When it comes to lawsuits against Pharmaceutical companies, they can be quite costly. Many cases have resulted in settlements reaching hundreds of millions of dollars, and a few have exceeded one billion. However, physicians are the ones that generally carry more risk if a patient experiences negative side effects or is injured from a medication.
Because a doctor is considered to be a learned intermediary, it’s up to them to decide whether or not a medication is safe for a patient to use. Typically, a manufacturer is only responsible when it fails to warn doctors about the dangers and side effects. But nonetheless, getting slapped with a lawsuit can be catastrophic for a pharmaceutical company.
One of the main reasons for lawsuits is because of off-label promotion. When a company violates safety regulations or ethical guidelines in this way, it can be a recipe for disaster. For that reason, it’s important to rigorously adhere to regulations and never advertise or promote the use of a medication off-label.
Failing to disclose safety data and poor manufacturing practices have been other common reasons for lawsuits. That’s why pharmaceutical companies must provide physicians and users with all pertinent safety information. At the end of the day, consumers should be fully aware of the risks involved with taking a medication and know what the potential side effects may be. It’s also crucial that companies ensure that every aspect of manufacturing is up to par.
Recent Notable Cases
Over the past decade plus, there have been several lawsuits where settlements were $500 million or more. Here a few of the most notable and how much the settlements were:
Schering-Plough which manufactures Claritin – $500 million in 2002 for poor manufacturing processes
- Allergan which manufactures Botox – $600 million in 2010 for off-label promotion
- Abbott Laboratories which manufactures Depakote – $1.5 billion in 2012 for off-label promotion
- GlaxoSmithKline which manufactures Paxil, Valtrex, Advair and several other medications – $3 billion in 2012 for off-label promotion, failing to disclose safety data and kickbacks to physicians