Category: Defective Products

Hernia Mesh Manufacturers Knew Device Was Dangerous

By Emily Cox

hernia mesh manufacturers

A new lawsuit alleges that hernia mesh manufacturers knowingly exposed Parietex patients to severe permanent injuries for financial gain.

Kimberly Pellegrin filed her claim on Tuesday in the Eastern District of Louisiana. She alleges that Parietex hernia mesh completely changed her life…in the worst way possible. Instead of helping her, her severe injuries from the defective mesh have completely derailed her very existence. And, there’s no end in sight. Despite numerous surgeries to repair the extensive damage from the Parietex mesh, Pellegrin still suffers from constant excruciating abdominal pain and swelling. Her injuries are so extensive that she can hardly walk anymore.

Furthermore, she claims the hernia mesh manufacturers knowingly put patients like her at risk for permanent injuries. According to her lawsuit, Medtronic, Covidien, Davol, and C.R. Bard have completely lost sight of their priorities. As medical device companies, these hernia mesh manufacturers have an inherent obligation to protect patients. However, the only thing that these companies appear to be protecting are their mutual bottom lines.

Litigation Against Hernia Mesh Manufacturers

Approximately 350,000 individuals undergo hernia repair surgery each year in the US. In most of these procedures, surgeons use hernia mesh implants to support the weakened tissue. However, studies indicate that the rate of complications is significantly higher for hernia surgery patients with mesh implants than for those without the devices. Yet, surgeons continue to refer to hernia mesh as the “gold standard” in hernia treatment.

Most of the defective hernia mesh products currently under investigation are made of polypropylene. But, Medtronic subsidiary Covidien decided to use polyester for Parietex instead and did not even conduct human trials before releasing the product into the stream of commerce to see how this change in material may affect patients. Like polypropylene, polyester causes a severe inflammatory response. However, it also has significant additional problems. The Parietex hernia mesh shrinks and contracts substantially once it is implanted. This causes the mesh to tear from securing tacks or sutures. Consequently, there is a high rate of hernia recurrence. Furthermore, once patients re-herniate, the hernia mesh tends to migrate or ball up, leading to a host of serious problems that necessitate additional complicated surgeries.

The Parietex Composite hernia mesh also has a collagen film that quickly disintegrates after implantation. This exposes the polyester to underlying organs. Consequently, severe infections and dense adhesions to the bowel are common complications from the hernia mesh. Since the late 1990’s, medical researchers have noted these long-term consequences and urged the hernia mesh manufacturers to remove the defective mesh from the market. However, the companies refuse to recall the hernia mesh and continue to profit off the pain of countless patients.

Pellegrin joins a growing number of individuals filing lawsuits against hernia mesh manufacturers like Johnson & Johnson, Bard, Ethicon, Medtronic, and Covidien over permanently debilitating injuries from these dangerous devices.

Hip Implant Patients Hit Up J&J for Massive Damages

By Emily Cox

hip implant patientsSix hip implant patients requested a federal jury to slam Johnson & Johnson with at least a nine-figure punitive damages award on Tuesday to punish the company for manufacturing and marketing a dangerous line of metal-on-metal hip implants despite knowing of substantial defects that significantly endangered patients.

The plaintiffs allege the Pinnacle Ultamet line of metal-on-metal hip implants caused severe tissue damage and intense pain. J&J’s DePuy Othopaedics unit manufactures the defective devices. The hip implant patients begged the jury for “justice” and to punish J&J for using humans as guinea pigs for an untested product that the company pushed to market too soon for financial gain. Plaintiff attorneys admonished J&J for “being indifferent to our health” and failing to warn surgeons of the significant risks and problems with the device to protect sales.

“Johnson & Johnson knew metal-on-metal wasn’t going to work,” a plaintiff attorney said.  “Johnson & Johnson hadn’t solved the metal-on-metal problems. They just went to market anyway. They were using our people as an experiment without telling them.”

The attorney went on to urge the jury to punish the manufacturers to send a message that companies shouldn’t sell “poison” and market it as candy. As for the extent of that punishment, he cited DePuy’s $4.2 billion corporate valuation and J&J’s $73.98 billion valuation. Consequently, he told jurors the companies would hardly feel a damages award upwards of even $100 million.

