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FDA Recalls, the Law and You

Experienced Lawyers

Almost everyday news reports tell of the latest set of protections passed down by a federal organization known as the FDA or USFDA. While everyone has heard of everything from regulations to recalls granted from this group, few people really know who they are or exactly what they do. However, every legal drug we take – both prescription and over-the-counter is carefully regulated by this federal agency.

Importance of the USFDA in our lives

The Food and Drug Administration is often referred to by its initials as the FDA or USFDA. It is a federally funded agency that is part of the US Department of Health and Human Services. The FDA was formed to protect and promote public health standards in a myriad of ways. This includes the strict supervision of prescription, over-the-counter medicines, vitamins and dietary products.

The FDA regulates regulate blood transfusions, bio-pharmaceuticals, vaccines and medical devices, including those that produce electromagnetic radiation. Veterinary medicine must adhere to FDA standards concerning veterinary products, pet food and feeds produced solely for livestock. Tobacco products are closely regulated, as is anything that can be smoked, used or consumed by the general public.

Federal Drug Administration Recalls

Congress granted the FDA the right to recall dangerous, harmful and defective products from the United States marketplace. This includes everything from prescription drugs that have been found to cause further illnesses rather than bring about improvement in patients. A recall may also be placed if a medical device is found to malfunction or a dietary supplement does not provide the health benefits it claims to provide.

Involvement of the Media

The many facets of the news media generally work together to get the word out when a recall has been issued. TV, radio, print and online news sources make a point of publicizing recalls to warn the buying public. The FDA cannot “order” a recall, but rather the agency notifies companies to voluntarily recall one of their products. This request might incur a consumer recall of peanut butter distributed from a particular supermarket chain. The FDA will also “request” a recall for a pharmaceutical manufacturer to remove a drug that has been found to cause fatalities amongst children and adults.

Usually companies recognize when one of their own products has malfunctioned or is not worthy of public consumption. These companies will immediately recall their own products without further interference. Should a company not be willing to recall a food, drug, device, cosmetic or other product that is found to be harmful, the FDA can seek a court order. Should it get to this point, the judge can order that the federal government literally remove the products in question without further corporate involvement.

Responsibility of the Manufacturer

To make sure food producers and product manufacturers adhere to FDA regulations, definite guidelines are put in place. Companies are expected to be fully aware of FDA product recalls, enact standards for their own recalls, and put in place their regulations to assure that their products are safely removed from the marketplace. When a manufacturer experiences a recall, the company must also supply the FDA with progress reports on the situation as it occurs.

Responsibility of the FDA

The FDA sets forth a series of guidelines under which distributors and manufacturers must undertake product recalls. This federal agency will monitor recalls, continually assessing the validity of that company, its compliance and actions. FDA investigators will later work to make sure the defective drug or product was properly destroyed or reconditioned for future sale.

Classes of Recalls

Consumers need to be aware of the levels or “classes” of recalls as defined by the FDA.

Class I recalls are the most serious. This type of recall is reserved for drugs, foods and products that can cause dangerous or even deadly results. Examples would be toxic foods, drugs or defective surgical products.

Class II is a recall concerned with a threat that may cause only temporary or non-life-threatening situations. A good example would be an over-the-counter cold drug that has been found to be less potent than originally advertised.

Class III is the least serious of recall levels. This type of recall is used when products are mislabeled or violate FDA guidelines with unfriendly consumer consequences. Product packaging that contains less than the number of advertised pills or ounces of food would be recalled in this fashion.

What if you or a family member has been hurt by a recalled drug, food or item?

Death, illness or personal injury can be caused by a recalled drug, food or product. This is when it becomes of the utmost importance to work with a law firm experienced in Personal Injury cases. Legal professionals understand how to research and proceed under these circumstances. An attorney makes sure that their client is financially reimbursed for life, limb and ongoing illness. Working with a trained lawyer is the best way to assure that future medical bills and living expenses are provided for on a satisfactory basis.

The Doan Law Firm, P.C.

The Doan Law Firm is well experienced in working with clients who have been hurt, made ill or injured by a wide range of pharmaceutical products. With an attorney by your side, your case can be either successfully settled or hard fought in the court system. Insurance companies and corporate manufacturers know that a victim with legal representation is not one to be taken advantage of.

Legal Expertise and Technology

The legal expertise of the Doan Law Firm is combined with today's latest technologies to make it easy for clients to receive the justice they deserve. A free case evaluation is available online so all prospective clients can better determine what to expect in a personal injury case. While many clients enjoy speaking with a lawyer in-person, other clients regularly communicate with their attorney using a toll-free phone number, email or online chat. To add to this convenience, clients may also use Skype and Facetime to speak directly with their lawyer.

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Contact an Experienced Personal Injury Lawyer

  1. After an accident, the responsible party's insurance company may try to reduce the claim amount. Commonly, insurance adjusters are trained to get information from the injured to assist in reducing the claim. Though some insurers are less guilty of this practice than others, it is important to realize that insurance companies are profit-oriented corporations and reducing claims results in increased profits for shareholders. This can create a situation for the injured in which they are offered a settlement that does not truly reflect the damages suffered. If you accept this settlement, you lose the ability to get more money should your injuries require further medical treatments. It is critical that victims get legal assistance in any personal injury case, and The Doan Law Firm is prepared to fight relentlessly for your rights.
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