Defective Pharmaceutical Drugs

Millions of Americans rely on pharmaceutical drugs to keep them healthy. These are often essential components of our daily care regimes. The majority of the time, these medications do exactly what they are intended to do and help us to live longer, healthier lives. However, in some cases, serious issues can arise in the way a drug was created, manufactured, packaged, sold, or prescribed, leading to serious complications, injuries, or death. In such cases, a lawsuit against the manufacturer or prescribing physician can be the best course of action.

FDA Approval

In order for any brand-name or generic pharmaceutical drug to be marketed and sold in the United States, it must pass an approval process conducted by the Federal Food and Drug Administration (the FDA). Before the drug is submitted to the FDA, it must undergo internal testing. This involves Pre-Clinical Research (the substance is tested for harm or toxicity, in a manner which may include living or non-living organisms). The next step is Clinical Research. During this phase, researchers will document how the drug behaves in the human body.

In the application to the FDA, the pharmaceutical company must disclose all relevant information about the clinical studies performed on the drug. At this point, a team from the Center for Drug Evaluation and Research (CDER) will review the submission. The team (comprised of doctors, chemists, pharmacologists, and other scientists) will study all findings, request further information if necessary, and make a determination. If the drug is approved, the FDA will work with the applicant pharmaceutical company to develop appropriate prescribing information.

Adverse Reaction and Reporting

An important part of the Post-Market Safety Monitoring process is the ability to report adverse reactions to the FDA. The organization maintains the Adverse Event Reporting System (FAERS), a database containing adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. Healthcare professionals (such as physicians, pharmacists, nurses, and others), consumers, and manufacturers are able to submit reports to FAERS.

Reports submitted to FAERS are evaluated by clinical reviewers in CDER and the Center for Biologics Evaluation and Research (CBER).  Based on this evaluation, the FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

FDA Recalls

It is possible that the volume and severity of adverse reactions to a pharmaceutical drug could prompt the FDA to recall the drug. There are three classifications of FDA recalls. A Class III Recall is one in which a drug is unlikely to cause any adverse health reaction, but some element of the product violates FDA labeling or manufacturing laws; A Class II Recall involves a drug that might cause a temporary health problem, or pose slight threat of a serious nature; a Class I Recall happens in the event that the drug could cause serious health problems or death.

Injuries Caused by Defective Pharmaceutical Drugs

Defective pharmaceutical drugs cause a wide range of side effects, injuries, and illnesses. The severity of these can depend on how long a victim was taking the drug, the dosage, and the individual characteristics of the patient. These injuries can be sudden (such drugs which cause a heart attack or stroke) or take much longer to develop (such as drugs associated with drastically increased cancer risk).

Examples of Pharmaceutical Drug Injuries

The following list serves to illustrate some of the injuries that might be caused by defective pharmaceutical drugs:

Permanent alopecia (hair loss) was a result of the chemotherapy drug Taxotere that many patients did not receive adequate warning prior to administration. Lawsuits brought against the manufacturer claim that it was aware of this potential side effect but did not disclose this information with physicians or patients.

The rare, serious disease nephrogenic systemic fibrosis has been linked to the use of gadolinium-based contrast agents (GBCAs). GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).

Incretin Mimetic diabetes drugs (designed to treat diabetes) were found to carry an extreme risk of severe pancreatic complications, including pancreatitis and pancreatic cancer.

Rexulti, an antipsychotic, was found to cause compulsive gambling as a side effect, a complication that the manufacturer did not include in warnings for years after the drug hit the market. 

Tasigna, a drug developed to treat leukemia, was found to cause atherosclerosis, a build-up of plaque in the walls of an artery that can cause a blockage of blood, which can cause a stroke or sudden death.

Saxenda, a pharmaceutical developed to combat obesity, has been linked to cases of pancreatic cancer. Saxenda is a newer incretin mimetic, which seeks to imitate a hormone produced in the intestines that signal satiety to the brain in order to promote weight loss (despite the documented issues with incretin mimetic drugs used to treat diabetes).

The manufacturer issued a voluntary recall Synvisc-One knee injection syringes after discovering bacterial contamination, which lead to serious complications, including pain and infections.

Mirena and Paragard, both intrauterine devices (IUDs) have, in some cases, migrated, causing damage including organ perforation. This includes organs which are vital to the reproductive process, including the uterus and fallopian tubes.

