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davidslepkow · 3 years ago

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INVOKANA LAWSUIT – KETOACIDOSIS & AMPUTATION | SGLT-2 INHIBITORS

If you feel that you have suffered harm as a result of taking Invokana, there is legal relief that is possibly available to you by filing an Invokana lawsuit or an Invokana amputation lawsuit. Invokana is infamous for causing: Fournier’s gangrene, diabetic ketoacidosis and kidney failure. When it was first introduced in 2013, Invokana was hailed as a first-of-its-kind medicine that would revolutionize the treatment of type-2 diabetes. The medicine is intended to act upon sodium-glucose transport proteins in order to help with the elimination of blood glucose. However, it became apparent soon after introduction that Invokana can cause serious side effects in patients that are taking the drug that can be as severe as amputation. Invokana side effects are a serious matter which must be taken seriously by both victims and Invokana lawyers. There have been numerous FDA warnings associated with this drug and sales growth of the medicine has been slowing as a result. Because of the complications that patients have suffered, there have been numerous Invokana lawsuits filed against the manufacturer of Invokana. Many victims are searching for information about: invokana lawsuit settlement.

Invokana lawsuit

“Canagliflozin, the generic drug for Invokana, is a sodium-glucose cotransporter-2 (SGLT2) inhibitor used in patients with type 2 diabetes as an adjunct to diet and exercise to lower blood sugar. This medication lowers blood sugar by removing sugar from the body through the urine with help from the kidneys. ” Diabetes in control

Update-8/1/2020- “As of August 2020… The Food and Drug Administration decided to remove the black boxed warning for the risk of leg and foot amputations. This decision was made after reviewing data from three clinical trials. These clinical trials revealed that canagliflozin reduced the risk of heart attack, stroke, or death and the risk of end-stage kidney disease in patients with type 2 diabetes. The heart and kidney benefit of this medication contributed to different uses. Findings also showed that the risk of amputation is lower than previously described when appropriately monitored. While the risk for amputations remains, it has been removed as a Box Warning and listed under the Warnings and Precautions section. Under the Warnings and Precautions section, it states to monitor patients for infection or ulcers of the lower limb and discontinue in these scenarios. As stated, even though leg and foot amputations are no longer a boxed warning, it is still listed as a warning and precaution for this drug.” Id.

“Earlier this week, the US Food and Drug Administration (FDA) removed the boxed warning concerning the risk of leg and foot amputations for Janssen’s (a subsidiary of Johnson & Johnson) sodium-glucose co-transporter (SGLT) inhibitor, Invokana (canagliflozin), including its combination varieties, Invokamet (canagliflozin + metformin) and Invokamet XR (canagliflozin + metformin extended-release). This is in the reversal of the FDA decision made in 2017, which required a boxed warning label describing the risk of leg and foot amputations associated with Invokana treatment for type 2 diabetes (T2D). With the removal of the boxed warning, it is expected that Invokana will experience a moderate rebound from the trend of decreasing US sales that have been occurring since 2017, likely due to the boxed warning and increased competition from other SGLT inhibitors.” Pharmaceutical technology

4/10/19- “As of April 2019, there were 965 Invokana lawsuits and 37 Farxiga lawsuits pending in federal courts. More than a thousand people have filed lawsuits against Type 2 diabetes drugmakers Johnson & Johnson, Bristol-Myers Squibb and AstraZeneca over injuries ranging from a flesh-eating disease called Fournier’s gangrene to life-threatening blood infections.” Drug watch

THE INVOKANA MDL:

IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION : MDL NO. 2750

UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

MDL NO. 2750 Master Docket No. 3:16-MD-2750

JUDGE BRIAN R. MARTINOTT

JUDGE LOIS H. GOODMAN

Chief Judge: Honorable Freda L. Wolfson

View case management orders

WHAT IS INVOKANA?

Invokana is a relatively new drug that is aimed at acting as a SGLT-2 inhibitor. The drug is taken orally as opposed to being injected. The way that the drug works is by inhibiting a certain kind of sodium glucose co-transporter. This transporter actually works to facilitate absorption of glucose into the kidneys. By going after the transporter, this forces glucose to be eliminated in the urine as opposed to going into the bloodstream. The end result should be a reduction in blood sugar levels.

