Alabama Man files IVC Filter Lawsuit

An Alabama man who required open-heart surgery when an IVC Filter migrated to his heart six days after being implanted has filed a lawsuit against Cordis Corporation and Johnson & Johnson. The IVC filter makers stand accused of selling a defective medical device and failing to adequately warn of its dangers.  Cordis is a subsidiary of J&J.

Related:  IVC Filter Lawsuit | Lawyer

The lawsuit was filed by an Alabama man injured by the OptEase® Retrievable Inferior Vena Cava Filter (“IVC Filter”) made by Cordis and J&J.

The man was implanted with the Cordis IVC Filter on April 20, 2016 in LaGrange, Georgia by Dr. William E. Behm at West Georgia Medical Center. He was discharged from the hospital in good health.

Cordis OptEase® Retrievable IVC Filter
Six days later, the man was readmitted to the hospital after feeling severe chest pains. An emergency cardiac catheterization revealed that the Cordis IVC Filter had migrated to his heart. The wayward filter was obstructing his right ventricle and right atrium.

The man was then transferred to Piedmont Atlanta Hospital in Atlanta, Georgia. On April 29, 2016, he underwent emergency open-heart surgery. Doctors removed the OptEase IVC Filter and repaired damage which the filter had caused to his heart’s atrium, ventricle, and tricuspid valve.

The man’s physicians said, “Surgery was necessary to treat and prevent imminent death or life-threatening deterioration and failure of his circulatory system.”

One-Month Recovery from Surgery
Following open-heart surgery, the man spent one month recovering in hospital. On May 23, 2016, he was transferred to an inpatient rehabilitation facility.  There he spent nearly four months recovering from his life-threatening injuries.

Cordis Corporation and Johnson & Johnson stand accused, in the lawsuit petition, of selling defective medical devices and failing to warn the man about dangerous risks.

The lawsuit is Case No. 60565803.  It was filed August 17, 2017 in the Circuit Court of the 11th Judicial Circuit in Miami-Dade County, Florida.

4,000 IVC Filter Lawsuits Pending

Roughly 4,000 other IVC filter lawsuits are now pending against B. Braun, Cook Medical, C.R. Bard, Johnson & Johnson, Rex Medical, and other medical device makers in state and federal courtrooms nationwide.



Monsanto Roundup Fight Erupts in Calif. Court

A Monsanto Roundup fight erupted in a California court Thursday, and led to a judge’s threatening to call security.  A law firm suing Monsanto for a plaintiff who claims he was injured by Roundup had released internal Monsanto documents.  Monsanto lawyers objected to the release of those documents.

Related:  Monsanto Lawsuit

The California federal judge admonished both sides in the contentious hearing August 24, 2017.  Monsanto lawyers alleged that an opposing attorney improperly leaked confidential documents in the multidistrict litigation over Roundup weedkiller’s alleged propensity to cause cancer.

Judge Chhabria:  “Plenty of Blame to Go Around”

U.S. District Judge Vince Chhabria said there was “plenty of blame to go around” over the legal dust up.  It all stemmed from a July 2017 meeting during which Monsanto lawyers argued that 86 disputed documents were irrelevant to the litigation and should remain under seal.  Plaintiffs’ attorney R. Brent Wisner then waited 30 days for Monsanto to file a declaration to defend its protective order.  Law360 reported that Monsanto wrote no such declaration.  Therefore, Mr. Wisner assumed Monsanto had decided not to pursue its argument that the documents couldn’t be unsealed, because the judge had threatened to sanction Monsanto if it continued to make what he called “frivolous filings.”

Judge Admonishes Both Sides’ Lawyers
Judge Chhabria noted Thursday that the confusion came from ambiguity in his protective order. Nevertheless, he said he was tempted to dismiss Mr. Wisner and possibly his law firm from the case for leaking documents which the judge said they knew involved a confidentiality dispute.  The judge said the plaintiffs’ knowledge of the confusion was made clear in a motion to clarify the order, filed as the evidence was being posted online.  But the judge also admonished Monsanto lawyers for claiming the documents’ confidentiality couldn’t be questioned because they weren’t relevant to the litigation.  Judge Chhabria called that Monsanto contention “almost laughable.”

Related:  Roundup non-Hodgkin’s Lymphoma Lawsuit

The judge said: “Mr. Wisner, along with other members of the leadership group, decided to ignore that this was a live dispute.  It seems obvious that these documents are relevant to the general causation phase of this litigation. It seems clear the position Monsanto was taking in the meet and confer was unreasonable. … The great irony here is had you teed this up before me in a joint discovery letter or a motion, I would have no doubt ruled in your favor and I would probably have had Monsanto pay the litigation costs.”

Glyphosate causes Cancer, says Monsanto Lawsuit
The multidistrict litigation consolidated in California alleges glyphosate – in Monsanto’s Roundup weedkiller – causes cancer.  Monsanto disputes that allegation.  Monsanto company executives and attorneys claim that decades of studies have found no link between glyphosate and cancer.

Roundup / Glyphosate Cancer Link

On the plaintiff’s side, the World Health Organization and several studies dispute Monsanto’s claims that Roundup is safe.  Several studies have found Roundup, of which glyphosate is only the main listed ingredient, to be a “probable carcinogen,” or a likely one.

The August 24 hearing on a recent order to show cause stems from a March 2017 pretrial order from Judge Chhabria.  The judge said then that he would not consider the plaintiffs’ challenges to the confidentiality of documents proffered by Monsanto, unless they were proven to be relevant to the case.  The judge also said that he would sanction Monsanto for unreasonable attempts to get or maintain confidentiality.

Mr. Wisner was accused of posting the documents on his firm’s website and of leaking them to The New York Times.  The Times reported that internal emails suggest Monsanto may have influenced research on its Roundup weedkiller product through EPA employees, and may have manipulated public opinion in the process.

Mr. Wisner brought a legal ethics expert, U.C. Hastings Professor Richard Zitrin, to represent him in Thursday’s hearings.  Mr. Zitrin said the documents were released in good faith, because Monsanto had failed to responded within the 30 days of Mr. Wisner’s challenging the protective order.  Mr. Zitrin said it was not Mr. Wisner’s job to warn Monsanto that its time was running out.

Judge: Lawyer became PR Man
The judge took exception to that Mr. Zitrin’s argument.  He said, “In light of the fact there was a live dispute, it absolutely was [Mr. Wisner’s] obligation.  The problem is he was not focused on being a lawyer.  He was more interested in being a PR man. … You’re saying he didn’t file a motion because Monsanto didn’t file a declaration, but he said to Monsanto, ‘We’re going to decide whether to file a joint letter or we’re going to file a motion.’  That was recognition.’”

When Mr. Wisner and Mr. Zitrin then began to debate about who should speak next , the judge told Mr. Zitrin to sit down or he would call security.

