Pharmaceutical Liability - An Overview
"Pharmaceutical liability" is a term used to describe the legal consequences a
manufacturer of drugs may face if its products injure people. The manufacturer
may be found liable for making and selling a defective product (a claim of
strict liability), or it may be found liable for not taking reasonable care to
keep its products from causing injury (a claim of negligence). The law treats
these two approaches to liability as distinct theories, and depending on the
particular facts of the case, a person might recover damages on one theory but
not the other. In some states, however, a statute creates a single claim for
product injuries, which may combine aspects of the two. Accordingly, if you
believe you may have a claim against a drug manufacturer, you should not
hesitate to seek legal advice from a lawyer with experience in this area.
What To Do If You Suspect You Have Been Injured By A Pharmaceutical
If you think a medicine you have been taking has injured you, there are a few
things you should do as soon as you can. One of the two most important parts of
building a successful case is to sue the right company. Thus, if possible, save
the container the medicine came in as well as any information you received with
it, such as a patient brochure or the packaging. The other most important part
of building a successful case is to sue the right company on time. Each state
sets a deadline for starting lawsuits arising from personal injuries, in some
cases the deadline is just a year. If you do not file on time, you will have no
case at all, no matter what happened, no matter how devastating the injury. In
some states, the time in which you must file begins on the date you took the
medicine; in other states, the clock may begin to tick from the date you suspect
or discover that the medicine may have caused your injury. You should consult
with a lawyer who has experience with personal-injury cases as soon as you
suspect you have been injured to ensure that your rights are protected
The United States Food & Drug Administration
Although drug companies hoping to sell their products in the United States must
comply with regulations and procedures mandated by the Food & Drug
Administration (FDA), the FDA does not guarantee drug safety. Once the FDA
approves a drug for a particular use, patients who are injured by the
drug-whether it is used for its approved purpose for some other reason (known as
"off-label" use), must look to the manufacturer for redress. Understanding how
the FDA approval process works and where its weaknesses are can be an important
part of a successful case against a drug manufacturer. A lawyer experienced with
pharmaceutical-liability matters understands the complex process of FDA approval
and can explain to the jury what effect it should have on your case.
Dietary Supplements and Herbal Remedies
The production and sale of dietary supplements and herbal remedies is a huge,
and largely unregulated, business in the United States. They are not "drugs."
Instead, they are treated like food. While dietary supplements and herbal
remedies products may be safe in most circumstances, they are not risk-free and
can cause serious side effects, just as "drugs" do. Under federal law, set forth
in the Dietary Supplement Health and Education Act of 1994, referred to as
"DSHEA," the manufacturer is responsible for ensuring that its products are
safe. DSHEA also sets forth rules for making claims about products and
information that must appear on labels. If you believe that a dietary supplement
or herbal remedy may have caused or contributed to your medical injury, you
should consult a lawyer familiar with products-liability and consumer-protection
law to see if you have a claim against the manufacturer and whether you can
recover damages for your injuries.
Legal Claims Against Drug Manufacturers
ClClaims against drug manufacturers usually take two forms: strict liability and
negligence. In a strict liability case, the focus is on the product and the
question is whether it has a defect that makes it unreasonably unsafe. In a
negligence case, the question is whether the manufacturer has acted with
reasonable care. In both cases, manufacturers may assert that medications have
reasonable risks or that another party (such as a doctor) is responsible for the
patient's injuries. Accordingly, if you believe you may have a claim against a
drug manufacturer, you should not hesitate to seek legal advice from a lawyer
with experience in this area.