Litigators used to working with expert witnesses in federal cases know the requirement of identifying the materials considered by the experts in forming their opinions. What happens when medical experts rely in part on their experience treating patients who have nothing to do with the litigation? According to a recent decision from the U.S. District Court for the District of New Jersey, the physician is required to produce those patients’ records to the other side as part of the rules governing expert discovery.
At issue in the case of In re: Benicar (Olmesartan) Products Liability Litigation, 2017 WL 970263 (D.N.J. March 13, 2017), were the expert reports and opinions of a gastroenterologist and pathologist affiliated with a major academic medical center in New York. In providing expert reports on behalf of plaintiffs who contended that their use of antihypertensives containing olmesartan caused sprue-like enteropathy, each physician referred to his own experience with patients. For example, the gastroenterologist wrote in his expert report that he “reviewed the charts of our most treatment-resistant patients,” and testified at his deposition that his review of patient charts “confirmed his opinion.” Similarly, the pathologist testified that he reviewed the charts of sixteen patients who took olmesartan and had seronegative celiac disease, and that his review of the charts contributed to his view that occurrence of enteropathy in people taking olmesartan was not a chance association.
The defendants moved to preclude the experts from testifying with regard to their clinical experience or review of patient charts based on the plaintiffs’ failure to produce the medical records referred to by the experts. The Court determined that preclusion would be a disproportionate sanction if the charts could be produced, and thus analyzed the question of the charts’ discoverability under the rule governing a litigant’s obligation to disclose materials considered by experts in forming their opinions.
First, the Court found unconvincing the plaintiffs’ argument that the experts could not produce the charts because they belonged to their employer (the medical center), writing that “since the experts were apparently able to easily access the requested records to review them, it is likely that they have ‘possession, custody or control’ of the records.”
Second, the Court rejected the plaintiffs’ contention that it would be too burdensome to “identify, collect, redact and produce the requested records” because the plaintiffs did not produce proof of the alleged burden. Moreover, the Court found that only a “discrete, identifiable and manageable number” of records were implicated, such that production by the experts “does not appear to be a material burden.”
Third, the Court viewed as “hyperbole” the plaintiffs’ argument that requiring experts to produce patient records would dissuade the most qualified physicians—those who “actually treat and study patients with the condition” at issue—from serving as expert witnesses. It again observed that the plaintiffs had not presented evidence to substantiate this argument, and held in any event that these concerns “do not trump the Federal Rules of Civil Procedure.”
Based on its ruling that the patient records reviewed by the experts were discoverable and should have been produced, the Court ordered their production, subject to redaction “to remove all personal identifying information.” Leaving open the possibility that the experts might nevertheless be unable to produce them, the Court directed in the alternative that the experts submit affidavits (i) substantiating their inability to produce the records, and (ii) providing information on who could be served with a subpoena for their production.
The experts subsequently provided affidavits explaining their inability to produce the patient records, stating that they were owned and maintained by their employer (the academic medical center). Along with their affidavits, the experts submitted a letter from the medical center’s office of general counsel that confirmed the experts’ inability to produce the records. The docket does not show further motion practice concerning this issue, which suggests that the defendants subpoenaed the institution and obtained the records from it.
Regardless of the outcome here, this case serves as a reminder of some potential complications when an institution’s clinical faculty serve as expert witnesses. From the institution’s perspective, it is advisable to create and document appropriate policies regarding physicians’ ability to access medical records for nonclinical purposes, such as serving as expert witnesses. Although the Court was unpersuaded by the argument that requiring production of all records relied on by an expert would impede the most qualified physicians from being willing to serve as experts, an institution’s outright ban on permitting such service by its clinical faculty would seem to implicate that concern, as well as antagonizing faculty and staff who supplement their income by serving as expert witnesses. The Court did not discuss HIPAA, but it is not clear that using patient records in this manner, unless they are first completely de-identified, would fall within a permissible purpose under the federal privacy regulations. Unless the institution is willing to accept the burden and risk of producing redacted records in cases like this, one approach is to clearly document a policy against accessing or reviewing patient records for the purpose of acting as an expert witness, and to remind staff members known to serve as experts how this policy serves the interests of both the institution and the expert by avoiding difficulties of the type encountered by the experts in this case.
For a physician engaged as an expert witness, carefully consider the potential obligation to produce medical records—and the difficulties that may result if institutional or professional rules, or state or federal privacy laws, preclude such production—before relying on those records to form and document an opinion. Even if the physician’s employer does not have a policy on this issue, no physician wants to be the person who prompts one to be formulated after the office of general counsel is served with a subpoena arising from his or her work as an expert witness. Here, for example, each expert stated in his affidavit that “if I had known when I was asked to act as an expert witness in this litigation that I would be subjected to an Order to produce the medical records of [institution’s] patients uninvolved in litigation, I would have declined to act as an expert.” And while the lawyers who engage the expert do not represent the expert, they should be highly motivated to avoid causing the expert trouble of the type seen here, and can provide guidance on what materials will have to be disclosed if the expert relied on patient records. The applicable rules vary, especially among the various state courts, so while the decision in this case from a federal court should serve as a cautionary reminder, the rules in other jurisdictions may be quite different.