Category: Defective Products

Pelvic Mesh Products Approved with No Clinical Trials in U.S.

By Emily Cox
Pelvic mesh products
Flickr/StickerGiant

New research indicates that stronger regulatory oversight could have prevented hundreds of thousands permanent, painful, and debilitating injuries from pelvic mesh products that the FDA approved with little research and no clinical trial data.

Oxford University researchers published their findings in The BMJ Open medical journal on December 6. The study suggests that the FDA approved more than 60 pelvic mesh products with little to no research to establish safety or effectiveness. Consequently, researchers indicate that regulatory failures are partially to blame for the vaginal mesh problems and injuries that have ruined thousands of lives.

The study looked at data on 61 devices the FDA approved through its controversial 510(k) “fast-track” approval program. The program only requires manufacturers show that devices are “substantially equivalent” to products the agency has previously approved. Researchers found that all the devices received approval by tracing their lineage back to a mere two devices. The Ethicon Mersilene Mesh received traditional approval back in 1985. The FDA approved the Boston Scientific ProteGen Sling in 1996.

However, researchers note that there is no logical basis for establishing equivalency with these older devices. The newer pelvic mesh products used new technology, materials, and designs. Consequently, the fact that these devices were drastically different in pretty much everything other than function should have raised red flags among regulators.

No Pelvic Mesh Products Underwent Clinical Trials

The study also found no clinical trials evidence for any of the 61 devices that showed they worked or were even safe before the FDA approved them. Furthermore, the researchers also found that the FDA later called for clinical trials in 119 cases. In those cases, 66 percent of manufacturers immediately yanked the device from the market, and 22 percent changed the device’s indication instead of subjecting it to intense scientific study.

Out of all these cases, only seven studies went as far as the recruitment process. However, none ever actually reported their outcomes.

“Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years,” the researchers concluded. “Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.”

Pelvic Mesh Products Lawsuits

Due to these regulatory failings, these devices have permanently maimed hundreds of thousands of women. Consequently, a tidal wave of transvaginal mesh lawsuits has come crashing through America’s court system. With little to no safety research or studies, substantial design defects slipped through cracks. These defects have left women with serious, often permanent complications. These include chronic pain, nerve damage, infection and loss of sexual function, as well as organ erosion and perforation. Erosion and perforation also can prevent the complete retrieval of the device, leaving toxic plastic behind in the damaged tissue.

Also, there’s evidence that these regulatory issues are not exclusive to the US. There appears to be a worldwide phenomenon of these agencies failing the citizens they’ve sworn to protect. These failings have only served to further corporate interests and profits. As a result, the pelvic mesh products litigation is one of the largest mass torts in recent years.

Currently, the most recent U.S. vaginal mesh trial is underway in New Jersey. The plaintiff rested her case this past Thursday, and defendants Johnson & Johnson and its Ethicon unit are expected to present their case throughout this week. Most expect a jury verdict sometime next week. So far, U.S. juries have found overwhelmingly for pelvic mesh plaintiffs, awarding multi-million dollar verdicts. Jurors have almost unanimously found that the manufacturers knowingly marketed these dangerous devices for financial gain.

Vaginal Mesh Investigation Set to Blow Lid Off J&J Implant Scandal

By Emily Cox
Vaginal Mesh Investigation
Flickr/Balint Földesi

A BBC Panorama vaginal mesh investigation is set to reveal that Johnson & Johnson subsidiary Ethicon failed to tell doctors about the implant’s permanent, painful, and debilitating side effects.

Panorama is the world’s longest running investigative current affairs documentary program. The findings of its vaginal mesh investigation will air Monday night. The program documents substantial conflicts of interest, negligent clinical trials, and weak regulatory systems that led to thousands of women to receiving a patently unsafe and dangerous implant. Furthermore, as Ethicon became increasingly aware of serious complications, the medical giant didn’t update doctors about the extent of the risks for its leading mesh device, Gynecare TVT.

The vaginal mesh investigation also discovered a shocking lack of clinical testing for the device. Ethicon launched the implant after only testing it on 31 women for five weeks and in sheep. Ethicon quietly withdrew the dangerous device from the market in 2012. However, not before thousands of women were already experiencing chronic pain and permanently debilitating conditions from the defective device.

