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What They Knew

“There is absolutely an increased risk of amputation with canagliflozin,” according to that trial, Mahaffey said. Even so, he said, “We have to put the risk of amputations in perspective with the clear benefits we are seeing”.

While Janssen Pharmaceuticals tested their drug to measure glucose levels, they failed to fully monitor the painful effects that could put patients in harm’s way. This is important to know because canagliflozin is a newer drug that worked in a completely different way than previous diabetes medications (it blocks glucose absorption that takes place in the kidneys and releases the excess glucose through the urine).

When They Knew It

Invokana was approved by the FDA in March 2013. By June 2015, the European Medicines Agency (which is similar to our FDA) started to evaluate the risk of canagliflozin due to the high number of complaints they were receiving. This was almost a full two years before the FDA put out a safety communication warning patients and doctors of the increased potential for amputations.

Millions of patients took Invokana and Invokamet, and hundreds of thousands have experienced painful, life-altering injuries even after many complaints were filed. Brenda Lozano of Texas took Invokana for a little over two years and suffered severe kidney damage which later resulted in a stroke. Brenda has accumulated expensive medical bills and she now has to live with the lifelong physical complications of her injuries.

Polley Dailey of Kentucky took Invokana for just over a year and then had to endure the amputation of her right leg. Brenda, Polley and many others are taking Janssen Pharmaceuticals to court because: 1. the new medication was never fully tested resulting in patients being the guinea pigs and 2. patients and doctors weren’t warned of the true extent of the risks involved with these medications. Janssen Pharmaceuticals misrepresented their drug as a safe option when they fully knew the potential harm that patients might experience.

In fact, in December 2017, over 990 Invokana cases had been consolidated in multidistrict litigation (MDL) in New Jersey. While this number may seem low, who knows how many Polleys or Brendas are out there?

Can I Make a Claim?

Did you take Invokana or Invokamet and suffered from an amputation? You may be able to make a claim if you meet the following qualifications:

  • You started taking Invokana after March 2013 OR
  • You started taking Invokamet after August 2014
  • You or a loved one experienced an amputation (or multiple amputations) involving toes, a foot or a leg.

Maybe you (or someone you know) have endured this horrible situation and now you have overwhelming medical bills, costly medications and you’ve lost time at work. Janssen Pharmaceuticals should have tested their medications thoroughly before putting it on the market to ensure that it was safe for patients and they should have told doctors and patients of the increased risk for amputations. Contact us today to see if we’re able to help you get the compensation that you deserve.

Invokana/Invokamet Warnings In The News

BREAKING (6/18/2018): FDA Requests Invokana Label Review Extension Due to Increased Risk of Amputations

In order to change a drug label, market a new dosage or strength of a drug, or change the way a drug is made, a pharmaceutical company must first submit a supplemental new drug application (sNDA) to the FDA. Johnson & Johnson, the makers of the type 2 diabetes drug Invokana (canagliflozin), recently submitted an sNDA application so that it’s label could add that Invokana reduces the risks of cardiovascular events in type II diabetes patients who are potentially at risk for cardiovascular (CV) disease. Invokana – along with its fixed-dose combinations Invokamet and Invokamet XR – is a sodium-glucose co-transporter-2 (SGLT2) inhibitor that is used for treating type 2 diabetes.

Unfortunately, Invokana currently has a black box warning – the highest warning given by the FDA – for the increased risk of amputations. Do the benefits of reduced cardiovascular complications outweigh the high risk for amputations?

Read Full Article

3/1/2018: Lawsuit Blames Invokana For Toe Amputation

According to a February 14th filing in the U.S. District Court, District of New Jersey, Richard Greenhut was prescribed Invokana in 2016 and took it as directed. On January 12, 2017, he was hospitalized for a swollen, ulcerated and malodorous second right toe, osteomyelitis and renal failure, which he claims were the direct result of his Invokana use. At that time, Greenhut underwent surgical amputation of the affected toe.

The plaintiff was readmitted to the hospital on January 25th due to ongoing ulceration and osteomyelitis. That same day, Greenhut underwent a right second ray partial amputation, which involved the removal of the corresponding metacarpal bones in the foot. He is now permanently disfigured and injured.

Read Full Article

8/31/17: Doctors Debate Danger of Popular Diabetes Drug After FDA Amputation Warning

Many San Diego doctors are taking their patients off of Invokana, a widely used diabetes drug, after a large industry-sponsored trial found it doubled the risk of lower limb amputations compared with those taking a placebo.

