IVC Filter Verdict: $4 Million

(March 30, 2018)  The first Bard IVC filter verdict in the U.S. District Court for the District of Arizona yielded a $4 million jury award for a woman injured by one of the blood clot filter devices. The jury ordered C.R. Bard to pay plaintiff Sherr-Una Booker $1.6 million for failing to warn her surgeon about problems linked with the filter, and an additional $2 million in punitive damages.  The jury found Bard 80% responsible, a radiologist 20% responsible.

The woman’s C.R. Bard blood filter broke inside her body, causing her to suffer open heart surgery. The jury found that Bard had negligently failed to warn the plaintiff and doctors of the device’s problems despite numerous reports of IVC filter complications.

The jury found 20% of fault attributable to radiology errors.  Law 360 reported that a radiologist “failed to flag a visibly separated filter piece on an X-ray in 2009, before Booker’s injuries developed to the point where she needed open-heart surgery.”  Bard’s share of the total damages amounts to $3.6 million.  Despite Bard’s arguments blaming the surgeon, the jury found the surgeon was only partially able to remove pieces of the broken IVC filter from the plaintiff’s body, and was not a cause of her injuries.

IVC Filters show no proof of efficacy but proof of harm

“We expect to see many more of these verdicts,” said attorney David Matthews, who deposed Ms. Booker’s interventions radiologist in the case.  “IVC filters show no proof of efficacy with proof of harm.”

Ms. Booker’s federal case is one of nearly 3,500 claims consolidated in the Ariz. MDL, where U.S. District Court Judge David Campbell is presiding. Ms. Booker filed the case after her IVC filter broke apart in her body. The judge limited the legal claims to defective design, failure to warn, and punitive damages. The plaintiff won all but defective design.

In addition to the $1.6 million award for failure to warn, the jury added another $2 million in punitive damages.

IVC Filter Verdict: $4 Million

First filed in February 2016, Ms. Booker’s lawsuit claimed that her injuries included IVC filter tilting, fracture and perforation. The case is 2:15-md-02641-DGC)

C.R. Bard faces an additional several thousand IVC filter lawsuits filed in state courts across the country.

IVC Filter History
IVC filters were first introduced in 1979. Since then, hundreds of thousands of IVC filters have been implanted in people.

IVC Filter Lawsuits
In August 2010, the FDA issued a safety communication that stated IVC filters “are not always removed.” The agency indicated then that known long-term IVC filter risks included lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization, IVC perforation. More than 7,000 IVC filter lawsuits have been filed in state and federal courts against C.R. Bard, Cook Medical, Johnson & Johnson, Cordis Corporation, B. Braun, Rex Medical, and other filter makers.

Related

•  First Bard IVC Filter Trial Scheduled

Lawyers can depose ex-Cook President

•  IVC Filter Verdict: $4 Million

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FDA Medical Device Proposal Threatens Public Safety

(March 29, 2018)  A new FDA medical device proposal threatens public safety, according to attorney David Matthews, who is preparing to try the first Cook IVC filter lawsuit in state court in the country.

The FDA now wants to work with medical device manufacturers to make it easier to get new devices to the market.  What could go wrong?  Plenty has gone wrong in the past.  Some FDA-cleared medical devices have been recalled by FDA; many have been “voluntarily” recalled by the device makers themselves.

For medical devices such as IVC filters, said Mr. Matthews, “the FDA follows the 510(k) ‘substantially similar’ mandate and does not do a safety and efficacy analysis which would be required under a PMA approval process.   Their hands are tied to a certain extent.    We all have to rely on the device manufacturers, and that is an inherently flawed process.”

“The history of the IVC filter provides valuable insight into the shortcomings of medical device approval in the United States,” said a JAMA article published online March 18, 2013.  The doctor authors noted that as the device approval or clearance process currently stands, “there is little incentive for IVC filter makers to embark on [testing] trials that can only eliminate their products’ market share.”

Thousands of Medical Device Problems

Thousands of people have had trouble with medical devices that include transvaginal mesh, metal-on-metal hip implants, knee replacements, IVC filters, hernia mesh, and many other medical devices.  It’s troubling, to say the least, that the FDA now wants to move devices through its review processes even faster.

Device makers argue that they can’t get their useful devices out to people fast enough, that they’re being held back by too much regulation.

Deregulation rules the Day in D.C.

As the Trump administration continues to assert that almost any regulations are bad for the economy, Mr. Trump’s FDA personnel appointments are working to create a new fast-track path to the market for medical devices.  Legal experts, however, say such a move may exceed the FDA’s authority and require some creative reasoning to justify to judges.

FDA Commissioner Scott Gottlieb proposed in December 2017 the creation of a quick route to market for certain products that may not meet the criteria for clearance under the agency’s existing fast-track pathway, known as 510(k).  Mr. Gottlieb said such fast-tracking would foster innovation, though it’s hard to follow his logic, if any logic applies – or matters anymore where corporate profits are concerned.