Judge: Monsanto Argument “almost laughable”
Judge Chhabria also scorned Monsanto’s arguments concerning confidentiality.  The documents at issue include internal communications in which employees at the company claim to have “ghostwritten” review articles that upheld findings that glyphosate does not cause lymphoma.

“How could you have taken this position that these documents are not relevant to the general causation of this case?” the judge asked Monsanto attorney Joe Hollingsworth.

Mr. Hollingsworth said they weren’t original scientific reports, but “literary surveys” that his client hadn’t cited as evidence in the case. “Those aren’t original reports by epidemiologists,” he said. “What none of those documents refer to is any original science that’s going to have to form the basis for an expert’s opinion. They’re irrelevant to Daubert inquiry.”

The judge said they contributed to Monsanto’s assertion that the scientific consensus was that there was no link between glyphosate and cancer, but a plaintiffs’ attorney pointed to a motion to dismiss that had cited a few of the articles Monsanto allegedly helped write.

The judge did not indicate how he would rule on the matter.

Monsanto Roundup Fight Erupts in Calif. Court

The MDL is In re: Roundup Products Liability Litigation, case number 3:16-md-02741, in the U.S. District Court for the Northern District of California.



Johnson & Johnson loses $417 Million Talc Cancer Verdict

A Los Angeles jury ordered Johnson & Johnson to pay a California woman $417 million this week, for failing to warn her that its talc products are cancerous.

On August 21, 2017, the Los Angeles jury issued the largest verdict yet in a series of trials which J&J has mostly lost. The drug and medical device giant has now lost 5 of 6 talc cancer verdicts.

Johnson & Johnson and its lawyers will have a harder time writing this verdict off as the product of an unfair venue, which they have done in the past.  The company lost one verdict in South Dakota, though that one received scant attention because the victim had survived chemotherapy (at least at the time of the trial); so the jurors awarded no damages.  Then J&J lost three high-profile verdicts in St. Louis Missouri.  Consequently, the company and its well-paid lawyers and bloggers have tried to write off those Missouri verdicts as a result of a judicial district unfair to corporate defendants.

Look now for attacks on California jurors, or the state itself, as J&J and its corporate apologists and well-paid trolls of every stripe will try to tattoo the state and its jurors to somehow explain away this one, too.

Could it simply be that the 12 jurors were sane and simply cognizant for the California trial?  Could it be that they heard the science from paid experts on both sides, then determined that it is more likely than not that Eva Echeverria’s ovarian cancer was caused by Johnson & Johnson talcum products?

Johnson & Johnson Failed to Warn
Like four previous juries, the California jury found that Johnson & Johnson failed to warn the 63-year-old woman diagnosed with terminal ovarian cancer about the risks of using J&J talcum products.

The California verdict marks the largest one yet in several suits that claim the company’s talc powder causes ovarian cancer.  More than 300 lawsuits are pending in California.  More than 4,500 talc cancer lawsuits are pending in the rest of the country.  All allege J&J ignored studies which linked its Johnson’s Baby Powder and Shower to Shower to cancer.

Plaintiff Dying of Ovarian Cancer
The plaintiff, Eva Echeverria, was diagnosed with ovarian cancer in 2007.  A surgeon removed a softball-sized tumor from Ms. Echeverria, but she is now near death.  She was unable to attend the trial.

In video-recorded testimony played for the jury, Ms. Echeverria testified that she used Johnson’s Baby Powder from age 11 until 2016, when she saw a news story about a woman with ovarian cancer who had also used Johnson’s baby powder.

Johnson’s Baby Powder is one of the company’s best-known products. It was once heavily marketed with the catchy jingle, “A sprinkle a day helps keep the odor away.”

Ms. Echeverria testified that if Johnson & Johnson had put a warning on its talc product, she would have stopped using it.

Jury deliberates Two Days
Jurors deliberated for two days, before awarding Ms. Echeverria $70 million in compensatory damages and $347 million in punitive damages.  The jury panel found there was a connection between her ovarian cancer and the baby powder.

J&J will appeal Verdict (of course)
Johnson & Johnson immediately announced that it would seek to overturn the verdict.  Company attorneys argued throughout the trial (as they will in their appeal) that science doesn’t back the connection between talc and ovarian cancer.

J&J said in a statement: “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s Baby Powder.”  (Sounds good if you say it fast enough.)

J&J lawyers argued throughout the trial that various scientific studies, as well as federal agencies, including the U.S. FDA, had not found talc products carcinogenic. (The FDA has also approved a couple dozen drugs that were later pulled for serious and sometimes fatal problems, but J&J lawyers didn’t include that information in their appeal to the FDA’s alleged authority.)

Among the studies J&J cited was one in 2000 by researchers at Harvard University that was part of the National Nurses Health Study of more than 121,000 women, 78,630 of whom said they had used talc.  Ovarian cancer eventually struck 307 of them.  The researchers concluded there was “no overall association” between talc use and “epithelial ovarian cancer.”  There was, however, a “modest elevation in risk” for one variety of the disease, invasive serous ovarian cancer, which is the one killing Ms. Echeverria, according to court documents.

Johnson & Johnson loses $417 Million Talc Cancer Verdict

Ms. Echeverria’s attorneys argued that women nationwide trusted Johnson & Johnson not to market an unsafe product.  They learned too late that J&J had known long ago about other research showing a relationship between talc and cancer.

1982 Study showed Talc Increases Cancer Risk
The lawsuit petition cited a 1982 study that shows women who used talc on their genitals were at a 92% increased risk for ovarian cancer.  The lead researcher in that study, Daniel W. Cramer, later advised Johnson & Johnson to put a warning label on the product.  The plaintiff’s lawyers argued that J&J failed to include the warning because it would have seriously cut into their profits, as warned women would not have used Johnson’s Baby Powder or Shower to Shower talc, or would have used the products much more sparingly.

According to the National Cancer Institute, ovarian cancer accounts for 1.3% of all new cancer cases in the United States.  It is the eighth most common cancer and the fifth-leading cause of cancer-related death among women.  Fewer than half of all patients survive five years after an ovarian cancer diagnosis.

Other J&J Talc Cancer Verdicts
Johnson & Johnson has prevailed in just one of six trials against the company in the talcum powder cancer litigation. In 2013, a South Dakota jury sided with a woman plaintiff who blamed J&J’s talc powder for her ovarian cancer, and three previous juries in St. Louis sided with plaintiffs, for a total of $197 million in verdicts against the company.  Five juries have now awarded plaintiffs more than $614 million in total verdicts against Johnson & Johnson in the talcum cancer litigation.




WebMD shills for Monsanto & Big Pharma

WebMD shills for Monsanto, Big Pharma, and other corporate giants.  Natural News has revealed how WebMD has never seen a Monsanto product or a Big Pharma drug or vaccination that it didn’t like.  It promotes them all, without question or critical comment.  Why?

