Lawsuit Alleges Elmiron Manufacturers Hid Risk of Retinal Injury

by Jeffrey Nadrich Managing Partner, Nadrich & Cohen, LLP

A lawsuit filed in August in North Carolina claims drug manufacturers hid a link between retinal injury and the interstitial cystitis medication Elmiron (pentosan polysulfate sodium) from the medical community and the public for years. Johnson & Johnson, its subsidiaries Janssen Pharmaceuticals and Ortho-McNeil, and Teva Pharmaceuticals are named as defendants in the complaint.

The plaintiff in the lawsuit is a North Carolina woman who was diagnosed with interstitial cystitis in or around 2003. She was prescribed Elmiron for the condition. She then proceeded to take the medication as prescribed until early 2020.

The complaint states the woman started having problems with her vision in or around 2015. She allegedly began suffering from blurry vision, vision distortion, pain in her eyes, problems reading, trouble with night vision and trouble adapting to the dark. The complaint says she was diagnosed with pentosan polysulfate maculopathy in 2019.

The Emory Eye Center in Atlanta, Georgia discovered pentosan polysulfate maculopathy when they found a new progressive eye disease in six of their patients. They poured through the histories of those patients and found that all six patients had taken Elmiron. The Emory Eye Center’s findings were published in 2018.

The complaint points out that the drug’s United States label wasn’t updated to warn about retinal injury until June 16, 2020. The complaint seeks to recover damages based on negligence – failure to warn.

North Carolina general statute § 99B-5 deals with claims based on inadequate warning or instruction. It states that the following must be proven by a claimant seeking to recover damages for a drugmaker’s failure to warn:

• The drugmaker acted unreasonably by failing to warn about the danger linked to their medication;

• The failure to warn was a proximate cause of the harm suffered by the claimant.

One of the following must also be proven:

• The drugmaker knew or should have known at the time the drug left its control without an adequate warning that the drug posed a substantial risk of harming a reasonable claimant;

• The drugmaker became aware of or should have become aware of the danger linked to their drug after the drug left their control.

The complaint argues that drugmakers acted unreasonably by failing to warn about the drug’s link with retinal damage, since the drugmakers “had a duty” to warn the public about the injury risk.

The complaint states that the plaintiff had “been damaged as a direct and proximate result” of the drugmakers’ failure to warn about their product’s risk of retinal injury.

The complaint, by noting that the discovery of pentosan polysulfate maculopathy was published in 2018 and that the drug’s U.S. label wasn’t updated until June 2020, argues that the drugmakers knew or should have known at the time the drug left its control that their drugs were linked with the condition.

The complaint notes that the Emory Eye Center found that a Janssen clinical trial found evidence of retinal damage in users of the drug which was “never followed up on, never warned about or otherwise disclosed. Instead, Defendants chose to ignore it.”

It is noted in the complaint that drugmakers received adverse event reports regarding serious visual complications in the United States and around the world. The complaint also notes that the drug’s Canadian label was updated in September 2019 to warn about the risk of serious visual complications.

The complaint also seeks to recover damages based on fraudulent concealment.

“Defendants were aware of the health risks inherent in Elmiron®, but intentionally chose not to disclose this material fact to patients,” the complaint claims. “Defendants’ failure to disclose and omission of material facts… was capable of deceiving and, indeed, did deceive a substantial portion of patients to a serious health risk.”

The complaint claims the plaintiff would have never taken the drug if drugmakers had disclosed the truth about the drug to her.

The complaint seeks to recover damages based on strict liability – defective design.

North Carolina general statute § 99B-6 covers claims based on inadequate design or formulation. It states the following must be proven to recover damages based on this statute:

• The drugmaker acted unreasonably in formulating or designing the product at the time of the drug’s manufacture;

• Acting unreasonably was a proximate cause of harm to the plaintiff.

One of the following must also be proven:

• The drugmaker failed to adopt a safer design or formulation, at the time the drug left its control, which could be reasonably adopted and would prevent or reduce the risk of harm without making the drug less effective;

• The design or formulation was so unreasonable at the time the drug left the drugmaker’s control that a reasonable person, aware of any relevant facts, would refuse to consume or use the drug.

The complaint claims that the drug “was defective when it left Defendants’ control… in that there were foreseeable defects in the design of the drug.”

The complaint states that the plaintiff was injured “as a direct and proximate result of” the drugmakers selling a defective product.

The complaint alleges that “better and safer methods of design” of the drug “were available and could have been utilized” by drugmakers.

The complaint seeks to recover damages based on breach of express warranty, arguing that drugmakers expressly warranted that their medications were safe to treat interstitial cystitis with when they were not.

Damages are sought by the complaint based on the North Carolina Unfair & Deceptive Trade Practices Act. The complaint argues that it was unfair and deceptive of drugmakers to fail to warn the public about their medication’s retinal injury risk.

Pentosan polysulfate maculopathy can involve many symptoms, including:

• Problems with reading

• Straight lines appearing curved

• Problems with eyesight in dim lighting

• Colors being less vivid

• Blurred vision, especially in the center of the field of vision

• Dark spots in the center of the field of vision

Harvard Medical School once treated a patient whose pentosan polysulfate maculopathy was still getting worse six years after she stopped taking the medication.

About The Author

Jeffrey Nadrich is the managing partner of Nadrich & Cohen, LLP, a California personal injury law firm which represents plaintiffs who are diagnosed with retinal injury after taking Elmiron.

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Created on Sep 10th 2020 17:29. Viewed 610 times.

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