The fast-track proposal is part of a broader effort by the agency to reduce the amount of clinical evidence required for medical device approvals.  Medical device companies could save millions of dollars and years of development time, if the plan is made law.

510(k) Approval Process
A product cleared under the auspices of 510(k) in current law must show substantial equivalence in materials and intended use to an existing legally marketed device, which is known as a predicate product.  Some 3,000 devices are cleared this way each year, making 510(k) the most common pathway for a medical device to reach the market.

The new FDA proposal would eliminate the need to test a new product against a specific predicate product.  Instead, 510(k) would be replaced by a set of technical standards that would serve as a kind of proxy for the predicate.  The FDA said it would release further details in “non-binding guidance” for industry players early this year.

Mr. Matthews said the agency appears to be changing the law to make it easier for device makers, at the expense of consumers, who need and have a right to expect safe and effective products.

Reuters reported that an expert in medical technology and public health law at the University of Florida, Lars Noah, doubts the FDA plan can hold up under legal scrutiny.

Mr. Noah said, “If somebody with standing wanted to challenge the FDA’s decision in court, a judge is going to say: ‘Show me the predicate.’  I don’t see how the court would side with the agency.”

Abbreviated 510(k)?
The head of the FDA’s medical device division, Dr. Jeffrey Shuren, said in an interview that the move would simply expand on something the agency is already doing with its rarely-used “abbreviated” 510(k) pathway.

The abbreviated route allows companies to show their device meets certain product standards but does not eliminate the need for a specific predicate.  Dr. Shuren said companies in future could show substantial equivalence “to a technology” rather than a product.

In some ways the FDA’s new proposal mimics a frowned-upon practice known as “predicate stacking” in which companies include multiple predicates in their application.  The new product might contain characteristics substantially equivalent to a conglomeration of predicates but not be substantially similar to a single product.

The new fast-track plan makes it appear FDA could now be encouraging stacking, which is hardly ideal, as several devices could be offered as predicates for various features, despite the fact that none may be a true predicate.  It appears the FDA is merely stacking the deck to allow companies to get devices to the market faster, despite a dearth of safety testing and a clear predicate.

The agency is already at work helping companies market digital health products for which the FDA is not requiring approval at all.  Nine companies, including Apple Inc., Roche Holding AG, and Johnson & Johnson will be “pre-certified” based on certain quality and technical metrics to release new digital health products without filing a 510(k) for each.

FDA Medical Device Proposal Threatens Public Safety

“Why is the FDA working with companies to help them waive the statutory obligation to file a 510(k)?” asks Mr. Matthews.  “The 510(k) clearance problems themselves are well documented, and now the FDA is working to help companies sidestep even that clearance altogether? It’s fair to ask whether that agency is working for companies or for people.  It’s fair to ask, for whom does the FDA work, and what are its priorities?”

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Just For Men Lawsuits

“Just for Men” hair and facial dye products may cause severe chemical burns and allergic reactions.  Affected men have reported swelling, scarring, and facial disfigurement.  Just For Men lawsuits may be filed for these problems.

Our product liability lawyers are reviewing “Just For Men” lawsuits for men throughout the United States and Puerto Rico.  If you have suffered injury after using “Just For Men” products, contact us for a free legal consultation.

What is “Just For Men”?

“Just For Men” hair coloring was originally released in 1987 by Combe, Inc.  The product is advertised as a hair, beard, and mustache dye for covering up gray hair. There are many products in the Just For Men line to darken gray hair, from beard and mustache coloring kits to hair and side burns.  Some are even designed to add accents of gray to hair.

In recent years, growing numbers of men have reported severe chemical burns and other allergic reactions after using “Just For Men.”

Just For Men problems / side effects:

•  Allergic reactions

•  Skin burns

•  Skin swelling

• Severe itching

•  Blisters and weeping sores

•  Trouble breathing due to throat swelling

Just For Men Allergic Reactions

Hundreds of men have reported adverse reactions.  Many have reported using Just For Men for years without incident, but then they suddenly suffered severe chemical burns and facial swelling. Many of the “Just For Men” problems emerged long after the men used the product.

While some have speculated that the company changed the formulation of Just For Men, Combe officials have publicly denied changing their popular formula.  If Combe is to be believed, sudden allergic reactions among men could possibly be linked to changes in a person’s body chemistry.

What is p-phenylenediamine?

“Just For Men” hair dyes contain p-Phenylenediamine, an organic compound considered to be one of the world’s most prevalent allergens.  People are exposed to p-phenylenediamine (PPD) primarily through permanent hair dyes which rely on chemical reactions (oxidaton) to fix the color.  PPD reacts with hydrogen peroxide to permanently bind the color to the hair.  PPD is part of a class of chemicals called aromatic amines, which are found in the plastic and chemical industries as byproducts of manufacturing.  PPD is also used in the manufacture of rubber and certain polymers such as Kevlar.  It also acts as a developing agent in photography.

