This case involves a child who was born with hypospadia and a congenital heart defect, which required the replacement of a cardiac conduit. The conduit was from a cadaver donor and the parents were told that it would have to be replaced in eighteen years. The child had a perfectly normal, healthy, and active life up to the age of twenty-one. The physicians on this case chose not to replace the conduit until the patient reached twenty-one years of age. By that time, the conduit had developed significant scar tissue and fused to the chest wall. During surgery, the chest was opened, and the conduit immediately ripped away from the chest wall causing a massive intraoperative bleed. The patient suffered a prolonged period of hypotension along with several seizures. As a result, the patient passed away shortly after the operation and the cause of death was attributed to cardiac arrest.

Arterial reconstructions in the pediatric population pose notable challenges to cardiac, vascular, oncologic, and pediatric surgeons. Small vessels, spasm, and the potential for growth over time should be considered before any repair procedure is performed. The choice of conduit for vascular reconstruction in the pediatric patient depends on the patient's specific circumstances. No single therapeutic strategy can be applied to all patient's. The patient's age, developmental status, and indications for reconstruction dictate the choice of a conduit. Research is underway on tissue-engineered conduits to decrease thrombogenicity and the tendency of the implant to create severe postoperative scarring. In the future, stem cells derived from bone marrow or embryonic stem cells might be used to regenerate vascular structures, probably over a synthetic absorbable conduit bed. The reconstruction of complex vascular structures by using computer-aided design may be used to fabricate custom-made tissue-engineered replacement conduits in the future.

1. Should the surgeon have been aware of these potential complications before attempting this repair surgery?

Dr. Jonathan M. Chen is a Professor of Cardiothoracic Surgery in the Department of Cardiothoracic Surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and is the Chief of Pediatric Cardiac Surgery and Director of Pediatric Cardiovascular services. He is also the David Wallace - Starr Foundation Professor of Clinical Pediatric Cardiology and is addition a Professor of Cardiothoracic Surgery in Pediatrics. He is one of the first in the country to receive new certification in congenital heart surgery by the American Board of Thoracic Surgery.

Child Suffers Brain Hypoxia During Cardiac Surgery

This case involves a defective drug. The plaintiff was a thirty-seven-year-old female who suffered from migraine headaches. Her doctor prescribed Topamax (topiramate) to decrease and prevent the headaches. One year after being prescribed Topamax, the plaintiff became pregnant with her first child. She continued to take the medication throughout her pregnancy. Nine months later, when the plaintiff gave birth, her child was born with a cleft palate and hypospadia. She did not take any other medication, nor did she consume alcohol or smoke during her pregnancy. Additionally, the plaintiff was not warned by her doctor, or the drug’s labeling, regarding any risks of taking Topamax when pregnant.

Generally speaking, pharmaceutical companies must warn about any known adverse side effects to taking their drug. Topamax is an anticonvulsant medication prescribed to treat symptoms associated with epilepsy, and was later approved for treatment of migraine headaches, as well. Pregnant females taking Topamax during their first trimester of pregnancy can raise the risk of severe birth defects. By adequately warning women and their doctors about the side effects of their drug, the pharmaceutical company gives patients and doctors the opportunity to choose a different form of treatment. It was generally known that infants who had been exposed to Topamax, prior to birth, had an increased risk of being born with an oral cleft. When such information is available to a pharmaceutical company, usually through testing, it must be disclosed to the public. Following extensive testing, any serious adverse effects or risks associated with the drug's use need to be disclosed to the relevant parties. This usually includes the FDA, patients, and the medical community. This is done through scientific publications that discuss the drug’s effects, in addition to any harmful effects the drug may cause. Furthermore, it is customary to have conferences which discuss both the good and the bad to alert the scientific community of the company’s drug.

1. How are warnings for pharmaceuticals determined, and what procedures are in place to ensure that relevant parties are informed of any dangers?

Topamax Allegedly Causes Cleft Palate in Newborn

This pediatric dermatology case involves a sixteen-year-old female who was treated with isotretinoin (Accutane) for acne leading to significant birth defects in her child. The young woman was being managed on less potent acne agents for two years until her acne began to persist. At this time, her dermatologist recommended she take an oral medication that worked systemically to treat her acne. The dermatologist asked the patient if she was sexually active, in which she truthfully answered yes. However, the physician did not ask about oral contraception or barrier use. Additionally, a pregnancy test was never ordered prior to initiating therapy. Six months after starting isotretinoin, she visited an OB/GYN due to missed periods and a positive, at-home pregnancy test. A pregnancy test in the office confirmed she was two months pregnant. Upon obtaining a medical history, the OB/GYN found out that she was prescribed isotretinoin, which warranted an emergent ultrasound. The ultrasound revealed significant defects in the developing fetus including facial deformities, hypospadia, and cardiac anomalies. Isotretinoin was immediately terminated. Six months later, the child was born with mental retardation as well as hearing and visual deficits.

