Re: Jorge Rudelli v. Eli Lilly & Co Civil Action No. 19-7464 (BRM) (ZNQ) United States District Court, D. New Jersey Filed June 11, 2021 Quraishi, Zahid N., United States Magistrate Judge LETTER ORDER *1 Dear Counsel: This matter comes before the Court upon discovery disputes between the parties. Plaintiff Jorge Rudelli (“Plaintiff”) submitted a letter to the Court requesting an order compelling Defendant Eli Lilly (“Eli Lilly”) to provide complete and unredacted responses to Plaintiff's second request for production of documents and to supplement its previous discovery responses to include information related to human resources representative and fact-witness, Amrit Mula. (Pl.’s March 30, 2021 Letter.) Plaintiff also requests that the Court extend all discovery deadlines by ninety days after Eli Lilly fulfills its discovery obligations to ensure that Plaintiff has sufficient time to complete remaining depositions. (Id.) Eli Lilly responded to Plaintiff's Letter, (Def.’s April 30, 2021 Resp.), and Plaintiff replied, (Pl.’s May 5, 2021 Reply)[1]. For the sake of brevity, the Court will only recite the facts related to the disputes identified in Plaintiff's March 30, 2021 Letter. Plaintiff contends that “[i]n October 2020, Reuters reported that the FDA had ‘uncovered serious quality control problems’ in the Validation Department at the [Eli Lilly] Branchburg Facility.” (Pl.’s March 30, 2021 Letter at 2.) That report included findings “that data on the plant's various manufacturing process[sic] had been deleted and not appropriately audited and that [Eli] Lilly employees had complained about... falsified records.” (Id.) On March 11, 2021, Reuters also published a “Special Report” involving former Eli Lilly HR Representative, Amrit Mula. (Id.) Plaintiff contends that this Report describes situations in which quality assurance records disappeared or were doctored and Mula's complaints concerned the “shredding bin incident” that led to Plaintiff's termination. (Id.) After learning of the initial Reuters Report, Plaintiff served Eli Lilly with a second request for production of documents, “seeking the FDA findings, the underlying and related documents, and documents concerning the history of document and data destruction issues at the Branchburg facility.” (Id.) Eli Lilly objected to Plaintiff's requests and on November 19, 2020, Plaintiff identified ten disputed matters that the requested information is relevant to. (Id.) On December 23, 2020, Eli Lilly responded to the second request for production of documents. (Id.) However, Plaintiff contends that Eli Lilly did not respond to the totality of Plaintiff's requests. (Id. at 3.) On January 8, 2021, Plaintiff served a deficiency letter upon Defendant, demanding complete responses. (Id.) One month later, Eli Lilly provided a supplemental response consisting of redacted materials. (Id.) On March 11, 2021, Plaintiff demanded full and unredacted document discovery related to the Mula Special Report. (Id. at 4.) Plaintiff also informed Eli Lilly that Eli Lilly knew about Mula's complaint, which allegedly mentions Plaintiff, since 2019 but Eli Lilly failed to disclose that information for nearly two years. (Id.) On March 30, 2021, Plaintiff submitted this discovery dispute and letter motion to compel to the Court. 1. Documents, Communications, & Investigations related to Missing Documentation *2 In the second request for production of documents, request # 2 seeks “all documents and communications constituting, relating to, arising out of, commenting on, or concerning the FDA Investigation”; request # 3 seeks “any document or communication constituting or relating to an FDA finding that validation and/or quality control data (including validation protocol) was deleted, destroyed, not preserved, altered and/or not appropriately stored by the Validation Department”; and request #13 seeks “all documents and communications from the previous 4 years stating, addressing or disclosing that the practices, policies or procedures of Validation Department were improper or deviated from an applicable standard in any regard, including data management or retention and/or quality control.” (Id. at 4-5.) Plaintiff disagrees with Eli Lilly's assertion that the FDA inspection does not concern relevant data and document destruction and therefore, does not need to be produced. (Id. at 5.) Plaintiff argues that a partially redacted inspection note describes Plaintiff's former supervisors Goss and Hoehn's involvement in a deviation related to validation documentation initially found missing. (Id.) Plaintiff