LIVERMORE, Calif. — Monty Patterson could not wait any longer when he threw back the curtain surrounding his daughter's hospital bed where a half-dozen medical personnel were trying to resuscitate her.

“I will carry that image in my head for the rest of my life,” he said later. “All the instruments were buzzing. She was flatlined. I just walked out of the room crying. I knew she was dead.”

That was Sept. 17. Holly Patterson had turned 18 just two weeks earlier. She was living at home with her father, working at Macy's and saving for college. Her father learned only hours before she died at ValleyCare Medical Center in Pleasanton that she had gone to a Planned Parenthood Golden Gate clinic a week earlier, about seven weeks pregnant, and had begun a “medical abortion” — a controversial combination of two drugs known as RU-486. He was told she was suffering a massive infection caused by fetal tissue fragments that had not expelled from her uterus.

Two weeks ago the Alameda County coroner's office issued an interim finding on Holly Patterson's death stating it had been caused by “septic shock due to endomyometritis [inflammation] due to therapeutic drug-induced abortion.” The final coroner's report was released Nov. 7 and stated that the case was closed.

Now the blonde, blue-eyed young Californian has become the most visible abortion death in American history. And her father, Monty Patterson, has joined a growing chorus to have RU-486 immediately withdrawn from the market.

Holly's Law

On Nov. 5, U.S. Rep. Roscoe Bartlett, R-Md., and Rep. Jim DeMint, R-S.C., introduced the RU-486 Suspension and Review Act of 2003, dubbed Holly's Law. They cited Holly's death and “other deaths and severe complications resulting from RU-486” as reason to “re-examine the procedures the Clinton administration FDA used to approve RU-486 in [September] 2000” and to suspend the drugs’ sale. The bill had 59 original co-sponsors, including House Majority Leader Tom DeLay, R-Texas; and Sen. Sam Brownback, R-Kan., introduced companion legislation in the Senate.

“This is a young, healthy 18-year-old. She takes the two drugs and she's dead,” Bartlett told the Register. “I don't know how often this could be expected to occur again, but one case certainly demands our attention.”

Monty Patterson and his wife, Donna, sent a letter to Capitol Hill endorsing the bill.

“As parents, we cannot allow our beautiful Holly's horrible death to be in vain,” it read. “The FDA has failed to carry out its mission of ensuring RU-486 is a safe and effective abortion-drug regimen. Holly has already paid the ultimate price. The RU-486 abortion drug should not be either a pro-life or a pro-choice issue. The most primary concern here must be the health and welfare of our children and young women.”

Bartlett is especially bothered that the FDA approved RU-486 under a special category of regulations reserved for dangerous drugs used to treat “life-threatening and serious illnesses” such as AIDS and cancer.

“I don't know when a healthy baby was considered a life-threatening illness,” he said.

Incorrect Use

But the paramount question that has emerged following Holly's death is why abortion clinics commonly use the drugs in ways the federal Food and Drug Administration has not approved.

At the Planned Parenthood Golden Gate in Hayward, Holly was required to sign a “Patient Agreement” provided by the drug distributor Danco Laboratories outlining the FDA-approved regimen. Then she was given an “alternative” agreement drawn up by the abortion clinic. Holly was administered mifepristone by “mid-level clinicians,” according to a statement made by Planned Parenthood Golden Gate spokeswoman Erin Brooks, and then she was sent home with instructions to self-administer vaginally the second drug 24 hours later.

Following FDA regulations she should have returned to the clinic 48 hours later and been given the second drug orally. Holly also received significantly different doses of the drugs than those the FDA approves.

Wendy Wright, a senior analyst with Concerned Women for America, a pro-family group, speculates that so-called “off-label” use of the drugs may just be abortionists cutting costs of chemical abortion.

“The first drug [for which clinics commonly decrease dosage to one-third] costs about $90 per pill,” Wright said. “The second drug, misopristol, [for which clinics commonly double the FDA dose] only costs pennies.”

Planned Parenthood representatives did not return calls for comment, but they have defended using “alternative” RU-486 regimens because they are based on more up-to-date trial data than the data the FDA used when it approved the drug in September 2000.

But in April 2002, Danco Laboratories and the FDA issued an alert to physicians, reporting serious complications suffered by RU-486 patients. The letter denied a “causal relationship” between the events and RU-486 but described women who had ruptured ectopic pregnancies (pregnancies outside of the uterus), including one who had died; two women who had experienced life-threatening bacterial infections, including one who died; and a 21-year-old woman who suffered a heart attack.

The letter included a stern reminder to abortion practitioners: “The FDA has not reviewed or approved other dosing regimens for early termination of pregnancy.”

Complications

At least 400 serious complications have been reported with use of the drug since its approval three years ago.

Asked why RU-486 prescribers are allowed to continue neglecting the “Prescriber's Agreement” outlining FDA protocol they sign before ordering the drugs from Danco, company spokeswoman Heather O'Neill said: “That's a question for health care providers and clinics.”

Danco only endorses the FDA regimen, she added, and referred to a page on the FDA Web site about doctors having freedom to prescribe drugs for “off-label” uses.

FDA spokeswoman Susan Cruzan referred to the same FDA question-and-answer page and added, “The FDA advises that people use [RU-486] according to its distribution plan.”

A citizen's petition by two doctors groups and Concerned Women for America that demands RU-486 be shelved was filed with the FDA in August 2002 and cites Danco's right to cancel orders to RU-486 prescribers who fail to abide by FDA regulations.

The petition also documents the FDA's ability to withdraw RU-486, including an October 2000 letter from an FDA official to a Congressman stating: “If restrictions are not adhered to, FDA may withdraw approval.”

Holly Patterson's death and Holly's Law are pressuring the FDA to respond to that 15-month-old petition. “It's under active review,” FDA spokeswoman Cruzan said. “That's all I can say.”

For Monty Patterson, however, that time can never be made up.

“How many more teen-agers and young women will have to pay the price,” he asked, “with their health — or with their life — before the FDA decides to act?”

Celeste McGovern is based in Victoria, British Columbia.