What to do when your meds make you sick
Whether you take an occasional over-the-counter medication for a short-term sickness or you’re on life-saving medication for an ongoing condition, you might feel grateful that there are so many options for drugs and pharmaceutical treatments for a wide variety of medical conditions.
As you should.
The vast majority of drugs and treatments are safe when used correctly. Big Pharma is one of the most tightly regulated industries, and most manufacturers take safety seriously. All medications or treatments must go through rigorous testing before they go to market.
However, even though a drug can’t be sold until it passes approval by the Food & Drug Administration (FDA), sometimes the tests don’t uncover long-term risks. In addition, there are times when a tried-and-true drug that’s otherwise safe becomes contaminated during production or there’s some other manufacturing defect that’s not discovered until it gets to market, and that can leave people injured or ill.
Pharmaceutical liability isn’t just about drugs — it also covers implants and other medical devices such as those used in breast implants, hip replacements, knee replacements, spinal fusions, and other treatments.
A drug recall is when a company voluntarily removes a defective drug from the market.
Sometimes the company discovers a defect and removes the drug on its own. Other times, the FDA requests that the company pull the drug from the market.
There are 3 classifications of drug recalls:
Class I: The product is dangerous or defective and could cause serious health problems or death.
Class II: The product might cause a temporary health problem or pose a slight risk of a serious problem.
Class III: The product is unlikely to cause any health problems but violates FDA labeling or manufacturing laws.
What leads to drug recalls?
- The medication is a health hazard that’s discovered after the drug has already been used.
- The medication is labeled incorrectly. Sometimes, the dosing instructions are confusing or there could be a dosing tool (like a cup or dropper) that’s incorrectly labeled. Incorrect labeling could also be an issue in which the packaging was used for the wrong medication (in other words, what’s on the box isn’t the same as what’s inside).
- The medication could’ve been contaminated during the manufacturing process. Whether the substance is harmful or not, if it’s something that doesn’t belong in the medication, it would be recalled when discovered.
- There was a manufacturing defect that relates to the product’s purity, quality, or potency.
Types of drug defects that lead to a pharmaceutical lawsuit
Most defective drug cases fall into the 1 of the following 3 categories:
- Design defect — When a product was made correctly according to its specifications, but the design made it unreasonably dangerous or it didn’t perform as expected when used in the intended manner.
- Failure to warn — Also called “marketing defects,” this happens when a product is designed and manufactured properly, but the package doesn’t include the correct instructions or warnings, and the lack of guidance makes it unreasonably dangerous to the user.
- Manufacturing defect — This is a product that was designed in a way that makes it safe to use, but the end result included a defect that made it unsafe.
When you can file a product liability claim
The basis for any personal injury lawsuit is that you were injured by another person or company’s negligence. The fact that you were taking a particular drug when it was recalled isn’t enough reason to file a claim if you weren’t actually injured by the circumstances of the recall.
You might be able to file a claim if you were injured because:
The product failed
There are a few aspects to this. First, not every medication works the same way on every person. We’ve all tried a drug that didn’t do what it was supposed to, and your doctor might tell you to try something else instead.
Along those same lines, most drugs and medical devices come with a lengthy list of potential side-effects. Your doctor isn’t required to inform you about every possible side-effect, but they should advise you about any that might be more likely for you because of your specific medical condition or history.
For example, if you begin a new medication and begin to experience joint pain, it could be because it’s a known side-effect, or it could be that it’s how your body reacts to that particular drug. Either way, it’s not a defect or product failure — it just means it’s not the right drug for you and you might need something different.
In those situations, you would not likely recover compensation in a legal claim. But, if you have a device like a hip implant and it fails or breaks and doesn’t work the way it’s supposed to, you might have a claim for a product failure in that instance.
There are newly discovered long-term effects
If you’re taking a drug that has been on the market for decades (and maybe you’ve been taking it for decades) and you begin to experience a symptom or effect that’s being reported as correlated with the drug, that’s worth exploring further.
How do you know if you’ve been injured by a defective drug?
If you start taking a particular drug and begin to experience symptoms that are unusual or unexpected, you should contact your doctor immediately.
However, if you’ve been taking a drug or had a device implanted for a long period of time, it’s harder to link your symptoms to the pharmaceutical.
Any change in your medical condition is worth a call to your doctor. When you visit the doctor, be sure to tell them:
- Exactly what symptoms you’re experiencing
- When your symptoms began and how often they occur (are they constant or occasional, certain times of day, etc.)
- What medications you’re taking (including any over-the-counter drugs, vitamins, or supplements)
Remember this, too:
Not every doctor stays current on the latest research about every drug, interaction, or side-effect. If your doctor dismisses your concerns, you’re always able to seek a second opinion.
