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Must Doctors Refer for Services They Oppose?

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Ontario’s highest court has ruled that doctors there must provide referrals to patients for services they oppose on moral or religious grounds.

Recently the Ontario Court of Appeal upheld a lower court judgment requiring doctors to comply with the “effective referral requirement” of the province’s College of Physicians and Surgeons. An effective referral requires the doctor to make an effort to connect their patient with another willing, available, and accessible health care provider if they oppose the treatment or service the patient seeks. They are not required to make a formal referral by providing a letter and arranging an appointment with another physician, except in an emergency where it is necessary to prevent imminent harm to a patient. Rather, the physician can ask staff to handle the referral. Alternatively, the court suggested that physicians could choose to specialize in a type of medicine where the issue of referrals for treatments they oppose is less frequent.

The intent of the College’s effective referral policy is to ensure that patients are not left to find a willing physician on their own without any assistance from the physician from whom they first sought care. A group of individual physicians and organizations argued that the policy infringes on their freedom of religion and challenged its constitutionality. They believe that the effective referral requirements would make them complicit in performing the procedures that they oppose.

The medical procedures objected to include abortion, contraception, infertility treatment, prescription of erectile dysfunction medication, gender re-assignment surgery, and medical assistance in dying. As noted by the court, these are often the most private, emotional, and challenging issues for patients to raise and discuss, even with a trusted family physician. As well, some of these decisions frequently confront already vulnerable patients:  those with financial, social, educational or emotional challenges; those who are young, old, poor, or addicted to drugs; those with mental health challenges or physical or mental disabilities; those facing economic, linguistic, cultural or geographic barriers; and those who do not have the skills, abilities, or resources to navigate their way through a complicated health care system. Family physicians fulfill the important role as “gatekeepers” and “patient navigators” for health care services. Further, decisions concerning many of these procedures are time-sensitive. A delay in accessing these procedures due to the absence of a referral can prevent access to them altogether.

The court stated that the effective referral policy is a compromise between rights of physicians and interests of patients, but ultimately found that patients should not bear the consequences of physicians’ religious objections. The nature of the physician-patient relationship requires physicians to act at all times in the best interests of their patients and to avoid conflicts between their own interests and their patients’ interests. The court found that the “general information” model proposed by the doctors opposing the policy (in which doctors would provide information or resources, but the patient would assume the responsibility for finding a non-objecting physician) would not meet the needs of most patients seeking personal and urgent medical advice and care, as few procedures can be accessed without a referral from a physician. In smaller, non-urban settings, patients may have additional difficulty in identifying a non-objecting physician given the more limited range of providers.

The court noted that while the effective referral policy of the Ontario College is not a perfect one for all physicians, it is not a perfect one for their patients either: they will lose the personal support of their physicians at a time when they are most vulnerable. The court found, however, that the College’s policy represented the best compromise possible between both sides with the goal of promoting equitable access to health care.

The British Columbia College of Physicians and Surgeons agrees that patient well-being is the single most important factor in ensuring an effective referral consultation process. The BC College, however, does not go as far as Ontario in requiring an effective referral. While physicians may make a personal choice not to provide a treatment or procedure based on their values and beliefs, the BC College only expects them to provide patients with enough information and assistance to allow them to make informed choices for themselves. This includes advising patients that other physicians may be able to see them, or suggesting that the patient visit an alternate health care provider. Where needed, physicians must offer assistance and must not abandon the patient, and must always treat the patient with dignity and respect. The College states that physicians in these situations should not discuss in detail their personal beliefs if not directly relevant and should not pressure patients to disclose or justify their own beliefs. In all cases, physicians must practice within the confines of the legal system and provide compassionate, non-judgmental care. Physicians are not obliged to see all patients, but they are required to treat those in need of emergent or urgent medical care.

*image courtesy of University Health News – universityhealthnews.com

Standard of Proof in Civil Trials

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In two recent US trials, juries found that the plaintiffs’ cancer was caused by exposure to certain common chemicals. In August, a California jury ruled that the plaintiff’s non-Hodgkin’s lymphoma was caused by his exposure to glyphosate, a popular herbicide sold under the name “Roundup,” and ordered Monsanto, the manufacturer of the product, to pay $289 million US in damages.  In July, a Missouri jury found in a class action involving 22 women, that talcum powder manufactured by Johnson & Johnson caused ovarian cancer, and awarded the plaintiffs $4.7 billion US in damages.

Conclusive links between cancer and these products has not been established by scientists, and Canadian health regulators, as well as regulators in governments throughout the world, still permit the use of both products. How could a jury find that these products caused cancer in the absence of scientific proof?

