Posted on 12/22/2004 3:10:18 PM PST by nickcarraway
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.
"[A] fourth one is unacceptable," she told the Times.
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.
Pro-life groups say the lawsuit is appropriate.
"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.
The pill has it's own adverse side effects.
This lovely young woman should have told the boy, "NO."
The young man should have said "Okay."
This is tragedy, heaped on tragedy. I hope the parents are successful.
Is this the same one that took it after the set time to take the drug? If someone presented me with a pill that would induce an abortion, I'd really wonder about the side effects. I feel for these parents BUT abortions carries risks. Even birth control pills have a certain risk factor.
And that RU 486 abortion drug
had an INSTANT, MAJOR side effect,
didn't it?
pingalingadingdong
Why?
What don't you understand about filing a lawsuit against a dangerous drug....one that is not regulated ...and promoted as a quick fix cure all!!
Yes, the young woman willingly took the drug....
..no doubt, influenced by the propaganda from Planned Parenthood and her peers.
This lawsuit is very appropriate!!
I wonder why "death" isn't listed as a side effect, as well as a possible side effect. When taken correctly, it WILL cause death. It may possibly kill the mother as well.
The drug did exactly what it was supposed to do - detach the fetus from the uterine wall. What has not been disclosed (at least I could not find it) is how long since conception the drug was taken. If within a few weeks the fetus is relatively small and when it detaches the resulting bleeding is self-limiting.
I suspect that the date of conception was miscalculated and the fetus was larger than estimated. The resulting bleeding was no self-limiting and the poor kid did not seek medical attention for fear of discovery. Its not readily apparant from reading all this the lag time between dosing and when she was admitted for treatment.
Abstinence is so effective at preventing all this.
Contraception will only lead to more abortions, since it isn't 100% fullproof, and "kids will be kids" and not use them correctly.
LifeSite, being a dishonest single-issue advocacy organization, always neglects to mention some important facts about this case. Holly had been bleeding heavily and in severe pain for several days -- all symptoms which she would certainly have been told to look out for and seek immediate medical attention for (not that anyone in their right mind would need to be told that such symptoms require prompt medical attention, regardless of whether one had taken any drug or undergone any procedure). She sought medical attention early on, but failed to tell doctors that she had taken RU-486 or been pregnant, and left the hospital. Her symptoms continued to worsen and she did not seek medical attention again. When her father found her writhing and crying in pain at his house, she lied and told him she just had bad menstrual cramps. Then she departed for her boyfriend's house to spend the night (she was 18 -- nothing her father could have done to stop her). The boyfriend finally took her to the hospital in the middle of night, when things had gotten much worse, but it was too late.
This girl died from stupidity, not from RU-486. Any number of medications and/or the underlying conditions for which they are prescribed, can produce bad complications, which can be fatal if not treated. If you go to your doctor with a severe infection, and s/he prescribes an anitbiotic, warning you that it may not work, and that if your symptoms worsen, you need to get to a hospital quickly, and then you fail to go to a hospital as your symptoms worsen for days on end, and you finally die, your relatives have no business suing the maker of the antibiotic or the doctor who prescribed it.
The precise mode of Holly's death was absolutely identical to that associated with untreated complications of natural miscarriage. Who does LifeSite want to see sued when a girl who doesn't want to tell anyone she's pregnant, dies because she refuses to seek medical attention after she miscarries and develops severe complications?
No, her parents didn't rush her to the hospital. Her father found her crying and writhing in pain at his house. She lied to him, saying she just had severe menstrual cramps. Then she left for her boyfriend's house to spend the night. Her boyfriend took her to the hospital after things got worse.
The death of this beautiful young woman is squarely on the feet of the anti-life warriors who will continue to propagate the lie that this is a quick, safe way to end a pregnancy in the quiet of your own home without the embarrassment of a clinic or surgical abortion.
It's precisely for this reason -- fear of being found out, and the strong possibility that a young girl will not seek help for complications -- that a drug with potentially fatal known side effects shouldn't be given.
