In the past few months there have been lawsuits against the Mirena intrauterine device (IUD) which is used for contraception. Many women have been using this device for birth control as it was represented as being safer than oral contraceptives that were on the market. Today, approximately over 2 million women are using the IUD. However, not all women have been satisfied with the results of the device. There have been claims from around the country that the device has led to side effects including miscarriages, excessive bleeding, extreme stomach and abdominal pain, and even hysterectomies. Bayer Pharmaceuticals, the manufacturer of the Mirena IUD, is being sued on the ground that it failed to warn women of certain risks associated with the device; that the product was defective and inherently dangerous; and that the label of the device was unfair and/or deceptive as it listed certain risks as uncommon when in fact they were common.
While the cases around the country proceed, the question has been presented, what is the role of a medical device or drug manufacturer in relation to that a of prescribing physician? Generally speaking, a manufacturer is ultimately responsible for any and all products it puts into the stream of commerce to the hands of a consumer. However, in Massachusetts (along with states across the country) courts utilize the “learned intermediary doctrine.” Under this theory, a manufacturer or supplier of a prescription drug is relieved from any duty to warn patients of the dangerous qualities of the prescribed drug.
The underlying theory behind the learned intermediary doctrine is that the physician acts as the “informed intermediary” between the patient and the manufacturer. As such, the physician is best suited to understand the complicated directions, warnings, risks, and implications of that drug. Once the physician is apprised of this small print, he or she informs the patient who makes the ultimate decision as to whether they want to use the drug or device. In the event that a manufacturer fails to include all relevant warnings and directives to the doctor, such as with the IUD case mentioned above, an injured patient may sue the manufacturer for breach of its duty to the physician.
Massachusetts has adopted an exception to the learned intermediary doctrine in relation to oral contraceptives. The courts have held that because a patient is actively involved in the decision to use most drugs associated with oral contraceptives, a physician has been relieved of his or her duty to be the responsible party where there is limited participation between the physician and the patient. Courts have held that there is too attenuated a relationship between an aggrieved consumer of oral contraceptives and the prescribing physician for purposes of liability.
While the cases against the Mirena IUD involve a device, and not a drug, the courts may apply the learned intermediary doctrine in absolving the manufacturer from liability if they find the warnings reasonably apprised physicians of warnings, as opposed to patients. Alternatively, even if the court were to apply the doctrine, the question remains as to whether the exception for oral contraceptives would apply to a contraceptive device.
Medical malpractice and medical device cases can be quite difficult to understand. If you believe you have a medical malpractice case or a products liability case, our office can help you. To schedule a free consultation with lawyer Daniel Cappetta, call our office today at (508) 969-9505 or fill out or contact form available on the right side of this page.