Keralink International, Inc. v. Stradis Healthcare, LLC

CourtDistrict Court, D. Maryland
DecidedMarch 30, 2021
Docket1:18-cv-02013
StatusUnknown

This text of Keralink International, Inc. v. Stradis Healthcare, LLC (Keralink International, Inc. v. Stradis Healthcare, LLC) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Keralink International, Inc. v. Stradis Healthcare, LLC, (D. Md. 2021).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

KERALINK INT’L, INC. * * * v. * Civil Action No. CCB-18-2013 * * STRADIS HEALTHCARE, LLC, et al. * ******

MEMORANDUM Pending before the court in this products-liability action are Geri-Care Pharmaceuticals Corporation (“Geri-Care”)’s motion to exclude the expert testimony of Stradis Healthcare, LLC (“Stradis”)’s hybrid fact/expert witnesses (ECF 92), and Geri-Care’s motions challenging the sufficiency of KeraLink International, Inc. (“KeraLink”)’s and Stradis’s responses to Geri-Care’s requests for admission (ECF 94, 96).1 The motions are fully briefed, and no oral argument is necessary. See Local Rule 105.6 (D. Md. 2018). For the reasons that follow, the motion to exclude will be granted in part and denied in part and the motions challenging the sufficiency of requests for admission will be denied in full. BACKGROUND This litigation arises from the inclusion of contaminated sterile eye wash (“Geri-Care Eye Wash”), allegedly produced by defendants InSource, Inc. (“InSource”) and/or Geri-Care, in sterile surgical packs used to recover corneal tissue. KeraLink, a national network of eye banks that recovers and distributes ocular tissue for use in corneal implants, purchased these from Stradis.

1 Also pending are Geri-Care’s motion for order to show cause (ECF 110), motions for summary judgment against Stradis (ECF 117) and KeraLink International, Inc. (“KeraLink”) (ECF 118), and motion in limine to exclude certain damages (ECF 129); KeraLink’s motion for summary judgment against Stradis and Geri-Care (ECF 123); and Stradis’s motion for summary judgment against KeraLink (ECF 127). Those motions will be addressed in a separate memorandum. (ECF 75, Second Am. Compl. ¶¶ 10, 13, 16–17). After the Eye Bank Association of America in 2017 notified its members that batches of Geri-Care Eye wash may be contaminated, KeraLink quarantined, and eventually could not use, some ocular tissue that had been recovered using Geri- Care Eye Wash, resulting in monetary damages. (ECF 75 ¶¶ 22–24, 28). KeraLink initiated this action in July 2018, and a month later, Stradis filed a third-party complaint against Insource and

Geri-Care, seeking indemnification and contribution. (ECF 1; ECF 10). Discovery in this matter was initially scheduled to close on June 15, 2020. (ECF 63, Scheduling Order). Because of disruptions in the discovery schedule caused by the coronavirus pandemic, Geri-Care sought and the court granted a 60-day extension of the discovery period, to August 14, 2020. (ECF 88, May 12, 2020, Order extending discovery deadlines). On July 9, 2020, Geri-Care moved to exclude two of Stradis’s witnesses from testifying as experts at trial (ECF 92). On July 30, 2020, and August 4, 2020, respectively, Geri-Care moved to challenge the sufficiency of certain of Stradis’s responses to Geri-Care’s requests for admission. (ECF 94, 96). These motions are ripe and ready for resolution.

