WHY RU486 WON'T SOLVE THE CONFLICT OVER ABORTION, BUT WILL GIVE RISE TO A LITIGATION NIGHTMARE

Those who have suggested that the abortion drug RU486 will end the conflicts over abortion in this country are, in a word, delusional. A division that has caused our most serious civil war since the Civil War — and that centers on a practice that I and many others believe amounts to killing babies — won't simply be solved by a pill.

What RU486 will really promote is not a solution to the conflict over abortion, but a litigation explosion. Aside from the serious spiritual, moral, emotional and physical repercussions of the drug, the legal fallout from RU486 will likely be enormous — perhaps unprecedented. This little pill is likely to spawn some large litigation.

RU486 (also known as Mifeprex) works by blocking progesterone, thereby removing the life support system for the embryo and causing its death. The uterus may expel the dead embryo, but in studies this happened less than ten percent of the time. And if it does not happen, women must take a second powerful drug, Misoprostol (also known as Cytotec). Indeed, RU486's label anticipates that it will be used in conjunction with Misoprostol. And the FDA's medication guide directs the patient who has taken RU486 to return to her doctor's office after two days to determine if she is still pregnant. If so, she is to take two Misoprostol tablets — and call no one in the morning.

RU486 has serious side effects such as pain, bleeding and disrupted sleep. Studies also found high infection rates among users because RU486 suppresses the immune system. Moreover, the drug's dangerousness is, to some extent, still unknown. Studies have not been done to gauge the drug's effect on women who are under 18, heavy smokers, or more than 49 days past their last menstrual cycle, or who have medical conditions such as hypertension and diabetes.

What is known is that however unsafe RU486 may be, Cytotec can be lethal. Cytotec was developed by G.D. Searle & Co. of Chicago, to prevent gastric ulcers, and originally FDA-approved in 1988 only for this use. Yet its common off-label use is to induce labor. No one has studied its effects as a labor inductor, since that was not its purpose. And last August, Searle itself warned against Cytotec's use for abortion — saying it could lead to maternal or fetal death, rupture of the uterus, hysterectomy, amniotic fluid embolism, shock, and other calamities.

Product liability suits are inevitable. And we shouldn't be surprised when they occur. Other unnatural devices, like breast implants and intrauterine devices, have triggered large litigation and liability. The only question is who will be included in the lawsuit sweep. Will Searle escape exposure through its written warning of Cytotec's risks? Or does Searle, knowing that Cytotec in practice is used for induction of labor and abortions, have an obligation to stop manufacturing it? Will the FDA itself be liable for its approval of the drug, since it knows the risk of birth defects if the pregnancy is not ended? Knowing the product's risks and side affects — include the risk that future children of women who take the drug could suffer from damage to the reproductive process — will Danco be liable for manufacturing RU486?

The FDA originally proposed stringent guidelines for doctors dispensing the drugs, including a national registry, and requirements that the doctors be trained in surgical abortions and have admitting privileges at a hospital an hour from their offices. But because of strong objection by pro-abortion groups and the National College of Obstetricians and Gynecologists, these guidelines were omitted. Several congressmen, led by Oklahoma Republican Tom Coburn, have proposed legislation putting them back. The lack of guidelines will complicate liability issues for doctors, enhancing the likelihood of litigation. Yet abortion advocates are threatening to explore legal options if guidelines take effect, claiming they will nullify the drug's approval.

Remember, these drugs were made to kill, and something meant to kill is likely to maim. Dead and damaged babies cause plaintiffs' lawyers to anticipate huge recoveries for their clients, and huge attorneys' fees for themselves — with the potential plaintiffs including mothers and father, children whose mothers took the drugs, and even grandparents. Ironically, patients who do not receive this allegedly safe drug, and are turned away by doctors, may also find some basis to sue. And no matter what the basis for the lawsuit may be, the line of potential defendants will begin with the doctors.

States have a compelling interest in protecting the welfare of the mother during an abortion. Many state laws concentrate on second and third trimester abortions. But RU486 and its companion drug Misoprostol should force states to revisit the question of how to protect women during the early trimester, when these drugs will be used.

Laws currently on the books will have to be reviewed, to see if they apply to the new drugs. For instance, Michigan prohibits dispensing a "family planning drug" in public schools. Kansas says that the use of drugs that inhibit or prevent implantation of an embryo cannot be outlawed. Several states limit how abortion drugs can be sold and advertised.

States will also have to grapple anew with concepts and requirements that are familiar in the context of surgical abortion, but may change in the context of abortion drugs — including requirements of parental consent for minors, and informed consent and waiting periods for adult women. Especially since the FDA waived the pediatric study for the abortion drugs, states will have to grope in the dark to redefine parental consent requirements for abortions effected through these drugs.

In addition, states will have to address the fact that abortion drugs radically raise the risk of emotional injury to women. Surgical abortions give women a buffer: the process is short, the woman's role passive, and the dead, unborn child never seen. In contrast, an abortion accomplished through drugs is prolonged, and the woman more involved. Worse, as she experiences fourteen days of pain and sorrow, she is mostly alone. In the end, she will see her unborn child, and learn it is a myth that an embryo bears no resemblance to a child.

What should the state do to protect women from such destruction? These pills will hit the black market with a vengeance, and access will be ready — and often without a doctor's supervision — so states must be prepared. What guidelines should states use to inform women of the risks they face before they consent to this quasi-experimental use of these drugs? And what is an adequate waiting period before a woman subjects herself to crushing emotional trauma?

When states pass or modify new laws addressing the new drugs, abortion advocates will, in turn, advance litigation challenging these laws. Litigation will multiply when pro-lifers creatively mobilize with fresh public protest strategies; the voice opposing prescription-pad abortion will be loud and lithe. Judges will tackle new legal arguments and counterarguments as these forces clash for Round Two of the fight over abortion.

RU486 will scar this nation. Unlike other countries, we have never accepted the proposition that life should be so easily snuffed out. And we are a nation obsessed with legal solutions. The women who use these drugs will suffer immensely — and the potent chemicals they take may have unimaginable genetic consequences. We can't walk the RU486 path without endless detours into courtrooms. It's a fool's errand putting a killing drug duo into the American marketplace, and it will end in tears — and in lawsuits.