Statement of Principles concerning pericarditis (Reasonable Hypothesis) (No. 90 of 2023)

The central concept is the “reasonable hypothesis” standard, which is lower than proof on the balance of probabilities but higher than mere possibility. Under s 120A of the VEA, the Authority determines SoPs that set out the factors that must exist to raise such a hypothesis. This SoP defines pericarditis as an inflammation of the pericardium, including acute pericarditis, chronic pericarditis, recurrent pericarditis, and constrictive pericarditis, but excluding haemorrhage from pericardial injury without inflammation. The ICD‑10‑AM codes I30, I31.0, I31.1, I01.0, and I09.2 are listed for reference but the meaning is controlled by the definition in subsection 6(2), not by the codes. Death from pericarditis includes death contributed to by a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure, or cessation of brain function) that was contributed to by the pericarditis.

“Relevant service” is defined in the dictionary as operational service, peacekeeping service, hazardous service, or British nuclear test defence service under the VEA, or warlike or non‑warlike service under the MRCA. This determines the jurisdictional scope: only those who rendered such service can rely on the SoP.

The “factors that must exist” in section 8 are the core substantive concept. There are 34 separate factors, each with its own temporal or causal condition. Many involve a time window before clinical onset or clinical worsening (e.g., open heart surgery within 20 years, cardiac ablation within 4 weeks, COVID‑19 vaccine within 4 weeks). Others require the factor to exist “at the time of” clinical onset or worsening (e.g., a peptic ulcer that erodes the pericardium, a systemic inflammatory disease, a malignant neoplasm). Asbestos‑related factors (32 and 33) include cumulative exposure thresholds: 1,000 hours in an enclosed space or 3,000 hours in open environment, with a latency of at least five years. “Clinical worsening” is used throughout but section 9(2) restricts its application to material contribution to aggravation of pericarditis where the condition was suffered or contracted before or during (but did not arise out of) relevant service.

“Drug from the specified list” is a defined term that includes 39 categories of drugs, ranging from common ones like anticoagulants and penicillins to more specific ones like immune checkpoint inhibitors, tyrosine kinase inhibitors, and tumor necrosis factor alpha antagonists. The list is exhaustive. Factor 27 applies when the person is taking a drug from the specified list at the time of clinical onset or worsening. Factor 28 is a separate, narrower pathway for any drug not on the list that is individually associated with pericarditis, subject to a de‑challenge or rechallenge criterion and a minimum seven‑day exposure.

The instrument also defines “terminal event” and “MRCA” and “VEA” in the dictionary. These definitions are essential for interpreting the scope and application of the SoP.

The SoP directly affects veterans, members of the Peacekeeping Forces, and members of the Forces under the VEA, as well as members under the MRCA, who have rendered “relevant service” and who claim that their pericarditis or death from pericarditis is service‑related. More specifically, it applies to any person who makes a claim to which section 120A of the VEA or section 338 of the MRCA applies. That includes living persons suffering from pericarditis and the dependants or estate of a deceased person where death was contributed to by pericarditis. The instrument also indirectly affects claims handlers, delegates of the Repatriation Commission, and the Veterans’ Review Board and Administrative Appeals Tribunal, who must apply the SoP when deciding whether a reasonable hypothesis has been raised. Legal practitioners, advocates, and medical advisors assisting claimants must understand the 34 factors, their time windows, thresholds, and the definitions to build or challenge claims.

The practical effect is that only those claimants whose pericarditis can be causally linked to one of the listed factors and whose service involved exposure, treatment, or a condition that satisfies that factor will succeed. For example, a veteran who developed pericarditis within four weeks of receiving a COVID‑19 vaccine during service may have a path under factor 29. A veteran who had a myocardial infarction within four weeks of pericarditis onset and sustained that infarction during service may rely on factor 18. Conversely, a veteran whose pericarditis has an idiopathic or purely genetic cause unrelated to any listed factor will not be able to raise a reasonable hypothesis, even if the condition is severe and service was arduous. The asbestos exposure factors (32, 33) will affect veterans who had documented, lengthy inhalation of asbestos fibres in enclosed spaces or open environments during service, but the high hour thresholds (1,000 enclosed, 3,000 open) may exclude those with less exposure. The drug list covers a wide array of medications, so veterans who were prescribed any of those drugs for service‑related conditions may have a claim, but they must establish the drug was taken at the time of onset. Claimants whose pericarditis worsened after service due to inability to obtain appropriate clinical management (factor 34) are also affected, though this factor is limited to clinical worsening, not initial onset.

