The Food and Drug Administration have rejected the drug maker H. Lundbeck A/S’s request to release its schizophrenia drug, sertindole, to treat a wider range of psychological ailments in a move that should preempt any products liability lawsuits from the prescription medication.
In a near unanimous decision, the FDA decided that sertindole was unsafe for broad use but that the drug was “shown to be acceptably safe for the broad treatment of schizophrenia.” The panel thus approved the drug for an “acceptably safe manner” of treatment in some patients.
However, since schizophrenics display a high risk for suicide, the panel considered recommending sertindole only as a last resort. That measure was not passed.
Our personal injury lawyers in San Diego look at cases such as these and wonder about any product liability issues. In a California product liability lawsuit, for instance, a manufacturer or supplier must guarantee its product’s safety and can be held liable by a products liability lawyer for any personal injury a product defect causes. Product defects can be found at any step of the way — from the product’s creation up until the point of when that product is used, including any foreseeable use or misuse of the product.
The FDA’s job is to make sure that prescription drug products are indeed safe for public use. Before any drug is approved, it must go through the FDA’s Center for Drug Evaluation and Research (CDER).
But even if a product receives FDA approval, a good personal injury attorney, like the ones at our San Diego firm, will make sure that his or her client receives the maximum settlement possible should a defective product harm or injure them.
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