This dermatologist did not inform the patient of a major isotretinoin side effect, teratogenesis. Isotretinoin is a Category X medication, meaning it has been proven to cause significant birth defects in the developing fetus. Some of the birth defects associated with isotretinoin include heart defects, craniofacial abnormalities, cranial nerve palsies, absent cerebellar vermis, and mental retardation. Before prescribing this agent to any female, a physician must do a urine beta-hCG level (pregnancy test). Females should have periodic pregnancy tests throughout their treatment. Additionally, it is important to educate on contraception. Two effective forms of birth control (or complete avoidance of sexual intercourse) must be used for one month before starting isotretinoin, during use, and for 1 month after stopping this drug. After 2005, only patients enrolled in the iPLEDGE program could obtain and use isotretinoin. Patients need to register with iPLEDGE and view a video at their doctor's office before receiving their prescription. Only physicians enrolled in iPLEDGE may prescribe isotretinoin, and only pharmacies enrolled in the program may dispense it.

Did this dermatologist meet the standard of care, and what should have been done before prescribing this acne medication?

Dermatologist Prescribes Acne Medication Leading to Fetal Defects

A products liability/consumer product safety expert witness for the defense provides feedback on a case involving multiple plaintiffs who claim that an SSRI antidepressant taken by mothers caused birth defects in their children. The drug at issue is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Plaintiffs, who are part of multi-district litigation located in Rhode Island, claim the defendant manufacturers of the antidepressant are liable because their defective product causes birth defects like hypospadia in children when it is taken by their mothers while pregnant.

SSRIs have been well-studied. Recent reviews from various medical professional organizations have concluded that there is no reliable scientific evidence demonstrating that SSRIs can induce congenital malformations. These conclusions stand in marked contrast to those expressed by the plaintiffs' experts, who appear to believe that first-trimester use of SSRIs can cause any and all human malformations, based on a hypothetical disturbance of a serotonin signaling mechanism that is not supported by animal models, preclinical animal testing, or human epidemiological studies. A 2013 meta-analysis of 29 high quality epidemiological studies of SSRI use during pregnancy concluded that this use was not associated with any increased risk for congenital malformations in general or cardiac defects in particular. Even more recent studies confirm this. Results of earlier studies finding a weak association with malformations are attributable to chance, confounding, or bias, not causation. Large, recent epidemiological studies and biostatistics demonstrate no increased risk for major congenital malformations associated with SSRIs, when compared with use of other antidepressants, or with pregnancies in untreated pregnant depressed women. Other risk factors such as maternal obesity, diabetes, smoking, alcohol use, lack of folic acid supplementation in early pregnancy, and individual genetic susceptibilities to malformations likely explain inconsistent findings of increased risk in a few of the earlier studies. These opinions are consistent with the general scientific consensus. The expert is a board-certified pediatrician and medical geneticist. Over the course of 35 years, the expert has worked in clinical genetics, dysmorphology, teratology, developmental disabilities, communicative disorders, and public health aspects of birth defects. The expert has written extensively on birth defects in peer-reviewed publication, and, among other credentials is founder of a birth defects conference.

1. Do SSRIs cause birth defects? 2. What studies support the defense argument?

Northeast

Rhode Island

Products Liability Expert Witness for Defense Opines on Claim That an SSRI Antidepressant Taken by Mothers Caused Birth Defects

This case involves multiple mothers who were prescribed a popular antidepressant by their respective physicians while pregnant. Neither the patients’ perinatology physicians nor the drug labels on the medication adequately warned the patients of the teratogenic nature of the drug, despite well-documented cases of the antidepressant in question causing birth defects. As a result of the mothers taking this drug, they gave birth to infants with a myriad of congenital defects, including hypospadia. It is believed that the company intentionally marketed the drugs to young woman, spending upwards of $100 million per year advertising this drug to women of childbearing potential.

