Women Want To Centralize NJ Taxotere Hair Loss Suits

(April 19, 2018) – Hundreds of women want to centralize their New Jersey state court hair loss lawsuits.  The cases allege that Sanofi-Aventis and other drug companies failed to adequately warn about the risk of permanent hair loss for those who use Taxotere, a breast cancer drug used with chemotherapy.

In a notice published April 18, the New Jersey state judiciary said its state Supreme Court has received an application to designate the lawsuits – against Sanofi U.S. Services Inc., Sanofi-Aventis U.S. LLC, Sandoz Inc. and Actavis LLC – as multicounty litigation.  The application also requested that Superior Court Judge James F. Hyland in Middlesex County be assigned the cases, because most of the Taxotere suits have been filed in his jurisdiction.

Plaintiffs File Request to Marry Cases
Lawyers for plaintiffs in approximately 353 such cases pending across New Jersey filed the application with judiciary officials in March 2018.  In arguing for court consolidation, they cited the large number of involved parties and common issues underlying the claims.

Related:  Taxotere Whistle blower Lawsuit Proceeds

The application read, in part: “Centralized management will conserve judicial resources and provide all parties with the benefits of coordinated discovery.”

It further stated: “Given the large number of parties, witnesses, and counsel, the cases would benefit from centralized management.  Centralized management will also minimize duplicative practice and inconsistent discovery rulings.”

The application stated that centralization would also help facilitate coordination with multidistrict litigation over the use of Taxotere in Louisiana federal court.

Roughly 333 of the New Jersey state lawsuits are pending in Middlesex County.  The remaining suits are filed in Camden, Union, Essex and Hudson counties, according to the application.  The plaintiffs live not only in New Jersey, but also in Pennsylvania, Maryland, Ohio and Connecticut.

The application says, “The parties submit that this geographical diversity makes centralized management necessary for the efficient handling of this litigation.”

Plaintiffs allege wrongful conduct by Taxotere Maker
The plaintiffs allege in the application that they suffered injuries because of the defendants’ wrongful conduct in designing, manufacturing, distributing, labeling, advertising, marketing, promoting, and selling Taxotere, a chemotherapy drug.

Taxotere – Permanent Hair Loss
Each of the lawsuits alleges that the defendants knew or should have known that Taxotere “causes and contributes to permanent disfigurement and hair loss,” yet failed to adequately warn of such risks. The application declares, “Further, all of the actions proposed for designation allege substantially similar violations of law and are based upon the same or substantially similar underlying claims surrounding the safety profile of Taxotere (docetaxel).”

The plaintiffs’ lawyers argued that the matters should be assigned to Judge Hyland because the vast majority of the cases are pending in his Middlesex County jurisdiction.  But the application also included the caveat that following pretrial proceedings in the MCL, New Jersey-based plaintiffs should be given the option of having their respective cases tried in their chosen counties.

The application argues: “A contrary decision would severely prejudice a New Jersey plaintiff who does not reside in or near the county to which centralized litigation is assigned, potentially requiring the plaintiff to live away from home, at great inconvenience and expense, due to the happenstance that there are multiple other related cases pending.”

“Allowing the MCL judge to transfer the cases for trial to the plaintiff’s chosen county will protect the plaintiff’s rights, while promoting the primary goal of centralization – efficiency and consistent management and orders through the discovery process,” says the application.

Women Want To Centralize NJ Taxotere Hair Loss Suit

The choice of court venue is always a contentious issue between plaintiffs and defense in drug cases like Taxotere. Plaintiffs’ attorneys always want to give their clients the best chance of a fair trial, while defense lawyers always want a venue which they feel will be the most advantageous for their corporate clients. Judges in these cases are expected to weigh all the legal issues involved, as well as issues of convenience for plaintiffs, court costs, and court time (which is also money) and make the fairest possible determination regarding the most optimal venue for trial. Venue is so important that a case can sometimes be close to won or lost simply by being assigned a certain venue.

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First Cook IVC Filter State Trial

(April 18, 2018)  Cook IVC Filter AttorneyThe first Cook IVC filter lawsuit to be tried in state court in the U.S. will begin on May 7, 2017 in Houston, Texas.   The plaintiff is a Texas firefighter who has brought suit against Cook Medical Inc., based in Bloomington, Indiana.  He is represented by David Matthews of Matthews & Associates Law Firm, in Houston, as well as Tim Goss of Freese and Goss in Dallas, Texas.  The trial is expected to last two weeks.

