ONTARIO
SUPERIOR COURT OF JUSTICE
B E T W E E N:
Taylor Achneepineskum and Jasmine Achneepineskum, by their Litigation Guardian, Samuel Achneepineskum, Martha Achneepineskum, Olivia Achneepineskum, Daryl Achneepineskum, Samuel Achneepineskum, J.R., and the said Samuel Achneepineskum, personally,
Richard C. Halpern, David R. Tenszen and Kate Cahill, for the Plaintiffs
Plaintiffs
- and -
Roy Laine, Geraldton District Hospital, Astra Zeneca Canada Inc., and Merck Frosst Canada Ltd.,
Darryl Cruz, Chris Hubbard and Sara Kushner, for the Defendant Roy Laine
Defendants
HEARD: October 29 – December 13, 2012 and January 21 - 25, 2013,
at Thunder Bay, Ontario
McCartney J.
Reasons For Judgment
Introduction
1This is a medical malpractice case in which the Plaintiffs allege that as a result of the negligence of the Defendant, Roy Laine (“Dr. Laine”), the Plaintiff Taylor Achneepineskum (“Taylor”), was born with or developed cerebral palsy shortly after birth.
2Counsel have advised that the cases against all Defendants except Dr. Laine have been dismissed; and further that the question of damages has been settled. Consequently, the only issues left to be decided by the court are the following:
(1) Did the Defendant Laine meet the standard of care required of his under the circumstances?
(2) Did the Defendant Laine do or fail to do anything that caused the Plaintiff Taylor’s injuries?
(3) Did the Defendant Laine have a duty of care towards the Plaintiff Taylor?
The Agreed Statement of Facts (Claimed History)
3The Agreed Statement of Facts, which for the most part are the clinical history of the case, and which are set out in detail in Exhibits 1, Exhibit 2 (Volume 1) and Exhibit 3 (Volume II) are the following:
“The facts set out below have been agreed upon between the parties. This statement does not purport to be a complete statement of the facts in this case.
The parties agree the records attached are authentic copies of the originals and are being admitted for the proof of the truth of their contents subject to the right of the parties to contradict through other evidence at trial. The records are not being admitted for the truth of the opinions contained therein.
The plaintiff Taylor Achneepineskum (“Taylor”) was born on April 7, 1993 at Geraldton District Hospital.
Taylor’s mother is Martha Achneepineskum (“Martha”) and her father is Samuel Achneepineskum. Martha was born on October 10, 1953. Martha was 38 years old when she became pregnant with Taylor. She was 39 years old when Taylor was born. Prior to Taylor, Martha had given birth to three children in 1974, 1975 and 1977, respectively. In 1976, Martha had a suspected miscarriage. Subsequent to Taylor’s birth, Martha gave birth to a baby girl on April 16, 1996.
During her pregnancy with Taylor, Martha resided in Ogoki Post, a remote community on the Albany River in Northern Ontario. Ogoki Post has a population of approximately 300 residents and is accessible on a fly-in basis only. The flight distance is approximately 227 km from Geraldton and 435 km from Thunder Bay.
The defendant Dr. Roy Laine is a general practitioner. Dr. Laine qualified for independent practice in 1969. Dr. Laine completed a residency in general surgery in 1973. Dr. Laine has maintained a general practice in Geraldton since 1979. He also maintains hospital privileges at the Geraldton District Hospital. In his practice, Dr. Laine has provided a broad range of medical care and services, including obstetrics.
In addition, Dr. Laine has provided medical services in the community of Ogoki Post since approximately 1980. Dr. Laine sees patients in a community clinic. He is the only physician providing medical care in Ogoki Post.
Dr. Laine first saw Martha in or about 1985 and her pregnancy in 1992, Dr. Laine occasionally attended on Martha. Martha also saw other physicians during this period.
Martha had a thyroidectomy in February 1991 for papillary thyroid cancer. In May 1992, Martha had an appendectomy.
Dr. Laine was Martha’s treating physician for her pregnancy with Taylor, managing both the antenatal care and Taylor’s delivery on April 7, 1993.
Prior to becoming pregnant with Taylor, Martha had a history of high blood pressure or what is referred to as chronic hypertension. She was prescribed anti-hypertensive medications over the years.
On September 22, 192, Martha attended at the clinic in Ogoki Post. A note made by clinic staff states “needs refills on meds”. Martha was seen by Dr. Laine. On that occasion her blood pressure was recorded as 148/80. The note states “off Isoptin → caused pain epigastrium”. Dr. Laine re-filled her prescription for Atenolol, an anti-hypertensive medication known as a beta-blocker. The visit note states “LNMP June (mid month)”. Dr. Laine ordered pre-natal blood work, a urinalysis, and an ultrasound. The visit note states “∆Hypertension”. A copy of the visit note for September 22, 1992 is at p. 1 of Volume I (“Vol I”). Copies of the laboratory results are attached at p. 2-7, Vol I.
An initial ultrasound was performed at Geraldton District Hospital on October 8, 1992. The report states: “There is a single, live intrauterine pregnancy. Measurements are consistent with a gestational age of about 14 to 15 weeks. No abnormalities are identified. There is a normal volume of amniotic fluid”. The placenta was described as being on the left extending from the anterior to the posterior wall of the uterus. The placenta was clear of the internal os. A copy of the ultrasound report dated October 8, 1992 is at p. 8, Vol I.
Martha was seen by Dr. Laine on October 13, 1992 in Ogoki Post. Her blood pressure was recorded as 130/80. Dr. Laine’s note states “^17 weeks gestation” and “? EDC March 23, 1993.” Dr. Laine also references the ultrasound done the prior week, “Had US Scan last wk 14 wk gstn”. Attached at p. 9, Vol I is a copy of the visit note for October 13, 1992.
On November 3, 1992, Martha attended at the Ogoki Post clinic and was seen by clinic staff. Her blood pressure was recorded as 120/80. Attached at p. 10, Vol I is a copy of the visit note for November 3, 1992.
On November 10, 1992, Martha attended at the Ogoki clinic and was seen by clinic staff. Attached at p. 11, Vol I is a copy of the visit note for November 10, 1992.
Martha was seen by Dr. Laine in his office in Geraldton on December 8, 1992. Dr. Laine’s note states “^26 weeks gestation”. Martha’s blood pressure is recorded as 124/80. Martha’s weight at the time was 180 lbs. At the visit, Dr. Laine ordered blood work, a urinalysis, and an ultrasound. Dr. Laine measured the symphysis-fundal height. Attached at p. 12, Vol I is a copy of the visit note for December 8, 1992. Attached at p. 14-21, Vol 1, are copies of the blood work and urinalysis reports.
A second ultrasound was performed at Geraldton District Hospital on Decembe r10, 1992. The ultrasound report states: “Present measurements correspond to approximately 25 weeks, could be a little more or less, earlier measurements being more accurate. Positioning still changing, presenting breech. Normal appearance of the single fetus. Normal posterior placenta and normal amount of amniotic fluid”. Attached at p. 13, Vol I is a copy of the ultrasound report dated December 10, 1992.
On January 20, 1993, March was seen by a nurse at the Ogoki clinic. Martha’s weight is recorded as 182 lbs and her blood pressure as 13/90. Her blok sugar was noted to be 8.9 by Glucoscan. Attached at p. 22, Vol I is a copy of the viit note for January 20, 1993.
On January 26, 1993, Dr. Laine saw Martha at the Ogoki clinic. The note states “EDC March 23”, “32 wk gestation”. Dr. Laine also references the ultrasound performed on December 10, 1992. Martha’s blood pressure is recorded as 120/80 and her weight was 184 lbs. The symphysis-fundal height was recorded as 26 cm. The fetal heart rate was recorded as 112 bpm. Dr. Laine also diagnosed mild vulvar varicosities. Attached at p. 23, Vol I is a copy of the visit note for January 26, 1993.
On February 9, 1993, Dr. Laine saw Martha again at the Ogoki clinic. Dr. Laine recorded “34 wk gestation”. Martha’s weight was 187 lbs. Dr. Laine noted a 25 lbs weight gain. Martha’s blood pressure was 130/80. The fetal heart rate was 120 bpm. The symphysis-fundal height is recorded as 30 cm and the fetus was noted to be in the vertex position. Dr. Laine prescribed “”Enteric ASA ½ tab daily”. Attached at p. 24 Vol I is a copy of the visit note for February 9, 1993.