The promotion of SSRIs such as this drug specifically to women of child-bearing age has been familiar to me for several years, and I would be interested in reviewing this case. I have been studying the marketing, prescription, and adherence to psychiatric drugs, with a particular focus on SSRIs and atypical antipsychotics, for about 15 years. I have researched inside major drug companies, psychiatric hospitals, and community clinics. Together with the director of pharmacovigilance at the World Health Organization and others, I have founded an organization to collect and evaluate side effect data of common drugs. My role is as an industry expert, which includes analysis of marketing strategies and how these impact claims made about specific drugs, in the scientific literature, in materials used to sell to physicians, and in direct to consumer advertising. Among my research publications into pharmaceutical marketing, several have entailed analysis of court documents (and/or attending trials and depositions). I have studied and taught marketing at the world’s leading business schools, and I have trained alongside medical residents in the field of acute psychiatry.

1. What is your experience with marketing plans for the pharmaceutical industry, specifically to the female population?

Location: Wisconsin B.A., Queens College Ph.D., Social Anthropology, Harvard University Resident training in Acute Psychiatry, Medical College of Wisconsin Former R******* A******** H****** U********* G******* S***** o* B******* A************* Former A******** P******** D********* o* M******** K****** G******* S***** o* M********* N*********** U********* Former A******** P******** D********* o* M******** R******* G******* S***** o* B******* A************* T******* U********* Current P******** o* M****** A*********** a** G***** S****** m**** u********* Current C*********** a** C********* i********** i******** f** t** s**** a** i********** o* d*** s*****

This expert has been researching and teaching marketing for over 20 years. He received his Ph.D. from Harvard University in Social Anthropology and is a specialist on medical and economic anthropology, drug safety, global business and marketing practices, and pharmaceutical marketing practices. His research concerns the commercial marketing of pharmaceuticals on the one hand and the evaluation of safety, adherence, and treatment costs and outcomes on the other. He is a Co-Principal and Co-Founder of an independent institute for the study and improvement of drug safety, which aims to improve the quantity and quality of adverse drug events reporting and to implement findings in health care. He has written many articles on pharmaceutical marketing practices and is extensively published in journals such as "Anthropology & Medicine" and books such as "Pharmaceuticals and Globalization: Ethics, Markets, Practices", while he sits on the Editorial Board of the "Transnational Marketing Journal". Currently, this expert is a Professor of Medical Anthropology and Global Studies at a major university.

Aggressive Marketing by Pharmaceutical Company Leads to Birth Defects

An infant with numerous congenital defects, including hypospadia and developed ventricular septal defect, rapidly developed epilepsy and compartment syndrome during an operation. Expertise in both heart failure and compartment syndrome was needed to comment on the case, which was instigated by a hospital’s attempts to operate and remedy some of the infant’s congenital defects. Instead of alleviating them, however, the infant developed metabolic acidosis with cool extremities and poor pulses directly after the procedure. When the hospital attempted to counter his condition with attempts to intubate and chest compressions, he became bradycardic and lost palpable pulses; by the time the patient was intubated, he was suffering from multiple metabolic abnormalities, including acute kidney injury and a shocked liver. He quickly developed seizures, and the hospital’s attempts to place a new arterial line in his right arm instead developed ischemia and required fasciotomies of the forearm and hand. Overall a complex case stemming from congenital defects, the competency of the hospital in administering care was questioned in trial.

Our hospital’s Pediatric Intensive Care unit regularly cares for children with similar congenital conditions. I would need more information about the operation and ensuing efforts to alleviate the infant’s condition in order to comment on the standard of care in this case, but I have been practicing pediatric critical care for about twenty years. I am also active in research and publishing related to the care of critically ill and injured children.

1. Do you routinely care for patients like the one described in this case? 2. What measures should be taken when ischemia of the digits is noted after arterial line placement?

Hypospadia Expert Witnesses

Find an expert witness near you

Hypospadia Expert Witness Case Studies

Child Suffers Brain Hypoxia During Cardiac Surgery

Topamax Allegedly Causes Cleft Palate in Newborn

Dermatologist Prescribes Acne Medication Leading to Fetal Defects

Products Liability Expert Witness for Defense Opines on Claim That an SSRI Antidepressant Taken by Mothers Caused Birth Defects

Aggressive Marketing by Pharmaceutical Company Leads to Birth Defects

Pediatric Care Unit Sued Over Infant Care

Connect with the Hypospadia expert witness you need to win your case