Talcum-Mesothelioma Verdict $29 Million against Johnson & Johnson

(March 19, 2019)  A California jury awarded a woman a talcum powder-mesothelioma verdict  of $29 million against Johnson & Johnson on March 13.  The woman sued J&J over asbestos contained in the company’s baby powder which, she said, caused her to develop mesothelioma.

Plaintiff Terry Leavitt said she routinely used two of J&J’s talcum powder products in the 1960s and ’70s.  She was diagnosed with mesothelioma in 2017. Mesothelioma is a cancer linked to asbestos exposure.  The latency period for mesothelioma can be 30-40 years.

The jury deliberated for two days before finding that J&J’s talc-based products were defective and caused Ms. Leavitt’s mesothelioma.  The jury also ruled that J&J failed to warn the public about the risks. The California Superior Court jury in Oakland awarded the plaintiff and her husband $29.4 million in damages.

Thousands of Talc-Cancer Lawsuits

Johnson & Johnson faces thousands of lawsuits which allege that J&J talc-based products have harmed people.  The Leavitt lawsuit was the first to go to trial since December 2018 stories published by Reuters and The New York Times reported that, for several years, J&J had feared that its baby powder might contain asbestos.  The company still denies, as it did throughout the latest trial, that its talcum powder contains asbestos.

J&J said it would appeal the verdict.  Reuters reported that the company claimed the trial was marred by “serious procedural and evidentiary errors.”  J&J also countered in a statement:  “The jury verdicts are not medical, scientific, or regulatory conclusions about a product.”

J&J Executive:  Talc Asbestos Powder

In December 2018, documents showed that J&J knew for decades that its baby powder was laced with small amounts of asbestos.  The deadly material can occur naturally underground near talcum, which is mined.  In the 1970s, a J&J executive warned that the company’s talc mines might not be free of asbestos.  The New York Times reported that a company memo said some of J&J talc products sometimes contained materials that “might be classified as asbestos powder.”

13,000 Lawsuits over J&J Talcum Powder

Recent cases have tested talc’s link to mesothelioma, but many other cases allege talc powder has caused ovarian cancer.  According to Reuters, Johnson & Johnson now faces more than 13,000 talc-related lawsuits nationwide.

$4.7 Billion Talc-Cancer Verdict

In 2018, a jury ordered Johnson & Johnson to pay 22 women $4.7 billion after  the women alleged that they developed ovarian cancer from using J&J talcum powder products.  More than $4 billion of the jury award consisted of punitive damages, which are designed to punish a defendant for wrongdoing.  In December  2018, J&J failed to convince a judge to throw out that verdict , but the company vowed to appeal that decision.

J&J Denies Talc Contains Asbestos

Despite several jury verdicts over a talc cancer link, J&J has always denied that its talcum has ever contained asbestos.   J&J claims that decades of medical studies have demonstrated that its talc is safe.  J&J has stated:  “Research, clinical evidence and nearly 40 years of studies by independent medical experts around the world continue to support the safety of talc.”

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Shocker: FDA hides Thousands of Medical Device Problems

(March 8, 2019) A shocking report from Kaiser Health News has found that the FDA hides thousands of medical device problems from patients and their doctors.  The FDA has, for nearly two decades, allowed medical device companies to file reports of injuries and malfunctions outside the well-known public database known as MAUDE, Manufacturer And User Device Experience Database.  The FDA, in effect, has been shown to keep separate sets of books: one, a heavily-censored and incomplete public set accessible to patients and providers; the other, a private and more complete (and therefore more relevant) set accessible only to some medical device manufacturers.

 “No matter how cynical you get, you just can’t keep up.”  – Lilly Tomlin

“Alternative Summary Reporting” Subterfuge

The FDA’s bookkeeping subterfuge – which the agency euphemistically calls “alternative summary reporting” – seriously compromises any legitimacy the FDA and MAUDE may have offered, which is an alarming development, to say the least.  Many medical experts have trusted the FDA and MAUDE to identify problems that could put patients in peril.

FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017. That means no doctors or patients saw those reports, or that they saw only a tiny fraction of them if they were similar to other reports made on the same type of device.

Dangerous Devices Lead to Secret Program

According to officials with FDA at the time, “alternative summary reporting” began two decades ago to cut down on redundant paperwork.  Former FDA official David Kessler said the program took shape after scandals over under-reporting of device problems spurred changes that allowed criminal penalties against medical device companies.

Thousands of injury and malfunction reports began coming to the agency each month. Kessler said some 15 staff members reviewed them. He said many reports were so similar that reviewing them individually was “mind-numbing.”  Kessler went to the FDA’s legal department and to device makers for a solution.  Medical device makers then wrote their own ticket; they would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year, or year. Nobody but the FDA would be able to put the actual injury numbers together after that, or the total number of adverse events.  The agency would no longer share those real numbers with the public, with patients and medical providers.