On the evening of February 19, 1993, Martha attended at the Geraldton District Hospital. The record states “LMP d12 June”, “gestation approx 38 weeks”, “c/o hemorrhoids, very swollen now”, “Hx of elevated BP since pregnant”, “taking ASA, stopped meds because of stomach irritation”, “Active fetal movement”, “denies any other problems”. Martha’s blood pressure was recorded as 150/90. Her last menstrual period is recorded as June 12. At this visit to the hospital, Dr. Laine attended on Martha. He recorded a symphysis-fundal height of 30 cm and a fetal heart rate of 120 bpm. The note states “EDC mid-march”. Dr. Laine ordered blood work, serum creatinine and BUN testing, a random blood sugar, RH antibody, urinalysis, and an ultrasound. Attached at p. 26, Vol I is a copy of the out-patient record for this visit. Attached at p. 28, Vol I is a copy of the lab report available for this visit.
The ultrasound was performed on February 20, 1993 at Geraldton District Hospital. The report states: “Present measurements correspond to approximately 35 weeks. Presently the fetus is in cephalic presentation. Normal appearance of the fetus. Normal posterior high placenta. Normal amount of amniotic fluid. No anomalies seen”. Attached as p. 27, Vol I is a copy of the ultrasound report.
On march 9, 1993, Dr. Laine saw Martha at the Ogoki clinic. The note states “EDC 23 March” and “38 wk gest”. The symphysis-fundal height is recorded as 30cm. The fetal heart rate is recorded as 110 bpm. The fetus was in the vertex position. Attached at p. 29, Vol I is a copy of the visit note for March 9, 1993.
On March 26, 1993, Dr. Laine saw Martha at his office in Geraldton. Martha’s blood pressure is recorded as 150/90 and she weighed 195 lbs. The note states “EDC 23 March 1993”. The symphysis-fundal height was recorded as 31 cm. The fetal heart rate was 120 bpm. The note states “US Scan 3wks ago”. It also states “Review 5 days”. Dr. Laine ordered a non-stress test at this visit. Attached at p. 30, Vol I is a copy of the visit note of March 26, 1993.
On March 29, 1993, Martha attended at the Geraldton Hospital. A non-stress test was performed. The nursing note states: “NST-Reactive Good fetal movement”. The nursing note also states “felt baby move early this morning”, “EDC March 23/93”, “Gravida [4] Para [3]”, “FHR 140-150 fluctuates”, “little bit of swelling at night”. Attached at p. 31, Vol I is a copy of the out-patient record. Attached at pp. 32-35, Vol I is a copy of the non-stress test.
Dr. Laine saw Martha at his office in Geraldton on March 31, 1993. Her weight was 198 lbs. Her blood pressure was recorded as 160/90. The note states “EDC March 10/93”. The symphysis-fundal height was recorded as 29 cm. The fetal heart rate was recorded as 120 bpm. The fetus was in the vertex position. The note states” on Atenolol od”, “Add Vasotec 5mg od”. Vasotec is an anti-hypertensive medication known as an ACE inhibitor. Dr. Laine ordered a non-stress test, an ultrasound and a urinalysis. Attached at pp. 36-37, Vol I is a copy of the visit note and the requisition for the NST.
By March 31, 1993, Martha was staying at the Grace Otawin Lodge in Geraldton. The lodge provides lodging to First Nations visiting the region for medical purposes. The visit note for March 31, 1993at p. 36, Vol I states “at lodge”.
On April 1, 1993, Martha attended at the Geraldton District Hospital. Her blood pressure was recorded as 130/80. The EDC was recorded as march 23rd. The non-stress test performed was reactive. The fetal heart rate was recorded as 120-140/min. Dr. Laine reviewed the non-stress test and noted it to be satisfactory. Attached at pp. 38-42, Vol I is a copy of the NST performed on April 1, 1993. A copy of the hospital out-patient record for April 1, 1993 is attached at p. 43, Vol I. Copies of the available lab reports are attached at pp. 45-46, Vol. I.
An ultrasound was performed on April 1, 1993. The report states: “present measurements correspond to term. Normal appearance of the single fetus. Cephalic presentation. Normal fundal placenta and normal amount of amniotic fluid. Normal mid-term pregnancy”. Attached as p. 44, Vol I is a copy of the ultrasound report dated April 1, 1993.
On April 5, 1993, Dr. Laine saw Martha at his office in Geraldton. She weighed 200 lbs and her blood pressure was recorded as 130/80. The symphysis-fundal height was recorded as 31 cm. The fetal heart rate was 120 bpm and the fetus remained in the vertex position. The visit note states “request NST few days”. Attached at p. 47, Vol I is a copy of the visit note for April 15, 1992.
On April 6, 1993, Martha attended at the Geraldton District Hospital and was admitted around 2230 hours. The note indicates that the onset of contractions was at 1300 hours. Martha was experiencing contractions every 3 min for approximately 40 seconds. Martha’s blood pressure is recorded as 160/100. The fetal heart rate is recorded as 120 bpm. Attached at pp. 50-51, Vol I is a copy of the Patient Profile Sheet.
At or about 2245 hours, Martha was transferred to a delivery room. Attached at p. 73, Vol. I is a copy of the delivery room checklist.
A note by Dr. Laine recorded at 2300 hours states “Vag –vertex. 6cm dilation. Stn -1, BP 160/100. Fetal monitor ok 125-135 FHR”. Attached at p. 52, Vol I is a copy of the doctor’s orders.
Attached at p. 73, Vol. I is a copy of the delivery room checklist. It records that at 2300 hours, the fetal heart was 120 bpm. Martha’s BP was 160/100.
A nursing note made at 2305 hours, states “Pt admitted to delivery room”. It also states “Pt unable to void at this time to provide a specimen. Lab in to draw admission blood work”. Attached at p. 67, Vol I is a copy of the nursing note. Attached at pp. 67-71, Vol I is a copy of the labour and delivery nursing Progress Notes for Martha.
Attached at p. 73, Vol. I is a copy of the Delivery Room Checklist. It records that at 2315 hours, the fetal heart was 117 bpm. Martha’s blood pressure is recorded as 150/102. A copy of the Labor Progress Chart is at p. 74, Vol I.
At 2330 hours, Martha is noted to be experiencing contractions every 2.5 min lasting 60 seconds, with no urge to push. The fetal heart is recorded as 125 bpm. Martha’s blood pressure is recorded as 140/100. Martha is noted to be tolerating labour well. A copy of the nursing note is at p. 67, Vol I. A copy of the Delivery Room checklist is at p. 73, Vol I.
The fetal heart rate was monitored electronically during the labour and delivery. Attached at pp. 57-66, Vol I is a copy of the fetal heart rate monitor strip. The date stamp and time on the tracing is incorrect.
The nursing note at 2345 hours states “? deceleration”. The note states “Pt turned on (Lt) side and ↑ H.R”. A copy of the nursing note is at p. 68, Vol I.
The nursing note at 2355 states “definite deceleration with contraction noted. Pt turned again on (Lt) side. Supervisor present and made aware of the situation”. A copy of the nursing note is at p. 68, Vol I.
The nursing note at 2400 hours states “Vag exam done by L. Donylyk. Pt fully dilated. Dr. Laine attempted to be reached. Pt feeling like “pushing”. Encouraged to Pant”. Pt panting and tolerating labour well. Set up for delivery. Perineum washed.” A copy of the nursing note is at p. 68, Vol I.
The nursing note at 0010 hours (April 7th, 1993), states “Dr. Laine present. Membranes ruptured. Dr. Lane made aware of FHR increasing and decreasing. AROM. Showed green thick meconium staining in amniotic fluid”. A copy of the nursing note is at p. 68, Vol I.
Taylor was born at 0012 hours. A nursing note at 10012 hours at p. 68, Vol I, states “++ mec staining to babe”. A second nursing note at 0012 hours states: “Pt nose and mouth suctioned c bulb syringe p delivery”. Pt ashen colour and ø heart rate detected on auscultation”. A copy of the nursing note is at p. 84, Vol I.
Dr. Laine commenced resuscitative efforts. A copy of the nursing Progress Notes for Taylor are attached at pp. 84-86, Vol I.
The one minute Apgar score was 1 or 2. The five minute Apgar score was 1. Her birth weight was 2980 grams. A copy of the newborn record is attached at p. 83, Vol I. A copy of Dr. Laine’s discharge summary is at p. 93, Vol I.
