Mass Tort

Invokamet® / Invokana® Diabetes Medication

Type 2 Diabetes Medications – Defective Drug Attorney – Burg SimpsonInvokana ® (canagliflozin) is a prescription diabetes medication that is used in combination with diet and exercise to lower blood sugar levels and lower blood glucose levels in adults with type 2 diabetes.

The most serious Invokamet ® and Invokana ® side effects are kidney damage, ketoacidosis, myocardial infarction, and lower limb amputation::

  • Kidney Failure (also known as renal failure diagnosis) occurs when the kidneys stop functioning correctly and do not properly filter waste products from the blood. Kidney failure is a serious medical conditions that requires treatment. These kidney problems can cause fatigue, confusion, weakness, muscle damage, and death.
  • Diabetic Ketoacidosis occurs when the body cannot use glucose for energy and instead breaks down fat and proteins. As a result, dangerous levels of acid, known as ketones, build up in the body causing symptoms such as nausea, vomiting, abdominal pain, and shortness of breath.  This is a serious, life-changing medical condition that requires intensive treatment and can result in organ failure, coma, or even death.
  • Myocardial Infarction (also known as a heart attack) occurs when blood flow is restricted to your heart, depriving it of oxygenated blood, causing heart failure. When the heart has a lack of oxygen supply for too long, the tissues begin to die. A heart attack is a serious medical condition that can cause death and requires immediate medical attention.
  • Lower Limb Amputations, or the surgical removal of a leg (either below or above the knee), foot, or toe(s) from the body.

The claim in the Invokana® cases is that if the manufacturer had warned of the possible risks involved with taking this medicine, patients could have possibly avoided these serious complications. Patients taking Invokana® would have also been warned from the beginning to keep a close eye on potential health issues. Burg Simpson is an award-winning law firm that has your best interests at heart. Contact one of our product liability lawyers today by filling out the Free Case Evaluation form if you have been harmed by this drug.

Additional Information

In clinical trials, patients on Invokana ® were more likely to develop diabetic ketoacidosis than patients on other SGLT2 inhibitors. Ketoacidosis normally involves very high level of sugar in the blood. Many Invokana ® users with normal or mildly-elevated blood-sugar have developed ketoacidosis. Because of ketoacidosis’ unusual symptoms, diagnosis can be delayed, resulting in a delay in treatment until it becomes life-threatening.

On May 15, 2015, the FDA issued a Safety Announcement that linked Invokana ® and other sodium-glucose cotransporter-2 (SGLT2) inhibitors to ketoacidosis. Additionally, on December 4, 2015, the FDA required Janssen to update Invokana®’s label to include ketoacidosis. The FDA received more than 70 reports of patients who were hospitalized with ketoacidosis between March 2013 and May 2015. It is not known how many cases were not reported to the FDA.

On February 25, 2016, the European Medicines Agency recommended a warning to doctors and patients in order to minimize the risk of diabetic ketoacidosis symptoms in patients taking SGLT2 inhibitors. If you have been affected by the serious effects of Invokana ®, call a Burg Simpson Dangerous Drug Attorney now to discuss the details of your case by filling out the Free Case Evaluation form.

Diabetic ketoacidosis is a medical condition that occurs when toxic wastes known as ketones build up in the bloodstream. The condition usually occurs when the body does not have enough insulin to use glucose (sugar) as a source of energy. Instead of using glucose as an energy source, the body starts burning fat cells, which releases ketones into the bloodstream. High levels of ketones in the body can result in the person going into a diabetic coma (passing out for a long time) or even death.

Symptoms of Diabetic Ketoacidosis can include:

  • Nausea and vomiting
  • Stomach pain
  • Tiredness, fatigue or decreased alertness
  • Deep, rapid breathing
  • Dry skin and mouth
  • Flushed face
  • Frequent urination or thirst that lasts a day or more
  • Fruity-smelling breath
  • Headache
  • Muscle stiffness or aches

Call Burg Simpsons attorney office for experienced legal assistance with your case today!