Kessler said reviewers could then quickly look for new problems or spikes in known issues. (They would no longer be bogged down by actual reports, real numbers, total adverse events and injuries that were “redundant.” ) When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, according to Kessler.

Few people even within the FDA knew about the program then or now, and that list Kessler mentions as being public then is no longer public. We do know, however, that transvaginal mesh makers are now part of it, able to hide the actual number of women injured by the controversial plastic mesh used for pelvic organ prolapse and stress urinary incontinence.

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

FDA Unplugged

The Kaiser Health News story suggests the FDA’s reporting deception was not uncovered until a surgeon performed his due diligence after a device he had used failed.

“Special Exemption” 

Dr. Douglas Kwazneski experienced a stapler malfunction during a liver surgery.  He then researched other possible adverse events involving the stapler.  He checked the FDA’s MAUDE database.  He found “there was nothing.”   But then he surveyed leading surgeons.  Two-thirds of them told him they had also experienced stapler malfunctions, or they knew a peer who had.

Dr. Kwazneski then discovered that the FDA had granted the makers of surgical staplers a special “exemption.”  This arcane arrangement allowed the device maker to file reports of malfunctions in a database hidden from both doctors and the public.

FDA Covers up 1.1 Million Events 

“[I]t seemed like a coverup,”  said Dr. Kwazneski, who practiced at the time in Pasco County, Florida.

Worse, the KHN investigation shows FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.  At least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository since 2016.  They all but disappear there, instead of being described individually in the publically accessible MAUDE database.

The hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA. Many of those were implanted in patients or used in thousands of surgeries. The adverse event reports for surgical devices have included surgical staplers, balloon pumps for blood circulation, and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.  “Voluntary?”

Secret Program

KHN notes that the FDA’s secret reporting program has been so obscure that many of the doctors and engineers dedicated to improving device safety don’t even know about it. Even a former FDA commissioner said he knew nothing about it.

Give the Kaiser Health News team all the credit.  They dug through abstruse piles of public records to find “oblique references to reporting exemptions.”  They had to ask the FDA questions for months before the erstwhile “public” agency finally confirmed that it supervised “reporting-exemption” programs and helped hide thousands of never-before-acknowledged instances of malfunctions or harm.

FDA Information Blackout Harms People

FDA records show that amid the agency’s blackout on information regarding device risks, patients have been injured, in some cases hundreds of times.

A former FDA official. Dr. Lori S. Brown, who accessed the data for her research, said doctors who relied solely on the FDA’s incomplete public reports could easily reach the wrong conclusion about a device’s safety record.

KHN wrote, “The FDA has also opened additional – and equally obscure – pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.”

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations.  “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

That’s hardly the stuff to build consumer confidence about medical device safety.

480,000 Hidden Reports in 2017

FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

FDA spokeswoman Alison Hunt said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.

1 Million+ Reports Hidden by FDA

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA.  But with the agency’s alleged new “transparency” push,” anyone unlucky enough to need a medical device (there are always alternatives)  might be able to find a public report and submit a Freedom of Information Act request to get information about incidents.  A response can take up to two years.

Ms. Hunt said in an email to KHN that the exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive.”

The “quality” of the FDA’s review of any medical device is so obviously compromised with the unveiling of the agency’s secret reporting program that such explanations would be laughable if the situation it has created weren’t so dangerous and irresponsible.

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Defibrillators Recalled by Stryker

The Stryker company is recalling thousands of defibrillators due to a malfunction of the device.  The US FDA reported that Stryker’s LIFEPAK 15 device may lock up after delivering a defibrillation shock.  The company said the malfunction may delay delivery of therapy, which can cause serious injury or death.

58 Complaints, 6 Deaths

Since 2009, nearly 60 complaints have been reported to the FDA over the Stryker device.  At least six people have reportedly died from the machine’s malfunction.  According to the FDA, Stryker is “instructing customers to continue to use their (device) according to the operating instructions until the correction can be completed.”

Stryker Recalls LIFEPAK 15 Defibrillator

Stryker itself said the six deaths appear to be related to the defibrillator’s lockup malfunction.   The company said it has become aware that certain LIFEPAK 15 Monitor/Defibrillators have been reported to experience a lock-up condition after a defibrillation shock was delivered. This condition is defined as a blank monitor display with LED lights on, which indicates power to the device, but no corresponding response in the keypad and device functions.

Stryker is contacting people affected by the recall and pledging to fix the problem.  The company says that if the device “exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10) of the (device) should be immediately followed.”

More than 13,000 devices are potentially impacted by the recall.  Stryker is advising patients to continue using their LIFEPAK 15 devices as usual until the company can fix the problem.

