Ovarian Cancer Screening not reliable – FDA

FDA recommends Pelvic Mesh not approved by FDA – The 510(k) Bluesagainst using screening tests for ovarian cancer

While power morcellators can spread undetected uterine cancer when used for fibroid removal or hysterectomies, word comes from the FDA that current ovarian cancer screening is not reliable. Morcellators can spread undetected cancer during hysterectomy or fibroid removal and lead to more serious forms of uterine and ovarian cancer.

FDA issued a safety communication September 7, 2016 to women and physicians, including those working in Primary Care, Obstetrics and Gynecology, Oncology, Gynecologic Oncology, and Genetic Counseling.

Morcellator Safety Questions Abound
The FDA said it was especially concerned about delaying preventive treatments for symptomless women at increased risk of ovarian cancer. But at the same time, the FDA recommends against using currently offered ovarian cancer screening tests.

That announcement begs the question of whether it is safe or reasonable to use a morcellator for any woman’s hysterectomy or fibroid removal procedure. Though morcellators appear to be a safe option for women who do not have cancerous fibroids or ovarian cancer, if ovarian cancer screening is not reliable, how can it be considered safe to use a morcellator on any woman?

Ovarian Cancer Genesis
The National Cancer Institute estimates that more than 22,000 women will be diagnosed with ovarian cancer in 2016. Ovarian cancer is the fifth leading cause of cancer-related deaths among American women.

Abnormal cells in or near the ovaries can grow into a malignant tumor that can turn cancerous. Women who have reached menopause or who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations are most at risk for developing ovarian cancer.

Summary of Problem and Scope

Despite research and published studies, no current ovarian cancer screening tests are sensitive enough to “reliably screen for ovarian cancer without a high number of inaccurate results,” wrote the FDA. That dearth of results comes despite several companies marketing tests which claim to screen for ovarian cancer and detect it.

Abcodia Incorporated
The FDA referenced Abcodia Incorporated in its safety alert. That company began marketing its Risk of Ovarian Cancer Algorithm (ROCA) test in the United States. It claimed ROCA could screen for and detect ovarian cancer before symptoms appeared. The company claimed its test could increase the chance for survival. But the data failed to support the company’s claims.

Women and Doctors misled by False Claims

FDA voiced its concern that women and their physicians could be misled by claims of ovarian cancer screeners that can’t reliably screen. The agency said it doesn’t want women to “rely on inaccurate results to make treatment decisions.”

FDA wrote:
“Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.”

False Positive, False Negative

FDA also said some ovarian screening tests could present a false positive reading. Such women might undergo more medical tests and even unnecessary surgery. They might then experience complications related to both. In addition, test results might not show ovarian cancer even though cancer is present (a false-negative). That could lead women to delay or not seek surgery or other treatments for ovarian cancer.

“At this time (Sept. 7, 2016), the FDA is not aware of any valid scientific data to support the use of any test, including using a test cleared or approved by FDA for other uses, as a screening tool for ovarian cancer.”

Morcellator Use Questionable at Best

With such a powerful statement from the FDA, it is fair to ask whether power morcellators for hysterectomy should be used on any woman at this time.  When power morcellators are used on undetected cancer tissue, they can spread the disease and even make it much more lethal.

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Forced Vaccination for You

In an unprecedented docmanpower grab that would effectively end democracy and the rule of law as we know it, the CDC has proposed a law that will remove whatever vestiges are left of our inalienable human rights. See it here and comment to take action. Forced vaccination is no longer just a dream of the future for pharmaceutical companies and the military police state that increasingly runs the country. Forced vaccination for you is here now.

Send Comments to CDC

The same agency which has committed fraud to deny parents compensation for vaccine-related injuries, the same agency that helps perpetuate the Zika Virus Misinfo Campaign, is giving us all until October 15, 2016  to comment on its little proposal to take “extra-Constitutional” powers. This thing is beyond breathtaking in its sweep and scope.  They don’t even do this in China or Russia. If the government has its way, anyone judged to be at a “precommunicable” stage can be apprehended, detained indefinitely, and injected with whatever little gift the CDC chooses to give them.