The SoP does not affect civilians, members who rendered peacetime service not falling within the “relevant service” definition, or claimants under other compensation schemes such as the Safety, Rehabilitation and Compensation Act 1988 unless those schemes adopt the SoP by reference.

The SoP imposes an evidentiary duty on the claimant to demonstrate that at least one of the factors in section 8 exists, and that the factor is related to their relevant service (section 9(1)). This is not a duty in the sense of an obligation to act, but rather a precondition to raising the reasonable hypothesis. The claimant has the right to rely on any factor that fits their medical history and service record. The decision-maker (the Repatriation Commission or delegate) has a corresponding duty to consider each factor that is raised by the evidence, or that might be reasonably suggested by the material, and to apply the exact terms of the SoP.

A key structural right is the ability to rely on clinical worsening under section 9(2). For a person whose pericarditis was suffered or contracted before or during relevant service but did not arise out of that service, they may still claim that the condition was materially contributed to or aggravated by a factor during service. The factors that apply to “clinical worsening” include all those listed in section 8, but only to the extent that the factor occurred before the worsening. This is a significant right for those who entered service with pre‑existing pericarditis or who developed it early in service from a non‑service cause and then experienced deterioration from a service‑related factor.

The interaction provision in section 10 imposes a duty to look beyond this SoP when a factor refers to another injury or disease covered by a separate SoP. For example, factor 11 (tuberculosis) triggers the application of the SoP for tuberculosis as in force from time to time. This means the claimant must also satisfy the factors in that other SoP to establish the tuberculosis itself is service‑related. This creates a cascading evidentiary burden and is a common source of complexity in practice.

Claimants do not have a right to have a factor recognised if the medical evidence does not meet the temporal or causal conditions. The SoP sets hard time limits: open heart surgery within 20 years, cardiac ablation within 4 weeks, smallpox vaccine within 4 weeks, etc. Missing these windows by even a day will defeat reliance on that factor, absent some other factor. Similarly, the asbestos cumulation thresholds are absolute: less than 1,000 hours in an enclosed space will not suffice, even if exposure was heavy but brief. These rigid thresholds are a matter of duty for the decision-maker to enforce, not a matter of discretion.

The dictionary definition of “terminal event” creates a right for the estate of a deceased person to claim death from pericarditis if the pericarditis contributed to any of the five listed terminal events, even if the immediate cause of death was pneumonia or cardiac arrest. This broadens the scope for death claims.

This SoP does not itself impose penalties. It is a rule for determining entitlement to compensation, not a regulatory or criminal instrument. However, enforcement mechanisms operate indirectly. A false or misleading statement made in support of a claim could attract penalties under the Criminal Code or the VEA itself, but that is not a function of this SoP. The primary enforcement mechanism is the administrative decision: if the decision-maker incorrectly applies the SoP and grants a claim that does not meet the factors, the decision may be reviewed and overturned, potentially leading to recovery of overpaid pension. If the decision-maker incorrectly refuses a claim by failing to consider a factor or misapplying a time limit, the claimant may seek merits review at the Veterans’ Review Board or appeal to the Administrative Appeals Tribunal and the Federal Court.

The Repatriation Medical Authority does not enforce compliance; it only determines the SoP. The Repatriation Commission enforces the correct application of the SoP through its internal processes. There are no monetary penalties in the instrument, but the consequences of non‑compliance for claimants are denial of benefits. For decision-makers, systematic misapplication can lead to adverse audit findings and reputational risk.

One could argue that the very structure of the SoP enforces a kind of discipline: by listing exhaustively the accepted causal pathways, it penalises claimants who cannot fit their case into one of the 34 boxes, regardless of the merits of their individual medical history. This is not a penalty in the punitive sense but a procedural bar. The prohibition against relying on factors not in the list is absolute; the decision-maker has no power to create new factors. That is the “penalty” of the rule: rigid adherence to the Authority’s view of sound medical‑scientific evidence.

The SoP is made under subsection 196B(2) of the Veterans’ Entitlements Act 1986, so it sits within the broader VEA framework. It applies to claims under section 120A of the VEA and section 338 of the MRCA. The SoP does not replace the underlying legislation; it supplements it by providing the medical‑scientific criteria for the reasonable hypothesis test. The VEA and MRCA already contain the substantive entitlement provisions, definitions of “service”, and the standard of proof. The SoP narrows what can constitute a reasonable hypothesis for pericarditis.

