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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 (7/18/2019): Fournier Gangrene and Genitourinary Infections With SGLT2 Inhibitors: ADA 2019 Update

In August 2018, the US Food and Drug Administration (FDA) added a warning about Fournier gangrene (FG) to the labels of all SGLT2 inhibitors, used to treat type 2 diabetes. And as reported by Medscape News this May, an update from the FDA Adverse Event Reporting System (FAERS) database found 55 cases in patients taking these drugs over the 6 years since the first SGLT2 inhibitor, canagliflozin (Invokana), entered the US market, compared with 19 cases in 35 years among patients on other classes of antiglycemic drugs.

Read Full Article

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

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

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LATEST ARTICLES

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

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.

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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/

Can Talcum Powder Really Cause Mesothelioma?

For many years there has been speculation concerning whether Johnson & Johnson’s Baby Powder causes ovarian cancer. Many cases have gone to court, and in July 2018, J&J was required to pay $4.69 billion to 22 women who blamed the talc-based product for causing their ovarian cancer. 2019 isn’t looking any better for J&J as they are expected to face almost three times as many trials involving their baby powder. However, there’s a bit of a spin on a few of these cases: instead of the plaintiff’s alleging that baby powder caused ovarian cancer, some plaintiffs are going after the billion-dollar company with accusations that their mesothelioma diagnosis is linked to baby powder use from decades ago. Is there merit to this claim?

Can Talcum Powder Really Cause Mesothelioma?

What is Mesothelioma?

“Mesothelioma is a rare, aggressive form of cancer that develops in the linings of the lungs, abdomen, heart or testes. The only known cause of malignant mesothelioma is asbestos, though there are other potential risk factors. Due to a long latency period, symptoms may take 10 – 50 years to develop after exposure,” explains Mesothelioma.com. 

What makes mesothelioma especially tragic is that it’s usually discovered in an advanced stage causing there to be few options for treatment. Medical professionals will do their best to help the patient to be comfortable, but traditional go-to’s like surgery, radiation, and chemotherapy offer only minimal hope to extend life expectancy. However, each person is different so it’s critical to discuss these options, along with alternative treatments and possible outcomes, with your doctors.

What Causes Mesothelioma?

Mesothelioma is only caused by asbestos. Asbestos refers to six naturally occurring minerals that have been used for decades for its abilities to resist fire, insulate buildings, it’s anti-corrosion properties and more. By the 1970s, however, asbestos became a hot topic in the news for the health hazards it created.  

So what does asbestos have to do with baby powder?

Asbestos and talc are often formed in nature near each other. Talc is a silicate made up mainly of magnesium, silicon, and oxygen. Asbestos is also a group of silicate minerals that share the same fibrous nature. Both are extremely soft and can be broken down into microscopic pieces.

Between the 1950s and 1970s, studies were conducted which found that baby powder samples were contaminated with asbestos. By the end of the 1970s, the demand for asbestos peaked with 25 countries producing nearly 4.8 million metric tons annually. Nonetheless, asbestos was banned in many countries because of the health risks that it caused including mesothelioma.

Mesothelioma occurs when microscopic fibers of asbestos get inhaled into the lungs. These particles settle into the lung’s lining and can’t be removed. Over many years, the fibers can cause enough irritation and damage to cause lung cells to turn cancerous which is why diagnosis can take years and even decades.

Law360 explains the basis for this most recent case against J&J: “The trial, which began on July 15, involves claims that Will Ronning, Douglas Barden, David Etheridge and D’Angela McNeill-George were exposed to asbestos in the baby powder when they were babies, which caused their terminal cancer.”

Seem far fetched? Consider these findings from a 2014 study conducted by a group of scientists in New York: 

  • “Through many applications of this particular brand of talcum powder, the deceased inhaled asbestos fibers, which then accumulated in her lungs and likely caused or contributed to her mesothelioma as well as other women with the same scenario.”
  • “Initial bulk analyses of 50 samples of this product in Laboratory A showed that all of the samples contained asbestos fibers. Eighty percent contained only anthophyllite asbestos, 8% only tremolite asbestos, 8% anthophyllite and tremolite asbestos and 4% anthophyllite, tremolite, and chrysotile asbestos.”
  • “We have traced the asbestos in the talc to the mines from which it originated, into the milled grades, into the product, and finally into the lung and lymph nodes of the users of those products, including one woman who developed mesothelioma.” 

Johnson & Johnson’s Responsibility

“We do not have any organized program to settle Johnson’s baby powder cases, nor are we planning a settlement program,” Ernie W. Knewitz, a company spokesman, said in an emailed statement in the Los Angeles Times. “Rather, we will continue to vigorously defend the safety of Johnson’s baby powder in the courtroom.”

“In 2019, there are at least 21 trials on court calendars targeting J&J over tainted talc, including more than 15 in California’s courts and one in Georgia set to start in March,” states the Los Angeles Times.

Prop 65 Cancer Warning Label

The current warning label for Johnson’s Baby Powder states: “WARNING: Keep powder away from child’s face to avoid inhalation, which can cause breathing problems. Avoid contact with the eyes. For external use only.”

J&J continues to deny the results of many studies and the claims of thousands of plaintiffs that their product creates an increased risk of cancer. In fact, there may be a potential trial in California over whether or not J&J’s Baby Powder should carry a Prop 65 warning label on its bottle to provide “a ‘clear and reasonable’ warning before knowingly and intentionally exposing anyone to a listed chemical” which may cause cancer.

Should baby powder have a warning label for cancer? We’d love to hear your thoughts! Please comment on our Facebook page or share on social media (links below) with your input.