Burden of Proof

A plaintiff in a civil trial, including a medical malpractice action, must establish their case on a balance of probabilities. An essential element of the claim is causation, which is established when the plaintiff proves, on a balance of probabilities, that the defendant caused or contributed to the plaintiff’s injury. This is not a matter of determining the cause of the plaintiff’s injury with scientific certainty, nor does causation need to be established “beyond a reasonable doubt” as required in criminal cases. A plaintiff must convince a judge or jury that, more likely than not, the defendant caused his or her injuries. As a result, the standard of proof in civil cases is lower than both the scientific and criminal standard.

Competing Scientific Theories

Often in civil trials, both the plaintiff and defendant present scientific and expert evidence that offers competing theories as to the cause of the plaintiff’s injuries. It is then up to the judge or jury to weigh the conflicting evidence and decide which evidence to believe and how much weight to place on it. A judge or jury may make a finding of causation in favor of the plaintiff in the face of evidence to the contrary if they believe the plaintiff’s evidence was stronger. In the cases mentioned above, lawyers on both sides challenged the scientific methods used and suggested potential for conflicts of interest among the researchers. However, in both of these cases, the juries were free to decide which science and which experts to believe, and found that the plaintiffs had met the standard required in civil cases and had established that the defendants’ products had caused their cancer.

Going Forward

Definitive scientific answers to questions about cancer risks from widely used chemicals is unlikely as it is unethical to conduct experiments deliberately exposing people to chemicals to determine if they develop cancer. Therefore, there will always be the possibility that an individual developed cancer due to another cause. Monsanto has stated they plan to appeal the California court’s decision, stating that glyphosate does not cause cancer and that they will continue to defend the product as safe and an essential tool for farmers.  Johnson & Johnson has indicated their plans to appeal the verdict to defend the safety of Johnson’s Baby Powder.

While it is essential that medical experts provide a firm opinion supporting the plaintiff’s theory of causation, medical or scientific experts ordinarily determine causation in terms of certainties whereas a lesser standard is required in civil cases. Therefore, a plaintiff can succeed in a lawsuit if they can prove that it is “more likely than not” that the defendant caused their injuries.

It remains to be seen if these verdicts will be upheld on appeal.

The Role of Genetics in Birth Injury Claims 

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Proving that a defendant’s actions caused or contributed to the plaintiff’s injuries is an essential component of any medical negligence claim. In claims surrounding birth injuries, this often means proving that the defendant physician’s or nurse’s actions (or inactions) lead to oxygen deprivation around the time of birth, which resulted in a hypoxic-ischemic brain injury and its resultant consequences for the plaintiff.

While it has long been known that oxygen deprivation around the time of birth can cause cerebral palsy, it has long been argued that only a minority of cases of cerebral palsy are due to hypoxic injuries at or around the time of birth. Rather, the defence argues, the injury must have occurred much earlier in the pregnancy and that earlier delivery during labour would not have prevented the injury. More recently, as the science of genetics has advanced, it is sometimes suggested that the cause of the child’s problems may be due to genetic abnormalities rather than any difficulties encountered during labour. In this article, we examine the current medical understanding of the role of genetics in neurodevelopmental disorders, and how Canadian courts have approached the defence of genetic predisposition in birth injury claims.

Our Current Understanding of Neurodevelopmental Disorders

Cerebral palsy (CP) is a term used to describe a group of non-progressive disorders affecting body movement and muscle coordination. The condition affects 1 out of every 500 children in Canada. While prematurity, hypoxia-ischemia, placental insufficiency, and prenatal infection are well-recognized causes of CP, up to one-third of children who develop CP lack these typical risk factors, leading researchers to suspect a genetic component to the disorder.

There are multiple types of genetic alterations that contribute to human genetic variability, many of which are not yet fully understood. Copy number variants (CNVs) are a type of structural variants involving alterations in the number of copies of specific regions of DNA that can be either duplicated or deleted. The role of CNVs is recognized in the clinical manifestations of a growing list of neurodevelopmental conditions, including attention-deficit hyperactivity disorder (ADHD), autism spectrum disorder, and severe intellectual disability. Similarly, recent studies have suggested that large chromosomal abnormalities may be involved in the development of cerebral palsy.2

Genetic research has the potential to provide a framework for understanding neurobiological pathways that, through genetic mutations, may lead to neurodevelopmental disorders. For ex- ample, recent research on autism spectrum disorder suggests that individually rare genetic mutations collectively are associated with a relatively common disorder. No specific brain region or cell type has been implicated, but genetic risk factors are recognized. The evidence suggests that autism is not a single disease, but a number of etiological distinct conditions with diverse pathophysiological mechanisms that manifest into similar behavioural patterns.3

