It is the responsibility of pharmaceutical drug development companies and manufacturers in the U.S. to develop and sell safe, effective medications. The United States government and its regulatory bodies, especially the U.S. Food and Drug Administration (FDA), are responsible for making sure that medications are safe for public consumption and that manufacturers are held to a high standard.
Unfortunately, the system doesn’t always work, and unsafe medications can and do reach the general public. Sometimes these medications have devastating side effects that do more harm than good.
What Are Side Effects?
A side effect is a problem, usually negative, that manifests as a direct result of taking a prescribed medication. Side effects can happen to anyone taking a medication. Some are easy to deal with while others can be dangerous, life-altering, or deadly.
For example, if someone takes an anti-histamine for a runny nose, he or she would be happy that it stops the runny nose, but might be annoyed if they also experience dryness in the mouth as a side effect. On the other hand, if a patient is taking a drug to lower his or her cholesterol and the medication ends up damaging the liver, causing debilitating pain, the consequences go well beyond frustration and turn into real danger.
How Dangerous Is Too Dangerous?
Most drugs have side effects, some of which can be unpleasant, but consumers who receive information about the potential side effects of their medications can make informed choices about whether to take a given drug and how to prepare themselves for the results. This is why pharmaceutical companies are required to notify consumers, medical professionals, distributors, and sales representatives of any and all known side effects of the drugs they manufacture.
Unfortunately, these notifications don’t always provide the last word on a drug’s side effects. Harvard University’s Edmond J. Safra Center for Ethics reports that prescription drugs have a 1 in 5 chance of having dangerous and serious side effects uncovered after they have gone through the approval process. The Safra Center also reports that prescription drugs cause a total of approximately 2.7 million adverse reactions annually.
When these additional side effects come to light, they may lead to a recall on the drug which attempts to address the issue. However, for many patients who have already taken the medication and experienced serious side effects, these recalls can come too late to do any good.
Common Side Effects that Lead to Lawsuits
All prescription drugs go through a rigorous and thorough approval process by the Food and Drug Administration. Regulators can and do approve medications even if there are some negative side effects. In general, though, approved drugs provide benefits which outweigh the side effects and risk affects associated with them.
FDA regulators are human, however, and drug companies aren’t always forthright about the known side effects of their drugs. These companies have a vested interest in getting their drugs approved for distribution to the public, and there have been numerous historical cases of companies who tried to cover up negative side effects associated with prescription drugs for financial reasons.
Even if a drug is FDA-approved and has cleared all safety and quality control measures, it does not mean that the pharmaceutical manufacturer is not liable if complications do arise once it hits the market and more people start to use it. In some cases, mistakes during the manufacturing process can compromise a drug that would have been safe if it was manufactured correctly. In these cases, the manufacturer may be liable for harm that results.
It would be nearly impossible to list every single prescription drug and side effect that could result in a valid claim. In general, though, side effects that cause harm and that are not described in the patient instructions, documentation, and packaging that comes with the drug — or that are worse than described — could lead to liability on the part of the pharmaceutical company or manufacturer.
Some examples of side effects that have led to lawsuits in the past include:
- Physical ailments: Physical pain as a result of prescription medication can interfere with daily life and make typical tasks seem impossible. Some examples of debilitating physical ailments include pain in the abdomen or joints, arthritis, and muscle spasms, among others.
- Heart issues: Medications are commonly recalled after release to the consumer market if it’s discovered that they cause cardiovascular problems, including but not limited to: heart attack, congestive heart failure, high blood pressure, blood clots, and other issues.
- Stroke: For pharmaceuticals that can cause circulatory issues like blood clots and artery damage, these medications can also expose patients who take them to an increased risk of a stroke.
- Suicidal ideation: It is well-document that some medications increase the risk of suicide. A number of pharmaceuticals have been linked to suicidal thoughts, from drugs that are used to prevent suicide, depression, and bipolar disorder to common painkillers.
- Liver damage: The harmful effect that prescription drugs and over-the-counter medications can have on the liver is often underrated. Damage to the liver frequently goes unnoticed or presents subtle symptoms that medication users don’t connect to a bigger problem.
- Death: If someone dies as a result of a prescribed medication side effect, the survivors of the deceased may be able to receive financial compensation through a wrongful death claim.
In order to successfully recover financial compensation in a lawsuit that arises from injuries or negative side effects from a medication, the person affected (or their loved ones, in the event of a wrongful death claim) will need to demonstrate that the medication was defective, dishonestly marketed, or had undisclosed negative side effects that caused harm. Depending on where and when the issue occurred, several people or entities could be at fault, including the company that developed the drug, the drug manufacturer and their employees, hospitals and their staff, or the pharmacy that dispensed the drug.
As you might guess by the number of different factors discussed above, lawsuits that involve prescription drug side effects can be very complex and may seem overwhelming to an ordinary person. That’s why you need to contact the legal team at Hossley & Embry if you or someone you love has been harmed by a dangerous or defective drug.
The Attorneys at Hossley & Embry Are Ready to Evaluate Your Prescription Drug Liability Case
Harmful drug side effects can devastate families and cause enormous pain and suffering to victims. If you have suffered or lost a loved one because of a harmful or defective medication, please give the attorneys at Hossley & Embry a call at (866) 522-9265. You can also fill out our convenient online contact form and we will be in touch promptly. We offer free consultations, and we have the resources available (including charter aircraft) to travel throughout Texas and the United States on short notice to investigate your potential claim.
References
Light, D.W. (2014, June 27). New prescription drugs: A major health risk with few offsetting advantages. Edmond J. Safra Center for Ethics at Harvard University. Retrieved from http://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages