Insulin Pump Lawsuit | 2025 Latest Updates

Insulin Pump Lawsuit Overview

The insulin pump lawsuits center on serious safety concerns with devices used by thousands of Type 1 diabetes patients, particularly children and teenagers.

The primary allegations involve device malfunctions leading to improper insulin delivery, resulting in serious injuries and deaths.

According to FDA reviews, between 1996-2005 there were 13 deaths and more than 1,500 injuries connected with insulin pumps.

These concerning statistics prompted multiple recalls, including a significant Class 1 recall of certain Animas insulin pump battery caps in 2008, and continue to raise questions about the safety of these widely used medical devices.

What’s The Problem?

Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators finds.

Between 1996-2005 there were 13 deaths and more than 1,500 injuries connected with the insulin pumps.

Latest Insulin Pump Lawsuit Updates

• August 12, 2025 – Tandem Diabetes Care has issued a voluntary medical device correction for selected t:slim X2 insulin pumps due to a speaker-related defect that may trigger a “Malfunction 16” alarm, causing unexpected stoppage of insulin delivery and loss of communication with continuous glucose monitoring, potentially leading to dangerous hyperglycemia requiring medical intervention. The company reports 700 confirmed adverse events—including high blood sugar incidents and medical interventions—and 59 injuries, though no deaths have been reported. Users received direct notifications in late July 2025 with guidance on recognizing the malfunction, and Tandem plans to release a software update featuring early speaker-failure detection and persistent vibration alerts to mitigate risks [4.].
• November 21, 2008 – The FDA in association with Animas Corporation initiated a nationwide Class 1 recall of certain battery caps used in the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump [1].
• May 5, 2008 – FDA regulators reported that insulin pumps had been linked to 13 deaths and more than 1,500 injuries among pediatric Type 1 Diabetes patients between 1996-2005 [2].

According to industry data, insulin pumps are a significant and expanding segment of diabetes care.

However, the most recent estimates indicate that the global insulin pump market was valued at approximately $6.6–7.1 billion in 2024 and is expected to grow further in the coming years.

FDA Reports and Statistics

According to FDA data, insulin pumps have been associated with a concerning number of adverse events, particularly among pediatric patients.

The agency’s review of insulin pump use among young people revealed that between 1996-2005, there were 13 deaths and more than 1,500 injuries connected with these devices [3].

The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database continues to receive reports of insulin pump malfunctions and related adverse events.

These reports include incidents of pump failure, over-delivery or under-delivery of insulin, and software issues that could potentially lead to serious health complications for users.

The FDA takes pediatric deaths seriously. – Dr. Judith Cope, The Agency’s Lead Author of The Analysis.

Insulin Pump Injuries & Complications

Insulin pumps can cause a range of serious injuries and complications when they malfunction or are used improperly, potentially leading to life-threatening situations for diabetes patients.

• Insulin Overdose: Pump malfunctions can deliver too much insulin, causing severe hypoglycemia (low blood sugar), which may lead to seizures, loss of consciousness, or death.
• Insulin Underdose: Device failures resulting in insufficient insulin delivery can cause dangerous hyperglycemia (high blood sugar), potentially leading to diabetic ketoacidosis (DKA).
• Infection at Insertion Sites: Catheter insertions can become infected, potentially leading to serious local or systemic infections requiring medical intervention.
• Device Component Failures: Battery problems, motor failures, or alarm malfunctions can lead to unexpected pump shutdowns without warning.

“Parents should be vigilant in watching their children’s use of the pumps. They didn’t advise against using insulin pumps but called for more study/research to address safety concerns in teens and even younger children who use the popular insulin pumps.- Researchers from the Food and Drug Administration.

Additional Type I Diabetes & Insulin Pump Information

Type 1 Diabetes affects an estimated 12-24 million people worldwide and occurs when the body attacks insulin-producing cells in the pancreas. Insulin regulates blood sugar levels, which when too high, can lead to heart disease, blindness and kidney damage.

Insulin pumps are used for Type I Diabetes, which accounts for approximately 5-10% of all Diabetes cases. Type I Diabetes is sometimes also referred to as “juvenile diabetes.”

According to the American Diabetes Association an insulin pump is a computerized device, about the size of a cell phone or pager (a fact that seems to be totally acceptable to teens.)

Kids most often wear their pumps hooked to their belts, or in their pants or shirt pocket.

The internal workings of a pump are both simple and amazing. There’s a reservoir that looks like a large version of a regular syringe.

The reservoir typically holds a two to three day supply of short-acting insulin. (Since pumps can immediately supply insulin to the wearer, medium- or long-lasting insulins are not used.)

Just like a regular syringe has a plunger that’s pushed to force the insulin out of the syringe, the reservoir has a plunger that’s pushed by a small pump, which is why we call this device an insulin pump.

Insulin pumps are popular because they allow young people to live more normal lives, giving themselves insulin discreetly in public and getting pizza with friends late at night. They’re a growing segment of diabetes care, with $1.3 billion in annual sales worldwide, said Kelly Close, a San Francisco-based editor of a patient newsletter. She said 100,000 teenagers may be using them.”- The Associated Press.

Do You Qualify for an Insulin Pump Lawsuit?

