Did your baby suffer a birth injury caused by medication?
The effects of prescription drugs on a baby in utero may be severe enough to cause injury or birth defects. For this reason, you should always talk to your doctor about any medications you take while pregnant, along with any herbal supplements or over-the-counter medications.
What medications have been involved in litigation for birth defects or injuries?
Expectant mothers may feel confused about which medications are most harmful to a developing baby. Information from drug manufacturers is a good place to start when researching the risks associated with certain medications.
Some of the drugs that have been linked to birth defects or injuries include the following.
Accutane, also known as isotretinoin, is a prescription drug used to treat an extreme form of acne, nodular acne, and certain cancers. When this medication is used during pregnancy, it can lead to serious complications. The potential problems can be so severe that many women who take Accutane agree to go on birth control to prevent pregnancy.
When this medication is taken during pregnancy, it can cause miscarriage, premature birth, developmental and intellectual disabilities and a variety of birth defects, including:
- Ear problems, including hearing loss and small or missing ears
- Cleft palate
- Vision loss
- Congenital heart defects
- Microcephaly (when a baby’s head is smaller than average)
Although certain antibiotics are considered safe to take during pregnancy, others can cause serious harm to an unborn baby.
Tetracyclines should be avoided past the 5th week of pregnancy, which is challenging as most women don’t know they’re pregnant until some time later. When used during pregnancy, these drugs can cause discolored teeth and problems with bone development in babies.
Sulfonamides should be avoided during the first trimester and close to the delivery date. Problems that can occur include:
- Cleft lip and palate
- Heart conditions
More than 23% of births in the U.S. are induced, accomplished through the use of Cytotec, an oral medication, or Cervidil, a vaginal insert. Both medications dilate the cervix and help produce contractions to allow birth to occur faster.
- Cytotec side effects for babies include hyperstimulation, uterine rupture and placental abruption. All of these side effects are potentially harmful to a mother and her future child-bearing abilities and can disrupt a baby’s oxygen flow.
Oxygen deprivation, known as hypoxia, can result in injuries to the baby, including:
- Cerebral palsy
- Developmental and intellectual disabilities
- Seizure disorders
- Cervidil side effects on babies include hyperstimulation. As with Cytotec, babies are at risk of hypoxia, which can cause a condition known as hypoxic-ischemic encephalopathy (HIE).
Cerebral palsy is one of the conditions that can result from hypoxic-ischemic encephalopathy. Severe brain damage or the death of a baby are also possible side effects associated with this drug.
DES is a synthetic form of estrogen that was once used to prevent pregnancy complications and miscarriage, as well as treat the symptoms of perimenopause. However, in 1971, this drug was found to carry the risk of cervical and vaginal cancer, known as clear cell adenocarcinoma.
The Food and Drug Administration (FDA) later determined it should no longer be prescribed to pregnant women after it was found that DES carried a risk of birth defects and developmental abnormalities for babies born to mothers who took the drug during pregnancy.
Diflucan is a common antifungal medication used to treat vaginal yeast infections. Although pregnant women commonly develop yeast infections, they should avoid using this drug before the 20th week of pregnancy. Using it earlier carries a higher risk of heart defects.
Pregnant women who develop yeast infections early in pregnancy should ask their doctors for an alternative to Diflucan.
Nonsteroidal anti-inflammatory drugs (NSAIDs)
NSAIDs like ibuprofen (Motrin), naproxen (Aleve), and aspirin are commonly used to treat pain. However, they should be avoided during pregnancy because they can cause oligohydramnios (low amniotic fluid) and kidney problems in the fetus.
Women can substitute these drugs with alternatives such as acetaminophen (Tylenol) for treating pain during pregnancy.
Pitocin is a synthetic form of oxytocin, a drug given intravenously (through an IV) to induce labor. This drug works by helping the cervix to dilate faster, enabling an easier birth with a decreased risk of complications. It should only be used in women who are past their due date.
The side effects of Pitocin on a baby are most often related to the consequences of contractions occurring too closely together and may include:
- Breathing problems
- Difficulty breastfeeding
- Difficulty maintaining correct body temperature
- Developmental delays
- An increased risk for autism
Mothers can also suffer injuries when given Pitocin. These are rare but can include:
- Excessive bleeding
- Severe allergic reactions
- Uterine hyperstimulation
- Uterine rupture
Thalidomide was once given to pregnant women to treat morning sickness but was found to cause serious birth defects in babies. The most common is phocomelia, which is characterized by hands attached to the shoulders with no arms or arms that are underdeveloped. In some cases, phocomelia can also affect the feet and legs.
Other birth defects can include:
- Extra toes
- Heart defects
- Facial nerve paralysis
- Clubbed feet
- Missing thumbs or thumbs with an extra bone
- Internal organ defects.
The drug has also been linked to miscarriage and stillbirth.
Zofran is a medication thought to be fairly safe during pregnancy, but some studies have indicated that it could lead to birth defects, including cleft palate and heart defects. These risks are said to be very small, but the Food and Drug Administration (FDA) has stated that women who have nutritional deficiencies and metabolic issues due to severe nausea during pregnancy carry a higher risk of having babies with birth defects after taking Zofran.
Warfarin, also called Coumadin, is a blood thinner used to treat individuals with deep vein thrombosis. However, if pregnant women take the drug during the earliest stages of pregnancy, it can lead to miscarriage, and when taken later in pregnancy, it carries the risk of the baby experiencing bleeding in the brain.
Women who take Warfarin are advised to take birth control or contraception to prevent pregnancy. Women who want to get pregnant and take the medication should speak with their doctors about switching to a safer drug.
Birth injuries and defects from medication errors
Even when pregnant women only take medications that have been proven to be safe during pregnancy, issues can still arise if medication errors occur. These errors are unfortunate but preventable mistakes that can harm patients, including pregnant women and their unborn babies.
