Most lawsuits related to unexpected severe side effects from prescription drugs fall under the category of product liability, which is a type of personal injury lawsuit. It would be a medication error if the doctor prescribed the drug irresponsibly, such prescribing it for a condition that it had not been approved to treat, prescribing an unnecessarily high dose, or ignoring risk factors in the patient’s health history that would show that the drug was unsafe for that patient. If the doctor prescribed the drug according to the manufacturer’s instructions, and the patient followed those instructions, then it is a case of product liability. In other words, the liability lies with the drug manufacturer and not with the physician. The drug manufacturer Bayer has paid more than two billion dollars in settlements to patients who became ill from taking Yaz, a hormonal contraceptive (birth control pill).
What is Yaz, and What are its Risks?
Yaz and Yasmin, as they are known in the United States, are hormonal contraceptive pills; one is taken daily, and the other is taken monthly. Like other oral contraceptives, it contains estradiol and a progestogen (a progesterone-like hormone), thus preventing pregnancy by preventing ovulation. The drug became commercially available in 2006. Bayer, the manufacturer of Yaz, advertised it on the platform that, while it worked similarly to other contraceptives, it was less likely to cause weight gain as a side effect. Like other contraceptives, Yaz can also reduce acne and can make menstruation less painful.
The progestogen in Yaz is drospirenone, a synthetic hormone, which is believed to be the cause of the patients’ negative side effects. Almost any kind of hormonal contraceptive can increase the risk of dangerous blood clots, but blood clots were especially common and severe in patients taking Yaz. (The risk is also present when drugs containing female sex hormones are given to menopausal women as hormone replacement therapy.) Blood clots were three times as common in women taking Yaz than in women taking other combined oral contraceptives (pills that contain both estrogen and progesterone). Thousands of patients were hospitalized because of blood clots and their complications, including stroke, and more than 200 patients died.
The Yaz Lawsuits and Their Settlements
Более 11000 пациентов подали жалобы после того, как в результате приема Yaz образовались тромбы. Байер рассчитался с пациентами, платя в среднем 12 000 долларов за пациента. По состоянию на 2017 год компания выплатила более двух миллиардов долларов и выплатила компенсацию за ущерб, связанный с Yaz.
Доступность противозачаточных средств во многом улучшила здоровье женщин. Тем не менее, прием гормонов сопряжен с риском, и производители лекарств не всегда достаточно осведомлены об этих рисках при маркетинге гормональной терапии.