Making your legal claim for a defective drug or device
If you file a claim for a defective drug or device, be prepared to answer these questions:
- Can you prove that the drug or device caused your injury or illness?
- Is the drug or device defective, and did that defect cause your injury?
- Was the defendant negligent in producing, labeling, marketing, or distributing the product?
If you can answer “yes” to these questions (and believe there’s evidence to support it), then you should call a lawyer who can help you file a North Carolina pharmaceutical liability lawsuit.
Pharmaceutical malpractice: suing a doctor or pharmacist in North Carolina
You might be familiar with the term “medical malpractice,” which refers to an injury caused by a medical provider. There are a few ways in which medical malpractice could overlap with pharmaceutical malpractice.
Pharmaceutical malpractice includes:
- Incorrect drug or dosage provided on a prescription
- Failure to read a patient’s medical chart in order to recognize a harmful medication interaction
- Incorrectly filling a prescription with the wrong drug or dosage
- Administering the incorrect amount of anesthesia
In most of these situations, the injury was caused not by the drug, itself, but by the provider. That means it becomes a pharmaceutical malpractice claim and not a defective drug claim.
Who can be liable for a defective drug?
- Manufacturer. The drug manufacturer could be at fault for any of the 3 causes of action in a pharmaceutical lawsuit — design defect, manufacturing defect, or improper marketing.
- Laboratory. In order to reach FDA approval, a drug must undergo rigorous testing and clinical trials. Mistakes in the testing process can have deadly consequences. Likewise, any falsification of results or fraudulent behavior would leave a laboratory vulnerable to a lawsuit.
- Doctor. If the drug reps lied to your doctor, that’s probably not the doctor’s fault. But if the doctor didn’t provide accurate information (or gave you insufficient information) about a drug’s side-effects, they could be liable for malpractice.
- Pharmacy. There are several layers of protocols required of a pharmacy to ensure that you receive the correct medication and dosage. Still, mistakes happen. If the pharmacy misread the prescription and gave you the wrong dose of a medication or pulled the wrong drug from the shelf, the pharmacy would be liable for your injury.
Can I protect myself from being injured by a defective drug?
In some instances, a drug-related injury will be out of your control, especially if it’s a side-effect that’s discovered after you’ve been taking it for a while.
But there are ways to protect yourself against drug-related mistakes:
- Ask questions. Your doctor might hand you a hastily written prescription that’s hard to read and understand, or they might electronically transmit a prescription to the pharmacy directly. Before you leave your doctor’s office, ask what the medication is and how much and how frequently you should take it. Your doctor is probably busy, but it’s part of their job to make sure you understand instructions for your treatment.At the pharmacy, ask again. Make sure they’ve checked your chart to make sure the medication isn’t going to cause a problem with any other medications you’re taking (either prescription or over-the-counter) or for your allergies if you have them. Sometimes an allergen is in the inactive ingredients in a medication, so it might not be obvious. Always check.
- Before you leave the pharmacy, check the bottle or box (inside the bag) to make sure the prescription is yours and not someone else’s.
- Review the printed information on the package. It should have a physical description of the medication (color, shape, and imprints). Make sure it matches the pills or liquid inside. You can also check an online medication website like RxList to ensure that the medication is correct and that it’s what’s normally prescribed for the condition or illness you’re being treated for.
Legal options for a pharmaceutical liability lawsuit
Some cases might be eligible for a class action lawsuit. A class action lawsuit is 1 claim for a group of people who have a similar issue or injury.
North Carolina adheres to a negligence standard in product liability cases. That means the plaintiff must prove that:
- The product was manufactured or designed in a way that was unreasonable and created a risk of harm to the consumer.
- The manufacturer failed to adequately warn the consumer of danger associated with the product.
- The manufacturer failed to provide correct instructions for using the product.
It’s also important to note that North Carolina follows the contributory negligence model. If the plaintiff (the injured person) contributed to their own injury in any way, no matter how small, they may not recover damages in a personal injury lawsuit. In a drug liability lawsuit, that might mean you took the medication for a longer or shorter period of time than it was prescribed, took more or less than prescribed, or even that you failed to store or maintain the medication in the manner specified in the instructions.
Sometimes a doctor will prescribe a medication for “off-label” use. That means it’s being prescribed to treat a condition that is different from what it was approved for by the FDA. This is legal, but if you are injured while taking a medication for an off-label use, it might limit your ability to make a claim.
Pharmaceutical liability is a very complicated area of law. Often, the companies involved have deep pockets and will spare no expense to defend themselves in a lawsuit. Now that doesn’t mean you can’t recover compensation for your injuries... it just means it’s not an easy road ahead.
If you believe you’ve suffered an injury or illness as a result of a defective pharmaceutical drug or device, it’s important to contact a lawyer right away. An experienced North Carolina pharmaceutical liability lawyer is the best person to review your claim and advise you of your legal options for compensation.