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).]

Paragard IUD MDL Created in North District of Georgia

Paragard IUD MDL Created in North District of Georgia

It’s an emerging tort that has potential to amass a number of cases.

Paragard is an IUD (intrauterine device) used to prevent pregnancy. It was approved by the U.S. Food and Drug Administration (FDA) in 1984.

Paragard is owned by Cooper Surgical, maker of surgical and laparoscopic instruments primarily for women’s surgical needs including devices for hysterectomy, pelvic surgery, and C-section procedures.

Because of the large number of reported complications, multidistrict litigation has recently formed in the North District of Georgia. Currently there are 95 cases filed.

Adverse events reported include the device breakage during explant (removal) surgery causing complications and injuries and the need for follow-up surgery to remove the pieces, infertility, and pain.

Other complications include:

  • Organ perforation
  • IUD arms embed in uterine wall
  • Migration outside of the uterus
  • Pieces difficult to locate
  • Ectopic pregnancy
  • Possible hysterectomy

Copper IUD

IUDs are an increasingly popular form of birth control. There are two types – hormonal and copper.

Paragard is a copper contraceptive that is advertised as “100% hormone free.” Made of flexible polyethylene plastic wrapped with a thin layer of copper coil around the arms and stem, Paragard blocks the sperm from reaching an egg and may also prevent implantation. The copper is emitted and incites an inflammatory reaction toxic to sperm and egg.

Paragard is the only copper emitting IUD used in the U.S. Three other IUDs on the market emit hormones – Mirena, Skyla and Liletta.

About the size of a pack of sugar, the user is not expected to feel Paragard. Periods are expected to be heavier and longer with spotting in between. Pregnancy with an IUD in place is associated with an increased risk of miscarriage, premature labor and delivery, and sepsis. There is even a 27% rate of miscarriage when the IUD is removed from a pregnant woman.

Long-term studies on animals to assess the potential of cancer with a copper-containing IUD have not been performed.

 

FDA and Paragard

The FDA has warned that Paragard removal may be difficult because of “partial penetration or embedment of Paragard in the myometrium” (middle layer of the uterine wall).

Since it was approved, the FDA has received more than 40,000 reports of complications associated with Paragard including 15 deaths, however, Paragard remains on the market.

In an FDA letter to CooperSurgical Regulatory Affairs, dated July 2019, the agency warns the direct-to-consumer (DTC) advertising with the dancing Paragard users, makes false or misleading representations about the risks associated with Paragard.

IUDs have long been associated with an increase in pelvic inflammatory disease (PID), infertility and death.

The use of an IUD as a reliable form of birth control has been around for decades but IUDs gained a bad reputation from the complications associated with use of the Dalkon Shield of the 1970s. Hundreds of thousands of women reported problems with pelvic inflammatory disease, infertility, spontaneous abortions, and death.  The Dalkon Shield incident encouraged the passage of the Medical Device Amendments of 1976, that, for the first time, gave the FDA some control over medical devices.

In another case of IUD complications, Bayer offered a $12.2 million settlement in 2018 to thousands of claimants over complications associated with Mirena IUD.


ParaGard MDL

On December 16, 2020, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order creating the Paragard MDL. So far, 95 cases have been filed in MDL 2974 in the Northern District of Georgia before U.S. District Judge Leigh Martin May. At the time, there were 80 actions pending in 36 districts.

The defective product action will include manufacturing defect, defective design, marketing, promotion, labeling, packaging, and distribution, and a failure-to-warn, gross negligence, and consumer protection law fraud. The plaintiffs seek punitive damages.

The defendants are alleged to have understood the risks from clinical trials and post-marketing complaints but failed to warn and instead concealed and suppressed the dangers, one complaint reads. (Plendl v Teva et al)

CooperSurgical opposed the centralization of cases but the JPLM rejected claims that the creation of an MDL would generate the filing of voluminous claims without due diligence by lawyers for the plaintiffs. Instead, it found the Northern District of Georgia serviced the convenience of the parties involved.  Six of the actions were already filed in the Northern District of Georgia. None of the cases has been resolved.

The new drug application (NDA) for Paragard was previously held by Teva Women’s Health, Inc. from November 10, 1995 to August 11, 2017. Most of the actions filed so far name Teva Pharmaceuticals USA, Inc. et al.

Previously, Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals Inc. DBA Teva Women’s Health Inc., acquired FEI (Finishing Enterprises Inc.) Women’s Health in 2005. The deal included the Paragard IUD.

