Adams v. Medtronic, Inc.

District Court, E.D. Texas·Decided January 23, 2024·No. 4:19-cv-00870·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION

§ JANET ADAMS and RANDY ADAMS, § § Plaintiffs, § § v. § Civil Action No. 4:19-cv-870-SDJ-KPJ § MEDTRONIC, INC., et al., § § Defendants. § §

MEMORANDUM OPINION AND ORDER On November 3, 2023, Defendants Medtronic, Inc., Covidien Holding, Inc., Covidien LP, and Covidien Sales LLC’s (“Defendants”) counsel emailed chambers, copying Plaintiffs Janet Adams and Randy Adams’s (“Plaintiffs”) counsel, requesting guidance on how the parties should proceed regarding a discovery issue—a disagreement on the designation of a document (the “Document”) produced during discovery and Defendants’ attempt to claw back the Document from production. On November 7, 2023, the Court issued an order scheduling a hearing regarding the discovery issue and directing the parties to file a joint letter brief detailing the discovery issue and including the Document for in camera review. Dkt. 117 at 2. On November 9, 2023, the parties filed the Joint Letter to Court for November 13, 2023, Hearing (the “First Joint Letter”) (Dkt. 125). In the First Joint Letter (Dkt. 125), Defendants argue that the Document is (1) confidential and thus, subject to the Protective Order (Dkt. 22), and Plaintiffs did not follow the procedures detailed therein; (2) not responsive to discovery because the Court limited discovery to the “EEA (circular) stapler” at issue in this case; (3) not relevant because it concerns different products and a different operations facility than those at issue in this case; and (4) protected by work product privilege. Dkt. 125 at 1–2. Plaintiffs responded that the Document is (1) not confidential and therefore, not subject to the Protective Order (Dkt. 22); (2) responsive to this case because it shows a systemwide failure in the company’s standard operating procedures to comply with regulations; (3) relevant to this case for the same reason as it is responsive—it shows a systemwide failure to comply with regulations; and (4) not protected by

privilege because “simply collecting a document” does not entitle the Document to be protected by work product privilege. Dkt. 125 at 3–5. On November 13, 2023, the Court held a hearing regarding the discovery issue. See Dkt. 117; Minute Entry for November 13, 2023. After hearing argument from the parties and acting under the assumption that the Document was properly designated as confidential, the Court issued an Order (Dkt. 126) setting deadlines regarding Plaintiffs’ delivery of Confidentiality Agreements for each of their experts to Defendants pursuant to Paragraph 9 of the Protective Order (Dkt. 22) and entering a stay regarding Defendants’ deadline to disclose experts. Dkt. 126 at 1–2. The Court further ordered that, to the extent the parties are unable to resolve the objections raised by Defendants in the First Joint Letter (Dkt. 125), the parties shall file a joint letter brief regarding

Defendants’ objections and Plaintiffs’ response. Id. at 1. Pursuant to the Order (Dkt. 126), Plaintiffs provided the Confidentiality Agreements for each of their experts and Defendants provided their objections. See Dkt. 130. On December 4, 2023, the parties filed the Joint Letter to Court Pursuant to November 28, 2023, Order (the “Second Joint Letter”) (Dkt. 130) (together with the First Joint Letter, the “Joint Letters”) (Dkts. 125; 130), notifying the Court that the parties were unable to resolve the objections raised by Defendants and addressing such objections. Dkt. 130. In the Second Joint Letter (Dkt. 130), Defendants raised two objections: (1) Defendants object “to all of Plaintiffs’ experts receiving, considering, and relying on the confidential [Document]” because the Document is (a) “not responsive to discovery,” (b) “not relevant,” and (c) “subject to work product considerations”; and (2) Defendants object to “Plaintiffs providing any documents marked as Confidential to their retained expert, Dr. Jason Moore.” Dkt. 130 at 3– 4 (emphasis in original). Plaintiffs responded to Defendants’ objections by asserting that: (1) “the [Document] in question is highly relevant to the present case”; and (2) Defendants’ argument

regarding Dr. Moore “lacks a factual basis supporting the notion that disclosure of confidential Medtronic documents to Dr. Moore would result in specific prejudice or harm.” Id. at 2–3. Plaintiffs further requested “relief from the Protective Order’s provision allowing a right for Defendants to object to disclosure of protected information to Dr. Moore.” Id. at 1. The Court construes the First Joint Letter (Dkt. 125) as Defendants’ motion to claw back the Document (the “Motion to Claw Back”) (Dkt. 125), wherein Defendants argue that the Document is confidential and privileged and thus subject to claw back. See Dkt. 125 at 1–2. The Court construes the Second Joint Letter (Dkt. 130) as Defendants’ objections to Plaintiffs’ experts pursuant to Paragraph 9 of the Protective Order (Dkt. 22) and Plaintiffs’ motion for relief from the Protective Order (Dkt. 22) (the “Motion for Relief”) (Dkt. 130). See Dkt. 130.

A. Defendants’ Motion to Claw Back 1. Designation of the Document First, Defendants argue that the Document is confidential and, thus, subject to the Protective Order (Dkt. 22). Dkt. 125 at 1. Plaintiffs contend that the Document is a public document and, therefore, not subject to the Protective Order (Dkt. 22). Id. at 4. The Court agrees with Defendants that the Document is confidential. The Document at issue is an Establishment Inspection Report (“EIR”) completed by the United States Food and Drug Administration (the “FDA”). Dkt. 125-1. According to the FDA website, EIRs are shared with the company at the close of an inspection of a regulated facility to determine a company’s compliance with applicable laws and regulations. FDA Form 483 Frequently Asked Questions, U.S. FOOD & DRUG ADMIN. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection -references/fda-form-483-frequently-asked-questions (last visited Jan. 19, 2024). However, only a segment of the information detailed therein is disclosed to the public. Inspection Classification

Database, U.S. FOOD & DRUG ADMIN. https://www.fda.gov/inspections-compliance-enforcement- and-criminal-investigations/inspection-classification-database (last visited Jan. 19, 2024). Although the full EIR may be requested directly from the FDA, the FDA is required to remove or redact any material that would be considered confidential prior to producing the EIR to the requesting party. At the hearing, Plaintiffs’ counsel argued that the Document is in a form that she believed would be the version, or close to the version, that would be released by the FDA to the public pursuant to a Freedom of Information Act (“FOIA”) request based on her experience in reviewing other EIR reports that have been made public. However, Plaintiffs’ counsel could not represent that the Document had been released to the public in its current form. Defendants’ counsel

responded that the Document was contained within Covidien’s confidential business papers and her understanding was that the Document would contain significantly more redactions in a version released by the FDA under FOIA. After reviewing the Document in camera and discussing it with counsel at the hearing, there is no indication that the Document produced in this case is a publicly disclosed EIR. The Document includes only one redaction. Dkt. 125-1 at 6. Some of the information in the Document could constitute trade secrets or other confidential information that is customarily kept private or closely held. See generally id. Therefore, the Court will assume that the Document is confidential for the purpose of the present litigation. Thus, the Document is subject to the Protective Order (Dkt.

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