Defibrillators are common throughout the civilized world.  The paddle-fitted, electrical devices are used to shock and revive people whose hearts have suddenly stopped beating. The National Institutes of Health explains that these devices are meant to “restore a normal heartbeat by sending an electric pulse or shock to the heart.  They are used to prevent or correct an arrhythmia, a heartbeat that is uneven, or that is too slow, or too fast.  Defibrillators can also restore the heart’s beating if the heart suddenly stops.

Heart experts at Johns Hopkins claim that at least 522 lives can be saved yearly in the U.S. and Canada by the widespread placement of automated external defibrillators. There is general consensus in the medical community that defibrillators are helpful devices when they are properly designed and used, and are functioning properly.

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IVC Filter Maker Cook hit with $3 Million Verdict

(Feb. 9, 2019) — An Cook Blood Clot Filter LawsuitsIVC filter company, Cook Medical, was hit with a $3 million verdict on Feb. 1 by an Indianapolis jury.  The jury returned their verdict just before midnight Friday.  They ruled that the Cook filter placed inside the plaintiff was defective.

Cook Celect Filter Trial

The case involved a 51-year-old dental hygienist whose Cook Celect inferior vena blood clot filter fractured and migrated in her body, eventually poking through her thigh and requiring open laparotomy surgery to remove.

Surgeons placed the controversial filter – which is alleged to trap blood clots – into the woman’s inferior vena cava March 2009 during lumbar spine surgery.  She complained in the next few months about hip pain, severe abdominal pain, and pain and swelling.

A CT scan in June 2011 showed her IVC filter had fractured in a prevertebral location abutting the anterior aspect of the L2-3 disc space and upper L3 vertebral body.  A follow up visit found  a “palpable mass” in the skin under her right leg.  The next day the woman pulled a 2-inch long metal object from her right thigh.  That object was part of the filter which had fractured inside of her vena cava and migrated.

In July 2010, surgeons attempted to remove the broken IVC filter but were unsuccessful.  Then, finally in October 2015, surgeons were able to remove what was left of the filter device.

Texas State Court Loss was Cook’s first

The troublesome filter in the Indianapolis trial concerned Cook’s “Celect,” which was also the subject of a jury trial and a subsequent verdict against Cook last Spring in Texas.

In May 2018, a state court jury awarded a Houston-area firefighter $1.2 million for a defective Cook Celect blood clot filter.  The case was similar in that the person implanted with the filter required open laparotomy surgery to have it removed.  And like the woman in this latest case, the plaintiff had it removed because it had migrated to where he feared it working like a “ticking time bomb” in his chest.

In the only other Cook IVC case to go to trial, an Indianapolis jury denied a woman’s claim for damages in summer 2017.  But in that case – a defense pick for trial – surgeons had been able to successfully remove the filter without resorting to open laparotomy surgery.

IVC Filter Problems

IVC filters have proven troublesome because even though they are often used as medical devices in the hopes that they will prevent DVTs, much evidence suggests that they don’t pass a risk-benefit analysis which is the gold standard of any medical device treatment.  Much evidence suggests that they have become accepted despite lacking evidence of being worth their risks.

IVC Filters give no benefit for Trauma Patients

Even though they are often used in trauma patients without the patients’ consent, there is no evidence that they offer trauma patients any benefit and are worth their risks.

No Long-term Benefits

Evidence has also shown that the longer removable IVC filters remain inside a patient’s vena cava, the more likely they are to cause problems.

In addition, evidence suggests that IVC filters don’t protect the patient from developing deep vein thrombosis (DVT) as well as their makers claim they do, while at the same time they can cause other problems which one who opts not to have a filter installed would not otherwise experience.

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Criminal Deceptions drive Drug Company Profits

Would you trust your life or the lives of your loved ones to known criminals?  Criminal deceptions drive drug company profits. Doctored studies, international bribery, deceptive marketing, outright lies, fraud, and kickbacks are the norm in the obscenely lucrative legal drug and vaccine business.  Big Pharma has been penalized with criminal fines from government far more than any other industry.  Drug companies are even dirtier, by comparison, than routine offenders such as “defense” contractors and oil companies like BP and Exxon.

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Big Pharma: Earth’s Most Corrupt Corporations

This is a hard fact on which your life may depend:  the pharmaceutical industry has the worst record of any industry for illegal violations of the law.  Drug companies make billions of dollars selling antidepressants and many other drugs that offer no demonstrable value but plenty of provable harm.  Here is a list of just a few bad Big Pharma actors and recent fines they’ve paid for their transgressions:

  • GlaxoSmithKline (GSK):  nearly $8 billion in 31 settlements
  • Pfizer: nearly $4 billion in 31 settlements
  • Johnson & Johnson: more than $2.8 billion in 19 settlements
  • Merck:  nearly $2 billion in 30 settlements
  • Abbott:  more than $1.7 billion in 16 settlements
  • Eli Lilly: more than $1.4 billion in 15 settlements
  • Teva:  nearly $1.5 billion in 13 settlements
  • Schering-Plough:  more than $1.3 billion in 6 settlements
  • Novartis:  $1.25 billion in 20 settlements
  • Astra Zeneca:  more than $1 billion in 20 settlements

