Chevy Bolt Fires

General Motors has recalled the Chevrolet Bolt electric vehicles for a second time after two more battery fires erupted in the owner’s cars.

These were vehicles that had allegedly received a fix last November.

Bolt owners are now being warned to park their vehicles outside, limit charging to 90 percent of the battery, and avoid charging them unattended.

The Second Recall

The National Highway Traffic Safety Administration (NHTSA), along with General Motors, has issued the latest consumer warning.

The Chevy Bolt model years 2017, 2018, and part of 2019 is the exact vehicle recalled initially in November 2020 after a fire erupted in the high-voltage battery pack under a backseat cushion. Almost 51,000 vehicles were affected, and owners were warned any fire could spread throughout the car and possibly cause a structure fire.

Two recent fires sparked this second recall in vehicles that had already received the November fix.

In early July, one of the Chevy Bolt electric vehicles that caught fire belonged to state Rep. Timothy Briglin from Vermont. The vehicle’s interior and some of the exterior were burned in the chemical fire as the battery cells can smoke and ignite internally. In this case, the electrical fire started within the area of the back seat. It is a similar fire to other Bolt EV fires reported to federal regulators.

Briglin had serviced the vehicle during the first recall, an indication the fix didn’t work. The fear is the combustion can cause a structure fire if the car is parked inside.  The other fire occurred in a Chevy Bolt in New Jersey.

In total, there have been nine battery-related fires in GM Bolts in the U.S., according to General Motors.

The first recall for Bolt involved diagnostic software monitoring for the defect and alerting the owners.

With this second recall, GM says it will replace the defective lithium-ion battery modules made by LG Chem. Both companies discovered a “rare manufacturing defect” in some battery modules that had the potential to cause a short and spark a battery fire.

The fix will be free to owners. It affects all BOLT 2017-2019 vehicles, whether or not they received the current software update. Consumers are encouraged to bring their vehicles to the nearest Chevrolet electric vehicle (EV) dealer to obtain the software update, the subject of the first recall.

An estimated 69,000 vehicles are affected globally. GM says it will notify customers when the replacement parts are ready.

GM Recommends

In the meantime, the automakers issued recommendations to Bolt owners.

  • Owners should park their electric vehicles away from their homes due to the fire risk. NHTSA also warned against leaving a vehicle charging overnight.
  • Chevrolet urges Bolt owners to use Hilltop Reserve mode or Target Charge Level to keep the charge under 90 percent. It is recommended you recharge the vehicle after a trip, although owners should not charge their vehicles overnight. Instead, after a charge, unplug the car and park it outside overnight. Leave at least 70 miles in the battery.
  • Bolt owners should visit NHTSA.gov/recalls. Enter your 17-digit vehicle identification number to determine if your vehicle is recalled. Call the closest dealership to schedule a free repair. Consumers can also visit www.chevy.com/boltevrecall or call the helpline at 1-833-EVCHEVY.

If there are additional fires, GM could buy back some of the vehicles to avoid litigation and triggering of state lemon laws.

The Future of EV

Expect a wave of electric vehicles to hit the market soon. Environmentally, an EV lessens our dependence on oil, thereby benefitting the environment. However, the problems linked to lithium-ion batteries and chemical fires remain unresolved.

The infrastructure bill, once it passes, will mark the most significant investment in transit in the history of the country as well as an investment in climate change.

Part of the infrastructure bill will include federal electric vehicles and 500,000 charging stations placed in communities and rural areas. The changes include electric transit busses and school busses resulting in cleaner air.

Tesla has reported the greatest number of fires related to the lithium-ion battery. In one case, a Tesla Model S Plaid reportedly caught fire in Pennsylvania with the driver behind the wheel. The locks malfunctioned, and the driver couldn’t escape the burning vehicle.

That particular Tesla had not been involved in a previous crash, as can happen after an accident when the lithium-ion battery is punctured.

It’s still uncertain whether there are more reports of fires with EVs simply because there are more on the road or if there is a greater risk of fire with EVs than with cars with internal combustion engines.

Also on the drawing board are lithium metal batteries which are beginning to show promise for commercial application.  Its anode is made of pure lithium, which increases energy density and charges much faster. The cathode is positively charged with the electrolyte in the middle. The challenge is to find a stable electrolyte for the new battery. Flammability tests of a novel fluoride electrolyte indicate its less likely to catch fire.

Competitors are joining the estimated $70 billion battery arena, searching for a longer-lasting and safer battery for the upcoming fleet of electric vehicles poised to overtake combustion engines in the U.S.

Sources:

Chevrolet https://my.chevrolet.com/how-to-support/safety/boltevrecall

NHTSA https://www.nhtsa.gov/press-releases/consumer-alert-important-chevrolet-bolt-recall-fire-risk

CNBC https://www.nhtsa.gov/press-releases/consumer-alert-important-chevrolet-bolt-recall-fire-risk

https://www.cnbc.com/2021/07/07/the-chevy-bolt-ev-belonging-to-vermont-lawmaker-who-backed-industry-catches-fire.html

Washington Post https://www.washingtonpost.com/business/gm-issues-2nd-bolt-recall-faulty-batteries-can-cause-fires/2021/07/23/ef6f4694-ebb5-11eb-a2ba-3be31d349258_story.html

Energy Post.eu https://energypost.eu/new-lithium-metal-battery-electrolyte-can-lengthen-range-of-evs/

Springer https://link.springer.com/article/10.1007/s10694-019-00944-3

talcum powder lawsuit

Gold Bond Talcum Powder Joins Cancer-Link Litigation

Johnson & Johnson continues to insist to this day that its baby powder is safe, despite pulling the original powder from the market, replacing the talc with cornstarch, a $417 million jury award, and nearly $4.7 billion awarded to a group of women who developed ovarian cancer.

For decades, the problem has been known even before tens of thousands of women filed personal injury lawsuits. Talc, the active ingredient in talcum powder, is mined near a naturally occurring mineral, asbestos, a known carcinogen with no known safe exposure level.

J&J’s internal documents show the company debated labeling the powder and warning against using it in the genital area as a deodorant, on sanitary napkins, or condoms.

Talcum powder is intended to be used externally. Still, researchers found when it’s used near the genitals, talc particles travel up the reproductive system landing dangerously close to the ovaries.

Instead of warning women, J&J kept quiet, the very act that has enraged juries who then awarded millions to the injured plaintiffs.

J&J took its talcum-based baby powder off the market in May of last year, replacing it with a cornstarch-based baby powder. Retailers were allowed to continue to sell their remaining products on store shelves. Meanwhile, J&J continues to distribute its talc-based powder outside of the U.S. and Canada.

You can also still find the original talc-containing J&J Baby Powder on Amazon.

Gold Bond

Like J&J’s Baby Powder, Gold Bond Medicated Body Powder, and Medicated Extra Strength Body Powder, are used to relieve an itch, rash, and absorb moisture. They both also contain talc.