Duramed was acquired by Teva USA in 2008. Cooper Companies, a Delaware Corporation with headquarters in Pleasanton, California, purchased assets of Paragard IUD in September 2017 for $1.1 billion. CooperSurgical is a subsidiary of Cooper Companies. Under Georgia law, successors-in-interest are liable.

 

Sources:

Pending mdl  https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-January-15-2021.pdf

FDA letter
https://www.fda.gov/media/129526/download

Hand Sanitizer from Mexico on Import Alert

Hand Sanitizer from Mexico on Import Alert

The warning was issued in January from the U.S. Food and Drug Administration (FDA). More than half of the alcohol-based hand sanitizers sent to the U.S. from Mexico contain dangerous ingredients toxic to Americans. The FDA has now placed all hand sanitizers labeled as alcohol-based and made in Mexico on a countrywide “import alert.”

Young children may have been the unintended victims of more than 900 accidental poisonings which have been reported to poison control centers around the country.

The agency recalled 75 brands of hand sanitizers contaminated with methanol, or wood alcohol. When ingested through the skin, methanol can be toxic and life-threatening when ingested.

Other complications include:

  • Nausea
  • Blindness
  • Vomiting
  • Headaches
  • Blurred vision
  • Seizures
  • Drowsiness
  • Confusion
  • Heart failure

Hospitalizations and deaths have resulted. It can take up to three days before the adverse health events are apparent.

Hand sanitizers are used when there is not a readily available source of soap and water to remove any exposure to the COVID-19 virus. The Centers for Disease Control and Prevention (CDC) recommends using an alcohol-based hand sanitizer with at least 60 percent ethanol, which may also appear on the label as ethyl alcohol (not methyl alcohol) or 70 percent isopropyl alcohol.

 FDA Action Regarding Hand Sanitizers From Mexico

An FDA review of all hand sanitizers from Mexico from April through December 2020 revealed 84 percent of the samples were out of compliance, with more than half containing either methanol or 1-propanol at dangerous levels. Methanol is not a listed ingredient.

Instead, the labels say the product contains ethanol. Some of the labels say “FDA-approved” even though there is no hand sanitizer that has FDA approval.

FDA has been working with the retailers to recall products and remove them from store shelves.

The FDA has issued 14 warning letters to manufacturers for the misleading labels and claims. The first consumer alert letter went out in June 2020 for nine hand sanitizers made in Mexico. From May to June, 15 adults were hospitalized after ingesting the tainted products.

Some people reportedly drink hand sanitizer to get an alcohol high. Others believe ingesting hand sanitizer can disinfect the body internally. Four have died and three suffered vision impairment.

Ironically, it was the FDA that issued a call for more companies to produce over-the-counter (OTC) hand sanitizers when COVID-19 hit the country in early 2020. Looking to cash in, many manufacturers began to manufacture the product. The FDA then relaxed some regulatory requirements for these new products.

The agency then reportedly swung the other way and supplies of hand sanitizer were detained at the border as the FDA required records demanding the hand sanitizer was in compliance with Good Manufacturing Practice requirements. Some law firms are calling that too heavy handed.

 Hand Sanitizer Recalls

The FDA has now expanded its recall to more than 200 different hand sanitizers allegedly containing wood alcohol. While Mexico is the main manufacturer, others are made in Guatemala, Turkey, Korea, China and six states in the U.S.

Of the 20 or more recent deaths associated with hand sanitizers, 16 involving methanol poisoning.  Seven of those cases were linked directly to Mexican-made hand sanitizer.

Costco, Walmart, and CVS all sold the hand sanitizers. The FDA has not revealed to CBS News how many of the poisonous products were sold.

Data from the National Poison Data System in January shows there were 938 hand sanitizer exposure cases in ten days in January that were reported to 55 U.S. Poison Control Centers.  That is a 57% increase from one year ago. Almost 600 cases involved young children under the age of 5.

Nationwide, 1,585 exposed to methanol were reported from May to August 2020, reports the American Association of Poison Control Centers.

It is a problem globally as well. Due to the popular myth that drinking hand sanitizer might clear you internally of the virus, about 800 people have died from drinking methanol, 5,900 have been hospitalized and 60 became blind, primarily in Turkey, Qatar, India, and Iran.

