Glenmark Hit with Class Action Lawsuit After Potassium Chloride Capsule Recall

New to ClassAction.org? Read our Newswire Disclaimer

A proposed class action lawsuit alleges Glenmark Pharmaceuticals falsely advertised the safety of its potassium chloride extended-release capsules prior to recalling the widely used drug last year due to a risk of serious adverse health effects or death.

Want to stay in the loop on class action lawsuits that matter to you? Sign up for ClassAction.org’s free weekly newsletter.

The 22-page lawsuit states that on June 25, 2024, the FDA announced that Glenmark would voluntarily recall 114 batches of potassium chloride capsules that the company said failed to meet dissolution rate standards. The FDA and New Jersey-based Glenmark stated that the failure of potassium chloride capsules to dissolve could cause high potassium levels, a condition known as hyperkalemia, which could cause an irregular heartbeat that may result in cardiac arrest.

The potassium chloride recall was designated Class I by the FDA, meaning that, were the capsules to remain in circulation, there would exist “a reasonable probability that the use of, or exposure to, [the recalled product]… will cause serious adverse health consequences or death,” the complaint relays. Per the lawsuit, potassium chloride is one of the most commonly prescribed medicines nationwide.

The recall announcement states that patients who require chronic use of potassium chloride extended-release capsules, particularly those with underlying comorbidities or conditions such as hypertension, renal dysfunction or heart failure, face a “reasonable probability” of developing hyperkalemia. The condition may spark potentially life-threatening health events such as cardiac arrythmias, severe muscle weakness and death, the filing relays.

“In other words,” the case states, “the most typical patients—those who depend on Glenmark every day to manage chronic conditions—are the most vulnerable to ‘severe potential life threatening adverse events’ and death.”

The lawsuit alleges that the dissolution rate defect for which the capsules were eventually recalled was likely present for several years, either disregarded or undetected by the company. It claims that Glenmark also likely sold similarly adulterated potassium chloride that was not included in the recall because it had already expired by the time the defects became publicly known.

Per the suit, these dangerous defects render the “adulterated” potassium chloride capsules completely worthless. According to the lawsuit, based on the size and expiration date range, the “dissolution defect” was likely present, “and either undetected or disregarded,” for several years.

“Glenmark’s overall course of conduct shows that it has chronically and systematically chosen to put its own profits ahead of patient health and safety,” the class action lawsuit scathes, noting that the company “been forced to undertake” more than 60 other recalls, affecting tens of millions of pills for quality-control problems, in recent years.

The complaint additionally claims that, until the recall, Glenmark continued to falsely advertise that the capsules were USP-compliant in naming, packaging and marketing materials even though the products did not meet the requisite USP minimum dissolution time standards or comply with the FDA’s Current Good Manufacturing Practice (CGMP) regulations.

Without these representations, the drug would not have been bought or sold by distributors, pharmacies and pharmacists, nor prescribed by physicians, the case argues. Similarly, consumers expect that the medicines they are prescribed and sold are effective and safe for their use, the filing stresses.

The class action suit also alleges that it is likely that Glenmark sold adulterated potassium chloride left out of the recall “because it had already expired by the time Glenmark’s defects became public.”

The Glenmark class action lawsuit seeks to represent anyone in Alabama who purchased the potassium chloride extended-release capsules that were recalled over failed dissolution standards or that similarly failed to meet applicable USP, CGMP and therapeutic equivalence requirements but was not recalled.

Learn all about the legal process: What is a class action lawsuit?