Hip Implant Patients Trial

The six hip implant patients trial began in mid-September. This is the fourth round of trials since 2014 in the multidistrict litigation (MDL). More than 9,000 individuals allege DePuy knowingly put hip implant patients at significant risk for financial gain. The first trial ended in a win for J&J. But, the plaintiffs took both rounds two and three with jury verdicts of $502 million and more than $1 billion respectively. However, the court substantially reduced these verdicts and appeals are pending before the Fifth Circuit.

For the past month, the court, FBI, and U.S. attorney’s office have investigated DePuy witness tampering allegations. The allegations involved a doctor who had treated three of the six plaintiffs. But, Judge Kinkeade said he could not impute the allegations to DePuy. As a result, he ruled the jury would not hear testimony related to the issue.

During the trial, plaintiffs told the Texas federal jury that J&J and DePuy valued marketing above research and development and pushed the Pinnacle hip by lying that it was 99 percent successful. Meanwhile, the companies actively concealed that the product shed metal particles into patients’ bodies, leading to metal poisoning and tissue loss. Furthermore, they used cheaper, less safe alternatives during manufacturing to keep costs down and profits up. Consequently, the devices essentially turned patient’s hips into “ticking time bombs.”

J&J suggested that if the jury decides to award damages that they return with a more modest figure than the plaintiffs had requested. The company requested a reward of the patients’ actual medical bills and small additional damages for pain and suffering. Depending on the plaintiff and the nature of their injuries, these would range from $50,000 up to $800,000.

In his rebuttal, a plaintiff attorney seized on the $50,000 figure J&J had suggested for plaintiff Uriel Barzel. Barzel is 88 and has a five-year life expectancy under New York law. The attorney suggested that $50,000 a day for Barzel’s remaining years would be more appropriate compensation for his injuries.

Mirena Pseudotumor Litigation Hits Critical Phase

By Emily Cox
Mirena pseudotumor
Bronze cast of Mirena IUD (Flickr/Sarah Mirk)

The Mirena pseudotumor cerebi multidistrict litigation (MDL) over serious harm caused by Bayer’s hormone coated device is now entering the discovery phase with lawyers taking a multitude of first-round depositions over the next month in Finland, London, and New Jersey. Due to the MDL’s aggressive track, the next twelve months could be critical for Mirena pseudotumor plaintiffs.

Bayer continues to maintain that its Mirena intrauterine device (IUD) is a safe and effective method of birth control. However, hundreds of young women are claiming the device caused pseudotumor cerebri (PTC), also known as intracranial hypertension (IH).

Mirena is a T-shaped plastic device coated with levonorgestrel, a synthetic progestogen hormone. Physicians insert the device into the uterus to prevent pregnancy for up to five years. However, no one is exactly sure how Mirena accomplishes this. According to the MDL’s statement of claim, “it is not known exactly how Mirena works, but Mirena may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival to prevent pregnancy.”

Consequently, lawyers are now taking depositions from Bayer representatives with knowledge of the company’s IUD product. Hearings to qualify expert witnesses, known as Dalbert Hearings, will begin in early 2018.

Mirena Pseudotumor Allegations

Peer-reviewed scientific evidence in the litigation indicates a number of distressing complications from Mirena pseudotumor cerebri. The most serious of which is permanent blindness. However, the condition also comes along with severe headaches, dizziness, blurred vision, neck stiffness, nausea, vomiting, and ringing in the ears. Along with varying levels of permanent vision loss, many Mirena users also experience weight gain. However, most physicians and consumers are not aware of the connection between the device and their symptoms. Bayer warns against Mirena stroke risks. But, the label does not mention any of these additional complications. Consequently, there could still be a significant number of potential plaintiffs that do not know that Mirena caused their injuries.

The FDA first approved the Mirena IUD for birth control in 2000. The agency expanded the device’s indications to include heavy menstrual periods in 2009. Approximately two million women in U.S., and 15 million more around the world use the IUD for birth control.