Recalled Brands of Hand Sanitizers

Among the 53 different Mexican manufacturers named in the recall are:

  • Yacana Hand Sanitizer, 70% Alcohol.
  • Blumen Advanced Instant Hand Sanitizer
  • Klar and Danver Instant Hand Sanitizer
  • Modesta Instant Hand Sanitizer
  • Eskbiochem Hand Sanitizer
  • The Honeykeeper Hand Sanitizer
  • Hello Kitty Hand Sanitizer
  • Assured Instant Hand Sanitizers
  • Bio aaa Hand Sanitizer
  • LumiSkin Advance Hand Sanitizer
  • QualitaMed Hand Sanitizer
  • NEXT Hand Sanitizer
  • NuuxSan Instant Antibacterial Hand Sanitizer
  • Modesa Instant Antiseptic Hand Sanitizer
  • Argent Defense Group
  • Dolphin Hands Sanitizer
  • V-Klean Hand Sanitizer
  • Medically Minded
  • Protz Real Protection
  • Alcohol Antiseptic

Consumers can check the “do-not-use” list at www.fda.gov/handsanitizerlist.

If someone ingests methanol, the antidote is an IV medicine called fomepizole which makes methanol less toxic to the body. It’s important to seek medical treatment immediately if this has happened to you or someone close to you.

 

Sources:

FDA
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use?ftag=MSFd61514f

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-place-all-alcohol-based-hand-sanitizers-mexico-import

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grupo-yacana-mexico-sas-de-cv-609824-01262021
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/grupo-yacana-mexico-sas-de-cv-issues-voluntary-nationwide-recall-all-lots-yacana-hand-sanitizer-due

https://www.accessdata.fda.gov/CMS_IA/importalert_1171.html

CBS
https://www.msn.com/en-us/news/us/hundreds-of-americans-poisoned-by-hand-sanitizer-this-month/ar-BB1d93RH

Natl Law Review
https://www.natlawreview.com/article/fda-places-all-alcohol-based-hand-sanitizers-mexico-import-alert

Morbidity and Mortality Weekly Report, August 14 2020

Upcoming Hernia Mesh Trials Ahead Name 3 Makers in 15,000 cases

Upcoming Hernia Mesh Trials Ahead Name 3 Makers in 15,000 cases

If the upcoming hernia mesh product liability trials are any indication, they could exceed the 100-thousand pelvic mesh cases amassed in West Virginia multidistrict litigation (MDL).

Thousands of litigants claim that an implanted polypropylene hernia mesh injured them severely. So far, there are three MDLs that have formed and since the COVID-19 court shutdown litigants had to be patient in 2020. With the new year, that may change.

Bellwether trials are being scheduled for the three mesh makers.

Ethicon, a division of Johnson & Johnson, Atrium Medical, and C.R. Bard/Davol are facing 15,000 cases filed by plaintiffs who claim defective design of the hernia mesh. With more than one million hernia meshes implanted in the U.S. every year, the potential numbers of litigants may ultimately exceed the pelvic mesh litigation.

Ethicon makes its hernia mesh from the same polypropylene (PP) that is used in pelvic mesh. It tends to shrink, erode, migrate, and become infected once implanted. Nerve damage is also reported as is sepsis and fatalities.

Ethicon’s PHYSIOMESH™ MDL 2782 is located in the Northern District of Georgia, Atlanta Division, MDL 2782 (1:17-md-02782-RWS).

So far, there are 3,334 cases filed there. The first trial is set for January 25, 2021 before Judge Richard Story.

Ethicon’s PHYSIOMESH™ is a flexible composite mesh coated with DS (Polydioxanone) film. The unique design was supposed to minimize adhesions and inflammation while facilitating incorporation of the mesh into the abdomen. Instead, plaintiffs argue that the layers coating the polypropylene prevented adequate incorporation of the mesh into the body and weakened the strength of the mesh. Physiomesh was taken off the market by Johnson & Johnson in May 2016.

Plaintiff Jim Crumbley had Physiomesh implanted which failed. He alleges defective design and manufacturing, failure to warn, negligence and a violation of Georgia’s consumer protection laws.

Atrium Medical

Atrium’s C-Qur hernia mesh lawsuits numbered 2,378 as of October and are consolidated in an MDL in New Hampshire before Judge Landya B. McCafferty in Concord (MDL 2753). Currently there are 2,477 with 2,433 unresolved. Carrie Barron is the lead plaintiff in this MDL with her trial set for January 20, 2021. Followed by Martha Luna. Case No.16-md-2753-LM.

Atrium is headquartered in Merrimack, New Hampshire.

Like Physiomesh, C-Qur is a polypropylene mesh coated with three fatty acids made of highly purified pharmaceutical grade fish oil. The presence of the oil allegedly presents a high rate of infection and rejection, organ perforation, inflammation, and encapsulation of the mesh with scar tissue which results in pain. Patients implanted with C-Qur have complained of adhesions of the mesh to the bowel, rashes, poor memory, and chronic dental problems.

