Policy & Practice


Wrongful Death Lawsuit

Ortho-McNeil Pharmaceuticals Inc. and Johnson & Johnson, makers of the Ortho Evra contraceptive patch, are facing a nearly $150 million lawsuit in the 2003 death of 17-year-old Ashley Lewis. The lawsuit, filed in the 22nd Judicial Circuit Court of Missouri in St.Louis, alleges that the companies failed to adequately warn the public and health care providers about the increased risk of thromboembolitic events with the patch. Ms. Lewis's doctors are also being sued for allegedly failing to advise her to discontinue use of the patch and failing to properly diagnose and treat her when she repeatedly reported symptoms of adverse reactions to the patch. Ortho-McNeil and the Food and Drug Administration recently updated the product's warning section to say that the patch has a higher steady-state concentration and a lower peak concentration than oral contraceptives. The steady-state concentration for ethinyl estradiol is about 60% higher for the patch, according to the new prescribing information. Spokesman Michael J. Beckerich said the companies would not comment on the litigation.

Sexual Assault Treatment Guidelines

The U.S. Department of Justice is once again under fire for its 2004 guidelines for the treatment of sexual assault survivors. Planned Parenthood Federation of America and the American Civil Liberties Union criticized the Justice Department for refusing to release certain records related to the development of the guidelines. Reproductive rights groups had previously slammed the national protocol for failing to address the use of emergency contraceptives for sexual assault victims. A coalition of these groups submitted a request for documents to the Justice Department in an attempt to figure out why emergency contraception was not included in the protocol. Although the Justice Department provided a set of documents used to develop the preliminary protocol, it did not release earlier drafts. Eric Holland, a Justice Department spokesman, said that he would not comment on the document request but said that there was a “victim-centered approach” at the heart of the national protocol and that physicians were encouraged to discuss all appropriate treatment options with patients.

Challenge to Illinois Contraceptive Rule

The Illinois regulation mandating that pharmacies that carry contraceptives must dispense all valid prescriptions for contraceptives, including emergency contraception, is being challenged in court. The American Center for Law and Justice filed a lawsuit in the U.S. District Court for the Central District of Illinois in Springfield, in December saying that the regulation infringes on the rights of pharmacists under the religious liberty provisions of the First Amendment and violates other state laws. The group represents five pharmacists who have been fired or suspended and two others. Illinois Gov. Rod R. Blagojevich (D) issued an emergency regulation last April; it was made permanent in August. The governor plans to vigorously defend the rule and a woman's right to access valid prescription drugs, according to his spokesperson, Abby Ottenhoff. Pharmacies that sell contraceptives have an obligation to fill the prescriptions without lecture and without delay, she said.

Teen Pregnancy Legislation

The latest effort to prevent teen pregnancy is new legislation, introduced in the U.S. House of Representatives last December, which would create grants to develop programs aimed at delaying sexual activity and helping parents communicate with teens about sexuality. The Teen Pregnancy Prevention, Responsibility, and Opportunity Act (H.R. 4644), was introduced by Rep. Robert Menendez (D-N.J.). If enacted, the legislation would provide funds to local educational agencies, state and local public health agencies, and nonprofit groups to educate sexually active teens and those at risk of becoming sexually active about the responsibilities of parenting.

Ban on False Information

The Health and Human Services Department may not deliberately disseminate false or misleading scientific information under a recent federal law. The provision, part of the fiscal 2006 HHS appropriations law, also prohibits the questioning of scientific advisory panel nominees about their political affiliation, voting history, and positions on topics unrelated to the capacity in which they are to serve. “If your doctor gives you misleading scientific information, it's called malpractice,” said Dr. Francesca Grifo, senior scientist and director of the scientific integrity program at the Union of Concerned Scientists. “It should already have been illegal for political appointees in government posts to knowingly provide false information, so this ban at HHS represents a modest but important first step in ensuring scientific integrity in federal policy making and better health care for us all.”

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