Recently, another Mirena MDL fell apart when the judge rejected plaintiffs’ expert witnesses. This MDL alleged the device could migrate, causing serious injury or ectopic pregnancy. However, the current MDL over Mirena’s potential to cause pseudotumors is a completely different litigation and moving forward.

Bayer is also facing more than 10,000 lawsuits over its Essure birth control device. These women allege that the permanent birth control device caused truly debilitating injuries. These include severe pain, heavy bleeding, organ perforation, depression, weight gain, nickel sensitivity, infection, allergic reaction, ectopic pregnancy, and even death. In addition to these problems, it is next to impossible to remove the device alone. Consequently, many young women face hysterectomy to remove the Essure coils.

Recently, congress members reached out to the FDA’s commissioner to request a meeting to address the agency’s inaction regarding Essure.

 

Colgate Strikes Talcum Powder Mesothelioma Settlement

By Emily Cox
Colgate talcum powder mesothelioma
Flickr/Marco Verch

Colgate-Palmolive agreed to settle a talcum powder mesothelioma lawsuit alleging that its talc products caused a Pennsylvania woman to develop the deadly lung disease tied to asbestos exposure.

According to court filings, Colgate moved to resolve Carol Schoeniger’s claim to avoid a trial in New Jersey state court. The court has not released the financial details of the talcum powder mesothelioma settlement. Consequently, it appears the corporation felt the evidence against them necessitated a quick and quiet resolution.

This is not the first time Colgate has found itself in hot water over talcum powder mesothelioma allegations. In April 2016, a jury ordered Colgate to pay $1.4 million to a woman who developed mesothelioma after exposure to its Cashmere Bouquet talcum powder.

So far, Colgate has settled at least 43 similar talcum powder mesothelioma lawsuits. And, the company still faces around 170 more lawsuits, claiming that its talcum powder products contain asbestos.

Concerns about the talcum powder mesothelioma connection date back to the early 1970’s. In 1972, local health officials in Baltimore requested the FDA to investigate talcum powder asbestos contamination.

In October 2014, the International Journal of Occupational and Environmental Health published a landmark talcum powder study. The study identified a potential link between an unnamed, but popular, brand of talcum powder and asbestos exposure. Researchers indicated that the produce may have caused at least one woman to die from mesothelioma.

Colgate Talcum Powder Mesothelioma Lawsuits in Context of Larger Litigation

The Colgate talcum powder mesothelioma settlement is merely a grain in the sand in the growing litigation. A constantly expanding number of talc users are accusing manufacturers like Colgate and Johnson & Johnson of failing to warn consumers that their talc powders pose a substantial cancer threat. Some of these cases contend that these products contain asbestos. Asbestos is often found in talc deposits. However, manufacturers have assured the public that their products are talc free for decades. But, the skyrocketing amount of talc users, mostly women, developing cancer indicate otherwise.

J&J is currently facing more than 5,500 Baby Powder and Shower-to-Shower lawsuits alleging that their products caused ovarian cancer. In fact, the Colgate settlement comes on the heels of a series of massive jury verdicts against J&J over failure to warn women of its talcum powder’s ovarian cancer risks. These include awards from $50 million upwards to more than $400 million with juries siding with plaintiffs in the vast majority of cases. While J&J has managed to overturn a couple of these verdicts on technical merits, analysts suggest that these verdicts indicate that juries aren’t buying J&J’s trial defense. However, J&J is still pursuing appeals in each of its lost cases and refusing to negotiate settlements. Asbestos exposure has not been a prevalent theme in the J&J litigation. However, plaintiff attorneys have brought it up at these trials, pointing to documentation that J&J ignored contamination for decades.

 

Target Fidget Spinners Linked to Toxic Levels of Lead

By Emily Cox
Target Fidget Spinners
Flickr/JoanDragonfly

A new study indicates that certain Target fidget spinners, a popular children’s toy, may contain extremely high levels of lead that exceed federal guidelines for certain toys.

