Janelle Brugaletta v. Calixto Garcia, D.O.Janelle Brugaletta v. Calixto Garcia, D.O.
Anthony Cocca argued the cause for appellant (Bubb, Grogan & Cocca, LLP, attorneys; Mr. Cocca, of counsel and on the briefs; Katelyn E. Cutinello, on the briefs).
Ernest P. Fronzuto argued the cause for respondent (Fronzuto Law Group, attorneys; Mr. Fronzuto and Casey Anne Cordes, on the
The opinion of the court was delivered by
OSTRER, J.A.D.
This medical malpractice case involves the Patient Safety Act (the Act),
By leave granted, Chilton appeals from the court‘s order. Chilton disputes the court‘s finding that Brugaletta suffered a SPAE and contends the court erred in compelling it to report the SPAE to the Department and Brugaletta. More importantly, Chilton argues the Act‘s absolute privilege over a self-critical analysis may not be pierced based on a failure to report a SPAE.
Rather, Chilton contends the privilege is conditioned solely on compliance with statutory and regulatory mandates governing the formation of a patient safety plan and related procedural requirements. See
We agree the privilege does not depend on compliance with the requirement to report a SPAE to the Department or the patient. We therefore reverse the trial court‘s order compelling partial release of a document revealing Chilton‘s privileged self-critical analysis. We also reverse the finding that there was a reportable SPAE because the finding lacked sufficient credible evidence in the record.
I.
In the underlying malpractice action, Brugaletta alleges she arrived at Chilton‘s emergency room on January 20, 2013, complaining of abdominal pain and a fever that had рersisted for seven days. A twenty-three-year-old college student, she also complained of bodyaches, weakness, and a cough “productive of . . . thick phlegm.” Her initial diagnosis was pneumonia. After she was admitted, she continued to complain of abdominal pain. A CT scan of her abdomen and pelvis was performed the day after she arrived at the hospital. It revealed a pelvic abscess that “most probably” resulted from a perforated appendix, аccording to one physician‘s report.
A large amount of purulent fluid2 was drained through the right ischial fossa.3 Although her abdominal symptoms soon improved, she developed fasciitis4 in the right thigh and right buttock muscle. One physician stated the fasciitis resulted from “the leakage of the drainage around the [ischial] nerve.” Beginning January 23,
February 13, 2013, she was still suffering from severe pain; she was instructed to use a walker or a person to assist her; and she was prescribed pain medication and intravenous antibiotics for administration at home.
In her initial complaint, Brugaletta alleged that Chilton and various providers negligently diagnosed and treated her condition. In particular, she highlighted the delay in diagnosing her “ruptured appendix and pelvic abscess.” In her first amended complaint, she added that physicians negligently failed to detect a second abscess on her CT imaging.
In response to Brugaletta‘s discovery demands, Chilton identified but withheld as privileged the document at issue in this case. Described as an “Event Detail History with all Tasks,” Chilton asserted it was privileged pursuant to the Act and implementing regulations, as well as other grounds.7 Brugaletta sought to compel production, initially seeking the court‘s in camera review. Chilton opposed and sought a prоtective order. In support, Chilton submitted the certification of Ebube Bakosi, M.D. the then-current chair of
Chilton‘s Preventable Events Review Committee (PERC), formerly known as the Patient Safety Committee.
The trial court ordered the document‘s production for in camera review. The court also permitted Chilton to file an ex parte brief to present document-specific arguments against disclosure. Upon review, the court found that Chilton prepared the document, which the court marked as DCP-2, in accordance with the procedural requirements of the Act and implementing regulations. However, the court concluded that the document revealed that Brugaletta had suffered a separate SPAE and Chilton failed to report that SPAE to the Department or disclose to Brugaletta.8
The court determined that when a hospital fails to report a SPAE to the Department or a patient, the court is empowered to compel it to do so. The court also concluded if the hospital‘s reporting failure was arbitrary or capricious, then the hospital shall lose its privilege under the Act. The court held that when the hospital has erred in failing to report without acting arbitrarily or capriciously, then a lesser remedy is appropriate. Applying those
Chilton made a “clear error in judgment,” but did not act arbitrarily or capriciously. The court concluded under those circumstances it was appropriate to release only the portion of DCP-2 that described the SPAE, while redacting the balance. Nonetheless, the portion to be disclosed still revealed aspects of Chilton‘s self-critical analysis.
This appeal followed. Chilton contends the court erred in compelling it to disclose DCP-2, albeit redacted. Chilton argues that the court lacked authority to review its determination that no SPAE occurred and to compel reporting; and, in any event, neither the Act nor the implementing regulаtions authorize the partial or total loss of the privilege when a hospital fails to report a SPAE when required. Brugaletta argues the trial court did not err, and its order promotes compliance with the Act‘s reporting mandate.9
II.