The lawsuit petition states that the plaintiff was surgically implanted with a Cook Celect inferior vena cava filter at Methodist Hospital.  On or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were “unsuccessful because the filter had tilted and become embedded in the wall of Plaintiff’s inferior vena cava.”

The vena cava is the blood vessel located beneath the heart which returns blood to the heart from the lower body.

Relevant facts regarding IVC filter removal as stated in the petition show the difficulty of removing the filter from the plaintiff.

Attempts to remove Plaintiff’s Celect IVC Filter
Approximately two months after the Celect filter was implanted, an interventional radiologist  attempted to remove it.  He was unable to remove the filter because it had tilted and the tip was embedded into the wall of Plaintiff’s vena cava.  After multiple unsuccessful attempts to retrieve the filter via access through Plaintiff’s jugular vein, he aborted the procedure.

In June 2015, another jugular removal procedure was attempted by an interventional radiologist. In connection with this attempted removal, imaging revealed that at least two of the filter legs had perforated through the wall of Plaintiff’s vena cava. This retrieval attempt was also unsuccessful.

Finally, on July 20, 2017, Plaintiff had a life-threatening, invasive open surgery to remove the perforated Cook IVC filter. During the open removal surgery, it was determined that Plaintiff had at least three IVC filter legs poking outside of his vena cava: one in his duodenum (bowel); one beginning to perforate his aorta; and one inside his lumbar vein, which had to be resected for the filter leg to be removed. The degree to which Plaintiff will recover from surgery, and the lingering effects of the perforated filter struts, has yet to be determined.

The petition further alleges that the plaintiff is now at risk for future migrations, perforations, and/or fractures from the retained filter.  He also faces numerous other health risks, including increased risk of clots and risk of death.  He will “require ongoing medical care and monitoring for the rest of his life and may ultimately require additional surgery in an attempt to remove the filter.”

The lawsuit petition alleges that the implanting doctor knew or should have known, inter alia, several things, including that:

  • only certain patients were appropriate candidates for an IVC filter.
  • the longer a Celect IVC filter remains in the body, the higher the risk of device fracture or failure.
  • the Celect filter is not effective to prevent clots and/or increases the risks of clots.
  • safer alternatives to the Celect IVC filter existed.
  • IVC filters, such as the Celect filter, should not be used in certain patients, such as the plaintiff.

Cook Celect IVC Filter Problems
The petition alleges that Cook Celect filters frequently tilt, migrate, perforate or fracture and thus, involve a high and increasing degree of risk to a patient who has been implanted with a Celect filter.

The petition further claims that Cook knew or should have known that the Celect device was defective and unreasonably dangerous for several reasons, inter alia, including:

•   Cook failed to conduct any clinical testing, such as animal studies, to see how the device would function once permanently implanted in the human body;

•  The Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. Such failures exposed patients to serious injuries, including: death, hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; severe and persistent pain; perforations of tissue, vessels, and organs; inability to remove the device;

•  Cook knew or should have known that certain conditions or post-implant procedures such as morbid obesity or open abdominal procedures could affect the safety and integrity of the device;

•  Cook knew or should have known these risks for the Celect filter were and are substantially higher than other similar devices;

•  Cook knew or should have known the Celect filter contained conditions which resulted in the device not performing as safely as the ordinary customer would expect;

•  Despite being aware of these risks, Cook misrepresented, omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use;

•  Cook failed to issue a recall of the Celect filter or otherwise notify consumers that a safer device was available.

IVC Filters
IVC filters first hit the medical market in the late 1960s. Several different medical device makers, including C.R. Bard, have introduced several different designs.

IVC filters are allegedly designed to filter or “catch” blood clots (called “Thrombi”) that travel from the lower portions of the body to the heart and lungs. The filters are designed to be implanted either permanently or temporarily within the vena cava.

The inferior vena cava is a vein that returns blood to the heart from the lower portions of the body. In certain people, for various reasons, thrombi travel from the vessels in the legs and pelvis, through the vena cava and into the lungs. These thrombi often develop in the deep leg veins. They are called “deep vein thrombosis” or “DVT.” Once they reach the lungs they are called “pulmonary emboli.” Pulmonary emboli present grave risks to human health, including the risk of death.

Someone who undergoes knee or hip joint replacement is at risk for developing DVT/PE. Obese patients are also at risk. So too are those who have vascular diseases, or those who have experienced previous strokes. Several other conditions also predispose some people to DVT/PE.

