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The makers of certain generic Avapro hypertension drugs face a class action lawsuit, over an irbesartan recall issued in October amid concerns that pills may be contaminated with a potentially cancer-causing impurity.
Barbara Kruk filed a complaint (PDF) earlier this month in the U.S. District Court for the Middle District of Florida, seeking class action status against Aurobindo Pharma, Ltd., Sciegen Pharmaceuticals, Inc., Westminster Pharmaceuticals, Inc. and Walmart.
According to the lawsuit, the companies sold generic Avapro (irbesartan) for years that was contaminated with a known human carcinogen, N-nitrosodiethylamine (NDEA). Not only were thousands of consumers bilked into buying a useless and potentially dangerous medication, but the complaint indicates that they must now undergo life-long medical monitoring due to the increased risk of lung, kidney and other forms of cancer.
In late October, the FDA announced an irbesartan recall after trace amounts of NDEA were found in products from the manufacturers. The contaminated active ingredients were manufactured by Aurobindo Pharma.
NDEA occurs naturally in certain foods and drinking water, but can be created as a byproduct of industrial processes, which is what the FDA believes occurred in this instance and with a spate of related valsartan recalls linked to the presence of a similar impurity, N-nitrosodimethylamine (NDMA). Both are considered probably cancer-causing agents by the International Agency for Research on Cancer (IARC).
The lawsuit notes that there were no such impurities in the original brand-name Avapro, and points out that generic drug manufacturers’ products are approved with the requirement that they be “therapeutically equivalent” to the original brand-name drug.
The lawsuit also notes the FDA has inspected Aurobindo’s manufacturing facility in India a number of times in recent years and has repeatedly found quality control and sanitation concerns, resulting in “Form 483” citations for conditions that violate FDA regulations.
“The FDA’s April 2017 inspection revealed that Aurobindo was, at the time of that inspection, failing to maintain its facilities in an acceptable state and failing to maintain its manufacturing equipment in an appropriate state, that Aurobindo’s laboratory controls did not include appropriate test measures, and that Aurobindo’s batch distribution processes were not the subject of thorough reviews,” Kruk’s lawsuit states. “In February, 2018, the FDA returned for another investigation of Aurobindo’s Hyderabad manufacturing plant. As a result of this follow-up investigation, the FDA issued Aurobindo with another Form 483, repeating the same quality-control concerns—unsanitary equipment, as well as, notably, the presence of mosquitos in close proximity to drug product—that could alter the safety, identity, strength, quality, or purity of its manufactured drug product.”
The plaintiffs seeks class action status for all consumers who purchased and used the recalled drugs, seeking reimbursement for their purchases, as well as the cost of future medical monitoring.
The manufacturing problems with irbesartan emerged only a few months after similar issues were discovered with the generic hypertension drug valsartan, which was distributed by other manufacturers with the carcinogenic impurity N-nitrosodimethylamine (NDMA).
The first valsartan problems surfaced on July 5, after European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals tested positive for NDMA. The FDA followed with its own recall announcement days later, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.
In September, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals, after an inspection report outlined a number of serious manufacturing problems at the company’s facility in late August. In the same month the FDA indicated that NDEA also appeared to be an impurity in some drugs, and warned that the recalls may expand to other hypertension medications.
A month later, the irbesartan recall was announced.
In addition to the complaint filed by Kruk, a number of valsartan recall class action lawsuits have been filed nationwide, with many seeking damages for the cost of future medical monitoring for individuals who may face a continuing risk of developing cancer.
For individuals diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, valsartan injury lawsuits are also being reviewed by product liability lawyers.