If you or a loved one were diagnosed with ovarian cancer or mesothelioma after exposure to Johnson & Johnson’s Baby Powder, please call Periscope Group today at (800) 511-3838. We want to hear your story and help in any way that we can.  

 

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Sources
“J&J Tried To Invade Atty Privilege In Talc Case, Judge Told.” Law 360. Accessed August 1, 2019. https://www.law360.com/articles/1183789/j-j-tried-to-invade-atty-privilege-in-talc-case-judge-told
“Talcum Powder as a Cause of Mesothelioma?” Mesothelioma.com. Accessed August 1, 2019. https://www.mesothelioma.com/blog/talcum-powder-as-a-cause-of-mesothelioma/
“Johnson & Johnson’s baby powder risk expands: It faces triple the cancer trials in 2019”. The Los Angeles Times. Accessed August 1, 2019. https://www.latimes.com/business/la-fi-johnsons-baby-powder-20181225-story.html
“Mesothelioma”. Mayo Clinic. Accessed August 1, 2019. https://www.mayoclinic.org/diseases-conditions/mesothelioma/diagnosis-treatment/drc-20375028
“What Is Asbestos?”. Asbestos.com. Accessed August 1, 2019. https://www.asbestos.com/asbestos/
“J&J Would Rather Fight a Cancer-Warning Lawsuit Than Let It Drop”. Bloomberg. Accessed August 1, 2019. https://www.bloomberg.com/news/articles/2019-07-27/j-j-would-rather-fight-a-cancer-warning-lawsuit-than-let-it-drop

“Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women”. NCBI. Accessed August 1, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164883/

Xeljanz and Risk of Amputation: What You Need to Know

One of the most despicable things about Big Pharma is when they know that a drug or medical device could cause a terrible health complication, and yet they fail to warn patients of this potentially life-changing problem. This is what’s happening in a current trial involving 68-year-old Arkansas resident Marilyn Stube. She took Xeljanz for four years to help her rheumatoid arthritis and ended up having both arms and legs amputated due to sepsis. Pfizer, the makers of Xeljanz, knew the risks but chose not to warn U.S. patients. 

Xeljanz and Risk of Amputation: What You Need to Know

What is Xeljanz?

Xeljanz is a relatively new medication that was introduced to the market in 2012 to address rheumatoid arthritis (RA). There are a variety of drug options available for RA, but Xeljanz works in a different way because it “is an anti-JAK, or Janus kinase inhibitor, which targets a specific cellular process that is involved in the immune response and resulting inflammation in RA. Xeljanz is the first drug of its kind,” explains Healthline. 

Xeljanz was intended to be prescribed for patients who didn’t respond to the existing drug options available for RA. However, while all medications have a risk of specific adverse effects, Xeljanz was found to have the potential to cause more serious risks that caused many doctors to decline to prescribe it to their patients.

Warning Signs

When Xeljanz was first approved to be sold in the U.S. by the FDA, the European Medicines Agency, Europe’s version of the FDA, rejected it. The European authorities deemed that this medication came with higher risks than the other available RA drugs on the market. Some of these complications could include severe infections, liver damage, gastrointestinal bleeding, increased blood pressure and cholesterol, and an increased risk of cancer. And it doesn’t just have the basic warnings that are spoken really fast at the end of a television commercial; Xeljanz has a black box warning – the highest warning given by the FDA – about how it can hinder the immune system causing major infections.

Hiding the Facts

If these dangerous complications weren’t scary enough, Pfizer failed to tell U.S. patients about the possibility of sepsis, a potentially fatal condition in which the patient is fighting a severe infection that has spread throughout the body. If a patient becomes ‘septic,’ they will likely have low blood pressure leading to poor circulation which can harm vital tissues and organs.

This is what happened in the case of Marilyn Stube. “After taking Xeljanz for four years for her rheumatoid arthritis, she started feeling pain, then fever, nausea and other symptoms in March 2017. In April of that year, she was diagnosed with septic shock, multi-organ failure, gangrene and Group A Streptococcus, requiring that she have both arms and both legs amputated at Baylor University Medical Center,” according to the complaint filed in the Western District of Arkansas.

On Xeljanz’s labels outside the U.S., they warn of the potential for sepsis which clearly shows that the company knew about the risk and hid this important fact from the American public. According to Law360, “Stube’s physician has signed a sworn declaration that he would never have prescribed Xeljanz for her if he’d known of the risk of sepsis and other ailments, saying he was relying on Pfizer’s product literature in deciding what medication was safest for Stube’s treatment.”

If you or a loved one are taking Xeljanz, it’s important to discuss the benefits and risks of your unique situation with a medical professional to determine the best medication for your condition. It’s also critical to know the potential adverse effects of each medication that you are taking so that you can know the warning signs; the quicker you can get medical care, the more likely you are to avoid severe complications.

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Sources
“Pfizer Hid Risks Of Sepsis, Amputation On Labels, Suit Says”. Law360. Accessed July 24, 2019. https://www.law360.com/articles/1179862/pfizer-hid-risks-of-sepsis-amputation-on-labels-suit-says
“Another Look At Marketing Vs. R&D In Pharma”. Science Magazine. Accessed July 24, 2019. https://blogs.sciencemag.org/pipeline/archives/2013/05/23/another_look_at_marketing_vs_rd_in_pharma
“Xeljanz: A Blessing or a Curse for Rheumatoid Arthritis Patients?”. Heathline. Accessed July 25, 2019. https://www.healthline.com/health-news/xeljanz-blessing-or-curse-for-ra-patients-100414#1
“Why was this RA med declared safe here, but not in the EU?”. Health Science Institute. Accessed July 25, 2019. https://hsionline.com/2014/08/18/european-medicines-agency/

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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