Patients are being switched to other medications even though the study’s authors say the drug’s benefits — a reduced risk of cardiovascular events including death, non-fatal heart attacks and non-fatal strokes — outweigh its risk of amputations.

The drug is prescribed for people with Type 2 diabetes. The patients in the trial were already at high risk for heart disease and other diabetes complications including amputations.

Read Full Article

6/12/17: Johnson & Johnson Drug Prevents Heart Attacks At Cost Of Amputated Toes

Invokana, a diabetes drug made by Johnson & Johnson, decreases the risk of heart attacks and strokes, but also increases the risk of amputation, particularly of toes.

The study also deepens the mystery about such drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which prevent the kidney from absorbing sugar from the blood. This lowers blood sugar, is good for the kidney, but leads to more urinary tract infections and weakened bones. But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s entirely unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” says Harlan Krumholz, of Yale University.

Read Full Article

5/18/16: Interim clinical trial results find increased risk of amputations with [Invokana]; FDA to investigate

The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

Read Full Article

 

5/15/15: FDA warns that [Invokana] may result in a serious condition of too much acid in the blood

 

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

Read Full Article

 

Filed Invokana Complaints & Damages

7/6/17: Dailey V. Janssen Pharmaceuticals, Inc.
5/26/17: Lozano V. Janssen Pharmaceuticals, Inc Et Al

As a result of the defective nature of INVOKANA, persons who were prescribed and ingested INVOKANA, including Plaintiff, have suffered and may continue to suffer severe and permanent personal injuries, including a stroke. 4. After beginning treatment with INVOKANA, and as a direct and proximate result of Defendants’ actions and inaction, Plaintiff developed kidney failure. Plaintiff’s ingestion of the defective and unreasonably dangerous drug INVOKANA has caused and will continue to cause injury and damage to Plaintiff

Read Full Case

Invokana Settlement Information

GET YOUR FREE Invokana/Invokamet CASE REVIEW TODAY

Invokana/Invokamet settlements are now being negotiated, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

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The Step-By-Step Guide To Taking Action

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

Biased and Falsified Studies: The Truth Behind Medical Research

Doctors need at least eight years of higher education and another seven years training in a residency and fellowship before they can really practice on their own in their field. That’s just one reason why we, as patients, put our trust – and quite literally our lives – in their hands.

Biased and Falsified Studies: The Truth Behind Medical Research

Drugs, treatments, diagnoses, and everything else that goes into treating our symptoms are quite complicated so we rely on their expertise to make us well. Unfortunately, this is also a business and like all businesses, there’s the motivation to make money. The lack of accountability and financial perks have created a serious conflict of interest between research doctors, pharmaceutical companies, and the medical professionals who rely on these studies to address their patients.

Why You Should Care About Medical Study Research

Okay, I admit it: I never even thought about how drugs or medical devices were put on the market until recently. Like most people, I didn’t have the time to care and I also figured that’s what my doctor is for. But the deeper I dug, the more I learned that millions of people are getting injured – and are even dying – because drugs and medical devices aren’t being properly tested.

Here’s one example: transvaginal mesh (TVM) was never tested in a vagina before it was put into millions of women’s vaginas. Johnson & Johnson paid the inventor of TVM, Swedish obstetrician and gynecologist Ulf Ulmsten, $1 million to prove TVM’s safety and effectiveness. Who wouldn’t do everything they could to skew the results in their favor? Now hundreds of thousands of women are living with pain, have broken relationships, and suffer from other complications due to this bad medical device.

The Core Conflict

Doctors don’t have the time or funding to do the research themselves, so they rely on experts in their respective fields to test new drugs and medical devices and to report the benefits and risks so they can best treat their patients. Like the TVM example, many researchers are getting funding and kickbacks for publishing papers promoting a certain drug or medical device in medical journals or for speaking at conferences. The main problem is the lack of transparency on the part of many doctors who fail to disclose that they are funded by the pharmaceutical company.  The New York Times reported that, “Dr. Jeffrey R. Botkin, an associate vice president for research at the University of Utah, recently argued… that researchers should face misconduct charges when they do not disclose their relationships with interested companies. ‘They really are falsifying the information that others rely on to assess that research,’ he said. ‘Money is a very powerful influencer, and people’s opinions become subtly biased by that financial relationship.’”

