Opinion
Master File (MDL No. 1348) 00 Civ. 2843 (LAK)
January 10, 2002
PRETRIAL ORDER NO. 44 (Redaction of Patient Identifying Information; Confidentiality)
In Pretrial Order No. 41 and an opinion dated December 20, 2001, the Court ruled that certain information concerning patients in clinical trials is producible over a claim of privilege provided adequate steps are taken to ensure that patient identifying information is deleted from the records. It directed the parties to endeavor to stipulate to the precise information that would be redacted and to submit any such stipulations by January 8, 2002. The parties have failed to reach complete agreement and therefore have submitted no such stipulations.
According to letters submitted to the Court, all counsel have agreed that the following information may be redacted:
• patient name and initials
• patient telephone numbers
• patient social security number
• patient street addresses
• name of patient
employer The parties disagree as to whether the names of other doctors that appear in a patient medical record should be redacted. In addition, counsel for certain of the subpoenaed parties wish to preserve the right to redact unspecified other information that might lead to identification of patients. Next, the partial agreements between plaintiffs and counsel for different subpoenaed parties are not coextensive. Finally, plaintiffs and Drs. Schwartz and Raskin are at odds over the extent to which plaintiffs ought to pay the costs of subpoena compliance by these non-party witnesses.
Redaction
The only substantive issue relating to patient confidentiality is whether the names of doctors appearing in patient records may be redacted — all of the other divergences reflect the failure of counsel to work out very simple matters. Drs. Raskin and Schwartz argue that they are obliged by 21 C.F.R. § 20.63(f), which is designed to promote the voluntary reporting by medical personnel of adverse events involving drugs, among other things, by protecting the confidentiality of their identities, to redact all third party physicians' and healthcare institutions' identities and addresses. Section 20.63(f) provides in relevant part that:
"The names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug . . . shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order.
* * *
This provision does not affect disclosure of the identities of reporters required by a Federal statute or regulation to make adverse event reports. Disclosure of the identities of such reporters is governed by the applicable Federal statutes and regulations." (Emphasis added)
It is readily apparent that Drs. Raskin and Schwartz have overstated substantially the scope of Section 20.63. First, it applies only to the FDA and to pharmaceutical manufacturers and therefore, presumably, not to them. Second, it shields only the identities of voluntary reporters, not all physicians and health care institutions mentioned in patient records. Nevertheless, the same policy that underlies Section 20.63 counsels caution here. Accordingly, the non-parties whose motions to quash recently were ruled upon by the Court may redact, in addition to the other items listed below, any information that Section 20.63(f) would preclude the FDA from disclosing, viz. "[t]he names and any information that would identify the voluntary reporter or any other person associated with an adverse event involving a human drug." They may not redact such information concerning the identities of doctors and institutions who made such reports under compulsion of law or who made no such reports.
The Court expresses no opinion concerning whether and to what extent such physicians and institutions may be subjected to discovery.
Finally, in the interest of uniformity, the order to be submitted shall permit redaction of the following information in addition to that referred to above:
• patient name and initials
• patient telephone number
• patient e-mail address
• patient social security number
• patient driver's license number
• patient insurance identification number
• patient address, including street, post box, city, state and postal zip code
• patient employer name and address
• any of the above with respect to members of patient's family
• emergency contact information
• any other information which counsel for the subpoenaed party in good faith believes may lead to discovery of the patient's identity
The order shall provide further that any redaction under the final category listed above shall be specifically identified as such, and the redacting party shall advise all counsel of the nature of the information with sufficient specificity to permit counsel to challenge the redaction.
Costs Counsel for Drs. Raskin and Schwartz seek to have plaintiffs pay their out of pocket copying costs and to pay for lawyer and paralegal time involved in complying with the subpoenas at the rates of $225 and $90 per hour, respectively. Plaintiffs balk, contending that the physicians' counsel has estimated that the total cost may approach $10,000.
Rule 45(c) permits a court to condition compliance with a subpoena so as to protect the subpoenaed person against undue hardship. The Advisory Committee Note to the 1991 amendment makes plain that "[a] non-party required to produce documents or materials is protected against significant expense resulting from involuntary assistance to the court." In this case, the risk of significant expense is occasioned by the fact that plaintiffs have subpoenaed privileged material which may be made available to them only in consequence of time consuming and exacting redaction for the purpose of protecting patient identities. The Court can see no reason why the physicians who have had the misfortune of receiving these subpoenas should be saddled with that cost. Further, the rates that their counsel proposes to charge are entirely reasonable. Accordingly, compliance with those subpoenas is conditioned upon the plaintiffs' agreement to pay the out of pocket copying costs and to compensate the physicians' counsel for their services reasonably rendered in redacting the documents at the hourly rates of $225 for attorneys and $90 for paralegals.
The parties are directed to submit, on or before January 17, 2002, agreed forms of orders setting forth the standards for redaction and their agreement with respect to confidentiality. The fact that the parties have advised the Court by letter that they have agreed to make Pretrial Order No. 3 applicable to this material is insufficient. This is a multidistrict litigation. The record ought to contain such an agreement. Further, while the Court believes it understands what is intended by the agreement concerning confidentiality, Pretrial Order No. 3 by its terms does not apply to non-parties and may require other tailoring to make its applications to these non-parties clear.
SO ORDERED.