On June 14, 2016, the FDA issued a Drug Safety Communication about the association between Invokana ® and acute kidney problems. The Safety Communication reported that “From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.

In approximately half of the cases, the events of acute kidney failure occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys. The FDA required Janssen to change Invokana®’s label to warn about the risk of acute kidney injury.

Independent medical researchers have also identified Invokana®’s association with kidney problems. According to QuarterWatch, a nonprofit group monitoring serious adverse event reports, Invokana®’s first year of sales was accompanied by numerous “serious injuries involving kidney function.”

In clinical trials, 13 patients on Invokana ® suffered an adverse cardiovascular event such as a heart attack or stroke during the first 30 days of treatment, compared to just one patient on a placebo. Data from the CANVAS trial (Canagliflozin Cardiovascular Assessment Study) linked Invokana ® to a 46% increased risk of cardiovascular events in the first 30 days of use. However, the product information related to Invokana ® does not adequately warn of this increase in risk.

On May 16, 2017, the FDA issued a Safety Announcement advising that data from two recently finished, large-scale clinical trials concluded that the type 2 diabetes medication canagliflozin (Invokana®, Invokamet®, and Invokamet® XR) “causes an increased risk of leg and foot amputations.” Upon learning this information, the FDA required Janssen to update Invokana®’s label to include a black-box warning concerning the almost two-times greater risk of lower limb amputations.  This risk may be even higher for certain individuals.

According to the FDA announcement, the CANVAS trial showed that over the course of one year, the risk of lower limb amputations in patients treated with Invokana® for type 2 diabetes was 5.9 out of every 1000, as compared to 2.8 out of every 1,000 for patients given a placebo (an inactive treatment or medication).

The FDA announcement also reported that the CANVAS-R trial revealed that the risk of lower limb amputation was equivalent to 7.5 out of every 1,000 in patients treated with Invokana®, with the risk only impacting 4.2 out of every 1,000 for patients treated with a placebo.

While amputations of the toe and middle of the foot were the most common among the study subjects, amputations of the leg both below and above the knee were also reported. Moreover, some of the study subjects required multiple lower limb amputations, sometimes involving both the right and left lower limbs.

Previously, on May 18, 2016, the FDA first released a Safety Announcement concerning interim clinical trial results that showed a possible increased risk of leg and foot amputation in patients taking Invokana® for type 2 diabetes.  At the time of the announcement, however, the two clinical trials evaluating the safety of the medication were ongoing. Final data regarding these risks has now been made available upon the conclusion of these trials.

You may be entitled to compensation if you or your loved one used Invokana ® or Invokamet ® as medical treatment for diabetes and developed kidney damage, ketoacidosis, or a myocardial infarction. Call us today to speak with a knowledgeable Burg Simpson Mass Tort Lawyer about the potential for your case.

No. We offer our clients a free, no-obligation case assessment by filling out the Free Case Evaluation form found on this page. We pay for the cost of obtaining your medical records, any expert reviews, and court filing fees. We only receive reimbursement and a fee for our work if the defendant manufacturer pays your claim. If you do not receive a recovery, then you owe Burg Simpson nothing.

Act now and don’t wait! Many have already filed a claim for Invokana ® lawsuits. Indecision could mean losing the opportunity to receive just compensation. The time you have to file a claim depends on a variety of different factors, including the state in which you live. Please call us now to discuss what those factors are.

This latest diabetes treatment was developed by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and approved by the FDA in March 2013. It was the first drug in a new class known as sodium-glucose cotransporter-2 (“SGLT2”) inhibitors.  Invokana ® helps improve glycemic control by causing the kidneys to remove sugar through the urine.  In August 2014, Janssen received FDA approval to begin to market Invokamet ® in the United States. Invokamet ® a fixed-dose therapy combining Invokana ® and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes.

