The upcoming year is going to witness lots of mass torts and MDL cases barreling forward in the United States. 3M earplugs, Zantac, IUD Paragard, and Elmiron lawsuits are only the tip of the iceberg. Let us have a gabbing on Elmiron lawsuit and Elmiron lawsuit settlement.
What is the Elmiron lawsuit about? To know that, we have to tap into interstitial cystitis, for which Elmiron became well received by the medical community.
What is Interstitial Cystitis (IC)?
Interstitial Cystitis or Bladder Pain Syndrome is a chronic condition causing abnormal pressure in the urinary bladder. It causes pelvic pain and makes the patient have a frequent urination tendency. In the United States, it is estimated that 83,000 men and 1.2 million women suffer from IC.
To clarify, let us check out the process of urination in the human body.
Urine from the kidneys passes through the ureters and into the urinary bladder. The urethra has muscles called sphincters that keep the urethra closed and help in preventing urine leakage. The urinary bladder is a pyramid-shaped organ when it is empty, and as it fills up with urine, it expands and becomes oval. When the bladder is filled with roughly 200 milliliters of urine, it initiates the micturition reflex by activating stretch receptors in the bladder wall. The detrusor muscle contracts while the internal urethral sphincter muscle relaxes. This autonomic reflex causes urine to flow into the urethra.
The stretch receptors also send signals to the thalamus and the cerebral cortex of the brain, giving voluntary control over the external urethral sphincter. These signals become muddled when you have interstitial cystitis, and you feel the need to urinate more frequently and with lower amounts of urine than normal individuals.
Causes of Interstitial Cystitis
The commonly reported Interstitial Cystitis causes are as follows.
- Autoimmune disorders
- Pelvic floor muscle dysfunction
- Mast cell abnormalities.
- Trauma in the urinary bladder or overstretching
- Defects in the lining of the urinary bladder.
- Vascular diseases
- Presence of abnormal substances in the urine.
Symptoms of Interstitial Cystitis
Interstitial Cystitis symptoms may vary in each individual depending upon the severity of the condition. The common symptoms are mentioned below.
- Chronic pelvic pain
- Pain during sexual intercourse
- Pain in the lower abdomen & lower back
- Pain in the perineum and urethra
- Pain in the vulva or vagina in females
- Pain in the testicles or penis in males
- Pain during urination
- Frequent urination with urgency
What is ELMIRON®?
ELMIRON® is the drug used to treat IC. Chemically ELMIRON® contains pentosan polysulfate sodium, and the drug is available as 100-mg capsules for oral usage. Pentosan polysulfate belongs to a class of anticoagulant medications known as low molecular weight heparins. It is a carbohydrate derivative that chemically and structurally resembles glycosaminoglycans. Most of the drugs in this class are used as anticoagulants or blood thinners.
Elmiron was developed and manufactured by Janssen Pharmaceuticals Inc, headquartered in Beerse, Belgium, and wholly owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen, and later in 1961, the company was purchased by Johnson & Johnson.
Elmiron was first approved by the FDA in 1996 and used to treat interstitial cystitis and bladder pain related to Urinary Tract Infections (UTIs). ELMIRON® is supplied in white opaque hard gelatin capsules with the following ingredients.
- Pentosan polysulfate sodium
- Microcrystalline cellulose
- Magnesium stearate
- Pharmaceutical glaze (modified) in SD-45
- Synthetic black iron oxide
- FD&C Blue No. 2 aluminum lake
- FD&C Red No. 40 aluminum lake
- FD&C Blue No. 1 aluminum lake,
- D&C Yellow No. 10 aluminum lake
- N-butyl alcohol
- Propylene glycol
- SDA-3A alcohol
- Titanium dioxide
When was Elmiron approved by the FDA? On September 26, 1996, Elmiron® was approved by the FDA to treat interstitial cystitis.
How Does Elmiron Help Interstitial Cystitis?
In patients with IC, the mucus lining of the urinary bladder is damaged by the abnormal molecules produced in the urine. Though the pharmacodynamics of Elmiron is not clearly studied, available reports indicate that Elmiron helps by adhering to the bladder wall, thereby buffering against the irritating substances released from the urine.
