Millions of drugs are frequently taken by innocent consumers who believe they are using safe products. Many products are considered risky and lead to unnecessary injuries deaths that could have been prevented. The law protects consumers against dangerous and defective products. As a consumer, it is important to know and to protect your rights.
We represent patients and victims involved in pharmaceutical lawsuits. Time limits apply, which may prevent you from being reimbursed for your injury. We encourage you to contact us if you, or a loved one, suffered side effects caused by pharmaceutical products. There are no legal fees, unless we are able to recover reimbursement for your harms and losses.
The Food and Drug Administration (FDA) announces product safety alerts and recalls. The FDA does not test the pharmaceutical products, but they review the results of the manufacturer. Once the drug is on the market, consumers may report problems to the FDA. When a manufacturer initiates a recall, it has to be reported to the FDA. FDA guidelines for manufacturer’s recalls are found in Title 21 of the Code of Federal Regulations, Part 78.
What is a Pharmaceutical Product Recall?
Drugs that are suspected of being potentially harmful to patients as a result of defective quality or efficacy may be subjected to a recall. A pharmaceutical recall is a call for withdrawing a product, changing drug labels or returning a certain batch, or an entire production of a drug, to the manufacturer. A recall is typically the result of safety and health issues.
The General Steps of a Pharmaceutical Produce Recall
- The Food and Drug Administration can be notified by the manufacturer when a problem is discovered;
- The FDA determines a recall by an inspection of the manufacturing facility;
- The Center for Disease Control and Prevention notify the FDA of potentially harmful products;
- The FDA receives reports of health issues from consumers.
If the FDA believes the public should be aware of potential dangerous pharmaceutical products, press releases and press conferences will be used to alert the public. The FDA’s Enforcement Report is constantly updated and posted on the FDA’s Website, located at www.fda.gov.
The FDA investigates the defects that caused the pharmaceutical product to be harmful or dangerous and undertakes all the necessary steps to ensure that the product is removed or corrected.
There are three recall classifications, namely Class I, Class II and Class III. A Class I recall involves defective products that can result in serious health conditions or wrongful deaths. Class II recalls warn the public that a certain pharmaceutical product can cause health problems and Class II are the result of manufacturing or labeling violations.
The Important Role of the FDA
The main role of the FDA is to protect the public’s health and to ensure safety, efficacy and quality pharmaceutical products. The Minister of Public Health appointed experts, each in their own field, to make important health decisions. There is a committee appointed for each category such as medical devices, drugs, psychotropic substances, food and narcotics.
The FDA evaluates product quality, manufacturing facilities and the advertising product to the public. Manufacturers have to comply with the regulations set by the FDA. One of the important roles of the FDA is to research and study technical data of products and to detect any adverse effects from consumer use of products.
The FDA provides information on products and strives to educate the public to choose products wisely. The administration works together with universities and pharmaceutical manufacturers in terms of research and development.
The Law Protects Consumers
Many manufacturers chose to place their desire for profits before the safety of people. A good example of a manufacturer who chose to place profit before the safety of the public, was the case of Glaxo SmithKline.
In July 2012, the largest settlement from 1991 to 2012 was reached between the United States Department of Justice and a pharmaceutical company. The settlement amount was $3 billion.
Glaxo SmithKline admitted guilt to criminal charges under the False Claims Act that was connected to the unlawful promotion of prescription drugs and bribing doctors. The company promoted medicines for use for which they were not licensed and also failed to report safety data. Pharmaceutical fraud is activities that result in false claims to insurers or programs for financial gain.
In the last few years, there is a tremendous increase in lawsuits filed against some of the drug manufacturers. Lawsuits are filed by patients and mothers who took certain drugs while being pregnant and gave birth to babies with related drug birth defects.
In order to determine if you have a bad drug lawsuit, we review the basic facts of your case, obtain supporting and necessary medical records and investigate all surrounding details. It is strongly recommended that you speak to recall attorney who has experience in fighting drug companies. Injuries caused by defective drugs are complex legal matters. Our top pharmaceutical injury attorneys and can advise you on the action to take in a lawsuit.
Millions of drugs are taken by innocent consumers who believe they are using safe products. Many products are considered dangerous and lead to unnecessary injuries or deaths. The law protects consumers against unsafe or defective products. As a consumer, it is important to know and to protect your rights. Call St. Louis drug lawyer Chris Dixon at 314-409-7060 or toll-free at 855-552-2337.
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