PPD was declared Allergen of the Year by the American Contact Dermatitis Society in 2006.  It has also been suspected of causing cancer.

PPD and Cancer

Aromatic amines in hair dyes such as PPD have long been suspected of being carcinogenic.  They are linked to increased incidence of bladder cancers, though studies examining cancer risk of PPD have found conflicting results.  the International Agency for Research on Cancer (IARC) states that it is unable to classify the carcinogenicity of p-phenylenediamine.

Hair Dye Allergies on the Rise – NIH

The National Institutes of Health noted in 2007 that allergic reactions to hair dye were on the rise, apparently because more and more people were dying their hair.   Allergic reactions became such a serious problem in the 20th century that PPD was banned from hair dyes in Germany, France, and Sweden.  In the U.S., where corporations are more likely to call the shots on chemicals, it’s buyer (and user) beware!

Related

Allergy to Hair Dye – NIH

•  Just For Men Lawsuits

•  www.SafeCosmetics.org

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Decline in IVC filter use fails to affect VTE hospitalization rates

Cook Medical, C.R BardCook IVC Filter Attorney and other IVC filter makers claim their devices lower rates of venous thromboembolism.  But a sharp decline in IVC filter use has failed to affect VTE hospitalization rates.

A letter published in the Journal of the American Medical Association reported in July 2017 that after the FDA issued a safety warning in 2010 about adverse events associated with IVC filters, their use decreased. However, that warning failed to impact VTE hospitalization rates.  If the filters were working as advertised, one would have thought that reducing their use would have raised VTE hospitalizations.

Researchers analyzed U.S. rates of IVC filter placement to determine any differences before and after the FDA’s August 2010 advisory. They analyzed VTE hospitalization rates to find whether changes in IVC filter use caused changes in VTE-related hospitalizations.

More than 1 Million Patients Analyzed
Satyajit Reddy, an internal medicine MD at Philadelphia’s Temple University Hospital, and some colleagues analyzed 1,131,274 patients in the National Inpatient Sample database.  All had IVC filters placed from 2005 to 2014.

The researchers found IVC filter placement increased 22.2% between 2005 (45.2 per 100,000 U.S. residents) and 2010, the year of the FDA advisory (55.1 per 100,000 U.S. residents).

Placement of the blood-clot filter devices then declined between 2010 and 2014 (39.1 per 100,000 U.S. residents).  That is when the statistics became interesting, strongly suggesting that the filters were doing nothing to stop or lower VTE.

Dr. Reddy and his colleagues wrote that the rate of VTE-related hospitalizations did not significantly change between 2010 (211.6 per 100,000 U.S. residents) and 2014 (211.3 per 100,000 U.S. residents).

Research Rebuttals
Although Cardiology Today reported speculation which claimed the decline in IVC filter placements was related to decreased reimbursement due to changes in the bundling of associated Current Procedural Terminology codes that went into effect in 2012, the decline actually began two years earlier, after the FDA advisory, wrote Dr. Reddy and his colleagues.

Dr. Reddy and fellow researchers also speculated that another possible factor was the introduction of nonvitamin K antagonist oral anticoagulants for treatment of VTE, but they also said its impact (if any) on IVC filter placements was not clear.

Decline in IVC filter use fails to affect VTE hospitalization rates

“Given the short- and long-term complications associated with [inferior vena cava filter] placement, the use of these devices should mostly be reserved for patients with an absolute indication like active bleeding,” Dr. Reddy and his colleagues wrote. They also noted that IVC filter placement remains much higher in the U.S. than in Europe, where the rate is less than 3 per 100,000 people.

IVC Filter Lawsuits’

Because IVC filters were never approved by the FDA, and because thousands of people have reported problems with their IVC filters tilting, breaking, and/or migrating, IVC filter lawsuits have been filed across the U.S.  Our law firm is handling and filing many of these lawsuits, including several against some of the largest IVC filter makers such as C.R. Bard and Cook Medical.  Contact us now for a free legal consultation if you have experienced any problems with an IVC filter.

Related

•  IVC Filters not FDA Approved
•  IVC Filter Lawsuit | Lawyer
•  Bard IVC Filter Lawsuit
•  Cook IVC Filter Attorney
•  Decline in IVC filter use fails to affect VTE hospitalization rates

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Driverless Uber Kills Pedestrian

(March 22, 2018) A driverless uber car killed a pedestrian in Arizona on March 18. It was the first reported pedestrian death linked to a driverless uber car. The incident caused Uber Technologies Inc. to temporarily pull its self-driving cars off the roads. Uber has been testing driverless cars in the U.S. and Canada.