Shopping on Amazon, you can now find some other Gold Bond options that have a prominent display on the top of the label that says on the front “Talc-Free.”

Gold Bond is a subsidiary of the French pharmaceutical company Sanofi. Besides menthol and zinc oxide, Gold Bond Baby Powder is now made with cornstarch.

Chattem is facing many lawsuits filed by women who have developed ovarian cancer.

Unlike the J&J cases where company documents confirm J&J knew asbestos could be contained in its baby powder, Gold Bond may not have the exact roadmap to litigation. Then there is the question of whether asbestos causes cancer. The International Agency for Research on Cancer does not believe that powders that contain talcum are inherently dangerous; the European Union has banned talc in health and beauty products.

Meanwhile, the U.S. Food and Drug Administration (FDA) has not stated its opinion on the risks that talc poses in health and beauty products. When J&J removed its talcum-containing baby powder last year, it did so of its own accord voluntarily and not as the result of an FDA ban. The FDA rarely orders pharmaceutical companies to remove products for fear of litigation.

Consumers Be Warned

In 2014, the estate of a woman who died of ovarian cancer filed a lawsuit against the maker of Gold Bond and J&J and Imerys Talc America, the talc supplier.

Janice Chakalos had used talcum powder for decades and died of ovarian cancer in 2012. She was 63 years old.   Her husband’s suit accused the manufacturers of failing to warn about the emerging evidence linking the powder to ovarian cancer.  It was filed in Superior Court in Somerset County, New Jersey, Case No. 3:14-cv-07079.

While litigation gets underway, consumers are warned not to use talcum powder anywhere near the body where it could travel internally. That includes baby powders and on a diaper.

In related litigation, Mesothelioma is caused by exposure to asbestos. The fatal cancer results when workers in construction come in contact with asbestos in construction, insulation, and mining talc. Anyone breathing in tiny asbestos particles, which resemble threads or tiny needles, can find them embedded in the victim’s lungs.

Mesothelioma litigation preceded talcum powder cases, and at one time, it contained the largest number of personal injury cases ever amassed in one court in the U.S.

At present, there are more than 34,000 lawsuits filed specifically against Johnson & Johnson over its talcum powder products and marketing in New Jersey, the home state of J&J.

On the issue of warning consumers, last year, a lawsuit was filed in Los Angeles accusing the suppliers and distributors of talc powder products hid the evidence that the products were dangerous to consumers. Not only J&J, but Gold Bond and Shower-to-Shower distributors were defendants, as were Dollar General, Walgreens, Walmart, Target, and CVS.

That lawsuit contents the companies violated California’s Safe Drinking Water and Toxic Enforcement Act of 1986. Also known as Proposition 65, it states that companies must tell consumers through a “clear and reasonable warning” that their products may cause cancer and other harms.

The lawsuit says those efforts to obfuscate date back to 1976 when the industry adopted “purity standards.” Under the standards, talcum powder could contain ten percent of “naturally associated minerals,” which could include arsenic, chromium, and lead, and the rest could be talc.

Consumers who have filed successful personal injury litigation have received compensation for medical costs and ongoing treatment, surgeries, hospital stays, and lost wages.

Sources: Time https://time.com/5839391/johnson-johnson-ends-talcum-baby-powder/#:~:text=Johnson’s%20baby%20powder%20on%20a,2019%20in%20San%20Anselmo%2C%20California.&text=Johnson%20%26%20Johnson%20discontinued%20its,to%20a%20decline%20in%20sales.

Asbestos.com https://www.asbestos.com/companies/gold-bond/

Euro Journal of Cancer Prevention https://journals.lww.com/eurjcancerprev/Abstract/2018/05000/Genital_use_of_talc_and_risk_of_ovarian_cancer__a.8.aspx

allow dental implants

Alloy Dental Implants

Madris Tomes Kinnard is a former Food and Drug Administration IT project manager. She left the agency because she felt its database did not deliver the adverse event reports in a usable way.

Kinnard then came up with a new database to focus on patient safety. Her business, Device Events, uses the 11 million pieces of data reported to the FDA but makes sense of the adverse events, or complications providing it to anyone who wants to understand how well the 175,000 medical devices in the market are working in the real world.

After they are on the market, tracking devices is useful to patients, doctors, hospitals, journalists, and law firms.

Watching the data is essential for several reasons. First, most medical devices, more than 90 percent, are not approved by the FDA but “cleared” under its 510(k) process. That means the devices can bypass clinical trials required of pharmaceuticals, and with an exchange of paperwork, can be put onto the market in about 90 days or less.

All the device maker has to do is claim that its device is substantially equivalent to a device already on the market, called the predicate device. It is up to the manufacturer to decide just how similar the devices are. With the emergency of new technologies and electronics added to devices, it is unlikely they are substantially equivalent to a device cleared decades ago.

This is a win-win for the manufacturers and not so much for the consumer.

Some of the most dangerous medical devices, later removed from the market or found to be defective, have been cleared through the 510(K), such as hip and knee implants.

Unlike Australia, which has a device event registry monitoring adverse events and looking for trends in complications, the U.S. relies on its MedWatch reporting system and the MAUDE database. Generally, problems are seen in the real world before the FDA notices, such as transvaginal mesh, Essure birth control device, and Metal-on-metal hip prosthesis.  Meanwhile, Australia noticed the complications reports coming in. That was the case with metal-on-metal hips (MOM), where Australia’s post-approval monitoring noted a high failure rate with the DePuy ASR implants and recalled them from the market in 2009, one year before a U.S. recall.

Device Events Notes Spikes in Injuries

Not that the FDA collects all data on devices that are harming patients.  Ten years ago, the Office of the Inspector General (OIG) estimated only 14 percent of adverse events are ever reported to the FDA.

Still, even with a fraction of the problems ever making it to the agency, Kinard and Device Events have tracked recent spikes in injuries.

For example, there has been a drastic spike in hernia mesh cases reported since 2017.  That year there were 3,149 complaints to the FDA. In 2020 that number jumped to 13,942 complaints. Hernia mesh, made of polypropylene, is used in the majority of hernia repairs.  Like the mesh used for pelvic organ surgeries, the same polypropylene can migrate, erode, and cause chronic pain and infection.

Hernia mesh has been known to erode into the colon. Often sepsis and death are seen as an outcome of a hernia mesh repair.

With one million hernia surgeries performed annually in the U.S. and doctors relying on mesh rather than an “old fashioned” suture repair, do the math to see the potential for hundreds of thousands of injuries annually.

Device Events has also noted a recent jump in injuries associated with dental implants.

Dental Implants

The FDA received over two million reports on dental implants. Primarily the complication results when the body rejects the dental implant.

The FDA wanted to have more dentists reporting to them about dental implants, and they did a video tutorial on how to report to the FDA about a year and a half ago. Since then, they’ve received 300,000 adverse event reports for dental implants.

According to The International Journal of Implant Dentistry, titanium alloy particles can deposit in surrounding tissue following corrosion and wear. This can lead to bone loss from inflammation or hypersensitive reactions that eventually lead to an implant failure in some patients.

