PERSONAL HEALTH : Frustaci Fallout : Couples Fear $6-Million Settlement May Make Potent Fertility Drug Scarce

You assume you’re about to enter a world of chaos when you ring the Miners’ doorbell. You expect screaming babies and frazzled parents and overflowing diaper pails.

But, all things considered, the household in Orange was surprisingly calm one recent morning. True, the babies cried, though generally not in sync. While Jeffrey fussed, Whitney giggled, Vincent slept and Brianna slurped her lunch from a bottle.

“They’re amazingly good babies,” said the foursome’s mother, Karen Miner, who--albeit a blur of perpetual motion--appeared unflappable.

Her thriving 6-month-olds, the first quadruplets born in Orange County, are a happy outcome of the fertility drug, Pergonal. She and husband Al resorted to the ovulation stimulator after attempting for years to have children.

Their miracle, though, was another family’s tragedy.

Patti Frustaci’s use of Pergonal produced septuplets five years ago. One baby was stillborn, three died shortly after birth, and the surviving three suffer from physical and mental handicaps.

Two weeks ago, the Riverside family settled, for $6 million, a malpractice and wrongful-death lawsuit against the infertility clinic that prescribed Pergonal to Patti Frustaci. She claimed that her doctor, Jaroslav Marik, did not adequately monitor her treatment. Marik countered that Frustaci ignored his advice regarding the potent fertility drug.

Karen Miner, who befriended other patients while undergoing treatment at Hoag Fertility Services in Newport Beach, worries that the settlement might someday hinder many couples’ pursuit of parenthood.

“If malpractice cases made doctors afraid to administer Pergonal for fear of being sued, then there would be a lot more disappointed and childless people out there,” said Miner as she cuddled one of her babies.

Hers is a common concern right now among infertile couples: that such lawsuits could put a lid on Pergonal.

“The loss of Pergonal would eliminate any chance I might have to become pregnant,” said Long Beach resident Diane Gold.

But many fertility specialists insist that the Frustaci case will not dissuade them from prescribing Pergonal.

Said Dr. Richard Marrs, director of the Institute of Reproductive Research at the Hospital of the Good Samaritan in Los Angeles: “It is the only treatment that currently exists for some types of ovarian dysfunction.”

Like Al and Karen Miner, tens of thousands of couples throughout the world credit Pergonal for their children’s births.

The drug--manufactured by Serono Laboratories, which specializes in infertility products--has been on the market for a quarter-century.

Jonathan Robbins, spokesman for the Swiss company’s U. S. headquarters in Norwell, Mass., noted that the company “has never been involved in a lawsuit.”

And that includes the one filed by Patti and Sam Frustaci. Their lawsuit involved Marik and the Tyler Medical Clinic in West Los Angeles--one of about a dozen U.S. clinics that helped test Pergonal in the 1960s.

In fact, Patti Frustaci again turned to Pergonal while still in the midst of her highly publicized lawsuit. Her attorney, Browne Greene, announced last week that Frustaci is two months pregnant with healthy twins.

The Frustacis’ first child, born 14 months before the septuplets, also was conceived with Pergonal.

The drug, derived from the urine of post-menopausal women, contains a hormone that nudges more than one of the ovaries’ follicles to ready their eggs for release--instead of the single egg sac that normally hatches during a menstrual cycle.

Pergonal’s injection is the first step in a two-stage procedure. Another hormone, called HCG, sparks the ripened follicles to unhand their eggs.

“The doctor always has the option not to start the final stages of ovulation,” Marrs said. “If we view six mature follicles through ultrasound, we recommend that the patient not receive HCG.”

But when ultrasound reveals fewer than five swollen follicles, ovulation usually is triggered with hopes that one or two eggs will become fertilized.

Often none of the eggs develop into embryos--an ongoing frustration for infertile couples--and the process must be repeated in future menstrual cycles. Extremely rare is the occasion that all of the eggs “take,” as in Karen Miner’s case.

After using Pergonal to accelerate her output of eggs, Miner was impregnated through a procedure known as GIFT, gamete intrafallopian transfer. Four eggs were removed from her uterus, then were mixed with her husband’s sperm and placed in her Fallopian tube.

“All we wanted was one little baby, and we were willing to do anything to get that one little baby,” she said.

Two months into her pregnancy, Miner learned that her one little baby was four. “I started crying and my husband started laughing,” recalled the 32-year-old former schoolteacher.

The couple prepared themselves for tiny, premature infants who would have to remain hospitalized for months. But although they were born eight weeks early, the four arrived in extraordinarily fine form.

Observed Al Miner: “We were very lucky.”

“Pergonal has helped a lot of people,” said reproductive endocrinologist Dr. Lawrence Werlin, who treated Karen Miner. “It is a very good drug.

“Fifteen percent of the general population is infertile, and we expect this to become an increasingly critical problem as more women postpone childbirth into their late 30s,” added Werlin, medical director for Hoag Fertility Services.

When monitored correctly with ultrasound screenings and estrogen level checks, Werlin said, the drug carries little risk of effecting a multiple pregnancy proportionate to Patti Frustaci’s.