Invokana consists only of canagliflozin. Invokamet adds metoformin to make for a combined medication. Metformin is another medication that is used to treat diabetes. It is intended to help make it easier for insulin to cause a reaction in cells. By taking Invokamet, patients alleviate the need to have to take two different pills by combining them in one medication.

HOW LONG HAS INVOKANA BEEN ON THE MARKET?

“Medical LRARITAN, N.J., March 29, 2013 – Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKANA™ (canagliflozin) for the treatment of adults with type 2 diabetes. INVOKANA™ is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials literature.” J & J announcement

WHO MAKES INVOKANA?

Invokana is manufactured by Janssen Pharmaceuticals, Inc. Janssen is a subsidiary of the pharmaceutical giant Johnson & Johnson. Invokana was approved by the FDA to treat type-2 diabetes in 2013. Around the same time, an application for FDA by Bristol, Myers Squibb for a similar drug to treat diabetes was initially rejected before it was approved.

Invokana has seen brisk sales since it received its FDA approval. The product had gained wide acceptance in the marketplace as one of the first of its kind of medications. However, as news of hazardous side effects of Invokana have emerged, sales have slumped and competitors have gained ground. In fact, sales have been falling as bad news has come out about Invokana.

INVOKANA SIDE EFFECTS

As mentioned above, it has emerged that there are some severe Invokana side effects that have resulted from the use of Invokana. There are several major areas of damage that have been caused by Invokana. The drug is known to cause damage to kidneys. Several patients have allegedly died from kidney damage caused by Invokana. In addition, use of Invokana has been connected to ketoacidosis. This occurs when one’s body produces too many ketones. This is a harmful blood acid that occurs when the body cannot produce sufficient insulin. Ketoacidosis is treatable if it is caught in time, but it often requires hospitalization. Another complication of Invokana is that is has been alleged to cause heart disease in patients. Invokana side effects are serious matters that must be carefully researched by victim.

COMPLICATIONS THAT HAVE RESULTED FROM INVOKANA

The most major invokana side effects and complication that has resulted from Invokana is an increased risk of amputations in patients. Diabetics already face a heightened chance that they will require an amputation. Many of the amputations allegedly caused by Invokana have been to the foot. Some doctors have speculated that the effect of Invokana is that it causes blood to pool in the foot. Others have surmised that Invokana decreases the fluid that flows through the bloodstream, exacerbating the already poor circulation of those with diabetes.

FDA INVESTIGATION

As the side effects emerged, the FDA did further investigation. As a result of the FDA investigation, box label warnings were required that called attention to the increased risk of amputation. In addition, the FDA recently issued a new warning in the face of a spate of infections that have been caused by Invokana. Although Johnson & Johnson has hotly contested the finding that Invokana can lead to amputation, sales of Invokana have lost ground.

THE INVOKANA LAWSUITS

There have been a multitude of invokana side effects lawsuits that have been filed against Johnson & Johnson in the wake of the news about Invokana. By early 2018, there were approximately 1,100 lawsuits pending related to side effects of Invokana. The lawsuits have alleged that Invokana is a defective product due to the side effects that it causes. The defect has been alleged to be a manufacturing. Alternatively, plaintiffs have described the defect as a design defect. The complaints allege that Johnson & Johnson failed to perform adequate testing before marketing the product to the public. Additionally, the suits claim that there was a more economical alternative available that would not have had the defects.

POSSIBLE SIDE EFFECTS

The plaintiffs have alleged that Johnson & Johnson has known about the possible side effects and took action to conceal the information from the public. The manufacturer allegedly continued to market the product in spite of its knowledge that the drug is dangerous. Johnson & Johnson had a duty to warn patients of the dangers associated with Invokana and failed to do so.

Additionally, the lawsuits accuse Johnson & Johnson of breaching several warranties that should come when a consumer purchases its products. There is an express warranty that Invokana was safe and fit for use for its intended purpose to treat diabetes. Finally, the invokana lawsuits allege that the manufacturer of Invokana was negligent in its manufacture and design of Invokana.

INVOKANA LAWSUIT SETTLEMENT

In response to the lawsuits, Johnson & Johnson set aside an accrual as an accounting method. An accrual is a form of liability. Here, it is apparently acknowledging that Johnson & Johnson will face some sort of liability from Invokana.