Section 10 of the instrument explicitly incorporates other Statements of Principles by reference. If a factor in section 8 refers to an injury or disease for which a SoP has been determined under subsection 196B(2) of the VEA, that SoP applies as in force from time to time. This means the SoP interacts dynamically with the entire corpus of RMA determinations. For example, factor 11 (tuberculosis) requires the claimant to satisfy the SoP for tuberculosis. This creates a chain: to establish pericarditis from tuberculosis, the claimant must first show that the tuberculosis itself is service‑related per its own SoP. Similarly, factor 15 (vasculitides) references seven specific conditions; many of those have their own SoPs. Factor 24 (sarcoidosis or amyloidosis) also likely triggers other SoPs.

The SoP also interacts with the common law and administrative law principles of review. While the SoP is a legislative instrument, its interpretation and application are subject to judicial review principles such as reasonableness and jurisdictional error. The Federal Court and the High Court have considered the operation of similar SoPs in cases such as Repatriation Commission v Gorton (2006) and Repatriation Commission v Bender (2010), though those cases are not cited in this instrument. The SoP does not override the requirement that the decision‑maker consider all the material, but it restricts which material can ground a reasonable hypothesis.

The instrument does not interact with state workers’ compensation schemes or private insurance, except indirectly: a veteran receiving a disability pension under the VEA or MRCA may have their private insurance benefits reduced or offset. The SoP itself contains no provision about offsets.

This instrument has no amendment history shown on its face. It is a standalone new determination. The SoP number (No. 90 of 2023) indicates it was one of many issued in 2023. It commenced on 28 November 2023. There is no indication that it replaces an earlier SoP for pericarditis; but by implication, any earlier SoP for the same condition would be superseded by this one, given the Authority determines SoPs that “must exist” and the instrument’s application provisions would override prior inconsistent determinations. However, the instrument does not expressly state that it revokes a previous instrument. It is possible that there was no previous SoP for pericarditis, and this is the first. Without the source saying otherwise, we cannot assert a replacement.

Future amendments may be made by the RMA under the same power. The note in section 10 that other SoPs apply “as in force from time to time” indicates that the RMA expects future changes to those other SoPs, but this SoP itself remains static until amended. Claimants and practitioners should check the Federal Register of Legislation for any subsequent amending instruments.

No litigation is reported in this instrument. The SoP has been in force only since late 2023, and at the time of writing there is no publicly accessible case law directly interpreting this specific instrument. However, there is a substantial body of case law on the reasonable hypothesis standard and the role of SoPs generally. The Federal Court and the Administrative Appeals Tribunal have repeatedly considered whether decision‑makers properly applied earlier SoPs for conditions like ischaemic heart disease, post‑traumatic stress disorder, and various cancers. Those principles will apply equally to this SoP. For example, the requirement that a factor “must exist” has been interpreted to mean the factor must be proved on the balance of probabilities, not merely hypothesised. See Repatriation Commission v Bey (1997) 79 FCR 364, where the Full Federal Court held that the existence of a factor is a question of fact to be determined on the balance of probabilities. That principle would apply here: to rely on factor 10 (systemic viral infection within 4 weeks), the veteran must prove on the balance of probabilities that the infection occurred within that window.

The interaction provision in section 10 may also generate litigation if a claimant argues that the other SoP has been incorrectly applied. The concept of “clinical worsening” in section 9(2) has also been litigated: in Repatriation Commission v Hatton (2003) 76 ALD 668, the Full Federal Court considered the meaning of material contribution to aggravation.

Several features of this SoP are traps for the unwary. First, the exclusions: pericarditis does not include haemorrhage from pericardial injury not associated with pericardial inflammation (s 6(2)(c)). A claimant with haemorrhagic pericardial effusion after chest trauma without inflammation will not fall within the definition, even if they have significant symptoms. The ICD‑10‑AM codes are merely referential; the clinical definition controls.

Second, the time windows are rigid and short for some factors. Factor 3 (cardiac ablation): 4 weeks. Factor 10 (systemic viral infection): 4 weeks. Factor 18 (myocardial infarction): 4 weeks. Factor 29 (COVID‑19 vaccine): 4 weeks. Factor 30 (smallpox vaccine): 4 weeks. If the onset is just outside that window, the factor is unavailable, even if a longer latency is plausible. Factor 1 (open heart surgery) and factor 2 (pacemaker/defibrillator lead insertion) allow 20 years, but factor 5 (trauma) also allows 20 years. Claimants must have precise dates.