Syphilis, Anyone?

Yes, forced vaccination will be the new normal if the CDC has its way. The Centers for Disease Control, the same outfit that helped murder black men in the Tuskegee Airmen Syphilis “Experiment,” now proposes that the federal government give it the right to vaccinate anyone, at any time, for any reason, with anything it likes. It’s a dream law for pharmaceutical companies who continue to reap billions in profits from untested, unproven vaccines like the shingles vaccine, gardasil vaccine (nightmare) and many others.

Whether you believe everything the government tells you or not doesn’t matter. Whether you believe vaccination in whatever form for whatever reason is good for you doesn’t matter. This new law would take all the thinking and decision making about vaccination and your own health choices out of your hands.

“Precommunicable”:  Unchecked, Unconstitutional Powers

This law would give CDC thugs the power to stop anyone, anytime, anywhere, for any reason, and detain them indefinitely for “quarantine” purposes.

CDC defines precommunicable stage to mean the stage beginning upon an individual’s earliest opportunity for exposure to an infectious agent.”

Note:  CDC does NOT need to give a medical exam to declare you or your city “precommunicable”.

Did you get that?  It means that anyone suspected of being precommunicable is subject to indefinite detention. No need to arrest you for thought crime, as in Orwell’s 1984; they can now “detain” you for being “precommunicable,” and “vaccinate” and educate you accordingly.

Real Target not “Those People”

Defenders of this monstrosity will point to swarthy foreigners whom they imagine – with the help of mainstream media whores and traitors – coming to pollute the homeland with all manner of infectious diseases.  But the real target is not “those people” (as General Robert E. Lee famously called the Yankee invaders).  Make no mistake: The real targets are you and yours, and your constitutional rights.  All you need do is just lie down and take it, and pretend you never had any human rights at all.

Red Flag News

Red flag news breaks this story that you won’t find on any mainstream outlet anywhere. Recent propaganda movies about killer virus outbreaks and measles outbreaks and endless mainstream media attacks against “anti-vaxxers” have helped usher in this monster. Read it and weep. It’s your life.

Forced Vaccination for You

In further maneuvers to set us up for this draconian move, Big Pharma shills in California politics like Democrat Senator Richard Pan and others have helped pass legislation to destroy informed consent for vaccinations. Similar moves are afoot in several other states.

Pay attention. Protect yourself. Call your representative if you care about informed consent, if you care about making your own health choices, if you think you have the right to do so. Remember, this law is not about “others,” regardless of how they trot it out to make it seem not only palatable but like a good and necessary idea.

This law is about you and yours, and it is a matter of life and death. I mean, raise your hand if you think this government is acting with your best interests in mind.

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FDA Invokana Reviewers’ Tepid Approval

FDA reviewers  Invokana Lawsuitexpressed concern over the safety and efficacy of Invokana before voting to approve it for sale. In fact, just 67% of them decided that letting Invokana hit the market was a good thing. An FDA committee met on January 10, 2013 to assess Invokana and determine whether it made sense to let Johnson & Johnson’s Jannsen Pharmaceuticals market it for help with diabetes.

FDA Reviewers Vote 8-7 and 10-5

An FDA committee of 15 people discussed new drug application (NDA) 204042 for canagliflozin tablets, or Invokana. It was submitted by Janssen Research and Development, LLC. A member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, Canagliflozin was, said FDA, developed to improve glycemic control in adults with type 2 diabetes mellitus.

The FDA report of the January 10, 2013 meeting says, “The committee members generally agreed that the benefit-risk profile of canagliflozin in patients with type 2 diabetes and moderate renal impairment should be considered differently from the general population. The committee members expressed concern about usage in these patients, owing to a decreased efficacy, especially when combined with an increased incidence of side effects. The committee members further discussed a discomfort with the relatively small volume of data to support use in this population (emphasis ours). (One) committee member also mentioned a concern over the cardiovascular risks of the drug, given an existing elevated cardiovascular risk in patients with renal impairment.”

The 15 committee members were asked to vote on two important questions to determine whether Invokana were worthy of market approval.