If you or a loved one has suffered the serious illnesses that Invokana® can cause, fill out the Free Case Evaluation form as soon as you can to discuss your case with a Burg Simpson Drug Attorney

Invokana ® Case Timeline To Date:

  • March 2013: Invokana® approved by the FDA.
  • August 2014: Invokamet® approved by the FDA.
  • May 15, 2015: FDA issued a safety announcement linking Invokana® to ketoacidosis.
  • December 4, 2015: FDA required Janssen to update Invokana®’s label to warn doctors and patients of the risk of ketoacidosis.
  • February 25, 2016: European Medicines Agency also recommended a warning to doctors and patients in order to minimize the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors.
  • May 18, 2016: FDA issued a safety announcement concerning interim clinical study results showing possible risk of leg and foot amputation for patients taking Invokana®
  • June 14, 2016: FDA issued a Drug Safety Communication about the association between Invokana ® and acute kidney injury.
  • December 7, 2016: Judicial Panel on Multidistrict Litigation transfers all Invokana® and Invokamet® cases filed in federal courts around the United States to the Honorable Brian R. Martinotti, District Judge for the U.S. District Court of New Jersey.
  • May 16, 2017: FDA issued safety announcement linking Invokana® to an increased risk of toe, foot and leg amputations. As a result, the FDA required Janssen to update Invokana®’s label to warn doctors and patients of this increased risk.
Gov. Hickenlooper Signs Workers Comp PTSD Bill Into Law

 June 8, 2017

Gov. Hickenlooper Signs Workers Comp PTSD Bill Into Law

The third time’s the charm for PTSD relief for Colorado’s first responders. After a pair of failed attempts over the past few years, the legislature finally sent a bill to the governor this year that would allow first responders to apply for mental impairment claim under Colorado workers’ compensation law after a “psychologically traumatic event.”… Read more »

Michael Burg Blasts Big Pharma

 June 6, 2017

Michael Burg Blasts Big Pharma

The political environment in DC couldn’t be better for Big Pharma. And it’s about to get worse, which is what worries Burg Simpson co-founder Michael S. Burg. “Dr. Scott Gottlieb, the newly appointed commissioner of the Food and Drug Administration, is so financially tied to Big Pharma that he could not possibly be a reliable… Read more »

Burg Simpson Eldredge Hersh & Jardine Selected to the Legal 500 List For 2017

 May 31, 2017

Burg Simpson Eldredge Hersh & Jardine Selected to the Legal 500 List For 2017

This Year Marks the Sixth Time the Denver-Based Law Firm Has Been Named to the Prestigious List May 29, 2017 (Denver, CO) – Burg Simpson Eldredge Hersh & Jardine, one of America’s foremost plaintiff trial firms, is proud to announce it has been selected to The Legal 500 for 2017 and founding shareholder Michael S…. Read more »

Nick D. Fogel Earns Workers’ Comp Honor

 May 24, 2017

Nick D. Fogel Earns Workers’ Comp Honor

The awards just keep coming in for the attorneys at Burg Simpson. The Professionals in Workers’ Compensation (PWC) named shareholder Nick D. Fogel the 2016 Outstanding Claimant Attorney of the Year. Nick is Burg Simpson’s workers’ compensation department head and has extensive experience working with clients who’ve been injured at work. “I was humbled and… Read more »

Device Recall - Dangerous Medical Devices Attorney – Burg Simpson

 April 24, 2017

What is a Medical Device Recall?

When a person undergoes a medical procedure involving the use of a medical device, that person trusts it’s safe and effective. Unfortunately, this isn’t always the case. When it becomes clear that a medical device is causing unexpected harm to consumers, a medical device manufacturer must take measures to address such serious problems. One such… Read more »

Reverse Shoulder- denver Mass tort lawyers - Burg Simpson

 February 17, 2017

Recall Alert: Comprehensive Reverse Shoulder Recalled by Zimmer Biomet

Zimmer Biomet has issued a Class I Recall of its Comprehensive Reverse Shoulder due to higher than reported fracture rates.  Zimmer Biomet issued the recall on December 15, 2016.  The Zimmer recall includes thousands of Comprehensive Reverse Shoulders.  The recalled devices were distributed between October 2008 and September 2015.  As part of the shoulder recall,… Read more »