argues that this is a “mirror image of the incident which led to Plaintiff's termination” and therefore, Plaintiff is entitled to documents sufficient to understand the details of that deviation. (Id.) Moreover, Plaintiff argues that there were several partially redacted notes revealing deviations related to deleted validation and quality control information. (Id.) Plaintiff contends that he is entitled to understand what was deleted, by whom, and Eli Lilly's response to the deletions. (Id.) Additionally, Plaintiff contends that Eli Lilly has redacted the inspection notes for all FDA interactions with any employee other than Goss and Hoehn, and such redactions prevent Plaintiff from discovering additional incidents that may have occurred. (Id.) Thus, Plaintiff argues that he is entitled to: (1) fully unredacted inspection notes for each day of the FDA Inspection, (2) documents and communications concerning the deviation noted on November 15, 2019, (3) documents and communications concerning the other document or data retention deviations noted, and (4) documents concerning investigations regarding any incident of documents or data being lost, destroyed, or misplaced. (Id.) In its response, Eli Lilly argues that “Plaintiff's request for fully unredacted inspection notes for each day of the FDA inspection is patently objectionable and is designed to harass Eli Lilly.” (Def.’s April 30, 2021 Resp. at 3.) According to Eli Lilly, the FDA inspections were site-wide and did not focus on Plaintiff's former Validation Department. Eli Lilly contends that its redactions are proper because of the breadth of the FDA inspections, the fact that Plaintiff's termination claim does not have anything to do with any FDA inspection, and none of the FDA's 483 letters reference Plaintiff in any capacity. (Id. at 3-4.) Eli Lilly argues that removing the redactions would reveal confidential information and commercially sensitive information about unrelated matters that have no bearing on this case. (Id. at 4.) Next, Eli Lilly argues that it has already produced non-privileged documents located after a reasonable search for documents related to the deviation noted on November 15, 2019. (Id.) Moreover, Eli Lilly argues that Plaintiff's requests are not tailored to the issues in the case, nor are they limited to a particular time frame. (Id.) Additionally, Eli Lilly argues that the requests listed in Plaintiff's letter are vague, ambiguous, and seek more information than what is covered in requests nos. 2, 3, and 13 in the second set of requests for production of documents. (Id.) *3 Plaintiff's request for fully unredacted inspection notes for each day of the FDA inspection is overbroad and not proportional to the needs of the case. As for documents and communications concerning the deviation noted on November 15, 2019, Eli Lilly asserts that it has produced non-privileged documents related to that deviation located after a reasonable search. To the extent that there are any additional documents concerning the November 15 deviation that Eli Lilly has not produced, the Court directs Eli Lilly to produce such documents. Turning to Plaintiff's request for documents and communications concerning the other document or data retention deviations noted and documents concerning investigations regarding any incident of documents being lost, destroyed, or misplaced, Plaintiff's request is granted. The Court finds that these requests are relevant and proportional to the needs of the case. The Court also grants Plaintiff's request for documents concerning investigations regarding any incident of documents or data being lost, destroyed, or misplaced, as that information is also relevant and proportional to the needs of the case. 2. Communications Related to Human Resources Investigations Request # 8 of the second request for production of documents seeks “all documents and communications relating to, evidencing, or constituting any HR or personnel action at the Branchburg facility relating to, arising out of, following temporally or in response to any FDA Inspection or FDA finding, including the discipline, reassignment, resignation or termination of any employee or manager of the Validation Department (specifically Goss or Hoehn).” (Pl.’s March 30, 2021 Letter at 6.) Plaintiff argues that the Mula Special Report and FDA Inspection disclosed numerous deviations involving lost, deleted, and falsified documents and data, some which involved Hoehn and Goss. (Id.) Plaintiff further argues that he is entitled to all documents regarding the HR investigation