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Sunday, January 11, 1998

First of Norplant contraceptive cases heads to trial

By PAULINE ARRILLAGA / Associated Press Writer

EDINBURG, Texas (AP) -- One woman claims she was so depressed she felt like killing her child. Another says she wanted to kill herself.

The common link between the two was a birth control device surgically implanted in their bodies.

This week, those two women and four others go to court to demand compensation from the makers of the Norplant contraceptive, alleging they were deceived about the severity of the drug's side effects.

It is the first of thousands of Norplant lawsuits to go to trial, and women, doctors and lawyers from around the country are waiting anxiously for the outcome.

"I'm watching the case with great interest," said Chris Parks, a Port Arthur lawyer who represents 800 women in a federal lawsuit against Wyeth-Ayerst Laboratories, the Pennsylvania company that manufactures Norplant.

"I feel very confident that if a jury's allowed to see all the facts, they'll come to the same conclusion that I have, and that is that these women were wronged by this company," Parks said.

Jury selection is scheduled for Tuesday in a state lawsuit brought by the six Texas women against Wyeth-Ayerst and its parent company, Madison, N.J.-based American Home Products Corp.

The women are among about 50,000 nationwide who filed suit over side effects they say they suffered while using Norplant. About 5,000 women have filed suit in South Texas.

The lawsuit demands actual damages totaling $3 million and exemplary damages equaling 1 percent of the net worth of American Home Products, the nation's largest pharmaceutical drug company.

For the nine months ending Sept. 30, 1997, American Home reported a net income of $1.5 billion and worldwide sales of more than $10.5 billion. The company's third quarter earnings dipped after it recalled the diet drugs Pondimin and Redux after studies linked them to serious heart damage. American Home also faces several hundred lawsuits involving those products.

Attorneys on both sides of the Norplant lawsuit said a court order prohibits them from speaking publicly about the case. Veronica Torrez, the only one of the six plaintiffs who could be reached by The Associated Press, also declined comment.

Norplant is a contraceptive system consisting of six matchstick-sized capsules surgically implanted into the upper arm. The capsules release a synthetic hormone into the bloodstream that prevents pregnancy for up to five years.

When it first went on the market in the United States in 1991, Norplant was hailed as a safe, effective and easy form of birth control. Then the lawsuits starting streaming in.

Women complained of a laundry list of health problems, ranging from headaches and weight gain to ovarian cysts and depression.

Sivia Cortez, a Hidalgo County resident and plaintiff in this week's trial, contends she was so depressed while using Norplant from 1991 to 1993 that she "felt like killing her child," according to court documents.

"This had never occurred before Norplant and never occurred after removal," she told a doctor in one medical report.

Another plaintiff, Maria Munoz, said her depression was so severe during the three years she used Norplant that she had suicidal thoughts.

Ms. Torrez said she went from a size 9 to a size 15 while using Norplant from August 1991 to July 1993. In court documents, she also said she suffered hair loss and was so depressed she could not spend time with her daughter.

"That was the biggest loss I suffered," she said in one medical report.

The lawsuit alleges Wyeth-Ayerst and American Home Products "purposefully downplayed and understated the health hazards, side effects and risks associated with the Norplant System."

It contends the companies, through promotional literature, "fraudulently sought to create the image and impression that the Norplant System was safe for human use."

The lawsuit also accuses the companies of targeting Hispanic women in the Rio Grande Valley, especially those who are poor and uneducated.

In a statement, Wyeth-Ayerst said it stands behind Norplant, calling it "one of the most extensively studied contraceptive methods."

Approved for distribution in 39 countries, Norplant has been used by about 1 million American women and 2.5 million women worldwide, the company said.

The contraceptive's makers also noted that they provide extensive educational materials to both the doctors who insert Norplant and the patients who use it. Those materials include warnings about potential side effects.

Last year, a Beaumont judge overseeing the federal Norplant cases threw out five lawsuits after finding that Wyeth-Ayerst adequately informed doctors of potential side effects.

Texas law provides that drug makers have a duty to warn only the doctor -- not the patient -- of a drug's potential side effects. The ruling has been appealed.

Despite the lawsuits, the Food and Drug Administration and several physician groups continue to support Norplant, calling the product a safe contraceptive that offers women a choice in birth control.

"It's a really, really good method for those women for whom it's appropriate," said Dennis Barbour, president of the 2,500-member Association of Reproductive Health Professionals in Washington, D.C.

"As a result of the greed on the part of the lawyers who are filing these suits, it could drive a very good, safe, effective product out of the market," Barbour said.

Parks, the lawyer in the federal case, insisted the lawsuits are not about greed.

"I felt the same way until I spent one morning meeting with these clients. These are really nice people, just like your neighbor or sister or mom," he said. "None of them came to me for any other reason than they were really hurt by this product."