Tiny Approval Margin

The first question J&J fails its Credo with Pelvic Meshput before the committee was: “Based on the data submitted and considering the points of discussion in question 3 [which involved Invokana cardiovascular risk], do you have any concern regarding a conclusion that a risk margin of 1.8 has been excluded for canagliflozin?”

The 15 members voted 8-7 to say that the drug passed an acceptable risk measure. That razor-thin margin can hardly be called a vote of confidence in the drug’s safety profile.

The next question put before the committee was all important: “Based on the information included in the briefing materials and presentations today, has the applicant provided sufficient efficacy and safety data to support marketing of canagliflozin for the treatment of Type 2 diabetes mellitus? The committee voted 10-5 on that question, better than 8-7 but once again hardly a ringing vote of confidence in the new drug.

Unknown Cardiovascular Risks
The FDA reviewer taking the minutes of the meeting cautioned that, “The committee members who voted ‘no’ cited similar concerns over unknown cardiovascular risk and usage in moderate renal impairment, which were frequently stated as overriding concerns (emphasis ours). One committee member who voted ‘no’ expressed comfort with the benefit-risk profile in combination therapy, but described a lack of comfort with usage as monotherapy since the drug had not been compared against metformin, which is the standard initial therapy in Type 2 diabetes. An additional committee member voiced concerns over the potential for renal damage, (emphasis ours) and suggested a possibility of prolonging hypoglycemia in the elderly.”

FDA Invokana Reviewers’ Tepid Approval

With such tepid Janssen_logo-JnJapproval, and now with the risk of ketoacidosis made much more clear with strengthened FDA Warnings for Invokana and Ketoacidosis, it is difficult to see why such a drug ever made it to the market in the first place. Not surprisingly, problems with Invokana and its link with ketoacidosis began to show up almost immediately after the drug’s approval.

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Country bans Johnson’s Baby Powder

The nation of Qatar Talcum Powder Ovarian Cancerhas moved to ban Johnson’s Baby Powder from grocery store shelves. According to Al Raya, a Qatar newspaper, Johnson’s baby powder was banned from Qatar stores in March 2016 while the country moved to examine the link between talcum powder and ovarian cancer.

Other parts of the world are also paying attention to the shocking verdicts against Johnson & Johnson and its baby powder and shower to shower talc products. In Malaysia April 2016, the Consumer Association of Penang (CAP) warned Malaysians that talc is toxic and can cause tumors.

Talcum Powder raises Ovarian Cancer Risk

Tiny talcum powder particles can embed in the lungs and the ovaries. Studies have shown women who use talcum powder as a drying agent or for feminine hygiene in their genital areas have a greater risk of developing ovarian cancer than those who use no talc. Ovarian cancer is often deadly, largely because it is difficult to detect until it reaches advanced stages.

Qatar Talcum Powder Ban

Qatar’s announcement came in the midst of plaintiffs winning three talcum powder cancer lawsuits in the United States.  Two of those verdicts resulted in large monetary awards for women who used talc and then later developed ovarian cancer and died.

The two large jury awards – $72 million and $55 million – strongly suggest that J&J’s baby powder and shower to shower products have some problems. While the baby powder cancer outcomes in the jury trials do not serve as definitive proof that talcum powder is carcinogenic to women, they do strongly support the notion of a link between baby powder and ovarian cancer. Both juries were shown documents in which it was clear decades ago that Johnson & Johnson officials were concerned about a baby powder ovarian cancer link.

The juries were also shown evidence that J&J targeted Black and Latino women even as it was clear to the company that these women were at greater risk of ovarian cancer through their use of talcum powder.

J&J Found Guilty of Conspiracy, Fraud, Negligence

Both juries which rendered huge awards were presented with extensive talcum powder cancer research. They were also shown several internal company documents which demonstrated that J&J company officials were long aware of a talcum powder cancer link.

The jury which awarded $72 million found J&J guilty of conspiracy, fraud and negligence for failing to warn American consumers of the talcum powder ovarian cancer connection.

Country bans Johnson’s Baby Powder

The Qatari Ministry of Municipality and the Environment issued the ban of talcum powder products on a temporary basis while it examines evidence presented in the baby powder cancer lawsuit. Qatar had convened a governmental committee to examine the safety of baby powder and other talc-based body products prior to the first large verdict, the $72 million award.