Mike Burg Holds First Book Signing for Trial by Fire at Tattered Cover

 August 18, 2016

Mike Burg Holds First Book Signing for Trial by Fire at Tattered Cover

Last month at the Tattered Cover Book Store in Denver, Colorado, a crowd of over 100 were treated to an evening with Burg Simpson attorney and author, Mike Burg. Speaking about his new book, Trial By Fire: One Man’s Battle to End Corporate Greed and Save Lives, Mike discussed his childhood and his motivations that… Read more »

Talcum Powder and Ovarian Cancer?

 August 12, 2016

Talcum Powder and Ovarian Cancer?

Many cases of ovarian cancer diagnosed each year may have been caused by the regular use of talcum powder. Talc is a mineral made up of silicon, magnesium and oxygen. Because of its unique ability to absorb moisture, talc is common ingredient in Johnson & Johnson Baby Powder, Shower to Shower, and other household products… Read more »

Ring of Fire: Even Republicans Are Disgusted by The Republican Party

 May 3, 2016

Ring of Fire: Even Republicans Are Disgusted by The Republican Party

A Ring of Fire first! Host Farron Cousins talks to former Senator Alan Simpson in a unique opportunity on Ring of Fire to speak with a Republican about the current state of the Republican Party.

CBS 4: Michael Burg Inducted to Trial Lawyer Hall of Fame

 April 28, 2016

CBS 4: Michael Burg Inducted to Trial Lawyer Hall of Fame

CBS 4 in Denver highlights Burg Simpson attorney Michael S. Burg’s induction into the Trial Lawyer Hall of Fame

Radio 850KOA: Michael Burg Inducted to Trial Lawyer Hall of Fame

 April 28, 2016

Radio 850KOA: Michael Burg Inducted to Trial Lawyer Hall of Fame

Denver’s Radio 850KOA ran a news story about Michael Burg’s induction into the Trial Lawyer Hall of Fame.

Burg Simpson Legal Minute: Civil Justice System

 April 21, 2016

Burg Simpson Legal Minute: Civil Justice System

Burg Simpson shareholder Calvin Tregre Jr. examines changes to the civil justice system, where limitations have been placed on monetary awards to seriously injured victims of corporate negligence. Are you protected?

Trial Talk magazine

 November 18, 2015

Trial Talk: Cross Appeal? Now What?

Burg Simpson Attorney and Shareholder Diane Vaksdal Smith’s article, published in CTLA’s Trial Talk, April/May 2015, addresses specifics of appellate practice and procedure. Download full article PDF

Net Neutrality

 November 18, 2015

Net Neutrality: A Panel Discussion

Rick D. Bailey contributes his opinion on Net Neutrality in this panel article published in Best Lawyers® Business Edition, Summer, 2015. Download full article PDF

The Trial Lawyer Magazine

 November 18, 2015

Homebuilders v. Homeowners

Threats to Shift an Already Tilted Playing Field More in Favor of Homebuilders Burg Simpson attorneys Jennifer A. Seidman and Ronald M. Sandgrund examine what could happen if lawmakers allow builders to take advantage of and mischaracterize the causes of the Great Recession’s lingering effects, and the facts regarding the real causes of the decline… Read more »

Rick Bailey - Hearing and Mishearing

 November 18, 2015

Hearing and Mishearing: Psychoanalytic Observations on the Attorney-Client Relationship

Trial lawyer Rick D. Bailey co-authored this white paper with David Stevens, a practicing psychoanalyst/clinical psychologist and associate professor at the university of Colorado Health Sciences Center. They address the attorney-client relationship throught the lens of psychoanalysis and cognitive neuroscience. Download full article PDF

Top 100 National Trial Lawyers Legal 500 Best Lawyers in America Super Lawyers US News 2014 US News 2014 Plantiffs Top 25 Most Influential Lawyers