The U.S. Public Interest Research Group (PIRG) issued the press release on November 9. The group warns consumers that Target’s Fidget Wild Premium Spinner Metal and Fidget Wild Premium Spinner Brass models have potentially harmful lead levels. The researchers alerted Target and the toys’ other distributor, Bulls I Toy, about their findings. However, both retailers have refused to address the problem according to the group.

The group’s laboratory testing found that the Brass models tested for 33,000 parts per million of lead. They found that the Metal models had 1,300 parts per million of lead.

Federal guidelines for toy manufacturers prohibit products that are marketed or intended for children younger than 12 years old from containing more than 100 parts per million of lead. However, the retailing giant is defending the Target fidget spinners. Both distributors refute claims that the toys are intended for children. The retailers claim the fidget spinners are marketed for children 14 years and older. This is outside the age range for the federal guidelines. Furthermore, they assert fidget spinners are not toys at all. However, PIRG is calling foul on this line of thinking.

“Saying fidget spinners aren’t toys defies common sense, as millions of parents whose kids play with spinners can tell you,” said Kara Cook-Schultz, U.S. PIRG Education Fund toxics director.

“The CPSC, Target and Bulls i Toy need to acknowledge the obvious — that all fidget spinners are toys. So, Target needs to immediately stop selling the toys that contain high amounts of lead, and issue a recall for those that they’ve already sold.”

Target Fidget Spinners Remain on Shelves

Target and Bulls i Toy are refusing to remove the fidget spinners from store shelves. The companies continue to maintain that the products are not toys even though they are within the toy sections on store shelves. Consequently, PIRG asserts that this constitutes deceitful marketing practices on the part of the retailers. However, the Target fidget spinners have packaging disclaimers that indicate they are for children 14 years and older. As a result, when PIRG brought concerns to the U.S. Consumer Product Safety Commission (CPSC), the agency indicated it would not step in to issue a recall.

As a final resort, PIRG released the public warning about the toxic lead levels. The group is urging parents to avoid allowing children under 12 to handle or play with the Target fidget spinners.

Childhood lead poisoning is considered the most preventable environmental disease among young children. However, more than half a million U.S. children have blood lead levels above the CDC’s level of concern.  Recently, the CDC considered reducing that level from 5mcg/dl to 3.5 mg/dl.

Lead poisoning in children increases the risk of brain damage, nervous system injuries, seizures, convulsions, mental retardation, coma, and even death.

First Cook IVC Filter Trial Goes to the Defendant

By Emily Cox

Cook

The Cook IVC filter multidistrict litigation got off to a rough start Thursday when a federal jury cleared Cook Medical of liability in the first trial over significant injuries caused by the company’s blood clot filters.

Plaintiff Elizabeth Hill’s trial focused solely on a strict liability claim that Cook defectively designed its Celect IVC filter. Hill’s filter migrated and perforated her small intestine and vena cava. After surgeons initially failed to retrieve the filter, it would be two more years before doctors were able to remove the device.  However, the Indiana jury found that Cook’s design was not at fault for Hill’s substantial injuries. After a three-week trial, the jury returned with a unanimous verdict in Cook’s favor.

Cook IVC Filter Federal Litigation

In 2014, the Judicial Panel on Multidistrict Litigation (JPML) centralized all Cook IVC filter lawsuits before U.S. District Judge Richard L. Young in the Southern District of Indiana. Federal consolidation reduces duplicative discovery and conflicting pretrial rulings that can bog down these types of massive litigations.

Hill is just one of thousands of other plaintiffs in the federal Cook IVC filter litigation alleging that their blood clot filters caused serious harm. Surgeons place these filters in the inferior vena cava to catch blood clots and stop them from travelling to the heart and lungs.

As the first Cook IVC trial concludes, parties in the Bard IVC filter federal litigation are in full trial preparation mode. The first trial in this litigation will commence March 13, 2018.  Judge David G. Campbell is presiding over the Bard IVC filter MDL in the District of Arizona. Then, the second trial in that litigation will get under way on May 15, 2018.