and action in connection with incidents of missing or destroyed data and documents. (Id.) Plaintiff contends that Goss and Hoehn resigned after multi-decade tenures with Eli Lilly after the above-referenced investigations, but Eli Lilly denies that their resignations were related to the FDA investigations. Thus, Plaintiff argues that he is entitled to (1) HR documents and communications regarding any employee alleged or found to have lost or destroyed data or documents and, (2) documents and communications relating to Hoehn and Goss’ resignation. (Id.) Eli Lilly argues that Request # 8 “does not call for broad discovery into Human Resources investigations pertaining to any employee.” (Def.’s April 30, 2021 Resp. at 5.) Moreover, Eli Lilly argues that Plaintiff's requests are vague, overbroad, unduly burdensome, not relevant to any claims or defenses, and not proportional to the needs of the case, as this case concerns Plaintiff's claim of discrimination based on race and retaliation. (Id.) Eli Lilly contends that Plaintiff should not have access to all Human Resources documents concerning other employees who allegedly lost or destroyed data or documents even if it includes Plaintiff's former supervisors Hoehn and Goss. (Id.) Eli Lily also argues that this request should be denied because Eli Lilly has already provided documents relating to the resignations of Goss and Hoehn and if Plaintiff believes Eli Lilly has additional documents, Plaintiff should identify what those additional documents might be. (Id.) The Court finds that Eli Lilly must produce Human Resources documents regarding employees who have lost or destroyed data or documents at the Branchburg facility. Because Eli Lilly asserts that Plaintiff was fired “because he attempted to destroy validation documents,” records of other employees who allegedly engaged in similar actions are relevant. (See id. at 4n.3.) As for additional documents relating to Goss’ and Hoehn's resignations, Eli Lilly asserts that it has already provided the relevant documents. Therefore, if there are any additional documents Plaintiff is seeking, Plaintiff must request the specific documents. 3. Consultant Reports Relating to Document or Data Retention Practices at the Branchburg Facility *4 In the second request for production of documents, request # 7 seeks “all documents and communications relating to, constituting, commenting on or concerning any internal investigation or audit by Eli Lilly pertaining to the subject matter of the FDA Inspection or any FDA Finding, or organized in response thereto” and request # 10 seeks “all communications among employees or consultants of Eli Lilly relating to, arising out of or in response to the FDA Inspection or any FDA finding.” (Pl.’s March 30, 2021 Letter at 6-7.) Plaintiff alleges that Eli Lilly retained consultants to address data and document preservation issues at the Branchburg facility. (Id. at 7.) Plaintiff further alleges that the Special Mula Report revealed that those consultants issued a five-year retrospective report and Eli Lilly implemented corrective action addressing the document preservation issues. (Id.) According to Plaintiff, the Special Report indicates that one action point involved the use of sticky notes to track documents and in this case, Hoehn alleges that a sticky note linked Plaintiff to missing documentation. (Id.) Therefore, Plaintiff argues that he is “entitled to (1) reports issued by consultants related to document and data retention practices, (2) policy changes or talking points issued by Eli Lilly related to document and data retention practices, and (3) communications related to the foregoing.” (Id.) Eli Lilly argues that the requests set forth in Plaintiff's March 30th Letter are not within the scope of requests nos. 7 and 10. (Def.’s April 30, 2021 Resp. at 6.) Eli Lilly also argues that it has already searched for and produced documents related to Plaintiff and his claims. (Id.) Eli Lilly argues that “Plaintiff's new requests are overbroad, unduly burdensome, not relevant to the parties’ claims or defenses, and not proportional to the needs of the case.” (Id.) Additionally, Eli Lilly argues that the time to bring these disputes has passed as the deadline to submit written discovery disputes was February 28, 2020. (Id.) The requests set forth in Plaintiff's letter are encompassed in requests nos. 7 and 10. Moreover, the requests are relevant and proportional to the needs of this case. Eli Lilly shall provide reports issued by consultants related to document and data retention practices. Eli Lilly shall