Valsartan is an off-patent component of several commonly prescribed drugs used to treat high blood pressure and heart failure. An impurity, N-nitrosodimethylamine (NDMA), has been found in some batches and is known to pose a cancer risk. The contamination is believed to be a result of a defect in the manufacturing process and may have been happening since 2012.
On the health side, people who take blood pressure and heart medications should check the bottle and prescription insert. If your medications contain valsartan, you should consult your doctor for medical advice about what to do next. Not all drugs containing valsartan are contaminated, but the contaminated drugs appear to be dangerous.
On the legal side, the important thing to know is that people who have developed or are at risk for developing cancer, liver damage or tumors are mobilizing for lawsuits in Canada and the U.S.
Valsartan recall list
The contamination was first thought to have occurred only in drug products manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China and Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals. Since then, Zhejiang Tianyu Pharmaceuticals, Taizhou, China also appears to be implicated. It is not clear that the level of contamination is the same from all sources, but information continues to develop.
The sixteen manufacturers (some of whom made and marketed more than one valsartan-containing drug) named in the August 27 notice include:
• Teva Pharmaceuticals labeled as Major Pharmaceuticals;
• Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC.;
• Teva Pharmaceuticals USA labeled as Actavis;
• AvKARE (Teva/Actavis);
• RemedyRepack Inc. (Prinston/Solco);
• A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco);
• Bryant Ranch Prepack Inc. (Teva/Actavis);
• H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco);
• Northwind Pharmaceuticals (Teva/Actavis);
• Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc;
• NuCare Pharmaceuticals Inc. (Prinston/Solco);
• RemedyRepack, Inc. (Hetero/Camber);
• AvKARE (Hetero/Camber);
• Preferred Pharmaceuticals, Inc. (Hetero/Camber);
• Torrent Pharmaceuticals Limited; and
• RemedyRepack, Inc. (Torrent).
More than 20 European countries, Canada, and the United States have recalled valsartan medications after NDMA was discovered in the active pharmaceutical ingredients.
NDMA is an organic chemical that forms in both industrial and natural processes and has been used to make liquid rocket fuel, softeners and lubricants, among other products. It is “reasonably anticipated” to cause cancer in humans, according to the U.S. Department of Health and Human Services. In addition, the Environmental Protection Agency reports that exposure to high levels of NDMA may cause liver damage. The products recalled in July and August 2018 contained higher than acceptable NDMA levels.
The risk of adverse health consequences appears to be dependent on two things: the size of the dosage and the length of exposure. The European Medicines Agency estimates that there will be one extra case of cancer for every 5,000 patients taking valsartan at the highest dose of 320 mg every day for seven years. Early studies do not appear to calculate the effect of smaller doses or longer periods of latency.
Class Action Lawsuits
Requests to launch a class-action lawsuit against pharmaceutical companies over valsartan were filed in Canadian courts in mid-July. In the U.S., litigation arising out of the recalls is in similarly early stages.
A class action lawsuit filed in the Southern District of New York on August 16, 2018 may, however, hint at things to come. The Complaint, on behalf of two individuals and others similarly situated, names Solco Healthcare, Prinston Pharmaceutical, Walgreens and Throggs Neck Pharmacy – the drug’s manufacturers, distributors and the retailers responsible for selling the prescriptions.
The Complaint alleges that plaintiffs were misled, and that valsartan-tainted drugs are worthless because they are contaminated with a carcinogen and are not fit for human consumption. Further, the lawsuit seeks damages for injuries sustained in consuming high levels of an acutely-toxic substance. The twelve counts include several related to breaches of warranty; deceptive representations about the drug’s safety; false advertising; fraud; strict liability for a manufacturing defect; negligence; and battery for the physical harm caused to the plaintiffs.
It is a comprehensive lawsuit that differs from more familiar bad drug cases because it is about a contaminated product rather than the unintended side effects of an approved drug. The plaintiffs’ bar will certain be watching closely as the lawsuit proceeds through likely settlement negotiations and litigation. This may be a harbinger of other valsartan cancer risk lawsuits to come.