These early IVC bellwether trials are not binding on any other cases in their mutual litigations. However, they can influence the resolution of thousands of pending cases. They also provide litigation parties an opportunity to see how a jury is likely to react to evidence that appears throughout the litigation. Furthermore, they allow both sides to evaluate the relative strength and weaknesses of their overall cases.

 

 

Aesculap Knee Defects Hidden by Manufacturer

By Emily Cox
aesculap
Flickr/D.L.

A new lawsuit claims that medical device manufacturing giant B. Braun concealed substantial Aesculap knee implant defects from regulators and aggressively marketed its line of ceramic-coated artificial knees, knowing that they were likely to fail and endanger patients.

Patients from Louisiana, Florida, and 10 other states filed the lawsuit this past month in Los Angeles Superior Court. They allege that B. Braun’s Aesculap Implant Systems unit marketed the “advanced surface” ceramic knees as superior to standard bare metal implants despite knowing of substantial failures. The company promised that the ceramic coating would make the implants last longer. However, this coating actually prevented the joints from properly bonding with patients’ bones. Consequently, the knees failed prematurely, requiring additional painful and risky corrective surgeries to either fix the defective Aesculap knees or replace the artificial joints altogether.

According to the lawsuit, Aesculap exploited the FDA’s 510(k) clearance program to gain approval for the dangerous devices. This program only requires that manufacturers demonstrate that new devices are as safe and effective as devices already on the market. This negates many of the precautions and protocols that ensure patient safety in the standard medical device approval process. Consequently, the FDA was unaware of fundamental problems with the ceramic knees.

Aesculap Knee Implant Defects

Plaintiffs claim that the Aesculap implants’ ceramic coating causes moisture to collect between the implants and the bone cement. This loosens the joints, causing them to fail prematurely, significantly endangering patients.

Normally, surgeons need to use a saw to cut through the bone cement adhering knee implants to the femur or tibia. However, surgeons found that Aesculap knee implants “were easily removed by hand, using just two fingers, or after a single mallet strike.”

Physicians notified B. Braun and Aesculap numerous times that joints they had removed had no cement attached whatsoever. But, the companies simply passed the buck back on to the surgeons. They blamed the brand of bone cement, antibiotics, and surgical cementing techniques – everything except for the defective implants. However, the manufacturers never included specific cementing instructions with the implants.

Aesculap concealed the scope of these problems from the medical community, the FDA, and even its own sales people. The company also never reported these significant failures to the FDA, continuing to profit from the dangerous devices. Furthermore, the manufacturers failed to properly test the devices before starting to cash in on them. Aesculop abruptly ended one clinical trial after one participating physician noted that the implant and cement bond had failed.

“Defendants terminated the study in bad faith to intentionally conceal the true risks and dangers associated with the ceramic coating,” the suit alleges.

 

Lawmakers Question FDA’s Essure Device Inaction

By Emily Cox

Essure Device

Amidst skyrocketing lawsuits, spiking reports of serious complications, and the removal of the Essure device from the worldwide market, except for the US, Congress members are looking to the FDA to answer for its failure to properly regulate Bayer’s dangerous birth control device.

In its 2016 annual report, Bayer indicated it was facing 3,700 Essure device lawsuits. By this October, that number had shot up to 10,600 cases pending against the pharmaceutical conglomerate in the US. Bayer also racked up nearly half a billion dollars in impairment losses from the litigation in 2016 alone.  As awareness of Essure’s severe and debilitating risks swept the globe, the company yanked the permanent birth control device from the global market except the US. However, Bayer continues to maintain that its Essure device is a safe and effective method of birth control.

But thousands of women worldwide claim that Essure device complications can be devastating. From Essure’s approval date through December 31, 2016, the FDA received 14,919 medical device reports on Essure complications. These reports included complications like severe pain, heavy bleeding, organ perforation, depression, weight gain, nickel sensitivity, infection, allergic reaction, ectopic pregnancy, and even death. In addition to these problems, it is next to impossible to remove the device alone. Consequently, many young women face hysterectomy to remove the Essure coils.

Congress Questions FDA’s Failure to Regulate Essure Device

So far, the FDA has only made Bayer include a black-box warning on Essure’s packaging outlining the various side effects. Women everywhere are calling for that the FDA to recall the Essure device. But, the agency is still sitting on the fence. Now, congressional leaders are calling for answers.

