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Contraceptive Patch Lawsuit

Ten women filed a lawsuit against the makers of the Ortho Evra contraceptive patch, alleging they were not adequately warned of the product's risks. The plaintiffs said they experienced blood clots after using the patch. The lawsuit, which was filed in New Jersey last month, claims Johnson & Johnson; Johnson & Johnson Pharmaceutical Research and Development LLC; and Ortho-McNeil Pharmaceutical Inc. “negligently designed, manufactured, marketed, advertised, and sold the Ortho Evra contraceptive patch by misrepresenting its safety, and failing to adequately warn of its risks.” The plaintiffs are seeking compensatory and punitive damages. The company said it had not received a copy of the charges and therefore could not comment, said Ortho-McNeil spokesman Michael J. Beckerich. However, he said when used as labeled Ortho Evra is a “safe and effective birth control choice for many women” and the types of adverse event reports that have been received for the patch are “consistent with the health risks of other hormonal birth control methods and the Ortho Evra product label.”

EC Web sites

Women need more information about emergency contraception (EC), according to articles in the July and August issues of the journal, Contraception. The article in the July issue examined usage of an English-language EC Web site by looking at e-mail queries received from July 1999 to June 2004. The second study, published in August, looked at an Arabic-language version of the Web site by analyzing user profiles and use patterns from June 1, 2003 to Dec. 31, 2004. Analyses of questions posed on an English-language Web site shows users are concerned about issues such as bleeding after EC use and whether EC use will prevent pregnancy if they engage in intercourse shortly after treatment. Users of the Arabic-language site also were interested in information about bleeding after use and in Web sites designed for an Arabic-speaking audience.

No More Caps in Wisconsin

The Wisconsin Supreme Court's decision to remove a 30-year-old cap on noneconomic damages in malpractice cases will have a devastating effect on physicians and patients, according to the American College of Obstetricians and Gynecologists. The court held that the cap, currently set at $445,775, was “unconstitutional beyond a reasonable doubt.” The cap had for the most part protected the state from the “medical liability insurance crisis sweeping the country,” ACOG President-Elect Douglas W. Laube, M.D., said in a statement. In 2004, Wisconsin ob.gyns. paid slightly more than $23,000 a year for their medical liability insurance compared with their colleagues in parts of Illinois, where annual premiums for ob.gyns. are more than $230,000, according to ACOG. Wisconsin medical groups are concerned that the decision “will force a wave of doctors to retire early or stop performing high-risk procedures,” said Susan Turney, M.D., chief executive officer of the Wisconsin Medical Society.

Tracking Birth Defects

The states and the federal government should devote more resources to birth defect surveillance systems and autism registries, according to a new report from the nonprofit group Trust for America's Health. While 47 states and territories are operating or actively planning birth defect surveillance programs, only 15 of the programs receive some financial support from the Centers for Disease Control and Prevention, though technical assistance is available to all programs through the CDC. The report also calls on officials to link existing data systems such as vital records, birth defects surveillance systems, newborn screening programs, immunization registries, educational data, and nationwide health tracking. The report is available online at

www.healthyamericans.org

Legislating Reproductive Health

A number of states have enacted laws addressing access to reproductive health services, according to an analysis by the Alan Guttmacher Institute. Since January, 17 states have enacted 23 laws that the group characterized as aiming to limit access to such services. These measures include mandating parental involvement for, or reporting of, minors' abortions; requiring that women seeking abortion receive counseling 24 hours before undergoing the procedure; and directing that women seeking an abortion be told that a fetus can feel pain after 20 weeks' gestation. But 14 states also have enacted measures that the Institute termed “positive” for women's access. The measures include protecting access to abortion clinics, permitting pharmacists to dispense emergency contraception, mandating insurance coverage of contraceptives, expanding Medicaid eligibility for family planning, and funding research involving embryonic stem cells.

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