Remember the '60's and '70's -- when all the pro-abortion propaganda focused on young women being aborted (and dying) from hatchet jobs by illegal practitioners? Some of them bled to death because they didn't want anyone -- usually their parents -- to know they were pregnant.
Of course, abortion is such a major industry nowadays, the practitioners could care less about the mental state of a teenager, and the fact that there is no adult present to supervise the patient.
I hope this death haunts the doctor who prescribed the drug, but I'm not holding my breath.
Contraception will only lead to more abortions, since it isn't 100% fullproof, and "kids will be kids" and not use them correctly.
There are many methods of contraception besides condoms. Parents are the primary link to a child's welfare. I'm not blaming the parents's, only saying that "PERHAPS" their involvement may have prevented her becoming pregnant in the first place.
Behind the Holly Patterson story
Brent Bozell
October 1, 2003
http://www.townhall.com/columnists/brentbozell/bb20031001.shtml
Holly Patterson died two weeks after her 18th birthday. Blonde and beautiful, graduating high school after three years, this young native of the San Francisco area had her whole life in front of her. But then she entered a Planned Parenthood clinic without her parents' knowledge and took the abortion-drug cocktail known as RU-486. Within a week, she was dead of septic shock, infected by pieces of the baby she was trying to expel.
The heartbreaking human interest of Holly's story did break through the national media's usual political defenses at least for a story or two. Morning shows on ABC and CBS, as well as evening shows on CNN and MSNBC reported it (although it couldn't be located on abortion-phobic Fox).
But the real story took place three years ago.
In September 2000, the Clinton administration rushed the approval of RU-486 through the Food and Drug Administration in case Al Gore's campaign wouldn't prevail to provide aid and comfort to the abortion industry.
None of the liberal media's anti-corporate impulses were excited by the plans of the abortion lobby and Danco Laboratories, the American manufacturers of RU-486, to surpass all the usual FDA safety procedures in a rush to profit from newly approved chemical abortions. Instead, it was all an occasion for joy. On NBC's "Today," news anchor Sara James proclaimed: "Abortion rights supporters call it a victory over medical McCarthyism."
Before RU-486 was approved, pro-life criticism was dismissed as political noise. Since then, all their criticism has been systematically dismissed by the press.
Last August, a group of pro-life researchers -- the American Association of Pro-Life Obstetricians and Gynecologists, Concerned Women for America and the Christian Medical Association -- filed a 90-page "citizen's petition" with the FDA outlining how Clinton's FDA ignored its own laws and procedures to rubber-stamp Mifeprex, one half of the two-drug RU-486 regimen. Mifeprex kills the baby by destroying the nutrient lining of the uterus. A few days later, Misopristol is used to expel the corpse from the womb. Here's what went wrong:
1. Lobbyists railroaded FDA approval through the accelerated review process known as "Subpart H," designed only for drugs intended to treat life-threatening illnesses where there is no safer remedy. Only in Washington is a healthy but unwanted baby considered a life-threatening illness. In fact, Holly's story suggests the opposite: Terminating the baby caused a life-ending illness.
2. The FDA regulations overlooked the usual scientific safeguards used in clinical trials. For example, while the trials used sonograms to determine the age of the fetus, FDA regulations have not required an ultrasound before usage -- even though the drug is not recommended for pregnancies beyond 49 days' gestation and it does not terminate ectopic (fallopian-tube) pregnancies. Whether or not Holly Patterson had an ectopic pregnancy is a crucial factor in investigating her death. In a previous case, an American woman bled to death because of a ruptured tubal pregnancy that wasn't distinguished from the normal heavy bleeding typical of an RU-486 abortion.
3. The FDA failed to test the drug on adolescents like Holly Patterson -- even though they represent a target market, since clinics advertise it as an abortion method that increases privacy. No doubt Holly thought RU-486 was preferable because it evaded a surgical procedure.