Three members of Congress sent a letter to the FDA Commissioner on November 3 requesting a meeting to address the agency’s inaction regarding Essure’s continually growing adverse events reports. They also suggested that this was part of an underlying trend in FDA medical device regulation.

The device is “a prime example of systemic medical device oversight shortfalls and insufficient enforcement to ensure the safety and efficacy of medical devices,” wrote Reps. Rosa DeLauro (D-Conn.), Jan Schakowsky (D-Ill.), and Louise Slaughter (D-N.Y.).

They also pointed to a Government Accountability Office analysis from 2015. The analysis indicated that medical device companies lack incentive to stay compliant with FDA post-market safety study enrollment requests. And, when they do, they are slow to report findings.

They said that these findings held true with Bayer’s post-market Essure study. Bayer planned to enroll 78 patients per month. However, the FDA website indicates that there is currently only one patient enrolled in the study altogether.

The letter goes on to list several questions the congress members have if the agency grants a meeting to get to the bottom of the FDA’s lack of involvement with Essure. They also indicated that they want to branch this out into a broader discussion about the FDA’s regulatory policies regarding Class III medical devices in general especially those approved by the FDA’s fast-track process like Essure.

 

Stryker Hip Implant Litigation Sets First Trial

By Emily Cox

stryker hip

The Stryker hip implant federal multidistrict litigation (MDL) over serious injuries from the company’s defective LFit v40 component is pressing forward with preparing for the first trial to go before a jury in September 2019.

The Stryker hip litigation centers on the company’s LFit v40 femoral head that was used in several hip replacement systems. The company removed the implant from the market this past year as disturbing complications from the Stryker hip component skyrocketed. Specifically, taper lock failures with the cobalt-chromium femoral head caused significant problems. These included metal poisoning, significant pain, inflammation, loss of mobility, disassociation, and the need for dangerous revision surgery. Plaintiffs in the litigation continue to suffer to this day despite undergoing additional invasive procedures. They allege that Stryker misrepresented the safety of the device to the detriment of thousands.  Now, they are out for justice against the negligent manufacturer.

Judge Indira Talwani issued the critical case management order on October 25. The order outlines essential future communication protocols and the process for selecting a group of cases for early trials. Parties are to submit a proposed order to address procedures for identifying cases and for case-specific discovery by December 1. They need to identify these specific cases by February 2, 2018, and complete common fact discovery by October 4, 2018. Then, the parties will engage in expert discovery, filing pretrial motions on evidence admissibility by March 2019. Finally, if Stryker hip settlements have not been reached following the discovery process, the Court will proceed with the first bellwether trial on September 16, 2019.

Stryker Hip Litigation

As the number of individuals filing lawsuits continued to escalate, the Judicial Panel on Multidistrict Litigation (JPML) centralized the litigation earlier this year before Judge Talwani in the District of Massachusetts in order to avoid duplicate discovery and conflicting pretrial orders that would further hold up the litigation.

This is not the first time that such measures have been necessary for defective Stryker hip systems and components. The JPML established similar proceedings following the 2012 Stryker Rejuvenate and ABG II recall. However, before these lawsuits could go to trial, the manufacturer agreed to settle the litigation. The company paid more than $1 billion in Stryker hip implant settlements to resolve cases for thousands of individuals who required revision surgery after the recalled implants failed.

Glyphosate Exposure Is Skyrocketing in America

But federal regulators are still failing to take acknowledge significant risks that have already caused the European Parliament to ban glyphosate.

By Emily Cox
Glyphosate Exposure
Flickr/Chafer Machinery

A new study indicates that glyphosate exposure is higher than ever. But, as Monsanto continues to saturate the market with crop seed that is genetically modified for glyphosate use, regulatory authorities continue to make little effort to track its health effects even in the face of mounting lawsuits asserting the popular herbicide causes cancer.