Third, the asbestos exposure thresholds are very high: 1,000 hours in an enclosed space, 3,000 hours in open environment, and a five‑year latency. A veteran who served for three years in a building where asbestos was present but not constantly disturbed will struggle to meet the hour threshold. The note about disturbance of dust or debris adds flexibility but does not reduce the hour requirement.

Fourth, the drug list is exhaustive. Factor 27 applies only if the drug is on the specified list. Factor 28 is an alternative but requires a de‑challenge/rechallenge observation and at least 7 days of therapy before onset. That is difficult to satisfy in many cases. Many common drugs like NSAIDs (except those derived from phenylbutazone) are not listed. A claimant whose pericarditis is caused by a drug not on the list will have no factor unless factor 28 can be proven.

Fifth, factor 34 (inability to obtain appropriate clinical management) applies only to clinical worsening, not initial onset. It also imposes a requirement that the inability be for a reason related to service (e.g., posting to a location without adequate medical facilities). This is a high bar and is rarely successful.

Sixth, the “clinical worsening” provisions in section 9(2) only apply if the pericarditis was suffered or contracted before or during relevant service but did not arise out of that service. If the pericarditis arose out of service, the claim is for the initial onset, not worsening. Claimants must carefully separate the two.

Seventh, the interaction with other SoPs (section 10) can create an infinite regress if the other SoP itself refers to further SoPs. Claimants must ensure they meet all downstream factors.

Eighth, the definition of “relevant service” excludes peacetime service under the VEA that is not operational, peacekeeping, hazardous, or British nuclear test defence service. A veteran who served only in Australia during peacetime and developed pericarditis after a routine vaccination not on the specified list may have no path.

For a claimant wanting to establish a reasonable hypothesis connecting pericarditis to relevant service, the first step is to obtain a precise diagnosis of pericarditis confirming inflammation of the pericardium and excluding haemorrhage without inflammation. The diagnosis should be supported by clinical records, ECG, echocardiogram, or other imaging. If the claimant died, the death certificate or coroner’s report should show pericarditis and a terminal event from the dictionary.

Next, identify all potential factors from section 8 that could apply. Each factor requires evidence of a specific event, condition, exposure, or treatment that is temporally linked to the clinical onset or worsening of pericarditis. The claimant should gather documentation:

• For surgical factors (1, 2, 3): hospital records, operative reports, dates.
• For trauma (5, 6): medical records of the injury, including electrical injury.
• For infections (9, 10, 11, 12): laboratory results, microbiology reports, dates of positive tests.
• For vaccinations (29, 30): immunisation records.
• For asbestos (32, 33): employment or service records showing dates, locations, and duration of exposure; roster records; safety reports; witness statements. The cumulative hours must be calculated precisely; a logbook or diary may help.
• For drugs (27, 28): prescription records, medication charts, pharmacy records showing the drug, dosage, and dates of therapy. For factor 28, clinical notes showing improvement on cessation or recurrence on rechallenge.
• For systemic diseases (13-26): specialist reports confirming the diagnosis (e.g., rheumatologist for vasculitis or inflammatory bowel disease; cardiologist for myocarditis).

All factors must be related to relevant service. The claimant must show that the factor occurred during or as a consequence of their service. For example, open heart surgery may have been performed at a military hospital, or the drug may have been prescribed for a service‑related condition. The causal link between the factor and service is separate from the link between the factor and pericarditis - the factor itself must be service‑related, not just the pericarditis.

If the pericarditis was pre‑existing (contracted before or during service but not arising out of service), the claimant must focus on clinical worsening. They need evidence of a clear worsening of symptoms or objective findings after the service‑related factor. Baseline tests before the factor and after are critical.

Practitioners should also check whether any of the factors refer to another injury or disease that has its own SoP (e.g., factor 11 tuberculosis, factor 15 vasculitides, factor 24 sarcoidosis). Those downstream SoPs must be satisfied. That may require separate evidence gathering for the underlying condition.

If the claimant cannot meet any factor, they may consider whether the pericarditis is a manifestation of another condition that is itself covered by a SoP (e.g., lupus or post‑cardiac injury syndrome). The decision‑maker must consider all medical evidence, but the SoP is a gate: without a factor, no reasonable hypothesis.

Document all evidence clearly, summarise which factor is relied upon, and address the temporal windows explicitly. For example: “The veteran received a COVID‑19 vaccine on 1 March 2023 and developed pericarditis on 20 March 2023, which is within 4 weeks (28 days), thereby satisfying factor 29.” Avoid vague claims.

Finally, if the claim is refused, the decision statement will identify which factor was not satisfied. The claimant can then seek review and provide further evidence addressing that gap.