A Nursing note at 0020 states: “Endotracheal tube (?size3) placed by Dr. Laine with ambubag attached. 02 @ 154 per mask prior to intubation”. Adrenalin was administered through the endotracheal tube. The nursing note states cardiac massage was commenced due to ø breath sounds and ø heart beat on auscultation. A copy of the nursing note is at p. 84, Vol. I.
A nursing note at 0025 hours, states that cardiac massage was stopped. The nursing note states “Pulse @ 120/min and strong. Remains to have 02 per ambubag [with] intermittent respirations on own. Colour improved slightly. Remains flaccid. Eyes opened. Babe dried well”. A copy of the nursing note is at p. 84, Vol I.
Dr. Laine spoke to Dr. Belda, a paediatrician, at Port Arthur General Hospital regarding the management of Taylor’s care and her transfer to that hospital. Dr. Belda recommended administering sodium bicarbonate.
Dr. Laine inserted an umbilical catheter. A nursing note at 0050 states “Babe has voided. Attempted to suck on ET tube. Remains flaccid. Resps have ↑ in rate (own resps).” Oxygen continued to be administered with the ambubag with “bagging”. A copy of the nursing note is at p. 85, Vol I.
A nursing note at 0055 hours states “Appears to have worsened. Colour poor. ø resps on own now.” A copy of the nursing note is at p. 85, Vol I.
A nursing note at 0100h states sodium bicarb given via umbilical catheter. Adrenaline given via the endotracheal tube. The note states: “ø pulse before meds given. Apical pulse returned post meds and compression. Chest crackles heard in (Rt) side (auscultated by Dr. Laine)”. A copy of the nursing note is at p. 85, Vol. I.
A nursing note at 0115 hours records adrenaline given via endotracheal tube. It states “Pt breathing better. Eyes open. Pt sucking on E.T. tube. some attempt to move hands/arms. Frequent chest assessments by Dr. Laine”. A copy of the nursing note is at p. 85, Vol. I.
A nursing note at 0130 states “CBC, Coombs & type done lab and chest x-ray done. Both results seen by Dr. Laine. Gastric contents aspirated from #5 feeding tube placed by Dr. Woolfrey. Contents sent for analysis. Pt seems to be improved. Air ambulance on its way.” It also states “Pt voided and mec’d. Still being “bagged” [with] ambubag. Chest has improved slightly”. The nursing notes are attached at pp. 85-86, Vol I.
The x-ray report states “There was quite significant bilateral diffuse alveolar consolidation, which means much fluid within the lungs. It looks mostly like respiratory distress syndrome with hyaline membrane”. A copy of the x-ray report dated April 7, 1993, is attached at p. 91, Vol. I.
Lab work for both Martha and Taylor was completed. Copies of the available reports are attached at p. 72, 88-90, Vol I.
By 0205 hours, the paramedics were in attendance. The nursing note at p. 86, Vol I, states “Pt has had ø apnea ø loss of heart beat since 0100 hr. Colour improved. Extremities pinker. Chest remains same. All lines and tubes remain intact and patent. Pt. Still being “bagged” [with] ambubag & 02 @ full flow”. The nursing note is at p. 86, Vol I.
A nursing note at 0241 states “Pt transferred to incubator”. The ambulance transfer record states “While preparing to transfer to our incubators PT 02 Sat dropped down to 50%, Dr. Laine stabilized before transfer”. A copy of the nursing note is at p. 86, Vol I. A copy of the Air Ambulance Transfer Record is at p. 95, Vol 1.
A note made at 0330 hours states the transfer team was en route by helicopter to Port Arthur Hospital in Thunder Bay. Dr. Laine accompanied Taylor to Thunder Bay. During the flight the incubator battery failed. Dr. Laine bagged Taylor during the flight. Copies of the transfer records are attached at pp. 95-99, Vol I.
At 1815 hours, Martha was discharged to the Grace Otawin Lodge in Geraldton for transfer to Thunder Bay to be with Taylor. A copy of the nursing note is at p. 71, Vol I. A copy of Dr. Laine’s discharge summary is at p. 100, Vol I.
Taylor was admitted to Port Arthur General Hospital at approximately 0410 hours. On admission to the Neonatal Intensive Care Unit (“NICU”), blood pressure was recorded as 46/26. The Port Arthur General Hospital daily records are attached starting at p. 103, Volume II (“Vol II”).
In the days after delivery, Taylor was diagnosed with perinatal asphyxia, meconium aspiration, ischemic myocardiopathy, cerebral haemorrhage and edema with seizures, renal ischemia, hypoglaecemia. hyperbilirubinemia, gastrointestinal reflux, lactose deficiency, oral thrush. Attached at p. 494-495,Vol II is the discharge note of Dr. DeSa.
A cranial ultrasound was performed on April 8, 1993. The ultrasound report states that the white matter appears slightly echogenic. A copy of report is attached at p. 194, Vol II.
A cranial ultrasound was performed on April 12, 1993. The ultrasound report states, amongst other things, that the periventricular white matter is diffusely hyperechoic suspicious for an anoxic insult. In the right frontal lobe there appears to be a more focal area of increased echogenicity which appears mass like measuring approximately 2cm. Attached at p. 306, Vol II is a copy of the ultrasound report.
A CT scan of Taylor’s brain was performed on April 14, 1993. The report states that many foci of intraparenchymal haemorrhage are seen within both cerebral hemispheres. Each is associated with slight edema. Attached at p. 347, Vol II is a copy of the CT scan report.
A cranial ultrasound was done on April 17, 1993. The report described increased echogenicity of the periventricular white matter. Attached at p. 388, Vol II is a copy of the ultrasound report.
A cranial ultrasound was performed on April 27, 1993. The report describes several cystic lesions within the head predominantly on the right. Attached at p. 476, Vol II, is a copy of the ultrasound report.
A cranial ultrasound was done on June 14, 1993 (66 days of age). The report states that several complex masses are identified intracranially. It describes that the masses noted previously on the right had decreased in size since the previous examination in keeping with resolving hematomas. No definite abnormality was identified within the left hemisphere. The ventricles were within the normal limits. A copy of the report is attached at p. 487, Vol II.
A CT scan was performed on May 10, 1994 (age 1 year and 1 month). The report describes a moderate degree of cerebral atrophy in both frontal areas. There was marked dilatation of the occipital horn of the right lateral ventricle. Attached at p. 498, Vol II is copy of the CT scan report.
A CT scan was done on July 8, 1997 (age 4 years 3 months). The report describes a porencephalic cyst in the right parieto-occipital region. Attached at p. 499, Vol II is a copy of the CT scan report.
Following her discharge from hospital, Taylor was subsequently diagnosed with Cerebral Palsy (“CP”), a non-progressive and profoundly disability neurological disorder that involves significant motor dysfunction and profound cognitive delay. Attached at p. 500-503, Vol II are the consultation notes of Dr. DeSa dated May 12, 1994 and October 31, 1995.”
Issue #1 – Standard of Care
A. THE LAW
4The standard of care required of a doctor has been defined as follows:
“Every medical practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. He is bound to exercise that degree of care and skill which could reasonable be expected of a normal, prudent practitioner of the same experience and standing, and if he holds himself out as a specialist, a higher degree of skill is required of him than of one who does not profess to be so qualified by special training and ability [emphasis added].
Reference: Crits and Crits v. Sylvester, 1956 34 (ON CA), [1956] O.J. No. 526 (C.A.) at para. 13, aff’d 1956 29 (SCC), [1956] S.C.R. 991 [Crits], Defendant’s Authorities, Tab 6.
The test of reasonable care applies in medical malpractice cases as in other cases of alleged negligence … The medical man must possess and use that reasonable degree of learning and skill ordinarily possessed by practitioners in similar communities in similar cases, and it is the duty of a specialist such as appellant, who holds himself out as possessing special skill and knowledge, to have and exercise the degree of skill of an average specialist in his field [emphasis added].
Reference: Wilson v. Swanson, 1956 1 (SCC), [1956] S.C.R. 804 at p. 10 (QL) [ Swanson], Defendant’s Authorities, Tab 18.”
5It is recognized, however, that where there are alternate treatment choices, as long as the chosen method is accepted by a “respectable minority” of competent physicians, then negligence will not be found:
“The Ontario Court of Appeal has described this principle as the “ter Neuzen principle” or the “respectable minority principle,” stating:
This principle holds that where the practice followed by a doctor is adhered to by at least a respectable minority of competent medical practitioners in the same field; it is not for the court to prefer the practice of the majority over that of the respectable minority. In other words, a doctor who acts in accordance with a respectable minority body of medical opinion will normally be absolved of negligence: see for example, Ellen I. Picard & Gerald R. Robertson, Legal Liability of Doctors and Hospitals in Canada, 4th ed. (Toronto: Thomson Carswell, 2007) at p. 362.”