Such errors can occur through:
- Prescribing the wrong medication or dose
- Having unclear or incorrect information on the medication’s label or packaging
- Improperly dispensing, distributing or administering the medication
- Improperly monitoring patients when starting new medications
Common causes of medication errors
The main causes of the above-mentioned medication errors include the following:
- Human factors and cognitive errors. Mistakes can happen when healthcare professionals are fatigued, overwhelmed, distracted or working under high-pressure situations. Cognitive errors, such as misinterpreting handwriting, confusing similar drug names or doses, or miscalculating dosages, can lead to medication errors.
- Communication breakdown. Poor communication between healthcare providers, including incomplete or inaccurate transfer of information during transitions of care (e.g., handoffs between shifts or transfers between departments), can contribute to medication errors. Inadequate communication with patients or their caregivers regarding medication instructions can also be a factor.
- Technological and systems issues. Technology-related factors, such as malfunctioning computerized order entry systems, barcode scanning errors, or issues with automated dispensing systems, can contribute to medication errors. Inadequate system safeguards, lack of double-check processes, or outdated medication-related technology can also increase the risk of errors.
- High workload and time pressures. Healthcare professionals working in fast-paced environments with heavy workloads may be more prone to errors. Time pressures can lead to shortcuts, inadequate verification processes, or rushing through medication-related tasks, increasing the likelihood of errors.
- Look-alike and sound-alike medications. Medications with similar names or packaging can lead to confusion and errors, especially if they are stored in close proximity or when verbal orders are communicated.
If your child was born with a birth defect or injury caused by a doctor or pharmacist’s medication error, you may be able to secure compensation through a birth injury lawsuit.
Can pharmaceutical companies be held liable for birth injuries?
When a medication is prescribed to a pregnant woman and it causes harm to her or her baby, legal actions can be taken against the pharmaceutical company responsible for manufacturing or distributing the medication.
Here are a few scenarios in which a drug company might be held liable for birth injuries:
- Defective drug. If a medication is found to have a manufacturing defect, design defect or inadequate warning labels that fail to provide sufficient information about potential risks during pregnancy, the drug company may be held responsible for resulting birth injuries.
- Failure to warn. Drug companies have a duty to provide adequate warnings and instructions regarding the potential risks associated with their medications. If they fail to warn healthcare professionals or consumers about the known risks of the medication during pregnancy, and this failure leads to birth injuries, the drug company may be held liable.
- Negligent marketing or promotion. If a drug company engages in deceptive or misleading marketing practices by promoting a medication for use during pregnancy without sufficient evidence of safety, and birth injuries occur as a result, the company may be held liable for those injuries.
- Inadequate testing or research. Drug companies have a responsibility to conduct proper testing and research to assess the safety of their medications, particularly for use during pregnancy. If they fail to conduct adequate testing or withhold important safety data, and birth injuries result from the use of the medication during pregnancy, the drug company may be held accountable.
- Off-label use. If a drug company promotes or encourages the off-label use of a medication during pregnancy (use not approved by regulatory authorities), and birth injuries occur as a result, the company may be held liable.
Contact an experienced birth injury attorney
It’s important to note that establishing liability against a doctor, pharmacist or drug company for birth injuries requires a thorough investigation, expert testimony, and a demonstration that the medication directly caused the harm. Consulting with an experienced attorney specializing in medical malpractice and pharmaceutical litigation is crucial to assess the merits of a potential case and navigate the legal process.
If your child has a birth defect or injury, a knowledgeable birth injury attorney can get you the help you need for your child. Choosing an attorney with extensive experience in birth injury cases will increase your chances of a better outcome in your case.
Reach out to our team at Brown Trial Firm today for your free consultation. We are ready to fight for you and your baby’s rights.
- Cerebral Palsy
- Caput Succedaneum and Cephalohematoma
- Neonatal Intracranial Hemorrhage (Childbirth Brain Bleeds)
- Hydrocephalus (Extra Fluid in the Brain Cavity)
- Cervical Dystonia
- Hemiplegia (Brain or Spinal Cord Injury)
- Hemorrhagic Stroke
- Neonatal Stroke
- Periventricular Leukomalacia (PVL) Brain Injury
- Infant Seizures
- Spastic Diplegia (Spasticity in the Legs)
- Top Risks for Birth Injuries
- Fetal Alcohol Syndrome
- G-Tubes for Newborns
- Medical Errors
- Cesarean Section & Birth Injury
- Negligence in Brain Cooling Treatment
- Craniosacral Therapy
- Fetal Intolerance to Labor
- Jaundice (Kernicterus)
- Breech Position
- Placental Complications
- Placental Problems
- Umbilical Cord Problems
- Uterine Rupture
- Cervical Incompetence (Insufficiency)
- Blighted Ovum
- Necrotizing Enterocolitis (NEC) - Intestinal Inflammation
- Cephalopelvic Disproportion
- Meconium Aspiration Syndrome
- Amniotic Fluid Embolism
- Birth Injury from Premature Delivery
- Developmental Delays
- Abnormal Cord Insertion
- Infections at Birth
- Chorioamnionitis Bacterial Infection
- Premature birth
- Oxygen Deprivation
- Birth-Acquired Herpes
- Placenta Previa
- Placental Abruption
- Mismanaged Fetal Malposition
- Obesity Related Birth Injuries
- Intrauterine Growth Restriction
- Blood Clots During Pregnancy
- Ectopic Pregnancy Misdiagnosis
- Myths & Facts About Birth Injuries
- Bacterial Vaginosis
- Gestational Diabetes
- Maternal Mortality Risk
- Oligohydramnios (Low Amniotic Fluid)
- Infections During Pregnancy