FDA Recalls, the Law and You
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
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
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
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.