At-risk people may be prescribed medications like Heparin, Warfarin, or Lovenox to regulate the blood clotting factors. Some at high risk who cannot manage with medications may receive an IVC filter in an effort to prevent thromboembolic events.

Wide Use with no Evidence of Efficacy
IVC filters have been implanted by the hundreds of thousands despite there being no reliable evidence which proves their safety and effectiveness. No evidence proves that IVC filters are worth their risks.

Evidence of harm without evidence of benefit
A 2013 paper published in the Journal of the American Medical Association by Vinay Prasad, MD and others offers a stern critique of IVC filters. The authors declare, “While the benefits of the IVC filter are hard to assess, the complications are evident.”  They conclude their paper with a warning: “Follow current standard of care and place filters where guidelines advise, or do not place filters, after informed consent informs patients that there is evidence of harm without evidence of benefit.”

First Cook IVC Filter State Trial
The Houston trial is expected to last two weeks.

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IVC Filter Controversy Rages

IVC filter lawsuits Cook Blood Clot Filter Lawsuitsare being filed because the preponderance of evidence fails to show that IVC filters are worth their risks.  We are consequently filing IVC filter lawsuits across the country.  Matthews & Associates Law Firm will try the first Cook IVC lawsuit in state court in the country in a trial beginning May 15, 2018 in Houston, Texas.

IVC filter makers such as Cook Medical and C.R. Bard sell fear, first, in order to promote their products.  They always point to the dangers of pulmonary embolism, and claim IVC filters are the only answer to PE when someone is contraindicated for blood-thinning medication.

Pulmonary embolism is undoubtedly a problem, for a reported 422 of 100,000 people in the United States. Left untreated, PE will occur in as many as 40% of all people who develop proximal deep vein thrombosis (DVT).

But identifying a problem doesn’t mean you’ve solved it, or even offered the best solution. Significant controversy surrounds the “appropriate indications” for IVC filter placement. Scientific literature regarding the safety and efficacy of IVC filters is woefully lacking.

Related: IVC Filters risk serious complications

All published guidelines agree IVC filters are indicated in patients who have an acute VTE and cannot receive anticoagulation medications.  Or they are indicated for those whom adequate anticoagulation has clearly failed despite evidence of appropriate use and effect.  Nevertheless, some indications are much more controversial.

Dr. Ido Weinberg and others pointed out in a 2012 IVC filter paper, Cardiovascular Interventions by the American College of Cardiology Foundation, that IVC filters are inserted perioperatively in patients undergoing surgical pulmonary embolectomy. The intent is to reduce the effect of post-surgical PE in this unstable population. In a retrospective analysis of mortality in 520 such patients who were unstable secondary to PE, and who underwent embolectomy – all of whom received an IVC filter – mortality was lower than in 430 patients who received no filter (25% to 58%). The authors wrote that other safety data are conflicting, yet the Society for Interventional Radiology guidelines and ACR appropriateness criteria inexplicably offer that data as a relative indication for placing an IVC filter.

IVC filters are also advocated for high-risk populations without VTE as a prophylactic measure, such as in trauma patients. But several points of controversy apply. First, placing a filter can add complications that include increased morbidity.  Second, patients are at risk for long-term complications if filters are not removed.  Third, studies have shown IVC filters are a poor choice for trauma patients.

IVC filters have also been advocated for people undergoing elective open gastric bypass surgery. Those who received the filters have not been shown to fare any better than those who did not. In fact, studies have shown IVC filter risks outweigh benefits for bariatric patients.

IVC filters are sometimes used in high-risk patients in conjunction with anticoagulation therapy. In a comparison of 251 patients who received both an IVC filter and anticoagulation meds, and 1,377 who received only anticoagulation, there was no difference in PE incidence at 90 days and 5 years, though a trend toward more DVTs in the IVC filter group.

Cochrane Review: compression and anticoagulation effective and safe
Dr. Weinberg and the authors write that, “It is noteworthy that a Cochrane review of combined intermittent compression and anticoagulation for VTE prevention in high-risk patients showed the combination to be effective and safe.”  Which would seem to seriously challenge the notion of IVC filter makers that their filters are the only option in town for high-risk patients.

Do IVC Filters prevent PE?
A population-based study analyzed hospital records from 1991-1995.  It found that the rate of rehospitalization for PE did not decrease with the use of IVC filters. Rehospitalizations for DVT, however, did increase with the increased filter use. Further, Cochrane database investigators could not draw firm conclusion as to whether the filters decreased PE at all.