It’s the Advertising Money, Stupid
WebMD takes most of its advertising money from Big Pharma corporations like Merck, maker of the dubious shingles vaccine, the dangerous MMR vaccine, and other troublesome vaccines that are far from as safe or as effective as advertised by Merck and WebMD.  The company known as WebMD is one that clearly knows which industry giants are paying its bills.  WebMD is, in point of fact, little more than a tireless promoter of not only Big Pharma drugs and ethically-challenged Monsanto, but any and all vaccination, regardless of real science (or lack thereof) or circumstances.

Related:  Five Most Dangerous Vaccines

Passive GMO Promotion
Corporate sponsorships taint WebMD’s recommendations and “passive” promotion techniques. WebMD advertisements are often designed to look more like editorials to disguise their real intent, fooling readers into thinking that the advertising they see is actually news of some sort.

Monsanto WebMD Partnership
Monsanto uses WebMD’s influence to serve its own agenda.  Monsanto produces several sponsored “advertorials” that can easily be mistaken for “real” content rather than marketing propaganda.  Monsanto also uses independent third parties to manipulate GMO content on WebMD’s web site. (Monsanto also colludes with the EPA to play down the dangers of Roundup and promote it.)

Web MD Internet’s Most Visited Health Site
WebMD is, unfortunately for the truth, the internet’s most visited health site.  Public perception is that it’s a trustworthy source of “independent and objective” health information.  Nothing could be further from the truth.  WebMD is a thinly-disguised corporate shill masquerading as a news site.  WebMD uses its influence to shamelessly promote corporate-backed health products and protocols.

WebMD’s Journalistic Subterfuge destroys Credibility
WebMD “Partnerships” destroy any credibility the site may have once had.  Partnerships and sponsorships infect WebMD’s recommendations across the board. “Passive” promotion techniques include advertisements designed to look like editorials.  This is journalistic subterfuge at its worst, and its most sophisticated.

Web MD Rigs Phony Test for Depression
The pharmaceutical drug industry’s capture of WebMD has been clear for a long while and is nearly complete.  In just one egregious example, Dr. Mercola has reported how WebMD’s free online depression test in 2010 was rigged to make any person responding feel like she needed professional help.  The only result a test respondent could receive was that she was at risk for major depression and should discuss her options with a doctor.

That phony “test” was sponsored by Cymbalta maker Eli Lilly.  The test’s intent was obvious – to make a person inquire about antidepressants, and hopefully start taking them, preferably forever.

This advertisement dressed up as a “consumer aid” to make people go from feeling normal to depressed caught the attention of Senator Charles Grassley.  He launched an investigation, but that announcement changed no laws and apparently no perceptions.  WebMD continues to hide advertising business as usual.  Consumer Beware!

Web MD Aids Monsanto
Monsanto is one of the latest multinational corporate giants to use WebMD for its own hidden agenda.  Nearly every WebMD article now includes a Monsanto-sponsored ad that boldly declares: “It’s time for a bigger discussion about food.”  This clever propaganda then links to Monsanto’s corporate take on soil, water, and honey bee-disappearance, with no other contributor’s point of view allowed.

Marketing Strategists Tout “Advertorial Sponsorships”
Marketing strategists say “advertorial sponsorships” are the best way to sell something today.  They are designed to fool consumers, so that they don’t realize they’re being sold something.

Back in the day, before deep-pocketed advertisers called the shots and completely ruled the publishing world, the line between editorial and advertising content was clear.  You knew whether you were reading an advertisement or an editorial.  Today, readers practically need degrees in journalism and science to know what they’re reading, who sponsored it, and why.

A business has to pay for a sponsorship/advertorial just like it would a regular ad.  In some cases, businesses pay significantly more than they would for a regular ad.  But corporations consider the expense of a sponsorship/advertorial ad well worth the cost.

As Dr. Mercola explains: “The venue where your sponsored advertorial is going (in this case, WebMD and its affiliates) has no input on the content – the advertiser has full control over the text of the ‘informative’ ad.  The advertiser can control how the information is presented on the page, as opposed to having to select a regular display ad format.”

The sponsored advertorial can be used in multiple publications.  Companies can reuse a sponsored advertorial as a stand-alone ad in other places.

Native Advertising’ further Blurs the Line Between Ads and Independent Content

Another form of this type of shrouded sales presentation is called “native advertising.” The key difference between a native ad and an advertorial is that a native ad fits more seamlessly into the Website which features it, making it even less noticeable as a sales pitch.

This sneaky ad is designed to make you think you’re reading a regular content article, when in fact it’s all marketing. In the case of WebMD, the advertorial/native ad line is so thin as to be non-existent. Many of WebMD’s disclaimers are barely noticeable, and rendered in a typeset which manipulates readers into skipping them entirely.

Dr. Mercola explains:  “This all amounts to massive collusion on the part of the industries partnering with WebMD to sell THEIR health goals and products without you realizing you’ve been sold something that may or may not be in your best interest at all.”

WebMD pushes Vaccination

When it comes to vaccination, WebMD publishes only those articles which make it seem as if vaccination is a tried and true science without enormous problems, which include lawsuits for dubious vaccines like Merck’s Zostavax.  Vaccination “science” is far from settled, but you wouldn’t know that if you read only WebMD’s narow take on the subject.  The same goes for Monsanto products, and Big Pharma drugs.

WebMD shills for Monsanto & Big Pharma

If you want to find out what is really going on in the world of GMO foods, Big Pharma drugs, and vaccination safety and efficacy, the best thing you could do is avoid WebMD.  You will find little truth there not colored by WebMD’s fealty to its corporate and government sponsors.  Selah!



Monsanto-funded Journalists fail to disclose Industry ties

An EcoWatch story broke the news two years ago of how Monsanto fakes news.  Time and again, Monsanto-funded journalists fail to disclose industry ties.  Journalists whom the company secretly pays write pro-GMO articles, or hit pieces against organic foods.  Those ostensible “journalists” fail to disclose their monetary (and career) conflicts of interest.  Those “journalists” work for Monsanto to produce fake news.

Fake Monsanto News – 27 Examples

In Nov. 2015, EcoWatch uncovered 27 examples of so-called journalists failing to disclose they were paid by Monsanto.

A Columbia Journalism Review story on whether science journalists should accept money from corporate interests triggered the research. The authors wanted to know whether journalists were disclosing their sources’ corporate ties and conflicts of interest. U.S. Right to Know reviewed recent articles to assess how often journalists, columnists and other writers quote academic sources without disclosing that they were funded by the chemical giant Monsanto.

