Q: Can a manufacturer of a medication be held liable for dangerous side effects resulting from usage if the medication was prescribed for off-label usage?
A: Off-label drug use is very common and has proven to be effective in a lot of different treatments. The FDA doesn’t regulate the prescribing practices of physicians for off-label uses. However, it does control manufacturers’ communications with physicians and the public about off-label drug uses and regulates usage instructions to ensure labeling does not contain off-label uses. It also prohibits advertising or other promoting of unapproved uses of drugs.
However, since manufacturers have a significant financial interest in encouraging off-label uses of their drug, some have been very successful in working around restrictions and promoting off-label use. This has been accomplished in a variety of ways that are considered ethical and legal, as well as ways that are a bit more sinister.
Physicians can clearly be liable for malpractice at times if the decision to prescribe a medication for off-label use was one outside the parameters of the applicable standard of care and resulted in harm to a patient. However, a more interesting question is whether a manufacturer can be held liable for dangerous side effects of an off-label usage. The short answer is no, yes and sometimes.
NO – At least one court has held that when a physician, as a learned intermediary, decides to prescribe a drug for off-label use, the manufacturer should not be liable for a failure to warn of side effects related to treating a non-indicated condition.
YES – On the opposite end of the spectrum, another court has held that there is no distinction between the risks associated with off-label uses and those associated with approved uses. Therefore, that court held that drug manufacturers must exercise reasonable care to warn of risks associated with any uses of the drug, whether approved or off-label.
SOMETIMES – Another court has held that a manufacturer’s exposure to liability might depend on what actions they took to promote off-label uses. If they clearly participated in promoting off-label uses, they could and should be liable for failure to warn of side effects related to the usage. Further, even if they did not participate is such off-label promotions, they could be liable if they knew or should have known that other manufacturers of similar products were promoting off-label usage and yet did nothing to prevent such usage, thereby acquiescing in such use and claiming for itself a share of the market.