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What They Knew

According to ConsumerSafety.org, “The connection [between talc and ovarian cancer] was first suggested in 1971, when a group of gynecologic oncologists noticed that 75% of the tumors they investigated contained talc particles. Since then, many researchers have agreed that talc use increases the risk of developing cancer. Recently, a report from May 2016 determined that 63% of women with ovarian cancer had dusted themselves with talcum powder.”

There are two distinct theories as to how talcum powder causes ovarian cancer. The first explains that when talcum powder is applied to the genitals, it can travel up the fallopian tubes and into the ovaries. This may irritate the tissue causing cells to irregularly multiple resulting in cancer. A second (and more recent) conclusion is that some talcum powder is contaminated with asbestos, a well-known carcinogen. Talc and asbestos are closely related: both are silicate minerals and both talc and amphibole asbestos – known as tremolite – are created by the same geologic processes and are both are forms of magnesium silicate. Many talc mines were contaminated with these tremolite asbestos fibers and then were made into talc products. Talc products have been tested for asbestos since the 1970’s, but according to two recent trials held in March and May 2018, the asbestos found in current talcum powder resulted in two patients being diagnosed with cancer (one in 2016).

When They Knew

Johnson & Johnson has known since 1971 that their baby powder could cause cancer, and yet they continue to deny these claims. The least that this billion dollar company can do is put a warning label on their product, and yet they refuse to do so because they believe that it will confuse their buyers. However, Valeant Pharmaceuticals, which bought J&J’s Shower to Shower brand, has a label on their talcum powder that currently states that is it, “intended for external use only” and that, “frequent application of talcum powder in the female genital area may increase the risk of ovarian cancer.”

What Can You Do?

If you or a loved one was diagnosed with ovarian cancer, you may be able to join the more than 6,000 other women who have filed claims against Johnson & Johnson. You may qualify if you:

  • Were diagnosed with ovarian cancer after 2006
  • Applied J&J’s baby powder to your genitals once a week for four years or once a day for two years or more.
  • Had major surgery, chemotherapy or radiation therapy after 2006
  • Had a loved one who died after 2006 due to ovarian cancer

You were never warned of the risk of using baby powder and Johnson & Johnson put sales above warning their faithful consumers. Contact us today. We would love to hear your story.

Talcum Powder Warnings In The News

BREAKING (3/14/19): California jury awards $29 million to woman with cancer who used J&J talc

A California jury on Wednesday awarded $29 million to a woman who said that asbestos in Johnson & Johnson’s talcum-powder-based products caused her cancer.

The verdict, in California Superior Court in Oakland, marks the latest defeat for the healthcare conglomerate facing more than 13,000 talc-related lawsuits nationwide.

Read Full Article

BREAKING (3/6/19): Did Johnson & Johnson’s Baby Powder Contain Asbestos? The U.S. Justice Dept. Has Subpoenaed J&J to Find Out

Johnson & Johnson Baby Powder is suspected of being contaminated with asbestos between the 1970s – 2000s. The SEC is reviewing company docs to find out the truth. Read more here.

Read Full Article

7/13/18: J&J’s Talcum Powder is Blamed for Ovarian Cancer, Victims Awarded over $4 Billion

Yesterday in St. Louis, a jury decided that Johnson & Johnson’s talcum powder is to blame for causing ovarian cancer in the 22 plaintiffs represented. The jury awarded $550 million in actual damages and $4 billion in punitive damages which means that each family who sued will potentially receive approximately $25 million.

While there have been previous trials in which women have claimed that talcum powder causes ovarian cancer, what makes this one different is the argument that their cancer was caused by the asbestos allegedly found in this product. Furthermore, this is the first trial where documentation was presented revealing that the leadership of J&J knew that there was asbestos found in their product and yet failed to warn consumers.

Read Full Article

5/25/18: J&J Jury Asks Judge to Slap Cancer Warning on Baby Powder

If Johnson & Johnson won’t put a warning on its baby powder that it may be tainted with asbestos, some jurors were ready to do it for them.

A California jury weighing J&J’s punishment over its handling of its iconic baby powder asked a judge May 24 if they could force the company to warn consumers that its Johnson’s Baby Powder could be contaminated with asbestos, according to the law firm that won the case against the health-care giant.

Read Full Article

5/23/18: J&j Hit With $21.7 Million Verdict in Another Talc Asbestos Cancer Case

Johnson & Johnson (JNJ.N) and its talc suppliers on Wednesday were hit with a $21.7 million jury verdict in a lawsuit by a woman who said she developed cancer after being exposed to asbestos in the company’s Baby Powder.

The verdict by a Los Angeles jury came down in the case of 68-year-old Joanne Anderson, who was diagnosed with mesothelioma, a form of cancer closely linked to asbestos exposure, and marked the second trial loss for J&J over similar allegations.

Of the $21.7 million the jury awarded in compensatory damages, J&J was assigned 67 percent, with the rest distributed among other defendants.

Read Full Article

 

5/21/18: Johnson & Johnson Continues to Battle in Court Over Cancer Causing Baby Powder

For decades Johnson & Johnson, the makers of the iconic baby powder, have denied claims that their product contains traces of potentially carcinogenic (cancer causing) asbestos. However, recent trials have determined that J&J’s baby powder is to blame for two victims who were diagnosed with mesothelioma. Current, a third trial is taking place in St. Louis involving 22 women who have been diagnosed with ovarian cancer after using this product. The evidence presented in these trials could impact the outcome of future cases concerning J&J and the link between talcum powder, asbestos, and cancer.

Read Full Article

4/11/18: Does Talcum Powder Cause Cancer? A Legal and Scientific Battle Rages

Visitors who walk into Deborah Giannecchini’s ranch house in Modesto, California, will notice a well-tended garden, four small dogs who greet every visitor with enthusiasm and a sign that hangs prominently displayed in her living room that reads “It’s never too late to live happily ever after.”

She got it when she was 62 years old, after she married her husband, Leland, but it could also represent her current mission: to help other women avoid the pain she’s experienced and allow them to have their own happy endings.

Read Full Article

GET YOUR FREE Talcum Powder CASE REVIEW TODAY

Talcum Powder 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

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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