IVC filter lawsuits filed against Cook and Bard argue that these companies did no relevant long-term studies which randomized patients to find the true effectiveness of their filters. They diligently avoided performing those tests because they knew their IVC filters had no true effectiveness, and that IVC filter benefits are often not worth their risks.

IVC Filter Risks
IVC filters can become embedded in the vena cava. They can also break apart, and their various pieces can travel to the heart, lungs, nearly anywhere the blood can take them in the human body. They have not been proven efficacious. They are decidedly dangerous, and that is why you see so many IVC filter lawsuits filed in state courts and in federal multi district litigation courts across the country.

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California Bill to Stifle Free Speech

(April 9, 2018)  A California senator who led the charge to kill informed consent for vaccinations in California just introduced a bill to stifle free speech in the state.

Jon Rappoport, in his ‘No More Fake News’ web site, reported the story, which is flying under the radar, by design, of course.  California Senator Richard Pan, the Merck Pharmaceuticals beneficiary behind the infamous 2015 law mandating vaccinations (which Merck makes with fraudulent data) for schoolchildren (the infamous SB277), now seeks to end free speech in California.  Mr. Pan’s draconian bill has dangerously far-reaching implications (if you believe in the 1st amendment); for it threatens to reach far beyond the state’s poorly secured borders.

The California senator’s new bill would clamp down on criticism of any Official Story.  If it passes, when a government agency – such as the hopelessly corrupt CDC, drug-industry compromised FDA, politically-compromised FBI, or honesty-challenged CIA – puts out an “official story,” any blog or comment which veers from that script will be subject to censorship, or “warnings.”  The end point for Mr. Pan and his corporate sponsors is to make readers swallow any official story without questioning its methods, motives, or dirty money trail.  Mr. Pan’s slippery financial ties to drug companies like Merck make it in his best interests to stifle the truth.

The bill to censor the free flow of information is titled “SB1424 Internet: social media: false information: strategic plan.”  SB1424 ostensibly targets social media based in California, but, as Mr. Rappoport writes, “as you read the bill, you see it appears to define social media as any Internet blog, website, or communication.”

Mr. Rappoport has recorded the whole brief bill for us. Here it is:

SB1424
This bill would require any person who operates a social media, as defined, Internet Web site with a physical presence in California to develop a strategic plan to verify news stories shared on its Web site. The bill would require the plan to include, among other things, a plan to mitigate the spread of false information through news stories, the utilization of fact-checkers to verify news stories, providing outreach to social media users, and placing a warning on a news story containing false information.

(a) Any person who operates a social media Internet Web site with physical presence in California shall develop a strategic plan to verify news stories shared on its Internet Web site.

(b) The strategic plan shall include, but is not limited to, all of the following:

(1) A plan to mitigate the spread of false information through news stories.

(2) The utilization of fact-checkers to verify news stories.

(3) Providing outreach to social media users regarding news stories containing false information.

(4) Placing a warning on a news story containing false information.

(c) As used in this section, “social media” means an electronic service or account, or electronic content, including, but not limited to, videos, still photographs, blogs, video blogs, podcasts, instant and text messages, email, online services or accounts, or Internet Web site profiles or locations.

Who will be able to afford to hire “fact checkers”?  Not the alternative web sites you depend on to clarify the fake news so often put out by CNN or The New York Times.  Those and other MSM outlets were  responsible for repeating ad nauseam the fake news regarding a non-existent WMD threat from Iraq.   Those MSM lies launched the 17-year-long war and occupation which has now claimed more than a million lives.  And even if independent news outlets could afford “fact checkers,” they would need to be officially sanctioned, no doubt.  And nothing could prevent Pan’s corporate friends from banning or placing warnings all over any videos they deemed “inappropriate” for whatever reason they might choose.

Only the very large news outlets that dominate the mainstream media – Fox Noise, CNN, MSNBC, the Washington Post, USA Today – and a select few others in print and online will be able to stay in business.  Only the publications that never tell us anything useful will be able to have their stories “fact checked.”   The idea is to bury all truth about dangerous vaccines, (MMR, Shingles, Gardasil. . . ) Monsanto’s Roundup cancer herbicide, harmful GM foods, toxic chemical farming, the aerial poisoning of the entire country, water fluoridation and other water problems, nanobots, Black-Ops, EMF dangers, banking crimes, endless undeclared war, unchecked immigration, our growing fascist police state, and many other corporatocracy crimes and subterfuges.

Under the guise of protecting children, Mr. Pan forced parents to give up their parental rights and turn them over to the government.  California law now says the children must submit to whatever vaccinations the government – along with Merck and the government’s other corporate partners – declare that they “need.”

