| Venue: | OK SC |
| Facts: | A guy has a nicotine-induced heart attack when he smokes a cigarette while wearing two Habitrol patches. |
| Posture: | None described. This may be just a certified question. |
| Issue: | Does the "learned intermediary" rule make up for warnings that would otherwise be skimpy or ineffective? |
| Holding: | Not by itself. |
| Rule: | A warning must not be misleading, and must be adequate to explain to the user the possible dangers associated with the product. Manufacturers are required to warn of foreseeable dangers, but not necessarily obvious ones. |
| Reasoning: | Certain products, such as prescription drugs, can not be made safe. The user must be adequately warned. The exception is the "learned intermediary" rule: doctors are supposed to warn patients. There are exceptions to that exception: mass immunizations are one, and cases where the FDA has mandated warnings directly to consumers are the other. That was the case here: the FDA has required warnings to the consumer. And these particular warnings were nto adequate. |
| Dicta: | |