Does Elmiron cure interstitial cystitis? Elmiron does not completely cure IC. However, the inflammation of the urinary bladder and bladder pain in IC patients may be reduced with the intake of this drug.
Is Elmiron Dangerous?
Till 2018 Elmiron was regarded as the savior for patients with IC. There came a twist in the story when Dr. Joseph T Nezgoda, and Dr. Nieraj Jain, from Emory Eye Center in Atlanta, observed pattern dystrophy in six patients. On further study of the patient histories, they found that all the patients took Elmiron for around sixteen years.
Detailed studies on the cases pointed out the relationship of Elmiron with pigmentary maculopathy that results in deposits in the macula. The findings appeared in the November 2018 issue of Ophthalmology and triggered the world of science to look into the matter.
Pigmentary maculopathy is a type of degeneration in the macula region of the eyes. The macula is the central portion of the retina and is the light-sensitive portion of the eye. Pigmentary maculopathy can cause dim vision, difficulty in reading, and difficulty adjusting to the dark or low lighting. There may be permanent vision loss in some cases.
A team of ophthalmologists from Kaiser Permanente in Northern California conducted a detailed study on the Elmiron issue. The result of the study indicated that about 25% of patients who were taking Elmiron had signs of maculopathy or severe eye damage.
Is Elmiron safe to take? The report presented at the annual meeting of the American Academy of Ophthalmology in October 2019 concluded that their studies had found clear signs of drug toxicity of Elmiron.
What is Elmiron Lawsuit?
Can Elmiron Cause Blindness? / Does Elmiron Cause Vision Damage?
When extensive research gave positive answers to these queries, it led to Elmiron lawsuits in the United States. Elmiron Lawsuit update 2022 indicates that there are around 900 lawsuits filed against the drug manufacturer. In 2021, the Elmiron lawsuit- Elmiron (Pentosan Polysulfate Sodium) Prod. Liab. Litigation, MDL 2973) was established in the U.S. District Court for New Jersey. Judge Brian Martinotti is in charge of the lawsuit for Elmiron.
Elmiron lawsuit claims that, with a prolonged usage of Elmiron, the patients were at risk of maculopathy and other eye disorders. The claimants accused Janssen Pharmaceuticals Inc did not disclose or warn the users of the potential retinal side effects.
Who Qualifies for an Elmiron Lawsuit?
Victims suffering from Elmiron-related eye injuries and vision problems can file a lawsuit against Elmiron. Let us find the Elmiron lawsuit criteria to know further.
- The individual must have been diagnosed with any eye disorder or vision problems listed below.
- Pigmentary/ Degenerative maculopathy
- Macular degeneration
- Reduced night vision
- Vision loss/ impairment
- Halo vision
- Macular retinopathy
- Pattern dystrophy
- Unilateral/ Bilateral blindness
- Blurred vision
- Metamorphopsia (distortion of linear objects or lines such that they appear curved)
- The individual must have taken the drug for at least two years.
- The vision problems listed should have started while taking the drug or within one year of stopping it.
If you are a victim of Elmiron drug side effect, your medical records would save your lawsuit. Seek the service of a professed Elmiron lawsuit attorney and get a detailed case evaluation. Gather all your medical records and proceed with a medical record review that would perfectly reflect your vision-related damages after the usage of the drug.
The strong defense argument in the Elmiron lawsuit is that the vision loss or maculopathy in the claimants is genetic or age-related. LezDo techmed reviews medical records with a special focus on the family history and medical history of the claimant. With our high-precise medical chart review report, defeating the defense arguments would be a cushy job.
Elmiron Lawsuit Status 2022
If you are a victim of vision loss or retinal damage due to the prolonged usage of Elmiron, you may seek the help of an Elmiron lawsuit lawyer. Have a case evaluation and join the burning Elmiron lawsuits.
The pending Elmiron lawsuit for eye injury in the federal courts has been consolidated into an MDL, both in federal court and New Jersey as the defendant is headquartered in New Jersey. After preparing a group of 20 Elmiron lawsuits for trial as bellwether test cases, three defendants have been selected for the bellwether trials. They are
- Julia Manning and Brian Manning (21-cv-11942)
- Opal Faye Broussard (21-cv-2028)
- Maria Windham (20-cv-14670)
To be considered a bellwether trial case, the plaintiff had to be prescribed and take Elmiron on or before November 7, 2021, and acquire pigmentary maculopathy or a retinal condition as a result of the drug.
