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When a drug is approved for sale by the U.S. Food and Drug Administration (FDA), its approval is contingent on it being marketed only to treat the conditions that it was designed and tested to treat during its trial phases.
In other words, if a medication approved by the FDA to treat high blood pressure is later discovered to help patients lose weight, its manufacturer must market it only as a blood pressure medication and not as a weight loss medication.
However, doctors can prescribe medications to patients to achieve effects other than their marketed purposes. This is known as prescribing medications “off-label.”
While off-label prescriptions are common and often effective, they can pose risks to patients like all medications. If you or someone you love gets injured by an off-label medication, here’s what you need to know about your ability to get compensation.
When prescribing a medication to be used off-label, doctors must take the same precautions and perform the same due diligence as they do when they prescribe any other medication. If they make negligent mistakes that harm their patients, they can be held liable.
These mistakes include:
When doctors prescribe medications for off-label usage, they do so with the assumption the medications are safe for patients. That’s because they know the medications passed multiple phases of clinical trials and FDA approval. However, several medications are recalled every year because dangers weren’t disclosed by their manufacturers or were somehow obscured during the testing process.
When drugs turn out to be dangerous because of negligent design, manufacturing, or testing, drugmakers can be held liable for any injuries that occur for both prescription and off-label uses. In many cases, drug manufacturers encourage doctors to prescribe their medications for off-label usage without actively marketing them for those purposes.
Although this helps drug makers skirt around marketing restrictions while increasing sales of their drugs, it further opens them up for liability if their drugs turn out to be unsafe. Many off-label drug injury cases involve proof that doctors were encouraged to prescribe drugs off-label by pharmaceutical company representatives and were told they were safe, even if the drug manufacturer did not do enough or any research or testing to prove their drug was safe for that use.
Patients are supposed to be able to trust their doctors and the pharmaceutical companies that make their medications. It’s even more important for patients to trust both of these parties when they’re prescribed medications for off-label usage. Unfortunately, one or both parties may be negligent in fulfilling their duties to protect patients and customers, and that can lead to serious complications and broken trust.
If you or someone you love was harmed by an off-label prescription medication, there’s a good chance it’s because of negligence. Whether it’s because your doctor made mistakes while prescribing the medication to you, or because the drug manufacturer failed to ensure that its product was safe for patients, your or your loved one’s injury shouldn’t have happened.
At Nurenberg, Paris, Heller & McCarthy, it’s our goal to help all patients injured by negligent doctors and pharmaceutical companies get the compensation they’re owed. Contact us anytime for a free consultation. We want to help you get the money you need for your medical bills, lost wages, and pain and suffering.
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