The review found 27 articles quoting (or authored by) university professors after they received Monsanto funding.  Alarmingly, the university professors failed to disclose their funding.  If even university professors – who obviously know better – fail to disclose their funding, how many other Monsanto-funded writers fail to disclose that the biotech bully from Missouri is paying them to promote Monsanto or help shield the company from liability?  Monsanto is now being sued by farmers and others for causing their non-Hodgkin’s lymphoma, for failing to warn people that Roundup is carcinogenic.

Collapse of Journalistic Standards, Personal Integrity

This is a failure of journalistic standards as well as personal and civic integrity.  Whenever a writer quotes sources about food controversies such as GMOs or organic food, readers have a right to know if Monsanto funded that writer or whether the writer has any conflicts of interest.

Cuttlefish Squirt Ink for Monsanto
These writers are like cuttlefish squirting ink for Monsanto, covering up the truth of the matter in a morass of disinformation, misinformation, or outright propaganda.  Failing to reveal obvious conflicts of interest fools the reading public about the credibility of Monsanto-funded academics, their support of GMOs, their criticisms of organic food.  It also detracts from the credibility of consumer advocates, or anyone else (like this writer, writing because science shows GMOs are neither safe nor nutritious) who wants the world to know the truth about Monsanto’s poison products and business model.

University Professors Shill for Monsanto, hide Secret Funding

EcoWatch found that many top media outlets quoted either University of Florida Professor Kevin Folta or University of Illinois Professor Emeritus Bruce Chassy, while failing to disclose that the “professors” had received funding from Monsanto.  The New York Times published documents that showed Professor Folta received Monsanto funding in August 2014, while Professor Chassy received Monsanto funding in October 2011, if not also prior to that date.

Fake Monsanto News from NY Times, Washington Post, Chicago Tribune, etc.

Failure to disclose Monsanto funds occurred at well-known news outlets, including the New York Times, Washington Post and Chicago Tribune. Other Monsanto-funded fake news appeared in science publications, such as Nature, Science Insider and Discover. Other fake Monsanto news came from magazines such as the New Yorker, Wired, The Atlantic. But fake Monsanto news was not and has not been limited to print and internet media. Well known broadcast outlets like ABC and NPR also published fake Monsanto news without revealing they were funded by Monsanto itself.

EcoWatch published this list of news articles quoting (or authored by) Professors Folta and Chassy after they received their Monsanto funding, yet failed to disclose that Monsanto funding.

•  New York Times: “Taking on the Food Industry, One Blog Post at a Time.” By Courtney Rubin, March 13. (Also ran in the Sarasota Herald-Tribune).
•  New York Times: “Foes of Modified Corn Find Support in a Study.” By Andrew Pollack, Sept. 19, 2012.
•  Washington Post: “Kraft Mac & Cheese Just Got Duller. You Can Thank (Or Blame) ‘The Food Babe’.” By Michael E. Miller, April 21. (Also ran in the Chicago Tribune).
•  Washington Post: “Proof He’s the Science Guy: Bill Nye Is Changing His Mind About GMOs.” By Puneet Kollipara, March 3.
•  Nature: “GM-Crop Opponents Expand Probe Into Ties Between Scientists and Industry.” By Keith Kloor, Aug. 6.
•  NPR: “Is The Food Babe A Fearmonger? Scientists Are Speaking Out.” By Maria Godoy, Feb. 10.
•  New Yorker: “The Operator.” By Michael Specter, Feb. 4, 2013.
•  The Atlantic: “The Food Babe: Enemy of Chemicals.” By James Hamblin, Feb. 11.
•  Wired: “Anti-GMO Activist Seeks to Expose Scientists Emails with Big Ag.” By Alan Levinovitz, Feb. 23.
•  ABC News: “Scientists Developing Hypo-Allergenic Apples.” By Gillian Mohney, March 22, 2013.
•  Science Insider: “Agricultural Researchers Rattled by Demands for Documents from Group Opposed to GM Foods.” By Keith Kloor, Feb. 11.
•  Columbia Journalism Review: “Why Scientists Often Hate Records Requests.” By Anna Clark, Feb. 25.
•  Discover: “Open Letter to Bill Nye from a Plant Scientist.” By Keith Kloor, Nov. 10, 2014.
•  Discover: “How to Balance Transparency with Academic Freedom?” By Keith Kloor, Feb. 27.
•  Discover: “Anti-GMO Group Seeks Emails from University Scientists.” By Keith Kloor, Feb. 11.
•  Forbes: “Zombie Retracted Séralini GMO Maize Rat Study Republished To Hostile Scientist Reactions.” By Jon Entine, June 24, 2014.
•  Forbes: “Did The New Yorker Botch Puff Piece On Frog Scientist Tyrone Hayes, Turning Rogue into Beleaguered Hero?” By Jon Entine, March 10, 2014.
•  Forbes: “You Can Put Lipstick On A Pig (Study), But It Still Stinks.” By Bruce M. Chassy and Henry I. Miller, July 17, 2013.
•  Forbes: “Anti-GMO Scientist Gilles-Eric Seralini, Activist Jeffrey Smith Withdraw from Food Biotech Debate.” By Jon Entine, May 29, 2013.
•  Forbes: “Malpractice On Dr. Oz: Pop Health Expert Hosts Anti-GM Food Rant; Scientists Push Back.” By Jon Entine, Oct. 19, 2012.
•  Forbes: “Scientists Smell a Rat In Fraudulent Genetic Engineering Study.” By Henry I. Miller and Bruce Chassy, Sept. 25, 2012.
•  Forbes: “The Science of Things That Aren’t So.” By Bruce Chassy and Henry I. Miller, Feb. 22, 2012.
•  Des Moines Register: “Consumers Are Misled About Organic Safety.” By John Block, Oct. 10, 2014.
•  Gainesville Sun: “Genetically Modified Foods Face Hurdles.” By Jeff Schweers, June 29, 2014.
•  Peoria Journal Star: “Hybrid Crops That Used to Offer Resistance to Rootworm No Match for Mother Nature.” By Steve Tarter, June 21, 2014.
•  Gawker: “The ‘Food Babe’ Blogger Is Full of Shit.” By Yvette d’Entremont, April 6.
•  St. Louis Post-Dispatch: “California Labeling Fight May Raise Food Prices for All of Us.” By David Nicklaus, Aug. 19, 2012.

Related:  Writer Henry Miller Outed as Monsanto Puppet, again

Two Compromised Professors, Thousands of “Others”
If university professors are this easy to capture and compromise, how much easier is it for Monsanto to pay “journalists,” bloggers and other hack writers (not on a university salary) to promote GMOs and attack organic foods and those who believe in and support them?

Fake “Independent” Experts
These two compromised professors who failed to disclose their Monsanto funding have received major media attention as “independent” experts on GMOs and organics.  The professor fakers only admitted to receiving their Monsanto funding after they were unmasked by emails uncovered by Freedom of Information Act requests filed by a consumer group – U.S. Right to Know.

