Benjamin Widlanski, Kozyak, Tropin & Throckmorton, left, and Francisco R. Maderal, Partner, Colson Hicks Eidson. Courtesy photos.

Two South Florida firms have united to file the first of what they say will be a string of putative mass tort lawsuits across the U.S. over allegations that a drug commonly prescribed for bladder issues could cause permanent retinal damage, vision impairment and blindness.

Kozyak Tropin & Throckmorton partner Benjamin Widlanski and Colson Hicks Eidson partner Francisco Maderal represent named plaintiff Tara O'Flaherty from Charlotte County.

Their client alleges Janssen Pharmaceuticals Inc. and its parent company New Jersey-based Johnson & Johnson should have investigated and warned consumers about the risks of prescription drug Elmiron, used to treat interstitial cystitis, a bladder condition that causes chronic pain, particularly common among women.

Plaintiff counsel said that because of the severity of the allegations in this case, investigating it felt somewhat like a prosecution for the two former assistant U.S. attorneys.

"Being among the first firms to investigate and bring a pharmaceutical case like this is very much like putting a prosecution together," Widlanski said. "So, being former AUSAs, it felt natural for us: gathering facts, researching law, developing the narrative and filing."

The U.S. Food and Drug Administration approved Elmiron in 1996, but the complaint points to multiple scientific studies that have since allegedly raised questions the drug's safety. In particular, the Emory Eye Center in 2018 published concerns about Elmiron after studying a group of women with maculopathy, a retinal disease. While none of those patients had a family history of eye problems, all of them were taking Elmiron, according to O'Flaherty's lawsuit.

The defendants said they have not been served yet but plan to fight the allegations.

"Interstitial cystitis is a painful and debilitating disease. Elmiron (pentosan polysulfate sodium) is the only FDA-approved oral prescription medicine that has been helping patients suffering from this condition for more than two decades," a Janssen Pharmaceutical spokesperson said via email.

Janssen's website does not say eye problems are a side effect of Elmiron.

O'Flaherty took Elmiron between 1994 and 2019, according to the lawsuit, which said she now has maculopathy and distorted and blurry vision.

Thousands of people could be affected, according to Widlanski and Maderal, who say more suits will follow in other states. But the attorneys' biggest obstacle will be finding those people, since Elmiron isn't as well-known as other drugs now at the center of class actions.

"We need people to learn about the dangers of taking this drug," Widlanski said. "It's been on the market for decades, and there are so many women who have already been injured by it. We just want them to learn the medical facts and their legal rights."

Going up against the pharmaceutical industry with a case like this is the best mode of safety regulation, in Maderal's view.

"Cases like these are a reminder that the American civil justice system is the only arena where the individual stands toe-to-toe with big corporations and can truly hold them accountable," Maderal said. "It's one of the most important pieces of our democracy. And it's especially important to keep that in mind now while access to our justice system is strained by COVID-19.

It's not the first time Kozyak Tropin & Throckmorton and Colson Hicks Eidson have pooled their resources. They've also tackled major Ponzi schemes together and sued over proton beam cancer treatment.

O'Flaherty's lawsuit accuses the defendants of strict liability, breach of warranty and negligence, and seeks compensation, statutory and punitive damages and attorney fees.

U.S. District Judge Sheri Polster Chappell will preside over the case in the Middle District of Florida.

Read the complaint:

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