(See ter Neuzen v. Korn, 1995 S.C. No. 79)
6Furthermore, it is clear that a physician cannot be held liable for exercising clinical judgment as opposed to professional fault:
“An error in judgment has long been distinguished from an act of unskillfulness or carelessness or due to lack of knowledge. Although universally-accepted procedures must be observed, they furnish little or no assistance in resolving such a predicament as faced the surgeon here. In such a situation a decision must be made without delay based on limited known and unknown factors; and the honest and intelligent exercise of judgment has long been recognized as satisfying the professional obligation.”
Reference: Wilson v. Swanson, 1956 1 (SCC), [1956] S.C.R. 804.
B. STANDARD OF CARE ISSUES
7Dr. Laine’s first appointment with Martha was September 22, 1992, and Taylor was born April 7, 1993, a period of about 6 ½ months. I intend to review Dr. Laine’s care on the basis of the major issues identified by the parties as follows:
(1) Dating of Pregnancy;
(2) Fetal Growth;
(3) Martha’s Hypertension, Pre-eclampsia and Protein Issues;
(4) Record Keeping (Antenatal Visits and Risk Assessment);
(5) Failure to Refer to Obstetrician;
(6) Failure to Induce or Refer for Induction;
(7) Prescribing Drugs (Enalapril); and
(8) Fetal Surveillance.
8The witnesses called on the issue of standard of care were Dr. Gregory Davies, Dr. Val Rachlin, Warren Douglas and Richard Szaho for the Plaintiffs, and Dr. Lawrence Oppenheimer and Dr. Laine for the Defendant.
9Dr. Davies, an obstetrician and gynecologist is presently a Professor in this field at Queen’s University. He is also a director of the Fetal Assessment Unit at Kingston General Hospital. He is a specialist in maternal fetal medicine and qualified as an expert because he had similar training in family medicine to Dr. Laine, and in particular had done “outreach” work from his base in Kingston to native communities along the James Bay coast. However, he is not a family doctor and his work, as it appears from his curriculum vitae, is in no way similar to Dr. Laine’s.
10Dr. Rachlin is a family physician practicing in the Department of Family and Community Medicine at North York General Hospital in Toronto since 1974. He has also taught as an Assistant and Associate Professor at the Department of Family and Community Medicine at the University of Toronto. His practice is obviously quite dissimilar to that of Dr. Laine.
11Dr. Oppenheimer is a specialist in obstetrics and maternal fetal medicine, and a Full Professor in the Division of Maternal Fetal Medicine – Department of Obstetrics and Gynecology – at the University of Ottawa. He has practiced at the Ottawa General Hospital as an obstetrician and gynecologist since 1991. In his work at the University of Ottawa he has been involved in training medical students, obstetrical residents, and fellows. Furthermore, he has been the Director of Clerkship for the Facility of Medicine at the University of Toronto Medical School since 1999. In that role he is involved in setting curriculum for medical students which, of course, involves the diagnosis and treatment of hypertension and induction.
12Dr. Oppenheimer is also eminently qualified to speak to the standard of care of a family doctor through his work on the Independent Obstetrical Panel of the Complaints Committee of the Physicians and Surgeons of Ontario since the year 2000. In this capacity he reviews cases as an expert, in an expert capacity to determine whether an individual doctor has provided an appropriate level of obstetrical care to his patients.
13Before proceeding it should be noted that Dr. Laine gave his testimony in an honest and straightforward manner. However, it was clear that his memory over events some 20 years ago was far from sure. Many of the answers he gave were merely answers to hypothetical situations. Thus his testimony must be viewed in this light.
(1) Dating of Pregnancy;
14When Martha first saw Dr. Laine on April 22, 1992, she indicated and he reported that her last menstrual period was mid-June. On the basis of this information, he calculated the due date as March 23, 1993. On October 8, 1992, the first of four ultrasounds was conducted, showing a gestational age of 14 to 15 weeks, and so the due date based on this would be between April 1 and April 8, 1993. This first ultrasound is considered the most accurate for gestational age. Taylor was born on April 7 – she was 40 weeks and 3 days of gestational period – which is neither post-date nor post-term (term being 37 to 42 weeks).
15The Plaintiffs claim that the failure to note the ultrasound date falls below the standard of care since it is important for the purpose of making important decisions in the future. I agree. Dr. Laine was Martha’s only treating doctor and clearly knew that the March 23 date was not the accurate date as determined by the October 8 ultrasound. In fact, he did note this on March 31, 1993 (even though he mistakenly noted that the new birth date was March 10 instead of April 10 – the date he had meant to write down). Regardless of this, Taylor was not post-term as suggested by some, and was born exactly when the October 8 ultrasound indicated she should be born.
(2) Fetal Growth
16Dr. Rachlin claimed that the problems with fetal growth over the term of the pregnancy should have indicated to Dr. Laine that a referral to an obstetrician was required, since this was now a Grade C pregnancy on the Antenatal II Chart. This is indicated when the symphysis-fundal height measurements of the fetus falls below the tenth percentile. In fact, Taylor was not below the tenth percentile on February 9 and 19, 1993. What happened was that Dr. Rachlin, who testified to this, incorrectly charted the fundal height on those dates.
17The more important part of this investigation as pointed out by Dr. Oppenheimer, is that charting the fundal height is only a screening, and if there is any question arising an ultrasound is the required test. Dr. Rachlin agreed that the ultrasounds done on December 10, 1992, February 20, 1993 and April 1, 1993 all showed fetal growth to be totally normal. Dr. Rachlin then revised his opinion and indicated that this was a Grade B pregnancy as determined on the Antenatal Chart II, not a Grade C. Dr. Oppenheimer agreed. In any event, Dr. Laine does not appear to be falling below the standard of care in this issue.
(3) Martha’s Hypertension - Pre-eclampsia and Protein Issues
18Dr. Rachlin was critical of Dr. Laine for not properly monitoring Martha’s blood pressure or properly monitoring protein in her urine for signs of pre-eclampsia. Pre-eclampsia is a condition which can sicken the mother and reduce oxygen going from the mother’s blood to the placenta, and then on to the fetus.
19Dr. Rachlin explained that there are two types of hypertension – mild and severe. A “severe” diagnosis requires two readings six hours apart equal to or greater than 160/110. 140/90 is normal. It is common knowledge that of the upper (systolic) number and the lower (diastolic) number, the diastolic is the more important number since the systolic is more prone to fluctuations.
20Martha’s blood pressure on January 20, 1993, was 130/90; on January 26, 1993 was 120/80; and on February 9, 1993 was 130/80. Dr. Rachlin agreed that one could conclude that any underlying hypertension was well controlled. Further, Dr. Davies and Dr. Rachlin agreed that the only antenatal blood pressure readings were of concern were February 19, 1993 – 150/90; March 26, 1993 – 150/90; and March 31, 1993 – 160/90.
21Of note here, as well, is that Dr. Laine examined Martha on March 9, 1993, and as is his practice, he would have taken her blood pressure, but it was not recorded.
22Now, while none of the above readings are considered severe by the experts, none were ignored by Dr. Laine. On February 19, 1993, he ordered an ultrasound scan, blood tests and urinalysis. On March 26 he ordered a non-stress test. On March 31 he ordered another non-stress test, an ultrasound and further urinalysis. And on March 31 he ordered a low dose of enalapril to respond to the elevated blood pressure. So it cannot be said that Dr. Laine failed to respond to increases in Martha’s blood pressure.
23Regarding diagnosis for pre-eclampsia, clearly Dr. Laine was aware of the necessity of testing the urine for protein (and so possibly for pre-eclampsia) since he ordered tests on February 19 and March 31 even though two previous tests had shown negative for protein in Martha’s urine. Strangely enough, of all the tests ordered over the course of this pregnancy, the results of these tests appear to be the only ones not in the clinical records. This, however, does not mean that the tests were not done and reviewed by Dr. Laine. Considering that he was operating out of three locations, the clinic at Ogoki Post, his own office, and the Geraldton Hospital, and 20 years having elapsed, it is not unlikely that some records, available at the time are no longer available.