Under the guise of combating “fake news,” Mr. Pan now leads the charge to wipe out all mainstream news competition.  He wants to be sure that MSM newsfakers are the only ones to which we will have unfettered access, to better keep all his dirty work and dirty money in the dark.

Speech Criminals
Mr. Rappoport explains that if this bill passes, agencies of the California government will develop numerous regulations for enforcement, including penalties for “speech criminals.”

This bill would not violate the 1st Amendment so much as wipe it out altogether.

Anything which Mr. Pan and his cronies would label a “conspiracy theory” – a term which the CIA put out in its infamous internal 1967 memo that sought to silence all criticism of the fact-challenged Warren Commission report that most of the country knew was full of lies – will be censored.  Warnings on any blog, comment or story not officially sanctioned will make most people turn away, if not run.  The idea is to make people afraid of their own shadow, like the CNN newsfaker Chris Cuomo telling us last year that only CNN was allowed to read Wikileaks leaked emails, that it was illegal for the rest of us to do so.

CNN Liar Tries to Scare Americans

Related:   Facebook Censorship and the Execrable Snopes

We Need a Tsunami of Protest in California

Mr. Rappoport calls for a “relentless tsunami of protest in California over this Orwellian bill.”  Anything less than that could turn these hounds of hell loose on all news not sanctioned by Richard Pan and the dysfunctional state he leads into one bad law after another.

Jon Rappoport explains:
“In case you believe there are too many websites and blogs based in California to enforce a new draconian law, let me explain how the game works. Behind closed doors, the state government would decide to focus on a few big issues. For example, gun control, vaccines, and immigration. Enforcement agencies would go after the biggest Internet operations expressing politically unacceptable points of view on those subjects. At first. A spread of smaller operations would feel the heat later.

So-called fact checkers would come from government supported groups who agree with Official Positions. In other words, they wouldn’t be fact checkers at all. They would be prime news fakers.”

When it comes to vaccines, for one example (like the awful shingles vaccine), they would cite the notoriously biased “experts” at the Centers for Disease Control, never mentioning that CDC buys and sells $4 billion of vaccines a year, and is hopelessly corrupt, partnering with Big Pharma and industry rather than regulating them.

California Bill to Stifle Free Speech

If we can’t crush this bill, we may not be able to hang on to what little is left of our ever-vanishing democracy.  Expect all the mainstream news whores and fakers to stand solidly behind it, because they are working for outlets which will be protected by it, as it seeks to wipe out their independent competition across the world.  Everyone knows by now that many, many non-mainstream, independent news outlets are way better, and more honest, than the MSM at reporting actual news that matters.  And way better at giving us the truth that the MSM so studiously avoids disclosing, so as not to displease their corporate sponsors and masters.

It’s a dirty world, but we could clean it up, if we can first identify the main sleaze bags doing the dirty work for Empire, people like California Senator Richard Pan.

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$37M Asbestos Talc Verdict against J&J

(April 5, 2018) A New Jersey jury today hit Johnson & Johnson and its talc supplier with a $37 million   judgment over claims from a man who said he developed mesothelioma after using J&J’s asbestos-containing talcum powder over several decades.

In a trial that lasted more than two months, jurors sided with plaintiff Stephen Lanzo, III and his wife. The jury found that J&J’s products, including its baby powder, contained asbestos. Further, it found that Mr. Lanzo’s exposure to asbestos since the 1970s played a substantial role in his contracting mesothelioma, a deadly disease.

The jury awarded compensatory damages of $30 million to Mr. Lanzo, $7 million to his wife, Kendra.  They held Johnson & Johnson 70 percent responsible for the damages, its talc supplier –  Imerys Talc America Inc. – 30 percent responsible.

Superior Court Judge Ana C. Viscomi asked the jury to return on Tuesday, April 10, for a punitive damages phase in the case.

$37M Asbestos Talc Verdict against J&J

In closing arguments, attorneys for Mr. Lanzo and his wife, Kendra, and defense lawyers for Johnson & Johnson and Imerys, strongly disagreed over the nature of tests performed by J&J.

A J&J attorney had claimed that the testing Johnson & Johnson and others did on J&J talc never turned up asbestos in either J&J’s talc mines or in its products on store shelves.  He said the plaintiffs may have presented studies showing certain minerals in J&J’s talc, but they didn’t have evidence that those minerals were asbestos.  He told the jury as much in his closing argument Monday.

