A jury in Seattle has awarded $400,000 to a woman who suffered a life-long-disabling stroke after taking 32 birth-control pills containing an average of one five-millionth of an ounce more estrogen than specified in the government-approved labeling.
The jury, returning the judgement May 20 against Wyeth Laboratories after a four-week trial in Superior Court, found that the pills were adulterated by the tiny excess quantity of ethinyl estradiol, an extremely potent sex hormone. The pills are trade-named Ovral.
Consequently, the jury found, the pills were unreasonably dangerous and a "proximate cause" of the injuries suffered by Laura Jurine, now 40, and insurance agent's wife who has a grown child by an earlier marriage and three young, adopted children.
The jury also found that Wyeth, a division of American Home Products Corp., had failed to give adequate warnings to prescribing physicians. The company is expected to appeal to the Washington State Supreme Court.
The official labeling for Ovral says it contains 50 micrograms-one 570,000th of an ounce-of ethinyl estradiol, which also is the estrogen component of some other brands.
Jurine had 20 Ovral pills remaining from her original supply. Food and Drug Administration technicians who ground up and analyzed the pills in accord with standard procedures found that the estrogen content was 57 micrograms, or 14.2 per cent more than the 50 listed on the label.
FDA regulations for good manufacturing practices allow producers to vary 10 percentage points either way from the ethinyl estradiol content specified in the labeling, i.e., from 45 to 55 micrograms in this case.
The reason the agency does not permit wider variations is that too little of the estrogen might lower reliability in preventing conception, while too much sharply increases the user's risk of thromboembolic or blood-clotting diseases.
Ethinyl estradiol is about twice as potent by weight as mestranol, the estrogen used in many pill brands. At the trial, Jurine's lawyer, Bruce J. Rothman of Portland, Ore., developed evidence that the slight excess of ethinyl estradiol in her pills increased her risk of suffering thromboembolic diseases by about 23 per cent.
Manufacturers face obviously difficult problems in trying to meet the FDA's exacting standards for the ethinyl estradiol content of each pill.
In making a single batch of Ovral, Wyeth officials said, they used an amount of the estrogen equivalent to one-third of a railroad tank car. Of 8 million Ovral pills produced in 1972, the company said, it tested only 90 for compliance with the FDA-approved range of 45 to 55 micrograms.
During the trial, Rothman cited Wyeth promotional materials, which emphasized to physicians the lower weight of ethinyl estradiol needed to accomplish the same result as mestranol while de-emphasizing that it is potency, not weight, that counts. He also disclosed letters to Wyeth in which the FDA critized the practice without making the company publicly repudiate it.
In 1970, Wyeth resisted an FDA proposal to require manufacturers to provide, in each package of pills received by a user, either a 150-word statement on risks and benefits or a detailed brochure normally available from doctors.
After the FDA adopted the proposal, some manufacturers elected to enclose the 150-word statement, usually in relatively large type. Wyethe chose to enlose the detailed brochure, but printed it in small type.
A Wyeth sales maimprinted magnifying glasses and directed them to give one to each physician on whom they called-after holding a glass over favorable portions of the physician labeling. The size of the type for which Wyeth thought magnification necessary was no larger than the type in patient brochures, Rothman said.
Jurine testified that in June, 1972, her physician had prescribed Ovral to prevent pregnancy and regulate her menstrual periods.
Six weeks later she sufferd a stroke that left her with a lifelong inability to use her left arm and a permanent, serious loss of function in her left leg, which has shrunk in size. She had to learn anew to walk. She suffered mental depression. She has largely overcome a speech impairment and paralysis of the left side of her face.
Last October, while her lawsuit was pending, stroke-like symtoms recurred. An expert neurologist who has studied the association between oral contraceptives and strokes suspected the pills. As a result, surgeons found and removed a growth in a neck artery that carries blood to the brain. Expert testimony linked the growth to the pills and to the first stroke.