If you've suffered a serious illness or injury from taking a dangerous drug, whether prescription or over-the-counter, you may be wondering what legal rights you have. Who do you file a drug lawsuit against? Common questions include:
• Can I sue the pharmaceutical company who made the drug?
• How about the U.S. Food and Drug Administration for approving it?
• Is my doctor liable for prescribing the drug?
• Does the pharmacy share any responsibility?
Let's discuss the options...
U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is "responsible for protecting the public health by regulating human and animal drugs, biologics (e.g. vaccines and cellular and gene therapies), medical devices, food and animal feed, cosmetics, and products that emit radiation."
Most people think the FDA approves all drugs on the market today, but that's not true. Some drugs are not subject to FDA approval (ex. "compounded" drugs), and others are only reviewed after they're put on the market. Read more about the FDA approval process .
Since the FDA was created, thousands of dangerous drugs have entered the market and caused harmful side effects, including serious illnesses and wrongful deaths. While the FDA has become better at finding potentially dangerous drugs, many have slipped through their fingers and made it to market.
You might think that if the FDA approved a dangerous drug which caused you harm, you'd be able to sue the FDA for their negligence. Unfortunately, the FDA is a government agency, therefore it has sovereign immunity. Sovereign immunity is a legal privilege stating government agencies can't be sued (unless they allow it, which rarely occurs).
Pharmaceutical Drug Companies
Before 2013, drug companies could be sued if their drug caused serious adverse side effects, injury, illness, or death. They paid out hundreds of millions of dollars in drug lawsuit settlements and jury verdicts.
In 2013, the U.S. Supreme Court made a historical decision. In the case of Karen Bartlett vs. U.S. Merck and Co. and Mutual Pharmaceutical Company, the Supreme Court ruled that once the FDA approves a drug, individuals are prohibited from suing the drug's manufacturer, even if it's proven that the drug caused harm!
In the Bartlett case, the plaintiff took the drug Sulindac, which allegedly caused her to suffer gangrene in her right arm as a result of "toxic epidermal necrolysis." The Supreme Court ruled that, because the FDA approved the drug Sulindac, the manufacturer has immunity from private and class action lawsuits.
Basically, the ruling stated drug manufacturers have a right to rely on the FDA approval system, and once a drug is FDA approved, pharmaceutical companies can't be sued. Otherwise, the court said, why does the FDA exist at all?
What this means to you is, if you've suffered a serious side effect or illness from an FDA approved medication, you are barred from filing a lawsuit against the manufacturer. (Supreme Court rulings are rarely overturned, but in the future it may happen.)
Doctors and Pharmacists
While you may not be able to file a lawsuit against the FDA or a drug manufacturer, you can sue your doctor or pharmacy if they prescribed a dangerous drug which caused you harm.
There's a difference between drug lawsuits and medical malpractice lawsuits. A lawsuit based on illness or injury caused by a doctor's negligence in prescribing medication, falls under the category of medical malpractice.
By law, doctors are held to a very high standard of care in the medical community. When a doctor deviates from the medical standard, and as result a patient is injured, the doctor is considered negligent, and therefore liable for any resulting injuries.
When a patient can prove a doctor's negligence was the direct cause of his injuries, the patient may be entitled to compensation for his or her damages. In extreme cases of negligence, an injured or deceased patient's family may be entitled to punitive damages.
Pharmacists have a legal duty of care when prescribing medications. They receive extensive training in pharmacology and must be familiar with every drug they dispense. This includes knowing about potentially harmful interactions between drugs when taken together.
It's up to the pharmacist and doctor to work together to make sure a prescribed drug will not injure the patient. In today's day and age however, communication between a doctor and pharmacist is often limited. The one who suffers most is the patient.
As a patient and customer, you have a right to rely on the expertise of your doctor, and the pharmacist who filled your prescription. When they fail to protect you from harm and you suffer injuries, you have a right to seek compensation.