Tauler Smith LLP recently filed a consumer class action complaint against Walgreens because the retail behemoth is allegedly selling Phenazopyridine Hydrochloride (Phenazo), an unapproved over-the-counter UTI drug, to unsuspecting customers in violation of California’s consumer protection laws. The class action suit, which was filed in federal court in California, alleges that Walgreens uses misleading advertising to deceptively sell Phenazo to treat urinary tract infections even though the drug is unsafe, ineffective, and unlawful to market to consumers.
For more information about the Walgreens UTI drug lawsuit, keep reading this blog.
What Is the FDA Approval Process for Over-the-Counter Drugs?
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of prescription and nonprescription drugs sold in the United States. Before over-the-counter drugs like Phenazo can be sold to consumers, they must be approved by the FDA. This can happen in one of two ways:
- The drug goes through the standard FDA approval process, which involves submitting a New Drug Application (NDA).
- The drug receives a drug monograph.
A drug monograph is a process that drug manufacturers can utilize to get their products approved for specific therapeutic uses in a particular category. In other words, a drug monograph is a way around the requirement for FDA approval as a finished drug.
New Drug Applications
Under authority granted by the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA typically requires drug manufacturers to submit a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) and provide clinical trial data to demonstrate the safety of a new drug before they can market it as a finished drug product.
When the FDA requested data on the safety and efficacy of all OTC urinary antiseptics/analgesics not yet reviewed by the FDA, the request included Phenazopyridine Hydrochloride (Phenazo). In this notice, the FDA stated that Phenazo had not been the subject of an approved NDA, meaning that the UTI drug’s safety was not demonstrated to the satisfaction of the federal regulatory agency.
OTC Drug Monographs
An OTC drug monograph allows drug manufacturers to lawfully market certain over-the-counter drugs based on the safety of a drug’s active ingredients. The monograph process involves a “rule book” that defines specific conditions under which an OTC drug may be considered safe and effective in a given therapeutic category. Under this approach, a manufacturer does not need FDA approval to bring the nonprescription drug to market because only certain ingredients are being marketed as safe for a particular use within a particular therapeutic drug category.
What Is Phenazopyridine?
Phenazopyridine Hydrochloride (Phenazo) is an over-the-counter drug used to treat symptoms of urinary tract infection (UTI), including urinary pain, burning, and discomfort. UTI is a medical condition that disproportionately impacts women, particularly women in underserved communities.
Millions of Americans trust pharmacies to sell them safe, effective, and lawful remedies for their illnesses, including urinary tract infections. For these consumers, pharmacies are the primary point of purchase for over-the-counter drugs, as well as the primary source of information for over-the-counter medications. Reliance on OTC medications is heightened in underprivileged communities where residents are more vulnerable to illness and health concerns due to lack of access to medical care.
Phenazo is marketed and advertised as a drug for urinary tract infections – but the UTI drug has not been approved by the FDA, which means that stores like Walgreens should not be selling it as an over-the-counter treatment.
Walgreens Sued for False Advertising of UTI Drug Phenazo
Argueta v. Walgreens Co. is a high-profile consumer class action lawsuit against the Walgreens Company, which operates the second-largest pharmacy store chain in the United States. The lawsuit, which was filed in the U.S. District Court for the Eastern District of California, accuses the pharmacy of unlawfully selling Phenazopyridine Hydrochloride (Phenazo) over the counter and marketing the misbranded drug as a finished drug product called “Urinary Pain Relief.”
The Walgreens class action alleges that Phenazo has never been approved by the FDA under the NDA/ANDA process, nor has Phenazo ever been brought to market under an established OTC drug monograph. In other words, the drug is allegedly being marketed and sold by Walgreens in violation of California consumer fraud laws.
Walgreens Accused of Violating California’s Unfair Competition Law (UCL)
Walgreens has been accused of violating California’s Unfair Competition Law (UCL) by selling the unapproved OTC drug Phenazo. The UCL is a far-reaching consumer protection statute that applies to many different kinds of unethical business practices, including hidden shipping insurance surcharges, false reference pricing, and deceptive advertising of over-the-counter drug products. The statute explicitly prohibits any “unlawful, unfair or fraudulent business act or practice,” as well as “unfair, deceptive, untrue or misleading advertising.” The basis for the class action lawsuit against Walgreens is that the pharmacy allegedly sells the Phenazo product in a manner that is likely to deceive the public about whether the drug is approved by the FDA and therefore lawful to sell over the counter.
Importantly, the UCL is a strict liability statute. This means that the plaintiff in a UCL claim does not need to show that the defendant intentionally or negligently engaged in fraudulent business practices; all that is needed is a showing that the unfair practice or act occurred. In other words, anyone who purchased an over-the-counter UTI drug product from Walgreens may be entitled to multiple forms of compensation, including restitution, statutory damages, and punitive damages.
Did You Purchase a UTI Drug at Walgreens? Call the California Consumer Protection Lawyers at Tauler Smith LLP
The California consumer protection lawyers at Tauler Smith LLP have filed a class action lawsuit against Walgreens over the sale of Phenazopyridine as an over-the-counter treatment for urinary tract infections. The proposed class of consumers eligible for the lawsuit includes anyone who purchased the Walgreens UTI product in California during the last four (4) years.