Legally Speaking

May 1, 2005

Intravaginal 5-FU blamed for injury In 1990, A 32-year-old Illinois woman was treated by her gynecologist for HPV with 18 intravaginal applications of 5-fluorouracil (5-FU) cream. She had typical side effects until 18 months later, when she was sexually assaulted and contracted herpes, which triggered a substantial increase in pain and burning. The woman suffered vaginal scarring and has permanent chronic severe vaginal pain and neuralgia.

Intravaginal 5-FU blamed for injury In 1990, A 32-year-old Illinois woman was treated by her gynecologist for HPV with 18 intravaginal applications of 5-fluorouracil (5-FU) cream. She had typical side effects until 18 months later, when she was sexually assaulted and contracted herpes, which triggered a substantial increase in pain and burning. The woman suffered vaginal scarring and has permanent chronic severe vaginal pain and neuralgia.

The woman sued the manufacturer of the 5-FU and the gynecologist, claiming that the intravaginal administration was experimental and that using a 5% strength was negligent.

The defense argued that the treatment was appropriate and that the patient's symptoms were psychologically induced and unrelated to the 5-FU. A defense verdict was returned.

The patient became fully dilated, pushed well, and had spontaneous vaginal delivery of a 6 lb, 4 oz infant. After delivery, she was noted to have brisk bleeding and passed a clot. Oxytocin was given IV and the woman's blood pressure suddenly dropped. Examination showed a cervical tear that probably extended to the uterus. Exploratory laparotomy revealed a cervical tear that extended well up into the uterus and required hysterectomy. The patient was eventually discharged and recovered well.

Nevertheless, she sued the physicians involved with her delivery, alleging negligence in the use of misoprostol, which was not FDA-approved for labor induction. She also claimed that the doses were excessive, monitoring was inadequate, and there was no informed consent. The woman contended that the tear was caused by hyperstimulation of the uterus by misoprostol.

The physicians claimed that use of misoprostol and the dosage were appropriate, and that the cervical tear had nothing to do with the drug and was a known risk of labor and delivery. The jury found for the physicians.

Legal perspectiveBoth of these cases involve off-label use of medications and were successfully defended. While FDA-approved drugs can be used for non-approved conditions, that can be hard to defend in a malpractice case. Juries often hear all known detrimental side effects of a drug and the package insert may be read aloud and blown up as a poster, even if the effects are not at issue in a given case.

In the 5-FU case, the drug's manufacturer was sued and the claim was that in 1990, there was a failure to warn that intravaginal drug use was experimental. In the misoprostol case, the manufacturer was not sued, most likely because the company had published a statement that the drug was contraindicated in pregnancy for any use, despite literature indicating its efficacy for cervical ripening in certain situations. Such a statement can bolster a plaintiff's case if a physician is accused of being at fault for a bad outcome allegedly associated with a particular drug.

Failure to timely diagnose breast cancer A Minnesota woman had bilateral mammography in March 1999. A stellate lesion external to an implant behind the nipple was found on the right side and was read as suspicious for malignancy and a biopsy was recommended. In April 1999, the mass was biopsied and a soft, irregular, fibrous mass was felt and dissected. The final pathologic diagnosis was fatty breast tissue and a fibrous component containing benign structures with small cyst formation. No evidence of cancer was found.