C-Qur was recalled by the FDA in 2013 after a number of adverse events were reported to the agency. The hernia mesh was not removed from the shelves of hospitals or doctor’s offices. Atrium simply wrote a letter notifying doctors to be aware the mesh coating could stick to the packaging.

C.R. Bard/ Davol & Ventralight ST Hernia Mesh

Plaintiff, Steven Johns is the first case that will go to trial April 19, 2021 in the Bard MDL (2846) based in the Southern District of Ohio. Columbus Ohio.  (Case 2:18-md-2846).

The New Jersey-based company is facing more than 8,000 product liability claims naming Bard’s Ventralex, Perfix, 3DMax.

In September, U.S. District Judge Edmund A. Sargus denied the manufacturer’s motion for summary judgment. Judge Sargus ruled the defense experts cannot say the mesh “is in no way defective,” or that the warnings about the risk are sufficient.

The judge issued a pre-trial order that the jury may award punitive damages to those who have been severely injured by the defective Bard Ventralight ST hernia mesh medical device. Failure to warn is party of the case against the defendant and Johns’ doctor said if he had been fully informed by Bad Davol he would not have used this mesh on the plaintiff.

Steven Johns v. C.R Bard, et al. (Case No. 2:18-cv-01509-EAS-KAJ), alleges he faces pain, hernia recurrence, and adhesions. Johns had surgery to remove the mesh and replace it with a new Ventralight ST.

West Virginia Product Liability Laws

West Virginia Product Liability Laws

Roughly 30,000 new products hit the American market every year, and the vast majority of those products never cause injury or illness. However, those that do tend to leave significant destruction in their wake. Products that are marketed irresponsibly, designed poorly, or otherwise unsafe can leave victims with tens of thousands of dollars in medical bills and other expenses.

If you or someone you love has been injured by a defective or dangerous product in West Virginia, it’s time to talk to an attorney and find out what your legal options are.

Types of Defects

A faulty product may be considered defective for a variety of reasons. While many people assume that fault always comes back to the company selling the product, liability can actually fall on any party involved in the design, creation, marketing, or distribution of the product.

The main types of product defects include:

  • Design defects. When the design of something is inherently flawed in a way that makes it unsafe to use, liability falls on the party responsible for designing the product. In this type of claim, the product was manufactured to the specifications given, but the specifications given were flawed.
  • Manufacturing defects. In this situation, the product was designed in a way that would make it safe and effective for the intended market. However, during the manufacturing of the product, errors occurred. Perhaps the company responsible for manufacturing did not perform proper maintenance on their machinery, used subpar materials, or skipped steps in the manufacturing process.
  • Marketing defects. Products are designed with a target market in mind and created for a specific use. If marketing paints products in a different light by recommending them to groups for whom the product is unsafe or recommends using products in a way that they should not be used, the marketing firm could be liable for victims’ losses.

Different Types of Liability Theories

Depending on the circumstances of your injury and the product that caused it, your lawyer may explore different theories of liability to determine which is best suited to your case. The main three theories used in these cases are:

  • When designing, creating, and marketing products, companies are expected to use a reasonable amount of caution to ensure that they are not putting consumers in harm’s way. If they fail to meet this standard and cause injuries, they may be liable for the damage caused.
  • Breach of warranty. Many products come with express or implied warranties. When companies fail to follow through on the terms of their warranties and someone is injured because of it, they may be held responsible for the consumer’s financial losses.
  • Strict liability. In some cases, it is nearly impossible to prove that a product caused an illness or injury. However, this does not mean that the product did not cause illness or injury. Under strict liability, a company involved in the design, creation, or marketing of a product may be held liable even if it cannot be proven that they were negligent.

Damages for a West Virginia Product Liability Claim

When you are injured because of a defective product, you can seek compensation for your losses. What you actually get is dependent on the details of your case, how competent and aggressive your attorney is, and how much pushback you get from the liable party. Some of the compensation you may ask for includes:

  • Medical bills, current and future. Medical bills are a leading cause of bankruptcy in the United States, so if someone else is liable for your injuries it is only fair that they also cover your medical expenses. Generally, this only includes medical costs you have already incurred. However, if your injury is serious enough to require ongoing or long-term care, you may also seek compensation for future medical expenses.
  • Lost wages and future loss of income. Taking time off work can be financially devastating, especially considering that most Americans live paycheck to paycheck. Whether you have to take a few days off of work to get treated for your injuries or you spend months away from work trying to heal, you deserve compensation for your lost wages. You may be awarded additional compensation if your ability to work is permanently affected.
  • If an injury leads you with permanent disability, you should receive compensation for the expenses that come with this significant change. You may need money to rework your home for disability access, purchase adaptive equipment, and pursue occupational therapy to learn how to live with your limitations.
  • Property damage. Some defective products cause property damage. Consider, for an example, a defective microwave that explodes and destroys your kitchen. These losses should also be compensated.
  • Pain and suffering. Not every loss comes with a clear financial cost. That doesn’t mean that those losses shouldn’t be compensated. Pain and suffering, mental anguish, loss of enjoyment of life, and other non-financial losses are still compensable.
  • Punitive damages. If your case goes to court, you may be awarded punitive damages. Courts award punitive damages not to make the victim whole, but to punish the liable party and discourage similar behavior in the future. In a product liability case, this may be done if the company knew about the defects beforehand but chose to go to market anyway.

