Chantix Lawsuit Heart Attacks, Arrhythmias, Stroke, and Peripheral Vascular Disease
According to an observational study conducted near the end of 2017, the medication varenicline, sold as the brand name Chantix, may increase the risk of a cardiovascular event. Chantix is marketed as a cessation-assist medication that helps individuals stop smoking cigarettes.
The study followed approximately 57,000 individuals who had recently been prescribed varenicline in Ontario. At the end of the study, which was designed as a retrospective analysis, the researchers concluded that there was a 34 percent increased risk of a cardiovascular event. The cardiovascular events noted were those that required an emergency room visit or hospitalization. To calculate this risk, the researchers compared the number of cardiovascular events observed while taking varenicline to an observational period before the subjects started their prescriptions. The study’s findings were published in American Journal of Respiratory and Critical Care Medicine.
In patients who had never suffered a cardiovascular event, the increase in, the risk of experiencing a cardiovascular event while taking varenicline was approximately 12 percent. The authors commented that the “true cardiovascular risk of varenicline likely lies between these two estimates.”
Andrea Gershon, one of the researchers that led the study, wrote, “We also observed a small 6% increase in the incidence of neuropsychiatric hospitalization and emergency department visits that were not robust to sensitivity analyses…Previous studies regarding the safety of varenicline have been conflicting and most examined people with relatively similar characteristics and backgrounds in highly controlled settings. We wanted to study varenicline among all kinds of people in the real world.” Gershon works with Toronto’s Institute for Clinical Evaluative Sciences.
Ontario is home to a multicultural, diverse population. The study was population-based and implemented a self-controlled risk interval design. The researchers gathered universal health administrative information.
The researchers conducted two different analyses. Patients who had just begun taking varenicline were observed from September 1, 2011 to February 15, 2014. These patients were followed from one year before they started taking varenicline until one year after their first dose of the substance. The researchers counted a variety of adverse events, such as neuropsychiatric and cardiovascular incidents. The researchers noted only those that led to a hospital stay or an emergency room visit. The events were counted from one year before the patients started varenicline to 12 weeks after they started. Most physicians prescribe varenicline for a 12-week period.
The researchers considered the following as cardiovascular events:
- Heart attack
- Peripheral vascular disease
- Unstable angina
- Other associated conditions
In the 56,851 subjects, 4,185 experienced at least one cardiovascular or neuropsychiatric hospitalization. As for emergency room visits, 4,720 experienced neuropsychiatric or cardiovascular events that required such medical attention.
The authors of the study wrote, “We estimate that 3.95 cardiovascular adverse events…per 1,000 varenicline users were attributable to varenicline during the 12-week risk interval.”
Since the study was observational, the researchers could not make any conclusions on cause and effect. The researchers added that they did not have access to information about the subjects’ smoking habits or whether they were taking the medication as prescribed.
The authors said, “Success in quitting smoking could have theoretically led to a lower cardiovascular event rate in the post-exposure control interval, making the event rate in the risk interval appear relatively high. However, given low cessation rates—even with smoking cessation therapy—and their impact, this would not likely have accounted for results observed.”
The researchers also considered that because of warnings from the FDA about the risk of neuropsychiatric events, both physicians, and their patients might have improved their monitoring for such incidents, which would “…prevent them from progressing.” The researchers posited, “This might mean our findings are generalizable to people who receive such monitoring and the (neuropsychiatric) risk of varenicline is greater in those who do not.”
What happens if a medication causes injuries?
Drug manufacturers, whether they sell prescription drugs or over-the-counter substances, must ensure that their products are safe for consumption. If a manufacturer’s products are ultimately determined to have dangerous properties that cause injuries to consumers, that manufacturer may be liable for damages in a products liability lawsuit.
A products liability lawsuit requires the consumer to prove the following elements:
- A product was defective;
- The consumer was injured;
- The consumer was using the defective product as instructed or as anticipated by the manufacturer; and
- The product’s defective nature was the direct cause of the consumer’s injuries.
Each of these elements must be proven for a consumer to prevail in a products liability lawsuit. If the consumer cannot support one of the elements with objective evidence, the claim will fail, and the consumer will be responsible for the financial losses he has endured as a result of the defective product.
There are three varieties of defects that may be present in a product:
- Design defects
- Manufacturing defects
- Marketing defects
A single product may contain all three defects.
Design defects are those that involve the product’s “blueprints.” For example, in metal-on-metal hip litigation, the problem is the design of the hip, because dangerous metal ions are released when the metal grinds together.
Manufacturing defects involve problems that arise as a product is being built, assembled, or distributed. For example, consider a shipment of clothing that is left in a hot warehouse for an extended period of time before it is shipped out to retailers. In the warehouse, the clothing becomes moldy. This would be an example of a manufacturing defect.
With marketing defects, the manufacturer has failed to include proper warnings or instructions with a product. For example, if a drug manufacturer knew that taking medication in conjunction with another medication could cause serious complications and did not provide this information in its packaging, a consumer who consumed both medications and was injured would be able to file a products liability lawsuit against the manufacturer.
What types of damages are available in a products liability lawsuit?
The damages in a products liability case vary significantly depending on the circumstances of the claim.
Damages may include:
- Medical bills
- The cost of future medical care
- Lost wages
- Pain and suffering
- Emotional distress
- The cost of modifying a home to accommodate an injury (such as installing wheelchair ramps and bath room safety equipment)
- Loss of consortium
- If a death has occurred, surviving family members may claim funeral and burial expenses, as well as the loss of the deceased’s future earnings
Documentation must support any damages claim. For example, medical bills from all providers who treated the claimant must be submitted. With the help of an experienced products liability lawyer, a harmed user has a much larger chance of obtaining a favorable outcome in the claim.
Injured consumers should make an appointment with a products liability attorney to defend all of your legal rights. There are deadlines in place that limit how long a consumer has to file a products liability claim against a manufacturer. If the consumer misses the deadline, the court may dismiss the case.
Call Parker Waichman LLP today
At Parker Waichman LLP, our attorneys offer a free case review to discuss your legal options. To schedule your free consultation with our firm, call 1-800-YOURLAWYER (1-800-968-7529) 24 hours a day, 7 days a week.
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