Drug manufacturers or pharmaceutical companies can get sued for different reasons. In this article, we’ll break down four of the most common reasons why these companies might get sued.
1 Health Risks to Consumers
One of the most common reasons why drug manufacturers get sued is because of health risks to consumers. If a drug has been approved by the FDA, it can be sold and used by patients in the United States. However, if any side effects are discovered after the drug has been released onto the market, patients can sue the manufacturer for damages caused by those side effects.
The Food and Drug Administration (FDA) regulates drugs but often does not have enough evidence to determine if a drug is safe for human use. As a result, there are many instances where drugs have been approved for use despite potentially life-threatening side effects.
Drug manufacturers are responsible for checking all ingredients in their products to ensure that they are safe for humans and animals alike. They also need to make sure their products do not interact with other medicines or other substances like food or alcohol.
Johnson & Johnson (J&J) is currently having to deal with a Tylenol lawsuit. It’s one of the most renowned dangerous drug lawsuits at present, and it exists because acetaminophen exposure to pregnant women from Tylenol has been found to cause ADHD in their children when born. That’s why J&J is being sued.
The Tylenol autism lawsuit settlement amounts that J&J will have to pay might not take away a lot from the manufacturers. However, the Tylenol autism and ADHD lawsuit stands witness that these careless manufacturers deserve to be sued, and their victims deserve justice.
2 Failing to Ensure Quality
Drug manufacturers are often sued because they fail to ensure the quality of their products. This can occur in several ways.
Inadequate testing
Drug manufacturers are required to carry out adequate testing before releasing a new drug to the public. However, they may not always do this, and then they are at risk of being sued if people suffer side effects as a result of using their drugs.
Poorly controlled production systems
Drug manufacturers are also expected to have well-controlled production systems in place so that they can ensure that each batch of drugs is safe for consumption. If the system fails or is not implemented properly, there is an increased risk of someone suffering side effects from using the drug.
Failure to show due diligence
If a drug manufacturer has failed to show due diligence when creating their product, this could lead to them being sued by consumers who have suffered side effects from using it.
As reported by Reuters, Eli Lilly got called out by a whistleblower over manufacturing problems. The company was also sued because of these issues. Thus, it’s not necessary that pharmaceutical companies will be sued by consumers or the government. Sometimes, even their own employees might do so because of ethical concerns. Pharmaceutical companies get into trouble when they cut corners in the process. Check out the infographic below to see how the process is supposed to go!
Infographic provided by The Emmes Company, a biostatistics organization
3 Fail to Ensure Effectiveness
Drug manufacturers are required by law to ensure that the drugs they produce are effective. If a drug is not effective, it can cause harm to the patient. This can include physical harm, such as liver damage or death, or psychological harm, such as depression or suicide. When drug manufacturers fail to ensure that their products are effective, they are liable for any injuries sustained by patients who use them.
4 Failure to Meet FDA Standards
As the drug manufacturing industry has grown, so has the number of lawsuits against manufacturers. One of the most common reasons for these lawsuits is the failure to meet FDA standards. The Food and Drug Administration (FDA) regulates drug manufacturing facilities in the United States to ensure that they meet certain standards to protect consumers.
The FDA issues guidelines for drug manufacturers on how to produce their products, including specifying how often to test samples and how long those tests should take. When a manufacturer fails to meet these standards, it can cause problems with the quality of their product, which can lead to injury or death for consumers.
On the FDA website, you’ll find a list of points where the FDA highlights some of the concerns it poses when it doesn’t approve a drug. Failure to meet the agency’s approval standards and yet, manufacturing and selling the drugs is illegal. Manufacturers can be sued if they’re involved in such illegal activities.
When the FDA does approve a drug, it almost always manages to make headlines, like the Leqembi drug for treating Alzheimer’s. Its approval made headlines in the papers, including The New York Times. Such news is hard not to notice and also keeps consumers aware of potential drugs they can have access to if necessary.
These were some of the top reasons why drug manufacturers often get sued. Most of these lawsuits are filed keeping public safety in mind. Thus, these lawsuits have become necessary in order to keep pharmaceutical companies in check.