Pre-trial discovery will conclude by September 9, 2022, and dispositive motions will be completed by September 20, 2022. The important deadlines in the Elmiron drug lawsuit are given in the table below.
Claimants Selected for Elmiron Lawsuit Bellwether Trials
The case of claimant Julia Manning is a plaintiff-selected bellwether based on a lawsuit filed in May 2021. As per the claim, Julia Manning took Elmiron from 2008 -to 2014, and she suffers from an injury to both eyes. The plaintiffs in this Elmiron lawsuit are suing Teva Branded Pharmaceutical Products R&D, INC.
The following are the counts on which the lawsuit is filed against the defendants.
- Strict Liability – Failure to Warn
- Strict Liability – Design Defect
- Negligent- Failure to Warn
- Negligent Design
- Fraudulent Misrepresentation
- Loss of Consortium
The second case of Opal Faye Broussard is a defendant-selected bellwether based on the Elmiron lawsuit filed by the claimant in January 2021. As per the claim, the claimant has vision loss and macular degeneration linked to the usage of Elmiron. The defendants in the cases are Janssen pharmaceuticals, INC and Johnson & Johnson.
The following are the counts based on which the lawsuit is filed against the defendants.
- Failure to warn
- Strict liability
The third case in the bellwether trial was the Elmiron lawsuit filed by Maria Windham in October 2020. It is a defendant-recommended case where the claimant had used Elmiron from 2012 to 2014. The plaintiff claims to suffer from retinal pigmentary changes, including macular degeneration. The main defendants in the case are Janssen pharmaceuticals, INC and Johnson & Johnson.
The following are the counts based on which this Elmiron lawsuit is filed against the defendants.
- Strict liability
- Breach of express warranty
- Breach of implied warranties
- Fraudulent misrepresentation
- Fraudulent concealment
- Negligent misrepresentation
- Fraud and deceit
- Violation of the new jersey consumer fraud act
- Product liability – design defect
- Products liability – failure to warn
- Product liability – manufacturing defect
- Punitive damages
How Much are Elmiron Lawsuit Settlements?
As per the expert Elmiron lawyers, the Elmiron eye damage lawsuit will end in a huge settlement. The Elmiron lawsuit amount may vary depending upon the severity of damages to the claimants.
As the Elmiron lawsuit MDL is a budding lawsuit, it is risky to speculate on the Elmiron lawsuit settlements. Like other MDLS, the Elmiron vision lawsuit will be classified into tiers based on the severity of the claimants’ damages. Plaintiffs with severe vision damages may be under the top settlement tier- tier 1 and other claimants under tier 2.
As per the experienced Elmiron lawsuit lawyers, the average Elmiron lawsuit settlement amounts are expected to fall between $10,000 & $600,000 per claimant.
Is Elmiron Still on the Market?
Has Elmiron Been Recalled? No, the drug is still revolving in the pharma market. The company didn’t warn about the risk of retinal pigmentary maculopathy until in the drug’s prescribing information in June 2020.
The other side of the fence is that, still ELMIRON® is the only FDA-approved drug in the United States for Interstitial Cystitis. It is widely prescribed by the physicians even after the boom of the Elmiron lawsuit. The FDA had not asked Janssen to recall the drug from the market, and the company had not announced any voluntary recall.
Let us wind up the blog with another study related to the lawsuit on Elmiron.
In July 2020, researchers from several institutions conducted a study on PPS-associated maculopathy in 11 patients. They had observed that, even after discontinuing the drug, none of the patients exhibited demonstrable improvement in vision. Nine patients were found to have worsening symptoms after discontinuing the medication.
Unlike other drug MDLs, Elmiron vision damage lawsuits have a solid research background showing the toxicity of the drug in inducing severe vision damage. Studies by Emory, Kaiser Research, etc., point out the same.
Still, the drug is not even been recalled. Strange but true!
Let us see how the Elmiron lawsuit barrel moves in 2022. Elmiron lawsuit attorneys would have a hard time fighting against a pharma shark, with the culprit still ruling the market. Do think Elmiron will go for a global settlement? Share your views.