Similarly, studies have indicated there is no single genetic mutation leading to CP, but hundreds of individual genes that may, in certain circumstances, contribute to a diagnosis of CP. Several genes mapping to intersecting pathways controlling neurodevelopment and neuronal connectivity have been identified, but like other neurodevelopmental disorders, the underlying genetics of CP is likely to be highly complex.4 Indeed, current medical science has not identified a clear underlying genetic cause of CP, evidenced by the fact that routine genetic studies are not yet recommended in the diagnostic assessment of children with CP, especially in children where other risk factors are identified.5 The mere existence of a genetic mutation does not add very much to the identification of a genetic cause for CP. The effects of a given genetic mutation can vary based on the nature of the mutation, the presence of environmental insults, and the context in which a mutation occurs. For example, a severely deleterious mutation may lead to a major effect, whereas a less damaging mutation that does not disrupt protein function as profoundly may lead to a smaller effect. Many mutations are known to have no effect on function at all. As a result, some mutations may be sufficient to cause a disorder by themselves. In other cases, a less damaging mutation which renders an individual more susceptible to a given disorder, coupled with an environmental insult such as ischemia, may be required to produce a neurodevelopmental disorder. Similarly, a single mutation may not lead to a diagnosis, but the cumulative effect of several less deleterious mutations acting together may lead to the disorder.6

Genetic variation can be protective or deleterious in a given situation. Many clinicians have cared for infants who have suffered apparently severe insults but have relatively good long-term outcomes. The converse is also true – many infants who do not show indications of having suffered severe insults have poorer outcomes that expected. These scenarios are also encountered in animal models of CP, suggesting the existence of genetic modifiers that may influence the extent of injury and eventual motor outcome.7

Susceptibility vs. Causation

The test for causation in negligence claims was set out by the Supreme Court of Canada in Clements (Litigation Guardian of )

  1. Clements:

The plaintiff must show on a balance of probabilities that “but for” the defendant’s negligent act, the injury would not have occurred. Inherent in the phrase “but for” is the requirement that the defendant’s negligence was necessary to bring about the injury – in other words that the injury would not have occurred without the defendant’s negligence. This is a factual inquiry. If the plaintiff does not establish this on a balance of probabilities, having regard to all the evidence, her action against the defendant fails.8

It is not necessary to prove that the defendant’s actions were the sole cause of the plaintiff’s injury. The law does not excuse a defendant from liability merely because other causal factors for which he is not responsible also helped produce the harm. It is sufficient to show that the defendant’s negligence was a cause of the harm.9

Applying this reasoning to the role of genetics in birth injury claims, if, for example, a defendant could show that the plaintiff had DNA variants that could render him or her more susceptible to thrombosis, hemorrhage, or ischemia (and therefore more susceptible to brain injury resulting in a neurodevelopmental disorder), this would not absolve the defendant of liability. An underlying genetic susceptibility would essentially render the plaintiff a “thin skull.” If the defendant’s negligence was still a necessary contributing factor to the plaintiff’s injury, without which injury would not have occurred, the defendant would still be liable for the entirety of the plaintiff’s injuries, even if they were unexpectedly severe owing to genetic susceptibility. As an example, genetic susceptibility could play a role in the case of a baby who experiences and unexpectedly poor outcome following an apparently minor insult, however this should not absolve from liability a physician or nurse who was negligent in their care. A tortfeasor must take his or her victim as he or she finds them and is therefore liable even though the plaintiff’s losses are more dramatic than expected.

If, however, a defendant can prove that the plaintiff suffered from a severe single-gene mutation that would lead to their neurodevelopmental disorder on its own, that may essentially render the plaintiff a “crumbling skull” – the defendant would not be liable for the plaintiff’s condition if the plaintiff would have suffered the same outcome in any event.

Genetic Defences in Canadian Courts

In Allen v. University Hospitals Board, 2000 ABQB 509, the infant plaintiff alleged that her injuries were due to the negligence of the defendants which exposed her to neurological damage due to lack of oxygen during labour and delivery. The plaintiff alleged that she had suffered perinatal asphyxia, that there were no clinical findings to support an underlying genetic cause of the plaintiff’s condition, and that her autistic features were likely a secondary finding to her brain injury. The defendant’s position was that if there were intermittent interruptions in oxygenation, these were not sufficient to cause the plaintiff’s injury, and her condition could be accounted for by a genetic cause.