Predictably, Johnson & Johnson decided to settle many of the lawsuits stemming from the Invokana side effects. There were over 1,000 cases that were pending in New Jersey as part of a multi-district litigation. These cases were are settled. The settlement amount is still confidential as of this writing. There will be a settlement fund that will be established to administer the payments to the plaintiffs. There are multiple other cases that are pending in other courts across the country. It is likely that there will eventually be settlement agreements in those cases as well.

INVOKANA LAWSUIT

If you have taken Invokana and have suffered some of these invokana side effects, you should immediately contact an invokana lawsuit lawyer to discuss your legal rights. You may be entitled to compensation for the invokana side effects and injuries that you have suffered.

Invokana has been marketed as an effective treatment for Type-2 diabetes. However, Invokana has been beset by safety issues and FDA warnings over the past several years, dating back to very shortly after it was approved. As a result of the myriad of complications that have been caused by the drug, the manufacturer now faces a large amount of product liability lawsuits that is growing by the day.

The developer of Invokana was Mitsubishi Tanabe Pharma. Through a licensing agreement, Janssen Pharmaceuticals is the marketer of Invokana. Janssen is a subsidiary of Johnson and Johnson. Invokana was given FDA approval to be used as a treatment for diabetes in 2013. Invokana is intended to act as a SGLT2 inhibitor which blocks certain proteins from being absorbed. Instead of being absorbed, when the medications works as intended, these proteins are eliminated through the urine.

WHY DOES INVOKANA CAUSE AMPUTATIONS?

“Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.” FDA

INVOKANA WARNING

“Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.” Id.

2017 WARNING

“We required the Boxed Warning in 2017 based on our assessment that the risk of amputations was very serious in relation to the potential benefit of canagliflozin, which was initially approved to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Subsequent FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses. Specifically, in 2018, canagliflozin was approved to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease; and, in 2019, it was approved to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease.” FDA

INVOKANA FDA WARNING

“Certain medications, such as Invokana, can also increase the risk of amputation. Invokana, the trade name for the drug canagliflozin, is prescribed to patients for the treatment of type 2 diabetes. The drug is licensed from Mitsubishi Tanabe Pharma Corporation to Johnson & Johnson’s Janssen Pharmaceuticals division for distribution throughout most of the world. ” https://medtruth.com/invokana-cause-amputations/ “According to Janssen Pharmaceuticals, Invokana lowers blood sugar (A1C) and the 300-mg dose is proven to reduce A1C levels more effectively than a competing drug from Merck called Januvia.” Id.

WHAT IS THE REASON FOR THE FDA INVOKANA AMPUTATION WARNING?

“Known Invokana side effects include ketoacidosis, kidney problems, urinary tract infections and a higher risk of broken bones. Amputation risk, however, is a new concern for users of the popular diabetes medication. In 2017, the U.S. Food and Drug Administration began requiring new ‘black box’ warnings to be added to Invokana labels to describe the increased risk of leg and foot amputations to patients.” Id. “The FDA acted following two large clinical trials, CANVAS and CANVAS-R, in which the data demonstrated that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with a placebo.” Id.

SGLT2 INHIBITOR

Invokana had previously been the market leading drug in the SGLT2 inhibitor space. However, negative reports and lawsuits surrounding Invokana as well as competition from a new drug have reduced Invokana’s sales. In 2017, sales dropped by 20 percent to $1.1 billion. Sales have further fallen in the first quarter of this year. Johnson and Johnson has been seeking to expand the label for Invokana, but has faced delays from the FDA as there have been strong concerns about the safety of the drug.

INVOKANA AMPUTATION

Invokana has had a long history of regulatory problems as safety issues regarding the drug have mounted in recent years. Invokana has gone from being perceived as a significant advance in the treatment of diabetes to a drug that has been linked with some severe side effects. This has placed the drug under a cloud that Johnson and Johnson has found it difficult to escape.

KETOACIDOSIS

The first issue with Invokana emerged in 2015 when it was reported that there were links between Invokana and ketoacidosis. Following that, the FDA issued a communication discussing possible links between Invokana and lower bone density and fractures. Shortly after that, the FDA required warnings that would detail connections between Invokana and bladder infections. Finally, in 2017, the FDA required a label warning that would discuss heightened risks of amputation that are faced by users of Invokana. The amputation risk has been a large driver of the drop in sales of Invokana. Although Johnson and Johnson has attempted to counter this with scientific data of its own, the label warning remains in place.

