A Contraceptive Casualty?

Mary Maifer is worried that many women may be using Ortho-Gynol Contraceptive jelly without knowing the potential risks of the popular spermicide.

"I saw a woman buying [Ortho-Gynol jelly] the other day, and I wanted to grab it from her and tell her she's crazy," said Maifer. "But then I thought, well, she's probably heard about [my case]."

In 1982, Maifer sued Ortho Pharmaceutical Corp., a subsidiary of Johnson & Johnson and the maker of OrthoGynol Contraceptive jelly, charging that her use of the product while pregnant caused her daughter's birth defects: a deformed right hand, no left arm, a blind eye and a cleft palate.

After two weeks of testimony, Atlanta District Judge Marvin H. Shoob, ruled that Ortho Pharmaceutical had had enough evidence of potential risks to warrant a stronger, more specific warning label on the product. Failure to warn, he wrote in his order, constituted a defect in the product and "proximately caused the birth defects [of Katie Wells]."

Maifer should have had the opportunity to know that birth defects were a possible side effect, ruled the judge, so she could have had the option of terminating the pregnancy.

In July 1985 Maifer and her daughter were awarded $5.1 million in actual damages.

Although in May 1986 damages were dropped to $4.7 million on appeal, they still exceed the $3 million profit Ortho says it makes from its $30 million spermicide sales annually.

The case is generating controversy. Scientists and physicians are debating whether spermicide can cause birth defects-and if so, which ones; family planning organizations are speculating on how many more unwanted pregnancies will occur if spermicide is taken off the market; and just about everyone involved is offering advice on what Ortho-Gynol's warning label should say in light of the Mailer suit.

If spermicide are found to be unsafe and forced off the market, the U.S. rate of teen pregnancy-already high-could skyrocket. According to one 1982 government study, about 3.4 million U.S. women use spermicide (with and without a diaphragm). But because they are easy to buy without a prescription and require no fitting or physician's examination, spermicide is one of the most popular forms of birth control among teenage women-the majority of whom use no birth control at all.

"It's been estimated that if spermicide were to be lost, the already astounding rate of teen pregnancy in this country would certainly go up higher," said Dr. Louise B. Tyrer, vice president for medical affairs at Planned Parenthood Federation of America.

Even with widespread use of spermicide among teenage women, the United States has one of the highest rates of pregnancy among teenagers in the developed world. The U.S. teen pregnancy rate is 96 per thousand, compared to 14 per thousand in Holland.

Mary Maifer was past her teens when she unexpectedly became pregnant in November 1980. She was already a college economics professor and mother of one healthy child. To avoid another pregnancy, she used Ortho Gynol Contraceptive Jelly and followed the instructions on the product precisely. But despite her precautions, in July 1981 she gave birth to a daughter with severe limb deformities.

At issue in Katie Wells v. Ortho Pharmaceutical was whether the spermicide could have caused the child's birth defects, and whether Ortho knew enough about the spermicidal risks to be held liable for failure to warn the users of its products of those risks.

Maifer and her attorneys had to prove that prior to Katie's conception, evidence was available to the company showing a possible link between the spermicide and birth defects and that an appropriate warning should have been put on the product's warning label.

The plaintiffs pointed to two such studies. In 1976, in a study commissioned by the National Institutes of Health, Dr. Frank W. Oechsli found a possible relationship between spermicide and birth defects. A year later, another study was published in the British Journal of Preventive and Social Medicine, indicating that spermicide have a significant potential of increasing the risk of limb deformity.

These studies and the questions of risk they raised, testified Dr. Earl Sutherland, an expert witness from the Rocky Mountain Drug Consultation Center, should have caused Ortho to change the warning label on its contraceptive product. Ortho's failure to provide such a warning, said Sutherland, fell beneath the customary standard of care in the pharmaceutical industry.

Ortho argued that while a few studies suggested a causal hypothesis, later studies had failed to replicate those , results. The methodology of one of the early studies, said a witness for Ortho, was "substantially flawed."

Outside the courtroom, the company was more derisive. The Oechsli study "isn't worth the paper it's printed on," said one source inside the company. "It's not a study. It's never been substantiated. It's never been duplicated."

For its defense, Ortho brought to the stand a pharmacist who served on the FDA committee that approved the product without a warning on possible birth defects. He testified that the panel members did not think an added warning was necessary after reviewing available studies.

Ortho said Katie Wells' birth defects resulted from amniotic banding, which is what happens when the tissues in the amniotic sac that hold the fluid supporting the fetus wrap around a finger or a limb.

Maifer's key witness, Dr. Bruce Buehler, director of Meyer's Children's Rehabilitation Institute in Omaha, Nebraska, examined Katie Wells on the stand and refuted the company's claim of amniotic banding. He said her left shoulder has a smooth rather than a dimpled stub, which is rare. For a smooth stub such as Wells' to result, he said, destruction of the limb bud would have to have occurred much earlier than four weeks after conception. Other defects in Katie Wells' shoulder also pointed away from amniotic banding.

