Dangerous Drug Information

A guide to understanding Dangerous Drug Accidents, including a list an explanation of the types of dangerous drugs, an overview of the Food and Drug Administration (FDA), an explanation of Product Liability Law as it pertains to Defective or Dangerous Drugs, a guide to determining fault, and the statute of limitations.

Understanding Dangerous Drugs · Types of Dangerous Drugs · Food and Drug Administration-FDA · Product Liability Law · Determining Liability · Statute of Limitations · Center for Drug Evaluation and Research

Understanding Dangerous Drugs

Dangerous Medical Drug Accidents are traumatic experiences, as the very medication that a patient takes to help restore their health leads to further medical issues, including in some cases, serious injury and death. The manufacturers of drugs, as well as pharmacists and doctors have a responsibility to ensure that the drugs they prescribe do not cause harm. Some drugs have dangerous side effects which are known and must be disclosed to patients before they are prescribed. Even in these cases, the benefits of the drug must outweigh its negative side effects.

The Food and Drug Administration (FDA) plays regulates prescription drugs, approving and monitoring their safety. However, the manufacturer is ultimately liable for any injuries from their medications. Dangerous Drug Accident Lawsuits are filed based on several causes, including: drug recalls; product failure; long-term side effects; improperly prescribed medication and improperly filled prescriptions.

There are reasons that so many defective drugs make it to the marketplace. Some of these include:

Sadly, many recalls do not occur until people have been seriously injured or killed because of the dangerous drug.

There are two primary types of lawsuits that arise out of improper perscriptions for drugs:

Types of Dangerous Drugs

Dangerous drug cases can be extremely complex and expensive, as they usually involve taking on large pharmaceutical corporations. Making the matter more complicated, there is no one type of dangerous drug case. The causes of defects in drugs can rage considerably. A drug may be dangerous because of a defect in the manufacturing process. This could be because of accidental contamination, poor quality control, inadequately trained employees, or even an intentional action by an employee. Other cases arise because of negative reactions to a drug. These may occur because the company was aware of the side effect, but failed to disclose it to the public, or because the were unaware of the side effect. Furthermore, they may not have known of the side effect because they failed to do the proper research and testing or because the long term side effects were impossible to know. Some dangerous drug cases may occur because of a dangerous interection with another drug or some other product. In these cases, the drug may not be harmful when used on its own, but only when used in conjunction with another drug.

Regardless of the cause of the drug recall, the underlying fact is that it causes more harm to the user than good, or because of some error, may be dangerous to users (such as errors in labelling or failure to warn) Common types of dangerous drugs include:

Some recent dangerous drugs include:

Food and Drug Administration-FDA

The Food and Drug Administration (FDA) a branch of the Department of Health and Human Services (HHS) and is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug's studies so that the Center can evaluate its data. The studies answer the question: "Does this drug work for the proposed use?" By analyzing the data, Center for Drug Evatuation and Research (CDER) reviewers assess the benefit-to-risk relationship and determine if the drug will be approved.

No drug product is "perfectly" safe. Every single drug that affects the body will have some side effects. Since the FDA considers both the benefits and risks of all medications before approval, side effects are generally not serious. For every drug FDA approves, the benefits are balanced against its risks. In addition, FDA makes sure the labeling (package insert) outlines the benefits and risks reported in the tested population. You and your health-care provider should decide together if the benefits outweigh the risks for YOU. Talking about your medicines with your health-care provider is just as important and good for your health as a complete check-up and taking your medicine as directed.

Product Liability Law

Dangerous Drug Lawsuits fall under the umbrella of Product Liability Law, because a dangerous drug is, in effect, a defective product; even when used properly, it does not restore health as it is suppoed to, but instead causes harm. The laws regarding dangerous drugs and product liability vary from one state to the next, however, they are all based upon the same three legal ideas:

Product liability lawsuits are built upon the legal doctrine of "strict liability," which means that the injured person does not need to prove that the drug company was negligent. Rather, all that needs to be proved was the the drug was directly responsible for the ensuing injury, and that the manufacturer could have known and done something about this. It sounds simply, but the lawsuits can be extremely complex and involve a considerable amount of expert testimony, so it is best to hire an experienced dangerous drug attorney if you are considering an action against a drug company because you were injured by one of their products.

Determining Liability

Determining Liability in Dangerous Drug Accidents can be extremely difficult and involve the expert testimony of a number of persons, as well as the experience of a dangerous drug lawyer. The first thing that needs to be determined is if the dangerous drug accident falls under product liability law or medical malpractice law. If the injury is the result of a doctor or pharmacist's error, then it is a medical malpractice lawsuit. These would be cases were the doctor fails to disclose dangerous side effects, prescribes a drug that negatively interacts with a drug you are already taking, or prescribes the wrong drug or the right drug in the wrong amount. It also involves cases where the pharmacists provides the wrong drug, or the right drug in the wrong amount. In these medical malpractice lawsuits, the doctor and/or pharmacist may be liable for damages and injuries associated with the dangerous drug accident.

Dangerous Drug Accidents that fall under product liability law are the fault of the drug manufacturer. Manufacturers of drugs have a legal duty to test the drugs and medicines before releasing them to the public, using testing criteria from the U.S. Food and Drug Administration (FDA). However, the fact that a drug was properly licensed by the FDA has no effect on the manufacturer's liability to an injured plaintiff, if the drug proves to be otherwise defective. That is, even if a drug was FDA approved, if it caused an injury, the injured person can bring a lawsuit against the manufacturer. The drug manufacturer is responsible for the accident, because they released a drug with a manufacture defect, a design defect, or because they failed to warn consumers of the dangers associated with use of the drug. If it can be proved that the drug, in the course of normal use, caused an injury, then there is a good chance that a successful product liability lawsuit could be brought against the manufacturer. In these cases, sometimes, the doctor and pharmacist may still be held liable, as they are "learned intermediaries," in passing the dangerous product on to the consumer.

Statute of Limitations

Dangerous Drug Accident Lawsuits must be filed within a certain period of time or the injured party is no longer legally allowed to file them. This is referred to as the statute of limitations. The statute of limitations begins at the time of injury, or the discovery of the injury (or the time when the injury, reasonably should have been discovered) and once it has elapsed, the injured party has no more legal options for recovering compensation for injuries and damages. In the cases of dangerous drug accidents, the statute of limitations varies from state to state, and depends on what type of lawsuit is being filed. The lawsuit for medical malpractice or personal injury differs from that of product liability in many cases. These issues can get complicated, so it is best to consult an experienced dangerous drug lawyer, so you know how to best proceed in order to protect your rights. Generally speaking, the longer you wait to file and Dangerous Drug Lawsuit, the harder it becomes to win your case. The following is the statute of limitations, by state, for personal injury. Bear in mind that this data may have changed, as they are updated regularly, and the data may not apply to your case, because of the details of your case. It should simply serve as a general barometer of the time limits that states put on personal injury lawsuits:

Center for Drug Evaluation and Research

The Center for Drug Evaluation and Research (CDER) is a consumer watchdog in America's healthcare system. CDER's best-known job is to evaluate new drugs before they can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely.

The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.

From aspirin to cancer treatments, CDER ensures that the benefits of drug products outweigh any known risks. The Center has oversight responsibilities for prescription, over-the-counter and generic drugs. This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have access, as quickly as possible, to promising new treatments. The Center oversees the research, development, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's label, or--if necessary--remove a product from the market. Specifically, CDER regulates:

All content on Accidents.com is for informational purposes only and is NOT intended as legal or medical advice. Please seek advice from a professional on any related topics.

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