24Regarding protein in the urine, another issue raised, particularly by Dr. Davies, was that the dip stick (single sample) tests ordered by Dr. Laine were not adequate as opposed to the 24 hour urine test. However, Dr. Rachlin and Dr. Oppenheimer both confirmed that in the 1990s the dip stick test was relied upon by doctors to check for protein in the urine in pregnant patients and it is apparently still satisfactory for testing for protein for the purposes of Antenatals I and II. Dr. Oppenheimer also confirmed that false positive results from the dip stick tests were very low and the 24 hour urinalysis was generally only used if the dip stick test demonstrated positive result for protein.
25Further, Dr. Oppenheimer testified that with negative tests September 9, 1992 and December 10, 1992, and only a “trace” showing on a test April 13, 1993, it was highly unlikely there was any abnormal protein in Martha’s urine during the pregnancy.
26For all of these reasons, I cannot conclude that Dr. Laine’s conduct fell below the standard of care in treating and monitoring Martha’s hypertensive situation.
(4) Record Keeping (Antenatal Visits and Risk Assessment)
27Record keeping is clearly an important part of medical care. It would seem clear that at the time of the first antenatal visit, a complete history of the patient’s medical condition should be taken and recorded to assist in assessing risks as the pregnancy develops. This was the position taken by Dr. Davies and Dr. Rachlin. In Ontario, this is often done by the use of a form called Antenatal I. Then, as the pregnancy develops, continuing information is recorded in a companion form – Antenatal II, and appropriate comparisons can be made. Use of these forms is helpful but not mandatory. Dr. Laine was familiar with these forms at the time of Martha’s pregnancy.
28While in this case Dr. Laine clearly failed to do and record a complete medical history, from the start, this does not mean that he did not properly care for his patient as the pregnancy progressed – that has to be determined by the evidence. However, it appears his record keeping, at least initially, did fall below the standard of care required under the circumstances.
(5) Failure to Refer to Obstetrician
29After a considerable amount of discussion, particularly around the testimony of Dr. Rachlin concerning Taylor’s size and the grading of this pregnancy in the Antenatal Form II, Dr. Rachlin agreed that Taylor was not undersized and this was a Grade “B” pregnancy. This means, according to Antenatal II, that consultation is not necessary but should be “considered”.
30Dr. Oppenheimer was also of the view that this was a Grade “B” pregnancy meaning it was not high risk, but possible problems had to be watched out for. Dr. Oppenheimer also thought that under the circumstances here, there was a good possibility that a consultant obstetrician would not have recommended any different treatment.
31While Dr. Davies disagrees with these opinions stating he thinks this was a Grade “C” pregnancy and that a consultation should have been done, the weight of evidence seems to be in the other direction.
32Consequently, I cannot see how the lack of a consultation here breached the required standard of care by Dr. Laine.
(6) Failure to Induce or Refer for Induction
33It seems to me that this was clearly a matter of clinical judgment. As Dr. Oppenheimer stated it is the doctor’s decision as to whether a pregnancy should be managed by natural birth or by way of induction. Inductions were not done at the Geraldton Hospital in 1993. Dr. Rachlin was not aware of this when he formed his opinion that Taylor should have been induced. Furthermore, he was unaware that Tyla, the next baby born after Taylor, had to be induced twice before she was born. Dr. Rachlin eventually agreed that unless there was evidence of protein in Martha’s urine the situation did not call for induction. Furthermore, the tests for inducing, as set out in Williams in Obstetrics (1989) – probably the highest regarded publication in obstetrics – indicates three items: (1) a rapid rise in blood pressure; (2) proteinuria; and (3) fetal growth restriction.
34Dr. Oppenheimer expanded on these factors. Firstly, mild blood pressure elevation late in pregnancy is not unusual and not dangerous to the fetus. Secondly, in Dr. Oppenheimer’s opinion , as mentioned earlier, protein was not an issue here, and thirdly, fetal growth was not an issue.
35Based on all these opinions, I am of the opinion that this was a clinical judgment properly made by Dr. Laine and consequently did not fall below the standard of care required.
(7) Prescribing Drugs (Enalapril)
36On March 31, 1993, Dr. Laine prescribed a very low dose of enalapril (the trade name being Vasotec) to reduce Martha’s blood pressure, which had risen to 160/90. The normal recommended dosage is 40 milligrams but Dr. Laine prescribed 5 milligrams. There was an immediate reduction of blood pressure to a normal range.
37It is alleged by the plaintiffs that prescribing this drug was a breach of the standard of care, since it should not have been given to a pregnant woman, and Dr. Laine should have known this.
38According to Richard Szako, representing the manufacturer Merck, company records show a plan had been set up to advise regarding enalapril problems. According to Warren Douglas, a drug representative for Merck, he had visited Dr. Laine and left him with samples of enalapril and may have left him with a Monogram.
39Apparently in March of 1992 a letter had been sent by the manufacture of enalapril to physicians, as directed by Health Canada, that for safety reasons, pregnant women should not be given enalapril, which is an ACE inhibitor, which reduces blood pressure.
40Dr. Laine does not remember receiving such a letter but does admit to keeping a current volume of Compendium of Pharmaceuticals and Specialities (CPS) on his desk for drug references, which he would have referred to.
41Now it was around this time that concern was being expressed regarding the use of ACE inhibitors in pregnancy. As an example in the 1992 volume of Williams Obstetrics (18th Edition) probably the most authoritative publication on the topic, there was no contraindications for the use of ACE inhibitors in pregnancy, there were no warning or precautions mentioned at all. All that is said is a suggestion that if it is to be used in pregnancy situations, one should balance the risks against the potential benefits. However in the 1993 version of Williams Obstetrics (19th Edition) ACE inhibitors were contra indicted in pregnancy.
42So even if Dr. Laine knew all of this, or should have known all of this, he was still faced with the problem of reducing Martha’s blood pressure for a few days until the birth, and so he chose to give her a minimal amount of enalapril. And the evidence has become clearer that Martha did not fill a prescription at the drug store, but only received a sample pack of perhaps four, 5 mg pills from Dr. Laine.
43And we now know from Dr. Reider and Dr. Koren that with such a small amount of the drug passing through the mother to the baby, and the immediate effect of reducing Martha’s hypertension that the risk/benefit valuation would fall largely in the benefit category.
44Furthermore as pointed out by Dr. Oppenheimer, the work of the researcher Tabacova, whose research was discussed at length in this trial, makes it clear that in the 1993 and well beyond that enalapril was being prescribed by doctors to their pregnant patients.
45In conclusion, therefore, it was Dr. Oppenheimer’s opinion on the basis of all of these facts, and with all other evidence at the time of the health of Taylor and Martha being positive, Dr. Laine met the required standard of care regarding his prescribing enalapril. I agree.
(8) Fetal Surveillance.
46Dr. Laine was constantly monitoring Martha’s situation with ultrasounds, non-stress tests (baby’s heart) and electronic heart monitoring during labour. Everyone agrees that all tests were “reassuring”, and in fact there were more ultrasounds than is usual in the course of a normal pregnancy. Furthermore, Dr. Oppenheimer indicates that the results of the ultrasound tests and the non-stress tests on April 1 indicated that as a general rule the fetus would be in good condition for the next seven days.
47In conclusion, it appears clear that the care delivered to Martha and Taylor by Dr. Laine met the standard of care required by a family doctor in the circumstances. While it may be that Dr. Laine failed in some areas, as mentioned, the major areas of care were well covered, and the standard of care was met.
(C) INFORMED CONSENT ISSUE
48The Plaintiffs have raised the issue of informed consent. There is no disagreement that the law of informed consent requires a doctor to provide adequate disclosure regarding the nature of treatment and attendant risks and to provide alternate treatment methods if necessary. Here, Dr. Davies and Dr. Rachlin take the position that Dr. Laine should have discussed the risks of enalapril with Martha as well as the option of induction. Dr. Oppenheimer, on the other hand, disagreed that in a normal pregnancy situation you had to discuss induction with the patient.
49The evidence indicates that Martha was induced with her first pregnancy so she knew about inductions. Dr. Laine said he would have discussed his examination of Martha on March 31 (including her increased blood pressure) with her and told her he was prescribing a small dose of blood pressure medication. Martha in her evidence does not deny that this could be the case.
50Two things are clear. The first is that Dr. Laine was not aware of pregnancy risks regarding enalapril at the time he prescribed it. And second, he had decided that induction was not indicated in this case. For these reasons, it makes no sense to suggest that he was obligated to inform Martha of any risks or alternatives. And, in any event, it is unlikely that she would not have followed any recommendations that he made, since there is no evidence whatsoever that over the many years that Dr. Laine treated Martha, and in particular with respect to this pregnancy, that she did not accept his recommendations.
