Parents of Teen Who Died From Abortion Drug Discuss Lawsuit

Livermore, CA (LifeNews.com) -- The parents of California teenager Holly Patterson, who died after taking the dangerous RU 486 abortion drug in September 2003, discussed the lawsuit they filed against the maker of the abortion drug with a local newspaper.

In an interview with the Contra Costa Times, the Pattersons said the lawsuit is their latest effort to draw attention to the risks associated with mifepristone.

"We've basically been doing a lot of work all year to bring about awareness and question the safety of this drug, and have been working on a lot of fronts," Holly's father Monty Patterson told the newspaper.

He said he and his wife Deborah are not filing the suit for money or fame. Instead, the lawsuit follows a long line of actions out of concern that the abortion drug is unsafe.

The Pattersons submitted a letter to Congress backing legislation to prevent further sales of the drug while it thoroughly investigates safety issues. Monty Patterson also met with FDA officials prior to the agency revising warning labels on the drug packaging.

"I don't think this drug is safe, and if it's not, it needs to be removed," Patterson added.

Deborah Patterson said she is worried about how the abortion drug, sold as Mifeprex, has already killed three women.

The Pattersons filed wrongful death and product liability lawsuits against New York-based Danco Laboratories and a Planned Parenthood abortion facility near San Francisco that gave Holly the drugs.

Holly Patterson reported severe pain and bleeding afterwards and died days later at a local hospital.

"This is a well-deserved lawsuit against those allegedly responsible for a young woman's tragic death," said Wendy Wright of Concerned Women for America.

"Holly Patterson paid the ultimate price for the Food and Drug Administration (FDA) buckling to abortion proponents' pressure to approve a drug that has only one purpose -- to kill a human being," Wright added.

The Patterson's lawsuit, filed in Alameda County Superior Court, says Danco failed to properly warn doctors of the potential dangers of Mifeprex.

lawsuit also names the Population Council, a pro-abortion group holding the patent rights to the drug and ValleyCare Health System, which operates the hospital where Patterson died.

Wright accuses the Population Council of conducting "substandard, biased trials on RU-486."

"Danco knowingly distributes it to abortionists that violate the requirements, and Planned Parenthood treats women like Holly as collateral damage in their pursuit of more abortions," said Wright, whose group filed a citizens petition with the Food and Drug Administration asking it to pull the abortion drug from the market pending review.

The FDA has received 676 reports of problems resulting from the abortion drug, including three deaths, seventeen potentially fatal ectopic pregnancies, and seven women had serious infections like the one that led to the death of Holly Patterson.

That prompted the agency to revise the already significant "black box" warning label placed on the drugs to include new information.

Q. What is the "abortion pill," or mifepristone?

A. Most people have heard of the abortion pill, RU-486. Mifepristone is the generic name for RU-486, which was developed in 1980 by the French pharmaceutical company Roussel Uclaf. Mifepristone is the first in a two-drug chemical abortion technique given to women who are up to 7 weeks (or 49 days gestational age) pregnant. First, a woman is given mifepristone, which acts to block progesterone-a hormone necessary to maintain pregnancy. Mifepristone causes the uterine lining to shed, disconnecting (and in essence starving to death) the developing unborn child. A second drug, misoprostol, is taken a day or two later and causes the womb to expel the now-dead embryo. Taken in tandem, the two drugs cause an induced abortion.

On September 28, 2000, mifepristone was approved by the U.S. Food and Drug Administration (FDA) for use in chemical abortion under the brand name MifeprexÂ®. The companion drug, misoprostol, was already available in the U.S. as a treatment for ulcers. Misoprostol is manufactured by Searle Pharmaceuticals under the brand name CytotecÂ®. In July 2002, the FDA approved a generic version of misoprostol distributed by IVAX Pharmaceuticals.