The court observed that the infant plaintiff displayed symptoms that were hard to categorize – it was unclear if they were symptoms of autism or were the result of some other neurological cause. The court found that while the infant plaintiff exhibited autistic features, the evidence supported the plaintiff’s theory that this was the result of neurological damage caused by birth asphyxia due to the defendants’ negligence. While in hospital following her birth, a host of tests were performed in an attempt to determine the cause of the plaintiff’s problems, but no identifiable cause could be found except for birth asphyxia.

The court noted that while there was evidence to suggest that the infant plaintiff was autistic and therefore that the cause of her problems was genetic, such evidence, while relevant, had its weaknesses: the gene or genes that might be responsible for autism had not been specifically identified, and some of the studies referred to, such as those involving twins, had very small population bases from which genetic conclusions had been drawn. The court found that the conclusions drawn from these studies were really working hypotheses. In the end result, the court concluded that even if the infant plaintiff suffered from autism, and even if autism is genetically based, the negligence of the defendants materially contributed to her neurological problems and current situation. More recently in Butler v. Royal Victoria Hospital, 2017 ONSC 2792, the infant plaintiff alleged that she suffered a hypoxic-ischemic brain injury that resulted in cerebral palsy when the artificial rupture of membranes performed by the defendant nurses resulted in compression of her umbilical cord for approximately 25 minutes. The defendants admitted a breach of the standard of care; the issue before the court was whether this breach caused the plaintiff’s injuries.

While the defendants conceded that the artificial rupturing of the membranes caused the plaintiff’s cerebral palsy, they argued that the fact that she suffered asphyxia in the neonatal period did not establish that this event was responsible for all of the plaintiff’s current issues. The defence argument was that the plaintiff’s cognitive and behavioural deficits would have emerged absent the defendant’s negligence because of genetically inherited ADHD. The court found that the overwhelming evidence was that the infant plaintiff suffered a severe hypoxic-ischemic event at the time of birth – the constellation of signs and symptoms, including Apgar score, blood gasses, and seizures in the immediate post- partum period were entirely consistent with having suffered this serious event. The court noted that the defence genetics expert, while offering the court the possibility of genetic factors playing a role in the plaintiff’s attention problems, confirmed that he did not, and could not, know if the plaintiff would have developed her current symptoms due to a genetic cause, as this was simply beyond the realm of current scientific knowledge.

Various genetic testing performed on the plaintiff had returned essentially normal results, indicating that there was no identifiable genetic component to the plaintiff’s profile. The defence argued that the plaintiff’s refusal to have further genetic testing of her and her family complicated the causation question. The court concluded that the entire genetic theory advanced by the defendant must fail because it required not only an unacceptable degree of speculation on the part of the trier of fact, but also because it would require the plaintiffs to prove a negative: that genetic information which might emanate from more sophisticated testing would rule out a genetic cause for the plaintiff’s condition.

Further, based on Canadian causation law, it appears that even if genetic testing had indicated a possible susceptibility in the plaintiff for ADHD, this alone would not be enough for the defendants to escape liability if the hypoxic-ischemic event caused by their negligence was a necessary contributing factor to the development of the disorder.

Wrap Up

While there is currently evidence indicating that genetic mutations may play a role in some cases of CP, autism spectrum disorder, ADHD, and intellectual disability, it must be understood that even if a genetic basis for a plaintiff’s injuries is discovered, this does not absolve a defendant of liability if the genetic component simply increased the plaintiff’s susceptibility to injury and the defendant’s actions were still a necessary contributing factor to the development of the disorder.

Our insight into the role of genetics in cerebral palsy and other neurodevelopmental disorders is in its early stages. We can only expect genetics to play a more significant role in our understanding of the underlying causes of these disorders – and therefore in birth injury litigation – as medical science advances.

This piece was originally published in the Verdict. You can read the read the PDF  on our Publications page.

*Photo courtesy https://www.thinglink.com/scene/771524646372638721

  1. Fahey, M. et al. The genetic basis of cerebral palsy. Dev Med Child Neurol 2017; 59(5) 462-469.
  2. Oskoui, et al. Clinically relevant copy number variations detected in cerebral palsy. Nat Commun 2015; 6:7949.
  3. De la Torre-Ubieta, et al. Advancing the understanding of autism disease mechanisms through genetics. Nat Med 2016; 22: 345-61.
  4. Fahey, supra.
  5. Oskoui, supra.
  6. Fahey, supra.
  7. Ibid.
  8. 2012 SCC 32, [2012] 2 SCR 181, at para. 8.
  9. Athey v. Leonati, [1996] 3 SCR 458, [1996] SCJ no. 102, at para. 19.