The uber vehicle struck a woman Sunday night as she was pushing her bicycle on a street. Tempe, Arizona police said the Uber vehicle was in autonomous mode with a human safety operator at the wheel when it hit 49-year-old Elaine Herzberg as she walked her bicycle.

The police said Ms. Herzberg later died of her injuries, after she was hit by the Uber Volvo as it was traveling around 40 mph. They said the car didn’t show any signs of slowing, and the Uber “driver” in the car was not impaired.

An Uber spokeswoman said Uber is investigating the incident and cooperating with authorities. So far, the only thing clear about the accident is that it confirmed the worst fears of critics who have sounded the alarm for years that driver-less cars would eventually kill somebody.

The Wall Street Journal, always ready to help promote any technology if it might make some corporation richer, reported that auto makers and technology companies have “braced for this inevitability but contend that the technology will ultimately save thousands of lives by eliminating human error.” (If it doesn’t eliminate thousands of humans first – people like Elaine Herzberg walking their bikes, say, or people jaywalking in stop and go traffic, expecting that some human being will have a heart and not run them down, because they know that the most dangerous place to cross some city streets is in a marked crosswalk.)

The biggest auto makers, like Toyota and GM, along with tech giants like Uber and Alphabet, Inc., are spending billions of dollars on driverless car technology. They hope to replace human drivers and turn the car travel world upside down.  Some technology company with the “right” design might be able to replace Toyota or GM as the transportation king of the world.

Uber calls its self-driving plans “existential” (whatever the hell that means in this context).  It just settled a costly lawsuit with rival Alphabet’s self-driving unit, Waymo, over what the latter alleged were stolen trade secrets.

WSJ reported that Uber has logged more than three million test miles in self driving cars. Waymo has conducted more than five million.

All those test miles did nothing for Elaine Herzberg, who only wanted to walk her bike on the side of the road, in the bike lane, and not get murdered.  But that was asking too much where profits are concerned.  (At least a human driver could have shed a tear and said he was sorry.)

Waymo, meanwhile, plans to begin commercial robot taxi services in Phoenix this year, as federal and state regulators are allowing Uber, Waymo and others to test their unproven technology on public roads.  More than 50 companies are licensed in California alone, with the caveat that they also have human operators in the car.

The National Transportation Safety Board and the National Highway Traffic Safety Administration said they were sending people to Tempe to investigate the death of Ms. Herzberg.  NHTSA said it was in touch with Uber, state and local authorities, and Volvo, the car maker Uber uses for self-driving vehicles.

Tesla Death in 2016
Tesla Inc. was the first to kill a human being in a self-driving car.  One of Tesla’s Model S electrics on “Autopilot” killed a man in a May 2016 collision on a Florida highway.  NHTSA said Tesla’s technology was not defective, while NTSB said Tesla shared blame by failing to include enough safeguards. Tesla, of course, defended itself. It said Autopilot makes its cars safer. Safer than what? One might ask.

Those cheerleading for driverless technology point to government figures that 94% of crashes involve human error.  U.S. road accidents killed 37,461 people in 2016.

Those pushing driverless technology trumpet the safety benefits, even though there are plenty of other factors to consider, including the autonomy of secular human beings. You probably won’t hear a lot about that as internet, television, and newspaper media will help promote this technology with few questions about its long-term costs and consequences to actual human beings, but it’s something to keep in mind, say, as you are walking your bike on the side of the road, or ordering your next Uber ride.  For whatever reasons you prefer, would you not like to be able to choose an actual person as opposed to a robot on wheels?

Hey Uber, Have a Heart. Give us an option.
Hey, Uber, how about an option as you move forward with your robot cars?  For those of us who value American jobs and people and maybe don’t mind paying a little extra for a human being rather than for a robot, you would be wise to give us the option of ordering either an actual human driver or a robot-driven car.  If you don’t give us the option, we’ll use Lift, or perhaps a local taxi service that doesn’t use robots.  You aren’t the only game in town, and we don’t appreciate your taking away American jobs to drive up your own profits. Thousands of human Uber drivers now count on us human riders for a living, and we are glad to help give them one.  Are we not?

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Judge calls Expert Testimony Against Roundup “Shaky”

A California judge has indicated that lawsuits against Monsanto’s Roundup in his court may be difficult to pursue.  The federal judge dealt a potential death blow to a lawsuit claiming Roundup causes cancer when he concluded last week that the plaintiff’s experts’ testimony against Roundup is “shaky.”  The case, as well as hundreds of others filed in the federal MDL, now stands in danger of not getting to trial.

First Judge to Opine on Roundup Toxicity

U.S. District Judge Vince Chhabria is the first judge to opine on the toxicity of Roundup, the world’s most popular poison. Roundup has been the center of controversy for more than 30 years, since the U.S. EPA bent its own rules and regulations to allow it on the market. The judge has indicated he may cut several or all of the plaintiff’s key witnesses, which could make the case impossible to pursue in his court. Such a move could also profoundly impact the outcome of more than 300 Monsanto lawsuits in his court. That’s the number of cases in federal courts trying to hold Monsanto liable for failing to warn about Roundup’s cancer risks.