We, as patients, need to demand more accountability and transparency in the medical world. Researchers need to disclose their relationship with pharmaceutical companies so our doctors can take the information with a grain of salt to fully understand the capabilities and risk factors for the treatments they are prescribing. The more products a company sells, the more money it makes. We should be treated with the drug or device that works best, not offers the biggest perk.


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Sources
“What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry”. New York Times. Accessed December 11, 2018. https://www.nytimes.com/2018/12/08/health/medical-journals-conflicts-of-interest.html

4 Tips for Camp Fire Survivors to Help Replace Destroyed Items

When everything is lost, where do you even begin to start to replace what mattered most? This is the big question that victims of the Camp Fire in Paradise and other California fire survivors are asking themselves. While family heirlooms, childhood crafts, and other priceless items can’t be replaced, other favorite pieces can be with a little time and effort.

4 Tips for Camp Fire Survivors to Help Replace Destroyed Items

Our Call Center Manager, Laura, lost her family home in Paradise and is now helping her parents to rebuild what was lost. She has been busy reaching out to over 80 companies asking for a bit of generosity to replace items such as her dad’s barbecue, safe, and other valuable pieces. Some businesses have been amazing and have given the items for free or asked for just the cost of shipping while others have declined to even honor their warranties. (And just so you know, this post has two motives: 1) to advise you on how to ask companies for help and 2) to inform you of businesses who are compassionate and generous so we can continue to support them!)

2. Ask for a replacement item or a discount

Some people may think that your insurance is going to cut you a fat check to purchase everything you need, but usually they will cover only 50 – 75% of the initial costs, so a discount or free item is going to be incredibly appreciated. It may be helpful to mention that you have insurance, but it only covers a fraction of your losses. Also, a discount is better than nothing. We want to support these businesses who are willing to do what they can, not cause financial stress. Requesting a discount can help you to get what you need while also providing a way for the company to help without causes financial strain.

3. Explain the importance of the item in your letter

For Laura’s family, Sunday night barbecues were the highlight of the week. Her dad, Chris, was proud of his skills and he even created a designated spot with pavers to house his grill. Laura reached out to Weber and explained “every Sunday night in our family means barbecue, beer and football… family dinners revolve around BBQ.” Guess what happened? They offered Chris a 22” model for free. Maybe the item isn’t the exact one that you requested, but this was so generous on the part of Weber and it was a huge step in getting life back to normal for Chris.

4. Give as much information about the original product as you can.

A company is more likely to replace the item if you have proof of ownership and that you were personally affected by the fire (and not a scammer). Here is a great sample that Laura wrote:

My dad owned two toolboxes from Snap On and he has always been a Mr. Fix It type of guy. I wanted to reach out, because we just lost our family home in Paradise, CA to the Camp Fire and now his toolboxes and tools are destroyed. The toolboxes themselves are brittle and can not be fixed and all the tools inside are melted together.

I wanted to see if there was any way I could get a discount to re order him at least one of the toolboxes. Unfortunately, their insurance is going to take months, maybe even years to pay out and I can’t afford to replace the toolboxes and tools myself at full price. If you could place just let me know I would really appreciate it.

I have attached photos of the toolboxes that I believe he had. I also attached before and after photos of our home in Paradise. You can see the toolboxes standing right in the middle of the ashes behind the garage door in the after photo.

Physically everyone made it out okay, but what remains of the place we all called home is devastating. I would really appreciate anything you can do to help out my family. Thank you so much in advance for your time.

 

Out of the 80+ companies that Laura has contacted, only four have responded. If you need a barbecue or custom made sign, please support Weber barbecues and Second to None Fabrication. These companies were awesome and we would love to see them rewarded for their generosity.

Those on Santa’s Naughty List? Snap-on Tools, KA_BAR knives, and Sentry Safe. On Sentry Safe’s website, they even state that, “Should your safe go through a fire, SentrySafe will send a replacement safe free of charge, so the things that matter most are protected for generations to come.” Not only would the above companies not replace the items, but they also refused to offer a discount.

It’s going to take time to contact businesses, but it may be worth the effort to start getting your life back together. We also hope that you’ll be pleasantly surprised at the compassion and kindness you’ll find.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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© All Rights Reserved • 2017 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

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