Monsanto News Fakers Like Fleas
Now, how many other news fakers are out there with “scientist” and “professor” titles defending Monsanto and attacking organics while hiding their secret Monsanto funding?  Think of them like fleas.  If you can find two, you know you’ve got a thousand you can’t yet see. “Independent” indeed!

Monsanto-funded Journalists Fail to Disclose Industry Ties

In future, one would hope that when “journalists” write about food, they carefully question their sources regarding any conflicts of interest.  Who or what corporation is funding this so-called food “expert”?  What PR or front group is used to fund this “expert” person to hide his ties with Monsanto, the real source of the funding?  This is a shell game played for decades, but the stakes have never been higher. Roundup is very likely killing people, while “professors” and other corporate shills provide desperately-needed cover for what is arguably a criminal enterprise.

Readers beware!



Roundup Carcinogenicity Evidence Clear since 1985

Monsanto’s official position is that no evidence shows Roundup or glyphosate can cause cancer.  The problem for Monsanto is that plenty of evidence shows Roundup, as well as its only identified active ingredient, glyphosate, is carcinogenic.  A Roundup lymphoma lawsuit petition from April 2016 outlined some history of which Monsanto cannot help but be aware.  Roundup carcinogenicity evidence has been clear since at least 1985, if not earlier.

Monsanto Knows Glyphosate Carcinogenic
Monsanto knew of glyphosate’s carcinogenic properties as early as the 1980s.

Related:  Monsanto Lawsuit

Roundup Carcinogenicity Evidence Clear since 1985

March 4, 1985: A group of the EPA’s Toxicology Branch published a memorandum classifying glyphosate as a Category C oncogene. Category C oncogenes are possible human carcinogens with limited evidence of carcinogenicity.

1986: EPA issued a Registration Standard for glyphosate (NTIS PB87-103214). The Registration standard required additional phytotoxicity, environmental fate, toxicology, product chemistry, and residue chemistry studies. All the data required was submitted and reviewed and/or waived.

October 1991: EPA published a Memorandum entitled “Second Peer Review of Glyphosate.” The memorandum changed glyphosate’s classification to Group E (evidence of non-carcinogenicity for humans). Two peer review committee members did not concur with the committee’s conclusions. One member refused to sign.

Roundup Toxicity Dwarfs Glyophosate Alone
Besides the toxicity of the active molecule in glypohosate, many studies support the hypothesis that glyphosate formulations found in Monsanto’s Roundup products are more dangerous,more toxic than glyphosate alone.

Since glyphosate is rarely, if ever, used alone, it is irresponsible, at best, for Monsanto to test only glyphosate. It is duplicitous, disingenuous, and quite possibly criminal, at worst, to test only glyphosate alone.

Related:  Roundup Cancer Lawsuit

1991 (or earlier): Evidence had demonstrated glyphosate formulations were significantly more toxic than glyphosate alone.

2002: Julie Marc published a study titled “Pesticide Roundup Provokes Cell Division Dysfunction at the Level of CDK1/Cyclin B Activation.” The Marc study found Monsanto’s
Roundup caused delays in the cell cycles of sea urchins, while the same concentrations of glyphosate alone proved ineffective and did not alter cell cycles.

2004:  Ms. Marc published a study titled “Glyphosate-based pesticides affect cell cycle regulation.” The study demonstrated a molecular link between glyphosate-based products and cell cycle dysregulation. The study noted: “[C]ell-cycle dysregulation is a hallmark of tumor cells and
human cancer. Failure in the cell-cycle checkpoints leads to genomic instability and subsequent
development of cancers from the initial affected cell.” Further, “[s]ince cell cycle disorders such
as cancer result from dysfunction of unique cell, it was of interest to evaluate the threshold dose
of glyphosate affecting cells.”

2005:  Francisco Peixoto published a study showing Roundup’s effects on rat liver mitochondria are much more toxic and harmful than the same concentrations of glyphosate alone.

The Peixoto study suggested the harmful effects of Roundup on mitochondrial bioenergetics could not be exclusively attributed to glyphosate.  They could be the result of other chemicals, namely the surfactant POEA, or alternatively due to the possible synergy between glyphosate and Roundup formulation products.

Roundup Adjuvants NOT INERT
2009:  Nora Benachour and Gilles-Eric Seralini published a study examining the effects of Roundup and glyphosate on human umbilical, embryonic, and placental cells. The study used dilution levels of Roundup and glyphosate far below agricultural recommendations, corresponding with low levels of residues in food. The study concluded that so-called “inert” ingredients, and possibly POEA, change human cell permeability, amplifying toxicity of glyphosate alone. The study further suggested glyphosate toxicity determinations must take adjuvants into account – the chemicals used in the formulation of the complete pesticide. The study confirmed adjuvants in Roundup are not inert; so Roundup is always more toxic than its so-called lone active ingredient, glyphosate.

Monsanto Knew or Should Have Known
The Delaware petition reads: “The results of these studies were confirmed in recently published peer-reviewed studies and were at all times available and/or known to (Monsanto).

“(Monsanto) knew or should have known that Roundup is more toxic than glyphosate alone and that safety studies on Roundup, Roundup’s adjuvants and “inert” ingredients, and/or the surfactant POEA were necessary to protect Plaintiff from Roundup.”

Monsanto Failed to Test Roundup for Safety

The petition further charges that Monsanto “knew or should have known that tests limited to Roundup’s active ingredient glyphosate were insufficient to prove the safety of Roundup.”

Monsanto is then charged in the petition with failing to appropriately and adequately test Roundup, Roundup’s adjuvants and “inert” ingredients, and/or the surfactant POEA to protect Plaintiff from Roundup.”



Monsanto sued in Delaware for causing non-Hodgkin’s Lymphoma

Monsanto was sued in the state of Delaware (Roundup Petition) for causing a man’s non-Hodgkin’s Lymphoma.  The plaintiff is New York resident Kenneth Panthen, who was diagnosed with NHL after using Roundup for several years.

Roundup Lawsuit Petition
The lawsuit petition says Mr. Panthen was injured “as a direct and proximate result of (Monsanto’s) negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, advertising, distribution, labeling, and/or sale of the herbicide Roundup®, containing the active ingredient glyphosate.”

Related:  Roundup non-Hodgkin’s Lymphoma Lawsuit

Mr. Panthen maintains that “Roundup® and/or glyphosate is defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce.”  He also alleges Roundup lacked proper warnings and directions regarding its dangers.

