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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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Free Guide Download

The Step-By-Step Guide To Taking Action

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

LATEST ARTICLES

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

There are many controversial issues that political candidates build their platforms on, and public health and the environment are certainly hot topics. Congresswoman Tulsi Gabbard (D-Hawaii) is the first federal legislator and presidential candidate to call for a ban on Roundup weedkiller and we’re thrilled that she’s bringing this important topic to the forefront of political debate.

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

Financial Contributions and Political Support

It’s no secret that mega corporations give financial contributions to political candidates and officials, not to mention lobbyists. In fact, Monsanto’s website even admits:

“Monsanto is committed to participating constructively and transparently in the political process, as such participation is essential to the Company’s long-term success. Our approach on corporate political contributions is driven by the significant impact that public policy decisions can have on our business and on the interests of our stakeholders.”

Fortunately, these political contributions are open to the public to view, so here are some numbers to think about:

Paid to the House of Representatives in 2013

Total paid by Monsanto to Democrats: $72,000
Total paid by Monsanto to Republicans: $190,500

Paid to Senate in 2013

Total paid by Monsanto to Democrats: $37,500
Total  paid by Monsanto to Republicans: $85,000

Contributions to Federal Candidates, 2018 cycle

Total Contributions from this PAC to federal candidates: $315,000 (33% to Democrats, 67% to Republicans)

House: Total to Democrats: $92,500; Total to Republicans: $193,500
Senate: Total to Democrats: $23,500; Total to Republicans: $41,500

When you consider the bills and political decisions that involve adding a warning label to the products, banning glyphosate, use on city property, and more, Monsanto’s contributions are having an impact on government regulations and thereby public health and safety.  

This is precisely why it’s so refreshing to hear that Congresswoman Tulsi Gabbard is standing up against Bayer (who acquired Monsanto in 2018) by stating on Twitter, “I’ve said it before, I’ll keep saying it: Ban roundup! It’s long past time we stopped relying on corrupt corporations with a profit incentive to fund science telling us their chemicals are ‘safe.’ Victims shouldn’t have to go to trial to get the truth.”

Between the two recent California trials that found in favor of the plaintiffs who were diagnosed with cancer due to use of Roundup, new studies that found that Roundup causes a 40% increased risk of cancer, and LA County’s recent ban of Roundup on county property, hopefully more politicians will listen to researchers and their constituents and ban Roundup.

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Sources
“Presidential Candidate Says ‘Ban Roundup!’” Organic Consumers Association. Accessed April 4, 2019. https://www.organicconsumers.org/blog/presidential-candidate-says-ban-roundup#close
“Extensive List of Politicians Paid Off By Monsanto”. Natural Society. Accessed April 4, 2019. http://naturalsociety.com/list-politicians-paid-off-by-monsanto/
“Political Disclosures”. Monsanto. Accessed April 4, 2019. https://monsanto.com/company/governance/political-disclosures/
“Monsanto Co.” Open Secrets. Accessed April 5, 2019. https://www.opensecrets.org/pacs/pacgot.php?cmte=C00042069

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

As someone who’s had medical issues ranging from chronic pain to infertility, I’m no stranger to being poked, prodded, given a plethora of prescriptions, and feeling more like an alien abduction than a patient being presented solutions to feel better. Sound familiar?

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

And why do we subjugate ourselves to being guinea pigs to test which therapies, pills, and mechanical parts will torment our bodies? It’s simple. We’re desperate for help and we trust the men and women in scrubs and suits to honestly want to help us. The FDA’s fast tracked 510(k) process,  doctors receiving “gifts” from pharmaceutical companies for prescribing their products, and sky high drug prices are just a few examples of the many parts of the system that are broken at the expense of patient health. Here’s another important flaw with the FDA and Big Pharma: their lack of post-market medical device follow-up.

But why should you take the time to learn about this? Consider these statistics:

  • In 2018, medtech (medical technology) stocks climbed 26%.
  • About 1.4 million hip and knee replacement surgeries were performed in 2017 alone and the number continues to increase each year.
  • The U.S. medical device market was $147.7 billion in 2016 and is projected to grow to $173 billion in 2019.

If you don’t already have a medical device, chances are high that you’ll either have one or you know someone who has one. Plus, this is big money for pharmaceutical companies so a variety of products are probably going to be advertised or recommended to you. Don’t you want to make sure that something this important is proven to help and not harm you?

The FDA’s 510(k) Approval and Post-Market Follow-up Process

The FDA established the 510(k) process to promote medical innovation and approve needed products to market quickly. However, this once “noble” function has now turned into a manipulation of Big Pharma to speed devices to market to for profit and to bypass expensive testing. The 510(k) process allows the FDA to fast-track paperwork through the system as pharmaceutical companies base their devices on previously approved ones… all without human clinical trials.

There are many problems to this practice. First of all, the products that they’re comparing the new one to may have been ineffective or harmful and taken off the market (such as the case involving Protegen transvaginal mesh). Secondly, this is how 70 percent of medical devices are being approved; again, WITHOUT human clinical trials. Is it any wonder why there are so many health complications and recalls concerning medical devices?!? Finally, the FDA is understaffed and underfunded which makes approving, monitoring, and following up on drugs and medical devices a nightmare.

Post market follow-up is critical to patient safety, as the FDA explains that the requirements, “include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”

Let’s take a closer look at a recent example that hit the news in March 2019. Mentor Worldwide MemoryShape breast implants were approved in 2013. It came to the FDA’s attention that the company failed to enrol the required number of subjects in the post market study, had poor follow-up rates with patients (only 61 percent), and significant data wasn’t consistent.

These studies are particularly important because in 2016 it was determined that breast implants can cause breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, which is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Post-market surveillance could not only ensure the safety of those in the study, but it can provide valuable information to prevent future patients from suffering from this disease.

Post-market surveillance is a critical part of the FDA’s job and public health depends on it. To quickly approve high risk medical devices and neglect monitoring how they work is not only negligent, but it deliberately disregards the health of the millions of patients that the FDA and pharmaceutical companies claim to be helping. It’s time to put patient health first.

 

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Sources
“FDA warns J&J unit and Sientra over breast implant compliance”. Medical Device Network. Accessed March 25, 2019. https://www.medicaldevice-network.com/news/fda-warns-jj-sientra-breast-implants/
“Robots, DNA And Implantable Devices — Why 2019 Isn’t Your Dad’s Medtech”. Investor’s Business Daily. Accessed March 25, 2019. https://www.investors.com/news/technology/medical-equipment-medtech-2019-preview/
“Defenders: How medical devices are approved by the FDA and why some say it no longer works” KVUE. Accessed March 25, 2019. https://www.kvue.com/article/news/defenders-how-medical-devices-are-approved-by-the-fda-and-why-some-say-it-no-longer-works/269-2a9bfbe6-dd7d-4b2b-a0c1-6bebe24998cb
“Postmarket Requirements (Devices)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm
“Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Why Are There So Many Drug and Medical Device Recalls?

As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Why Are There So Many Drug and Medical Device Recalls?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

  • Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
  • Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
  • Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
  • Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

  • Failure to meet product specifications: 25%
  • Deviations from current Good Manufacturing Practice (cGMP): 23.9%
  • Sterility: 12%
  • Mislabeling: 10.9%
  • Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

  • Software issue: 79
  • Mislabeling issue: 43
  • Quality issue: 36
  • Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

Other Important Facts to Know

  • Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
  • You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

 

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Sources
“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3
“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1

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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