Crystal Mesh: The inside story of how women’s health was traded for quick cash Get The Book

(800) 511-3838 |

Proton Pump Inhibitors (PPI) Tied To Kidney Disease/Failure

Proton Pump Inhibitors (PPI) and Kidney Disease – What They Knew, When They Knew It

Heartburn (also called “acid reflux” or “gastroesophageal reflux disease/GERD”) is a common problem that plagues millions of people; so much so that in 2013, over 15 million Americans were believed to have been prescribed Proton Pump Inhibitors (PPIs) to treat this condition… and that number doesn’t even reflect the people using the over-the-counter versions. PPIs can include both the prescription and over-the-counter brands such as Nexium, Prilosec, Prevacid, and Protonix, but just because they’re easily accessible doesn’t mean that they’re safe. Millions of patients are now reporting that they are suffering from kidney disease or kidney failure after taking this popular medication.

What They Knew

Dr. Adriane Fugh-Berman, professor at Georgetown University Medical Center and the director of the university’s PharmedOut project, reports that 30 to 70 percent of PPI users don’t need to use these drugs. GERD can be simply treated through diet and lifestyle changes, and yet expensive marketing tactics and the over-prescribing of these medications are causing millions of patients to be at risk. In fact, in 2015 and 2016, more than $250 million was spent on advertising for over-the-counter and prescription PPIs. However, with so many patients taking this medication, doctors started to notice the connection between chronic kidney disease and patients who were taking PPIs.

When They Knew It

Many studies have proven the connection between PPIs and the increased risk of bone fractures and kidney injuries, and yet the pharmaceutical companies failed to warn patients of the increased potential for long term harm.

1996 – 2006 – In Australia, PPI prescription rose by 1,318% in just one decade.

2006 – The New England Journal of Medicine published their findings on the link between PPIs and acute interstitial nephritis which can cause sudden or long term kidney damage.

2011 – The advocacy group Public Citizen sent a petition to the FDA asking for a black box warning – the strongest warning available – alerting consumers of the potential for drug dependency and the increased risk of bone fractures. The FDA finally responded in 2014 and rejected the request.

2014 – FDA issues warning that PPIs can cause acute interstitial nephritis, which can result in permanent kidney damage or renal failure.

2016 – A study was published in the Journal of the American Medical Association which stated that those who suffered from kidney sensitivity problems were about 20 to 50 percent higher for those using PPIs than those who were not. Additionally, the Pharmaceutical Journal states that, “once a patient has taken a PPI for longer than a few weeks, acid hypersecretion can occur on discontinuation. This causes rebound symptoms, and frequently establishes a vicious cycle of drug reinitiation and long-term continuation.” This means that patients patients can become dependant on the drug as their body relies on it to manage their acid reflux symptoms.

2017 – Kidney International published a report that found that patients who were using PPIs had a 20 percent higher risk of developing chronic kidney disease and end-stage renal disease.

What Can You Do?

If you took prescription or over-the-counter Nexium, Prilosec, Prevacid, or Protonix and suffered from chronic kidney disease, renal failure, acute kidney injury, acute interstitial nephritis, bone deterioration, or bone fractures, you may be able to make a claim against the pharmaceutical manufacturers. These medications were sold for over 18 years before they warned patients of the potential for these dangerous complications. Call us today to see if you are eligible to make a financial claim.

PPI Warnings In The News

BREAKING (4/17/18): Leawood Attorney Looks to Give Big Pharma Heartburn with PPI Lawsuit

Leawood lawyer Kirk Goza filed suit against some of the biggest pharmaceutical companies in the United States, on behalf of 27 clients who took acid reflux medication that allegedly caused kidney damage.

Read Full Article

11/3/17: PPI Use Heightens Risk for Chronic Kidney Disease

People who use proton pump inhibitors, or PPIs, had a 1.4-fold increased risk for chronic kidney disease, according to an analysis of Taiwan national health insurance data.

Read Full Article

7/3/17: Some Heartburn Drugs Linked with Higher Risk of Death

Some heartburn drugs used by millions of Americans are associated with a higher risk of death, a new study suggests, but people on the drugs should talk with their doctor first before stopping the medicines, experts say.

Read Full Article

PPI Complaints & Damages

9/22/17: Armstrong v. Astrazeneca Pharmaceuticals, LP (NJ)

PPIs are used to reduce acid production in order to lower the risk of duodenal ulcer recurrence and NSAID-associated gastric ulcers as well as gastroesophageal reflux disease (GERD), dyspepsia, acid peptic disease, and other hypersecretory conditions, including Zollinger-Ellison Syndrome.

As a result of the defective nature of PPIs, persons who ingested this product, including Plaintiff, have suffered and may continue to suffer from kidney injuries including acute interstitial nephritis (“AIN”), acute kidney injuries (“AKI”), chronic kidney disease (“CKD”) and renal failure, also known as end-stage renal disease (“ESRD”).

Read Full Case

5/3/16: Mason v. Astrazeneca Pharmaceuticals, LP (IL)

As a result of the defective nature of PPIs, persons who ingested this product, including Plaintiff, have suffered and may continue to suffer from kidney injuries including acute interstitial nephritis (“AIN”), acute kidney injuries (“AKI”), chronic kidney disease (“CKD”) and renal failure, also known as end-stage renal disease (“ESRD”).

Read Full Case

4/30/14: Public Citizen Injunction Complaint to FDA

As a result of the defective nature of PPIs, persons who ingested this product, including Plaintiff, have suffered and may continue to suffer from kidney injuries including acute interstitial nephritis (“AIN”), acute kidney injuries (“AKI”), chronic kidney disease (“CKD”) and renal failure, also known as end-stage renal disease (“ESRD”).

Read Full Case

GET YOUR FREE Proton Pump Inhibitor (PPI) CASE REVIEW TODAY

Proton Pump Inhibitor (PPI) 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.

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

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

Crystal Mesh – Audiobook

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

##
Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

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.

HON Code Certification

© All Rights Reserved • 2019 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

Protected by Copyscape

© All Rights Reserved • 2019 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

HON Code Certification

Pin It on Pinterest