You may qualify for an insulin pump lawsuit if:

• You or a loved one used an insulin pump for Type 1 diabetes management
• The insulin pump malfunctioned or failed to operate as intended
• You experienced serious complications such as severe hypoglycemia, hyperglycemia, or diabetic ketoacidosis
• You required medical treatment, hospitalization, or suffered lasting injuries due to the pump malfunction
• The insulin pump in question was recalled or had known defects
• The incident occurred within the statute of limitations for your state

Evidence Required for an Insulin Pump Lawsuit

• Medical records documenting your diabetes diagnosis and insulin pump prescription
• Documentation of the specific insulin pump model and serial number
• Medical records showing injuries or complications related to the pump malfunction
• Evidence of hospitalization, additional treatment, or ongoing care resulting from the incident
• Any communication with the manufacturer regarding the device issues
• The malfunctioning device itself, if possible
• Photographs of any physical injuries or device damage

Damages You Can Recover

• Medical Expenses: Costs for emergency care, hospitalization, follow-up treatments, and ongoing care
• Lost Wages: Compensation for time missed from work due to injuries or medical treatment
• Pain and Suffering: Damages for physical pain and emotional distress
• Permanent Disability: Compensation for lasting health effects or disabilities
• Wrongful Death: Damages for families who lost loved ones due to insulin pump failures
• Punitive Damages: Additional compensation in cases where manufacturers showed gross negligence

Insulin Pump Recall Information

On November 21, 2008, the U.S. Food & Drug Administration (FDA) in association with Animas Corporation initiated a nationwide class 1 recall of certain battery caps used in the:

• OneTouch Ping System
• Animas 2020 Insulin Pump
• Animas IR1200 Insulin Pump
• Animas IR1250 Insulin Pump

To learn more, please visit Animas Insulin Pump Recall.

This Class 1 recall, the FDA’s most serious recall classification, indicated that there was a reasonable probability that the use of these defective battery caps could cause serious adverse health consequences or death.

The recall was initiated after reports that the affected battery caps could fail, potentially interrupting insulin delivery and leading to serious health complications for users.

In addition to the 2008 Animas recall, various insulin pump manufacturers have issued recalls for specific models or components over the years due to defects that could potentially impact insulin delivery or device function.

Patients using insulin pumps should regularly check the FDA’s medical device recall database or contact their device manufacturer to ensure their pump is not affected by any current recalls.

Statute of Limitations for Insulin Pump Lawsuits

The statute of limitations for filing an insulin pump lawsuit varies by state, typically ranging from 1 to 6 years from the date of injury or discovery of the injury.

The “discovery rule” may apply in many states, meaning the statute of limitations begins when you discovered or reasonably should have discovered that your injury was caused by the defective insulin pump.

States with shorter limitations periods include Tennessee (1 year), Kentucky (1 year), and Louisiana (1 year). States with longer limitations periods include Maine (6 years), North Dakota (6 years), and Minnesota (6 years).

For medical device cases, some states may also have a “statute of repose,” which sets an absolute deadline for filing a claim regardless of when the injury was discovered.

These statutes typically range from 5 to 10 years from the date the device was first sold or implanted.

Given these variations and complexities, consulting with an attorney promptly after experiencing issues with an insulin pump is crucial to preserve your legal rights and ensure your claim is filed within the applicable deadline.

FAQs

1. How long do I have to file an insulin pump lawsuit?

The time limit to file an insulin pump lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.

2. What evidence is needed to support an insulin pump lawsuit?

Evidence needed to support an insulin pump lawsuit includes medical records showing the use of the insulin pump and resulting complications, expert testimony linking the device to the injuries, and any documentation of additional treatments required.

3. How can I report a malfunction or injury caused by an insulin pump?

You can report a malfunction or injury caused by an insulin pump to the FDA through their MedWatch Online Voluntary Reporting Form. Providing detailed information helps track and address medical device safety issues.

4. Can I file a lawsuit if my insulin pump was recalled but I wasn’t injured?

Even without physical injury, you may have legal options if you required additional medical monitoring, experienced emotional distress, or incurred costs replacing the recalled device. Consult with an attorney to evaluate potential economic damage claims.

5. What types of insulin pumps have been involved in lawsuits?

Various insulin pump manufacturers have faced litigation, including Medtronic, Animas Corporation, Tandem Diabetes Care, and others. Lawsuits have involved issues such as software defects, mechanical failures, and inadequate safety warnings.

6. How much compensation could I receive from an insulin pump lawsuit?

Compensation varies widely based on injury severity, medical costs, economic losses, and other factors. Successful claims may range from thousands to millions of dollars, with cases involving permanent disability or death typically resulting in higher settlements.

7. Will filing a lawsuit affect my ability to get medical treatment?

Filing a lawsuit against an insulin pump manufacturer should not interfere with your ability to receive medical treatment. Healthcare providers are obligated to provide appropriate care regardless of pending litigation.

Get a Free Insulin Pump Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for injuries related to defective insulin pumps. Most states have a statute of limitations of only 2-3 years from the date of injury or discovery, with some states allowing as little as 1 year to file a claim.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or attorney fees
• Payment only if we secure compensation for you

If you or a loved one have been injured by a defective insulin pump, you should contact us immediately. You may be entitled to compensation by filing an insulin pump lawsuit and we can help.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73593
2. https://www.seattletimes.com/seattle-news/health/insulin-pumps-linked-to-teen-deaths/
3. https://www.hcplive.com/view/insulin_pump_safety#:~:text=A%20federal%20review%20of%20use,by%20teens%20using%20the%20pumps.
4. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tandem-diabetes-care-issues-voluntary-medical-device-correction-select-tslim-x2-insulin-pumps