4. The FDA normally requires that the selection of patients in a drug trial be random, that some patients receive a placebo to create a control group, and that participating physicians are not told who is and is not receiving the actual medication. In the FDA's supposedly scientific trials for Mifeprex, the selection of subjects was not random, and no one received a placebo.
This petition was ignored by the networks. But they also ignored Danco's admission to the FDA in April 2002 that no less than 400 women suffered complications after using RU-486. Two women had died after using Mifeprex, one from that ruptured tubal pregnancy and one from a fatal bacterial infection. Canadian drug trials were halted when a participating woman died.
Holly's father, Monty Patterson, learned about the problem too late. He told the San Francisco Chronicle, "The medical community treats this as a simple pill you take, as if you're getting rid of a headache. The procedure, the follow-ups, it's all too lackadaisical. The girl gets a pill. Then she's sent home to do the rest on her own. There are just too many things that can go wrong."
Will anything happen to prevent more teenage girls from dying? Here are two reasons for pessimism: The FDA has no enforcement mechanism that requires Danco to share all the reports it receives on negative effects. And there is no greater supporter of unrestricted abortion in American society than that "watchdog" entity entrusted to shed light on this horror.
Brent Bozell is President of Media Research Center, a TownHall.com member group.
©2003 Creators Syndicate, Inc.
Holly Patterson
Dead from Safe & Legal Abortion
http://www.pregnantpause.org/safe/patterson.htm
Funeral services for Holly Patterson were held at Callaghan Mortuary in Livermore, California. She died at the ripe old age of 18, from a safe and legal abortion.
According to her obituary in the Contra Costa Times, Holly graduated from high school a year early. She was in student government, and "enjoyed writing, and loved music, cooking, eating and playing softball and Powder Puff football". There was a reception following the funeral at the county fairgrounds, where she worked as a teen.
Holly's father didn't even know she was pregnant until the hospital called to tell him that his daughter had been brought in following complications from an abortion.
"Every time I think about it, I think, 'She suffered in silence,'" he says. "She felt she would disappoint everyone around her, and then she had to carry that whole load. I wish she could have told me so I could have helped her."
He has told the press that he later learned that Holly and her boyfriend went to Planned Parenthood on September 10, 2003, where she was given RU-486, the "abortion pill". On September 14 her boyfriend took her to Valley Care Medical Center's emergency room, where she complained of severe cramping and bleeding. She was told that this was normal following an RU-486 abortion, was given some pain killers and sent home. Three days later he took her back, and the next day she was dead.
Doctors at Valley Care say she died from septic shock and infection resulting from incomplete expulsion of the fetus. That is, parts of the dead baby were left in her womb. At a press conference, Marcy Feit, CEO of the hospital, called for an investigation into the safety of RU-486. "We're going to be asking the FDA to give us some answers about the safety of this drug," she said. The abortion drugs "have had a controversial history since they were first approved in 2000."
Danco Laboratories, which manufactures the drug, says it has referred to the FDA about 400 reports of adverse effects, most involving excessive bleeding but some involving bacterial infections. Five to eight percent of women who use RU-486 require surgery to stop bleeding or deal with other complications. At least two women in America have died shortly after using RU-486, though the FDA says there is no "proof" that the abortion pill was responsible.
The FDA approved RU-486 in 2000 under "Section H", a special "fast track" procedure which is normally used only for emergency approval of life-saving drugs. Many of the normal rules that are intended to insure safety were ignored so the abortion pill could be rushed onto the market. In Holly's case, one of the procedures the FDA did call for -- that the second pill be taken under medical supervision -- was ignored, and instead she was sent home with a vaginal insert and told to do it herself.
September 26, 2003, 9:15 a.m.
“No Magic Pill”
Holly Patterson, R.I.P.
By Susan E. Wills
http://www.nationalreview.com/comment/wills200309260915.asp
“There's no quick fix for pregnancy, no magic pill," Holly Patterson's sobbing father told reporters on September 19, two days after she died from a massive bacterial infection apparently brought on by a failed RU-486 abortion.