Causation in Medical Malpractice Actions

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To win a medical malpractice law suit the plaintiff must prove two things:  that the health care providers did not meet the standard of care expected of them, and that the failure to meet the standard of care is what caused the plaintiff’s injuries.  This second element is called “causation.”  Causation is often the more difficult hurdle for the plaintiff to meet.  In the following article, Lindsay McGivern provides a description of how the courts view causation in complex medical malpractice claims.

The general principles of causation in medical malpractice claims have long been established. Medical malpractice actions are subject to the same requirements as other types of personal injury torts; the plaintiff must prove, on a balance of probabilities, that the defendant caused the injury. The generally applicable test is the “but for” test which requires the plaintiff to show that ‘“but for” the defendant’s negligent act, the injury would not have occurred.’1 The difficulty in medical malpractice claims arises from the complexity of proving cause and effect in a medical context. Proof of causation almost always requires expert evidence.

Compounding the difficulty of proving causation in medical malpractice claims is the difference between medical and legal causation. In the legal context, causation need only be established on a balance of probabilities. The ‘“but for” test is to be applied in a robust common-sense fashion.2 This robust and pragmatic approach to the causation analysis is applicable in cases where the defendant leads no evidence to the contrary and in cases involving conflicting evidence for the judge to weigh.3 Legal causation does not demand scientific precision or scientific evidence of the precise contribution the defendant’s negligence made to the injury.4 It is “essentially a practical question of fact which can best be answered by ordinary common sense”.5 Although the burden of proof remains with the plaintiff, in some circumstances a common sense inference of causation may be drawn from the evidence without positive scientific proof.6 In a medical context, causation is subject to stricter requirements. The conclusions that can be drawn from studies require a high level of precision to establish statistical significance. Cause and effect in medicine involves scientific proof. When medicine is an integral part of a legal claim, it is important to maintain a clear divide between these two understandings of causation. As was observed by Sopinka J. in Snell v Farrell:

“It is not therefore essential that medical experts provide a firm opinion supporting the [p]laintiff’s theory of causation. Medical experts ordinarily determine causation in terms of certainties whereas a lesser standard is demanded by the law.”7

Causation can Support a Legal Claim

In Goodman v Viljoen 8, this medical/ legal causation dynamic was central to the outcome of the case. It provides an excellent example of the different standards of proof in the medical and legal contexts. The case also illustrates how inferences of causation can support a legal claim despite a complex medical backdrop and medical uncertainty.

Mrs. Goodman was pregnant with twins when she developed a urinary infection for which she was prescribed antibiotics. The following week, Mrs. Goodman experienced a leakage of fluid and made a call to the office of her obstetrician, Dr. Viljoen. She never spoke directly with Dr. Viljoen but reported the fluid leakage to his secretary who subsequently called back to advise that this was related to her infection and that Mrs. Goodman should continue to take her antibiotics. Two days later, Mrs. Goodman went into premature labour. Upon attendance at hospital, her physician confirmed that her membranes had ruptured. Her twins were born at 29 weeks gestation via caesarean section. They subsequently developed cerebral palsy.

In order to succeed in the action, the plaintiffs had to prove that the twins’ cerebral palsy was caused by the defendant’s negligence. The defendant acknowledged that if Mrs. Goodman reported a leakage of fluid, the standard of care required him to see her or send her immediately to hospital. Whether this report was made was at issue at trial but on appeal the only issue was causation. The difficulty the plaintiffs faced was in proving that, had the defendant properly treated Mrs. Goodman, the twins would not have developed cerebral palsy despite their premature birth. The prematurity itself was unrelated to the defendant’s negligence. There was no suggestion that anything the defendant should have done would have allowed Mrs. Goodman to carry the twins to term. Consequently, the plaintiffs needed to establish that it was the inadequate treatment, and not the prematurity, that resulted in the twins developing cerebral palsy.

PVL caused Cerebral Palsy

There was no dispute amongst the experts that the twins’ cerebral palsy was caused by diffuse periventricular leukomalacia (PVL). PVL is a known risk of prematurity. The Ontario Court of Appeal described the process of injury in this way:

“PVL involves the inadequate blood supply to an area of the premature baby’s brain referred to as the watershed zone. Arterial blood supplies to the brain meet in the watershed zone. In premature infants, the arterial membranes may not develop fully. The brain cells affected by PVL are unstable and vulnerable. The expert evidence suggested that the damage to the affected areas of the brain caused by PVL occurs during delivery or in the first few days following birth.”

….

PVL is associated with the later onset of [cerebral palsy]. The descending nerve tracts to the legs and arms pass through the area of the brain adversely affected by PVL.