An Insider Exclusive Special reveals how:

  1. The Pharmaceutical Industry – generating $650 plus billion dollar a year  – has been the most profitable business in the U.S. by treating “disease” as an industry. It accounts for nearly 30 percent of the Gross Domestic product.
  2. Much of Big Pharma’s ‘success’ lies in the connections between the companies and the ‘symptoms management’ health care industry.  Encouraging symptoms and treating them pays; preventing diseases or symptoms does not pay.
  3. The medical establishment works closely with multinational drug companies focused first on profits.  Healthy people don’t add to profits.
  4. Lots of drugs MUST be sold. In order to achieve sales, anything goes: lies, fraud, kickbacks, ghostwritten medical “literature,” studies made with predetermined outcomes, you name it. Doctors function primarily as the principal salespeople of the drug companies, which is the way the entire scam was all set up more than 100 years ago, beginning with Rockefeller medicine’s Flexner Report published in 1910. This “Report” was used to effectively establish a monopoly on “healthcare”  that continues today.  Doctors who continue to promote Rockefeller medicine today are rewarded with research grants, gifts, and lavish perks.
  5. International bribery, corruption, and fraud run rampant in the testing of drugs. Criminal negligence exists in the unsafe manufacture of drugs, and not just in China.
  6. Many people don’t realize how drug companies are accused today of endangering public health through wide scale fraudulent marketing schemes. Drug company scams include covertly attempting to persuade consumers that they are ill. Drug companies also bribe doctors, and misrepresent safety test results on their products.

Today the drug industry continues to get away with deceptive “Off Label Marketing.”  Sadly, the American Medical Association (which was convicted of conspiracy to destroy its competition) and the FDA are complicit in allowing doctors to continue to prescribe drugs for “off label” purposes.  Because of this broken system, drug companies continue to get away with deceptive drug marketing.  After they pocket billions of dollars in profits for dangerous or worthless drugs, they then often pay only a small percentage of those billions in fines and settlements.

Medical-Pharmaceutical Complex

Make no mistake: there exists today a Medical-Pharmaceutical Complex that does not work for the long-term betterment of peoples’ health.  This Complex works instead for the short- and long-term goal of drug company profits.  Hence the billion-dollar fines, but it is hardly enough to fix the broken system rigged against the health and betterment of the individual.

The pharmaceutical industry has strayed from its original mission of discovering and manufacturing useful drugs – if that were ever its goal.  It has become, instead, a vast marketing monster with unprecedented control over our fortunes, which are inextricably tied up with the enormous amounts of insurance money we all are now required to pay regardless of how little we use the broken system.

Drug Companies control the Healthcare System

Drug companies now exercise nearly limitless influence over medical research, education, and the behavior of individual doctors. Those who don’t do what Big Pharma dictates that they do – prescribe dubious or dangerous drugs for marginal or even imaginary maladies encouraged by slick advertising campaigns – are ostracized from the medical profession and even driven out altogether.

Only in America can a drug company executive or lobbyist charged with a laundry list of morally repugnant behaviors – medical fraud, criminal salesmanship, gaming the insurance industries, lying to federal officials, manipulating the data of drugs that have killed people – get away with a fine, then receive a financial bonus while enjoying a surge in his company’s stock price after a settlement.  China fines and even executes individuals for such transgressions, but in America it’s all about financial rewards, as long as the criminal fines don’t exceed the profits.

“Alternative” Medicine Canard

It is a function of the dysfunction of our medical system that the AMA and the Medical-Pharmaceutical Complex has succeeded in calling any approach to health not sanctioned by the state “alternative” medicine.  That term is meant to function pejoratively to dismiss anything not sanctioned by the Complex as anti-scientific, but it is also a term which the medical monopoly has used to keep us all from exercising our God-given right to choose whatever therapy we would like.

It should be clear to anyone capable of thought that whatever one chooses is an “alternative.” Chemotherapy, for just one example, is only one “alternative,”  and not a very good one at that, failing 97% of those who consent to it.  But chemo is not called an “alternative” where insurance companies are concerned.  Insurance companies work hand in fist with the Complex to pay only for those drugs or therapies which Big Pharma and its D.C. lackeys dictate will be paid for.  This situation constitutes a medical insurance monopoly, but no mainstream publication will call it that, because the five outlets which own and operate our mainstream “news” are owned by the same multi-national conglomerates which own the drug companies and run the Medical-Pharmaceutical Complex.

