Failure to Disclose Rare and Serious Side Effects of a Prescribed Medication


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Every year individuals are injured by prescription medications that they use to treat another condition. Injured victims may consider seeking monetary compensation for the damages that they sustained because of these drugs. However, it is important that they understand the steps leading up to a lawsuit and whether they have a viable claim.

Dangerous Side Effects

Consumers who see television or print ads from prescription manufacturers may be familiar with the many types of side effects that drugs may cause. Some of these side effects are relatively minor, such as causing a dry cough. Others may involve cause brain infections, meningitis, impotence, sterility, liver damage or even death.

Involvement of the FDA

Before a drug can legally be placed on the market, it must receive approval from the United States Federal Drug Administration. The pharmaceutical company that wishes to release the drug is required to submit a New Drug Application and provide clinical evidence that the drug brings about the effect that it claims and that it is safe. This clinical evidence is comprised of testing of the drug on animals and later humans. If the FDA determines that the benefits outweigh the risks, it approves the drug.

However, it is not uncommon for the FDA to discover after it has approved a drug that it poses certain risks. After the drug is taken on a larger scale, problems may begin to crop up. If the FDA receives serious reports about the side effects of a drug, it may take regulatory action, such as requiring clear warnings to be added to the medication’s label. In extreme cases, the risk may be so grave that the FDA completely removes the drug from the marketplace.

MedWatch

To try to keep up with the side effects that prescription medications cause, the FDA operates the MedWatch program. This is a post-marketing program that relies on the voluntary input of information from patients and healthcare professionals. Individuals who want to provide information about a side effect can go to MedWatch’s website or call a toll-free number.

Medication Guides

In some cases, the FDA may require a Medication Guide to be included with a specific prescription medication. These are paper handouts that address issues related to a specific medication. They may also contain additional information to help individuals avoid serious adverse side effects. These Medication Guides may be required if the FDA determines that specific information is necessary to prevent serious adverse side effects, patients should be informed about information to make informed decisions regarding possible side effects of the medication or the patient needs additional directions to ensure that he or she uses the medication in a way that ensures its effectiveness.

Manufacturer Liability

Medication manufacturers may be held liable when a prescription medication causes dangerous side effects. Manufacturers have a duty to test their products before releasing them into the stream of commerce. They have a duty to warn consumers of the dangers that they know about. However, if they do not know about a particular danger or side effect, they are not held liable for these. The duty to warn consumer is continual in nature, so if a manufacturer does not learn about a potential side effect until after release of the drug, it still has a duty to report these dangers. However, drug manufacturers can satisfy their duty to warn by explaining the side effects by telling doctors and pharmacists about them, who then have the duty to share this information with patients. The duty to warn patients does not require drug manufacturers to account for extreme reactions sustained by unusually susceptible individuals. They are not expected to think about every possible adverse side effect that could result in every type of plaintiff.

Rules Pertaining to Advertisements

The FDA also has rules regarding the type of information that must be provided in drug manufacturer ads. For example, product claim ads must include the benefits and risks of using a particular drug. These ads cannot be false, exaggerate or mislead patients. These ads must identify the name of the drug, at least one use of the drug that the FDA has approved and the most significant side effects of the drug. Print product claim ads must include a brief summary of the drug and all the risks listed in the approved prescribing information form. Additionally, it must contain a line about MedWatch that is approved by the FDA.

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Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer.

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