The first step for a patient is to take a diagnostic patch test to determine any metal injuries. An alloy dental implant can be a mixture of titanium with almost any other element.  By definition, an alloy is a man-made material.

While most people get titanium, it’s an alloy and can contain other metals such as cobalt and chromium. Those are metals that have caused trouble with metal-on-metal hips.

Even an allergic reaction to titanium alone was noted in one study involving 1,500 dental implant patients.

The FDA considers if your body rejects your dental implant, it is not a malfunction of the device, but it is a severe injury.

Another metal used in the alloys is nickel, a naturally occurring metallic element. With about one-third of the population allergic or sensitive to nickel, patients need to ask what’s in the device they are about to have permanently implanted in their mouth.   If you cannot wear earrings with nickel, certainly a dental implant containing it is out of the question.

About ten to 15 percent of the population is allergic to metals, so in considering any permanent implant, it is crucial to know the composition of the implant.

Report Your Injury to the FDA

As imperfect a system as the FDA is in monitoring medical devices after they are released on the market, it is still all that we have at present to notice any spike in injuries. If you or your client has an adverse reaction to a medical device, contact the FDA MedWatch division and report the injury.

Make sure it’s reported correctly and do a follow-up if your condition changes. Keep in touch with the FDA instead of relying on the doctor to do the reporter. Neither the doctor nor the manufacturer has an incentive to report a complication with a device.

###

Sources:

Colgate https://www.colgate.com/en-us/oral-health/implants/titanium-rejection-symptoms-are-you-allergic-to-your-dental-implant

Reuters https://www.reuters.com/article/us-nobelbiocare-lawsuit/dentist-seeks-u-s-class-action-suit-vs-nobel-biocare-idUSTRE6641BV20100705

London Institute of Dentistry https://www.mdpi.com/2673-1592/2/2/11

PubMed https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633690/

TampaSteel https://tampasteel.com/what-is-a-metal-alloy/

Implant Institute https://implante.institute/blog/can-i-be-allergic-to-titanium-dental-implants/413#:~:text=Virtually%20all%20implants%20are%20alloys,also%20found%20in%20the%20implant.

PubMed https://pubmed.ncbi.nlm.nih.gov/18705814/

https://pubmed.ncbi.nlm.nih.gov/24027897/

The International Journal of Implant Dentistry notes that due to implants‘ corrosion and wear, titanium alloy particles can get deposited in the surrounding tissues. In some people, this can cause bone loss due to inflammatory reactions or hypersensitivity reactions that cause implant failure.

Colgate https://www.colgate.com/en-us/oral-health/implants/titanium-rejection-symptoms-are-you-allergic-to-your-dental-implant

Says first step is to take a diagnostic test such as a patch test to detect metal allergy and the commercially available MELISA test.

National Institutes of health – Allergy related to dental implant and its clinical significance, 2013 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753052/ Talks about other metals that are part of alloy and may intensify allergic reactions.

Titanium allergy: A Literature Review, 2014 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4248517/

An allergic reaction can be rationally guessed subsequent to metallic implant placement, based on clinical features linked with allergy, such as rash, urticaria, pruritus, oral erythema, swelling in the region, eczematous lesions, or hyperplastic lesions of periodontal tissue (the peri-implant mucosa).Aug 19, 2013

Allergy related to dental implant and its clinical significance

https://www.ncbi.nlm.nih.gov › articles › PMC3753052

https://www.drsirin.com/blog/having-allergic-reaction-to-dental-implants/ there are metal free options.

BioMed Research International Side effects of dental metal implants: Impact of Human Health (Metal as a Risk factor of Implantologic Treatment) 2019 https://www.hindawi.com/journals/bmri/2019/2519205/

Journal of Prosthodontic Research Allergic contact dermatitis caused by titanium screws and dental implants 2015 https://www.sciencedirect.com/science/article/pii/S1883195815001115

A critical review of dental implant materials with an emphasis on titanium versus zirconia, 2015 https://www.researchgate.net/publication/273685161_A_Critical_Review_of_Dental_Implant_Materials_with_an_Emphasis_on_Titanium_versus_Zirconia

LEGAL

THERE IS ALREADY a class action filed against Nobel Biocare of Zurich Switzerland because 8% of implants were lost after implant.  US District Court for central California, each member of the class can be reimbursed. Involving thousands of dentists involved in a $1.3 M settlement, May 2013. https://www.massdevice.com/nobel-biocare-settles-450m-class-action-13m/

Legal: Other mistakes with dental implants https://protectingpatientrights.com/blog/dental-implant-mistakes/

Seresto Flea and Tick Collars Linked to 1,700 Pet Deaths

You’ve seen the ads of cute family pets running through the fields. They are protected from fleas and ticks because of their Seresto collars, so says Elanco, the manufacturer.

But instead of eight months of protection from fleas and ticks, thousands of pets have turned up injured or dead, according to a nonprofit group, far more when compared to other flea collars.

Pet owners have been harmed too, yet the U.S. Environmental Protection Agency (EPA) has done nothing to inform the public or remove the danger from store shelves.

That may change now that CBS News, the Midwest Center for Investigative Reporting, and USA Today have broken the story on the national news.

Now two pet owners have filed a class-action lawsuit against Elanco Animal Health, alleging the company misrepresented the safety of their product. In one case, a dog died suddenly. In the other, the Siberian Husky developed cancer in the area near the collar.

Dozens more lawsuits are expected to be filed around the country.

A Top Seller

Seresto has been on the market since 2012. The popular pet and flea collar was developed by Bayer and is now marketed and sold by Elanco.

The maker claims it is safe for both dogs and cats while it kills fleas and ticks. Seresto contains two pesticides – imidacloprid and flumethrin – which are supposed to be released in small doses into the skin of cats and dogs.

The pesticide will “repel and kill various harmful insects” which include ticks, flea larvae, fleas, and lice, so says Elanco.

The nonprofit, Center for Biological Diversity, has taken over informing the public where the EPA has not. Using a public records request, the center found that since 2012, the EPA has received at least 1,698 reports of pet deaths, and more than 75,000 reports of harm linked to the collars. Included in the data are nearly 1,000 reports involving harm to humans who came too close to the flea collars.

That is far more than is seen in other pet collars and the agency has known about problems for years but failed to alert the public, says Karen McCormack, a retired EPA employee.

The Environmental Protection Agency (EPA) is supposed to monitor pesticide products and inform the public. That has not happened.

In terms of human harm, a 12-year-old boy was hospitalized with seizures and vomiting after being exposed to the Seresto collar on his dog.

In another incident, a 43-year-old man slept in the bed with four of his dogs who wore the collars. He developed throat irritation and ear drainage. His doctor said he had a hole in his ear drum.  When he took the collars off the dogs, the symptoms went away.

Despite the reports, the agency took no action to address these outcomes.