Good News

The good news is that more and more people are waking up to the scam, to the medical monopoly controlled by the pharmaceutical industry.  Someday, we may even be able to retake our own rights to medical choice, have our insurance company pay for treatments that we choose, according to our own lights, instead of only those “choices” dictated to us by Big Pharma and the medical monopoly that still controls our broken “healthcare” system.

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3M pays $9 Million for Soldiers’ Defective Earplugs

Earplugs Linked to Hearing Loss

(Jan. 7, 2019) The 3M company agreed to pay the U.S. government $9.1 Million last summer to settle a lawsuit over defective earplugs that allegedly caused our soldiers hearing loss and/or tinnitus. That sum included $1.9 Million for a whistleblower who said the company knew the plugs were defective.

Related:  Defective Earplug Lawsuit

Minnesota-based 3M made the earplugs for U. S. soldiers stationed mostly in Iraq and Afghanistan from 2003 to 2015.  The Dual-Ended Combat Arms™ Earplugs (CAEv2) – now discontinued – were standard equipment for soldiers during those years.

Acting in good faith that the plugs would do what the company claimed, the U.S. Defense Logistics Agency distributed millions of dollars’ worth of them to thousands of service members, putting them at risk for permanent hearing loss or impairment.

The Defective CAEv2 Earplugs

The plugs featured a dual-ended design. They were meant to be used as either traditional earplugs, or they could be flipped over to provide normal hearing while protecting the wearer’s eardrums from gunfire noise and explosions.

The main complaint was that the earplugs were too short to be effectively inserted into a user’s ears. The too-short design led to the plugs gradually loosening in some ears, effectively rendering them useless to protect from hearing damage.

Whistleblower:  3M Knew Earplugs Defective

Though 3M has admitted no wrongdoing in the settlement, a whistleblower said 3M and its predecessor, Aearo Technologies, knew about the plugs’ design problems as early as 2000.  The earplugs failed to pass safety tests then.

Defective Earplug Lawsuit

The defective earplug lawsuit’s allegations were issued under whistleblower provisions of the False Claims Act.  That law allows private parties to sue on behalf of the U.S. government if they believe the lawsuit’s defendants submitted false claims for government funds. The law also allows whistleblowers to share in any funds recovered from a successful lawsuit.

As part of the defective earplug lawsuit resolution, the whistleblower will receive $1,911,000, according to the Department of Justice.

Legal Help for Soldiers with Hearing Loss

More than 2.6 million veterans are receiving disability compensation for hearing loss and tinnitus (ringing or buzzing in the ears), according to the Veterans Administration (VA).

Our law firm is investigating defective earplug hearing loss lawsuits.   We are considering legal action for anyone who meets the following criteria:

  • Served in the military 2003-2015
  • Was issued earplugs during service
  • Suffers from permanent hearing loss or tinnitus

Contact Matthews & Associates for a free legal consultation in a potential defective earplug lawsuit. Our attorneys and legal assistants may be able to help you take legal action for your hearing loss.

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Vaccine Maker Fined $1.3 Billion for Fake Vaccines

(Oct. 22, 2018)  China.3 Billion for Fake Vaccines"> imposed a $1.3 billion fine on a company responsible for selling fake vaccines.  Vaccines given to hundreds of thousands of Chinese children were later determined to be expired, or were so soon-to-be-expired that they could not work as advertised – for those who believe that the vaccines in question could be said to work at all.

Related:  Shingles Vaccine?  Really?

The government fined the Changchun Changsheng Biotechnology Company last week amid public furor over the fake vaccines.  The New York Times noted that the scandal comes at a time of increasing anxieties among China’s growing middle class.  Many Chinese were already palpably angry about several recent drug and food safety scandals.

The usual “experts” – like Wang Yuedan,  immunology professor at Peking University, quoted in the NY Times – claim the large fine will help bring “order” to the vaccine industry.  But that ‘apologia’ falls flat in the face of recent history of vaccine fraud in China.

In 2016, about two million improperly stored Chinese vaccines were sold from an overheated, broken-down storeroom.  The main suspect was a hospital pharmacist who had been convicted of trading in illegal vaccines in 2009, then was doing the same thing again two years later.

U.S. Vaccines made in Chinese Facilities

Most U.S. vaccines are now made in Chinese facilities, and the U.S. FDA has virtually no power to oversee their production or test them for safety or efficacy.

Hillary Clinton played the lead role in allowing Chinese vaccine manufacturers to completely bypass US vaccine testing requirements (see The Bolen Report).  After Mrs. Clinton’s “work” in 2014, China was allowed to ship vaccines directly from Chinese factories to American children, with no quality control beyond inspecting the labels.  The lurid details were trumpeted by the WHO as a triumph:  China enters the Global Vaccine Market.

The World Health Organization wrote of the Clinton plan:  “The Clinton Health Access Initiative (CHAI) has been working with Chinese suppliers to support their applications for WHO prequalification for several vaccine candidates for the last two years, says Joshua Chu, CHAI’s Director, Vaccines Markets.”