All Formulations of Roundup

“Roundup,” says the petition, “refers to all formulations of Defendant’s Roundup products, including, but not limited to, Roundup Concentrate Poison Ivy and Tough Brush Killer 1, Roundup Custom Herbicide, Roundup D-Pak herbicide, Roundup Dry Concentrate, Roundup Export Herbicide, Roundup Fence & Hard Edger 1, Roundup Garden Foam Weed & Grass Killer, Roundup Grass and Weed Killer, Roundup Herbicide, Roundup Original 2k herbicide, Roundup Original II Herbicide, Roundup Pro Concentrate, Roundup Prodry Herbicide, Roundup Promax, Roundup Quik Stik Grass and Weed Killer, Roundup Quikpro Herbicide, Roundup Rainfast Concentrate Weed & Grass Killer, Roundup Rainfast Super Concentrate Weed & Grass Killer, Roundup Ready-to-Use Extended Control Weed & Grass Killer 1 Plus Weed Preventer, Roundup Ready-to-Use Weed & Grass Killer, Roundup Ready-to-Use Weed and Grass Killer 2, Roundup Ultra Dry, Roundup Ultra Herbicide, Roundup Ultramax, Roundup VM Herbicide, Roundup Weed & 3Complaint for Damages Grass Killer Concentrate, Roundup Weed & Grass Killer Concentrate Plus, Roundup Weed & Grass killer Ready-to-Use Plus, Roundup Weed & Grass Killer Super Concentrate, Roundup Weed & Grass Killer1 Ready-to-Use, Roundup WSD Water Soluble Dry Herbicide Deploy Dry Herbicide, or any other formulation of containing the active ingredient glyphosate.”

Injuries were Avoidable
The Monsanto lawsuit petition also states that Mr. Panthen’s injuries, “like those striking thousands of similarly situated victims across the country, were avoidable.”

The petition also explains that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7. U.S.C. § 136 et seq.: “FIFRA requires that all pesticides be registered with the Environmental Protection Agency (EPA) prior to their distribution, sale. . .”

EPA does not verify Roundup Safety
Part of the EPA registration process requires a chemical maker to perform a variety of tests to evaluate the potential for exposure to pesticides, toxicity to people and other potential so-called “non-target organisms,” and other adverse effects on the environment.  EPA registration, however, is no assurance or finding of safety, says the petition:

“The determination the EPA makes in registering or re-registering a product is not that the product is safe (emphasis ours), but rather that use of the product in accordance with its label directions ‘will not generally cause unreasonable adverse effects on the environment.’” 7 U.S.C. § 136(a)(c)(5)(D).

FIFRA defines “unreasonable adverse effects on the environment” to mean “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” 7 U.S.C. § 136(bb).  FIFRA thus requires the EPA to make a risk/benefit analysis in determining whether a registration should be granted or allowed to continue to be sold in commerce.

EPA does not Test Monsanto Products
FIFRA generally requires that a registrant like Monsanto conduct health and safety testing of its pesticides.  However, most people are surprised to learn that Monsanto and other pesticide makers perform their own tests; an agency like the EPA simply peruses those tests.  The government does no safety testing of its own.

The petition explains: “The government is not required, nor is it able, to perform the product tests that are required of the manufacturer.”

Just as drug companies attempt to hide behind “FDA approval,” despite the fact that FDA does no drug testing of its own, Monsanto has attempted to hide behind EPA registration as some sort of official government certification of safety.

The other problem with that dubious position is that secret Monsanto emails between Monsanto executives and EPA officials in charge of registering (and, one can only hope, regulating)  Roundup show that EPA employees worked to help Monsanto.  Recently-released documents show that EPA officials helped slow reviews of Roundup/Glyphosate, and helped Monsanto sidestep any meaningful regulations.  Several EPA officials have helped engineer public perception for the benefit of Monsanto.

Glyphosate a Probable Carcinogen
Monsanto became gravely concerned with public perception and legal problems after the World Health Organization declared in 2015 that glyphosate is a probable carcinogen.  Many of the legal cases regarding glyphosate in Roundup are based on that World Health Organization’s declaration.  But the WHO is far from the only organization to find deeply troubling problems with glyphosate.



Trump moves to stop Screening Truck Drivers for Sleep Disorder

The Trump administration has withdrawn a proposed law to screen truckers for a hazardous sleep condition.  Sleep apnea can threaten the lives of every driver on the road, because sleep-deprived drivers are a potential danger to every other driver.  Nevertheless, President Trump sees it as an unnecessary regulation overly burdensome to truckers.

How Asleep should Truckers Be on the Road?
The Atlantic Monthly asks, “How asleep should truck drivers be on the job?” Public Citizen, meanwhile, is leading a related lawsuit against President Trump’s edict that no new regulation can be put into law unless two other regulations are rescinded. This idea – backed by the Koch Brothers, Chamber of Commerce and ALEC – may benefit corporations, but it puts ordinary citizens at risk.

Conductor with Sleep Apnea injures 100 People
Sleep apnea entered the national safety debate with a bang last summer in New Jersey when a conductor with undiagnosed sleep apnea crashed his train into a crowded station in Hoboken.  That accident injured more than 100 people. Obstructive sleep apnea affects alertness. It can make people spontaneously sleep even during stimulating activities.

The New Jersey accident is just one high profile case. How many tragic trucking accidents have been caused by truck drivers with undiagnosed sleep apnea?  That number is sure to be at least in the hundreds, considering the number of commercial truck drivers and train engineers who use the nation’s public roads and rail tracks.

In March of 2016, the Obama administration proposed that deadly sleep-related accidents should be prevented where possible. One approach was to begin sleep apnea-screening of train engineers and truck drivers.

On August 11, 2017, the Trump administration announced that it had withdrawn that proposed sleep test requirement. The reason was the same as always, part of a larger effort to remove any regulations that might limit economic growth.

NTSB “Disappointed” with Change
The National Transportation Safety Board, which has advocated screening truckers for sleep apnea for years, said through a spokesmodel that it was “disappointed” that the DOT withdrew this “much-needed” rule.

Sleep Apnea affects 1 in 10 People
The sleep-inducing condition is increasingly common, affecting at least one in 10 people to some degree. Obstructive sleep apnea in serious cases can give someone symptoms that sound like classic narcolepsy. Such a person can fall asleep with little to no warning. It is similar to narcolepsy, though the primary problem is respiratory. People with sleep apnea don’t breathe well while sleeping at night. This degrades the quality of the sleep, and leaves people impaired and exhausted throughout the day.

Trump moves to stop Screening Truck Drivers for Sleep Disorder
The problem with dropping screening is that sleep apnea applies even to many people who report sleeping well for seven or eight hours each night. These people are unaware that their breathing interruptions are precluding deep, restorative cycles. Without those deep cycles, accidents are more likely to happen. It only makes sense to screen people whose jobs involve trucking or training enormous machines at high velocities, always a potential recipe for human tragedy.

Trucker Objections Fair

Many truckers fairly object to being tested for sleep apnea if they have to pay for it themselves.  It can cost upwards of $1,000.  The fair answer is to make the corporations pay for the testing.   Those that make the most profits from our roads need to pay the freight to better safeguard those who do the heavy lifting and the OTR driving, as well as all the rest of us who must travel on public roads.