J&J Responds

A J&J representative in Qatar insisted Johnson’s baby powder and other talc products are safe for regular use, despite the jury awards.

Qatar continues to test talcum powder for safety. Until the government agency concludes its investigation, Qatar stores will not be permitted to sell Johnson’s baby powder.

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Did Tylenol kill Alabama Woman?

A lawsuit that Tylenol Lawsuitclaims Tylenol killed an Alabama woman in 2010 is scheduled to start trial Sept. 19, 2016 in a Pennsylvania federal court. The petition claims acetaminophen in extra strength Tylenol caused  acute liver failure that killed the woman.

Tylenol Bellweather Trial

A federal judge presiding over the woman’s case has designated the lawsuit as a bellweather or test case. This means it could determine the future direction of a few hundred other lawsuits consolidated in his docket. All make similar claims, that Tylenol is linked with liver failure.

Rana Terry, sister of the deceased Denice Hayes, filed a lawsuit in 2012 against the maker of the over-the-counter drug, McNeil Consumer Healthcare, a division of Johnson & Johnson, which is also named as a defendant. The petition alleges the companies are responsible for the death of Ms. Hayes.

The lawsuit alleges Ms. Hayes, 51, died from acute liver after taking Tylenol and Tylenol Extra Strength. The lawsuit petition says Denice Hayes was treated August 23 at Helen Keller Hospital, where she was diagnosed with catastrophic liver damage. She was then transferred to University Hospital in Birmingham, where she died eight days later.

Pennsylvania Federal Court

The lawsuit was originally filed in the Court of Common Pleas in Philadelphia, then transferred to federal court in Pennsylvania. It is one of several lawsuits claiming liver damage from Tylenol at or just above the recommended dosage. The Tylenol cases are consolidated under U.S. District Court Judge Lawrence F. Stengel in Philadelphia.

Judge Stengel summed up the Terry case in a recent order: “This is the first ‘bellwether’ scheduled for trial. (Bellwether) trials should produce representative verdicts and settlements. The parties can use these verdicts and settlements to gauge the strength of the common MDL (Multi District Litigation) claims to determine if a global resolution of the MDL is possible.”

200 Tylenol Cases in MDL

Some 200 other cases are also included in the MDL, in addition to several similar cases filed in New Jersey state court.

Acetaminophen Leading Cause of Liver Failure

Ms. Terry’s lawsuit claims acetaminophen is the leading cause of acute liver failure in the United States.

Prior to her Aug. 31, 2010 death, Ms. Hayes took doses of Tylenol at appropriate times and in appropriate amounts, says the lawsuit.

The petition states that, “Tylenol (was) defectively designed and placed into the stream of commerce by defendants in a defective and unreasonably dangerous condition.”

Tylenol makers failed to warn, says lawsuit

The lawsuit also claims that McNeil and J&J failed to test and place adequate warnings and instructions on the over-the-counter drug.

The lawsuit also claims that Tylenol’s makers intentionally concealed Tylenol and acetaminophen safety issues in order to dupe doctors into recommending it to patients, including Ms. Hayes.

The lawsuit does not name any specific amount of damages that it seeks.

Though the lawsuit will be tried in Philadelphia, Judge Stengel has ruled that Alabama state law will govern the case.

In November 2015, the judge denied McNeil’s motions for summary judgment on several issues, including a request for dismissal of the punitive damage claims under Alabama’s Wrongful Death Act.

FDA on Acetaminophen

In January 2014, FDA asked health care providers to stop giving patients high doses of acetaminophen over concerns about possible liver damage.

A McNeil spokesperson, Marc Boston, responded by email to AL.com regarding the lawsuit’s claims against the OTC medication:

“We are reviewing the rulings and continue to prepare for trial. TYLENOL® (acetaminophen) has more than 50 years of use and over 150 studies to support its safety and efficacy, and, when used as directed, has one of the most favorable safety profiles among over-the-counter (OTC) pain relievers.