The Chinese have killed our pets with poisoned dog and cat food, produced tainted rabies vaccines, sickened many thousands of us in our homes with toxic drywall, and sold us expired or sub-standard drugs and vaccines before (if, again, you believe that vaccines work at all).  Our own agencies, like the FDA, have virtually no power to oversee them; yet we are to believe that these vaccines made in China are safe and effective?

Even the Chinese don’t believe their vaccine makers now, or their own government’s ability to keep them safe from vaccine profit seekers.  So, are you really so certain that you should dismiss and attack anyone who questions vaccination?

Do you know where the vaccines they are forcing on your school-aged children are produced?  Do you know what’s in those vaccines?  Do you know what kind of quality control is brought to bear on those vaccines?  The FDA doesn’t know.  But you do?

Related:  Vaccines All Contaminated with Cancerous Toxins

Do you know enough to scornfully label any vaccine skeptic an “anti-vaxxer,” as the mainstream news outlets all routinely do at the behest of their Big Pharma advertisers?  There are plenty of troubling vaccines which kill or injure people severely.  Just ask those injured by Merck’s Shingles Vaccine (Zostovax), Merck’s highly dubious Gardasil vaccine, or the usually worthless but always dangerous influenza vaccine.

Educate Yourself

Educate yourself.  Your life or the life of your child may depend on it.  It’s not enough to ignore the details, like the problems of trusting China with injecting aborted fetal cells, pig’s blood, mercury, aluminum, glyphosate, and other toxins directly into your bloodstream.  How can people who read food labels not know what’s in the vaccines pumped directly from China into their children?  How can people who read food labels have so little understanding of the secret processes and the woeful production “standards” of the catalogue of  vaccination poisons being pumped into them?

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How Diabetes Drugs cause Dangerous Genital Infections

The US FDA announced on August 29, 2018 that certain diabetes drugs can cause dangerous genital infections.  The agency warned that people suffering from type 2 diabetes can be injured by a terrible “side effect.”  These popular drugs – Invokana, Invokamet, Farxiga and Jardiance — can increase the risk of a flesh-eating bacteria infecting the genitals.

The FDA issued a warning about sodium-glucose cotransporter-2 (SGLT2) inhibitors, drugs  commonly prescribed for treating type 2 diabetes.  These drugs were linked, over a five-year period, to a dozen rare cases of genital infection known as Fournier’s gangrene or necrotizing fasciitis. This potentially lethal malady causes the skin to die.  All 12 patients who developed it required hospitalization, according to the FDA.  One person died.

SGLT2 Inhibitors linked to Flesh-eating Bacteria

The SGLT2 inhibitors have been linked to cases of a flesh-eating bacterial infection that attacks the perineum, the skin between the anus and the vulva or the anus and the scrotum.  An infection of the perineum affecting this part of the body is called Fournier’s gangrene.  It is a rare but potentially fatal condition.

Fournier’s gangrene is more common in men than women.  It can spread to other parts of the body, according to medical experts.  It can also rapidly progress to involve the entire genital area, and even infect the abdominal wall.

The 12 cases of this infection that the FDA saw spurned the agency into requiring that all  SGLT2 inhibitors now include a warning about this risk in the prescribing information. The medications in this class include canagliflozin (Invokana & Invokamet), dapagliflozin (Farxiga), empagliflozin (jardiance) and ertugliflozin (Steglatro). The drugs are available as single-ingredient medications or in combinations, such as with metformin.

How do these infections occur?

Type 2 diabetes occurs when the body can’t remove sugar from the bloodstream.  In a diabetic, the cells fail to respond to insulin, the hormone that helps move sugar into the cells.  SGLT2 inhibitors can help lower blood sugar by causing the kidneys to remove sugar from the body through urine. This process can stabilize blood sugar levels.

Unfortunately, this process can also lead to infections, because anywhere there is higher blood sugar, there’s an increased risk of bacterial infection.  Bacteria is all over us, and a sugary environment is a great breeding ground for bacteria. When one eliminates more sugar through urine, a greater concentration of bacteria reaches into the genital area.  This area then becomes an   inviting environment for bacteria.

Bacteria can become a problem only when there is an entry point to infect, such as a small cut from shaving or a skin ulcer near the genitals.  When that happens, the infections can become serious and require many surgeries to remove all of the infected tissues, which is exactly what happened to the 12 people in the FDA report which led to the newly required warnings.

How Diabetes Drugs cause Dangerous Genital Infections

The FDA warning includes instructions for any patients taking these drugs to seek immediate medical attention if they experience any signs of swelling, itching or irritation in the genital area, or if they experience a fever above 100.4 degrees Fahrenheit (38 degrees Celsius).  The bacteria that can cause necrotizing fasciitis can spread quickly, so it’s vital to seek immediate treatment at any sign of infection and a general feeling of ill being.