We review the trial court‘s discovery decision for an abuse of discretion, but we shall not defer to the trial court‘s decision if “based on a mistaken understanding of the applicable law.” C.A. ex rel Applegrad v. Bentolila, 219 N.J. 449, 459 (2014) (internal quotation marks and citation omitted). We review legal issues de novo, including the trial court‘s interpretation of the Act. Ibid.
In interpreting the Act and effectuating the Legislature‘s intent, we look first to the plain language, reading it as an integrated whole. Id. at 459-60. “If the plain language is clear, the court‘s task is complete.” In re Kollman, 210 N.J. 557, 568 (2012). If it is unclear or ambiguous, we may resort to extrinsic aids. Ibid. “It is not the function of [a] [c]ourt to ‘rewrite a plainly-written enactment of the
(continued) was entitled to access Chilton‘s ex parte brief, the hearing transcripts “placed on a sealed record,” and the judge‘s sealed statement of reasons for its order.
We also decline both parties’ request that we endorse the trial court‘s procedural measures for protecting the document‘s confidentiality during its proceedings pending our review. The court‘s thoughtfulness is evident. We also appreciate the parties’ desire for guidance. However, this aspect of the matter is not disputed. It also is conceivable that in another cаse and setting, a trial judge‘s exercise of discretion might call for different measures. We therefore believe it is inappropriate for us to reach the issue.
Legislature []or presume that the Legislature intended something other than that expressed by way of the plain language.‘” DiProspero v. Penn, 183 N.J. 477, 492 (2005) (quoting O‘Connell v. State, 171 N.J. 484, 488 (2002)). We respect, although we are not bound by, an agency‘s statutory interpretation embodied in its regulations. See Hargrove v. Sleepy‘s, L.L.C., 220 N.J. 289, 301-02 (2015); see also Mayflower Sec. Co. v. Bureau of Sec., 64 N.J. 85, 93 (1972) (stating an appellate court is “in no way bound by the agency‘s interpretation of a statute“).
In this case, we do not write on a clean slate. The Supreme Court in C.A. reviewed
We focus on distinct obligations the Act imposes on a hospital: self-critical analysis and reporting. With respect to self-critical analysis, a hospital must create a safety plan establishing a dedicated patient safety committee.
obligation involves two recipients: regulators and patients. See
The definition of a “serious preventable adverse event” is gleaned from the definitions of its constituent terms. An “adverse event” is “a negative consequence of care that results in unintended injury or illness.”
To encourage compliance with the two obligations — self critical analysis and reporting — the Act creates a privilege. “The Act attaches a privilege to specific information generated by health carе facilities in two distinct processes: the reporting of adverse events to regulators [and patients], and the investigative process that may or may not lead to such
reporting.” C.A., supra, 219 N.J. at 467. This evidentiary privilege is broad: The covered items “shall not be . . . subject to discovery or admissible as evidence or otherwise disclosed in any civil, criminal, or administrative action or proceeding . . . .”
The Act separately defines the privilege over reports depending on their potential recipient. With respect to reporting to regulators,
At issue in this case is the privilege over self-critical analysis. In addition to creating a privilege over SPAE reports to patients, subsection (g) extends a privilege to “[a]ny
documents, materials, or information developed by a health care facility as part of a process of self-critical analysis
Thus, the only statutory precondition of this self-critical analysis privilege is compliance with subsection (b), pertaining to safety plans. The plain language of subsection (g) does not condition the privilege over self-critical analysis on compliance with the reporting obligation. In other words, so long as the self-critical analysis is conducted according to the proper procedures as set forth in the hospitаl‘s safety plan, it is protected.
Although the regulations clarify preconditions of the privilege, they do not vary our conclusion that the privilege over a self-critical analysis exists independent of compliance with the reporting obligation. Specifically,
materials, and information (including RCAs [root cause analyses] and minutes of meetings) developed by a health care facility exclusively during the process of self-critical analysis, in accordance with
The fact that the privilege is conditioned upon procedural (and not substantive) concerns is further established by an examination of the regulations cited by subsection 10.9(b). The first оf the three cited regulations,
We recognize that the third,
depends on reporting SPAEs to the Department. Notably, subsection 10.6(l) addresses the required contents of a root cause analysis. We presume the reference in subsection 10.9(b) to a self-critical analysis performed in accordance with section 10.6 was intended to require compliance with subsection 10.6(l).
In short, the relevance of the three regulations, including section 10.6, is their impact on the manner in which self critical analyses are performed. They elaborate the “process of self-critical analysis” cited in subsection 10.9(b).
