When do medication side effects merit a lawsuit?
On the back of an Advil package, there are warnings, such as “this product may cause a severe allergic reaction”, “stomach bleeding warning”, and “heart attack warning”, to name a few.
These warnings are legally required by the Food and Drug Administration. On all medicines, adequate warning labels must be provided. However, every year, millions of Americans are forced to visit their doctor’s office due to side effects from prescription or over-the-counter drugs. The injuries can be severe, or even fatal.
The FDA is responsible for ensuring that the drugs they approve work correctly, and that health benefits “outweigh known risks.” To be approved by the FDA, medicines must undergo a rigorous testing process.
There is a three phase human testing process.
Phase 1 includes between 20-80 healthy people, and is meant to determine what the most frequent side effects are. Phase 2 includes hundreds of people; this phase is meant to determine effectiveness. Phase 3 tests thousands of people. In Phase 3, more information is gathered about the drug’s safety and effectiveness among different populations and with different dosages.
The FDA also will recall drugs, if need be. Some notable past drug recalls include Accutane (the popular acne drug), Vioxx (a pain medication that caused 28,000 cardiac deaths or heart attacks), and Darvocet (another pain medication that caused heart problems).
Either way, manufacturers are required to notify consumers, medical professionals, distributors, and salespersons of any and all known side effects of their medications.
Side effects are broad. They can be mild, like headaches or fatigue. They can also be extremely serious, like joint pain, ulcers, arthritis, liver damage, a stroke, nervous system damage, and more.
In certain instances, a patient suffering from side effects can pursue legal action, in what is known as a defective product liability claim.
Typically, these claims fall into three categories: (1) defective manufacture (2) defective design or (3) failure to provide adequate warnings about the risk involved in taking a medicine.
If the patient is warned of potentially serious side effects by the prescribing party (physician, pharmacist, etc.) and chooses to take the medicine anyway, then the patient is unlikely to succeed in his pursuit of damages.
The person affected must show that the medication was defective, dishonestly marketed – failure to warn, or had undisclosed negative side effects that caused harm.
If you or a loved one has suffered severe side effects from a medication that you were not warned of, we can help get you the compensation you deserve. Contact the experienced attorneys at Cohen & Cohen today for a free case evaluation.