Type 2 Diabetes Treatment Options Exist

SGLT2 inhibitors are not the only game in town for those who suffer from Type 2 diabetes. Good hygiene can help minimize the risk of necrotizing fasciitis, and Type 2 diabetes can be controlled in ways which don’t involve taking SGLT2 inhibitors.

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Diabetes Drugs cause Gangrene

(Sept. 24, 2018)  Diabetes drugs can cause Fournier’s gangrene.  That was the shocking conclusion of the FDA last month after the agency said it received reports that 12 people contracted gangrene or necrotizing fasciitis after taking a popular diabetes drug.

Invokana, Farxiga, Jardiance, or Steglatro can raise the risk of a nightmarish flesh-eating bacteria that can infect the genitals and cause partial amputations.

A serious genital infection has been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT-2) inhibitors.  The serous infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.

The U.S. FDA announced the infection warning on August 8, 2018 after receiving a dozen reports of individuals who had been diagnosed with the potentially fatal gangrene or necrotizing fasciitis after using an SGLT-2 inhibitor. Several of those infected people required multiple surgeries, and one person died from the infection.

What are SGLT-2 Inhibitors?

SGLT2 inhibitors — sodium-glucose cotransporter-2 – are prescribed by doctors to help lower blood sugar in adults with type 2 diabetes.  SGLT-2 drugs lower blood sugar by causing the kidneys to remove sugar through the urine.  Brand-name SGLT2 inhibitor drugs (and their active ingredients) include Invokana (canagliflozin), Farxiga (dapagliflozin), Jardiance (empagliflozin), and Steglatro (ertugliflozino).   Steglatro is also FDA approved to lower heart attack and stroke risk in adults suffering from type 2 diabetes and heart disease.

What is Fournier’s Gangrene?

Fournier’s gangrene is a life-threatening bacterial infection of tissue under the skin that surrounds the perineum’s muscles, nerves, fat, and blood vessels.  The perineum is the space between anus and scrotum in the male, and the skin between anus and vulva in the female.

Diabetes raises Risk Factors  

The FDA web site states that “having diabetes is a risk factor for developing Fournier’s gangrene.   But this condition is still rare among diabetics.  There’s a dearth of published literature regarding the occurrence of Fournier’s gangrene for men and women.  Fournier’s gangrene occurs in roughly 1.6 out of 100,000 males annually in the U.S.  It most frequently occurs in males aged 50-79 (approx. 3.3 out of 100,000).

At least 12 Diabetes Drug Gangrene Cases reported to FDA

In a five-year period since the first SGLT-2 drug was approved by the FDA — from March 2013 to May 2018 — the agency said it found 12 cases of Fournier’s gangrene in patients taking an SGLT-2 inhibitor.  That number includes only reports submitted to FDA and found in the medical literature.  The FDA admits there may be more cases about which it is not aware.  Most experts generally agree that only 1-10% of a given drug’s adverse drug events ever get reported. That would put the actual number of people injured by Fournier’s gangrene or necrotizing fasciitis from SGLT-2 drugs somewhere between 120 and 1,200.

1.7 Million SGLT-2 Prescriptions in 2017

The U.S. FDA estimates that 1.7 million patients filled a prescription for an SGLT-2 inhibitor in 2017.  The agency said the 12 Fournier’s gangrene cases it saw involved 7 men and 5 women.  All the injured people developed Fournier’s gangrene several months after filling an SGLT2 inhibitor prescription.

Diabetes Drugs cause Gangrene

The FDA said that in the 30 years prior to 2013, it had received reports of just six cases of Fournier’s gangrene (all of which occurred in men) from all other antidiabetic drug classes.

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Women’s Pelvic Mesh Use Suspended in England

(August 9, 2018)transvaginal mesh Women’s pelvic mesh use was suspended in England last month pending government review.  English regulators suspended the surgical use of transvaginal mesh after listening to mesh-related horror stories from several women.  The politicians listened as dozens of women detailed stories of how the mesh has caused them excruciating misery and endless pain.

Related:   Transvaginal Mesh Lawsuit

The suspension means surgical mesh meant to treat stress urinary incontinence is not to be used again in England until the mesh meets five strict conditions which thousands of mesh-injured women campaigned to demand.  Many of the women belong to a group of 6,100 people called ‘Sling the Mesh.’  Members have called attention to problems with both women’s pelvic mesh, hernia mesh, as well as rectopexy mesh, used to treat rectal prolapse.

Sling the Mesh

“This is incredible news,” said ‘Sling the Mesh’  founder Kath Sansom.  “It is a testament to people power.  Our members have written, emailed, attended Parliament and lobbied to get this result, and I am delighted.”

The government review of mesh is scheduled to conclude in March 2019.  It will determine if the suspension of the plastic mesh used in people will become permanent.