In genetically caused birth defects, like amniotic banding, said Dr. Buehler, the tips of the fingers are most likely to be missing. Wells lost the middle joints in her fingers.

Buehler said he recommends that physicians routinely order ultrasound tests to detect possible limb deformations in women who inadvertently continue to use spermicide after conception. He began recommending that ultrasound tests be used, he said, after reading an article by Dr. Hershel Jick in 1981. The Jick study found a "prevalence of certain major congenital anomalies," especially limb-reduction deformities, in vaginal spermicide users.

Ortho, however, maintains there are no risks of birth defects in using its spermicide and says neither the product nor its warning label will be changed.

"Our official policy," said an Ortho spokesperson, "is that to the best of our knowledge there is no adequate scientific or medical information or scientific studies that show any increase in the risk of birth defects with the use of spermicide."

But, as long as questions remain about the safety of spermicide, critics say that the warning label on such products should be changed to reflect the potential problems.

To support such a warning, Sybil Shainwald, cofounder of the National Women's Health Network, cites the Committee on Drugs of the American Academy of Pediatrics' caution that "there is no drug, whether it's over the counter or a prescription drug, that has been proven to be without risk for a fetus when that drug is administered to a child-bearing woman."

Dr. Sutherland believes the warning on such spermicide should be even more serious: "Discontinue use if you suspect you're pregnant, because the product might increase the risk of fetal malformation."

But Ortho refuses to change either the product or its current label, which warns women only against possible pregnancy and genital infections.

"It is not usual and customary to warn about risks unless the scientific community, including the FDA, find that it is a valid concern," said Dr. Tyrer. "And that has not been the case with spermicide." Tyrer served on the seven-member FDA committee that unanimously agreed that the alleged link between spermicide and birth defects did not mandate an additional warning on the Ortho-Gynol label.

But Ortho's influence over the FDA's sub-advisory panel, charged Simmons, made its findings suspect.

At least one doctor, Robert L. Brent, an expert on malformation in organisms, who served on the FDA subadvisory panel met with Ortho attorneys to discuss the allegations about spermicide and birth defects prior to the FDA meeting.

Six months after he had met with Ortho attorneys, Brent served on the FDA committee that ruled unanimously that it could not find "an increased risk or association of the alleged malformations with exposures to spermicide, and that no change in the product labeling should be suggested."

Dr. Brent never informed the committee he had been contacted by Ortho about the spermicide lawsuit. Soon after the panel had adjourned, Brent was retained by Ortho as a consultant.

Judge Shoob said Dr. Brent's "association with Ortho before and after the December 1983 (FDA) Committee meeting created serious doubts not only about Dr. Brent's credibility and objectivity in this trial, but also about the weight this Court should attribute to the Committee's findings."

Dr. Tyrer, who served with Brent on the FDA panel, says Brent's actions do not represent a conflict of interest. "You can't tell them they can't go to work for some comWpany after they've been on the FDA panel," she says. "People are free to choose for whom they will work." hen a three judge panel of the 11th Circuit

U.S. Court of Appeals upheld judge Shoob's verdict in May 1986, there were rumors that Ortho-Gynol would pull its spermicide off the market. Even the company seemed unsure what the future of its contraceptives would be.

Joseph Beidler, attorney in charge of spermicide for Johnson & Johnson, said in a May 19, 1986 interview with the Wall Street journal that in light of the damage award and the expectation of further lawsuits, he did not know whether the company would be able to keep the contraceptive on the market. "This contraceptive method cannot survive an onslaught in the courts," he said.

The following day, a company spokesperson said Beidler was "in error," and reaffirmed Johnson & Johnson's commitment to keeping its product on the market.

Larry Feinberg, a financial analyst who specializes in pharmaceuticals at Dean Witter Reynolds, Inc. in New York, believes there is little chance that Johnson & Johnson will pull the product. Even if the company does stop making and selling spermicide, said Feinberg, the impact on Johnson & Johnson would be "essentially zero." Ortho Pharmaceutical's combined spermicide product sales of $30 million were less than one percent of the company's total sales of $7 billion last year.

But if Ortho Pharmaceutical, with a 75 percent corner on the market, does stop selling spermicide, Tyrer says, "it might [create] a domino effect, and we might lose all spermicide."

"We'd have very little left-the condom, sterilization and the birth control pill and that would be it," she says. "It would be a disaster."

But Simmons and Maifer aren't asking that Ortho Pharmaceutical pull its spermicide off the market, they only want the warning on the product changed.

"The company is afraid if it puts a warning on the label, it would chill the sales of the product," Simmons said.

But, he added, "If you're supposed to warn and you don't, then you have to pay the damages."

Deborah Begel is an anchor and reporter for WBAI-FM in New York.