The EPA proposed re-approving imidacloprid last year because its class of insecticides, neonicotinoid, is connected to the death of bees and butterflies. The pesticide is banned in the European Union for outdoor use while it is used for agriculture crops in the U.S.

Flumethrin is the active ingredient in one product only, Seresto.

In a 2012 study, Bayer uncovered that combining pesticides can increase its efficacy, known as a “synergistic effect,” meaning they are more toxic when used together.

The EPA is supposed to monitor products that contain pesticides yet has sat on this information it has known for years, according to the retired EPA employee, talking to USA Today.

Congress is Now Involved

A Congressional subcommittee is now asking for Elanco’s CEO to conduct a voluntary recall of the collars and to issue a full refund to customers.

“We believe that the actual number of deaths and injuries is much greater, since the average consumer would not know to report pet harm to EPA, an agency seemingly unrelated to consumer pet products,” Rep. Raja Krishnamoorthi wrote in a letter to Elanco.

He is chairman of the subcommittee on Economic and Consumer Policy.

Elanco says it will not consider a voluntary recall.  According to USA Today, Bayer reported an annual revenue of more than $300 million on sales of the collar.

Not only might the manufacturer be liable but Amazon.com is the top-selling seller of Seresto collars.

Some Amazon reviews warn other Seresto customers. “The collars “put us through hell,” says one when used on an Australian Shepherd and the dog “developed severe itching and became very irritable after installing this Bayer Flea and tick collar. She started running into walls in our home and became very delirious.”

Another review says the dog had “some neurological problems” after putting on the collar.

Yet another said, “Two of my dogs have developed a terrible reaction to the chemicals that resulted in a nasty rash that needed treatment with antibiotics to prevent infection.”

Litigation will center on false advertising by Bayer HealthCare, LLC along with the fact that federal regulators have failed to take action even though Seresto collars have the greatest number of reported health incidents when compared to other flea collars.

Elanco says there is no established link between exposure to Seresto and pet death and blames “misleading media coverage” for the adverse event reports about minor effects such as skin irritation.

Sources:

Elanco https://www.petbasics.com/campaign/seresto-safety/

USA Today https://www.usatoday.com/story/news/investigations/2021/03/02/seresto-dog-cat-collars-found-harm-pets-humans-epa-records-show/4574753001/

https://www.usatoday.com/story/news/investigations/2021/03/26/seresto-flea-tick-collars-lead-class-action-lawsuit-pet-owners/7011012002/

Belviq Litigation

According to the Centers for Disease Control and Prevention CDC), it’s estimated that at least one-third of the U.S. population is obese, measured by the BMI or Body mass index scale.

For many, the task of losing weight is just too challenging, so a drug that promised to help you regain a more normal weight sounded like a miracle.

Until it wasn’t.

Belviq was a weight loss drug approved by the Food and Drug Administration (FDA) in 2012. It promised to be a solution for obese people who also had weight-related complications such as high blood pressure, high cholesterol, or type 2 diabetes.

Belviq was the first-in-its class selective serotonin 5HT2c receptor agonist, which claimed to control the user’s appetite. It worked by activating serotonin receptors in the brain, telling the body that it was full as if they had just had a meal.

While the drug may have worked for some, it did not prove to be a miracle weight loss drug. In three trials of almost 8,000 patients, they lost an average of 3 to 5 percent of their body weight. For a 200-pound man, that translates to six to 10 pounds.

Then there was the other issue. In some users, it’s alleged to have caused cancer. Belviq is now off the market and the focus of an increasing number of product liability lawsuits.

Belviq is also known as lorcaserin HCI. It was prescribed to people who were technically obese; that is, they had tried several diets unsuccessfully. They may also have had comorbidities such as diabetes or high blood pressure. The drug came in two forms, the original and an extended-release, Belviq XR.

Both drugs are made by Arena Pharmaceuticals and manufactured in Switzerland with Eisai Inc. While Arena manufactured Belviq, Eisai was the exclusive distributor.

As of now, both companies are named defendants. The company insists the drug continues to have a positive benefit-risk profile, as demonstrated in more than 22,000 patients enrolled in more than 30 drug trials.

Eisai and Arena

The FDA requested Eisai voluntarily withdraw the drug in February 2020 due to the risk of cancer. The companies did so.

The agency determined that the risk exceeded the benefit after looking at a long-term study on Belviq, the Camellia-TIMI 61 trial.

There were 12,000 people enrolled in the five-year study, a randomized clinical trial at 400 sites in eight countries. Clinical trials are required to receive FDA approval.

Compared to the placebo, 7.7 percent of users developed cancer, while placebo users had a cancer risk of 7.1%. That is a slight risk, considered statistically significant.

The cancers included:

  • Lung Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Cancer along the Digestive Tract

The risk usually resulted from a six-month or longer use, and these were the only types of cancer noted by researchers. Patients were advised to stop taking Belviq and Belviq XR and seek alternatives for weight loss. Health care professionals and hospitals stopped prescribing and dispensing the medications.

The FDA’s relationship with the pharmaceutical industry is such that it prefers to strongly suggest that a drug be withdrawn rather than mandate it be removed from the market for fear of being sued.

Shortly after it entered the market, Public Citizen issued a warning about Belviq and the possible risk of heart complications. The companies were mandated to do post-marketing studies looking for potential heart problems. Instead, the trials did show that users developed cancer after taking Belviq for a while.

Even when it was approved, there were already studies linking the weight loss drug to an increase in cancer risk, but the FDA approved it anyway and required the manufacturer to monitor side effects post-market.

The similarities between Belviq and fen-phen are undeniable.

That appetite suppression drug was also pulled from the market in 1997 because of its link to fatal heart valve problems. Arena Pharmaceuticals submitted data to the FDA showing the agency heart problems were not a problem with Belviq if taken at a low dose.

Before that, Xenical, approved in 1999, and Meridia, both weight loss medications, were taken off the market when heart problems became apparent. It was that pattern that caused the FDA to reject the first Belviq application in 2010.

Litigation

Earlier in 2021, Eisai and Arena Pharmaceuticals attempted to have the design defect claims dismissed.

In one lawsuit filed in the Eastern District of Louisiana by plaintiffs Stephanie and Robert Fuller (case no. 2:20-cv-01675), they claimed that the companies fraudulently represented to regulators, the medical community, and the public that the drug was safe and effective for its indicated use.  They allege that problems with the drug were intentionally concealed from the public, and the medicine is responsible for Stephanie’s breast cancer.

On January 15, 2021, Judge Lance M. Africk agreed that the Fullers did not completely state their claim and granted the company’s motion to dismiss the manufacturing defect and breach of warranty claims.

However, the companies failed to have a design defect claim dismissed, and the case will continue in the same venue.

Litigation will focus on what the companies knew and when they knew about the weight-loss drug and the cancer risk. Aftermarket, the companies failed to follow through with studies to monitor the cancer risk. Failing to inform the public about the danger of Belviq resulted in a delayed recall, exposing many more patients to danger.