Serono spokesman Robbins pointed out that every Pergonal prescription comes with an insert spelling out the drug’s odds: 80% of Pergonal-aided pregnancies result in single births; 15% in twins; 5% in triplets or more. In the general population, between 1% and 2% of full-term pregnancies are twins, and .01% are triplets.

While Werlin doubts that the Frustaci case will make experts such as himself wary of administering Pergonal, he said the settlement likely will induce doctors who do not specialize in the field to refer infertile patients elsewhere.

“This drug should be prescribed only by physicians who use it all the time--not by general ob/gyns (obstetrician/gynecologists),” he said.

Dr. David Mildrum, a fertility specialist at South Bay Hospital in Redondo Beach and a UCLA professor, agreed that the Frustaci settlement will discourage non-specialists from prescribing Pergonal--a “second-line,” last-resort drug used only after milder hormonal stimulants have failed.

“When drugs such as Clomid (a ‘first-line’ ovulation enhancer) have not been successful, the gynecologist should refer the patient to a specialist,” Mildrum said.

A spokesman for The Doctors’ Co., which insures Tyler Medical Clinic, said that the generous settlement will not affect the company’s underwriting policy.

“This is our only claim against an infertility clinic in the history of our company,” said Sheldon Davidow. “(Pergonal) does not concern us at all. Rather, when evaluating underwriting risks, we always have and we always will look at the qualifications of the physicians prescribing the drug.”

The Doctors’ Co., based in Napa, is the country’s largest physician-owned liability insurer, covering 14,500 doctors.

“As tragic as these cases can be for both the doctors and the patients, they are the nature of our business,” Davidow said. “That’s what we’re here for--we try to keep that in perspective.”

If her use of Pergonal were to result in a dangerous multiple pregnancy, said Darlene Messinger, she would not file suit against her doctor as did the Frustacis.

“Dr. Werlin has made me fully aware of all the implications and side effects of the drug,” said Messinger, 36, an assistant principal with the Fullerton School District. “I feel that the decision to take Pergonal is ultimately my responsibility.”

Infertile couples often become so desperate that they will attempt to achieve pregnancy at almost any cost--and infertility treatments can, indeed, be costly.

“Just in the past eight months my husband and I have spent $12,000 on the GIFT procedure,” said Messinger, who has been trying to conceive for 12 years. “Our health insurance company denies fertility claims. I don’t even want to think about how much we’ve spent in total.

“I know a woman going through in vitro fertilization who said, ‘Well, we’ll just mortgage our house,’ ” Messinger added. “I have friends who are absolutely single-minded in their pursuit of producing a child. People become obsessed with it.”

Diane Gold, 41, described her five-year battle against infertility as “incredibly frustrating, very painful.”

“It attacks one’s whole emotional circuit--especially for people of the generation who learned that if we work hard enough at something, we can attain whatever we want,” Gold said.

“Having a child just seems to be your birthright. I may have to come to terms with the fact that life is not always fair, but I’m not yet willing to give up on the chance to carry a child.”

After investing $40,000 and eight years into the goal of pregnancy, Carey Okrand at last met success and is expecting twins.

The Van Nuys resident remembers her experience with infertility as “obsessive, depressing and lonely.”

“You start to feel isolated as a couple when you see all your friends around you and your younger siblings having babies, and you still don’t have any children,” said Okrand, 37.

Miner said the heartbreak of infertility was so consuming that it will nag her forever: “I don’t stop feeling it, even with these four little bundles of joy. The hurt is still there. Just talking about it makes me cry.”

That pain is what strengthened the Miners’ decision to forgo “selective reduction,” in which one or more fetuses in a multiple pregnancy are aborted to better the others’ chance of survival.

“There’s a risk that (through selective reduction) you can lose the entire pregnancy,” Karen Miner said. “And if that had happened, and we were never able to achieve a pregnancy again, I don’t think we could ever forgive ourselves.”

Patti and Sam Frustaci also shunned the procedure--in their case, because abortion conflicted with their Mormon faith.

Fertility specialist Marrs does not discuss the option when counseling his patients about available treatments. “I don’t feel comfortable telling them: ‘I’m going to do everything I can to get you pregnant, and by the way, if we overshoot the mark you can have selective reduction,’ ” he said.

“(A doctors’) job is to make sure that we don’t put our patients in that situation in the first place. These are individuals who have spent years and years trying to achieve a pregnancy. To ask them to abort one or two of their fetuses is a cruel and tortuous question--although it is a question that, unfortunately, we have to ask from time to time.”

Dr. Manuel Porto, director of maternal-fetal medicine at UCI Medical Center, said that selective reduction seldom is recommended in multiple pregnancies of three or fewer fetuses.

“We do well with triplets, but quadruplets are a gray area,” said Porto, who delivered the Miners’ babies. “If you get beyond that (four fetuses), the number of successful outcomes is extremely low.”

For Al and Karen Miner, the gamble paid off fourfold.

“People say, ‘You have four infants? Oh, you poor thing!’ ” Karen Miner said, laughing. “And I say, ‘You’re wrong. I feel very blessed to have four.’ ”