Doctors Acetaminophen Warnings

In recent years, some doctors have warned their patients about the risks of acetaminophen.

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Shingles Vaccine causes Shingles

People conditioned Zostovaxby years of vaccine propaganda may find it not newsworthy that the shingles vaccine causes shingles. For thinking people, however, this might be a news item. What sense does it make to be “vaccinated” against something when that vaccination gives a person the exact malady it is advertised to resist? In August 2014, the FDA moved to make Merck include on its Zostavax shingles vaccine the “side effect” of “shingles.”

 FDA: add “Shingles” as “Side Effect”

FDA sent a letter to Merck Sharp & Dohme Corp. August 28, 2014:

We have approved your request (to) update the Package Insert, Section 6.3 Postmarketing Experience to include “infections and infestations: Herpes zoster (vaccine strain)” and to update the Patient Package Insert to include “Shingles” in the “What are the possible side effects of ZOSTAVAX?” section.

The Magic Bullet: Vaccination

Years of propaganda touting the influenza vaccine every “flu season” have turned many of us into Pavlovian dogs that salivate at the sound of a bell because we’ve been taught to associate it with dinner. We have all been “taught” for decades to associate vaccines with the eradication of some natural malady or other. When we hear the latest vaccine advertising pitch – which cleverly doesn’t sound like advertising – and always leads with the horrors of what is going to happen to us if we don’t vaccinate, we can’t wait to run to Wal-Mart or Walgreen’s or to our own doctors to preempt this terrible scourge with the magic vaccine bullet.

Problem, Reaction, Solution

It is the oldest advertising trick in the book – a riff off the old Hegelian Dialectic: Problem, Reaction, Solution –  and the most effective. In the case of the shingles vaccine, we are shown horrific pictures of people uglified with red skin rashes, and given their horror stories of the terrible pain associated with shingles. Sometimes the pictures are animated reproductions, or something, but we get the idea:  Yikes!  How do I keep this terrible thing from happening to me?  Help!  (Shingles can be a problem, of course, but it’s also a complete non sequitur to imagine this Zostavax vaccine is the answer; let’s stay focused.)

Help is on the way, of course, with the magic of vaccines. Whether you favor left-leaning propaganda from MSNBC, say, or the New York Times, or whether you prefer right-leaning flavor from Fox News or The Wall Street Journal, the answer is the same: Get yourself vaccinated and you can once again sleep the sleep of the righteous.

Shingles Vaccine causes Shingles

The problem is that shingles vaccine, in this case, doesn’t work very well. And just one more small thing, hardly worth a mention, really:  The shingles vaccine can give you the very disease its maker and media pushers claim it will protect you from.

Vaccine Lottery

But forget all that. Pay no attention to that man behind the curtain. Just go ahead and play it like the vaccine lottery. Those shingles vaccine “side effects” are so rare, every major media outlet will tell you, and the horrors of shingles so great, that the vaccine is worth the risk.

Just take your marching orders and go get yourself vaccinated.  Don’t make waves. Don’t ask wearisome questions.  Follow the herd.

The End.

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Shingles Vaccine Deaths Unreported

Shingles vaccine syringedeaths have gone virtually unreported in the mainstream media. Mainstream advertising outlets largely function as propaganda mouthpieces for Big Pharma. The New York Times, Wall Street Journal, CBS, NBC – all the major newspaper and television stations – rarely see a Big Pharma advertising campaign they don’t like. None have reported how Bill Gates polio vaccine caused 47,000 cases of polio in India.

Nor has any mainstream outlet ever reported that  in 1976, Dr. Jonas Salk testified that the live-virus polio vaccine was the ‘principal if not sole cause’ of all reported polio cases in the U.S. since 1961.

Money doesn’t Talk; it screams

“Money doesn’t talk; it screams,” as John Lennon said, and nothing screams like advertising money.