Chhabria heard from about a dozen witnesses including toxicologists, statisticians and an oncologist. He took special interest in two epidemiologists who study how humans contract disease.

Chhabria said on March 14 that he has a “difficult time understanding how an epidemiologist in the face of all the evidence that we saw and heard last week can conclude that glyphosate is in fact causing non-Hodgkin lymphoma in human beings.” The judge called the evidence that glyphosate is currently causing NHL in human beings “pretty sparse.”  The judge was apparently impressed by all the Monsanto-sponsored studies the chemical giant had trotted out earlier to exonerate glyphosate.

The judge also seemed to have fallen for Monsanto’s ploy, which it has gotten away with for decades, through the EPA and other regulatory bodies, to test only glyphosate, instead of the entire concoction of Roundup, which experts estimate to be 1,000 more toxic than glyphosate alone.  Nobody uses glyphosate alone, but Monsanto has been able to make that substance the key to the whole poison puzzle.

Reuters reported that it remains to be seen which witnesses the judge will allow to testify at trial on behalf of more than 700 farmers, landscapers and gardeners. All claim that exposure to glyphosate – through skin contact or inhalation — caused their non-Hodgkin lymphoma.

Judge Chhabria appeared to give some credit to Beate Ritz, a public health professor at the University of California at Los Angeles, for having conducted independent analysis.  Still, he called Ms. Ritz’ conclusion that glyphosate causes NHL in humans “dubious.”  He indicated she might be the only witness he allows to testify for the plaintiffs, but even she is at risk of elimination.

Why Not Let a Jury Decide?

Monsanto isn’t completely off the hook, based on what Chhabria said last week.  At this stage he is acting as a corporate gatekeeper to exclude evidence not backed by what he calls scientific rigor, or to at least give the appearance that he is doing so. (Politics frequently prevails in federal court; there’s no way around that fact.)  His position allows him to decide which witnesses are qualified as “experts” who can present their conclusions to a jury. Chhabria said his role is to decide whether the testimony is “in the range of reasonableness,” not whether glyphosate causes cancer.  If you think “reasonableness” is an awfully broad, subjective term, you are exactly right, in your own subjective way.  Why not let a jury decide?

Chhabria also termed the epidemiology for Roundup causing cancer as “loosey-goosey” and called it a “highly subjective field.” (Isn’t that what trials are for?)  But Chhabria may not be able to ride roughshod over all the plaintiffs’ cases.  Some constraints for eliminating witnesses may leave the plaintiffs’ room for Ritz to testify, he conceded.  Maybe Ritz “is operating within the mainstream of the field,” he said.  “Maybe that means it’s up for the jury to decide if they buy her presentation.”

Chhabria’s use of the word “buy” clearly shows his bias against the plaintiff’s case(s).

The judge noted that Ritz was the only plaintiff’s expert not to rely on a 2015 determination that glyphosate is a probable human carcinogen by the International Agency for Research on Cancer, an arm of the World Health Organization.  He said that wasn’t enough to argue exposure to glyphosate is more likely than not the cause of the plaintiffs’ cancer.  (A fair legal assessment)

A lawyer for the group suing Monsanto, said “the weight of the epidemiology, toxicology and mechanistic science strongly supports” the conclusion that Roundup causes non-Hodgkin lymphoma.  “Our experts used valid methodologies to arrive at their conclusions,” he said in a  statement emailed to Reuters.  “Ultimately, we think courts will agree.”

Judge calls Expert Testimony Against Roundup “Shaky”

Judge Chhabria apparently already does not agree, so good luck to plaintiffs in these cases. Our prayers go out to them, and to the truth of Roundup toxicity, that the facts  may all come clear in this litigation.  Let the truth come out!

The case is In re: Roundup Products Liability Litigation, MDL 2741, U.S. District Court, Northern District of California (San Francisco).

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Roundup attacks vital gut bacteria

(March 15, 2018) While Monsanto attorneys argue in California federal court this week that those attacking Roundup for causing cancer are using junk science to do so, more science has found that Roundup attacks and destroys vital bacteria in the human gut.

Gut bacteria has gained a lot of attention lately as being crucial for every facet of human health: mental, physical, and spiritual.  (The Holy Bible and other religious tracts are full of stories about Jesus and others fasting in spiritual purification rituals.)  Recent studies have found that poor gut health can lead to heart disease, or to Alzheimer’s, and a host of other tragic maladies. Several studies have found gut health to be indispensable for sound mental functioning. Children with autism are routinely found to have terrible gut health.  One prominent researcher has recently offered evidence to implicate Monsanto’s glyphosate in autism spectrum disorder.

