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Pharmaceutical drugs are part of the care plan for millions of Americans, from those with serious and chronic illness to those who take a daily prescription for less serious conditions such as season allergies. Fortunately, these medications mostly do exactly what they are intended to do and allow us to live healthier lives. However, in some cases, issues can arise in the way a drug was created, manufactured, packaged, sold, or prescribed, resulting in serious complications, injuries, or death.
Common Defective Drug Injuries
When these types of issues occur, rendering a medication dangerous, we often refer to it as a defective pharmaceutical drug. You may have heard, through commercials soliciting plaintiffs or investigative news reports, about certain high profile cases of defective pharmaceutical drugs. The damages caused by these drugs is extremely diverse and can vary in severity depending on a variety of factors. The following list represents some of the injuries and diseases caused by defective drugs. It is by no means an exhaustive list of every documented adverse reaction but is merely meant to illustrate some of the possible effects.
A stroke occurs when blood flow to an area of the brain is cut off. When this happens, brain cells begin to die as a result of oxygen deprivation. The abilities controlled by the area of the brain with cell death (such as memory and muscle control) are lost. The severity of a stroke will depend upon the location of the brain where it occurs and the amount of cells that die in this area. A stroke can be fatal. Strokes are the fifth leading cause of death in the United States.
Several defective pharmaceutical drugs have been found to increase a patient’s risk of stroke. Tasigna (the brand name for the drug Nilotinib) is a pharmaceutical used to treat chronic myelogenous leukemia. It works by stopping or slowing the growth of cancer cells. While the drug is effective to treat cancer, studies have shown that patients are at a higher risk for stroke. Patients on Tasigna have shown symptoms such as intracranial atherosclerosis, which is the build-up of plaque in the arteries that supply the brain with blood, causing the narrowing and blockage of these vessels and increasing the chance of a stroke.
A heart attack occurs when the flow of blood to the heart is blocked. The blockage is most often a buildup of plaque in the coronary arteries (the arteries which supply the heart with blood). The plaque eventually breaks away and forms a clot. The interrupted blood flow can damage or destroy part of the heart muscle. Heart disease is the leading cause of death in the United States.
Actemra is a drug which was approved in 2010 to treat moderate to severe rheumatoid arthritis. The drug works by reducing inflammation to lessen pain. An investigation conducted seven years after FDA approval found that the drug may increase patients’ risk of heart disease and associated complications, including heart attack.
Cancer is second only to heart disease as a leading cause of death in the United States. Cancer may take many forms, depending on the location of the malignancy.
Incretin mimetics are a class of drug used to treat diabetes and obesity. They work by stimulating insulin and suppressing glucagon to help control blood glucose. However, research conducted on these drugs has found negative effects, specifically to the pancreas. Patients were found to have a significantly increased risk of developing pancreatitis. Manufacturers were required to add warnings around pancreatitis to labeling for certain incretin mimetics. Some research has suggested that patients are also at an increased risk for pancreatic cancer. Additionally, research suggests that these types of drugs may be responsible for increased risk of both benign and malignant tumors on the thyroid.
Organ perforation occurs when the wall of an organ is completely penetrated. This can cause serious damage to the organ, as well as damage to the body as a whole due to serious infections, such as sepsis. Certain medical devices have been found to perforate organs due to defective design, or a tendency of the device to shift within the body and endanger other organs.
Intrauterine devices (IUDs) such as ParaGard and Mirena are birth control devices that are implanted in the uterus and work to prevent pregnancy by releasing hormones or using copper to create a hostile environment for sperm. In certain cases, these devices have shifted within the body and, in some cases, have damaged or perforated other parts of the body, such as the fallopian tubes. This can have not only a risk of serious infection but can also pose serious risks to fertility.
Mental Health Impacts
Most defective pharmaceutical drugs and medical devices have negative physical effects on the body. However, some medications can have a serious effect on brain chemistry and negatively impact mental health and behavior.
One such impact was found with the antidepressant Rexulti. Rexulti (brand name for the drug brexpiprazole) is marketed as a drug that, when combined with other antidepressants, can reduce the symptoms of major depressive disorder. However, the drug has been found to worsen certain compulsive behaviors, most notably gambling. Patients reported an increase in urges related to gambling (and some other compulsive behaviors) as well as a decreased ability to control these urges after taking Rexulti.
The inability to adequately test pharmaceutical drugs for the impacts that they may have on pregnant women was one of the reasons why modern-day FDA regulations on medications exist. Several high profile cases of severe birth defects caused serious concern from both the public and government officials.
A classic case of a defective drug is that of Thalidomide. Thalidomide was marketed in West Germany, first to treat anxiety, insomnia, gastritis, and tension and eventually used to treat morning sickness in pregnant women. When the drug was being tested, scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm a developing fetus. It was first distributed as a prescription drug but eventually became over the counter. It was quickly linked to horrifying birth defects. Between 5,000 and 7,000 infants were born with a malformation of the limbs, and only about 40% survived. Before the risk of birth defects had been adequately recognized, the drug spread from West Germany to other countries, including Canada. In the United States, the FDA refused to approve thalidomide for marketing and distribution. The official responsible for refusal, Frances Oldham Kelsey, was given a Presidential award for distinguished service from the federal government for not allowing thalidomide to be approved for sale.
Thalidomide had a significant impact on the testing of pharmaceutical drugs on pregnant women worldwide. While this testing has improved the ability to identify risks to pregnant women and fetuses, there are still pharmaceutical drugs being developed which are linked to serious birth defects.
Selective serotonin reuptake inhibitors (SSRIs) are medications used to treat depression and other mental health conditions. They work by blocking the reabsorption (reuptake) of serotonin in the brain, making more serotonin available, which helps to combat depression. Research conducted by the Centers for Disease Control found that some birth defects occur about two or three times more frequently among babies born to women who took certain types of SSRI medications early in pregnancy. These included defects of the formation of the heart and skull and abdominal wall.
Certain pharmaceuticals have been found to cause permanent deformities. The chemotherapy drug Taxotere has been linked to permanent alopecia (hair loss). Patients were not adequately warned that the hair loss would be permanent (as contrasted to the vast majority of chemotherapy treatments which result in temporary hair loss). Risperdal, a drug used to treat schizophrenia and other mental disorders in adults, was found to have been marketed to children without adequate warnings related to the potential side effects it might have on a young child. Adolescent males developed gynecomastia (enlarged male breasts) at an alarmingly high rate, among other side effects.
Defective Pharmaceutical Drug Attorneys
Victims of defective medical devices and pharmaceuticals may not even be aware that the drug or device was indeed defective. It can be difficult to parse unintended side effects from an underlying medical issue which necessitated treatment in the first place. Our team has decades of legal experience and extensive resources necessary to investigate these types of cases. Contact us for a free consultation to discuss the specifics of your case.