A class-action lawsuit has been filed against a pharmaceutical company in New Jersey for recalling millions of capsules of a commonly prescribed cardiac drug that may have presented significant health concerns.
Glenmark Pharmaceuticals Inc., USA, with its headquarters in Mahwah, is accused of marketing faulty potassium chloride capsules that did not dissolve correctly in the body. The action was filed in federal court in Newark.
On or around June 25, 2024, Glenmark recalled 114 batches of the capsules nationally after the U.S. Food and Drug Administration reported that the product did not pass dissolving tests.
The recall was placed in the FDA’s most dangerous Class I category, which denotes a risk of death or serious damage.
The medication is frequently used to treat low potassium, or hypokalemia.
The action is being led by Martha Brewton, a citizen of Alabama, who bought the drug for herself and other patients in her state.
She claims that her pharmacy informed her that the medications she was given were included in the recall.
The FDA and Glenmark have stated that the capsules may release potassium too rapidly, which could result in dangerously elevated potassium levels, irregular heartbeats, and cardiac arrest, particularly in patients with kidney or heart disorders.
According to the complaint, Glenmark’s medication was actually a rapid-release medication more suited for an execution rather than the extended-release medication the business had assured patients of.
In addition, Brewton’s lawsuit claims it wants to combine with a previous action that claimed Glenmark’s faulty potassium chloride capsules injured thousands of patients across the country and killed a woman in Maine.
Brewton alleges that by claiming the capsules met U.S. Pharmacopeia standards, which are meant to guarantee drug quality and safety, Glenmark deceived physicians, pharmacies, and patients.
The case contends that the medications should never have been sold since they were virtually worthless.
It also highlights Glenmark’s past manufacturing problems.
According to the complaint, the business has issued over 60 medicine recalls and received numerous FDA warning letters since 2019 for issues ranging from contamination to incorrect labeling.
For herself and other Alabamans who purchased the recalled medications or possibly defective but unreported ones, Brewton is pursuing damages.
The lawsuit charges Glenmark of violating Alabama’s consumer protection statutes, fraud, and breach of promise.
A request for comment was not immediately answered by Glenmark.
Max Marks, Aaron Block, and Roshan D. Shah, Brewton’s lawyers, declined to comment on the case.
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