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Seeking truth, transparency, and resolution for injured consumers

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Periscope Group provides information, resources, and compassionate legal counsel, advocating on behalf of those facing injustice due to prescription drug complications and medical device failures.

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Allergan Recalls Textured Breast Implants

The FDA requested that Allergen pull from the market their textured breast implants due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Learn more now.

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Roundup is used on playgrounds, gardens, and it’s been found in popular cereals and granola bars. Can this herbicide really harm your kids?

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Periscope Group provides information, resources, and compassionate legal counsel, advocating on behalf of those facing injustice due to prescription drug complications and medical device failures. Contact us today to see how we can help!

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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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