The FDA recommends misoprostol for use in conjunction with mifepristone. However, one month before FDA approval for the abortion drug combination, Searle issued an alert to physicians, warning that misoprostol was not approved for use in pregnant women and that using the drug can cause "rupture or perforation requiring uterine surgical repair, hysterectomy," "severe vaginal bleeding" and "maternal death." 1 Despite this warning, the drug is often used by physicians to induce childbirth. The FDA reports 35 uterine ruptures and 10 infant deaths linked to misoprostol between 1988 and 2000.2 Since 1997, misoprostol is blamed for the deaths of two women who received the drug and then died during or after childbirth.3 Searle, a subsidiary of Pharmacia Corporation, has not studied or approved Cytotec for use in labor induction or abortion.

Mifepristone is the first drug legally prescribed in the U.S. for the sole purpose of ending a human life. It is not a contraceptive, as it is used after the mother knows she is pregnant and the unborn baby is developing in her womb.

Q. What are the risks to women to take mifepristone?

A. On November 15, 2004, the FDA announced labeling changes to highlight the risks and complications associated with mifepristone, including "serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death." 4 The most recent death involved a California woman who died in January 2004 after taking the drug. 5

Officials with the FDA are also reportedly investigating the September 17, 2003 death of 18-year old Holly Patterson. The Livermore, California resident died at a local hospital seven days after receiving mifepristone and misoprostol at the Hayward Planned Parenthood affiliate. According to local press reports, ValleyCare Health System officials are calling on the FDA to pull mifepristone from the U.S. market until a safety review can be conducted, describing the drug combination as having "a controversial and an extensive history of problems." 6 The California state health department is also investigating Patterson's death.

According to the FDA, mifepristone-in conjunction with misoprostol-is linked to two additional abortion-related deaths between June 1998 and November 2001. The FDA data also reports another 22 women who required hospitalization or another "intervention to prevent permanent impairment or damage" after taking mifepristone during the same time period.7

In Tennessee, the family of 38-year old Brenda Vise filed a medical malpractice lawsuit against the abortion clinic that gave Vise mifepristone, alleging that failure to correctly diagnose her ectopic (or tubal) pregnancy caused her death five days after taking the drug.8

The drug manufacturer, the New York-based Population Council, reported the deaths and hospitalizations to the FDA in accordance with federal law. Critics, however, say that the negative side effects of mifepristone are probably under-reported, as physicians are not required to report problems to drug manufacturers. 9

Even before the February 2002 release of this data, supporters of mifepristone acknowledged that the chemical abortion it triggers is not a quick and easy process. Common side effects are potentially serious and include abdominal pain, nausea, vomiting, diarrhea and vaginal bleeding. Five to 8 percent of women require a follow-up surgical abortion because the chemical abortion fails.10 During the U.S. clinical trials, at least one woman who used the drug hemorrhaged so severely that she lost one-half of her blood and nearly died. 11

One published study based on the U.S. clinical trials of mifepristone found that "[E]xcessive bleeding necessitated blood transfusions in four women and accounted for 25 of 27 hospitalizations (including emergency-room visits), 56 of 59 surgical interventions, and 22 of 49 administrations of intravenous fluid." The study reported that one in 100 women participating in the trials were hospitalized with complications ranging from bleeding to abdominal pain and vomiting, which women described as severe and incapacitating.12

Byron C. Calhoun, M.D., of the American Association of Pro-Life Obstetricians and Gynecologists, states, "We can foresee many significant problems that women will encounter should medical abortion become an accepted standard of care. From the clinical trials, we have a generally good idea of the complication rates, which we believe are unacceptably high. One can only imagine the thousands of young women who have taken mifepristone who will be sitting at home wondering how much bleeding is too much."13

Q. What is the history of the FDA's approval of the drug?

A. Clinical trials conducted to receive FDA approval for a new drug can take from seven to 10 years. U.S. trials for approving mifepristone were conducted in about one year, beginning in 1994 and ending in 1995.