Actemra, developed to treat the inflammation caused by rheumatoid arthritis, has been linked to serious complications that were not disclosed to patients, such as heart attack and stroke.

Ocaliva, a newer drug which targets a rare chronic liver disease, was the subject of an emergency health communication by the FDA in late 2017, when it was found to have potentially worsened liver conditions in a small number of patients (resulting in fatalities). 

One of the most commonly recognized prescription drugs in the US, Viagra, is the subject of concern over reports that it has been linked to higher rates of melanoma.

A group of drugs known as proton pump inhibitors (PPIs) has been linked to serious complications (especially with long-term use) including bone fractures and kidney disease.

The blood thinners Xarelto and Pradaxa have been the subject of lawsuits claiming that they caused unstoppable and in some cases fatal bleeding.

Several selective serotonin reuptake inhibitors (SSRIs), commonly prescribed antidepressants, have been linked with serious birth defects.

Risperdal, a drug intended to treat schizophrenia and other conditions in adults, was found to have been marketed to children without adequate warnings related to the potential side effects it might have in a young child. Adolescent males developed gynecomastia (enlarged male breasts) at an alarmingly high rate, among other side effects.

Actos, another anti-diabetic drug, has been the subject of lawsuits from patients who developed bladder cancer, congestive heart failure, and other serious injuries.

Compensation for Damage Caused by Defective Drugs

As illustrated by the examples above, defective pharmaceutical drugs can cause severe complications, such as cancer, which can be incredibly costly to treat, and may require lifetime care. Many patients who suffered due to a defective drug seek compensation via a personal injury lawsuit.

Class-action lawsuits are commonly seen in these types of cases. In these claims, a group of plaintiffs (known as the class) who have suffered common harm due to the behavior of the same defendant choose to group together to bring a claim against the defendant. 

A common form of this type of litigation involving defective pharmaceuticals is Multi-District Litigation (MDL). These types of cases occur when a very large plaintiff group in different federal districts across the United States allege the same (or similar) complaint against one single defendant. The court system will combine these claims into one single claim to be litigated in one federal district. 

However, individuals may still be able to pursue solitary claims against the manufacturer of the drug, or a prescribing physician, based on the circumstances of the case. 

Damages

The money awarded to a group of plaintiffs or one single plaintiff is called damages. The purpose of damages in a civil case is to make the victim (or the party representing the victim) as close as possible to the state that he or she was in before the injury at issue occurred. 

When a victim is bringing a defective drug claim, damages often seek to cover medical bills. These could include expenses for the treatment required to deal with the immediate effects of the drug (such as hospitalization, surgery, physical therapy), the expenses that the victim will accrue throughout his or her lifetime (this can include chemotherapy, occupational therapy, prosthetic devices, future surgery, medication, home modifications, and much more). In addition to these costs, the victim may have missed a significant period of work and/or may not be able to return to the same job following the illness or injury. Damages can include lost wages and payments for reduced earning capacity. Plaintiffs may also be able to seek damages for less tangible losses, such as pain and suffering.

In a case where a victim has died as the result of a defective drug, his or her loved ones may be able to recover for past medical bills, the future economic losses which could impact the family, funeral expenses, and much more.

The expenses discussed above are only examples of the costs that may be recovered as damages in a personal injury case. Each case is unique, including the losses suffered, and any damages awarded will be affected by these unique circumstances.

Claims Against a Manufacturer for Defective Drugs

When a defective drug does cause serious complications (or even death), the most common target of a lawsuit is the manufacturer. The manufacturer can be responsible for a defective drug if it failed to adequately test for, and document, all potential risks/side effects while developing the drug. It may also be liable if some issue during the manufacturing or packaging of the drug caused a defect. 

Claims Against a Prescribing Physician

It may be appropriate to bring a claim against a physician who was responsible for prescribing a defective drug. If a doctor fails to adequately warn a patient about the potential side effects of a drug and/or does not provide adequate instructions regarding the proper use of the drug, he or she may also be liable. It is also possible that a hospital or other healthcare institution could share liability.

Defective Pharmaceutical Representation

Claims regarding defective pharmaceutical drugs can be incredibly complex, and often times victims aren’t even aware that the side effect they experienced was due to a defective drug and not the underlying medical issue for which they were seeking treatment. The team at Gilman & Bedigian have decades of legal experience and extensive resources necessary to investigate these types of cases. Contact our team for a free consultation to discuss the specifics of your case.