Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 1 of 7 PageID #:4972
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF
`ILLINOIS EASTERN DIVISION
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`HOSPIRA, INC.
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`C.A. No. 1:16-cv-00651
`C.A. No. 1:17-cv-07903
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`Hon. Rebecca R. Pallmeyer
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`Plaintiff,
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`Defendants.
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`v.
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`FRESENIUS KABI USA, LLC,
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`FRESENIUS KABI’S OPPOSITION TO HOSPIRA’S MOTION TO EXCLUDE
`DR. ERIC SHEININ’S DEPOSITION TESTIMONY AT TRIAL
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`Defendant Fresenius Kabi USA, LLC files this reply in opposition to Hospira’s tardy
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`motion in limine to exclude deposition testimony of Hospira’s own expert, Dr. Eric Sheinin.
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`Hospira retained Dr. Sheinin as an FDA expert, to address the FDA’s view on the ready-for-
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`patenting test, but now hopes to avoid his deposition testimony on the issue and instead rely on
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`other non-FDA experts at trial.
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`Fresenius Kabi made clear—in the witness lists exchanged before the pretrial order—that
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`it would call Dr. Sheinin by deposition if he was not called live. (D.I. 53-7, 17-cv-07903.)
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`Hospira did not file a motion in limine. Fresenius Kabi again raised the issue with the Court
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`during the July 6, 2018 pretrial conference. (Transcript of Proceedings Before the Honorable
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`Rebecca R. Pallmeyer, 42:19-44:22). Again, Hospira did not file any motion. Indeed, the Court
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`indicated that it could “take this up at trial” without further motion practice. (Id. at 44:22).
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`Nonetheless, Hospira waited until July 15, the day before trial, to file a motion, and that too a 15-
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`page motion.
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`Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 2 of 7 PageID #:4973
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`I. The Designated Testimony is Within the Scope of Dr. Sheinin’s Expert Report
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`The questions and answers designated by Fresenius Kabi are well within the scope of Dr.
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`Sheinin’s expert report.
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`a) Questions Related To The Sufficiency of Stability Data In The Asserted Patents
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`Dr. Sheinin’s expert report opines that the IND did not disclose an invention that was
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`ready for patenting. Sheinin Rep. ¶ 22.1 To do so, Dr. Sheinin specifically addressed stability
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`data. In paragraph 30 of his report he states that in order to be ready for patenting the invention
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`needs to be described in sufficient detail to allow a person of ordinary skill in the art (POSA) to
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`practice the invention. Id. at ¶ 30. On page 26 of his report, Dr. Sheinin supports his position by
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`arguing that the “stability data in IND 32, 934 does not indicate long-term stability.” He then
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`dedicates six paragraphs to explain that the stability data in the IND is not sufficient detail for the
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`invention therein to be ready for patenting. Id. at ¶¶ 91-96.
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`Given Dr. Sheinin’s opinion focused on stability data, Fresenius Kabi asked about related
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`stability data and the amount of stability data sufficient for an invention to be ready for
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`patenting. That was the scope of his expert opinion that Hospira offered, and now has chosen to
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`withdraw. But Dr. Sheinin’s previous opinion as to whether the stability data in the asserted
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`patents is sufficient to support the claimed inventions opened the door to assessing the basis of
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`his opinion, the stability data in the IND, and the methodology applied in coming to that opinion.
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`Indeed, the very purpose of an expert deposition is to test the bounds of an expert’s opinions
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`through questions, and to explore conflict with other experts that the same party is offering.
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`1The Rebuttal Report of Dr. Eric Sheinin, dated May 21, 2018 is attached as Exhibit A to
`Hospira’s Motion in Limine. (D.I. 60, 17-cv-07903)
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`2
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`Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 3 of 7 PageID #:4974
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`At deposition, Dr. Sheinin answered questions applying his own analysis about ready-for-
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`patenting to the stability data in the IND to show that a POSA would find the data sufficient to
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`demonstrate stability. Sheinin Tr. at 82:17-83:9.2 Dr. Sheinin further testified that he believed
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`he was a POSA and further testified that he reviewed the ’106 patent and had relied on it in
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`coming to his opinion. Thus, the now objected-to questions were appropriate and within the
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`scope of the expert report.
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`b) Questions Related to Disclosures In The IND
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`The basis for Dr. Sheinin’s opinion that the invention in the IND was not ready for
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`patenting is based on an evaluation of the disclosures set forth in that document. As already
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`discussed above, Dr. Sheinin opined that there is not enough information generally and stability
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`data specifically for the invention in the IND to be ready for patenting. The questions that
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`Hospira is now trying to exclude relate exactly to the very contents of that same IND. Sheinin
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`Tr. at 107:22-109:6. For example, the objected-to questions asked about linearity data in the
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`IND. Id. Per Dr. Sheinin’s testimony that data provides information regarding the stability of
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`the dexmedetomidine drug – undermining Dr. Sheinin’s original view of how much data was
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`enough to reach conclusions. Thus, there is no argument that the objected-to questions were
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`appropriate and within the scope of the expert report.
