New Orleans, LA Dangerous Drugs Lawsuit Lawyers
Unfortunately, there are unsafe drugs in circulation, either for over the counter purchase or by prescription, which can have serious side effects. While we are led to believe, particularly by enormous advertising campaigns, that a drug on the market has been thoroughly and adequately tested, this is sometimes not the case. Drug manufacturers make billions of dollars from the sale of their products. In the effort to profit from a drug, manufacturers will sometimes rush the process, putting it out on the market before it has been adequately tested. As a result, there are often drugs on the market which have unknown or hidden side effect. In addition, there are many times when a manufacturer does not adequately communicate or warn of dangerous side effects that it does know about.
Drug Side Effects
While there are side effects associated with all drugs, some are considerably more harmful or dangerous than others. Many drugs have mild side effects, like headaches or dry mouth. Others, however, have serious, or even life-threatening side effects, like internal bleeding, cardiac problems or even cancer. When prescribing medication, doctors must decide if the benefits of a drug outweigh the risk that the side effects pose. It is also important to understand that not everybody reacts to drugs the same way. Regardless, where there are some people who react a certain way to the use of a drug, both the drug company and your doctor have are responsible for informing you of a drug’s side effects, even if they are infrequent or rare, and to protect you from dangerous drugs.
Sometimes, doctors prescribe drugs for off-label use. This means that the FDA has tested the drug, but not for the condition the doctor intends to address by prescribing the drug. When a doctor prescribes a drug for off-label use and that drug causes serious injury or death, that doctor can be held accountable. The same standard applies for drug companies. If a drug company markets a drug, or urges a doctor to prescribe a drug for off-label use, the drug company can be held liable for serious injuries or death that result from the use of the drug for the off-label purpose.
A drug recall occurs when a manufacturer removes a drug from the market. Recalls can be forced by the U.S. Food and Drug Administration (FDA), or conducted voluntarily by the manufacturer. There are several types of FDA classifications which describe the categories of drug recalls:
Class I recall
: reasonable probability exists that use of or exposure to a drug will result in serious negative health consequences or death
Class II recall
: exposure to the drug may cause temporary and or/reversible negative health consequences; the likelihood of experiencing a severe side effect is small
Class III recall
: use of or exposure to the drug may, but likely won’t, cause an adverse reaction in the consumer
occur when the affected drug has a minor defect that is not subject to FDA legal action, but the product is removed from the market in order to correct the problem. This could occur where a manufacturer has reason to believe that a product was tampered with, even though it wouldn’t necessarily be a manufacturing issue that caused the potential problem.
are FDA warnings to patients, physicians and other health care providers related to side effects associated with specific drugs. A safety alert does not, however, take a product off the market. For example, the FDA may issue a safety alert if more recent medical studies tie a serious side effect with a drug that is not warned of in that drugs labeling, or was not known at the time the drug was approved by the FDA. While an FDA safety alert is not a recall, it may trigger a market withdrawal or cause a drug to be given a new warning label.
Medical Device Recalls
Medical device recalls are issued where a dangerous or defective medical device causes serious injuries or death. These recalls usually result from mistakes that a manufacturer could have, and should have, prevented. Whether the recall stems from poorly trained workers not manufacturing the product correctly, or from a design defect that the manufacturer should have identified through proper testing, the recall is necessary to protect consumers from unreasonable harm. Errors like these can result in serious injuries and death, and when they do, the medical product manufacturers who are responsible can be held liable for their negligence.
FDA Medical Device Recalls
The FDA evaluates the risks of the defect and codes the medical device recall as a class I, II, or III medical recall to express the level of danger the recalled product presents, as follows:
Class I Recall – a product has potential to cause serious injury or death
Class II Recall – a device is not likely to cause serious injury, but may cause permanent damage
Class III Recall – a device does present a risk, but is unlikely to cause injury or death
If you or a loved one has been injured by a defective or dangerous product, learn about your legal rights from an experienced Louisiana personal injury lawyer by calling 504-581-4892 or by filling out our free, no obligation case review form.