Ms. Sansom brought the anti-mesh campaigners to Parliament, which led to an internal investigation by the National Health Services, as well as debates in the House of Commons.  That action led to more public awareness of the severe complications surgical mesh can cause.  In the U.S., widespread use of transvaginal mesh has led to a virtual catastrophe, with more than 100,000 women filing lawsuits at one time over plastic mesh complications.

In February 2018, the government announced a review of surgical mesh.  Regulators planned to meet face-to-face with citizens around the UK.  Health and Social Care Secretary Jeremy Hunt said the government’s final recommendation should be publicized next March.

Baroness Julia Cumberlege led the mesh review.  Medical Mesh News Desk reported that she was so moved by the stories she heard that she suggested  an immediate suspension in the use of surgical mesh for stress urinary incontinence (SUI).  Ms. Cumberlege believes rectopexy mesh for rectal prolapse should also be suspended.

Human Suffering outweighs Benefits of Mesh

“We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively,”  Ms. Cumberlege told the Daily Mail.  “ We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.  I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.”

Baroness Julia Cumberlege

“We had to act now,” said Ms. Cumberlege.  “My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.”

Five Conditions Must Be Met

There’s no ban for now, but a “halt” to procedures pending five conditions:

  1. Surgeons may perform an SUI operation only if they receive proper training and regularly perform surgeries.
  2. Surgeons must report every procedure to a national database.
  3. A surgeries registry will be maintained to note the type of procedure and the woman involved.
  4. Complication reports to the MRHA must be linked to the register.
  5. Specialized centers must be identified and accredited to deal with complications and removals.

As in the U.S., mesh proponents claimed that only prolapse surgeries should be banned.  Health regulators, however, acknowledge that three-quarters of pelvic mesh surgeries are done to treat SUI, and they account for most of the horror stories.

An estimated 130,000 UK patients have had an SUI or POP procedure in the past decade.  Complication rates have been found up to 42%, with 30% reporting a lost or reduced sex life, and urinary infections reported at 22%, with bladder perforation in 31 percent of cases.

Women across the globe have complained of pelvic mesh complications.  Mesh-injured women  in Scotland have also addressed their government directly and achieved a suspension on the mesh used for SUI.   That suspension came in 2014 after a consistent talking campaign as well as extensive media coverage from an enterprising reporter, Marion Scott.

New Zealand also suspended mesh use for pelvic organ prolapse (POP) as well as incontinence, while Australia suspended mesh use for POP.  Hundreds of Australian women have filed lawsuits against Ethicon over its mesh implants.

Sling the Mesh Reaction

Ms. Sansom, who is also a CambsTimes reporter, said, “I think the really positive thing about the suspension is the government is finally listening to us and realizing just how awful it is when these mesh implants go wrong.”

She noted the government is not suspending the use of mesh for rectal prolapse, which Ms. Cumberlege also called for.  Ms. Sansom also noted the same plastic is used for hernia repairs and they are starting to get the same complications, pain loss of sex life, autoimmune conditions.

British Urogynaecology (BSUG) Disagrees with Mesh Suspension

The British Society of Urogynaecology (BSUG) strongly disagrees with the decision to suspend the use of surgical mesh for stress urinary incontinence recommended by the All Party Parliamentary Group (APPG).

The government’s decision is not based on any scientific logic or thinking, claim BSUG  members. The statement is signed by Professor Jonathan Duckett chairman of the BSUG.

Kath Sansom:  BSUG Deluded

Kath Sansom tells MND that the BSUG group is “Absolutely deluded, defensive, sounds very angry, totally not supportive to women and peddling the tired old myth that this is the most trialed procedure out there.  These are the aggressive urogyn surgeons.  It is very clear they have put a lot of pressure on Govt following Baroness C’s call to “pause.”

Government Trials Flawed

Ms. Sansom believes the government trials that are underway are flawed for several reasons:

  1. Most trials are not randomized, but simply mesh vs. mesh; there’s no control group.
  2. Most trials are short term, roughly two years, shy of when most problems start.
  3. Tiny cohorts: One study of 90 women drops to 58 after 17 yrs., a drop of 22%. Even a 5% drop adds significant bias to a study.
  4. Poor quality of life (QoL) studies fail to look at new onset of chronic pain, nerve damage, urinary infections, loss sex life, etc.
  5. Most QoL questions are based on the SUI pad test. Ludicrous!
  6. Many trials authors have conflicts of interest. In the Pt. 3 trial above, two authors were paid by Ethicon, which makes the mesh slings being “tested.”
  7. Many trials come up with damning statistics and then ignore them. One by Brubaker et al shows a 42% risk, but the abstract/conclusion claims it is only short term and says mesh is an effective treatment option. (Ludicrous!) Busy doctors don’t take the time to read through every report so they believe the hype.

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