When it comes to prescription drugs, there’s what’s referred to as a “learned intermediary.” Medications must be prescribed by a medical provider and/or dispensed by a pharmacist before they get into a patient’s hands. Therefore, there are several individuals that bear the responsibility of advising a patient of the potential risks of taking it.
These same people are also likely to be on the front line treating patients who suffer ill effects from taking a drug. It’s their responsibility to inform the Federal Drug Administration (FDA) of any known complications posed by them.
At the same time, while the FDA tests drugs before they’re released on the market, it’s the responsibility of drug manufacturers to do their own independent clinical studies of a drug before submitting it to them. It’s also their responsibility to inform them immediately of any known concerns associated with it.
In the case of the latter, a drug manufacturer is subject to a duty to warn the FDA, prescribers and patients of any known side effects as well as the death risk their product poses. From a legal perspective, a drug manufacturer is seen as an expert on the product it produces. It’s assumed that they’ve invested significant research in producing a safe drug that is capable of doing what is advertised.
As part of its responsibility, a drug manufacturer is charged with remaining accessible to be consulted regarding ill effects it may cause. It’s their responsibility to record adverse reactions and to follow-up in investigating them.
In some cases, a patient may have been harmed by a prescription drug, yet not be aware of it until some years have passed or evidence has accumulated. In cases like this, victims may be able to wage negligence claims against drug manufacturers with a statute of limitations beginning long after when the medication was first taken. In cases like this, time may only begin to toll from when the causation was first identified.
If you’ve been injured or suffered a debilitating injury or illness from what you believe is a defective drug, then a Houston pharmaceutical injury attorney can provide guidance in your case.