PVL may be caused by hypoxia, that is reduced oxygen in the blood flow circulating to the affected area of the brain, or ischemia, that is a deficiency in the blood supply to the affected area of the brain due to reduced blood pressure. Either hypoxia or ischemia results in the death of brain cells in the affected area of the brain. fte twins’ PVL was likely caused by ischemia.”9

Babies born earlier than 34 weeks gestation are more susceptible to PVL than term babies and PVL is the most common cause of brain injuries in premature infants.

It was undisputed at trial that if Mrs. Goodman had seen a doctor on the day she reported the fluid leakage, she would have received two doses of antenatal corticosteroids. Antenatal corticosteroids induce the production of enzymes throughout the fetus within 24-48 hours of administration that serves as a substitute for the surge of hormones that happens in full term babies immediately before birth. This hormone surge accelerates the maturation process and assists in the transition by the fetus to life outside the womb, but it does not occur in premature babies. Administration of antenatal corticosteroids is known to have short term and long term benefits in premature babies. Since Mrs. Goodman never saw a doctor the day she reported the fluid leakage, she was not given antenatal corticosteroids until the day of the twins’ birth, so close to the time of birth that it was probably ineffective, and there was only time for a single dose. The discrete causation issue became whether “but for” the failure to receive a full dose of antenatal corticosteroids, the twins would not have developed cerebral palsy, or the severity of their cerebral palsy would have been materially reduced. The defence position was that causation could not be proven in the absence of any direct scientific proof of a cause and effect relationship between the administration of antenatal corticosteroids and a reduction in a premature baby’s risk of developing PVL. The defence argued that since there were no clinical studies or any other form of direct scientific evidence showing such a correlation, the plaintiffs’ claim must fail. The plaintiffs argued that causation could be established on the balance of probabilities without the kind of evidence required for the scientific standard of proof. Two experts (a neonatologist/ pediatrician and an obstetrician/maternal fetal medicine specialist) opined that had Mrs. Goodman received a full dose of antenatal corticosteroids two days before her babies were born, the twins would not have developed cerebral palsy, or, alternatively, their disabilities from cerebral palsy would have been less severe.

Correlation between Administration of Corticosteroids and Fetal Brain Development

The plaintiffs structured their case around “biological plausibility.” There was evidence showing that antenatal corticosteroids had a maturation effect on tissues in various parts of the fetus, including  the  lungs  and  intestines.  This  maturation  process reduced the risk of other conditions known to cause cerebral palsy. The plaintiffs’ experts opined that one could infer that the maturation of membranes known to occur in other parts of the fetus would work in a similar way in the parts of the brain adversely affected by PVL (the arteries located in the watershed areas of the premature baby’s brain) and reduce the risk and the severity of PVL. While there were no studies showing a correlation between administration of corticosteroids and reduction in PVL, the plaintiffs’ experts pointed to other studies to support their opinion. Studies had shown that administration of antenatal corticosteroids had a positive effect on neonatal blood pressure and precipitous drops in blood pressure is a known cause of PVL. Administration of antenatal corticosteroids had a known correlation with reduction in a different type of leukomalacia than the twins had. An animal study showed a correlation between administration of corticosteroids and fetal brain development. Finally, an analytical review of 21 controlled studies reported a reduction in the risk of cerebral palsy through the administration of antenatal corticosteroids. However, this reduction was not statistically significant for scientific purposes, it did not distinguish between full term and preterm babies, and it did not differentiate between the causes of cerebral palsy. On the other hand, the review also did not consider those babies who developed cerebral palsy but suffered fewer disabilities as a result of antenatal corticosteroid administration.

The trial judge accepted the biological plausibility theory. She found:

“On the totality of the evidence before me, it is reasonable to infer that since PVL results from the immaturity of the pre-term infant’s brain and vascular system, and [antenatal corticosteroids] have a maturational effect beyond lung function to mature these systems, that it is more likely than not that the administration of [antenatal corticosteroids] would reduce the risk of PVL. ftus, but for the defendant’s negligence, the twins would not have suffered from PVL, and consequently would not have suffered from [cerebral palsy].

Even if I am incorrect in my conclusion that the PVL (and therefore the [cerebral palsy]) would not have occurred but for the failure to receive a full course of [antenatal corticosteroids], this is not fatal to the plaintiffs’ claim. I am satisfied that the evidence be- fore me establishes on a balance of probabilities that [antenatal corticosteroids] reduce the risk and severity of [cerebral palsy] in general, that is, no matter what the cause of the [cerebral palsy].”10

Causation not Proven

Despite the fact that the most applicable scientific analysis did not reach a level of statistical significance, and the fact that none of the literature specifically found a connection between the use of antenatal corticosteroids and PVL, the trial judge was able to draw logical inferences from the recognized effects of antenatal corticosteroids in humans and in animals.

