Dangerous Side Effects of Using Medications Off-Label

Using Off-Label Medications Can Be Dangerous

We often get asked the question, “can we hold a manufacturer of medication liable for dangerous side effects resulting from usage if the medication was prescribed for off-label usage?”

The answer isn’t quite so simple.

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. The FDA also regulates usage instructions to ensure labeling does not contain off-label uses. It also prohibits advertising or other promoting of unapproved uses of drugs.

Manufacturers Role in Off-Label Drug Uses

However, manufacturers have a significant financial interest in encouraging off-label uses of their drug.

In fact, 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 technically ethical and legal. But they’ve also used ways that are a bit more sinister.

Off-Label Medications

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 the side effects of off-label usage.

The short answer is no, yes and sometimes.


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.


On the opposite end of the spectrum, another court determined 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.


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 in 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.

Get Help with a Dangerous Drug Case

If you or a loved are facing injuries due to a dangerous drug, contact VanDerGinst Law today.

We have knowledgeable and experienced attorneys who can help guide you through the complexities of your case.

We will help you obtain the financial compensation you deserve.

The consultation is free and there is never a fee unless we win.

Call VanDerGinst Law at 800-797-5391.

The law is tough, being injured is tougher. We’ll make it easier for you.

The information contained on this website is presented by VanDerGinst Law P.C. It is not intended nor should it be construed as professional legal advice. The information is general in nature about the Firm, the scope of services we offer, and our community outreach, it is not legal advice. Please contact us by phone, email, mail, or via this website for inquiries. Contacting us does not create an attorney-client relationship. Please contact a personal injury attorney for a consultation regarding your situation. This website is not intended to solicit clients outside the State of Iowa and/or the State of Illinois.

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