Eisai, Inc. is a Delaware corporation with a business headquartered in Woodcliff Lake, New Jersey. Arena Pharmaceuticals GmbH is a Swiss Corporation with a principal place of business in San Diego, California.

The bottom line is, as always, that the companies put profits before patients.

Patients are advised to proceed with standard cancer screenings, not special screenings, if they have taken lorcaserin.

At this time, cases are expected to be filed around the country.

Resources:

Eisai media room https://eisai.mediaroom.com/2020-02-13-Eisai-to-Voluntarily-Withdraw-BELVIQ-R-BELVIQ-XR-R-in-the-U-S

FDA Voluntary Request https://www.fda.gov/news-events/fda-brief/fda-brief-fda-requests-voluntary-withdrawal-weight-loss-medication-after-clinical-trial-shows

AARP https://blog.aarp.org/healthy-living/new-weight-loss-pill-5-things-you-should-know

Peloton Treadmill Deaths

Peloton Treadmill Deaths

The Consumer Product Safety Commission (CPSC) has issued an urgent warning about the Peloton Tread + treadmill (Tread Plus) – that it poses a significant risk to children and pets. This after more than 20 children and pets have reportedly been dragged under the machine.

The CPSC has a video to show just how it happens. The $4,300 machine led to one toddler’s death in a tragic accident and another 39 incidents of injury including burns, scrapes, head injuries, and broken bones.

Peloton CEO John Foley sent out an urgent message, “I can’t tell you how much this news and horrible reality has hit me personally and our entire team at Peloton. While we are aware of only a small handful of incidents involving the Tread Plus where children have been hurt, each one is devastating to all of us at Peloton.”

THE CPSC is also investigating a February incident where a three-year-old boy sustained a significant brain injury after being trapped. The CPSC reports that the toddler was trapped under the Peloton Tread Plus and found by his father to be pulseless. The little boy had tread marks on his back and marks on his face and neck.  He was resuscitated but now has a brain injury.

On the market since 2018, the machine enjoyed skyrocketing popularity during the COVID shutdown in 2020 when sales soared 135%.

For its part, the CPSC released a video of its own showing a toddler initially having his hands on a ball that is dragged under the treadmill. The toddler’s arms then go further under the machine with the ball, then the machine fails to stop and it continues to drag the child until his face is being sanded by the moving tread. After he pops out for a second his entire body is sucked under the machine.

Only when another trapped item, an inflated ball, lifts the treadmill high can the child wiggle free and runs off crying. This video shows a home gym setup where children also play.

The CPSC has not recalled the Peloton Tread Plus and neither has the manufacturer issued a voluntary recall. Instead, it says consumers should stop using the treadmill if there are small children at home or any pets. In some cases, injuries occurred when an unsupervised child had access to the machine, such as in the video released by the CPSC.

If that is not possible the CPSC urges people to have the machine in a locked room restricting access by children and pets.  Keep an exercise ball and any object away from the treadmill. When not in use, unplug the treadmill and keep the key out of the reach of children.

Peloton is the maker of bicycles, as well as treadmills and with the CPSC announcement, its stock price fell. CEO Foley had a problem with the CPSC stern warning saying there is no reason for adults to stop using the Peloton Tread + calling the warning “inaccurate and misleading.”

He issued another statement saying:

The Consumer Product Safety Commission’s unilateral press release about the Peloton Tread+ treadmill is inaccurate and misleading. The Tread+ is safe for Members to use in their homes and comes with safety instructions and warnings to ensure its safe use. Like all motorized exercise equipment, the Tread+ can pose hazards if the warnings and safety instructions are not followed. The Tread+ is not for children under 16. Peloton warns Members not to let children use the Tread+ and to keep children, pets, and objects away from the Tread+ at all times. Any owner of a treadmill – whether made by Peloton or not – should follow these warnings, as they are included in the applicable safety standards, which the Peloton Tread+ meets.

At no time did Peloton try to impede the EPSC investigation insisted Foley, even though it refused for a month to release the name of the child who died.

Peloton Treadmill Design Fix

It seems the general design of any treadmill is a potential problem. According to the CPSC, there were more than 22,000 emergency room visits due to treadmill-related injuries.

Among those injuries about 2,000 were involved children under the age of 8. Additionally, there are some reports of pets being swept under the machines.

Meanwhile, Consumer Reports has pulled its recommendation for the Tread + based on the deaths and injuries, citing its capable of the type of injuries not seen in other treadmills.

At War with Safety Regulators

In answering why Peloton refused to give the name of the child killed to the CPSC for nearly a month, the Peloton CEO says he was trying to protect consumer privacy, not interfere with a federal investigation. It took a subpoena issued by the CPSC to force Peloton to hand over the information.

The CPSC can file a lawsuit if it decides to force a recall by Peloton without the company’s cooperation.

A class-action lawsuit has been filed in California. Shannon Albright of Rocklin, California, in the Northern District of California, says that Peloton has not conveyed the potential safety hazards of its machine and in fact, its advertising conveys images of parents and children in front of the product.

Citing a violation of the applicable consumer protection laws in the state, Albright is suing for $5 million in damages.

The case is Albright v. Peloton Interactive, Inc., N.D. Cal., No. 3:21-cv-02858, complaint 4/20/21.

 

Sources:

Washington Post, April 19, 2021
https://www.washingtonpost.com/business/2021/04/19/peloton-accidents-safety-battle/

https://www.washingtonpost.com/opinions/2021/04/22/why-peloton-is-no-corporate-hero/

Fox
https://www.foxbusiness.com/lifestyle/peloton-sued-tread-child-safety

Bloomberg
https://news.bloomberglaw.com/product-liability-and-toxics-law/peloton-faces-consumer-lawsuit-over-tread-safety-issues

Paraquat Litigation

Paraquat Litigation

Paraquat is a highly toxic and widely used herbicide and, according to Friends of the Earth, is the “most acutely toxic herbicide” in the U.S.

Manufactured by the Swiss company, Syngenta, paraquat is used to kill various types of weeds in soybean fields and crops, including marijuana. According to the Department of Agriculture, on U.S. soybeans, the number of pounds used is up more than fourfold over the past decade.

If the smoke from the crop is inhaled, it can cause lung damage. And its use had doubled between 2006 and 2016 according to the National Water-Quality Assessment Project (NAWQA).

According to the Environmental Protection Agency (EPA), “one small sip can be fatal and there is no antidote.”

The Syngenta plant in Huddersfield, England produces the weed killer.

Its use has been banned in the European Union since 2007 and paraquat is being phased out in Brazil, and even China began phasing out use in 2012 “to safeguard people’s lives,” but in the U.S. last October, the U.S. Environmental Protection Agency (EPA) reregistered paraquat and agreed to allow its continued agricultural use here.

While the herbicide Roundup is the subject of about 125,000 lawsuits because of its suspected link to Non-Hodgkin lymphoma, leukemia, and multiple cancers, paraquat is just now emerging as the target of a growing number of product liability lawsuits with a suspected link to Parkinson’s Disease.