The medical journal JAMA published the glyphosate exposure study today. Researchers indicate that human glyphosate exposure has increased almost 600%  in the past decade. Given the prevalence of the herbicide on the worldwide market and serious allegations of its toxicity, one of the most surprising findings is that it’s essentially the only one of its kind. Studies have evaluated how much glyphosate is in our food, air, and water. However, this is one of the only studies that has looked into how much of this chemical is making its way into our bodies. Given its widespread use, the study merely confirms what many scientists have feared for the past decade.

“This study demonstrates something many scientists have been worried about,” says Michael Hansen, Ph.D., senior scientist at Consumer’s Union. “As use of the chemical grows, more of it is getting into our bodies.”

The Rise of Glyphosate Exposure

Glyphosate is the active ingredient in the popular weed killer Roundup. Beyond lawns, gardens, and golf courses, it’s used on a wide range of crops. In fact, Roundup helped Monsanto corner the global seed market with its genetically modified Roundup ready crops, launching GMOs into mainstream commerce. These crops include maize, cereals, legumes, sunflower, potatoes, and cotton.

As its use has grown, so have concerns over potential risks from glyphosate exposure. In 2015, the World Health Organization classified glyphosate as a probable carcinogen. Earlier this year, California mandated cancer warning labels for products containing the chemical after the pending Roundup cancer litigation released Monsanto internal documents that indicate the agrochemical giant knew that glyphosate exposure may cause cancer. And, now the European Parliament has voted in favor of totally banning glyphosate by 2022.

However, despite all of this, U.S. federal regulators are shockingly silent on glyphosate. In fact, the EPA continues to insist that glyphosate is safe. And, in 2013, the agency actually increased allowable levels so that twice as much of the herbicide can be used on certain crops. Furthermore, somehow, the Department of Agriculture’s pesticide program still does not monitor glyphosate. Likewise, the Centers for Disease Control and Prevention’s program on human exposure to environmental chemicals does not factor glyphosate exposure.

“It’s a huge gap in our safety net,” Hansen says.

U.S. Glyphosate Exposure Findings Reflect Regulatory Indifference

Monsanto’s domination of America’s food chain through lobbying, insidious legal tactics, and its genetically modified seeds, manufactured solely for the purpose of increasing glyphosate’s market share, has come at a price. And, if worldwide cancer concerns are legitimate, then the price may be too high.

California researchers in the Rancho Bernado study measured the urine concentrations of glyphosate of 100 elderly people living in the large southern California suburb. They collected samples between 1993 and 1996, and then again between 2013 and 2016.

Researchers found a staggering increase in overall glyphosate exposure levels that exceeded detection limits. Originally, only 12 of the samples had detectable levels of glyphosate. By the 2010’s, 70 not only had detectable levels. They had thirteenfold the concentration of these levels compared to the 1990’s. Also, the body’s release of metabolite chemicals required to process the chemical increased by more than 300 percent. Researchers expressed concerns over their findings and indicated that the chemical has made its way into the regular dietary intake of many Americans.

“We’re being exposed to more and more of this chemical,” says Paul J. Mills, Ph.D., a professor at the UC San Diego School of Medicine and the study’s lead author.

“Most people don’t even realize that they are consuming it through their diet.”

Mills and his fellow researchers are planning several follow-up studies to assess health outcomes and glyphosate exposure in different parts of the country.

Glyphosate Exposure Risks Are Still Largely Unknown

In 2016, Environmental Health published a report that looked at glyphosate exposure in human and animal studies. Researchers found a link between glyphosate exposure and numerous health problems. These included liver and kidney damage, non-Hodgkin’s lymphoma, and endocrine disruption. However, very few human studies exist on glyphosate exposure. So, researchers had to rely on mostly animal studies.

Consequently, there’s no way to truly assess how much glyphosate is potentially harmful to humans.

“The safety limits we have right now are complete guesses,” says Bruce Blumberg, a scientist at the University of California at Irvine who has studied glyphosate.

Given recent developments that indicate that Monsanto had its hand in glyphosate studies that the EPA used to determine the chemical’s safety, it might be about time that the U.S. took a page from the European Parliament’s playbook and revisited glyphosate’s safety.

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