The vaccine industry, a multi-billion-dollar cash cow, is so well protected by government fiat (the 1986 Vaccines Act) and media advertising cash, that the dark side of it rarely sees the light of day, regardless of the facts, which are largely decided by whoever has the most money to say what they are. There’s nothing new under the sun, as Ecclesiastes teaches, but there are still facts to consider in the hysteria surrounding all the vaccine hype and the endless “anti-vaxxer” name calling fallacy visited on anyone wishing to discuss the facts or the larger picture. Here’s a fact you don’t see reported: people have died from the shingles vaccine. A lot of people. Perhaps as few as 90. Perhaps as many as 9,000. Is that a small price to pay for a “vaccine”? Perhaps, if you believe the vaccine works, and if you or someone you love is not one of the 90, or 9,000 dead.

Nearly 9o Shingles Vaccine Deaths Reported

The National Vaccine Information Center  reports that 89 deaths have been linked with the shingles vaccine. The Vaccine Adverse Events Reporting System (VAERS) has received reports on shingles containing vaccines since 1990.

Shingles vaccine promoters will argue that the VAERS system reports adverse events that vaccinated people associate with the shingles vaccine, that those deaths may simply be apriori, or merely incidental to the vaccination. Some, perhaps. But all? And the 90 deaths associated or linked with the shingles vaccine in 15 years may be closer to 900, or even 9,000.  This is well known, and here’s why.

Vaccine Events Wildly Under-reported

It is common knowledge – except for anyone working in mainstream media – that adverse events from vaccines are wildly under-reported. This well known weakness of VAERS skews all the numbers trotted out by vaccine profiteers and their legions of media and medical shills. Further, federal health officials have done little to increase vaccine provider reporting to VAERS since the 1986 passage of the National Childhood Vaccine Injury Act. This act vaccinates vaccine makers against liability with regard to vaccines forced on children, but it also requires that vaccine adverse events be reported. That first part is followed religiously by the courts, that second not so much.

Only 1-10 % Adverse Events Reported

The National Vaccine Information Center (NVIC) reports that during the meeting of the National Vaccine Advisory, CDC officials reported that only between one to 10 percent of vaccine adverse events are reported to VAERS. Therefore, the VAERS system that receives some 30,0000 adverse event reports annually should be receiving a minimum of 300,000 adverse event reports (if actual events were really reported), or as many as 3 million adverse events related to vaccines. It’s easy to skew numbers, and nobody skews them better than vaccine profiteers.

CDC promotes More Under-reporting

The CDC, sadly, is now proposing that all VAERS reports be submitted online. No more paper forms will be allowed. Much like the new American voting system – a sham if ever there was one (read Mark Crispin Miller and BlackBoxVoting.org) – the paperless trail will be much easier to disappear. Doctors and nurses and others will no longer be able to scribble an adverse vaccine event on paper when they have a moment. They will be forced to go to a computer and jump through all the attendant hoops. This paperless idea from CDC virtually guarantees we will see fewer adverse event reports (all in the name of “Progress,” of course). NVIC therefore opposes the CDC’s proposal to eliminate the option of submitting handwritten reports.

NVIC writes: “The proposed shift to a completely ‘paperless’ system is likely to result in even more underreporting of vaccine adverse events and penalize those who are not computer literate. These changes could also hinder the effective monitoring and detection of unusual vaccine adverse events occurring in the general population by health scientists.”

Reporting Doctors feel Threatened

NVIC further reports that, “CDC officials also stated that doctors viewed language in the current form relating vaccine provider identification as ‘threatening’ and inferred liability. The new language created by CDC officials to address these concerns does more harm than good because it assumes that all Americans are being vaccinated solely by their primary health care provider rather than in pharmacies, grocery and big box stores, senior living facilities, public health clinics, the work place or in school clinics.”

CDC officials apparently live in a different world than the one you and I inhabit.

NVIC says what’s also missing from the CDC’s proposed new VAERS form is information about vaccine reactions in siblings. Why is the CDC always erring on the side that favors Big Pharma and other corporate entities, and why is mainstream media always doing the same thing? Follow the money.

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Secure your Shingles Vaccine Records

Waiting for a Rx Recordslaw firm to order records of your shingles vaccination in a potential shingles vaccine lawsuit could fatefully harm your potential case. By law, pharmacies, hospitals and other medical records entities are required to produce records within one month of receiving a request; however, long experience has taught us that this virtually never happens. Therefore, it is best to secure your shingles vaccine records if you can, or the records of any other vaccine or prescription drug you ever take.