Since the late 1990s, surgeons have used these implants to treat minor incontinence and prolapse in women. The insertion procedure for the net-like devices is non-invasive and quick, but the complications are anything but.

The program is airing just more than a week after Christina Brajcic, 42, of Ontario, Canada, lost her fight to mesh complications. Brajcic was the first woman to officially die from the dangerous implants. But, hundreds of thousands more women are now unable to walk, work, or even sit down from device complications. These include chronic pain, nerve damage, and loss of sexual function, as well as organ erosion and perforation. Consequently, some of these women even report feeling suicidal.

Vaginal Mesh Investigation Into Instructions for Use Leaflet

Panorama found that an associate medical director at Ethicon warned that the instructions for use (IFU) leaflet for Gynecare was insufficient. The IFUs were designed to teach doctors how to insert the implants. They also detailed the implant’s risks so that doctors could explain these to patients.

At the time, the leaflet indicated that the side effects were “transitory,” but countless women continue to experience permanent complications.

“From what I see each day, these patient experiences are not ‘transitory’ at all,” the associate medical director wrote in an email.

Ethicon took this under advisement. But, the company ultimately decided not to warn that the complications could be permanent. Rather, Ethicon decided the leaflet wording, including the word “transitory,” was “appropriate for the intended users – trained pelvic floor surgeons” after reviewing complaints. Consequently, surgeons continued to remain in the dark as to the permanency and severity of Gynecare’s complications.

BBC Panorama interviewed Dr. Wael Agur, a consultant urogynaecologist, to determine how much surgeons rely on the information for use leaflet.

“It’s so important for me as a surgeon to understand full the risks of a medical device I’m about to implant during a surgical procedure, and my first resource would be the instructions for use,” he said.

“I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the instructions for use, so I fully understand these and communicate them.”

Vaginal Mesh Investigation Puts a Face to U.S. Pelvic Mesh Litigation

Back in September 2017, a Pennsylvania jury ordered Ethicon to pay Ella Ebaugh $57 million for her lifelong sentence to constant, excruciating pain from its Gynecare TVT device. However, Ethicon is still trying to dodge accountability for maiming thousands of women worldwide and is appealing the verdict.

Ebaugh received the vaginal tape in May 2007 to help cure mild incontinence. When her condition didn’t improve, physicians implanted a second TVT device. By 2011, she was in severe pelvic pain and having sudden urinary urges. Physicians found that the mesh had eroded into her urethra, literally mangling it. Ebaugh underwent a series of extensive surgical interventions. However, doctors were unable to repair all the mesh’s damage or even remove all the polypropylene materials from her body. As a result, Ebaugh’s continued chronic pain has left her needing a walking stick and mobility scooter.

“If I was told that I would need a wheelchair to get around, if I was told that I was going to live with permanent disabilities for the rest of my life, I wouldn’t have had a surgery for a simple stress urinary incontinence problem,” Ebaugh told Panorama in her first UK interview.

“The pain that I have I will have to live with for the rest of my life. There’s nothing they can do to help me,” she added.

Ebaugh’s verdict is the largest to come out of Pennsylvania’s mass tort pelvic mesh program so far. However, the latest trial launched Nov. 27 in New Jersey and should last until Christmas. This trial is also focusing on claims that Johnson & Johnson and Ethicon knew their vaginal mesh products were unreasonably dangerous but pushed them on unsuspecting women anyway to line their already considerable coffers.

Non-Hodgkins Lymphoma Claims Against Monsanto Continue to Mount

By Emily Cox
non-hodgkins lymphoma
Flickr/Mike Mozart

On the heels of the European Union approving the use of the controversial weed killer glyphosate for the next five years, individuals continue to surge forward with claims that the herbicide causes non-Hodgkins lymphoma.

Patricia Lashock filed the most recent of these claims Thursday, claiming severe and permanent harm from the weed killer. She alleges that she developed non-Hodgkins lymphoma after using glyphosate-containing products, including the Roundup, from 1977 to 2010. Lashock joins hundreds of other individuals asserting that Monsanto falsified scientific studies and colluded with worldwide regulators to hide glyphosate’s substantial health risks. Furthermore, internal Monsanto documents indicate that the manufacturer knew Roundup could cause cancer and non-Hodgkins lymphoma.

