Redactions Of Death Data In The Form of Clinical Trial Study Days Ruled Improper
- ILS Team
In In re Onglyza (Saxagliptin) & Kombiglyze XR (Saxagliptin & Metformin) Prods. Liab. Litig., No. 5:18-MD-2809-KKC, (E.D. Ky. Aug. 19, 2020), at issue before the Magistrate Judge was Plaintiffs’ motion to compel arising from their claim that Defendants engaged in improper redactions of relevant information.
Among the redaction types addressed by the Magistrate Judge were those relating to death dates and treatment durations, both critical to the question of causation in the case. Defendants claimed that the redacted information constituted protected health information (“PHI”) pursuant to the parties’ Stipulated Protective Order. However, the Court noted that while specific calendar dates of death would qualify as protected health information, the death and treatment dates actually at issue in Plaintiffs’ motion were dates in the number of study days, rather than calendar dates, and thus would fall outside the Stipulated Protective Order.
Defendants also argued that the death date and treatment duration information redacted was unnecessary in any event because Plaintiffs had access to the same unredacted information in Defendants’ production of clinical trial submissions and Plaintiffs could easily cross-reference the documents to determine the study day of death. On this point, the Court stated that it “cannot conceive how this information—that Defendants have provided in another format and offered to produce here—is information that must be redacted.” Moreover, “Defendants should not take the extra step of redacting this information and then force Plaintiffs to untangle the redactions by ‘cross-referencing’ the data with other documents.”
Plaintiffs also claimed that certain exhibits submitted by Defendants contained improper trade secret redactions and that the exhibits were publicly available documents. While the Defendant admitted that the redacted information was publicly available, Defendant contested whether the exhibits themselves were publicly available documents. Noting that a publicly available document or information cannot be entitled to confidential treatment under the parties’ Stipulated Protective Order, the Magistrate Judge granted Plaintiffs’ motion to both documents that are publicly available and to redactions that are public information even where the entire document is not public.