Last month, in a landmark decision, the Supreme Court of Ontario awarded Pauline Buchan of Mississauga over $800,000, plus legal costs, against Ortho Pharmaceutical (Canada) Limited.
Mrs. Buchan, now 35, suffered a stroke in 1971, 34 days after she started taking Ortho Novum 1/50, an oral contraceptive pill. She has suffered permanent brain damage, and partial paralysis of her left arm and leg, she is unable to look for permanent employment outside the home.
This case is the first such action by a consumer against a birth-control pill manufacturer in Canada.
19 times more likely to suffer strokes
Mrs. Buchan’s lawyers successfully proved that her stroke, caused by a blood clot which blocked her carotid artery, was caused by the pill which upset the balance in the chain of cells and chemicals that make blood to clot and that stop bleeding.
Dr. David Sackett, founder of the epidemiology department at McMaster University, testified that women using the pill are 19 times more likely to suffer strokes than non-users. This was proved by a 1983 British survey of 46,000 women. He cited other studies which show that women taking the pill are 6 times more likely to die of stroke than non-users. Dr. Sackett also said that the pill is to blame in 95% of cases where a user suffers a stroke – and that the stroke probably wouldn’t have occurred if she wasn’t using it.
Dr. Vladimir Hachinski, a University of Western Ontario neurologist, cited an Ontario study which showed that strokes in women rose 40% after the birth control pill came into widespread use.
Also at issue in the case was whether or not Mrs. Buchan had been sufficiently warned of possible side-effects when the pill was prescribed. She testified that she was not told by her physician of side-effects and said, “I didn’t think they would give me a drug that would harm me.”
Dr. Earl Plunkett, a member of the 1970 federal government committee studying the pill, told the court that they had been “concerned about alarming the public unnecessarily.” He said the committee concluded it was “irrational” to warn of “unproven” dangers that might affect only a few women.
Mr. Justice Richard Holland agreed that the manufacturers had been negligent in not warning users and doctors of potential dangers. “There appears to be an unavoidable risk that a small percentage of users will suffer serious complications from using oral contraceptives,” he said in his judgment. “In this sense the product is dangerous, and in my opinion there is created a high duty to warn the consumer of danger.”
While Ortho had complied with Canadian regulations concerning printed warnings to the consumer, the judge stated that the regulations “are surely minimum warnings.” He noted that in the United States the per-capita consumption of birth control pills fell after substantial warnings were included with the product, suggesting that many women felt the risks were unacceptable.
Only minimum warnings
The U.S warning spells out in considerable detail the known dangers of the pill. “Blood clots (in various vessels in the body) are the most common of the serious side-effects of oral contraceptives,” it says. “A clot can result in a stroke … a heart attack … or a pulmonary embolus. Any of these can be fatal. Clots also rarely occur in the blood vessels of the eye, resulting in blindness or impairment of vision in that eye.”
The ‘package insert’ also includes mention of other methods of birth control, has a chart showing comparative risks, and notes, ” Oral contraceptives are the most effective method, except sterilization, for preventing pregnancy. Other methods when used conscientiously, are also very effective and have fewer risks.
The Canadian warning currently available with packages of Ortho Novum pills briefly mentions only a few of the problems associated with the pill. Potentially serious side-effects are only mentioned on page 11 of the 14-page booklet. It then goes on to say, “Now that we’ve told you all about the adverse side effects that can sometimes occur with oral contraceptives, we think it’s time you heard about the benefits you may experience while on the pill.”
The Canadian government has little information
The Canadian government has very little information on pill-related problems. The Health Protection Branch keeps a record of problems reported by doctors, but notes that not all suspected cases are reported. Between 1970 and 1981, it received 387 reports of serious side effects suspected as linked with the pill – including 10 deaths.
Ortho plans to appeal the Ontario Supreme Court ruling. Whatever the outcome of the appeal, it is to be hoped that stricter regulations will be enacted regarding the printed warnings in each packet of pills.