U.S. Senate Could Destroy Your Rights with H.R. 1215

Tort reform pushed by the U.S. Congress and the U.S. Chamber of Commerce has always been a ruse.  The game has always been to attack lawyers in order to disguise the real target: the citizen and the citizen’s inalienable rights.  H.R. 1215 is the same animal.  Dressed up as a bill to “protect” people’s access to healthcare, it does the opposite.

H.R. 1215 Would Severely Limit Courthouse Access

The duplicitously named “Protecting Access to Care Act of 2017″ does everything BUT protect peoples’ access to healthcare.  What it mostly does is severely limit a U.S. citizen’s access to the courtroom.  It virtually wipes out class action lawsuits – whether for credit card fraud committed by a major bank, rank discrimination,  negligence, or even outright criminality committed by any corporation.  It also makes it all but financially impossible for a plaintiff’s law firm to pursue pharmaceutical drug or medical device cases for their injured or dead clients.  All of this is done under the guise of saving money; but this bill doesn’t do that, either.  Limiting a victim’s ability to collect fair and just compensation not only makes survival more difficult for that person, it also undermines any real accountability of the negligent party, the corporation.  The U.S. Supreme Court erroneously granted corporations personhood with its unconscionable ruling in the duplicitously-named  “Citizens United” case.  The rancid H.R. 1215 bill takes that catastrophe a step further, moving us all further down the road to complete corporate servitude.

Make no mistake: the end game is clear.  Like the Trump juggernaut, this bill moves under the guise of a populist movement which pretends that it will help people.  But the people ARE the target, and this new war is the same as the old:  It’s corporate power vs. people power.  If you have not figured that out yet, God help us all.

H.R. 1215 Violates the Constitution
The Seventh Amendment of the U.S. Constitution guarantees a U.S. citizen’s right to a civil trial by jury.  Despite all its phony language about “protecting” people, H.R. 1215 works in direct violation of that right.

What is the Protecting Access to Care Act of 2017?
The summary of the bill, H.R. 1215, reads: “To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system.” In short, this is a bill designed to take away your rights to a jury trial, and to limit how much compensation an injury victim can collect.

Medical Errors are 3rd Leading Cause of Death in the U.S.
Medical errors are the third leading cause of death in this country. So how are your rights being “protected” if we limit your compensation?  Is your child’s life worth just $250,000? According to Mitch McConnell and Paul Ryan it is. This bill will not only not “protect” you and your family. It will also destroy any incentive that the medical industry has to actually fix that problem. What has happened in Texas with its Draconian “tort reform” will open the door to that happening all over the country. H.R. 1215 will preempt your state’s laws that would formerly protect you from the kinds of things that have happened to Texas patients with their many perverted, imprisoned doctors, which the state’s twisted Tort Reform enables.

What damage caps will H.R. 1215 put into place?
The new bill places no caps on economic damages, a small silver lining in a black cloud. It will, however, drastically limit the amount of non-economic damages you may be able to collect – and in a sneaky way, too. From the bill (excerpts in bold are ours):

“In any health care lawsuit, the amount of noneconomic damages, if available, shall not exceed $250,000, regardless of the number of parties against whom the action is brought or the number of separate claims or actions brought with respect to the same injury.

“The jury shall not be informed about the maximum award for noneconomic damages. An award for noneconomic damages in excess of $250,000 shall be reduced either before the entry of judgment, or by amendment of the judgment after entry of judgment, and such reduction shall be made before accounting for any other reduction in damages required by law.

“In any health care lawsuit, each party shall be liable for that party’s several share of any damages only and not for the share of any other person. Each party shall be liable only for the amount of damages allocated to such party in direct proportion to such party’s percentage of responsibility.”

More Problems with H.R. 1215
Damage caps have always been a problem, but we have deeply-rooted concerns about the rest of the bill. H.R. 1215 also stands to:

  • Eliminate the class-action lawsuit
  • Make all healthcare claims federal claims, thus eliminating states’ laws
  • Allow insurance companies to pay claims via payments, not all at once

Soft targets of the bill, plaintiff attorneys – who fight for injured people – will have their fees arbitrarily limited.  Defense attorneys – who represent the corporations that caused harm – have no such limits placed on their pay.  The surgeon who hacked off the wrong leg, or the intern who mislabeled a chart and killed someone with a drug overdose, or the doctor who missed your cancer diagnosis?  Their “defense” attorneys can charge whatever they want.

Why H.R. 1215 is bad for injured people and their families
This Congressional bill aims to fix a “crisis” that even medical malpractice insurers say does not exist.  The Doctors Company, one of the country’s largest medical malpractice insurance providers, says, “Doctors are paying less for malpractice insurance than they did in 2001 – without any inflation adjustment. (And) the rate of claims has dropped by half since 2003.”

Despite a mountain of evidence to the contrary, including years of studies, research, data collection and other hard evidence, this Congress continues to perpetuate the lie that limiting the civil justice system, in terms of which kinds of lawsuits you can bring and in how much money an injured person can collect, will do anything at all to save money when it comes to health care.

All so-called “tort reform” has ever done is hurt more people more often. The Protecting Access to Care Act of 2017 essentially says that it doesn’t matter how severe, how catastrophic, your injuries are.  Your life is worth $250,000, end of story.  Is that what your life is worth?  How about your child’s life?  If it costs a plaintiff’s attorney $250,000 to put together a medical malpractice case (and it typically costs at least that much), and the highest possible payout is $250,000, do you think you will be able to find an attorney to represent you?

What is Your Life or Injury Worth?
If a surgeon accidentally nicks your wife’s artery and she dies during back surgery, is that worth only $250,000 for you and your family?

If a doctor fails to recommend an emergency C-section because the umbilical cord is wrapped around your unborn baby’s neck, and your child suffers permanent brain damage that requires lifetime nursing care running into the millions of dollars, is that worth just $250,000 to you?

If a doctor prescribes the wrong medication to your spouse and it kills him, is that worth just $250,000?

U.S. Senate Could Destroy Your Rights with H.R.1215

Whether you have ever needed a medical malpractice or a personal injury attorney or not, you would be wise to contact your U.S. Senators today and tell them to vote “No” on H.R. 1215.  The only ones who will benefit from this bill are the corporations that cause people harm.

Matthews & Associates, meanwhile, will continue to fight against this obscenity of a bill.  We have always fought for the individuals’ rights against the corporation that harmed them.  We are lawyers working for people.  We don’t work for corporations, ever.

To learn more about our services, contact us at any time. Call or email for a free legal consultation.



Ten Deaths Linked With Hernia Repair Physiomesh

At least ten deaths have been linked with hernia repair Physiomesh™, according to U.S. FDA reports.  Mesh News Desk worked with Device Events to bring these deaths to light.

