Accutane contains the active ingredient Isotretinoin. According to numerous conducted studies the use of Isotretinoin can result in severe side effects including the loss of a fetus by pregnant woman. As reported by The Guide to Best Practices in the Prescription of Accutane, woman who are pregnant should not use the drug. More so, practicing medical doctors should provide for routine pregnancy tests and monitored birth control medication for women who wish to use the drug before it is prescribed. The failure to provide for proper pregnancy testing for women who are prescribed the acne medication can establish a basis for medical malpractice if the fetus is lost.
: Our law firm is dedicated to providing legal representation for individuals who have suffered harm due to the negligent or wrongful actions of at fault parties including practicing physicians who’s act of medical negligence result in significant harm.
FDA Guidelines for the Use of Accutane by Females: The United States Food and Drug Administration has labeled medications with containing the active ingredient Isotretinoin a contraindication in females of childbearing potential unless the patients meets pre-qualification and conditions during the use of the drug. A list of the following conditions which have to be met by women who wish to use the drug include…
- The female must not be pregnant
- She must be able to comply with mandatory contraceptive measures
- She must have had at least 2 negative urine or serum pregnancy tests
- Must be committed to the use of 2 forms of effective contraceptive medication
- Must have signed a Patient Information/Consent form.
For further information on FDA warning on the use of Accutane see here
How to Prove Medical Malpractice – Failure to test for Pregnancy Before Prescribing Accutane
: A cause of action for medical malpractice is established when the failure of a practicing physician to follow guidelines in the treatment of a medical condition cause significant harm to the patient. The basic analysis of a medical malpractice claim are as follows…
Accutane Resulting in Birth Defects
- The Patient is owed a duty by the practicing medical doctor
- The medical doctor breached the duty of care owed – i.e. failed to provide for urine base pregnancy tests for the patient before prescribing the medication
- The breach of the duty of care resulted in significant harm.
: The use of medications containing the active ingredient Isotretinoin during pregnancy has been shown to result in an extremely high probability of congenital birth defects. Specific abnormalities in children born to mothers who were on the acne medication include,
Compensation Available for Parents
- Defects in the shape and configuration of the skull – anotia, micropinna.
- Cleft palate
- Congenital defects in the development of the eye
- Abnormalities in the cerebral cortex
- Heart and cardiovascular abnormalities
- Glandular and hormonal defects – thymus gland
: Parents who have lost their unborn do to the use of accutane or because of the failure of the prescribing medical doctor to perform the proper tests may be entitled to compensation for all damages incurred. A calculation of settlement value for such cases is dependent on several factors including (1) All medical and health related expenses (2) Pain and suffering mental anguish resulting from the death of a fetus and or defects in the newborn. (3) Costs associated with the medical, rehabilitation, and daily nursing care of a child who has developed birth defects. (4) Lost wages and loss of future income.
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