What if your medicine leaves you injured?
Just about everyone has a need for medication at some time in their life. Whether it’s an over-the-counter drug for the common cold, or a prescription for a short-term illness or ongoing condition, most of us trust our medical providers to recommend or prescribe drugs that will keep us happy and healthy.
But what if they don’t?
More importantly, what if a medication or pharmaceutical device actually causes you injury?
What is pharmaceutical liability?
Pharmaceutical liability is within the area of law known as product liability. There are 3 causes of action in a product liability lawsuit:
- 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.
There are a variety of reasons why a drug or device could cause injury.
For example, a manufacturer could bring a drug to market with insufficient clinical testing or trials, labeling or marketing could be inadequate, and contamination or other accidents happen even in tightly regulated labs.
In several cases, the drugs themselves were fine. The design and manufacturing was exactly right, and they were effective when used properly.
However, the pharmaceutical companies were so eager to get their products in the hands of consumers that they would market the drugs in a deceptive way to doctors. That’s right — the people we trust most to keep us safe and healthy were being misled, themselves.
Drug representatives often engage in off-label promotion, which means they encourage doctors to prescribe drugs for treatment that isn’t approved by the Food & Drug Administration (FDA) for that particular use.
For example, Johnson & Johnson paid a $2.2 billion settlement for a Risperdal lawsuit. Risperdal was approved in the early 2000s to treat schizophrenia. However, the company’s representatives were promoting it to physicians to treat elderly dementia patients for anxiety, agitation, depression, hostility and confusion. There were also reports that Risperdal was marketed to physicians for use in children and individuals with mental disabilities.
Risperdal was found to cause stroke or cardiac-related deaths in elderly patients. It can also cause breast growth in men.
The lawsuit claimed that J&J knew that the medication would be harmful when used in ways that were outside the FDA-approved uses. The marketing was deceptive and aggressive, failed to provide adequate warnings, and concealed side-effects.
Unfortunately, the Risperdal case is just one example of pharmaceutical companies manipulating physicians. By providing incorrect information or kickbacks in order to convince them to prescribe a drug that wouldn’t ordinarily be used for a certain treatment, the pharmaceutical companies make a lot of money.
Who can be liable in a pharmaceutical liability lawsuit?
There are several potential defendants in a pharmaceutical liability lawsuit.
- 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.
- Pharmacy. There are several layers of protocol required of a pharmacy to ensure that you receive the correct medication. 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.
It’s always your right to ask. When you pick up a medication at the pharmacy, mention each drug — prescription or over-the-counter — that you’re currently taking and ask whether the new medicine would be a problem with any of those.
If you know you have an allergy to a medication (most frequently antibiotics), ask about that, too. Sometimes, the allergen is in the inactive ingredients. You’re always better off asking than not asking.
Always check the actual box or bottle (not the bag) to ensure that it has your name and not someone else’s. One of the biggest mistakes pharmacies make is giving medications to the wrong customers.
Finally, look at the printed information on the package. It should have a physical description of the medication (color, shape, any imprints). You can use an online medicine identification website like RxList to double-check that the medication inside the bottle is the same as the description on the outside, and that it’s normally prescribed for the condition or illness that you’re being treated for.
What types of actions lead to pharmaceutical lawsuits?
Your medication might have a manufacturing defect, design defect, or marketing defect. But how do you know if you’ve been injured by a defective drug?
There are 3 ways to know if you might be eligible for a California pharmaceutical lawsuit:
1. Product failure
If you’re taking a medication or using a pharmaceutical device and it isn’t doing what it was intended to do, you might suffer injury. Of course, medications don’t have the same effectiveness in every person — some medicines simply don’t work for some people, and that’s not anyone’s fault per se.
Likewise, if you read the fine print on your package insert, you might see that there’s a lengthy list of possible side-effects. Your doctor isn’t required to inform you of every side effect that can happen, but they should tell you about something that’s likely to affect you because of your specific condition or medical history—or those side-effects that are the most common.
For example, if you begin a new medication and after a few days, you begin to experience debilitating headaches, it’s possible that it’s a known side effect, or that you’re particularly sensitive to that particular drug. That doesn’t mean the product has failed. It means that it’s not the right medication for you.
A product failure, on the other hand, is if you have a device like a hip replacement, breast implant, or other implanted object, and it breaks down and doesn’t work the way it was intended.
2. Drug recall
A drug recall happens when the FDA receives reports of adverse effects from a medication, usually that patients are suffering negative effects when the medication is used for its intended purpose.
