The Role of FDA Warnings in Elmiron Lawsuits in Illinois

 Posted on March 25, 2024 in FDA

Interstitial cystitis, a chronic bladder condition, impacts millions of Americans. For years, the prescription medication Elmiron provided relief for many IC patients. However, recent studies have linked the long-term use of Elmiron to serious vision complications like pigmentary maculopathy. This has prompted numerous lawsuits against the drug's manufacturer, Janssen Pharmaceuticals, with the adequacy of Elmiron's safety warnings emerging as a critical issue. An Illinois lawyer can help you understand the role of FDA warnings in Elmiron litigation.

FDA Warnings and Drug Liability

When the U.S. Food and Drug Administration (FDA) approves a drug for consumer use, pharmaceutical companies have a duty to provide proper warnings about potential risks and side effects. Failure to adequately warn patients and doctors can expose drug makers to legal liability under Illinois product liability law.

In Illinois, plaintiffs can hold drug manufacturers strictly liable for injuries caused by an unreasonably dangerous product as long as the product was used as intended. One way a drug can be deemed unreasonably dangerous is if the manufacturer fails to provide adequate instructions or warnings.

The Elmiron Warning Timeline

Elmiron (pentosan polysulfate sodium) is a prescription drug used to treat bladder pain and discomfort associated with interstitial cystitis. While on the market since 1996, it was not until 2018 that eye specialists began reporting cases of vision complications like retinal maculopathy linked to long-term Elmiron use.

In response to these reports, the FDA approved changes to the Elmiron label in June 2020 to warn about the risk of pigmentary maculopathy among patients with long-term use. However, plaintiffs allege that the drug maker Janssen Pharmaceuticals was aware of potential vision risks well before the 2020 warning and should have provided an earlier warning.

Impact on Elmiron Litigation

The timing and sufficiency of Elmiron's warning label will be a key issue in lawsuits brought by Illinois plaintiffs against Janssen. Under the state's Product Liability Act, manufacturers must properly warn about any dangers that could have been reasonably anticipated.

If Janssen knew or should have known about the risks of vision problems associated with Elmiron prior to 2020 based on clinical trials or adverse event reports, the company could be liable for failing to provide an adequate warning. An insufficient or delayed warning deprived patients and doctors in Illinois of critical safety information needed to make informed decisions about using Elmiron.

How an Illinois Lawyer Can Help

Suppose you or a loved one took Elmiron for an extended period and suffered vision complications like pigmentary maculopathy or retinal maculopathy. In that case, you may be entitled to compensation through an Elmiron lawsuit. A lawyer at Newland & Newland, LLP can:

• Investigate when Janssen knew or should have known about risks and whether warnings were sufficient and timely under Illinois law.
• Gather evidence of your injuries, vision impairment, and medical costs related to Elmiron use.
• Calculate damages you may be owed for medical bills, lost wages, pain and suffering, and more.
• File an Elmiron lawsuit and represent you through negotiations or trials to maximize your recovery.

Contact a Palatine, IL Product Liability Lawyer

With FDA warnings as a key factor, having a Schaumburg, IL product liability attorney analyze the warning timeline and advocate for your rights as an injured patient will be crucial in Elmiron cases. With more than five attorneys on staff, you do not need to face this complicated litigation alone. Call Newland & Newland, LLP at 847-797-8000 for a free consultation.