“If somebody came to me and said they wanted to test Roundup I know how I would react – with serious concern,” a Monsanto scientist confided in a 2001 internal email.

Glyphosate is the primary ingredient in Roundup and the best-selling herbicide in the world. However, this should come as no surprise. Monsanto essentially owns the global seed market. It has made sure that the majority of its seeds are glyphosate dependent, making worldwide agriculture Monsanto dependent.

Consequently, despite substantial indications that glyphosate causes non-Hodgkins lymphoma and even an official carcinogenic classification from the World Health Organization, the EU bowed to this dependency this past week when it voted to extend its authorization for glyphosate for an abbreviated five-year period. However, the deliberations over the extension were unusually lengthy and combative. Monsanto’s tainting of glyphosate scientific reviews with its meddling was a particular point of contention.

France led the opposition to allowing the use of glyphosate to continue. French President Emmanuel Macron announced after the vote that he had requested government officials to come up with a plan to ban the herbicide in his country within three years.

Round-up Non-Hodgkins Lymphoma Federal Litigation

Lashock’s case will join hundreds of other similar cases pending in the federal multidistrict litigation (MDL).  In October 2016, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all Roundup non-Hodgkins lymphoma lawsuits. Judge Vince Chhabria is presiding over the litigation in the Northern District of California. Due the complexity of the litigation and number of plaintiffs, the panel felt that judicial efficiency would be best served through centralization. This reduces duplicate discovery and conflicting rulings that can further bog down these already complicated proceedings.

Judge Chhabria previously agreed to Monsanto’s proposal to bifurcate the federal Roundup litigation. Consequently, the court will first address issues of general causation over the link between Roundup and non-Hodgkins lymphoma. Expert testimony for this portion of the pretrial process begins March 5, 2018. The court will then move on to case-specific issues to determine if Roundup caused the cancer of specific plaintiffs. As a result, it is possible that the first state court trials will begin ahead of the federal trials.

 

 

 

 

Toxic Mesh Deemed Unreasonably Dangerous

By Emily Cox
Toxic Mesh
Flickr/Eek the Cat

A new product liability lawsuit over substantial defects with Bard Perfix hernia mesh alleges the toxic mesh caused severe complications and inflammation. Ultimately, additional risky and painful surgical procedures were necessary to remove the dangerous mesh.

Bruce C. Baptist filed the complaint on November 17 in the Eastern District of Louisiana. Baptist indicates that C.R. Bard and Davol knew that the Bard Perfix mesh was unreasonably dangerous and toxic. Consequently, the hernia mesh poses serious health risks following implantation that require additional invasive surgeries to address.

Surgeons implanted the toxic mesh into Baptist’s body during hernia repair surgery in November 2015. According to his lawsuit, the human body attacks the hernia mesh as a foreign substance. The sterilization process further damages the already defective mesh, causing it to degrade and weaken. Consequently, the toxic mesh releases a number of harmful chemicals into the body.

“Defendants’ polypropylene surgical mesh is made of woven polypropylene which is a cheap plastic that degrades and erodes through tissue once implanted,” the lawsuit states. “The woven design of polypropylene surgical mesh creates small pores or holes. Nerves grow into the small pores or holes and attach to polypropylene surgical mesh soon after implant. As polypropylene surgical mesh erodes, polypropylene surgical mesh pulls and stretches the attached nerves causing debilitating pain.”

Baptist further indicates that an unacceptable number of reports link the toxic mesh to numerous other complications. These include erosion, tissue reactions, organ perforation, bleeding, severe pain, shrinkage, infection, and hernia recurrence, as well as mesh migration and degradation. Furthermore, his lawsuit indicates that it is often difficult or impossible to completely remove the mesh.

Toxic Mesh Litigation

Baptist joins a growing number of individuals filing similar hernia mesh lawsuits alleging dangerous mesh toxicity and debilitating design defects with the popular surgical hernia repair products. Most of the currently pending cases involve Atrium C-Qur or Ethicon Physiomesh. However, increasingly people are taking Bard to task for similarly defective devices.