also provide information regarding policy changes and/or talking points related to document and data retention practices issued by Eli Lilly. Next, the Court turns to Eli Lilly's argument regarding the written discovery dispute deadline being February 28, 2020. In September 2020, the fact discovery deadline was extended to January 20, 2021. (ECF No. 34.) In January 2021, Plaintiff submitted a letter requesting another extension of the fact discovery deadline. (ECF No. 39.) Plaintiff alleged that he became aware of a public reporting by Reuters in November 2020, which led to Plaintiff serving a second request for production of documents. (Id.) Plaintiff asked the Court to extend the fact discovery deadline by ninety days to April 20, 2021 because he was waiting for responsive documents from Eli Lilly and he still needed to complete depositions. (Id.) After that request, the Court extended the fact discovery deadline to April 20, 2021. (ECF No. 41.) As a result, the Court finds good cause to extend the February 28, 2020 written discovery dispute deadline and therefore review the instant letter motion to compel as timely. 4. Responses Relating to Staffing of the Validation Department In the second request for production of documents, request # 12 seeks “all documents and communications (including employee complaints) from the previous 4 years stating, addressing or disclosing that the Validation Department was inadequately staffed, trained, supervised or managed, whether or not those documents were produced to the FDA.” (Pl.’s March 30, 2021 Letter at 7.) Plaintiff argues that this case involves factual disputes as to whether Plaintiff's performance had declined towards the end of his employment or whether the Validation Department was understaffed, thereby creating an untenable workload. (Id.) Plaintiff further argues that staffing is also relevant to whether Eli Lilly had a motive to retaliate against Plaintiff for taking medical leave to care for his mother. (Id.) Plaintiff contends that the Mula Special Report indicates that Mula and other employees have complained about inadequate staffing. (Id.) Thus, Plaintiff asserts that he is entitled to documents related to employee complaints or investigations of inadequate staffing. (Id.) *5 In its response, Eli Lilly argues that Plaintiff has already admitted that Eli Lilly granted each leave request Plaintiff submitted. (Def.’s April 30, 2021 Resp. at 6.) Eli Lilly further argues that Plaintiff's only basis for connecting his termination to his leave is Hoehn's requests that Plaintiff consider rescheduling some of his mother's doctor's appointments, which Plaintiff sometimes did and sometimes did not do. (Id.) Eli Lilly argues that the adequacy of staffing has nothing to do with Plaintiff's retaliation claim. (Id.) Additionally, Eli Lilly argues that as to Plaintiff's argument that the inadequate staffing created an untenable workload, whether Eli Lilly's employees complained about the adequacy of staffing is not relevant to Plaintiff's claim that he experienced retaliation. (Id.) The Court finds that documents addressing whether the Validation Department was inadequately staffed are relevant. Specifically, such documents are relevant to whether Eli Lilly's management retaliated against Plaintiff for taking medical leave. However, this request must be limited in scope to documents and communications addressing inadequate staffing in the Validation Department, not the entire Branchburg facility. 5. Documents Related to the Mula Special Report Request #13 of the second set of requests for production of documents seeks “all documents and communications (including employee complaints) from the previous 4 years stating, addressing or disclosing that the practices, policies or procedures of Validation Department were improper or deviated from an applicable standard in any regard, including data management or retention and/or quality control.” (Pl.’s March 30, 2021 Letter at 7-8.) Plaintiff argues that Amrit Mula, a key fact witness in this case, was a whistleblower and was terminated as a result. (Id. at 8.) According to Plaintiff, Mula's complaints included issues relevant to this case including staffing issues and issues of document retention. (Id.) Plaintiff argues that Eli Lilly is entitled to (1) “all documents relating to Mula's whistleblowing, including letters, internal complaints, and internal communication; and (2) “documents and communications related to other whistleblowing activity at the Branchburg Facility.” (Id.) Plaintiff also argues that “[i]f other [Eli] Lilly