The trial judge’s findings were upheld on appeal. The dissenting judge ultimately concluded that causation was not proven in this case but did not dissent on the legal question of whether the evidence had to reach a level of statistical significance before it could prove causation on a balance of probabilities:

“Scientific evidence revealing a trend suggestive of a causal connection between fact A and fact B is not discarded at trial because it does not reach the level of scientific proof. Instead, that evidence is considered along with any other evidence that is relevant to the question of causation.”11

Where the dissenting judge differed from the majority was on the matter of quantification of the risk. The majority judgment held that it was not necessary for the court to have experimental evidence that quantified the reduction in the risk of PVL to prove causation on a balance of probabilities. The experts were able to use their clinical experience to fill in the gaps in the scientific evidence. The Ontario Court of Appeal in this case specifically recognized the complexities of proving causation in this and other medical malpractice cases where, not uncommonly, there are no specific scientific studies that are determinative of the issues before the court. The courts analyzed the evidence, which did not reach a level of scientific certainty, considered the opinions of experts able to supplement the studies with their clinical experience and used logical inferences to find proof of causation. Goodman v Viljoen provides a helpful and important illustration of the legal principles of causation. It highlights the differences between medical and legal proof and offers an example of how common sense can be used to infer causation in the appropriate circumstances.

This piece was originally posted on the Verdict. You can read the read the PDF  on our Publications page.

  1. Clements v Clements, 2012 SCC 32, [2012] 2 SCR 181 at para 8 [Clements]
  2. Clements, supra note 1 at para 9
  3. Snell v Farrell, 1990 CanLII 70 (SCC), [1990] 2 SCR 311 at para 33 [Snell ]
  4. Clements, supra note 1 at para 9
  5. Athey v Leonati, 1996 CanLII 183 (SCC), (1996), 140 DLR (4th) 235 at para 16
  6. Athey, supra note 5 at para 16; Clements, supra note 1 at paras 10, 11
  7. Snell, supra note 3 at para 34
  8. 2012 ONCA 896, [2012] OJ No 6332
  9. Goodman, supra note 8 at paras 17, 19, 20
  10. Goodman, supra note 8 at paras 51, 53
  11. Goodman, supra note 8 at para 85

Electronic Medical Records – Behind the Screen

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In medical malpractice we rely on the integrity of medical records as the foundation for understanding our client’s case. As more clinicians and hospitals move toward electronic medical records, lawyers must know what kind of information is available from those records and how to access it.

In the world of paper medical charts there is nothing wrong with a clinician making a late entry in a chart, as long as it is clearly marked as a late entry; but, it is an offence for a clinician to go back and alter medical records. Although it is possible in some cases to identify alterations to a medical record made after the fact, there is a chance that an alteration could go unnoticed. In the world of electronic medical records however, there is an audit trail that tracks all changes made to a medical record. There will also be an access log that identifies who has viewed a patient’s records, and which part of the record they looked at. Audit trails and access logs can provide a detailed timeline that for the most part cannot be altered and in some cases, that audit trail will be critical to understanding the nature of the wrongdoing.

Robert Kucheran

The question is no longer “How can I figure out who saw these records or if somebody changed these records after the fact.” Now the question is “How do I get a copy of the access log or audit trail, and how do I figure out what it means?”

Patient Privacy and Security

Most of the legislation that applies to medical records is aimed at ensuring the privacy and security of patient health care information. Although there is less regulatory content aimed at ensuring that these records are not altered after the fact, the health regulatory colleges are beginning to address this issue. For example, the Bylaws of the College of Physicians and Surgeons mandates that a physician’s medical record system must, among other things, contain the patient’s demographic information, the patient’s presenting complaint, the results of the medical history and physical examination, what investigations were ordered, the provisional diagnosis or diagnosis, treatment recommendations, medications prescribed and the follow-up plan. This information must be capable of being reproduced promptly in a hardcopy and the system must audit or record any subsequent changes made.

An example of a long established electronic health record system is British Columbia PharmaNet that in 1995 was the first such system implemented in Canada. Since its inception, PharmaNet not only has been capable of logging every prescription dispensed in all community pharmacies British Columbia in a common database, it also has ensured the availability of access logs and the maintenance of audit trails. Consequently, any patient can request a print-out of their own PharmaNet profile, as can a third party authorized by the patient. That profile contains a record of all prescriptions dispensed for the person, back to the inception of PharmaNet. From a legal point of view, perhaps more importantly, the PharmaNet record also includes an ac-cess log – a record of the names of anyone who has accessed that patient’s PharmaNet profile other than at the time of dispensing a prescription and the date of access. For instance, every time you request a copy of your client’s PharmaNet profile, there will be an access log recorded of the date that the system administrator accessed your client’s PharmaNet profile to prepare the report you requested. There may also be other accesses recorded – if a patient attends at a physician’s office or an emergency room their profile may be accessed to assist in patient care.