The FDA approved mifepristone under a set of rules often referred to as the "Fast Track" process. This approval process was created in 1992 to expedite the approval of drugs for serious or life-threatening illnesses and allows the FDA to put drugs on the market after less testing than other medicines. FDA officials indicate that this accelerated path was chosen for mifepristone because it gives authorities increased control over how the drug is prescribed and how quickly it can be pulled from the market. However, critics accuse the FDA of misapplying the approval option to expedite what amounts to illegal approval of Mifeprex.

Q. Was the FDA decision to "fast track" mifepristone influenced by politics?

A. Initially, Roussel Uclaf was hesitant to bring mifepristone to the United States. Both the Reagan and (first) Bush Administrations were hostile to the idea, and U.S. pro-life leaders were vocal in their opposition, declaring their intention to boycott Roussel Uclaf or any other company involved in bringing mifepristone to the U.S. The Clinton Administration, however, took a different view and pressured Roussel Uclaf to help bring the drug to the U.S., which resulted in the patent donation to the Population Council.

The Population Council experienced major difficulties in its attempts to identify a manufacturer to make the drug, a distributor to make it available to physicians and pharmacists, and investors to fund the venture. Once these necessary steps were accomplished, the 2000 presidential election was fast approaching and with it the potential (and eventual) election of George W. Bush, who opposed the use of the drug for chemical abortion. Based on then-candidate Bush's opposition, critics believe the FDA was urged to quickly approve the drug while the Clinton Administration was still in office.

Q. Who is manufacturing the drug for U.S. markets?

A. The Population Council and Danco Laboratories, the U.S. company formed to distribute mifepristone, were unable to identify a U.S.-based pharmaceutical company willing to manufacture the drug. So, they turned overseas to Communist China, where Danco signed a contract with the state-owned Shanghai Hua Lian Pharmaceutical Co., Ltd. Congressional investigators say the Chinese company and its Shanghai plant have been cited by federal regulators for bringing mislabeled and impure drugs into the United States.14

Q. Did the FDA put adequate "safeguards" in place to protect women's health when approving Mifeprex?

A. No. According to FDA documents, physicians prescribing mifepristone must meet specific qualifications. However, in its position statement regarding mifepristone, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) points to several areas of concern where physicians say the FDA did not go far enough to protect women's health.

http://64.233.161.104/search?q=cache:IaHTF4jsmGsJ:www.family.org/cforum/fosi/bioethics/faqs/a0027731.cfm+Mifeprex&hl=en

This is going to probably sound callous but oh well.

10 years ago, a drunk 18 year old girl in my town wrapped her car around a telephone pole, killing herself and her 17 year old friend. Her post revealed a post-mortem BAC of 0.35. I am not sure how she even made it to the car much less drove it but she did. Alcohol poisoning occurs above 0.3. Her parents sued the bar and won. It was bullshit. This happened on St Patrick's day. The bar has over 10,000 people inside and out. And it was proven that she did not get the beer herself, someone else got it for her. How can the bartenders be held liable for this? It is terribly tragic that she died so young and took another friend with her. Both families suffered immeasurable grief. But no one held her down and forced that much alcohol down her throat. She drank it willingly. Her parents want to blame someone else for their daughter's stupidity, because, after all it's always the other guy's fault, their precious little girl was the victim here. She got drunk, she got in a car and she killed herself and her friend. Granted her friend was not very smart either, she did after all get into a car with a drunk.

This girl took an abortion drug. She was unmarried and pregnant. She chose to take the easy way out and kill her baby. She lied to her parents and the physicians about taking the drug. She could have gotten help that would have saved her life but instead she kept up the rouse so her parents would not know the truth. Menstrual cramps??? I live with three women, a wife and two teenage (16 and 18) daughters. When have menstrual cramps ever been totally incapacitating? She paid for her stupidity with her life. It's callous but it's the truth. And you can't hold the drug company liable for the stupidity of people that take their drugs. I am firmly against abortion in nearly all circumstances and am totally against the drug but it's the principle of the thing.

And I am surprised the right to life people would support anything having to do with abortion. I damn sure don't.

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