What regulators have not stopped, lawsuits may.

Uses for Syngenta Paraquat

Weeds have become resistant to Monsanto’s popular Roundup, so paraquat is marketed as an alternative.

Paraquat dichloride is also known as Gramoxone SL 2.0 Herbicide. Other names include:

  •       Para-SHOT
  •       Helmquat
  •       Parazone
  •       Firestorm
  •       Ortho-Paraquat
  •       Quick-Quat
  •       Devour
  •       Blanco

Paraquat products must be registered for use in the U.S. and they are considered Restricted Use Pesticide (RUPS). Because of its toxicity, any user must be a trained certified applicator.

The Link to Parkinson’s Disease

There has been a suspected link and emerging evidence linking paraquat to Parkinson’s for decades but a National Institutes of Health (NIH) meta-analysis of 104 studies and more than 3,000 citations was a game-changer. It showed elevated health effects, such as Parkinson’s Disease (PD) on farmers, and people living near the fields where it’s used.

Parkinson’s is characterized by tremors, body rigidity, and impaired balance which does not improve with treatment. Exposure to paraquat was associated with about a two-fold increase in risk.

A scientist with the National Institutes of Health, Freyda Kamel, said research on the link was “about as persuasive as these things can get.”

Health consequences have been known for years and a low level of exposure can even cause adverse health effects. They include:

  • Parkinson’s disease- paraquat exposure more than doubles the risk of developing Parkinson’s
  • Brain damage
  • Kidney injury
  • Liver injury and failure
  • Lung damage
  • Heart failure
  • Birth defects and stillbirths
  • A reduced sense of smell

Besides human exposure, paraquat lingers in the environment affecting amphibians, fish, and rabbits.

The Protect Against Paraquat Act, introduced in July 2019 will protect the environment and farm workers. https://www.congress.gov/bill/116th-congress/house-bill/3817

H.R. 3817 has been referred to the Subcommittee on Biotechnology, Horticulture, and Research calls for the EPA to cancel the registration for all uses of paraquat, to ban its sale and eliminate the existing stock of paraquat as well as ban its residue on food.

Paraquat Litigation

At least 14 lawsuits around the country have been filed by agricultural workers exposed to the herbicide who have been diagnosed with Parkinson’s Disease. A motion has been filed to have the U.S. Judicial Panel on Multidistrict Litigation (JPML) form an MDL in federal court in the Northern District of California.

Litigation claims the defendants failed their responsibilities to warn workers and failed to take any precautions to prevent exposure. There was a failure to properly instruct certified applicators to avoid toxic exposure.

For its part, Syngenta has long rebutted the link saying, “We would never market or continue to market any chemical which we genuinely felt posed a health risk or an environmental risk.”

But internal company documents show a debate within the company on how to make the product safer.

[See  Paul Rakoczy v. Syngenta Crop Protection et al., Case No. 4:21-CV-02083, filed in the U.S. District Court for the Northern District of California; and Michael Joseph Kearns et al. v. Syngenta Crop Protection et al., Case No. 3:21-CV-00278, filed in the U.S. District Court for the Southern District of Illinois.]

The lawsuits name Syngenta, the Swiss company, and Chevron USA, which held the rights to sell paraquat under a 1960s agreement. Syngenta is now owned by the Chinese National Chemical Corporation, ChemChina, after a 2016 merger.

For its part, Syngenta has long rebutted the link saying “We would never market or continue to market any chemical which we genuinely felt posed a health risk or an environmental risk.”

According to one law firm, that in March filed the first two product defect lawsuits against Syngenta, the company ignored and downplayed the known risks despite decades of research linking the weed killer to Parkinson’s Disease.

A trial is set for May 10 in St. Clair County Circuit Court in Illinois. Hoffman v Syngenta promises to show jurors that Syngenta knew for decades its product causes Parkinson’s Disease.

Litigators may also want to focus on each of the EPA’s Restricted Use Products (RUPs) that are coming up for review.  ###

 

Sources:
Mass tort nexus
https://mail.google.com/mail/u/0/#search/paraquat/FMfcgxwLtZmXLCDLlqHkszkwvzMslMhQ

 

New York Times
https://www.nytimes.com/2016/12/20/business/paraquat-weed-killer-pesticide.html

The Guardian
https://www.theguardian.com/environment/2013/apr/29/bee-harming-pesticides-banned-europe

Environmental Health News
https://www.ehn.org/pesticide-exposure-and-risk-for-parkinsons-disease-2652501248/scientific-studies

https://www.natlawreview.com/article/paraquat-exposure-alert-paraquat-linked-to-parkinson-s-disease-agricultural-workers

Beyond Pesticides
https://beyondpesticides.org/dailynewsblog/2020/10/captured-by-extremist-pro-pesticide-agenda-a-broken-epa-reregisters-several-toxic-pesticides/

National Law Review
https://www.natlawreview.com/article/paraquat-exposure-alert-paraquat-linked-to-parkinson-s-disease-agricultural-workers

Toxic Metals in Baby Food Litigation Growing 

Toxic Metals in Baby Food Litigation Growing 

Arsenic, lead, cadmium, mercury – all heavy metals you might expect to find in a machine shop, not baby foods. A shocking report was issued February 4 from the House Committee on Oversight and Reform, and based on an investigation, “Healthy Babies Bright Futures,” from a coalition of seven nonprofits interested in environmental health.

The Committee report found unacceptably high levels in 95% of all baby food tested  that far exceed these limits such as 177 times the acceptable level of lead, 91 times arsenic, 69 times more cadmium that accepted and 5 times the mercury that is allowed.

Inorganic arsenic, lead, cadmium, and mercury have been declared a danger by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO).

The focus of the report was four companies that manufacture baby food – Gerber, Hain, Beech-Nut, and Nurture. Mercury was found in baby food from the latter company. Three others – Walmart, Campbell’s Soup/ Plum, and Sprout failed to disclose information about their baby foods as part of the report.

The levels are so shocking that on March 8, plaintiffs requested the Judicial Panel on Multidistrict Litigation (JPML) create an MDL in New York to gather the 40 plus cases filed so far from 12 different federal district courts.

How Babies Developing Brains Are Effected

Babies eat solid foods at about six months of age. Heavy metals, even trace amounts, can seriously affect the developing brain and that harm can be permanent. Diminished IQ can lead to lower intelligence, antisocial behavior, and diminished future economic productivity.

The new study estimates that arsenic and lead from rice-based foods have resulted in more than one-fifth of 11 million drop in IQ points in young children from birth to 24 months.

Lead exposure at a young age can damage the central and peripheral nervous system resulting in impaired hearing, shorter stature, learning disabilities, and impaired formation and function of blood cells, says one complaint.

There is no safe limit for lead. The Environmental Protection Agency (EPA) regards a safe level in drinking water at zero.