But there is much more information available about each pre-scription than you see on the PharmaNet record. The computer system of the pharmacy where the prescription was dispensed will include every detail of the prescription, including the specific directions that were on the patient’s medication label, the initials of the pharmacist and the technician involved in dispensing the prescription, and the price charged to the patient. There also is an audit trail of every change that has been made to a prescription showing the original version of the label and if any changes have been made to that label. The system records what change was made, who made the change, and the date and time the change was made.

There is electronic medical record information everywhere technology is used in health care. Some departments in a hospital, for example, diagnostic imaging, may have electronic records that must be requested separately. Similarly, community health workers and outreach therapists may have their own versions of electronic records that are not integrated into a larger comprehensive health care record for a patient. Even medical equipment such as infusion pumps may record information about when an infusion was started, what the volume of the syringe was, and at what rate the infusion was running, although this information will not be found in the patient’s chart. Vital signs monitors used in hospitals and medical clinics often include a log of the results for a patient, although those results may be handwritten into a patient’s chart if a paper-based system is in use. Even the now common home blood glucose moni-tor or blood pressure cuff likely retains a log of the data.

How do you Access Data?

But, if you need this data to effectively represent your client, how do you access it? How can you recover audit trails of the electronic records? Firstly, to avoid missing crucial information, you need to make your request as specific as possible. For example, you may want to ask for all entries made, changed and deleted over a particular period of time in a particular system. You may also want to ask for screenshots of the electronic medical record if you need to know, for example, what information a particular physician had available to them when they were reviewing the lab results at a particular time?

You may want to know who accessed a certain report, when they accessed it and even where they were when they did it, as well as for how long they had access to it. Technical specifications can also be important. For instance, you might want to know what the systems settings are for automatically logging off a user if there has been no activity. Although each hospital will have procedural guidelines that instruct system users to ensure they log off before they leave a computer, no doubt there will be potential that a defendant might claim that a record has been altered in their name because they didn’t log off.

Distance medicine facilitated by electronic health information is becoming more common. For example, it is possible that there may be a CT scan ordered by a physician in one small hospital, conducted by a radiology technician in another hospital, then reviewed by a radiologist in a third hospital. If your client was injured as a result of a problem related to diagnostic imaging it may be important to gather information from audit trails and/or access logs about the CT requisition, the CT scan itself, the timing of the radiologist’s access to the imaging, the radiologist’s inter-pretation and recommendations, if any, and when and how the radiologist sent that information to the treating physician. This information can be critical to create a time-line of when events unfolded, the events themselves, and to determine if changes were make to the records after a bad outcome became known.

Screen shots can also be useful when many individuals are involved. For example, if the issue you are investigating relates to the possibility of an error in processing a tissue sample in a laboratory, it will be vital to understand which laboratory tech-nician was involved in each step of the process. If a department relies on an electronic system for tracking the sample, screen shots that show the date, time, initials of the laboratory staff member, identification of the patient, and the processing number of the sample, might be the best or only way to determine who was involved in each step. These screen shots would not be available through the medical records department, and would need to be requested through the specific department involved and possibly the information technology department.

Hospital Staff May Need to Assist

The medical records department of a hospital is not necessarily the department that can produce an audit trail or access logs. Generally medical records departments deal with requests for the records themselves, but it is likely to be the health information technology department that will produce audit trails and access logs. The hospital may need to enlist the assistance of the hospital’s information technology staff to access the audit trails and confirm how much detail is available through the system in use at the hospital.

If the information of interest comes from a specific piece of medical equipment, the vendor for the equipment may be able to help you understand what information should be available and how to access it. Still, it will likely be necessary for the hospital’s biomedical engineering department to obtain that data.

The information available through access logs and audit trails of a patient’s medical records can be critical in helping you fully understanding your client’s case. There is no single entry-point for accessing this information. Of course, once the action is started, if the hospital is one of the defendants it will be necessary to make requests for these records through counsel. Regardless of where you direct your request for records, make sure you understand what information could be available beyond the medical record that would routinely be produced, so you can create a detailed and complete timeline for your case that includes a thorough understanding of who accessed your client’s records, and what, if anything, they did to those records.

This piece was originally posted in The Verdict. You can also read the PDF from our Publications page. 

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