Thousands of women with transvaginal mesh claims have known for years of the dangers of polypropylene (plastic) mesh implanted in the human body.  Now, as many of the women’s pelvic mesh cases are settling, several trial lawyers are taking on hernia mesh lawsuits.

One Million Hernia Repairs

More than a million hernia repairs are performed yearly.  Many recipients of the plastic mesh used for hernia repairs are now reporting the same problems that transvaginal mesh patients did.  Hernia mesh victims report chronic pain, infection, mesh shrinkage, mesh migration, organ perforation, and more.

Medical device injury lawyers are focusing primarily on coated hernia meshes.  They are preparing cases for future litigation, specifically Atrium C-Qur and Physiomesh™ made by Ethicon, a division of Johnson & Johnson (JNJ).  Ethicon voluntarily recalled Physiomesh™ from the market in May 2016.

The Urgent: Field Safety Notice, notes two unpublished studies found that Physiomnesh™ had higher failure rates for laparoscopic ventral hernia surgeries than other meshes used in a German and Danish Medical Registry.

The voluntary product recall states unpublished data found, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using Ethicon Physiomesh™ Composite Mesh were higher than the average rates of comparative the comparator set of meshes among patients in these registries.”

Physiomesh Cleared by FDA, Not Approved

Some 300,000 patients have likely been implanted with Physiomesh™ since it was cleared by the FDA for sale via the 510 (k) process in 2010.   FDA Clearance does not mean FDA Approval, which is why the makers of these products can still be held accountable in the civil court system.

The Field Safety Notice notes nothing about hernia mesh deaths.

Device Events:  Ten Deaths Linked with Physiomesh™
‘Device Events’ is an investigative tool that uses proprietary algorithms designed by developer Madris Tomes, a former FDA investigator.   Ms. Tomes now investigates under-reported or mis-reported entries to the FDA complication databases, in order to identify patterns of injury or death.  In all, Ms. Tomes shared (with Mesh Medical Device News Desk) seven (7) injury and ten (10) death reports linked with Physiomesh™ hernia mesh.

Dirty Data skews True Picture
“While the FDA requires manufacturers and hospitals to report deaths due to devices, if there is any leeway or room for interpretation, often the reports come in as injuries or malfunctions. Tens of thousands of deaths have been extremely difficult to find due to this regulatory ambiguity and dirty data. This can be the critical data point needed for mesh and countless other medical device cases.” – Madris Tomes, Device Events

Further exploration of deaths and injury via additional search terms (such as manufacturer and a host of search terms used to unearth findings), are available via a subscription to Device Events.

Mesh Maker Must Report Adverse Events
Hospitals, medical device makers and importers are required to file adverse event reports with the FDA.  Lawyers, doctors, and patients may also file an adverse event report to the FDA. (See how here.)

An Adverse Event report means the device “may” have caused or contributed to death or serious injury, according to Isaac Chang, Ph.D, Director of the Division of Postmarket Surveillance with the FDA.

Certain malfunctions, such as a product failure, improper design, labeling and manufacturing problems, failure to meet performance specifications and use error must also be reported. Those incidents may have been a factor in a death or serious injury.

Sepsis and Infection
The ten deaths linked with Ethicon Physiomesh reported to the MAUDE database, almost always involved infection.

Sepsis is the most common word for a bacterial, fungal or viral infection of the bloodstream, according to Mayo Clinic here. Sepsis should be treated in the early stages before progressing to severe septic shock, which can be fatal, especially in an older person or one with a weakened immune system.

Sepsis’ origin can be the introduction of an invasive device or injury to the bowel, which then releases bacteria into the system.

Ten Deaths Linked With Hernia Repair Physiomesh
Organs can fail from severe sepsis, gangrene or tissue death.

Patient 8 died from sepsis after straps of the mesh were turned into the fascia violating the bowel.  Bowel violation, says a report on the patient.

Patient 14 is listed as an injury report, even though it later said the “patient had a generalized infection and died” after a Physiomesh™ implant and suffering two injuries to the small intestine.

In some cases, initial injury reports are not updated when the patient expires.

Mesh breakage of Physiomesh report to MAUDE
Patient 23 is an injury report with sepsis and the “mesh breaking up” and a “hole in the mesh” necrosis, and “resection of small bowel,” yet the reporter, JNJ, says the “mesh met the finished goods criteria.”  In other words, it did not test as defective.

Physiomesh™ problems have included a failure of the mesh to incorporate with the body, largely blamed on the laminated coating on the polypropylene (PP).

The Physiomesh™ is constructed of knitted filaments of extruded PP (plastic) with an additional dyed polydioxanone film marker, added for orientation purposes. The coatings were added to each side to avoid contact with tissue and organs and bowel. But with no PP exposed, the hernia mesh may not incorporate into the body, leaving it potentially floating and moving around in the patient.

Also, since less PP (plastic) was used to make Physiomesh™ “lightweight,” it is considered to be weaker than standard hernia mesh made of polypropylene.

The Physiomesh™ may tear apart as a result, according to trial attorneys pursuing these cases.

Natural Hernia Mesh Death?
Patient 20 was considered obese with chronic steroid use. Those are the factors contributing to his surgical site infection and wheezing, according to the entry.  The mesh separated and did not adhere to the intestinal loops.  Fasciitis and infection were observed.

A new mesh was implanted. The patient died four weeks after the Physiomesh™ was implanted. His death was attributed to bronchoaspiration and respiratory failure.
An autopsy was not ordered due to the “natural death.”

When Patient 24 presented with a 104.5 fever following his Physiomesh™ implant, as well as sepsis, he had the mesh removed. In 12 hours, the report says, “the patient got better.”

FDA Reports favor Mesh Maker
Two of the reports to the FDA seem tortured to avoid connecting the mesh to the patient’s death.

In the Patient 21 death report, which notes complications and sepsis after a mesh implant, the mesh maker reports there is “no reason to suspect the mesh malfunctioned and caused the patient death.”

Patient 16’s death, J&J reports, is “not related to mesh but to co-morbidity.” The patient had two surgeries, was bleeding from the trocar site and had necrosis of the colon.

Another death report, Patient 17, reports that he died six days post-op. The patient was enrolled in a study of patients with peritonitis to prevent incisional hernias. The patient suffered three small bowel resections during the procedure. The patient passed out in the hospital and hit his head. He died after 45 minutes of resuscitation.

Ethicon Response
Ethicon’s newer version of Physiomesh, Ethicon Physiomesh™ Open Flexible Composite Mesh Device, was approved via 510(k) October 23, 2014. It remains on the market and is not related to the withdrawal of Physiomesh.

Removing Physiomesh™ from the market does not qualify as an FDA recall, notes J&J.

A call from Mesh News Desk to J&J to respond to these reports went unanswered by deadline. Jane Akre of the Desk said that any additional comments will be added when and if they are received.