The FDA approved Atrium C-Qur in March 2006. The device features a polypropylene mesh with an Omega-3 gel outer coating. But, significant injury reports connect this “protective” coating to infections, allergic reactions, and other substantial problems necessitating further surgeries.

Johnson & Johnson’s Ethicon unit introduced its Physiomesh in March 2010. The massively defective product featured a unique, multilayer design that produced substantially higher profit margins. However, it failed spectacularly on returns on investment when it came to patient health. Amidst outrageously high failures, the manufacturers quietly withdrew the product from the global market in March 2016.

As the toxicity of these mesh products becomes more and more clear, the FDA continues to protect Big Pharma over injured U.S. patients with its inaction against these dangerous devices.

 

Hip Bellwether Hits J&J with $247M Verdict

By Emily Cox

DePuy Pinnacle Metal Hip BellwetherA federal jury slammed Johnson & Johnson and its DePuy Orthopaedics unit with a $247 million verdict today in the latest Texas hip bellwether trial over grossly defective metal-on-metal hip implants. This is the third consecutive nine-figure verdict in the multidistrict litigation (MDL).

The Texas jury unanimously found J&J and DePuy liable for numerous design and manufacturing defects in the Pinnacle hip line, as well as deceptive business practices and fraud. Jurors ruled that the companies had acted recklessly and maliciously, endangering patients for financial gain. They awarded $90 million and $78 million in punitive damages against J&J and DePuy respectively to punish the companies for their reprehensible behavior.

The jury awarded more than $77 million for medical expenses, as well as pain and suffering, for the six New York plaintiffs. This includes the plaintiffs’ actual past medical expenses and future costs they will incur because of their substantial injuries from the defective metal hips. The hip bellwether jury also awarded four of the plaintiffs’ spouses $1.7 million for loss of consortium damages.

Hip Bellwether Trial Verdicts

The verdict comes after a two-month trial. Plaintiffs alleged that the companies concealed substantial defects and risks to profit from the dangerous metal hip implants. This was the fourth hip bellwether in the ongoing MDL. The federal litigation has more than 9,000 cases that claim Pinnacle Ultamet’s design defects caused painful and debilitating injuries. In 2016, federal juries found in favor of two groups of plaintiffs from Texas and California. Jurors awarded them $502 million and more than $1 billion damages respectively. However, the court later reduced these verdicts to $150 million and $543 million. In the first hip bellwether, the jury sided with J&J against a singular Montana plaintiff.

Specifically, the jury found the companies liable for design defects, negligent design, deceptive business practices, inadequate warnings, negligent manufacturing, manufacturing defects, and negligent misrepresentation. They also found J&J and DePuy intentionally misled surgeons and fraudulently concealed hip defects from patients and surgeons. Furthermore, jurors found J&J guilty of negligently undertaking of a duty to provide services to DePuy and aiding and abetting the subsidiary in its abhorrent conduct. The jury did not find that the company had intentional misrepresented the hips’ safety directly to patients.

Hip Bellwether Trial

During the hip bellwether, plaintiffs told jurors they’d suffered an array of serious injuries. These include severe tissue damage that caused permanent muscle loss, intense pain, loss of hip movement, and permanent disabilities. They also alleged the defective Pinnacle hip shed metallic debris into their bodies. These debris caused substantial side effects like heavy metal poisoning, pseudotumors, and hip failure. J&J and DePuy never warned surgeons of these risks and could have avoided them with a safer design.

The hip bellwether plaintiffs claim J&J and DePuy valued marketing above research and development. The companies rushed the defective hip into production without human clinical trials to capture a greater market share. Instead, they used unwitting patients as guinea pigs. Furthermore, they lied to surgeons that the Pinnacle product was 99 percent successful to increase sales. J&J and DePuy also used cheaper, less safe alternatives in manufacturing the hips to keep costs down and profits up. The resulting defects in the metal implants turned patients’ hips into “ticking time bombs.”

During closing arguments, plaintiffs’ counsel urged the jury to punish J&J “for being indifferent to our health” with a massive punitive damages award to send a message to other companies that they can’t expect to get away with selling “poison” and marketing it as candy.

Despite overwhelming evidence to the contrary, J&J continues to deny putting profits above patient safety.

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.

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