51Clearly, then, Dr. Laine did not fall below the standard of care in failing in his responsibility to inform Martha properly.
Issue #2 - Causation
(a) The Law
52Causation is established when the Plaintiff proves on a balance of probabilities that the Defendant caused the injury complained of. The test has become known as the “but for” test, and has been recently summarized by the Supreme Court of Canada in the case of Clements v. Clements (2012 SCC 32, 2012 S.C.J. No. 32) where it is said at para. 46:
“The foregoing discussion leads me to the following conclusions as to the present state of the law in Canada:
(1) As a general rule, a plaintiff cannot succeed unless she shows as a matter of fact that she would not have suffered the loss “but for” the negligent act or acts of the defendant. A trial judge is to take a robust and pragmatic approach to determining if a plaintiff has established that the defendant’s negligence caused her loss. Scientific proof of causation is not required.
(2) Exceptionally, a plaintiff may succeed by showing that the defendant’s conduct materially contributed to risk of the plaintiff’s injury, where (a) the plaintiff has established that her loss would not have occurred “but for” the negligence of two or more tortfeasors, each possibly in fact responsible for the loss; and (b) the plaintiff, through no fault of her own, is unable to show that any one of the possible tortfeasors in fact was the necessary or “but for” cause of her injury, because each can point to one another as the possible “but for” cause of the injury, defeating a finding of causation on a balance of probabilities against anyone.”
53From a review of the opening statement by counsel for the Plaintiffs, and of the evidence presented on behalf of the Plaintiffs, it is clear that the Plaintiffs’ case at the start revolved around the use of the drug enalapril (trade name Vasotec) which was prescribed to Martha by Dr. Laine on March 31, 1993, as the “but for” cause of Taylor’s injury. However, in final submissions, it appears that Plaintiffs’ counsel resiled from this position, and took the position that enalapril was only a contributing factor to the Plaintiff’s injury – the “but for” cause being Martha’s hypertension in the third trimester, which caused placental insufficiently in the fetus. I intend to deal with both of these theories.
(c) The Evidence of the Witnesses
- Evidence of Dr. Jacques Belik
54Dr. Balik testified for the plaintiffs as a neo-natal and peri-natal specialist i.e. looking after newborns during birth, after birth, and also involved in prenatal treatment. He is presently a professor of physiology and professor of paediatrics at the University of Toronto. At the present time he is also attached to the Hospital for Sick Children in Toronto as a Senior Associate Scientist, and as a member of the Physiology and Experimental Medicine Research Group. He has published and spoken widely in his field, as well as tutoring numerous masters and doctorial students. Dr. Belik testified that prior to birth only 5% of the fetus’ blood goes through the lungs – the other 95% is filtered through the mother. At birth, the blood pressure in the lungs has to decrease to allow 100% of the blood to go through the lungs, and if this does not happen the heart can be damaged by having to pump harder to get blood (and oxygen) to the other organs.
55Such a situation can be caused by a decrease in blood pressure in the fetus at birth, this can happen when meconium, which is the baby’s first stool, is released early into the amniotic fluid surrounding the baby. If this happens, and the baby “gasps” due to straining for oxygen, then the meconium is aspirated into the lungs, causing decreased ability of the lungs to accept and oxygenate the blood flowing through to the heart and the rest of the body. This lung condition is called persistent pulmonary hypertension, which can be caused in other ways, but in this case meconium ingestion seems to be how it happened. So, when Taylor, who had a good heart rate before she was born, was born with virtually no pulse and no respiration, and it took some 13 minutes to get her heart going properly, Dr. Belik concluded that her heart had been damaged prior to birth and things had become progressively worse afterwards, all resulting from the low blood pressure caused by the enalapril, and eventually resulting in damage to her brain. He did indicate, however, that other stresses at birth can cause the same situation, i.e. the umbilical cord around the neck, very forceful labour, or perhaps the baby’s position squeezing the umbilical cord. Interestingly enough, Dr. Belik had excluded Martha’s high blood pressure as a significant factor affecting the fetus. He said it might have caused mild placental insufficiency, but not enough to hinder growth, and concluded that if enalapril had not been administered the odds would have been that it would have been a normal birth.
56Dr. Belik also explained how enalapril acts in the body to reduce blood pressure. The kidneys filter out waste products in the blood and expel them through the urine. The enalapril affects the enzyme action in the kidneys, resulting in a lowering of the pressure, in the kidneys. This should show up in decreased urine production but that was not the case with Taylor.
- Evidence of Dr. Gregory Davies
57Dr. Davies testified for the Plaintiffs as an expert in obstetrics and gynecology, with a specialty in initial fetal medicine. He testified both as an expert on standard of care as well as causation. His qualifications are set out in paragraph (9)
58Regarding causation, Dr. Davies agrees with Dr. Belik that even though other causes were possible, all indicators lead to the conclusion that the cause of Taylor’s injury was hypotension (hypoxemia) after birth caused by enalapril given before birth, i.e. meconium aspiration, length of enalapril treatment, need for ventilation and medication to restart Taylor’s heart and failure of a heart rate at birth. He agrees that the hypoxic-ischemia probably occurred between the end of the end of the fetal heart strip monitoring Taylor’s heart during labour and delivery, that prior to delivery there was nothing to indicate damage to Taylor’s brain, heart or kidneys. He also said the fetal stress test would show if there was a hypoxic situation within the fetus “most of the time” and this was not the case here. Finally, regarding placental insufficiency prior to birth, Dr. Davies thought this could be a factor in Taylor’s condition, but indicated that Martha’s hypertension, without the addition of enalapril, would have been unlikely to cause such a bad outcome.
- Evidence of Dr. Derek Armstrong
59The Plaintiffs called Dr. Derek Armstrong, an expert pediatric neuro-radiologist, to give evidence concerning causation. Dr. Armstrong, in his every day work is a staff member in the Division of Neuroradiology at the Hospital for Sick Children in Toronto. He is an associate professor in the Department of Radiology, University of Toronto. He belongs to numerous professional organizations, has trained numerous fellows, attended meetings and lectured worldwide in his field and has written extensively.
60Dr. Armstrong explained that the brain is divided into two hemispheres. The ventricular systems in each hemisphere hold fluid that circulates around the surface of the brain. Grey matter is a layer covering the surface of the brain – white matter is under the grey and covers everything except the ventricles. The brain is nourished by glucose and oxygen and waste products are absorbed in the blood stream around the brain. Ultrasound brain scans are used to determine injury to the brain. Echogenicity is the quality of the echoes on the tests.
61There are two types of injuries that increase the echogenicity on the scan – mechanical and failure of oxygen or glucose. Cerebral edema is brain swelling showing up on the scans. The scan results can also tell the timing of the original injury.
62From the ultrasound of April 8, 1993 – the day after Taylor’s birth – Dr. Armstrong calculated the initial injury was due to oxygen deprivation 24 to 48 hours before, i.e. around the time of Taylor’s birth.
63An ultrasound of April 12, also showed hemorrhaging, which happens when the brain swells which usually lasts for five to seven days and then when the swelling decreases the injured blood vessels rupture and bleed into the white matter. So again, by counting backwards, this takes us to an injury date around the time of the birth.
64Finally, a review of the scan done on April 14, 1993 still shows some swelling, shows multiple hemorrhages within each hemisphere, with moderate bleeding into the ventricles.
65Dr. Armstrong’s opinion is that the first injury was a hypoxic-ischemic event caused by a drop in blood pressure associated with heart stoppage. This initial event happened around the time of birth. The second injury was multiple brain hemorrhaging, results in cerebral palsy, which, in Dr. Armstrong’s opinion, is a permanent condition. Cerebral palsy is a non-progressive injury of the brain that causes motor dysfunction and developmental delays. Dr. Armstrong’s opinion was not challenged.
- Evidence of Dr. Michael Reider
66Dr. Reider was qualified to give expert evidence as a pediatric pharmacologist regarding the effect of drugs on Taylor, and was called to give evidence on behalf of the Plaintiffs. I will review his qualifications later.