In stark contrast, Mr. Lanzo’s attorney countered on Tuesday in his closing argument that the company’s talcum powder contained asbestos for years.  He claimed J&J hid that fact from consumers and regulators by using tests that it knew would fail to detect the toxic mineral.

“They came up with the method that was never going to find the asbestos that was there,” he told jurors, “so they could certify that they looked and never found it.”

The jury apparently believed the plaintiff’s version of J&J’s testing.

J&J won one similar lawsuit against the company last year, but it faces many more in which plaintiffs claim they’ve suffered mesothelioma from long exposure to J&J talcum powder products.

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IVC Filter Makers Liability over FDA Process

Lawyers for bothBard IVC Filter Lawsuit | Blood Clot Filter Lawyer IVC filter plaintiffs and IVC filter manufacturers continue to tussle in court over the FDA’s role in allowing different IVC filters to be sold on the market. Defense lawyers would like juries to believe that IVC filters were approved by the FDA for implanting in people’s inferior vena cava. Plaintiff’s lawyers want juries to know that IVC filters were never approved by the FDA for use in people. Can both sides be right? What gives?  IVC filter makers face liability over a little-known but common FDA process.

Federal Preemption for Medical Devices
The makers of medical devices which have been approved by the FDA through its regular Pre-market Approval (PMA) process typically avoid lawsuits against those products. That vanishing liability is a a direct result of a 1970s act that changed the nation’s long-established tort law.  Federal regulatory preemption of medical devices began with the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act of 1938 (FDCA). 21 U.S.C. §§ 360c-1; 21 U.S.C. §§ 301 et seq.

Related:  IVC Filter Lawsuit | Lawyer

In a nutshell, the 1976 Act means that any medical device approved by the FDA through its PMA process immunizes its maker against legal liability. Whether or not the device turns out to hurt more people than it helps doesn’t matter. If the FDA approved it, people injured by such a device are out of luck. They had, and still have, little to no chance to remedy their grievances in court.

IVC Filters Not Approved by FDA
IVC filters, by contrast, have not been approved by the FDA.  They never went through the agency’s PMA process.  Instead, IVC filters have been “cleared” by the FDA under the auspices of the agency’s 510(k) clearance process. This process greatly abbreviates the PMA path. It allows the agency to “clear” devices for the market without putting them through the rigorous testing required of devices which seek full FDA approval.

The FDA web site explains, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.”  The term “substantially equivalent” can, of course, be very subjective.

Because devices “cleared” through 510(k) are not subject to the same rigorous testing as products put through the PMA process, the companies that make them can still be subject to civil liability.

In the first IVC filter trial in the Phoenix MDL court against C.R. Bard last month, the plaintiff’s attorneys sought to keep misleading characterizations of the FDA’s device approval processes from coming before the jury. They felt that any mention of the FDA allowing the filter on the market could prejudice the jury. The Arizona federal judge overseeing the case denied the plaintiff’s motion to preclude evidence about the devices’ 510(k) clearance.  But the judge also moved to clarify for the jury the FDA’s role in the IVC filter’s market presence.

IVC Filter Makers Liability over FDA Process

The judge said that he would allow the FDA evidence “in context” and would not allow the 510(k) clearance to be used as evidence that the devices are approved by the FDA. (In Re: Bard IVC Filters Products Liability Litigation, MDL Docket No. 2641, No. 15-2641, Sherr-Una Booker v. C.R. Bard, Inc., et al., No. 16-474, D. Ariz., 2018 U.S. Dist.).

Bard loses $4.6 Million Verdict in First IVC Filter Trial
Having learned that the FDA had not approved the IVC filter but had only allowed it under the auspices of its 510(k) program may have helped sway the jury into seeing the problems caused by the product.  The jury awarded the plaintiff $4 million, $3.6 million of which was assigned to C.R. Bard, maker of the IVC filter.

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YouTube Censorship Threatens Democracy

Wake up! Americans! What will you do when there’s no one left to speak for you?

YouTube censorship threatens our democracy. There are no two ways about it. If we allow YouTube to censor non-profane, non-obscene speech for political or social or any other reasons, we are allowing our democracy to slip away. And if you can’t stand up for another’s right to free speech despite not agreeing with that person’s speech, then you’re not for free speech. You’re a fascist, a stooge, a shill, or a fool. These are lean times for speech. Apparently they don’t teach civics to the young folks anymore. Be that as it may, all adults need to stand up and pay attention or our liberties will continue to slip away.