DISCUSSION I. Motion in Limine to Exclude Hybrid Witnesses Geri-Care moves to exclude as expert witnesses for Stradis two witnesses Stradis designated as hybrid fact/expert witnesses, Patrick Walker and Robin Nalley, arguing that Stradis’s disclosure of Walker and Nalley was deficient under Rule 26(a)(2)(C). On May 1, 2020, Stradis disclosed Walker as Stradis’s Vice President of Operations at Stradis before, during and after the recall of Geri-Care Eye Wash and that he is expected to testify regarding the following: Mr. Walker is expected to testify based on his knowledge of Stradis’ response to the October 2017 Notices and the January 2018 Geri-Care Eye Wash recall, including but not limited to identification of possibly contaminated lot numbers and coordination for removal from use of such lot numbers. Additionally, Mr. Walker is expected to testify to his knowledge of Stradis’ surgical packs, including, but not limited to, the contents of the surgical packs, the packaging of the surgical packs and the sterilization process of the surgical packs. Further, Mr. Walker will testify to Stradis’ compliance with guidelines from the federal and Drug administration (“FDA”) and the international Organization of Standards (“ISO”) for Stradis’ surgical packs. Finally, Mr. Walker is expected to testify regarding the financial impact on Stradis due to the October 2017 Notices and the January 2018 recall.

Mr. Walker’s testimony will be based on his personal knowledge, training and experience in medical products, sterilization product validation and supply chain strategy. Also, these conclusions are based, in part, upon methodologies and practices widely accepted in these industries. Mr. Walker will also rebut all or part of any testimony of any expert who testifies on behalf of [KeraLink], [Geri-Care], or [InSource]. (Stradis’s Expert Disclosure, ECF 92-2 at 1–2). Robin Nalley was the Quality and Regulatory Manager for Stradis before, during and after the October 2017 Notices and the January 2018 recall of Geri-Care Eye Wash. Stradis disclosed that she is expected to testify as to the following: [Ms.] Nalley is expected to testify based on her knowledge of Stradis’ response to the October 2017 Notices and the January 2018 Geri-Care Eye Wash recall, including but not limited to identification of possibly contaminated lot numbers and coordination for removal from use of such lot numbers. Additionally, Ms. Nalley is expected to testify as to Stradis’ investigation and her correspondence with representatives from KeraLink, Geri-Care, and InSource regarding Geri-Care Eye Wash that was included in Stradis surgical packs. Ms. Nalley will also testify as to her correspondence with recipients of Stradis surgical packs, which included Geri-Care Eye Wash. Further, Ms. Nalley will testify to the measures enacted by Stradis to mitigate further exposure to possible contamination from Geri-Care Eye Wash included in Stradis surgical packs.

Ms. Nalley’s testimony will be based on her personal knowledge training and experience in quality assurance and regulatory compliance. Also, these conclusions are based, in part, upon methodologies and practices widely accepted in these industries. Ms. Nalley is expected to testify, generally, as to regulatory compliance and to rebut all or part of any testimony of any expert who testifies on behalf of KeraLink, Geri-Care, or InSource. (ECF 92-2 at 2–3). Under Local Rule 104.10, a party need not provide the comprehensive report required under Fed. R. Civ. P. 26(a)(2)(B) for the disclosure of expert witnesses retained by a party to provide expert testimony for witnesses designated as “hybrid fact/expert” witnesses. “The hybrid witness exception from additional disclosure requirements applies where ‘testimony is given arising out of personal observations made in the normal course of duty.’” Adell Plastics, Inc. v.

Mt. Hawley Ins. Co., No. JKB-17-00252, 2019 WL 2359441, at *1 (D. Md. June 4, 2019) (quoting Nat’l R.R. Passenger Corp. v. Ry. Express, LLC, 268 F.R.D. 211, 216 (D. Md. 2010)).2 For those hybrid fact/expert witnesses, the party need only “disclose the existence of any hybrid fact/expert witness pursuant to Fed. R. Civ. P. 26(a)(2)(A), and disclose the subject matter on which the witness is expected to present evidence under Fed. R. Evid. 702, 703, or 705, as well as a summary of the facts and opinions to which the hybrid fact/expert witness is expected to testify, pursuant to Fed. R. Civ. P. 26(a)(2)(C).” Local Rule 104.10 (D. Md. 2018).

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Bluebook (online)
Keralink International, Inc. v. Stradis Healthcare, LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/keralink-international-inc-v-stradis-healthcare-llc-mdd-2021.