67Dr. Reider testified that Taylor’s having no heart rate, and not breathing and needing resuscitation at birth was caused by a lack of oxygen due to one of four things: septic (infection), difficult delivery, metabolic (cell) disorder and hypotension (low blood pressure). He ruled out everything but hypotension, and decided this was caused by the enalapril Martha had taken because:
(1) up to the time of birth there was no enalapril induced fetopathy, i.e. no loss of amniotic fluid, no growth restrictions, no heart problems, no kidney difficulty, no reduced urine;
(2) after taking enalapril blood pressure was lowered in Martha and Taylor, the fetus could not handle the stress of delivery, the heart stops, no respiration, meconium aspiration adds a complication from rectal relaxation, this caused pulmonary and other problems and also the drugs needed to get the blood pressure up indicated that this was all a drug related problem.
68Dr. Reider agreed that the dosage given was very low, i.e. 5 mgs per day, and since only 60% of this amount is ingested into the mother, and of that 60% only 3% reaches the placenta, the amount the fetus received is considerably less than would be recommended for a child (and of course we now know that Martha apparently did not fill the prescription and may have only received a package of four 5 mg. pills from Dr. Laine).
69Dr. Reider’s conclusion was that the cause of the difficulties at birth was a hypoxic-eschemic event which happened between the last fetal tests and the birth. He said the stress of birth and labour was the “precipitating” factor and that enalapril prevented Taylor from responding well due to its effects on her. Dr. Reider comments that if the stress of labour could have been avoided, i.e. by caesarian section, then the difficulties would have also been avoided.
- Evidence of Dr. Gideon Koren
70Dr. Koren is a pediatric pharmacologist. He testified on behalf of the defence. I will review his qualifications later. He stated that there was no fetopathy, i.e. pattern of disease, in Taylor that would indicate enalapril was involved in her hypoxic-eschemic situation at birth. Enalapril lowers blood pressure by inhibiting a hormone (enzyme) in the kidney which increases blood pressure which could result in:
(1) lack of urine being produced (anuria) – (Taylor had voided three times before getting to Thunder Bay and well thereafter);
(2) squashed skull due to a lack of amniotic fluid “since a baby’s urine is a source of amniotic fluid at this point” not present;
(3) high creatine (waste material) in the blood – showing kidneys are not working properly is not present; and
(4) olioghramdosis which is a lowering of amniotic fluid – which was not present here either.
71Another indication that enalapril was not involved was the low dose (2.5 mgs is the lowest dose given) and Dr. Laine prescribed 5 mgs for a very short period of time (seven days maximum). This amount of drug in a 200 lb. woman would mean that very little of the drug would cross the placenta to the baby. It was Dr. Koren’s position that a baby could receive directly “100 fold” larger amount than Taylor would have received without damage.
72Dr. Koren also pointed out that there are other causes, such as chronic hypertension, that could explain such a situation without the use of a drug. He also pointed out that atenolol, a beta blocker, taken for the whole of the pregnancy, would have more of an effect than enalapril which had been taken for seven days.
73Dr. Koren also pointed out that Taylor had persistent pulmonary hypertension as a result of aspirating meconium into her lungs and that is why she had hypoxia. He knows of no information that would indicate that enalapril causes persistent pulmonary hypertension in newborns.
74Finally, Dr. Koren points out that if enalapril was a cause, then the effect (i.e. low blood pressure) would have disappeared after birth but it did not.
75Dr. Koren’s conclusion, all considered, is that it was very unlikely, and biologically impossible, for enalapril to materially contribute to the outcome here.
- Evidence of Dr. Michael Marrin
76Dr. Marrin, a pediatrician and neo-natologist, was called to give evidence for the defence. He is currently Associate Professor of Pediatrics at McMaster Universty, and a staff member of the Hamilton Health Sciences Corporation. Consequently, he is involved in Teaching, Administration & Research in the field of Neo-natology. He is chair of the Evaluation Committee & Academic Progress Committee at De Groote School of Medicine. He is a Representative on the Medical Counsel of Canada and presently President of the Council. He has published extensively. He summarized the cause of Taylor’s brain injury as follows:
(1) evidence of some placental insufficiency before birth - i.e. blood tests after birth showed fetus releasing immature blood cells to capture more oxygen; i.e. relationship between the head circumference and the birth measurements; i.e. peeling skin may also have been a sign of placenta insufficiency;
(2) intrauterine event – in the latter part of labour – this caused Taylor to be depressed (no heart rate and no respiration);
(3) the depression continued for several minutes after birth;
(4) the depression continues for a couple of days thereafter;
(5) brain injury resulted from an intrauterine event and the events that followed;
(6) the low, undetectable heart rate for the first 13 minutes of life resulted in reduced blood pressure and reduced profusion of blood oxygen to the brain;
(7) Taylor’s lungs were impaired because of a condition known as persistent pulmonary hypertension – a paralysis caused, in this case, by meconium aspiration into her lungs in turn leading to the reduced flow of blood and oxygen.
77Dr. Marrin full agrees with Dr. Koren that enalapril was not the cause of Taylor’s brain injury. He explains, as Dr. Koren did, that enalapril works by restricting enzymes in the kidney that increase blood pressure. Blood pressure in the kidney constricts vessels so filtration process can work. If pressure is reduced by enalapril so should urine production. Here, there is no evidence of enalapril even before birth since she was borne with urine in her bladder. There was also no evidence after birth in Geraldton or Thunder Bay, even though Dr. Marrin felt it possible you could have a reduction in pressure in the kidneys without it showing up. However, Dr. Marrin felt it unlikely that if enalapril did cause a change in other organs, then it would surely show up in the kidney as well since that is the organ which creates the process.
78Dr. Marrin suggested that even though it was a dramatic intrauterine event at the time of birth that caused the hypoxic-eschemic situation, Taylor was less able to withstand this because of an increase in Martha’s blood pressure after February 19, 1993, which resulted in some placenta insufficiency.
7.. Evidence of Martha Achneepineskum
79Martha testified that Taylor was her fourth child – that all her children were vaginal deliveries, that she could remember no problems or complications with her pregnancy with Taylor. She is not sure where she got the enalapril pills but she does remember taking them.
CONCLUSION ON CAUSATION
A. Enalapril As A Cause
80In this case we have the benefit of hearing evidence from two excellent pediatric pharmacologists, Dr. Michael Reider and Dr. Gideon Koren. While they are the experts in this case I must rely on for a final opinion on the effect of enalapril, unfortunately they do not agree. Consequently I must decide whose opinion I should respect on this topic.
81Dr. Reider is a professor in the Department of Pediatrics, Physiology and Pharmacology and Medicine at the University of Western Ontario. He has a doctorate which focuses on the topic of adverse drug reaction. His clinical and patient care duties include directing an Adverse Drug Clinic and Drug Exposure Clinic at the Children’s Hospital of Western Ontario. He, of course, is connected to all the appropriate professional associations, has received numerous honours for his work and has received considerable research funding and has published extensively.
82Dr. Koren is currently a full professor at both the University of Toronto and the University of Western Ontario. At Toronto he is a Professor of Pediatrics, Pharmacology, Pharmacy and Medicine. At Western he is Professor of Medicine, Pediatrics and Pharmacology/Physiology.
83Dr. Koren is also connected with the Hospital For Sick Children in Toronto. He is a staff pediatrician and ward chief as well as Associate Director for Clinical Research. He was involved, from its inception, and is a supervisor in the Motherisk Program which is a program staffed by some 70 researchers, students and professors, specializing in the effect of drugs on children. This organization receives some 200 calls per day from doctors and citizens with requests for information in drugs.
84Dr. Koren is on numerous professional boards, editorial boards, is a reviewer for all the respected journals regarding articles his field. He, of course, has written extensively in his field. He estimates he has received some $55,000,000.00 research grants. He has testified as an expert in his field in numerous cases.
85I cannot imagine anyone more up-to-date or more current on the use and effect of drugs involved in this case than Dr. Gideon Koren. Without wishing to repeat Dr. Koren’s opinion as set out earlier, I would just say that I accept his opinion that enalapril was not a cause of Taylor’s injuries. As Dr. Koren set out there was no fetopathy which would indicate enalapril adversely affected Taylor, and in particular, there was no decrease in urine which would indicate enalapril, which acts in the kidneys, was involved.
86Furthermore, as Dr. Reider has testified, the amount of enalapril involved was very small. Dr. Koren’s opinion is also supported by Dr. Marrin.
87Finally, as I indicated earlier, the Plaintiffs have themselves resiled from their initial position that enalapril is the cause of Taylor’s injury. They now say that the case was Martha’s hypertension during the third trimester, and that enalapril only aggravated this problem.
88So, for all of the above reasons, I find that the Plaintiffs have failed to prove that enalapril was the cause of Taylor’s injuries.
