US supermarket giant Walmart and three pharmaceutical companies have been sued by a class action suit which alleges the “cheap” Indian-made blood pressure and diabetes drug they sold was contaminated in dirty factories covered in flies—and unwitting US users now face an increased risk of cancer and disease.
According to the suit filed this week in a Florida federal court, Walmart and the three companies—named as Aurobindo Pharma, ScieGen Pharmaceuticals and Westminster Pharmaceuticals, “contributed to the production and sale of impure drugs.”
The drugs, known as irbesartan tablets, contain a probable human carcinogen, N-nitrosodiethylamine, the suit claims. Irbesartan was recently was recalled by some U.S. manufacturers concerned about the impurity.
The lawsuit contends that consumers were injured by paying the full price for their medication containing the tainted medication and by paying for incidental medical expenses.
“These medications are worthless because they are contaminated with carcinogenic and harmful NDEA and are thus not fit for human consumption,” the lawsuit charges.
The batches of irbesartan were contaminated due to manufacturing defects at generics manufacturer Aurobindo Pharma’s production facility in India, according to the U.S. Food and Drug Administration (FDA).
“These generic equivalents, such as irbesartan, are supposed to be of equal quality and equal safety as the brand-name drugs,” the complaint states. “These medications are worthless because they are contaminated with carcinogenic and harmful NDEA and are thus not fit for human consumption.”
The contaminated product was revealed to the public after FDA recalls were released in late October, with the first one announcing that Aurobindo recalled 22 batches of the active pharmaceutical.
A few days later, pill manufacturer ScieGen Pharmaceuticals and distributor Westminster Pharmaceuticals, also defendants in the case, announced recalls of their own.
“The recall of irbesartan tablets was unexpected but initiated with public health and safety at the forefront of this decision,” Westminster CEO Gajan Mahendiran said in an Oct. 30th statement.
Westminster manufactured, labeled and packaged the drug in Florida before shipping the product nationwide to Walmart.
The FDA found in April 2017 that Aurobindo failed to keep its facility and manufacturing equipment in Hyderabad, India, in an appropriate state and that its laboratory controls and batch distribution process were also subpar.
A further review in February showed that the plant continued to suffer from the same problems, notably mentioning dirty equipment and the presence of “vermin, including rodents and insects, in building used for manufacturing, packaging and storage.”
The complaint says more than 100 predicted class members who purchased the contaminated pills face an increased risk of cancer and disease. The companies have been accused of negligence, breach of contract, strict product liability and violation of Illinois consumer protection laws.
“The plaintiff and the putative class members purchased medication that was adulterated and they never would have purchased it had they known that the medication was adulterated,” the consumers’ counsel John Sawin said. “Millions, possibly tens of millions of dollars were spent purchasing this medication.”
This is not the first time that “cheap” India-made drugs have proven problematic. A May 2017 report revealed that it was unknown “how much more worse it can get . . . Practically no one in the West believes clinical trial data from India,” and that at least 45 manufacturing facilities in India are under some type of regulatory action from the FDA.
An American Enterprise Institute report from 2013 revealed that “companies in developing countries are increasingly falsifying data about the quality of their medicines.”
“Indian producers in particular strive to reduce costs by substituting cheaper ingredients or skimping on good manufacturing practice . . .”
A 2014 report found that “US investigation has found consumers may not be getting what they bargained for in some generic imports from India,” even though India’s pharmaceutical industry supplies 40 percent of generic prescription drugs consumed in the US.
Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty and paid a US$500 million penalty for distribution of adulterated medicines between 2004 and 2007.
The FDA reports refer to plants with “flies too numerous to count”, fudged test results, defective storage for sensitive equipment and samples in pools of water from melting ice. One drug company executive pleaded with the FDA to allow his products into the US so that he could more easily pay for fixes.
Some drug manufacturing in India and other emerging economies is global best practice. Other production is both shoddy and dangerous. The World Health Organization, for example, estimates that one in five drugs in the Indian market are fakes.
The official Drug Controller General of India (DCGI), G N Singh, told India’s largest business newspaper, the Business Standard, that the Indian drug industry would “collapse” if forced to comply with the “stringent norms followed elsewhere.”
In answer to a question about the Raxanaby case, Singh told the newspaper that “…[O]ur society and our economy are different from those in the US. If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country.”