Why You Need a West Virginia Product Liability Attorney

The field of product liability law is complex, and without an attorney to help you with your claim, it’s unlikely you’ll get far in your quest for compensation. There are multiple legal theories that may be applicable to your case and you’ll need to meet a substantial burden of proof to get compensation.

An attorney can take this weight off your shoulders and allow you to focus on healing from your injuries. Through their investigation, they will figure out which party is liable for your injuries, how the product directly led to your injuries, and what it will take for you to receive fair compensation.

From there, they will move on to negotiations. Companies spend a substantial amount of money on their legal teams, so you want an attorney who is aggressive and willing to stand up to corporate lawyers. A seasoned attorney will build a solid case that proves why you deserve compensation and fight back against the other side’s efforts to discredit your injuries. And if your case goes to court, they will be ready to fight for every penny you deserve.

Contact a West Virginia Product Liability Lawyer Today

Defective products cause untold amounts of damage every year, but you don’t have to fight the company alone. With the help of an experienced product liability attorney, you can pursue just compensation for your injuries. Get in touch with an attorney today to help you with your case.

Elmiron Bladder Pain Drug Warning Added by J&J

Elmiron Bladder Pain Drug Warning Added by J&J

Made by Janssen Pharmaceuticals, a division of Johnson & Johnson, Elmiron (pentosan polysulfate sodium), was approved by the U.S. Food and Drug Administration (FDA) to protect the bladder wall from irritants in urine, which causes interstitial cystitis or painful bladder syndrome.

Elmiron actually works like heparin and is a weak anticoagulant, acting like a blood thinner.

It is not a cure, but Elmiron promised to provide some relief to the painful symptoms for the three to eight million women affected from the pain associated with the inflammation or irritation of the bladder. It’s estimated up to four million men may also suffer from interstitial cystitis, which may be due to a defect in the protective lining of the bladder.

Symptoms include a burning sensation and urinary urgency, a feeling of discomfort of pressure in the bladder or lower abdomen, pain during intercourse, and pelvic floor muscle pain.

Now, 24 years after its approval, Elmiron is linked to maculopathy, the most common cause of blindness.

Janssen Pharmaceuticals, a division of Johnson & Johnson, added a warning in June concerning a potential life-altering retinal disorder – pigmentary maculopathy. This was added to the side effects already appearing on the instructions for use (IFU) including abnormal liver function, nausea, diarrhea, and hair loss.

Sufferers usually experience vision loss after at least two years. The vision problems must have onset within a year of stopping the drug or during its use. Damage may stop if caught in the early stages of drug use.

Scientific Studies

Three ophthalmologists conducting a review of patients at Kaiser Permanente in Northern California found about one-quarter of users of Elmiron displayed signs of eye damage. Taking a closer look at 91 patients who had taken an average of 5,000 pills found 22 patients with signs of drug toxicity.

Emory Eye Center in Atlanta, Georgia also noted six patients who were long-term users of Elmiron developed changes to their macula, the part of the eye which allows us to see with detail and clarity.

Lawsuits alleging a failure to warn the public and doctors about the risk of vision problems are now being filed. Tens of thousands of patients may be affected.  Patients who have filed report they are experiencing blurred vision and vision impairment including retinopathy and maculopathy.

Patients with liver issues should consult with their doctor before using the drug.

WARNINGS

Retinal Pigmentary Changes

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.”

Symptoms of Elmiron use may include:

* Dimming vision

* Difficulty reading

* Difficulty adjusting to the light

* Loss in a field of vision

* Loss of night vision

* Difficulty seeing objects that are close

* Blindness

* Halo vision

* a diagnosis of pigmentary maculopathy

*A diagnosis of macular degeneration

* A diagnosis of Macular Retinopathy

* A diagnosis of Retinal Deterioration

* A diagnosis of Pattern dystrophy

LEARN MORE:

American Academy of Ophthalmology 
news release

FDA Prescribing Information for Elmiron

May 2018, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium