Novo Nordisk Recalls Cartridge Holders In Some NovoPen Echo Insulin Delivery Devices

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Novo Nordisk Insulin Cartridges May Crack Or Break

Device maker, Novo Nordisk, implemented a recall of insulin cartridge holders that are used in a number of NovoPen Echo batches because they may crack or break should they be exposed to certain chemicals such as cleaning agents.

The NovoPen Echo is used for insulin treatment by people who are diagnosed with diabetes. Using a device with a cracked and/or broken cartridge holder may cause the NovoPen Echo device to deliver a reduced dose of insulin. This minimized dose may potentially lead to high blood sugar.

Patients who are using one of the recalled insulin pens should check their blood sugar levels more frequently until they receive a new cartridge holder. Patients should also contact their health care provider if they believe they are experiencing hyperglycemia.

The affected batches were distributed between August 1, 2016 and June 22, 2017 to distributors, sales representatives, and replacement programs for further distribution to pharmacies, healthcare providers, and patients across the country. Novo Nordisk indicated that it is notifying distributors, pharmacies, healthcare professionals, and patients by mail and is arranging for product replacement. Replacement cartridge holders will be provided for NovoPen Echo from the following recalled U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135. If a patient is in possession of a NovoPen Echo device with a batch number that is not mentioned above, there is no reason for concern and they can use the pen, which should work as intended.

The batch number of the Novo Pen Echo and NovoPen 5 pens can be found by dialing up the pen. The NovoPen Echo can be red or blue in color, the NovoPen 5 can be blue or grey.

Novo Nordisk indicated that it has received a number of complaints of damaged cartridge holders and has received some reports of adverse events, to date. Novo Nordisk also indicated that it has corrected this problem and has determined no other component of the pen is affected.

Parker Waichman LLP has spent decades representing clients in drug and medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a Novo Nordisk insulin device lawsuit.

This is not the first time Novo Nordisk has faced a medical device recall. In September 2016, Novo Nordisk Inc. issued a nationwide recall of six batches of its GlucaGen HypoKit (glucagon [rDNA origin] for injection) due to detached needles on the syringe in the kit. The recall followed two customer complaints from the United Kingdom and Portugal and involved detached needles on the syringe with Sterile Water for Injection (SWFI).

The GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients diagnosed with diabetes and who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.

Untreated hypoglycemia may eventually lead to unconsciousness and seizures, which can become fatal. If blood glucose levels are not rapidly restored, ongoing hypoglycemia may lead to a decline in brain glucose levels, which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion, and eventually coma or death.

The affected products were distributed starting February 15, 2016.

The most common side effects of GlucaGen HypoKit include nausea, vomiting, temporary fast heartbeat, or pounding in the chest (tachycardia).

What is Diabetes?

Currently, over 29 million Americans have been diagnosed with diabetes; however, for the some six million individuals who have been diagnosed with diabetes and who need insulin to manage their disease, access to insulin is a matter of life and death.

According to WebMD, individuals diagnosed with diabetes either have a total lack of insulin—this is known as Type I diabetes—or individuals produces too little insulin or are unable to use insulin effectively—this is known as Type 2 diabetes.

Type 1 diabetes, previously known as juvenile-onset or insulin-dependent diabetes, occurs when the body’s immune system destroys the cells that release insulin, which eventually stops insulin production from the body. Without insulin, the body’s cells cannot absorb glucose (sugar), which is necessary to produce energy. Type 2 diabetes, previously known as adult-onset or non–insulin-dependent diabetes, occurs at any age, but is more apparent in adulthood. When individuals are diagnosed with Type 2 diabetes, their bodies are not able to use insulin in the correct way, a condition known as insulin resistance. As Type 2 diabetes worsens, the pancreas may make less and less insulin, a condition known as insulin deficiency, according to WebMD

Both types of diabetes increase risks for various serious complications and are the leading cause of blindness and kidney failure and are critical risk factors for heart disease, stroke, and, and foot or leg amputations, WebMD notes.

The warning signs of high blood sugar—hyperglycemia—generally appear gradually and might include flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing one’s appetite, feeling or feeling sick (nausea or vomiting).

Meanwhile, the price of insulin has more than tripled between 2002 and 2013 to more than $700 per patient. This means that many patients in need of insulin are unable to pay for the live-saving medication. In fact, one federal lawsuit accuses the three insulin manufacturers of conspiring to raise their prices. Not surprisingly, Novo Nordisk is among the group along with Eli Lilly and Sanofi. All three denied the allegations, according to CBS News.

The high price of insulin, coupled with increasing insurance deductibles has left many people diagnosed with diabetes, and who rely on insulin, facing challenging decisions. Physicians are saying that, with no way to pay, patients are facing impossible choices, according to CBS News correspondent Anna Werner.

Filing an Insulin Lawsuit

If you or someone you know is interested in filing a personal injury lawsuit involving Novo Nordisk insulin products, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).