Furthermore, were reporting SPAEs a condition of the self critical analysis privilege,
In C.A., the Court upheld a hospital‘s assertion of the self-critical analysis privilege over a document pertaining to a child born with anoxic brain injury. C.A., supra, 219 N.J. at 452-54. The Court held that the hospital complied with the
Act‘s broad prerequisites set forth in
The Court expressly rejected a connection between complying with the reporting obligation and the self-critical analysis privilege. The hospital had decided that the treatment did not result in a SPAE. Id. at 471. Significantly, our court found that decision “debatable,” and concluded the newborn suffered a “potential” SPAE, and thе hospital should have referred the matter to its patient safety committee to determine whether it was reportable. C.A. ex rel Applegrad v. Bentolila, 428 N.J. Super. 115, 153-54 (App. Div. 2012), rev‘d, 219 N.J. 449 (2014). But the Supreme Court responded:
Contrary to the suggestion of the Appellate Division panel, the Hospital‘s conclusion that the event was not reportable does not abrogate the statutory privilege. Nothing in
N.J.S.A. 26:2H-12.25(g) limits the privilege to settings in which the incident is ultimately determined to be subject to mandatory reporting underN.J.S.A. 26:2H-12.25(c) . The Patient Safety Act‘s privilege is not constrained to cases in which the deliberative process concludes with a determination that the case is reportable underN.J.S.A. 26:2H-12.25(c) .
[C.A., supra, 219 N.J. at 471 n.14.]
In Conn, we emphasized the dichotomy between the two obligations — reporting and self-critical analysis — and the accompanying privileges. At issue was the privilege under
Finally, we note that predicating the self-critical analysis privilege on complying with the SPAE reporting obligation could lead to a result that we doubt the Legislature intended. We have in mind cases where a hosрital denied that a serious adverse event was preventable. In general, the proponent of an evidentiary privilege must establish the prerequisites of the privilege. See Horon Holding Corp. v. McKenzie, 341 N.J. Super. 117, 125 (App. Div. 2001) (applying attorney-client privilege). Thus, to assert the self-critical
analysis privilege, the hospital would have to prove a serious adverse result was not preventable if it did not report it. The proofs would likely overlap with those relevant to the alleged negligence in the underlying casе. We doubt the Legislature contemplated that a court would need to conduct such a mini-trial in which the burdens are reversed in order to recognize the self-critical analysis privilege.
III.
We must still consider whether the trial court erred in (1) determining that Chilton violated its reporting obligation, and (2) compelling it to report to the Department and Brugaletta. The court predicated its order on its finding that Brugaletta suffered a SPAE. We conclude that the finding lacked support of sufficient evidence in the record. See Rova Farms Resort, Inc. v. Investors Ins. Co. of Am., 65 N.J. 474, 484 (1974). We therefore reverse the trial court‘s order compelling Chilton to report.11
We may presume for purposes of our analysis that Brugaletta suffered an “adverse event” consisting of the fasciitis of her right lower extremity, which was a “negative consequenсe of care that result[ed] in unintended injury or illness . . . .” See
But the trial court did not identify record evidence for the conclusion that this was a “preventable event” — that is, it “could have been anticipated and prepared against, but occur[red] because of an error or other system failure.” See
(continued) report it. Second, we do not address whether a plaintiff has a private right of action to compel a hospital to fulfill its reporting obligation, particularly as it relates to reporting to regulators. See R.J. Gaydos Ins. Agency, Inc. v. Nat‘l Consumer Ins. Co., 168 N.J. 255, 271, 272 (2001) (noting that we have “been reluctant to infer a statutory private right of action where the Legislature has not expressly provided for such action” and setting forth a test for ascertaining whether a private right of action is implied). In this regard, we note the Depаrtment is empowered to enforce the reporting requirement by imposing penalties up to $100,000 on non-compliant general hospitals.
The evidence does not support a finding that the causation element was satisfied. The record clearly supports the trial judge‘s finding there was an error in Brugaletta‘s care. We may assume for argument‘s sake that the error could be “anticipated and prepared against.” However, the trial court does not rely on an expert opinion to conclude that Brugaletta‘s serious adverse event occurred “because of” that error. Under the facts of this case, an expert opinion was essential. See Kelly v. Berlin, 300 N.J. Super. 256, 268 (App. Div. 1997) (“[I]n general, a jury
In sum, the trial court erred in compelling Chilton to: (1) disclose the redacted memorandum revealing its self-critical analysis, and (2) report an alleged SPAE to the Department and Brugaletta.
Reversed.
CLERK OF THE APPELLATE DIVISION