Related:  Glyphosate Unsafe on Any Plate

Gut bacteria, beyond any doubt, profoundly influences immune function, digestion, brain function, virtually every job tasked to the human body and mind.  A trove of recent research has repeatedly shown the power of healthy gut bacteria as well as the dangers of an unhealthy gut.

The good news is we now KNOW the importance of gut health.  The bad news is that our human guts are all under attack by a ubiquitous chemical which has been show to destroy gut microbes. Monsanto’s glyphosate, which was first used to strip metal off of pipes, now strips healthy flora and fauna from our own guts.

Glyphosate Glyphosate Everywhere

Every glyphosate exposure study done has shown that most of us have become contaminated with the toxic chemical, whether we eat GMO foods directly, or whether we adhere strictly to a non-GMO diet and do all we can to steer clear of Monsanto’s most lucrative poison.  At this moment, we cannot escape this toxic soup.  Glyphosate is everywhere in our environment, in the air, water, and in most of our food, if not directly, then through simple drift across neighboring fields.

Roundup Cancer Lawsuits

Glyphosate is already at the center of hundreds of Roundup cancer lawsuits, filed by people stricken with non-Hodgkin’s lymphoma after they were exposed to Roundup.  A judge overseeing the litigation in California federal court is showing signs of buying Monsanto’s claim that no hard evidence links glyphosate to cancer.  Regardless of any trial outcomes, glyphosate will continue to poison the world for a very long time, killing plants, bees, and people.

Roundup attacks vital gut bacteria

Medical problems linked to an imbalance of gut bacteria include:

•  colorectal cancer

•  diabetes

•  liver disease

•  cardiovascular disease

•  asthma

•  inflammatory bowel disease

•  autism

•  obesity

Glyphosate Gut Damage Regardless of Exposure Levels

The latest study over glyphosate and gut microbes was led by Professor Gilles-Eric Seralini of the University of Caen.  The study team examined rats’ fecal samples and assessed their gut microbiomes.  Female rats exposed to glyphosate experienced significant changes regardless of their dose. As an added horror, glyphosate also damages the microbial activity of soil, so it’s the poison that keeps on poisoning.

The researchers suggest glyphosate could be linked with the recent spike in gut disease in industrialized nations that genetic reasons alone can’t explain.

Because glyphosate is only one active ingredient in Roundup, experts see a need to repeat the study using a bigger group of animals to compare the effects of glyphosate alone as well as to Roundup.  Other ingredients in Roundup, called adjuvants, could be making any effect much more pronounced.

Sadly, even criminally, in regulatory evaluations of pesticides, only glyphosate alone is tested for long-term safety, which means calculations of safe levels are obviously inaccurate.

Professor Seralini believes the full toxic effects of Roundup on us could easily be 1,000X more awful than glyphosate alone. He believes the glyphosate levels allowed in our food and drinks are at least 1,000X too high.  He said: “The acceptable levels of glyphosate residues in food and drinks should be divided immediately by a factor of at least 1,000 because of these hidden poisons.”

Related

•  Montanto Lawsuit | Lawyer

•  Roundup Cancer Lawsuit

•  Roundup non-Hodgkin’s Lymphoma Linked

•  Roundup attacks vital gut bacteria

 

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Medical Devices May Harm more than Help

(March 12, 2018) There’s a decided prejudice in our “modern” society which tends to embrace with little question any new technology that comes along. Like private investigators, we tend to follow the money. Because we know corporations spend millions on R&D, we tend to think they get what they pay for and so will we, if we use their latest device. But the plain fact is that corporations don’t always get what they pay for and neither do we.

Techno “Values” (not so fast)

Technology has of course helped many of us for many reasons; but there comes a time when it is necessary to ask whether a new technology or device is always the best choice.  The law of diminishing returns can apply to any technology as well as to economics.

Related: Thousands get Stents that May Do More Harm than Good

Consider the leafblower, for example. It may be faster than the beautifully simple (and beautifully quiet) rake, but does that mean it’s always superior?  Whether or not you want to fire up its ear-shattering engine to blow your leaves and allergens onto the neighbor’s property or street – in order to have them blown back next day by an equally obnoxious noisemaker – is one technology choice that likely won’t threaten your health or your life.  When it comes to choosing (or not choosing) a medical device, however, your choice could dramatically alter your life, or even end it.

Absent Cardiologists Get Better Results
A recent USA Today  story puts the medical device choice in perspective.  A Harvard study published Friday, March 9, 2018 in the Journal of the American Heart Association found that patients nationwide who had a heart attack during the biggest interventional cardiology conference of the year fared better than those who got sick in the weeks before or after the conference.

The paper reported that the results are either a statistical fluke, or that interventional cardiologists – who insert stents to open arteries – sometimes do their patients more harm than good.