Two weeks earlier, Holly, who had just turned 18, "seemed happy and healthy." But that was before she entered the Planned Parenthood clinic in Hayward, California, about seven weeks along into her pregnancy.
It's unclear whether Holly was given a dose of Mifeprex (the knock-off brand of RU-486 made in China and distributed in the U.S.) or simply a prescription for the drug during her September 10 visit to Planned Parenthood. We do know that when taken alone, RU-486 causes a complete abortion only about 60 percent of the time, leaving a patient vulnerable to serious infection and hemorrhaging. For this reason, a second drug (Cytotec in the U.S.) must be taken about 48 hours after RU-486 to cause uterine contractions, which help expel the embryo. Holly took one of these drugs — most likely Cytotec — at home on Saturday, September 13.
Under the protocol approved by the Food and Drug Administration (FDA) Cytotec is supposed to be given orally and under medical supervision. But some Planned Parenthood clinics and abortionists, who apparently can't be bothered with multiple visits and monitoring women onsite, tell patients like Holly to administer the drug vaginally, at home, with no medical supervision.
This laissez-faire approach markedly differs from protocols mandated in other countries where RU-486 is legal, such as France, China, Sweden, and the U.K. These countries require patients to be monitored by medical staff for four hours or longer after taking Cytotec (or a similar drug) to ensure that no cardiac complications or severe allergic reactions occur, and to determine if the embryo has been expelled.
By Sunday, Holly was "bleeding severely, in acute pain and unable to walk." Unfortunately, these symptoms may not alert emergency-room staff to potentially life-threatening complications because heavy bleeding and painful cramping are exactly what's expected in an RU-486 abortion. So it's not surprising that when Holly's boyfriend took her late Sunday to Valley Care Medical Center (VCMC), she was sent home with painkillers.
In the early hours of Wednesday, September 17, Holly returned to VCMC. That afternoon she died from septic shock, the result of a massive systemic infection. The attending physician told her father that the infection developed because she "hadn't aborted all of the fetus, and she had fragments left in her."
Predictably, Planned Parenthood concedes nothing beyond the established fact that a patient "who recently sought health-care services" at a Planned Parenthood "health-care center" died "at a hospital in Pleasanton." A mere coincidence, really, and anyway she died at a hospital, not one of their "health-care centers."
And Danco Laboratories, the U.S. distributor of mifepristone (RU-486) under the brand name Mifeprex, can be expected to deny any link between the drugs and Holly's death. Following a similar death in September 2001, Danco insisted that RU-486 did not cause the septic shock which killed a woman taking part in Canadian drug trials. And that's technically true, of course. The infections are caused by dead human embryos or parts thereof which are not fully expelled. So the fault lies with the embryos, not the drug that successfully killed them but proved less than successful in evacuating them.
Although Danco has sent the FDA about 400 reports of "adverse events" related to RU-486 — ranging from excessive bleeding to bacterial infections and death — Danco maintains the drugs are "safe." It seems that safety is a subjective and flexible concept. "Mifepristone Questions and Answers," an FDA fact sheet, cautions: "Patients should also understand that safe does not mean risk free."
Does the average patient, the average teen understand she may be risking her life taking RU-486 when she's repeatedly exposed to statements like these: "It's what women have wanted for years: a safe and effective way to end pregnancy — taken orally, without surgery — early on" and "It's the first [FDA] approved pill providing women with a safe and effective non-surgical option for ending early pregnancy" (www.earlyoptionpill.com).
The FDA's mifepristone fact sheet explains that the agency "will approve a drug if it determines that the benefits exceed the risks for the approved use." But exactly what benefit exceeded the risks to Holly, or to a 15-year-old girl whose "adverse event" report describes a "life-threatening hospitalization" and the following symptoms: abdominal pain, adult respiratory distress syndrome, lung infiltration, pelvic pain, purulence, and septic thrombophlebitis? Where was the benefit to a dozen other girls and women described in RU-486 adverse-event reports who experienced "failed" or incomplete abortions which "required intervention to prevent permanent impairment/damage"?
