Prescription drugmaker Barr Laboratories Inc. was recently sued by the parents of a California woman who died after taking an oral contraceptive. The parents' defective drug claim alleged that their daughter died after taking Kariva, a birth control pill.
The woman allegedly developed a blood clot that led to a fatal pulmonary embolism during a trip to India. The lawsuit filed by her parents alleges that Barr Laboratories failed to disclose risks associated with Kariva, including "unreasonable danger of blood clot and pulmonary embolism, muscle weakness and/or damage, and conditions related thereto."
Barr Laboratories made three arguments at trial:
- The drugmaker's failure to warn was not the proximate cause of the woman's death because the prescribing physician was independently aware of the increased risk of pulmonary embolism with use of oral contraceptives. The doctor said that she knew oral contraceptives could cause blood clots and routinely warned her patients of this.
- The woman's "independent choice" to take a long-haul flight to India caused her fatal medical condition. The risks of long-haul flights were also commonly known to the medical profession and therefore the drugmaker was not obligated to provide a warning about this.
- Any failure to warn was immaterial because the prescribing physician did not read the package insert or rely on any warnings provided by the drugmaker.
Unfortunately for the parents, the court agreed with the drugmaker's arguments. Under California law, a drugmaker's duty to warn of the risks associated with a prescription drug run to the physician, not the patient. A drugmaker is also not responsible for warning of risks known to the medical community at large because no harm can be caused by failing to warn of an already known risk.
The court agreed that the physician already knew the increased risk of clots, deep vein thromboses and pulmonary emboli from oral contraceptives and that the medical profession had "common knowledge" about the increased risk of deep vein thrombosis from long-haul flights. The parents' case against the drugmakers was therefore dismissed, although it appears that they will continue to pursue a wrongful death action against the physician.
Source: Samanta v. Barr Laboratories Inc., 2011 WL 3039057, Court of Appeal, Fourth District, Division 3, California. July 25, 2011