Plum and Campbell refused to cooperate with the Subcommittee or to produce their testing standards or any test results regarding heavy metals in their food.  Instead, they “self- declared” that their baby food met some unspecified criteria for toxic heavy metals.

FDA Response to Heavy Metals in Baby Food

The question is where do these heavy metals come from and who is responsible for monitoring the problem?

The problem was uncovered nearly a decade ago with rice. Rice, such as infant rice cereal, rice dishes and rice-based snacks were found to be high in inorganic arsenic, the most toxic form of arsenic.

In addressing the Committee report, the FDA says some elements such as arsenic and lead exist in the environment and may have entered the food supply naturally through soil, water, or air.  Even using organic farming practices will not eliminate this concern. Other toxins may be the result of factory farming, pesticides and fertilizers, genetic engineering of food, and past contamination.  Air pollution carries metals that fall to earth.

The FDA’s scientists routinely monitor levels of toxins in baby foods, the agency says as well as other foods consumed by adults.

The FDA has set the maximum allowable levels in bottled water at 10ppb (parts per billion) inorganic arsenic, 5 ppb lead, and 5 ppb cadmium. The EPA has an upper allowable level of mercury in drinking water at 2 ppb.

Litigation may focus on whether or not metals can cause autism or ADHD in the child who consumes products with toxic metals.

As of yet, there is no ceiling established by regulators for these toxic chemicals, with the exception of guidance issued on inorganic arsenic in infant rice cereal, which in 2006 was limited to 100 ppb.

With an absence of a specific threshold, plaintiffs who have filed actions so far that point to that absence of a number and claim protection.  Food manufacturers are currently free to test only ingredients, not the final product.

Lawsuits So Far Regarding Heavy Metals in Baby Food

At least 10 Lawsuits have been filed in wake of the Congressional Report Detailing ‘Dangerous Levels’ of heavy metals found in baby food.

Erin Smid, of Illinois, is the head of a consumer class action filed on February 11, 2021, [Smid v. Campbell, Plum PBC 1:21-cv-02417, New Jersey]. The Campbell company owns Plum which advertises its philosophy is “Little ones deserve the very best food from the first bite.”

The complaint states that defendants do not list heavy metals as an ingredient on the products’ label nor do they warn of the potential presence of heavy metals in their products. Because of that absence, the products’ labeling is deceptive and misleading, says the complaint.

Count I alleges violations of Illinois Consumer Fraud and Deceptive Business Practices Act. Count II is a violation of Illinois Uniform Deceptive trade practices act. Count III is unjust enrichment.

Gerber and Beech-Nut are also accused of misleading consumers about their baby food. Gerber foods make up about 80 percent of the market and that class action hopes to represent plaintiffs from across the country. Beech-Nut claims its foods are “100% Natural” and that its foods are tested for heavy metals.

Another action in New York filed by 43 plaintiffs over toxic metal contamination in baby products asks that cases be consolidated in New York federal court. New Jersey and Northern California may be filed into an MDL to consolidate more than 40 lawsuits from 38 proposed class actions.

For its part, a number of manufacturers say they are setting their own standards since there are no federal limits or guidance.

Healthybabyfood.org suggests more can be done by manufacturers such as sourcing rice from fields with lower arsenic levels, growing it with natural soil additives that reduce arsenic uptake, and growing rice strains less likely to uptake arsenic. Also, manufacturers can combine rice with other multi-grain products that contain less arsenic.

The consumer coalition urges the FDA to act immediately to establish health-based limits for toxins in infant food and set a protective level testing program similar to the Consumer Product Safety Commission’s action over children’s toys.

Parents have the alternative of making their own solid foods by steaming or blending soft ingredients. 

 

Sources:

House Oversight Congressional Report
https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2021-02-04%20ECP%20Baby%20Food%20Staff%20Report.pdf

Healthy Baby report
https://www.healthybabyfood.org/sites/healthybabyfoods.org/files/2019-10/BabyFoodReport_FULLREPORT_ENGLISH_R5b.pdf

FDA Response
https://www.fda.gov/food/cfsan-constituent-updates/fda-response-questions-about-levels-toxic-elements-baby-food-following-congressional-report

Food Navigator
https://www.foodnavigator-usa.com/Article/2021/02/16/FDA-weighs-in-on-heavy-metals-in-baby-food-as-lawsuits-pile-up

Harvard Health
https://www.health.harvard.edu/blog/heavy-metals-in-baby-food-what-parents-should-know-and-do-2021030522088#:~:text=Arsenic%2C%20lead%2C%20and%20cadmium%20were,food%20products%2C%20and%20did%20not.

johnson & johnson talc lawsuit

Johnson & Johnson Preparing Talc Litigation

Johnson & Johnson, (J&J) is facing 25,000 talcum powder lawsuits filed by women who claim J&J’s Baby Powder contained asbestos that caused their cancers. The company announced recently it has set aside $3.9 billion in talc-related litigation costs and settlements.

The information was contained in a securities filing, released February 22, and it represents twice the amount the New Jersey-based company had planned to set aside for talc verdicts.

The healthcare giant has lost millions in talc-cancer jury trials after jurors are told how J&J knew from the early 1970’s that its raw talc sometimes tested positive for small amounts of asbestos but failed to alert the public. Talc is mined from the same areas as asbestos mines.

Just last year a lower court ruling was upheld awarding damages to 22 women, however the court lowered the award from $4.69 billion to $2.12 billion to compensate the women who claimed that Johnson’s baby powder led to their ovarian cancer.

Years ago, company advertisements encouraged women to use baby powder in their genital region to stay dry and feel fresh. At one time, J&J not only produced its baby powder with talc but the brand Shower-to-Shower as well.

The company continues to believe that it has strong legal grounds for the appeal of this verdict, as well as other verdicts that it has appealed,” according to an official statement.

Attorney Mark Lanier, who brought one of the largest punitive damage awards in the U.S., tells Bloomberg. “Now J&J wants a get-out-of-jail-free card. A responsible company would pay their debts.”

Meanwhile, J&J is appealing the $2.12 billion Missouri verdict to the U.S. Supreme Court claiming the verdict was excessive.

[See Jefferson City, Missouri Ingham v. J&J, No. SC98674;
Appeal – Ingham v Johnson & Johnson et al, No. ED 207476]

While J&J says it has confidence in its talc products, the millions lost due to litigation and a decline in sales, caused the company to take its talc off the market last year in the U.S. and Canada blaming “misinformation” around the safety of its baby powder.

It didn’t help when, in October 2019, the Food and Drug Administration (FDA) recalled 33,000 bottles of baby powder due to trace amounts of asbestos found in a bottle.

Talc continues to be used in cosmetics. Consumers should check body powders to see if the manufacturer has switched from talc to cornstarch as the main ingredient.

As many as 20,000 cases of ovarian cancer are diagnosed every year, according to the Centers for Disease Control and Prevention (CDC). An estimated 14,000 cases prove fatal.