These are not isolated events. A major World Health Organization (WHO) study documented the infection risk associated with RU-486 abortions: 30 percent of women who had incomplete RU-486 abortions developed pelvic/genital-tract infections. The reason for this high infection rate: One side effect of the RU-486 drug combination is immune-system suppression. For this reason, the WHO study calls for women to receive antibiotics for six weeks following an RU-486 abortion.
In April 2002, Danco sent an FDA-approved "dear doctor" letter warning of safety issues associated with prescribing RU-486, i.e., undetected ectopic pregnancies and bacterial infections which had resulted in patient deaths, and informing them of a 21-year-old woman who died of a heart attack three days after taking RU-486. But you won't find that in the promotional materials.
The current FDA protocol requires that patients return two weeks after taking RU-486 so the physician can verify a complete termination and the absence of complications. But Holly Patterson and the Canadian patient who died from septic shock didn't live long enough for the follow-up appointment.
The WHO study, the dozen adverse-event reports of failed/incomplete abortions, and two fatalities from septic shock should make it clear that the RU-486/Cytotec drug regimen is not safe in the hands of teenagers. Nor is it safe in the hands of abortion-facility staff who leave it up to frightened girls to determine if a life-threatening complication is developing.
And because the mode of action and side effects of RU-486/Cytotec mask the very symptoms that would alert medical personnel to life-threatening complications like ectopic pregnancy, incomplete abortion, and uncontrolled bleeding (which nearly cost an Iowa woman her life during U.S. drug trials), RU-486 abortions are unsafe even if the current FDA protocols were followed.
These risks inherent in RU-486 abortions simply do not outweigh the sole purported benefit of avoiding a surgical abortion. Last year those risks were detailed and documented in a "citizen petition" to the FDA filed by the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association, and Concerned Women for America. Had the FDA acted on the petition, Holly might still be alive.
Although she was living at home, Holly's father did not learn of her pregnancy and abortion until a few hours before she died. He wants to tell teenage girls who become pregnant that "no matter what, no matter how bad things are, talk with family and friends. We will support you. Family has the strength to pull you through anything...."
Anything, perhaps, other than a "safe and effective" RU-486 abortion.
— Susan E. Wills is associate director for education at the pro-life office of the United States Conference of Catholic Bishops.
The Population Council is an international, nonprofit, nongovernmental organization that conducts biomedical, social science, and public health research. For more than 50 years, the Council has been evaluating and developing sustainable approaches to enhancing people's health and well-being
From the "non-profit" liars who own the patent...
Mifeprex™ (Mifepristone) for illness and other nonabortion uses
In addition to providing a safe, effective method of early abortion, mifepristone shows promise as a treatment for a number of serious diseases and conditions.
Research has shown that mifepristone could be useful in remedying ovarian cancer, serious psychotic depression, and uterine fibroid tumors. The drug may also be of value in treating endometriosis, endometrial cancer, meningioma, some types of breast cancer, and in assisting labor inductions. Mifepristone might hold promise for the treatment of HIV and Alzheimer's disease as well.
Though the U.S. Food and Drug Administration has only approved mifepristone for early abortion, the Feminist Majority Foundation offers a way to obtain the drug to treat serious illnesses. Information about the Compassionate Use Program can be obtained directly from the Foundation (http://www.feminist.org/rrights/compassionateuse.asp).
http://www.popcouncil.org/mifeprex/illness.html
******
From the FDA, Sept. 2000 when they approved it...
Under the approved treatment regimen, a woman first takes 600 milligrams of mifepristone (three 200 milligram pills) by mouth. Two days later, she takes 400 micrograms (two 200-microgram pills) of misoprostol, a prostaglandin. Women will return for a follow-up visit approximately 14 days after taking mifepristone to determine whether the pregnancy has been terminated.
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