Update:  Shooting at YouTube over its Censorship

YouTube has now become one of the gravest threats to free speech that we’ve seen in our country in a long, long while. For just one egregious example, YouTube “disappeared” 1,700 Natural News videos, along with his 350,000 followers.  The owner of the web site, Mike Adams, posts many stories which question our political landscape. He also writes a lot of pieces that uncover fake or misleading news in mainstream media, Monsanto’s poisoning of the world, Big Pharma’s deathgrip on the healthcare “industry,” the dangers of vaccination covered up entirely by all major media. Mr. Adams writes and makes video about natural cures, home remedies, gardening, the raising of goats, urban survival, and many other subject potentially relevant to us all.

Mr. Adams and his staff and guest writers often question the “official story” of various events. In short, he does all the things our mainstream media fail to do anymore (if they ever did). He asks questions and he looks for answers. He doesn’t believe the first thing he sees or the first soundbite released by a politician or an official government spokesman. You know. He does what used to be called “Journalism.” The kind we rarely see, except in so-called “alternative” web sites. Since every choice anyone makes for her news source is an alternative, it’s absurd and demeaning and misleading to call sites “alternative.” (This is just one more way language has been perverted and twisted to twist our minds into mush and manipulate us.)

There was no one left to speak for me
Martin Niemöller (1892–1984) was a Protestant pastor who spoke against Hitler. He spent the last seven years of Nazi rule in concentration camps. He left us with a pretty good example of what happens when we put up with censorship and demonizing of the “other,” the person whom we imagine is not like us, so that we can imagine ourselves safe, insulated from the evils of silencing others. Mr. Niemöller is best remembered for his famous poem:

“First they came for the Socialists, and I did not speak out—
Because I was not a Socialist.

Then they came for the Trade Unionists, and I did not speak out—
Because I was not a Trade Unionist.

Then they came for the Jews, and I did not speak out—
Because I was not a Jew.

Then they came for me—and there was no one left to speak for me.”

It Can’t Happen Here?  Don’t Kid Yourself.  It’s happening now.

Millions of people were “disappeared” in old Russia when she was a communist dictatorship. Nazis also disappeared people by the millions. Both regimes began with heavy censorship programs. If YouTube is allowed to censor Mike Adams and Natural News and any other people or opinions it doesn’t like, where does that stop? Censorship’s intended goal is to get people to self censor, which begins by censoring one’s own thoughts. Orwell called that “thought control.” His dystopian nightmare novel, 1984, featured visits from the Thought Police when people were suspected of not thinking correctly. With YouTube’s actions, we are taking the first step down that terrifying road. There’s no sugarcoating it. You either get on board for freedom of speech and defend it with your words and your freedom of thought, or you write your ticket to fascism, or something even worse.

Good Americans would be wise to visit this link, read this story, and become part of a Twitter tweetstorm to stop YouTube from ushering in a nightmare society of frightened people who don’t have the guts to protect their democracy.

For convenience, I’m also pasting Mr. Adams announcement here below:

“Join the #RestoreTheHealthRanger tweetstorm to demand an end to YouTube censorship of intelligent speech

(Natural News) Today we’re announcing a tweetstorm activism effort to reach out to YouTube’s twitter accounts with demands to #RestoreTheHealthRanger channel.

Several weeks ago, YouTube terminated the entire Health Ranger video channel without warning, wiping out over 1,700 videos and 350,000+ subscribers. This was done as a politically motivated censorship action to silence intelligent voices that dare to question the power monopolies of the status quo.

All this week, join Health Ranger / Natural News fans in tweeting out the reasons why you enjoy Health Ranger video content and demand a restoration of “TheHealthRanger” channel. Direct your tweets to these YouTube accounts on Twitter:

@YouTube
@TeamYouTube
@YTCreators

Be polite, of course, but let YouTube know why you value Health Ranger videos and intelligent commentary. Watch my video for more details — or click here to view it on Vimeo — and read YouTubeCensorship.com to stay up to date on the latest censorship schemes by Google and YouTube.”

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Warming Blanket Recall

More bad news came recently for a 3M warming blanket used for hip and knee replacement surgeries that may cause serious infection.  FDA issued a Class 2 recall of 165,000 Bair Hugger Forced Air Warming Blankets on Feb. 12, 2018. The blankets were recalled for a design problem that may prevent them from warming up people during surgery, which is the blanket’s sole intent.

3M’s recall notice said health care providers should identify and discard any Bair Hugger underbody blankets affected by the recall. Recalled lot numbers are R10359, R10360, R10361, R10362, R10363, R10364, R10365 and R10366. They represent some 33,108 cases of five units each distributed worldwide.

