Norplant users detail pain, losses suffered from contraceptive.

Last fall, a small group of women sat in a dimly lit room at the National Press Club in Washington, D.C., and told reporters of their experiences with Norplant.

Blindness, weight gain, depression, severely irregular or prolonged menstrual cycles, headaches, and dizziness are among the side effects the women said they suffered from using one of the more effective and well-promoted contraceptives since The Pill became widely available across the United States in the 1960s.

Norplant is a five-year reversible contraceptive system, approved by the Food and Drug Administration (FDA) in 1990, that consists of six silicone-coated, matchstick-sized capsules containing a steroid that is called Levonorgestrel.

The Norplant capsules, which are surgically inserted in the upper arm, are distributed by Pennsylvania-based Wyeth-Ayerst Laboratories, a division of American Home Products. The capsules slowly release the contraceptive steroid into a woman's body over the five-year life of the system, preventing ovulation and, therefore, pregnancy. Some 1 million Norplant kits have been distributed to U.S. women, primarily through welfare agencies and nonprofit organizations, such as Planned Parenthood.

Wyeth-Ayerst contends the Norplant system is safe and effective.

Lawyers for women seeking redress from the company have filed at least seven class-action lawsuits across the United States, with most of them filed last summer. (Norplant Suits Multiplying, TRIAL, Oct. 1994, at 17.)

To date, a judge certified a plaintiff class in a Chicago case one year ago, and lawyers for plaintiffs conducting multidistrict litigation in Texas expect a class-certification ruling later this summer. (Doe v. Wyeth-Ayerst Laboratories, Inc., No. 93 L 11096 (Ill., Cook County Cir. Ct. filed June 20, 1994); Doe v. Wyeth-Ayerst Laboratories, Inc., Civ. A. No. 1:94CV442 (E.D. Tex. filed July 21, 1994).) The remaining cases are in the discovery phases of trial.

Last September--a few months after the flurry of lawsuit filings--the Association of Reproductive Health Professionals and the National Association of Nurse Practitioners in Reproductive Health called reporters together for a media briefing at the National Press Club. Wyeth-Ayerst Laboratories sponsored the meeting.

Medical professionals from Planned Parenthood, several universities, and the associations were prepared to dispense information about Norplant.

Plaintiffs' attorneys Harold Dampier Jr. of Houston and Michael Hackard of Sacramento, California, had already called their own briefing to coincide with Wyeth-Ayerst's. The two lawyers and an assistant stood in the foyer of the press club, passing out bright orange flyers to reporters who were on their way to the Wyeth-Ayerst press conference, asking them to attend another to "ensure that both sides of the Norplant issue are addressed."

Wyeth-Ayerst's publicity people abruptly shut down their media briefing, citing "lack of interest" by the press, despite the fact that several reporters were present.

Dampier, head of ATLA's Norplant Litigation Group, along with Hackard and women who contend they were harmed by Norplant, addressed the reporters.

The women, each seeking class-action status in the Texas lawsuit against Wyeth-Ayerst, are unified in their goal: to oust Norplant from the market.

"We've got to stop it," said one of the women, Dawn Valenzuela, through tears, calling for Norplant's demise. "It's not fair. People shouldn't have to go through this."

Valenzuela said she received Norplant in 1991 and immediately developed bleeding and apparent nerve damage where the contraceptive system was inserted.

Valenzuela's body was undergoing other changes as well. She said she menstruated continuously from the day Norplant was inserted until its removal nearly a year later.

She said her doctor told her that the use of Norplant made it medically necessary for her ovaries and most of her fallopian tubes to be removed, preventing her and her husband Ricardo from having another child.

Near the couple sat Jaine Rositas, a slight 36-year-old single mother of two whose brown hair was trimmed asymmetrically around her face--a style designed specifically for hiding the effects of Norplant, she said.

"I have no sight in my left eye," Rositas said, charging that the optic nerve damage she suffers resulted from the Norplant system that was implanted in her arm in 1992. "It's almost like having cancer. My eye is just dying."

Lawsuits stemming from Norplant use focus on three general areas: migration of Norplant capsules inside the arm, medical complications, and inadequate insertion and removal training for health care practitioners.

A fourth area of controversy that has emerged recently centers on questions about possible damaging effects of the silicone used in the contraceptive's dispensing capsules.

Norplant users, like people who received silicone breast implants, have reported immunological problems that may be linked to the silicone. Scientists generally believe silicone is an inert substance. It is used routinely in an array of medical devices, including artificial organs and joints, penile prostheses, and contact lenses.

In 1992, however, FDA Commissioner David Kessler called for a voluntary moratorium on the use of silicone gel breast implants, saying available data was insufficient to ensure users' safety. (Gina Kolata, Legal System and Science Come to Differing Conclusions on Silicone, N.Y. Times, May 16, 1995, at D6.) Recently, courts have handed down substantial awards based on the presumption of a health hazard.

New York plaintiffs' attorney Sybil Shainwald, a member of the Plaintiffs' Steering Committee for current Norplant litigation, testified before the FDA in the late 1980s as a member of Health Action International, a consortium of health groups worldwide.

Shainwald said she opposed FDA approval of Norplant because of problems similar to those now known in the United States that were reported in other countries.

"It was the quickest approval of anything I'd ever seen," Shainwald said of the FDA's action. "It was much quicker than the [approval of the] cervical cap. [The FDA] thought they could control the problem of teenage pregnancy, I suppose. [In doing that, they overlooked the problem of AIDS--they weren't teaching women to protect themselves.] It's a hormone with all its attendant problems, and a contraceptive device that must be surgically removed.

"More and more women are receiving Norplant, and that is a very big deal," Shainwald said. "There are a wide range of injuries, and I don't think they are minor injuries, as the defendant would like people to believe."

Bain Pearson, a plaintiffs' attorney in Houston, said her office gets phone calls every day on Norplant.

"One of the bigger, more common problems is that [health care providers] who put in Norplant are not properly trained, and now they don't want to touch [women who received the implants] because the implants are too hard to get out."

Women who believe they have been harmed by Norplant can consider joining class-action litigation in Alabama, Florida, Illinois, Louisiana, Pennsylvania, and Texas, or they may file individual suits, Pearson said. Potential plaintiffs also may join the Eastern District of Texas class-action litigation by filing suit in their own jurisdiction's federal court.

"A lot of people have no idea these suits are going on," Pearson said. Unlike plaintiffs in the breast implant litigation, the people most likely to have used Norplant will have limited sources of money, power, and influence to remove the contraceptive system from the market, she said.