This often happens because the testing simply didn’t uncover one of the side-effects. You should be notified by your doctor or pharmacy if a drug you’re currently taking is recalled, but it’s a good idea to check online every so often, too.
3. Long-term effects
Sometimes, certain effects of a drug happen after long-term use. Once enough patients have taken a drug for years or decades, there might be reports of a correlation between that drug and other adverse health events.
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).
If you think what you’re experiencing is linked to a drug you’re taking, don’t be afraid to say so to your doctor. They might say it’s not the cause, and you might have something else going on. But if it is related, they’ll explore that possibility.
What if your doctor doesn’t take your concerns seriously?
Unfortunately, this happens. A doctor might not be current on the latest research or side-effects reported for a certain drug. Or, perhaps they even feel like they made a mistake in prescribing it to you. If your doctor insists that the drug isn’t the reason you’re having negative symptoms and doesn’t have some other diagnosis, you can seek a second opinion.
Legal options for a pharmaceutical liability lawsuit
If your doctor determines that a drug or pharmaceutical device is to blame for your condition or injury, your next step is to find a pharmaceutical liability lawyer. There are California lawyers who specialize in pharmaceutical and product liability lawsuits.
It’s important to realize that the law continues to change with respect to pharmaceutical liability. In a recent case, the California Court of Appeal strongly limited a claim based on a design defect.
Christopher Trejo was 7 years old in 2005. He had just returned home from a strenuous soccer practice and was experiencing aches and soreness in his legs.
After a few days, Christopher continued to experience muscle pain, and he also had a fever. He took a Motrin. He remained feverish and achy for several days, so he continued to take Motrin at the dosage and frequency specified on the bottle.
On the second day, he began to break out in blisters in his mouth. There was no warning on the Motrin bottle about blisters. At trial, Christopher testified that if he knew there was a risk of blisters, he wouldn’t have taken the medicine. Over the course of the next 10 days, Christopher’s condition became worse, and he was treated in a hospital for blisters and open wounds all over his body. He remained in the hospital for more than a month.
Christopher was diagnosed with SJS/TEN, which is a rare disease that is believed to be an allergic reaction to a drug. Symptoms of SJS/TEN include fever, malaise, skin redness, rash, and blisters.
At trial, Christopher’s lawyer argued that his TEN was caused by Motrin. He said that TEN is a side-effect that can occur even when the patient has taken a dose that’s less than the minimum recommended dosage.
Christopher’s lawyer and others submitted a petition to the FDA requesting a safety review of Motrin and other NSAIDs. They wanted to know whether the manufacturer had withheld safety information about the risks of SJS and TEN associated with ibuprofen.
In the original lawsuit, the court found that the manufacturer was liable for negligence and strict liability design defect, along with negligent failure to warn. This was based on the assertion that Motrin was inherently defective because dexibuprofen could be used instead of ibuprofen to treat the same symptoms, but without the same risks.
Previous court decisions in California said that prescription pharmaceutical manufacturers wouldn’t be held liable for strict liability design defect. This was because the court believed that doing so would discourage manufacturers from doing research and developing life-saving pharmaceuticals because they’d be so fearful of lawsuits. They determined that the public benefit of continuing to produce pharmaceuticals at affordable costs was worth avoiding design defect lawsuits.
However, Trejo is the first case that applies that principle to over-the-counter drugs, too. The bottom line is that a plaintiff can’t pursue a design defect claim only on the theory that the manufacturer should have used a safer alternative formulation of the drug.
Result: The court found the manufacturer to be liable on the claim for negligent failure to warn, but not for the strict liability failure to warn.
What does this mean for you?
Any case against a pharmaceutical company will have a lot of legal wrangling. These companies have deep pockets, and they’re willing to go to great lengths to protect their reputations and money-making products.
If you were harmed by a pharmaceutical, your lawyer will ask questions such as:
- Can you prove that the drug or device caused your injury?
- Is the drug or device defective, and did that defect cause your injury?
- Was the defendant (manufacturer, supplier, hospital, physician, etc.) negligent in producing, labeling, marketing, or distributing the product?
Your lawyer will then advise you about your best legal options. Some pharmaceutical injuries have enough plaintiffs that you could qualify to join a class action lawsuit that’s already in progress or about to begin. If not, your lawyer will assess your situation and suggest a course of action.
Start with the free Enjuris directory to find a California personal injury lawyer to evaluate your claim. A pharmaceutical liability claim will be complex, and your lawyer will walk you through each step of the way.