Pharmaceutical Liability

Pharmaceutical liability refers to legal theories and				controls used to maintain the drug's quality are
ways to prove that the manufacturer of a				adequate to preserve the drug's identity, strength,
prescription drug, over-the-counter medication,				quality, and purity.
dietary supplement or herbal remedy may be				The NDA documents the drug's history including what
responsible when the drug causes injury or death.				happened during the clinical tests, what the
The Food and Drug Administration ("FDA") is the				ingredients of the drug are, the results of the animal
government agency that is responsible for ensuring				studies, how the drug behaves in the body, and how
that our drug supply is safe and effective. Approval				it is manufactured, processed and packaged. After
of prescription drugs is the job of the FDA's Center				the FDA approves a drug for a particular use,
for Drug Evaluation and Research ("CDER").				patients who are injured by the drug must look to
Since 1938, every new drug has been the subject of				the manufacturer for redress, whether the drug is
an approved New Drug Application ("NDA") before				used for its approved purpose or for some other
U.S. commercialization. The NDA is the mechanism by				reason (known as "off-label" use). Manufacturers will
which drug sponsors formally propose to the FDA				sometimes try to persuade a jury that, because the
that the FDA approve a new pharmaceutical for sale				FDA approved the medication, the manufacturer
and marketing in the U.S. The data gathered during				should not be liable for any injuries the medication
the animal studies and human clinical trials of an				caused, particularly in cases of "off-label" use.
Investigational New Drug become part of the NDA.				In some instances, a company discovers that one of
The FDA reviews the medication and may approve it				its products is defective and has the potential to
for sale, but the FDA does not guarantee drug				cause injury, pain or death. The company may recall
safety.				the drug entirely on its own. In others instances, the
The purpose of the NDA is to provide enough				FDA informs a company of findings that one of its
information to permit the FDA reviewer to reach the				products is defective and suggests or requests a
following key decisions:o Whether the drug is safe				recall. Usually, the company will comply. If the firm
and effective in its proposed use(s), and whether the				does not recall the product, then FDA can seek legal
benefits of the drug outweigh the risks.o Whether				action. FDA actions may include seizure of the
the drug's proposed labeling or package insert is				available drug, and/or an injunction against the firm,
appropriate, and what it should contain.o Whether the				and a court order for recall of the product.
methods used to manufacture the drug and the

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Pharmaceutical Liability