Researchers examined 30-day survival rates of Medicare patients who suffered heart attacks during their cardiologists’ five-day conventions.  They found that an extra 1.5% survived heart attacks which happened during the convention, as opposed to those who had heart attacks before or after it.

The difference means that thousands of lives were saved when cardiologists were at a five-day convention when their patients suffered heart attacks. The differences couldn’t be explained by the number of emergency stents implanted in patients, according to study leader Anupam Jena, an associate professor at Harvard medical School and Massachusetts General Hospital in Boston.

This research raises important questions about the safety and efficacy of placing stents in patients. The data suggest that stents should be placed only in those who are suffering a heart attack caused by a blocked artery. Where the cause of a heart attack is less clear, the disease may be managed by medication, which is usually overseen by general cardiologists, according to Robert Yeh, an interventional cardiologist and co-author of the study.

IVC Filters
IVC Filters, inferior vana cava filters placed in the vein returning blood to the heart, with the advertised purpose of trapping blood clots, are another questionable device. Though they’ve been used extensively by many doctors for some ten years or so, their safety and efficacy is very much in question.  There is virtually no evidence blood clot filters help.  As a result,  IVC filter lawsuits have  been filed throughout the country.  Lawsuit petitions in these cases argue that some IVC filters even cause more problems than they solve.

Hernia Mesh
For at least 100 years, surgeons used simple suturing for hernia repairs, where surgery was deemed necessary.  Then someone got the bright idea of using plastic mesh instead.  The results have been catastrophic for many people, who, if given the choice again, would gladly choose the “old method” rather than the latest new plastic technology.  Hundreds hurt by hernia mesh have filed hernia mesh lawsuits throughout the country.

Transvaginal Mesh
Tens of thousands of lawsuits have been settled over transvaginal mesh made by Johnson & Johnson, Boston Scientific, C.R. Bard and others.  Thousands of women who suffered stress urinary incontinence or pelvic organ prolapse sued mesh makers and had their lawsuits settled.

Medical Devices May Harm more than Help
Medical device makers like C.R. Bard and Cook Medical will continue to develop and promote all manner of the latest technology in IVC filters, surgical mesh, and other medical devices of dubious value.  Whether or not one chooses to use that latest medical device is a potentially life-changing choice.  It is a decision not to be taken lightly.  Attractive medical device models who sell doctors and shiny brochures do not a magic product make. One would be wise to perform a lot of research to see if any medical device is worth the risk of being implanted with it.

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Diabetes Drug Raises Risk of Foot, Leg Amputations

The diabetes drug Invokana raises the risk of foot and leg amputations. As a result, the FDA required Johnson & Johnson to add new warnings to the Invokana drug label in 2017.

The agency required the warnings after two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana (canagliflozin), as those given a placebo. The FDA announcement came May 17, 2017, along with a posting on its website.

FDA Boxed Warning
The FDA said the warnings include a boxed warning, which is reserved for the most serious possible adverse events.

Diabetes Drug Invokana
Invokana is part of a newer class of type 2 diabetes drugs called SGLT-2 inhibitors. These drugs are promoted to help remove excess blood sugar through urine. Other drugs in the class include AstraZeneca’s Farxiga and Eli Lilly’s Jardiance.

Amputation Risk Doubles for Invokana – Study
The FDA noted that results of one clinical trial showed the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000 in a year’s time, compared with 2.8 out of 1,000 for patients given a placebo drug.

A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.

Diabetes Drug Raises Risk of Foot, Leg Amputations
The FDA said amputations of the toe and middle of the foot were the most common, but that partial leg amputations also occurred below and above the knee.

The National Diabetes Statistics Report from 2017 said that some 23.1 million people – or 7.2% of the U.S. population – had diagnosed diabetes. The total included 132,000 children and adolescents younger than 18; 193,000 children and adolescents younger than 20. About 5% of people with diabetes are estimated to have type 1 diabetes.

Among U.S. adults 18 or older, data for 2013–2015 indicated American Indians/Alaska Natives had the highest prevalence of diagnosed diabetes for both men (14.9%) and women
(15.3%) Prevalence varied by region, from 6.0% among Alaska Natives to 22.2% among American Indians in certain areas of the Southwest.

Overall, prevalence was higher among American Indians/Alaska Natives (15.1%), non-Hispanic blacks (12.7%), and people of Hispanic ethnicity (12.1%) than among non-Hispanic whites (7.4%) and Asians (8.0%). Among Hispanics, Mexicans had the highest prevalence (13.8%), followed by Puerto Ricans (12.0%), Cubans (9.0%), and Central/South Americans (8.5%).

Among Asians, Asian Indians had the highest prevalence (11.2%), followed by Filipinos (8.9%), and Chinese (4.3%). Other Asian groups had a prevalence of 8.5%. Prevalence varied sharply by education level, which is an indicator of socioeconomic status. Specifically, 12.6% of adults with less than a high school education had diagnosed diabetes versus 9.5% of those with a high
school education and 7.2% of those with more than a high school education.

Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease.

Invokana Lawsuit Help

Anyone who has taken Invokana and suffered an amputation could be eligible for financial compensation for pain and suffering, loss of income and quality of life.  Contact an experienced drug injury attorney now for a free legal consultation.

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Roundup causes Cancer, Experts tell Judge

(March 6 2018) A parade of experts testified to a judge in California this week that Monsanto’s Roundup causes cancer.  The testimony came as part of the first trial in the country against Monsanto over its popular weedkiller Roundup.  U.S. District Judge Vince Chhabria heard evidence from several plaintiffs’ experts who said Roundup causes cancer, and then he heard testimony from several Monsanto experts who claimed Roundup is perfectly safe and no evidence suggests otherwise. What conclusion could anyone draw but that “Science” takes on a whole new meaning where Roundup is concerned.

Related:  Monsanto Lawsuit

Before jury selection gets underway in this first scheduled trial, Monsanto seeks to stop the Roundup litigation in its tracks by having the judge dismiss the case on the grounds that no science links Roundup with cancer.  If Judge Chhabria were to rule that no credible evidence shows Roundup causes cancer, or that plaintiffs don’t have the right “experts” to prove up the cases, Monsanto could escape prosecution in some 350 cases in California, and, potentially, in all 3,500 cases filed against the company for Roundup cancer cases nationwide.

The arguments from both sides came in a six-hour hearing before Judge Chhabria, presiding over the federal multidistrict litigation, and California Superior Court Judge Iona Petrou, handling similar claims in state court.  The experts testified that there was statistically significant evidence showing prolonged exposure to glyphosate – Roundup’s primary active ingredient – raises one’s chances of developing non-Hodgkin’s lymphoma.

A hematopathologist employed at City of Hope National Medical Center testified that several epidemiological studies he examined showed glyphosate could double one’s chance of developing non-Hodgkin’s lymphoma. Dennis Weisenburger said that between those studies and several animal studies explained two possible ways glyphosate causes cancer. He said he was convinced of a correlation between glyphosate and the disease.

Glyphosate Genotoxic in Living Cells
Mr. Weisenburger said he synthesized all the information and weighed it as a whole.  He said, “There’s good data to conclude exposure to glyphosate increases the risk of non-Hodgkin’s lymphoma.  (There’s) a body of evidence that’s pretty compelling that glyphosate and its formulations are genotoxic in living cells.”

Monsanto has tried to have the case thrown out on a technicality concerning “expert” testimony. Law360 reported that Monsanto’s motion for summary judgment argues that the Roundup cases should be thrown out because “testimony proposed by six plaintiffs’ experts failed to meet the admissibility requirements for scientific evidence as set by the U.S. Supreme Court’s Daubert standard.”  Monsanto argued that the plaintiffs’ experts used “results-driven methods” to show evidence that links Roundup’s glyphosate with non-Hodgkin’s lymphoma.

Testimony: Glyphosate Doubles Cancer Risk

Dr. Beate Ritz testified at length. An occupational and environmental epidemiologist, she reviewed the validity of studies based on sample size, statistical significance and research biases.  She lauded a famous Swedish study which found glyphosate doubles the risk of non-Hodgkin’s lymphoma, and also a Canadian study which found similar results for farmers exposed to Roundup more than two times per year.

A Monsanto attorney on cross examination pointed out that most of the studies Dr. Ritz referred to did not consider other possible pesticide exposures.

Judge Chhabria said, “This continues to be an issue for me.  I still don’t understand how or why it would be a bad idea to adjust for other pesticide exposure.”

AHS Study Deeply Flawed
Dr. Ritz also attacked the Agricultural Health Study, a National Institute of Health analysis begun in 1993 which found no correlation between glyphosate and non-Hodgkin’s lymphoma in North Carolina and Iowa farmers.  Dr. Ritz acknowledged some merits of the study, but said its glyphosate results were deeply flawed.  She said the AHS first surveyed the farmers in the 1990s, but when NIH returned for an update years later, a third of the original farmers failed to follow up.  She also said that glyphosate use was rare at the beginning of the study, but heavy by the follow-up date.

“The use of glyphosate changed mid-baseline,” she testified.  “I have to downgrade the importance of the AHS study that otherwise, I really love.  I just can’t take it seriously.  All the other effects are drowned out in the noise of exposure misclassification.”

Roundup causes Cancer, Experts tell Judge

The AHS study was obviously on both sides’ minds as potentially pivotal in these cases. Monsanto’s VP of Global Strategy lauded it, telling Law360 after the testimony that AHS was “the largest epidemiological study of glyophosate ever.”

We haven’t heard the last word from the AHS study, or from Monsanto, or plaintiffs who believe their non-Hodgkin’s lymphoma was caused by Roundup exposure.

Stay tuned. . .

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