree that the disputed technology at issue, a catheter delivery system, involves design principals that are driven by the expertise of an engineer. Dr. Erdman's qualifications include a Ph.D. in...