Waiting for Pharmacy Records

A wait of three months or longer is often the norm after we order pharmacy records. Even a nine-month wait for records is not entirely unusual. That long wait can spoil a case. The necessary records may have been purged by the pharmacy or hospital administration in the interim. If and when that happens, the potential case could be lost before it ever starts.

Records Purging at Record Pace

Drug stores and pharmacies such as Walgreens, CVS, Wal-Mart and others are purging their records faster every year. Many previously kept their customers’ pharmacy records for 10 years or longer. Not any more. Many now purge their records in as little as five or six years, some now in as short a span as three years.

Protect your Pharmacy, Medical Records

To protect your own interests and to help make or expedite your potential shingles vaccine lawsuit – or any drug case lawsuit – it would be wise to secure your pharmacy records right now, today. In the future, it would also be wise to get and keep a copy of every prescription you’ve ever filled. Ideally, you don’t want to be in a position of waiting for a law firm to secure your records.

Matthews & Associates Orders Records

At Matthews & Associates, we order pharmacy and medical records for virtually every client we sign; nevertheless, given the vicissitudes of nearly always being forced to wait several months for records to appear, we advise all of our clients who we think have a case to get their records themselves as soon as possible.

Free Consultation

Matthwes & Associates offers a free legal consultation for anyone who was diagnosed with shingles after receiving the shingles vaccination, and anyone who suffered eye injury as a result of the shingles vaccination.

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Shingles Vaccine Eye Damage

The shinglesZostovax vaccine Merck Pharmaceuticals has been marketing since 2006 now comes with a warning that it could cause eye damage. February 17, 2016, the FDA approved a label change to Merck’s Zostamax vaccine prescribing information. The change to the label added “Eye Disorders: necrotizing retinitis.” Merck consequently faces Shingles Vaccine Lawsuits over this dubious vaccine.

Keratitis Vision Damage from Vaccines

WebMD reported that researchers found 20 cases of keratitis in children and adults that occurred within a month of receiving a chickenpox or shingles vaccine. Keratitis symptoms for adults developed within 24 days of vaccination, while symptoms in children began within 14 days of vaccination. Researchers concluded there is a probable relationship between the vaccine and the eye inflammation, though the study wasn’t designed to prove the vaccine actually caused the condition. (Of course it wasn’t.)

Keratitis causes inflammation and scarring of the eye tissue. If one fails to get treated fast, it can lead to permanent vision loss.

Health Sciences Institute (HSI) points out in a Jan 21, 2016 piece that the researchers say they don’t know why the shingles shot may cause keratitis, but we do know that keratitis has been linked to autoimmune disorders, and that shots like the shingles vaccine can profoundly short circuit the immune system.

The mainstream media didn’t miss a beat, of course, telling us that despite these little “side effects” (hardly worth a mention, really), it’s still a good idea to get the shingles vaccine, and never mind the fact that it barely works at all, or perhaps causes more cases of shingles than it prevents.

Shingles Vaccine causes Shingles

The mainstream failszostovax to tell us that the shingles vaccine causes shingles. Funny they leave that out, because even the FDA is aware now that the shingles vaccine features an absurd problem.  In August 2014, FDA approved a change to the shingles vaccine warnings label to include that the shingles vaccine causes – wait for it – shingles!  Yes, you read that right.

Shingles Vaccine Fails to Work as Advertised

HSI further points out that “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up. And if you’re over 70, you’d be lucky to get those odds.”

So these people from WebMD and other mainstream media outlets who take endless money in advertising from Big Pharma and never see a drug or vaccine campaign they don’t like, are now telling you it’s worth risking eye damage, maybe up to blindness, to take a shingles shot that fails more than 99 percent of the time, and uh, just happens to also give you shingles? That’s a chance worth taking? You take it, friend. We shall pass on the shingles vaccine.