B. Martha’s Hypertension as a Cause
89The Plaintiffs’ claim based on Dr. Marrin’s testimony that an increase in blood pressure from February 19, 1993 – or in fact a pre-eclampsia condition – resulted in less oxygen getting to the placenta thus effecting the fetus so it was less able to tolerate the stress of labour, and enalapril aggravated the situation and this was the cause of Taylor’s injury.
90This argument is difficult to make since the Plaintiffs’ evidence on causation has all been directed at enalapril.
91As far as pre-eclampsia is concerned this is the condition where a pregnant woman has hypertension i.e. blood pressure over 140/90, along with protein in her urine. In dealing with standard of care there has been much said about protein and I have accepted that it was unlikely Martha had a protein problem during the pregnancy.
92Preeclampsia as explained by Dr. Davies does not appear to have occurred here. It is very serious, some of the effects being seizures, brain hemorrhages, myocardial events, and placental disruption. There is a more severe form called HELLP syndrome, which can cause dysfunction of the liver, a breaking up of blood cells, and a dysfunction of platelets. None of these symptoms were ever exhibited by Martha, who reported a pregnancy without any problems.
93Regarding Martha’s hypertension, Dr. Belik was also asked directly about Martha’s blood pressure and placental insufficiency. In commenting on Dr. Marrin report, Dr. Belik said there may have been some placental insufficiency demonstrated, but certainly not enough to hinder fetal growth.
94Furthermore, Martha’s recorded blood pressure never went over 150/90 until March 31 when Dr. Laine prescribed the enalapril. As has been explained a diastolic pressure is the most important number because it is less subject to fluctuations. Martha’s diastolic blood pressure never went over 90, and dropped to 80 after the enalapril was given. And her systolic pressure never went over 150 until March 31, when it was at 160, and lowed by enalapril. Surely this is very “mild” hypertension.
95Also, Dr. Davies stated that if there was a hypoxic (decrease in oxygen) situation occurring is should show up on the fetal heart strip much of time as variations on the strip. The March 29, 1993 strip, he says, does not show such variations.
96Consequently it is difficult to see how it could be concluded that Martha had a serious hypertension problem.
97And regarding the alleged effect of enalapril, Dr. Marrin concedes if it had any effect at all, it would be minimal.
98Also of note is that all of the four ultrasounds taken throughout the pregnancy were reassuring as were the heart monitors, showing there was no cause for concern that there was not a viable healthy fetus waiting to be born.
99Finally I would say this. For the most part all witnesses agree that at some time during the few minutes between the end of the fetal heart monitor strip and Taylor’s birth an event occurred which led to her injury. We are not sure what that event was. However, Dr. Marrin gives an opinion as follows:
Re-Examination by Mr. Cruz (pp. 80 – 784 – Marrin re-examination):
“Q. Dr. Marrin, this morning when Mr. Halpern was cross-examining you he was talking to you about intrapartum asphyxia. Do you remember?
A. Yes.
Q. And he drew this Exhibit 97 with you and so I’m looking at it now, and as I understood the discussion the “X” in the top left corner is a point in time when the baby’s in good condition. Is that how you understood it?
A. Yes.
Q. And then the oxygen drops and the baby ultimately decompensates as you discussed with Mr. Halpern. Is that right?
A. That’s correct.
Q. And so when did Taylor go through this process, in your opinion?
A. Well, I think it occurred close to the time of her birth. Specifically, I would think within the last hour and probably within the last several minutes. The reason for saying that is that she was so profoundly depressed at birth. If she had gone through this process – if something had caused this process to occur to the degree that we are discussing here, and that had occurred, for example, many hours before she was born, she would not have survived in utero, I think, to be born alive, or there would have been a process like this that occurred in utero – that process went away; it abated for some reason. She would have had some period of time to recover, to some extent, prior to being born and I would not expect her to have been as profoundly depressed at birth as she was. So, I think for me, a very important observation here is how depressed she was at birth and that to me means that this – specifically this process we were describing, was occurring virtually up to the time of her birth.
Q. All right and to the extent that Exhibit 97 contemplates – contemplates the oxygenation being good at the beginning of that process, in the minutes before birth or time before birth, and there’s a drop in oxygenation that follows after that good starting point, what accounts for the drop in oxygenation?
A. Well, the – if I understand the question correctly, what will account for the drop in oxygenation is some – something fairly acute has happened during the course of the labour which has interrupted oxygen delivery to the baby. We don’t really know what that something was, but the fall in oxygen delivery would have occurred – could have occurred quite rapidly reaching that inflection point where there is now a – a steady decline toward decompensation. I’m not sure if I understood the question correctly, but I think that’s…
Q. I think you partially answered it?
A. Okay.
Q. So you’ve said that something happened acutely. What are the options?
MR. HALPERN: Well, this is something that that could have been explored in-chief. This is a new area now. I’ve – if my friend wanted to ask this of Dr. Marrin, he should have done it in-chief, not in cross – not in re-examination.
MR. CRUZ: It’s not a new area. This is responding to a cross-examination where my friend draws a diagram should a drop in oxygenation and I’m asking…
THE COURT: Yeah, I – I think that’s fair.
MR. HALPERN: All right.
MR. CRUZ: Q. So what are the options for the – or what are the potential reasons for that drop from good, down the line?
A. Well they will include compression – compression of the blood vessels feeding the – the mother’s blood vessels going to the uterus and supplying the placenta so that with each uterine contraction there will be come compression of those vessels and at least a transient or intermittent interruption of oxygen delivery to the placenta and therefore to the fetus. Another possibility is the next probably likely possibility, given that common things are common, is that there was some at least intermittent or at least partial compression of the umbilical cord such that the oxygen that was coming from the mother’s body getting across the uterus to the placenta was not able to be delivered through the umbilical cord from the placenta to the baby. Those would be the two common scenarios for and intrapartum kind of hypoxic ischemic process. We talked about other more catastrophic things that may occur such as abruption of the placenta, but that we – we don’t have evidence that that occurred here.
Q. All right so to the extent you’ve named two things, absent those two things or one of those two things being present, could this kind of decompensation occur?
A. No and I wonder if it maybe important to clarify that this kind of decompensation could not occur, absence some very sudden change in oxygen delivery to the fetus, and have that child survive for more than a couple of hours in that kind of an environment. So, all of the discussion that we have had about whether or not there was placental sufficiency, to what degree there may have been interruption of sufficient oxygen delivery to the fetus, and to what extent Taylor may have shown that she was trying to adapt to that environment, those things would not by themselves create the scenario that we have outlined on the graph here. There has to have been a new, very substantial interruption of oxygen delivery to result in this, and the pattern that we discussed this morning illustrated here would likely be evolving over less than an hour, something in that range.”
100So it seems that Dr. Marrin is identifying the likely “but for” cause of Taylor’s injuries to be interruption of oxygen due to cord compression or difficult uterine contractions at birth.
101So I conclude, for all of the above reasons, that the Plaintiffs have failed to prove that Martha’s hypertension or pre-eclampsia was the cause of Taylor’s injuries.
Issue #3: Duty of Care
102Counsel for the defence indicated earlier that if enalapril (Vasotec) was not found to be the cause of Taylor’s injuries, that the defendants position would be that duty of care was no longer an issue in the case to be decided by the Court. Since that is the case this issue will no longer be addressed.
CONCLUSION
103In conclusion, since I have found that plaintiff has failed to prove on a balance of probabilities that either the defendant Dr. Laine’s conduct during his care of Martha fell below the required stand of care, nor anything that he has done or not done was the cause of Taylor’s injuries, the Plaintiffs’ case has failed and is hereby dismissed.
COSTS
104If a cost hearing is necessary, arrangements will be made through the trial co-ordinator in Thunder Bay within the next 30 days.
The Hon. Mr. Justice J. F. McCartney
Released: February 27, 2013
COURT FILE NO.: CV-95-0336
DATE: 2013-02-27
ONTARIO
SUPERIOR COURT OF JUSTICE
B E T W E E N:
Taylor Achneepineskum and Jasmine Achneepineskum, by their Litigation Guardian, Samuel Achneepineskum, Martha Achneepineskum, Olivia Achneepineskum, Daryl Achneepineskum, Samuel Achneepineskum, J.R., and the said Samuel Achneepineskum, personally,
Plaintiffs
- and –
Roy Laine, Geraldton District Hospital, Astra Zeneca Canada Inc., and Merck Frosst Canada Ltd.,
Defendants
REASONS FOR JUDGMENT
McCartney J.
Released: February 27, 2013
/mls