By Randall K. O'Bannon, Ph.D.
NRL-ETF Director of Education & Research
The California Department of Health and Human Services has released the results of its investigation into the death of Holly Patterson, the young teen who died September 17, 2003, after receiving RU486 from her local Planned Parenthood clinic.
The report does not challenge the county coroner's earlier conclusion that Holly died as a result of a massive infection resulting from her drug-induced abortion. However, it specifically faults the clinic for failing to follow procedure.
The hospital where Holly died is not cited for any negligence in its efforts to treat her. But both the clinic and the hospital are taken to task for failing to report her death in an appropriate manner.
Both the Valley Care Medical Center and Planned Parenthood's Hayward clinic were faulted by the state for failing to report the death as an "unusual occurrence." A hospital spokeswoman told the San Francisco Chronicle (2/25/04) that Valley Care did report Holly's death to the coroner's office, but didn't think it met the criteria. A spokeswoman for the state health department said that the death "of a very young woman who had received drugs for an early medical abortion" certainly did qualify as such an occurrence (Mercury News, 2/25/04).
Planned Parenthood officials said they didn't report the death because Holly died at the hospital, rather than the clinic, implying that the hospital was responsible for reporting the death. The state told Planned Parenthood it was wrong in that assumption (Mercury News, 2/25/04).
Planned Parenthood was also reprimanded by the state for not obtaining Holly's signature on one of the three required consent forms.
Holly's father, Monty Patterson, said he and his wife were "appalled" by the lack of accountability shown by the clinic and the hospital.
"Holly died," Patterson told the Mercury News. "These two groups didn't even feel it was necessary to report her death. What is there now, just hand-slapping involved?"
Chemical abortions using RU486 are complicated and painful, involving not just one drug, but two, and multiple office visits. Patients take the first drug, RU486, in the doctor's office, the effect of which is to begin to shut down the baby's life support system. Deprived of nutrients and oxygen, the baby starves or suffocates to death.
A second drug (the prostaglandin misoprostol) is administered a couple of days later to stimulate powerful uterine contractions to expel the tiny corpse. In the protocol approved by the U.S. Food & Drug Administration (FDA), the patient is supposed to come back to the office to take this drug orally.
However, many clinics are allowing women to take the second drug home with them and self-administer the tablets vaginally. This was the procedure in place at the Hayward Clinic, according to the East Bay Express. A final visit a week or so later would ascertain whether or not the chemical procedure resulted in a dead baby.
According to the Contra Costa Times (2/25/04), the health department focused on deficiencies related to the clinic's instructions regarding the second step. The report indicated, "The written patient instruction provided to the patient (that was part of the medical record), did not have any evidence that the patient was instructed on a step-by-step procedure on how to self-administer the prostaglandin, according to the Contra Costa Times. There was no instruction on handwashing prior to the insertion or that the tablets should be inserted with a bare or gloved finger or if the fingernails should be short or free of nail polish. These are simple measures to prevent infection." 1
Planned Parenthood said that the patient received a written instruction sheet and was told to wash her hands thoroughly before inserting the misoprostol. However, state investigators also noted that an informational video used by the clinic lacked a demonstration of the proper at-home vaginal insertion procedure. Clinic officials said the tape was only meant to be a supplement to the consent procedures.
The health department also indicated that Planned Parenthood failed to obtain Holly Patterson's signature on the clinic's "Request for Provision of Surgery or Other Special Services" authorization, one of three required consent forms. According to the Mercury News, the health department spokesperson said the unsigned form had "crucial information about the care and procedures for her to follow when she returned home."
Planned Parenthood promised to institute a "plan of correction" in which it would require clinic counselors to initial patient signatures on all three forms and report any future "unusual occurrences" (Contra Costa Times, 2/25/04). Nothing in public press accounts gives any indication of plans by PPFA to alter its procedure with regard to the administration of misoprostol, to address the California health department's concerns, or to comply with the proscribed FDA protocol.
The FDA investigation into Holly's death is still ongoing. But Monty Patterson has his doubts about whether the government is being told everything about the damage done by the chemical abortifacient.
"If hospitals and abortion clinics don't feel they should be responsible to report a death to the state," Patterson told the Contra Costa Times, "what makes the FDA or the drug manufacturer believe they will consistently and accurately receive reports on adverse events or deaths related to drugs?" (2/26/04).
Patterson takes no position on abortion, but supports federal legislation that would rescind the government's 2000 approval of RU486. "This is outside the abortion debate," he told the Contra Costa Times (2/26/04). "[T]his is about the health, safety and welfare of children and women."
1. In the October 2003 edition of NRL News, we wrote the following: "That vaginal administration of misoprostol by the patient herself might provide the opportunity for the introduction of bacteria into the bleeding area seems at the very least to be plausible concern." It now appears that California Health Department officials are making the same observation.