employees have made whistleblowing claims, which have not been disclosed, they should be identified and produced immediately.” (Id.) Eli Lilly argues that Plaintiff's request is broader than what is set forth in Request # 13. (Def.’s April 30, 2021 Resp. at 7.) Moreover, Eli Lilly argues that documents related to Mula's allegations concerning FDA inspections or the manufacturing department are not relevant to Plaintiff's employment discrimination claims concerning members of the Validation Department. (Id.) Eli Lilly further argues that Plaintiff's retaliation claim does not give him “an open license to fish for documents concerning any other non-specific, alleged ‘whistleblowing activity’ that any other unnamed employees may have engaged in.” (Id.) Eli Lilly contends that Plaintiff's requests are vague, particularly Plaintiff's use of the term whistleblowing, overbroad, unduly burdensome, not relevant to any claims or defenses, and not proportional to the needs of the case. (Id.) The Court finds that Plaintiff's request must be limited to documents and communications concerning practices, policies, or procedures of the Validation Department. Request # 13 is limited to the Validation Department, and therefore, Plaintiff's request in his March 30th Letter should also be limited to the Validation Department. Plaintiff's request set forth in his March 30th Letter is broader than Request # 13 because he requests all documents and communications for the entire Branchburg facility. The Court will grant Plaintiff's requests so long as they are limited to the Validation Department. The limited requests are relevant and proportional to the needs of the case. 6. Request for Extension of Discovery *6 Plaintiff requests that the Court provide a date for Eli Lilly to make a full production of relevant information in its possession, followed by a 90-day period for Plaintiff to complete depositions. (Pl.’s March 30, 2021 Letter at 8.) Eli Lilly does not object to an extension of the fact discovery deadline for the remaining depositions, but Eli Lilly requests a 45-day extension instead of 90-day extension. (Def.’s April 30, 2021 Resp. at 7.) Eli Lilly shall provide the documents that the Court has ordered it to provide no later than fourteen (14) days after the entry of this Order. Additionally, the Court will extend the fact discovery deadline to sixty (60) days from the date that Eli Lilly produces its responses. In sum, It is on this 11th day of June, 2021 ORDERED that, 1. Plaintiff's request for fully unredacted inspection notes for each day of the FDA inspection is denied. To the extent that there are any additional documents concerning the November 15, 2019 deviation that Eli Lilly has not produced, the Court directs Eli Lilly to produce them. Plaintiff's request for documents and communications concerning the other document or data retention deviations noted and documents concerning investigations regarding any incident of documents being lost, destroyed, or misplaced is granted. Plaintiff's request for documents concerning investigations regarding any incident of documents or data being lost, destroyed, or misplaced is granted. 2. Plaintiff's request for Human Resources documents regarding employees who have lost or destroyed data or documents at the Branchburg facility is granted. 3. Plaintiff's request for reports issued by consultants related to document and data retention practices is granted. Eli Lilly shall also provide information regarding policy changes and/or talking points related to document and data retention practices issued by Eli Lilly. 4. Plaintiff's request for documents related to staffing complaints is granted, however, the documents shall be limited to those related to the inadequate staffing in the Validation Department. 5. Plaintiff's requests for all documents relating to Mula's whistleblowing, including letters, internal complaints, and internal communication and documents and communications related to other whistleblowing activity at the Branchburg facility must be limited to the Validation Department of the Branchburg facility. 6. Eli Lilly shall provide the documents that the Court has ordered it to provide no later than fourteen (14) days after the entry of this Order. 7. The fact discovery deadline is extended to sixty (60) days from the date that Eli Lilly fulfills its discovery obligations. Footnotes [1] The parties submitted their respective letters in camera, as they contend their letters and attached exhibits contain confidential information subject to the Discovery Confidentiality Order.