Prescription drugs, over the counter medications, and medical devices are supposed to help people feel better. Pharmaceutical and device companies spend millions, and sometimes billions, of dollars researching and developing products that target specific diseases, conditions, and symptoms. Unfortunately, while many of these products heal people, bring relief, and even cure diseases, they may also cause harm, secondary conditions, or debilitating side effects.
From medications to treat type 2 diabetes to surgical mesh and addictive drugs that are supposed to relieve chronic pain, there are so many dangerous drugs and products on the market it can be hard to keep up. Some have been recalled, while others have simply had strong warnings added to them by the U.S. Food and Drug Administration (FDA). Many of these dangerous products have also triggered lawsuits against the manufacturers by people who suffered terrible consequences of using them.
Side Effects: Balancing Risks and Benefits
Nearly all medications, from the mildest over the counter painkillers, to restricted prescription medications treating serious conditions, have the potential to cause side effects. In an ideal world a medicine would only target the disease or symptom it treats, but in reality most drugs are not that specific. It is expected that most drugs will cause most people some side effects. Doctors and patients have to weigh the risks and severity of those side effects against the benefits of using the drug.
For example, antidepressants like Celexa, Effexor, Zoloft, and others are approved for use in adults, not children. There is a potential side effect in children, teens, and young adults of suicidal thoughts and behaviors. Not all young people will experience this side effect, but it is a risk, and a serious one. A doctor and parents of a young person have to decide if that risk is worth the potential benefit of a child finally getting relief from depression when other medications and therapies have failed.
To be able to weigh the benefits and risks, doctors need to have all the information. Pharmaceutical companies are supposed to thoroughly test their products, including conducting extensive clinical trials and recording and reporting all side effects. Sometimes these tests are not enough to catch all potential side effects, and they are only seen later after a drug or device is approved. In other cases, a drug company may have actually acted unethically or illegally to get a product to market and earn revenue in spite of known risks.
Pharmaceutical Companies and Unethical Actions
Drug makers have a responsibility to report all side effects and risks of medical devices and medications. This doesn’t always happen, though. Some companies have been found to actively hide unfavorable results to get approval or to avoid the FDA’s dreaded black box warning on a drug label. Others have paid kickbacks to get doctors and medical facilities to purchase their drugs for patients for whom a device or drug is not approved.
Some of these instances of unethical actions are subtle and hard to detect, and may not even be illegal. One example is the case of Merck pushing the drug Fosamax. This is a drug that was designed to treat bone loss, specifically for women experiencing osteoporosis during and after menopause. Fosamax turned out to have some pretty serious side effects, including sudden femur fractures, esophageal problems, and a terrible condition called osteonecrosis, or bone death, of the jaw.
Lawsuits have been started against Merck over Fosamax because patients believe that the company pushed the use of the drug in cases when it wasn’t needed putting a lot of women at risk. Merck pressed for the use of Fosamax in women with osteopenia, a potential precursor to osteoporosis. The FDA also warned Merck that it was advertising the drug in a way that overemphasized its benefits and downplayed its risks.
Other companies have actually been found to be guilty of violating laws in how they market their drugs. Such was the case with Daiichi Sankyo and Benicar, a drug for treating high blood pressure. Benicar can cause a severe and debilitating gastrointestinal condition called sprue-like enteropathy. The U.S. Department of Justice found the company guilty of violating the False Claims Act for making misleading claims about Benicar and its safety. The company was fined $39 million over the illegal marketing.
Examples of Dangerous Drugs and Products
Whether drug companies knowingly or unknowingly send a dangerous drug out to the market, there are many examples of drugs and devices that can harm patients. Transvaginal mesh, for instance, is now classified by the FDA as a high-risk device. In using it to treat women with pelvic organ prolapse or stress urinary incontinence, these mesh products have caused cases of internal bleeding, infection, organ damage, and even death.
The number of drugs available to treat type 2 diabetes has grown in the last decade as the number of cases of the chronic condition also grows. Drug companies have rushed to get these drugs out to an ever-growing and profitable market, but many of them have proven to be harmful. Most of these medications, like Byetta and Januvia, have been found to increase the risks of developing one or more certain types of cancer, including bladder, pancreatic, and thyroid cancer.
Newer blood thinners belong to another category of drugs that have proven to be potentially harmful and even deadly for some patients. They have also been controversial with the manufacturers being accused of downplaying risks and overstating how effective they are compared to older blood thinners like warfarin. Some of these newer drugs don’t even have antidotes, which means that excessive bleeding becomes a real and deadly danger. Some of the problematic blood thinners have been Eliquis, Pradaxa, and Xarelto.
When patients suffer because of side effects and risks of drugs and devices and they were not adequately warned of those risks, drug companies often have to pay. Patients, and sometimes in the case of those who died the loved ones of patients, file lawsuits against drug makers when they believe they could have done more to protect them.
Some of these cases fail for the plaintiffs, but often juries and courts find in favor of the patients. In other cases, the drug company may settle out of court out of fear that a jury will award a much bigger settlement. Some examples of lawsuits that ended in settlements for patients include Avandia, a type 2 diabetes drug made by GlaxoSmithKline that has been found to cause heart failure. The company has paid out more than $200 million.
Often times, even when there is a settlement, a drug company will refuse to admit to any wrongdoing. When Forest Laboratories was faced to pay a $313 million settlement over Celexa, an antidepressant that increases the risks of suicidal thoughts in young people, the company actually admitted guilt. It admitted to promoting the drug for use in children and young adults, even though it hadn’t been approved for use in that population.
Dangerous drugs and products will likely continue to be placed on the market, both by unscrupulous drug makers and by those that made an honest mistake. Doctors and consumers must continue to push these companies to do better by bringing side effects to light and continuing with lawsuits in cases of wrongdoing and negligence.