The Volokh Conspiracy - Activist Mothers:

This story, about anti- "Big Food" activist Robyn O'Brien, reminds me of the story of Betty Mekdeci. In 1975, Mekdeci gave birth to a son with limb reduction birth defects; the cause of most such birth defects is unknown. Not satisfied with that answer, she began a quest to determine what caused her child's suffering, and persuaded herself that the culprit was the morning sickness drug Bendectin, which she had ingested during pregnancy. (Similarly, after one of her children suffered a severe food reaction, O'Brien decided that there is a "profit-driven global conspiracy whose collateral damage is an alarming increase in childhood food allergies".)

Mekdeci then hired famed torts lawyer Melvin Belli to represent her and her child in litigation against the manufacturer of Bendectin, Merrell Dow Pharmaceuticals. As I've written in the Michigan Law Review:

In 1977, when Mekdeci brought her lawsuit, fourteen epidemiological studies of varying strength and quality had examined the relationship between Bendectin and birth defects and found no association. While these studies were not powerful enough to rule out some connection between Bendectin and birth defects, they certainly provided no cause for alarm. Bendectin had been on the market since 1956 with no serious doubts raised regarding its safety in the scientific or medical community. Nor did Bendectin contain suspiciously toxic ingredients: one active ingredient of Bendectin was a simple B vitamin, and the other was an ingredient used in a popular over-the-counter sleeping pill.

Meanwhile, Mekdeci's evidence that Bendectin did cause birth defects was "remarkably thin." Many chemicals are known not to be teratogens in humans, so the mere fact that pregnant women ingested a pharmaceutical product such as Bendectin did not mean there was an inherent risk. Beyond the mere fact that she ingested Bendectin during pregnancy and later gave birth to a child with a limb reduction birth defect, Mekdeci's evidence of causation consisted primarily of eighty-six reports to the FDA of other women who had also given birth to children with limb reduction defects after taking Bendectin.

.... [T]he mere fact that dozens or even hundreds of children were reported to have been born with limb reductions after their mothers ingested Bendectin doesn't, by itself, even suggest a risk. Approximately thirty million women took Bendectin, and by chance alone there would be ten thousand limb reduction defects among children born to these women.

Nevertheless, with the help of Belli's publicity machine, the Bendectin litigation eventually drew thousands of plaintiffs and cost Merrell Dow several hundred million dollars in defense costs (though not a penny was ever paid to a claimant, the courts universally overturning the 40% or so of jury verdicts favoring plaintiffs.)

Despite FDA approval, Bendectin, the only drug proved safe and effective in combating nausea and vomiting in pregnancy, remains unavailable in the U.S. (but is available everywhere else), having been taken off the market at the height of the litigation to avoid further lawsuits. Studies have shown that the rate of limb birth defects in the U.S. has not been affected by the removal of Bendectin from the market, but hospitalizations for severe morning sickness have soared.

Meanwhile, the persistence of plaintiffs in pursuing the Bendectin litigation despite mounting evidence of Bendectin's safety and the complete lack of valid contrary evidence, combined with juries nevertheless frequently ruling in favor of the plaintiffs, eventually became the leading cause of a severe backlash in federal courts against "junk science," culminating in Daubert v. Merrell Dow Pharmaceuticals, itself a Bendectin case, and it progeny.

Professors Michael Green and Joseph Sanders have written rather similar books on the Bendectin saga, though Green tends to be more sympathetic to the plaintiffs. My own much briefer recap of the Bendectin litigation can be found in the Michigan article mentioned above.

	[David Bernstein, January 10, 2008 at 9:00am] Trackbacks Activist Mothers: This story, about anti- "Big Food" activist Robyn O'Brien, reminds me of the story of Betty Mekdeci. In 1975, Mekdeci gave birth to a son with limb reduction birth defects; the cause of most such birth defects is unknown. Not satisfied with that answer, she began a quest to determine what caused her child's suffering, and persuaded herself that the culprit was the morning sickness drug Bendectin, which she had ingested during pregnancy. (Similarly, after one of her children suffered a severe food reaction, O'Brien decided that there is a "profit-driven global conspiracy whose collateral damage is an alarming increase in childhood food allergies".) Mekdeci then hired famed torts lawyer Melvin Belli to represent her and her child in litigation against the manufacturer of Bendectin, Merrell Dow Pharmaceuticals. As I've written in the Michigan Law Review: In 1977, when Mekdeci brought her lawsuit, fourteen epidemiological studies of varying strength and quality had examined the relationship between Bendectin and birth defects and found no association. While these studies were not powerful enough to rule out some connection between Bendectin and birth defects, they certainly provided no cause for alarm. Bendectin had been on the market since 1956 with no serious doubts raised regarding its safety in the scientific or medical community. Nor did Bendectin contain suspiciously toxic ingredients: one active ingredient of Bendectin was a simple B vitamin, and the other was an ingredient used in a popular over-the-counter sleeping pill. Meanwhile, Mekdeci's evidence that Bendectin did cause birth defects was "remarkably thin." Many chemicals are known not to be teratogens in humans, so the mere fact that pregnant women ingested a pharmaceutical product such as Bendectin did not mean there was an inherent risk. Beyond the mere fact that she ingested Bendectin during pregnancy and later gave birth to a child with a limb reduction birth defect, Mekdeci's evidence of causation consisted primarily of eighty-six reports to the FDA of other women who had also given birth to children with limb reduction defects after taking Bendectin. .... [T]he mere fact that dozens or even hundreds of children were reported to have been born with limb reductions after their mothers ingested Bendectin doesn't, by itself, even suggest a risk. Approximately thirty million women took Bendectin, and by chance alone there would be ten thousand limb reduction defects among children born to these women. Nevertheless, with the help of Belli's publicity machine, the Bendectin litigation eventually drew thousands of plaintiffs and cost Merrell Dow several hundred million dollars in defense costs (though not a penny was ever paid to a claimant, the courts universally overturning the 40% or so of jury verdicts favoring plaintiffs.) Despite FDA approval, Bendectin, the only drug proved safe and effective in combating nausea and vomiting in pregnancy, remains unavailable in the U.S. (but is available everywhere else), having been taken off the market at the height of the litigation to avoid further lawsuits. Studies have shown that the rate of limb birth defects in the U.S. has not been affected by the removal of Bendectin from the market, but hospitalizations for severe morning sickness have soared. Meanwhile, the persistence of plaintiffs in pursuing the Bendectin litigation despite mounting evidence of Bendectin's safety and the complete lack of valid contrary evidence, combined with juries nevertheless frequently ruling in favor of the plaintiffs, eventually became the leading cause of a severe backlash in federal courts against "junk science," culminating in Daubert v. Merrell Dow Pharmaceuticals, itself a Bendectin case, and it progeny. Professors Michael Green and Joseph Sanders have written rather similar books on the Bendectin saga, though Green tends to be more sympathetic to the plaintiffs. My own much briefer recap of the Bendectin litigation can be found in the Michigan article mentioned above.