The Bair Hugger is a single-use blanket that keeps patients warm before surgery. Four out of five hospitals use the single-use device today. The blankets are used in approximately 90 percent of all hip and knee surgeries.

Warming Blanket Lawsuits
3M Co. faces warming blanket lawsuits from more than 4,200 people who claim the company’s popular “Bair Hugger” surgical warming blankets circulate contaminants and cause debilitating deep-joint infections.

The Bair Hugger forced-air warming blanket has been used in more than 200 million surgeries since 1987.  Lawyers for the Minnesota-based 3M company say no study has proved the blanket causes surgical infections.

3M company spokeswoman Donna Fleming Runyon told the Star Tribune:  “3M will vigorously defend the product and the science against these unwarranted lawsuits. (We) think (plaintiffs’) attorneys are using bad science to blame their clients’ infections on a device that has helped so many people.”

Inventor says Device Creates Infection Risk
Attorneys representing the injured people say research shows the device can spread airborne contaminants while warming up surgical patients.  Dr. Scott Augustine, the inventor of the device developed in the 1980s, is expected to testify that it creates infection risk, especially for joint-surgery patients.

“There is no question that it’s a true phenomenon. It’s happening. And it’s easy to show,” said Dr. Augustine, a Minnesota Twin Cities anesthesiologist and entrepreneur who now opposes Bair Hugger use. “With regard to orthopedic infections, a scare is what’s needed. This product should never be [used] on another orthopedic patient.”

Dr. Augustine would be a witness with some baggage. He pleaded guilty to a health care-related misdemeanor in 2004, paid a $2 million fine, and denied any wrongdoing.  Today he is chief executive of Eden Prairie’s Augustine Temperature Management, which sells a competing patient-warming device called the HotDog, which uses conductive heat similar to an electric blanket.  The Bair Hugger uses forced air.

Dr. Augustine said he regularly lectures to health care professionals about his concerns regarding the Bair Hugger device.

3M sells various disposable Bair Hugger patient-warming blankets that retail from $6 to $24 each. The blankets include rows of inflatable tubes that fill with hot air to warm patients.  The goal is to improve surgical outcomes by preventing heat loss from the body’s core and reduce hypothermia risk from anesthesia.

A separate warming unit, connected by a hose, pumps air into the Bair Hugger blanket.

Dr. Augustine says that Arizant “stumbled onto” the discovery that the warming unit can disrupt the carefully designed flow of sterile air inside an operating room. He said waste heat from the unit builds up under the operating table and creates convection currents that can stir up contaminants from the floor and embed them on the surface of a knee or hip implant.

“We studied this extensively for about 18 months. I can tell you with 100 percent certainty that the waste heat rises every single time. This was reported before 3M even bought the company,”said Dr. Augustine. “3M can say that it doesn’t happen. … But when you are going against a basic law of physics, it’s kind of an absurd thing to say.”

Bone and Joint Journal Backs Plaintiff’s Theory
In November 2011, the Bone and Joint Journal in the United Kingdom published a paper from a study of experiments with mannequins and research on past patient records that found the Bair Hugger created a “significant” increased risk for deep-joint infection compared with patients who used the HotDog. The study used statistical regression to report an infection rate of 3.1 percent with forced air, compared with 0.8 percent with the HotDog.

Defense Evidence
A medical-evidence entity, ECRI Institute, evaluated the Bair Hugger and HotDog data. ECRI concluded in 2014 that there wasn’t sufficient evidence to determine whether one system was better at reducing surgery-related infections.

A systematic review of past studies published in the Journal of Bone and Joint Surgery in Massachusetts last year concluded, “forced air warming can impact [air] flow under certain very specific conditions, but any actual clinical impact on surgical site infections must be considered unproven at this time.”

3M claims the Bair Hugger’s safety is supported by 60 randomized controlled clinical trials since its development in 1987.

One plaintiff’s attorney who represents some people suing 3M said the cases could be tough to prove because no direct evidence shows the Bair Hugger stirring up contaminants, then placing them into any particular patient’s surgical wound.

The burden of proof is on the plaintiffs to prove that the blankets are more likely than not causing infections.  The attorney noted that similar indirect evidence on relative risks was the basis for tens of thousands of lawsuits filed against Merck & Co. over its $4 aspirin Vioxx. Merck eventually agreed to pay $4.85 billion to resolve those cases.

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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.

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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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