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`c) Questions Related to The Review of Stability Data By Statisticians At the FDA
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`Dr. Sheinin’s expert report provides extensive opinions regarding the review process that
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`an IND may undergo at the FDA. In paragraph 72 of his report he provides a list of individuals
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`at the FDA who may review an IND submission. In that list he specifically identified
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`2 The Deposition Transcript of Eric Sheinin, dated June 15, 2018 is attached as Exhibit B to
`Hospira’s Motion in Limine. (D.I. 61, 17-cv-07903)
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`Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 4 of 7 PageID #:4975
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`“Statistician.” He also provided information regarding the role of a Statistician in the IND
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`review process including stating that they “[m]ay also evaluate stability data provided in the
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`submission.” The objected-to questions merely inquires further into the role of a statistician,
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`including the type of data that a statistician would review. Sheinin Tr. at 73:22-75:12. Such
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`questions are entirely appropriate. Just because those opinions contradict opinions of Hospira’s
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`other trial witnesses is not a basis to exclude.
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`II. The Law permits Fresenius Kabi to Use Dr. Sheinin’s Deposition At Trial
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`Dr. Sheinin’s deposition testimony is admissible both because (a) it is a deposition of an
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`unavailable witness and (b) the testimony is a party admission.
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`a) Fresenius Kabi Is Entitled To Use Dr. Sheinin’s Deposition Pursuant to the
`Federal Rules of Evidence
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`Pursuant to FRCP 32(4) “A party may use for any purpose the deposition of a witness,
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`whether or not a party, if the court finds … (c) that the witness cannot attend or testify because of
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`age, illness, infirmity or imprisonment.” Such is the case here. Since the pretrial conference, the
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`parties have learned that Dr. Sheinin is unavailable, and is no longer able to testify at trial even if
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`Hospira intended to call him live. Therefore, Fresenius Kabi has the right to use Dr. Sheinin’s
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`deposition testimony as part of its case in chief.
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`Further, the Northern District of Illinois has held that the deposition testimony of an
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`opposing expert sought to be introduced at trial is considered a party admission, and therefore
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`would not constitute hearsay. Bone Care Int’l, LLC v. Pentech Pharms., Inc., Case No. 08-cv-
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`1083, 2010 U.S. Dist. LEXIS 10489 at *34-*35 (N.D. Ill. 2010); see also Glendale Fed. Bank,
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`FSB v. Ul.S., 39 Fed. Cl. 422, 425 (1997) (holding that prior deposition testimony of an expert
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`witness put forward as a testifying expert at trial is an admission against the party that retained
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`the expert.)
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`Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 5 of 7 PageID #:4976
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`b) The Seventh Circuit Law Permits the Use of An Opposing Expert’s Deposition
`Testimony At Trial
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`In S.E.C. v. Koenig, the defendant argued that the district court committed error when it
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`allowed the S.E.C. to use defendant’s expert video deposition as part of its case in chief even
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`though the expert was not listed in the S.E.C.’s list of potential witnesses. 557 F.3d 736, 743 (7th
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`Cir. 2009). The 7th Circuit determined that no error was made and held “[a] witness identified as
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`a testimonial expert is available to either side; such a person can’t be transformed after the report
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`has been disclosed, and a deposition conducted, to the status of a trial-preparation expert whose
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`identity and views may be concealed.” Id. at 744. In this case, not only has Dr. Sheinin been
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`proffered as an expert witness on behalf of Hospira, submitted an expert report and been
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`deposed, but he was also listed on Fresenius Kabi’s pretrial witness list. There is simply no basis
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`to exclude his deposition testimony.
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`The Norther District has similarly determined that a party cannot exclude prior expert
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`testimony that it has proffered but later determined “was more harmful that helpful” because
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`expert’s prior testimony “was an admission of a party opponent under Federal Rule of Evidence
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`801(d)(2)(c).” Pentech, 2010 U.S. Dist. LEXIS 10489 at *35, citing In re Hanford Nuclear
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`Reservation Litig., 534 F.3d 986, 1016 (9th Cir. 2008). That is the situation here: Hospira cannot
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`withdraw Dr. Sheinin’s opinions simply because it no longer likes them.
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`Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 6 of 7 PageID #:4977
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`Dated: July 17, 2018
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`Respectfully submitted,
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`/s/ Imron. T. Aly
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`Imron T. Aly (IL Bar No. 6369322)
`Kevin M. Nelson (IL Bar No. 6275586)
`Joel M. Wallace (IL Bar No. 6304223)
`Emily M. Peña (IL Bar No. 6321281)
`Tara L. Kurtis (IL Bar No. 6323880)
`233 South Wacker Drive, Suite 7100
`Chicago, Illinois 60606
`(312) 258-5500
`ialy@schiffhardin.com
`knelson@schiffhardin.com
`jwallace@schiffhardin.com
`epena@schiffhardin.com
`tkurtis@schiffhardin.com
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`Ahmed M.T. Riaz (pro hac vice)
`666 Fifth Avenue, 17th Floor
`New York, NY 10103
`(212) 753-5000
`ariaz@schiffhardin.com
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`Attorneys for Defendant Fresenius Kabi USA,
`LLC
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`Case: 1:16-cv-00651 Document #: 127 Filed: 07/17/18 Page 7 of 7 PageID #:4978
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`CERTIFICATE OF SERVICE
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`I, Tara Kurtis, an attorney at the law firm of Schiff Hardin LLP, hereby certify that on
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`July 17, 2018, I caused a true and correct copy of the foregoing FRESENIUS KABI’S
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`OPPOSITION TO HOSPIRA’S MOTION TO EXCLUDE DR. ERIC SHEININ’S
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`DEPOSITION TESTIMONY AT TRIAL to be electronically served on counsel of record via the
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`Court’s CM/ECF system.
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`/s/ Tara Kurtis
`Tara Kurtis
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