Mining Talc

Rio Tinto Minerals and its talc subsidiary, Luzenac America, mined the talc J&J used from a facility called Three Springs in Western Australia.  Both companies have been named in lawsuits. U.S. actions also include defendant, San Jose-based Imerys Talc America, a talc mining company that acquired Luzenac in 2011.

The lawsuits have claimed the mining company knew for decades that of the potential for their talc to contain asbestos. In February 2019, J&J’s talc supplier, Imerys Talc America, Inc. and two affiliates filed a voluntary chapter 11 petition to reorganize in bankruptcy court.

Scientists have found small pieces of talc in tumors growing on the ovary. The talc is believed to enter through the vagina and make its way into the uterus through the fallopian tube to reach the ovary where it incites inflammation and cancer.

Mesothelioma

In October 2020, J&J announced it would pay about $100 million to settle one-thousand cases. Some involved cancer from mesothelioma, a malignancy that results from inhaling asbestos fibers. Tumors form in the lining of the heart, lungs, or abdomen. Asbestos is the only known cause of this aggressive cancer.

A 2019 lawsuit in New York state court resulted in a $325 million award to a woman who had developed pleural mesothelioma cancer. Her husband states she was a long-time user of Johnson’s baby powder.

The first talc-mesothelioma trial in New Jersey in 2018 resulted in a $25.9 million jury award to a couple.

The Verdicts Continue

In November 2020, a Brooklyn woman was awarded $120 million alleging her cancer resulted from exposure to asbestos from J&J’s baby powder. The judge lowered her original award of $325 million from the jury, which included $300 million in punitive damages.

Jurors reacted to evidence at trial that showed the company knew from 1971 to the early 2000s that J&J’s talc had, at times, tested positive for small amounts of asbestos.

Donna Olson testified she used J&J’s baby powder for more than 50 years.

The Normal Course of Business

In its securities filing, J&J refers to the cost of talc litigation as “the normal course of business.” It includes in that grouping billions to pay the ongoing cost of litigation including opioid, defective hip prosthesis, Xarelto, Elmiron, transvaginal and hernia polypropylene mesh.

So far, 41 states have joined an investigation into the company’s marketing of its talcum products.

In January 2020, New Mexico filed a consumer protection case alleging J&J deceptively marketed and sold its talcum powder by making misrepresentations about the safety of its products.

In June 2014, the Mississippi Attorney General filed a complaint against J&J alleging a violation of the state’s Consumer Protection Act by failing to disclose the alleged health risks of the talcum-based baby powder. Oral arguments were held in February 2021.

Litigation has been filed in state courts in Missouri, New Jersey, and California.

Stockholders are involved in litigation against the company as well filing actions against Johnson & Johnson and certain named officers alleging the company violated federal securities laws by failing to disclose what it knew about alleged asbestos contamination in talc-based body powder.

 

Sources:

 

10-K J7J
https://johnsonandjohnson.gcs-web.com/static-files/e2a329b4-aeb6-438d-a449-f0e282cf8ee0

 

3m earplug lawsuit

3M Defective Earplug Trial Set for April

The 3M company has reached a milestone, a dubious distinction. With 233,575 defective product lawsuits filed, the multidistrict litigation (MDL) naming Minneapolis-based 3M over its Combat Arms Earplugs, has now become the largest mass tort in history, exceeding the number of asbestos cases filed in multidistrict litigation in one court (192,118).

Combat Arms Earplugs, Version 2 (CAEv2) were originally sold by Aearo Technologies. Aearo was then sold to 3M. Both companies are alleged to have supplied the earplugs to the four branches of the military under government contracts from 2003 to 2015.

At no time were the users warned the earplug could fail, allowing the user to be harmed from loud sounds like gunfire or explosions. Any member of the military issued the earplugs is eligible to file a complaint if they have suffered hearing loss as a result of the defective earplugs. Other injuries include deafness, permanent hearing damage, and tinnitus or a ringing in the ears.

Judge Casey Rodgers of the Northern District of Florida in Pensacola will preside over the lawsuits. The first trial is set for April 2021. In that case, three veterans claim they suffered hearing loss.

Last December, five veterans asked for their cases to be grouped together in a single trial. The five also allegedly suffered hearing damage and because their cases are so similar their argument for consolidating was that they involved “overlapping, and frequently coextensive, issues and facts.”

A district court has the option to consolidate multiple cases when there is a common question of law or fact, under the Federal Rule of Civil Procedure 42(a).

Judge Rodgers decided that three of the five should be consolidated and prepared for trial in April. She believes jurors will be able to keep the individual facts straight. The two remaining cases will be set for trial in May and June. Four bellwether trials have been selected to be heard.

Estimates are that litigants could be awarded up to $300,000 for their issues.

 

The Evidence

The earplugs in question were dual ended. The yellow end was supposed to be inserted in the ear so that the wearer could still hear low-level sounds such as commands.  The other end was green and designed to completely block sound. Their design was supposed to protect the user from the loud noise coming from a firearm, however, plaintiff attorneys allege that a defective design allowed the earplugs to loosen and move out of the ear canal. In doing so, they failed to protect the ear and the user’s hearing.

The failure of the earplugs was allegedly not revealed to the military.

Service members allege they were supplied with the earplugs to be used during their training. Instead of working as promised, a measurement of their hearing conducted by military-issue audiograms proves they were injured during their service.

According to the Veterans Administration, tinnitus and hearing loss are the #1 and #2 service-related disabilities that affect veterans. The rate of a hearing disability claim has steadily risen since 9/11 at a faster rate than the 20 years prior impacting now about 2.7 million veterans.

3M

In response, 3M believes the large number of cases is the result of marketing by plaintiff law firms.

In an article in the Charleston Post and Courier newspaper, the company says “(3M) worked in close coordination with the U.S. military on the CAEv2 product, and its design reflected the direction and feedback of individuals acting on the military’s behalf. We deny this product was defectively designed and caused injuries, and we will vigorously defend ourselves against such allegations,” said spokesman Tim Post.

The allegations were originally brought to light in a qui tam or whistleblower lawsuit filed under the False Claims Act.

A $9.1 million settlement offered by 3M in July 2018 to the government was intended to resolve allegations that 3M knowingly sold dual-ended earplugs to the U.S. military that were too short for proper insertion, without disclosing their defective nature.

The Department of Justice (DOJ) noted the payment was received under enforcement of the False Claims Act. The settlement resolves allegations brought forth in a qui tam or whistleblower lawsuit which permits private parties to sue on behalf of the government when they believe they have observed government waste and fraud. In this case, the whistleblower observed 3M allegedly submitting false claims for funding from the government.

The whistleblower received $1,911,000 for his effort.  There is no admission of liability as a result of the lawsuit.

Acting Assistant Attorney General Chad A. Reader told Disabled Veterans.org, “Government contractors who seek to profit at the expense of our military will face appropriate consequences.”

[United States ex rel. Moldex-Metric v.3M Company, Case No. 3:16-cv-1533-MBS (D.S.C).]