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Defective Drugs And The Right To Consent

Posted by on Jun 21, 2016

Prescription or over the counter drugs are designed to make patients well. When taken the right way, these substances can have individuals up and about in no time. These drugs are consistently tested for any potential side effects before they are sold in the market. If there is any potential harm, it is the responsibility of the manufacturer to inform the public of such. Unfortunately, this is not happening and customers find themselves at the receiving end of the side effects.

According to the website of Karlin, Fleisher & Falkenberg, many pharmaceutical companies will not pull out their drugs from the market due to the impact to their sales even if there is evidence that is a defective drug. It is the customers or patients who are the losers in this case as they will end up experiencing pain and suffering, injuries, and even death. Here lies the concept of informed consent on the part of the patient.

Informed consent is the legal right of a patient to be informed about the side effects of a treatment or in this case a drug. A breach of this right makes the manufacturer liable for product liability claims. Doctors and drug manufacturers are ethically bound to inform patients of the side effects of the drugs they are offering. Manufacturers have the responsibility to provide all the information needed by patients to help them make an informed decision about the drug.

Sometimes, manufacturers are used to off label prescription meaning they use the drug for unapproved use without regard if it will harm the patient. What the manufacturer is after is profit more than the welfare of the patient. If something does happen to the customer, they have some basis for filing cases because they were misinformed.

In the case of defective drugs, claims filed by patients would be judged based on the presence of the Four D’s. The first one is duty. In this case, they should have informed the patient about the side effect of the drug. The second D is derelict. The patient must be able to prove that there was sub-standard care in not informing them of the side effects.

The third D is direct. There should be a direct connection between the action of the manufacturer and the effect of their negligence. Lastly, there should have been damages which resulted to compensable harm to the patient. If all these elements are present and the plaintiff is able to prove it in court, then they have a case against the drug manufacturer.

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