As we have discussed in prior posts, warnings involving medical devices and/or prescription drugs are issued not to the end user patient, but to the doctor prescribing or using the device. This does not, however, release the drug or device manufacturer from the duty to adequately warn of the dangers of using the device or product. In fact, it simply complicates the issue of what an adequate warning looks like. Take the recent case of Horrillo v. Cook Inc., 10-15327, 2012 WL 6553611 (11th Cir. Nov. 7, 2012) [PDF]. This case involved a stent manufactured by the defendant and approved by the FDA for use in bile ducts. Dr. Michael Rush, however, used it during his angioplasty surgery on Margaret Horillo, not in a bile duct, but in her renal artery.
Within 24 hours of the procedure, Ms. Horillo suffered a serious stroke.
The warnings included by the manufacturer read as follows:
First, it stated that the device was “intended for use in palliation of malignant neoplasms in the biliary tree,” which is to say, treatment for cancer in the bile ducts. Second, under a heading entitled, “WARNINGS,” the instructions for use cautioned that “[t]he safety and effectiveness of this device for use in the vascular system have not been established.”
Deposition testimony in the case, however, revealed that stents such as this one were regularly used “off label” in the vascular system. In fact, Dr. Rush had used this particular stent in the past in renal arteries. The off-label use was so widespread, in fact, that the FDA called Cook and several other such manufacturers together about the issue before this surgery was performed. As a result of that meeting, Cook sent a letter to the hospital where Dr. Rush did the surgery warning of the risk of stroke.