Pharmaceutical companies often find themselves caught up in litigation because of the drugs or medicines that they manufacture and sell. Generally, the manufacturer of a drug is obligated to test the product before it is put on market using the test criteria and guidelines issued by the U.S. Food and Drug Administration (FDA) agency. Even though this criteria is seen as industry standard, this doesnt absolve a drug manufacturer who has had their product approved by the FDA from liability to injured people.
As it is the case with most drugs, except those that you can buy over-the-counter with no prescription, there is always an intermediary between the drug manufacturer and the end user. This is usually the doctor who prescribes the medicine, the nurse that advises on the proper dosage and use or the pharmacist who fills a specific prescription. The lines of liability arent as clear cut as they could be. That is why often it makes sense to talk to an experienced personal injury attorney who has dealt with this type of case before.
The Case of Unavoidably Unsafe Products
Some drugs will always have harmful side effects, no matter how carefully they are made. If pharmaceutical companies were treated the same way as electrical appliance companies are, there would be no drugs to speak of. So drugs that are considered unavoidably unsafe are still allowed on the market because of the potential benefits that they bring to the user. If the drug has been manufactured to be as safe as possible and the label includes adequate warning text, users cannot usually sue the drug manufacturer for defective manufacturing. However there are exceptions as we have seen with the recent low testosterone lawsuit cases.
When Is A Product Considered Unavoidably Unsafe?
A product is considered unavoidably unsafe when it cannot be made safe for its intended use. The legal system generally looks at 4 criteria before deciding whether a product is unavoidably unsafe or not: preparation, marketing, risk vs benefit ratio and whether the product has any alternatives.
If a mistake happens in the manufacturing process of the drug and the drug causes serious side effects, the product is not unavoidably unsafe. When it comes to the pharmaceutical industry, the product must work as intended. If its not prepared correctly or if the ingredients contain impurities, it is not unavoidably unsafe.
If the drug is marketed inadequately and the drugs label does not contain appropriate warnings, it cannot be considered unavoidably unsafe. That is why all drugs have clear and direct instructions as to who it is intended for. Similar to this, if the drugs instructions and label does not caution against the adverse side effects it can cause, it is not considered unavoidably unsafe.
Utility vs Risk
For a drug to be approved and considered unavoidably unsafe its utility or benefits have to outweigh the risk. As an example, if a drug relives your headache but causes cancer then it is obviously not unavoidably unsafe. Drugs ranging from birth control to dermatological products (such as Accutane) have been found to be sufficiently helpful to warrant the risk associated with their usage.
If an alternative product exists that would deliver the same result at a lower or no risk rate, then the drug cannot be considered unavoidably unsafe. Courts will look at what alternatives there are and take into consideration their cost, efficiency and safety to determine if there are any available alternatives.
Pharmaceutical Companys Duty to Warn
Drug manufacturers have the duty and obligation to warn of any side effects that a drug creates. However they are not required to do when it comes to unknown dangers. A drug manufacturer will often instruct a pharmacist or a clinician about these dangers.
The drug manufacturer, by virtue of creating the drug, is seen as an expert and has a legal obligation to update medical professionals on any updates regarding the drugs and medicine that they manufacture, including any potential adverse effects. A manufacturer has to warn about any side effects and drug reactions even if they are statistically rare.
Drug Injury and Time Lapse
Sometimes, the plaintiff wont be able to identify the specific drug that caused the injury or the period when the drug was taken because of significant passage of time that has occurred (for example in cases where the drugs were taken during pregnancy). In pregnancies, the damage may not even be evident until the child is born. Another classic example of the time lapse problem are asbestos-exposure cases. Oftentimes the attorneys will try to come up with a number of theories that shift the burden to potential defendants or to distribute damages among different manufacturers who can be held liable.
Vaccine Injury and Children
The National Childhood Vaccine Injury Act helps those who have been injured by childhood immunizations to obtain compensation without lengthy and costly litigation procedures. Attorneys who are representing such clients are required to inform them about the possibility of redress under this Act.
What To Do If Youve Been Injured As A Result of Taking Medication
Drug injury cases are often complex and proving legal fault often requires an experienced team of attorneys. There are a number of theories under which a plaintiff can make a claim but the same claim can be defeated just as well by someone who has experience with this type of case. It is therefore important to consult an experienced personal injury attorney if you or a loved one has suffered as a result of taking defective medication.