Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, October 1, 1995 TAG: 9510020111
SECTION: NATIONAL/INTERNATIONAL PAGE: A-5 EDITION: METRO
SOURCE: SHARON COHEN ASSOCIATED PRESS
DATELINE: LENGTH: Long
It was all a frightening mystery to Kimberly Thompson: the throbbing migraines, the shortness of breath, the shocking 40-pound weight gain in just three months.
``It was the worst part of my life, wondering what is happening to your body,'' said the 25-year-old Chicago mother of two. ``There were times I would cry and say, `What's wrong? Is it me?'''
It was clear to Rhonda Rice something was terribly wrong when she was hospitalized five times in a year.
``I was having anxiety attacks, irregular heartbeats, fainting spells,'' the 31-year-old Texas woman said. ``Getting up out of a chair would exhaust me. I had severe hair loss. My face would break out in boils. I had a lot of problems.''
Both women hope to prove their ailments had a common source: Norplant, a contraceptive touted as a major medical advance when introduced in the United States, and now, just 41/2 years later, the target of a flood of lawsuits that could jeopardize its future - and, some say, perhaps even the future of birth control research.
Norplant, the first major new contraceptive since the birth control pill came on the market 30 years ago, was hailed as a safe, effective, no-fuss form of protection. Six matchstick-size silicone-coated rods are implanted under the skin of the upper arm, releasing a synthetic hormone into the bloodstream that prevents pregnancy for up to five years.
Nearly 1 million U.S. women tried Norplant. Now, 50,000 users have retained lawyers to sue over it, according to Chris Parks, a Texas attorney representing 600 women. Most claim they weren't adequately warned of the scope and severity of side effects - including headaches, weight gain, persistent menstrual bleeding, hair growth or loss, ovarian cysts, anemia and depression - or removal problems.
``They were sold a dream and got a nightmare,'' Parks said. ``If you tell women all the facts about Norplant, they will not be interested. ... The side effects don't go away, and that's what [the company] wants everyone to believe.''
``Women who thought they made intelligent choices about birth control now hate themselves,'' said Jewel Klein, a Chicago attorney representing 4,100 women in a state class-action suit, including Thompson, whose implants were removed after three months. She said her health improved after that.
The manufacturer, Wyeth-Ayerst Laboratories, a division of American Home Products Corp., maintains Norplant is a good contraceptive - the Food and Drug Administration recently reaffirmed its support - and claims the litigation has been orchestrated by avaricious lawyers, some of whom were involved in the global $4 billion breast implant settlement.
``We believe in Norplant and in its safety and its efficacy,'' said Audrey Ashby, a Wyeth-Ayerst spokeswoman. ``We're going to defend the cases vigorously ... and we hope the product will be vindicated in court.''
On Tuesday, attorneys head to court to ask a federal judge in Texas to certify a national class-action suit on behalf of women claiming Norplant injuries. All federal cases were consolidated last year.
The attorneys claim Norplant wasn't adequately tested (several trials were in Third World countries), doctors weren't adequately trained, and women - many of them young and poor - weren't adequately counseled.
They also claim users weren't warned that silicone, which has been controversial in breast implants, could cause serious health risks.
The company said Norplant has been tested for more than 20 years - including on more than 1,000 U.S. women - and been approved for distribution in 39 countries. It also said it provided extensive training for doctors.
The silicone - less than a gram - commonly is used in medical devices, such as pacemakers, Ashby said, adding that revised warning labels note the ingredient.
Ashby contends the timing of the litigation isn't coincidental: While only about 20 suits were filed through 1993 when 800,000 women had Norplant, that number skyrocketed to 309 - 59 seek class-action status - in the past 11/2 years.
``We feel Norplant was a new mark,'' she said, with the increase coming as breast implant cases wound down and publicity intensified. She cited one day when nearly identical lawsuits with the same typographical errors were filed in Minnesota, Texas and Kansas.
``It's greed,'' said Dr. Elizabeth Connell, professor of gynecology and obstetrics at Emory University's School of Medicine in Atlanta and a contraceptive expert for 30 years. ``You have a bunch of attorneys who have deep pockets. As soon as they empty one, they look for the next one. That's what's happened here.''
She said attorneys have employed the same tactics as in breast implant cases: recruiting women through media advertisements, then conducting seminars on what experts to use.
And while no one disputes women are sick, the doctor said, data don't support a cause-and-effect relationship with Norplant.
Connell also fears this controversy could discourage companies from developing new contraceptives in what already is a shrinking U.S. industry.
``It's one of the worst things I've seen in all my years in medicine and one of the worst things that's ever happened to women,'' she said.
Parks, however, insists this is no ploy by mercenary lawyers.
``It's impossible from a public relations campaign to blame 50,000 women, so you blame their lawyers,'' he said. ``Lawyers aren't supposed to be popular.''
While the legal battles have just begun, the publicity already has taken its toll: Daily sales have plummeted from 800 to 60, Ashby said.
Dr. Richard Ellenbogen, a Detroit area obstetrician-gynecologist, said he has removed about three-fourths of about 75 implants he had inserted. ``I don't know of any physicians putting them in anymore,'' he said.
Though Ellenbogen hasn't seen significant problems, he said at least half of his Norplant patients suffered side effects. ``I don't think it's a very good means of birth control,'' he said.
Dr. Keith Brown, an osteopath in the Chicago suburb of Elmhurst who participated in a Wyeth-Ayerst training program, disagrees.
``It's as safe as any other form of birth control ... when inserted properly and people are counseled properly,'' he said, noting he has received few complaints among his few hundred Norplant patients.
Gloriane Angellotti, 37, recently had her implants removed after nearly five years and had no problems. ``I thought it was great,'' she said. ``It worked, and it was convenient. That's the bottom line.''
But those who've sued said some doctors told them nothing and warnings didn't include some illnesses, while playing down others. For example, potential side effect listings include weight gain and prolonged bleeding, but don't indicate that could mean 60 pounds or menstruation for 45 straight days.
Linda Salazar, a 21-year-old New Mexico mother of two, blames Norplant for gallstones, anemia, depression, a thyroid disorder and 16 consecutive months of menstrual bleeding that cost her a job.
``I couldn't nurse my baby,'' she said. ``I couldn't sleep at night. I had joint pains. I shouldn't be feeling those things at 19 years old. ... I've never been that sick in my entire life. I was an emotional wreck.''
In mid-October, the company will begin including a voluntary patient acknowledgment form, asking Norplant users to sign a statement saying they understand the risks and benefits of the product.
by CNB