Ivokana has been the subject of a variety of lawsuits in the past several years. The major areas of causes of action have been those associated with ketoacidosis and amputations. In February 2018, Johnson and Johnson disclosed in a Securities and Exchange Commission filing that it was currently named as a defendant in approximately 1,100 lawsuits pertaining to Invokana. According to Johnson and Johnson, the number of lawsuits related to this drug continues to increase, and the company expects more lawsuits to be filed in the future. Johnson and Johnson has established an accrual for these lawsuits. Currently, the main litigation regarding Invokana is a multi-district suit that has been brought in the United States District Court for the District of New Jersey. This is where Johnson and Johnson is headquartered. There are cases pending in several other state courts as well as Canada.

JOHNSON AND JOHNSON FAILED TO ADEQUATELY WARN

The claims against Johnson and Johnson are rooted in product liability. The lawsuit alleges that Johnson and Johnson failed to adequately warn the public of the dangers associated with Invokana. Johnson and Johnson is alleged to have also marketed Invokana for off-label purposes such as weight loss, reduced blood pressure and Type-1 diabetes. According to the complaint, not only did Johnson and Johnson fail to warn of the dangers, but it willfully misrepresented these risks to consumers.

JOHNSON AND JOHNSON KNEW OR SHOULD HAVE KNOWN OF THESE RISKS

According to the complaint, Johnson and Johnson knew or should have known of these risks based on data that they possessed. Even if Johnson and Johnson did not have this data, they had the ability to obtain this data through proper testing of the drug or through other efforts to learn about the side effects. The complaint alleges that, even after Johnson and Johnson learned of the increased risks of the drug, it continue to defend the drug to the public and to doctors. According to the plaintiffs, the failure to warn of the dangers makes Johnson and Johnson strictly liable.

DEFECTIVE DESIGN

In addition, the lawsuits allege that Invokana was defectively designed. The fact that Invokana caused these side effects made it defective at the time of its design and manufacture. According to the complaint, the design defect outweighed any benefits that could be obtained from the medication. In addition, the plaintiffs have alleged that the defendants were negligent in the design on the medication. Finally, plaintiffs have stated that Johnson and Johnson breached express and implied warranties associated with the drug.

DID DEFENDANTS FRAUDULENTLY MISREPRESENTED THE SAFETY OF INVOKANA?

The most serious accusation contained in these lawsuits is that the defendants fraudulently misrepresented the safety of Invokana. Johnson and Johnson is alleged to have intentionally omitted these side effects when it had a section in the drug user guide that specifically asked about possible side effects. Johnson and Johnson should have warned consumers that Invokana was more dangerous than other diabetes drugs due to the potential side effects about which it knew or should have known.

CONSOLIDATED INTO A MULTI-DISTRICT LAWSUIT

Currently, these cases are pending in front of the courts. In order to reduce duplicative discovery requests, these cases have been consolidated into a multi-district lawsuit. This is not the same as a class action suit since the plaintiffs can still receive individualized compensation if they prevail. There have been no settlements reached and no decisions issued in the case. Currently, Johnson and Johnson is still contesting liability in this case.

If you have been taking Invokana and believe that you have suffered harm, you should immediately consult with an Invokana lawsuit attorney regarding your legal options. The attorney can inform youwhether you are entitled to a invokana lawsuit settlement. Due to the statute of limitations, potential plaintiffs have a limited amount of time in which they can file an invokana amputation lawsuit and still obtain relief. An invokana lawsuit is a very serious matter and you need representation from the best invokana lawsuits law firm.

DOES INVOKANA CAUSE HAIR LOSS?

Hair loss is not a side effect of invokana. “Hair loss wasn’t a side effect of Invokana in any clinical trials. If you’re concerned about hair loss, talk with your doctor. They can help you determine what’s causing it and ways to treat it.” Medical news today

HAS THERE BEEN AN INVOKANA RECALL?

There has been no Invokana recall as a result of Invokana amputations.

Sources:

FDA

Type two diabetes

law.com

#invokanalawsuit

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