1. Establishing Product ID and Injury ID
Our Physicians have been specially trained to approach SSRI case reviews. We understand the vital necessity is to establish
Product ID/Proof of Use: Whether mother took SSRI, dosage, duration details
Injury ID: We will establish from the medical records whether child developed characteristic/specific birth injury
Our Reviewers Team underwent a One Day Workshop conducted by our MD – OBGYN Specialist on various birth injuries that SSRIs can cause i.e.
(1) Cardiac Injuries – Atrial Septal defects, Ventricle Septal Defects, Tetrology of fallot, Patent ductus arteriosus, Patent foramen ovale, coarctation of aorta, left or right ventricular hypertrophy, aortic insufficiency, congestive heart failure, , super ventricular tachycardia, Transposition of the great arteries
(2) Cranial and Neural Injuries: hydrocephalus, craniostynostosis, neural tube defects, Spina bifida
(3) Lung Injuries: Pulmonary Hypertension, Persistent pulmonary hypertension, pulmonary valve stenosis, respiratory failure
(4) Urogenital defect
(5) Omphalocele, Anal artesia, Digestive system defects
(6) Physical Deformity: cleft pallet, limb reductions, Club feet
2. Separate Chronologies for Mother and Child
Though the injuries are caused in the child, since it is the mother that ingests the SSRI we will provide separate summaries for mother and child
Summary of Mother: Focuses on Pregnancy medical condition, need for taking SSRI, whether SSRI is recommended, any abnormal labs/tests/medical condition, monitoring of fetal development, drug intake details
Summary of Child: Starting from birth – when did the defects develop, complications, consultations, treatment and management of defects
3. Physician Case Notes
Apart from summaries we also deliver Physician Case Notes covering interesting case findings, contradicting details, critical details not available etc.
No Evidence of Zoloft Intake
On complete review records from mother and child, we do not find any evidence in the available records that Ms. XXXX (mother) took Zoloft during her pregnancy. Child was born premature and suffered from congenital heart disease, hypospadias, left cephalohematoma.
Suggestions: We need to check whether the complete set of medical records were received, also discuss with mother and get details about Zoloft intake, retrieve pharmacy bills for the pregnancy period.
Injury as a result of Zoloft
We note that Ms. XXX (mother) was started on Sertraline (Zoloft) for depression during her pregnancy but we do not have records as to when Ms. XXXX was started on the aforementioned drug and who prescribed it. She suffered from Preterm labor, mild preeclampsia, and borderline elevated neural tube defect risk. Her baby (XXXXX) developed cardiac anomalies, and dysplastic tricuspid valve with moderate tricuspid regurgitation, dilated right atrium and right ventricle due to Zoloft ingestion
MD Specialist Review
Our MD Specialists get involved in SSRI case reviews as needed. Few examples where their consultation and opinion was sought
1. Our OBGYN/Radiologist reviewed the Sonogram films on a case where mother took SSRI and child developed truncus aterioriosis. In this case client wanted to confirm whether the defect was noted in the sonogram films as the parents were not advised about this defect
2. MD Neonatal Intensive Care Pediatric Specialist – was approached on a case in which child developed hydrocephalus – opinion was hydrocephalus was due to inappropriate management of meningitis condition
3. OBGYN Specialist – opinion sought whether SSRI was recommended for the patient. Our answer was yes.