More Shingles Vaccine “Side Effects”

The Zostovax label lists the most common side effects as “headache, redness, pain, itching, swelling, hard lump, warmth, or bruising where the shot was given.”  Other “side effects” include:

• allergic reactions, which may be serious and may include difficulty in breathing or swallowing. (breathing is kind of important, so you may want to read this one.)
•  chickenpox
•  fever
•  hives at the injection site
•  joint pain
•  muscle pain
•  nausea
•  rash
•  rash at the injection site
•  shingles
•  swollen glands near the injection site (that may last a few days to a few weeks)

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Cook must produce IVC Filter FDA Reports

Virtually every IVC Filterlawsuit involves a judge’s issuing key rulings that impact the outcome. A judge’s decisions for the court can hinder plaintiffs  – such as the recent judge in the Mirena birth control cases who ruled to exclude all the plaintiffs’ experts, which challenges the hopes of women who have alleged Mirena injury. On the other hand, a judge’s rulings can also help plaintiffs.  A recent judge’s ruling in the Cook IVC filter multidistrict litigation has allowed plaintiffs to continue building their cases.

“Discovery” Allowed in Cook’s Reports to FDA

In May 2016 in the Cook IVC filter multidistrict litigation set in Indiana, a federal judge refused to bar Discovery involving plaintiffs’ allegations that Cook failed to file reports to the FDA that showed bad results with some Cook IVC filters.

Adverse Device Events allowed in IVC Filter Cases

Plaintiffs in the Cook IVC filter cases requested Discovery relating to information Cook Medical delivered to the FDA regarding the outcomes of patients implanted with Cook IVC filters. The plaintiffs’ group believes Cook underreported IVC filter device problems to the FDA. The group wants access (Discovery) to all information regarding whatever Cook shared or possibly failed to share with FDA.

Cook Medical requests Protective Order to Conceal Reports

Cook Medical responded by filing a motion for “protective order,” which would have effectively barred Discovery of reports Cook made to FDA. Cook argued that it had no duty to produce this information to the plaintiffs, based on some recent court decisions.

Cook IVC Filter MDL Magistrate Judge Tim Baker disagreed with Cook’s attorneys. Judge Baker ruled that this information requested by plaintiffs is potentially relevant to the claims in the case. He ruled that Cook has an obligation under the Rules of Civil Procedure to produce this information. Since Judge Baker denied Cook’s motion, the company is now required to produce this FDA reporting information to attorney David Matthews and other lawyers representing plaintiffs in the MDL.

Discovery

Once a lawsuit is filed, defendants have a chance to “answer” or enter a plea to the complaint, either by admitting the complaint is true or by denying its veracity. Following the filing of these “pleadings,” the battling parties engage in formal discovery. Discovery in civil litigation is the exchange of documents and information between the parties. The Rules of Civil Procedure require Discovery. This occurs when one side writes questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. The parties then use that information to build their cases for trial.

Discovery Decision Impacts IVC Filter Cases

The court’s decision allows the plaintiffs to “discover” information Cook sent to FDA regarding Cook IVC filters and adverse events. Plaintiffs’ cases may be aided if those Cook reports to FDA are false, misleading or incomplete. Plaintiffs’ petitions now charge that Cook misrepresented IVC filter efficacy and safety, and that Cook failed to adequately warn of the risks.

IVC Filter Problems Underreported?

If it turns out that Cook underreported problems with the Cook IVC filter, the defense of the learned intermediary doctrine could be stripped from the case. The learned intermediary doctrine means that a medical device manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” such as the doctor or implanting surgeon. It is that learned intermediary’s responsibility to inform the patient of the risk-benefit analysis, the benefits and risks of using the medical device. Medical device makers typically argue to the court that they notified the doctor (and therefore the patient) about the risks involved; it is the doctor’s responsibility to explain those risks to the patient.

However, if the IVC filter (or other device) maker underreported problems to the FDA, the learned intermediary doctrine becomes meaningless. The physician could not have informed the patient of the real risk-benefit profile if only limited information were available, especially if that information were withheld. Consequently, if Cook Medical can be shown to have underreported or misreported IVC filter problems to FDA, its defense could be substantially weakened.

Related

FDA Reporting Regulations:

Medical device makers must report to FDA (1) within 30 calendar days of learning information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health problem.

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