When you take a prescription medication, you trust that it will improve your health and well-being.
But what if the very drug meant to protect your heart was secretly putting you at risk of developing cancer?
This situation is the alarming reality faced by countless patients who took contaminated valsartan, a common medication to control blood pressure.
In 2018, the discovery of cancer-causing impurities in specific batches of valsartan sent shockwaves through the medical community and sparked a wave of lawsuits against the drug's manufacturers.
As the litigation unfolds in 2024, more and more patients are coming forward to share their stories and seek justice for the unimaginable harm they've suffered.
What Exactly is Valsartan?
Valsartan is a commonly prescribed medication used to treat high blood pressure (hypertension).
It belongs to a class of drugs called angiotensin II receptor blockers (ARBs), which work by blocking a substance that causes blood vessels to tighten, thereby improving blood flow and reducing strain on the heart.
Pharmaceutical companies sell valsartan under several brand names, such as:
- Diovan
- Prexxartan
- Several generic valsartan
While it has been effective in managing hypertension for many patients, recent discoveries have uncovered a troubling link between certain contaminated batches of the drug and an increased risk of being diagnosed with cancer.
Risks Lurking in Contaminated Valsartan
In July 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several valsartan-containing products after detecting the presence of a probable carcinogen, N-nitrosodimethylamine (NDMA).
Further testing also revealed another potentially cancer-causing impurity, N-nitroso diethylamine (NDEA), in some valsartan medications.
These contaminated batches were traced back to two overseas manufacturers:
- Zhejiang Huahai Pharmaceutical Co. Ltd. in China
- Hetero Labs in India
The FDA later estimated that for every 8,000 people taking the highest dose of contaminated valsartan daily for four years, there would be one additional case of cancer.
While this may seem like a small risk, the sheer number of patients exposed to these tainted drugs over several years has raised serious concerns.
Who's Been Affected by Contaminated Valsartan?
The impact of the valsartan contamination is far-reaching.
The FDA estimates that over 1 million patients may have been exposed to contaminated valsartan between 2014 and 2018 in the U.S. alone.
Many of these individuals have since been diagnosed with various types of cancer, including:
- Liver cancer
- Stomach cancer
- Colorectal cancer
- Bladder cancer
For patients who took valsartan to manage their high blood pressure, learning that their medication may have caused their cancer diagnosis has been a devastating blow.
The physical, emotional, and financial toll is immense, so many victims are now seeking help from the legal system.
Holding the Responsible Parties Accountable
So, who's to blame for the valsartan contamination crisis?
The primary defendants in the growing number of valsartan cancer lawsuits are the two overseas manufacturers, Zhejiang Huahai Pharmaceutical Co. Ltd. and Hetero Labs.
However, plaintiffs have named other companies involved in the drug's supply chain in separate litigation, including distributors and retailers.
At the heart of these legal claims are allegations that the defendants failed to monitor and test for impurities in their valsartan products properly.
This apparent breach of duty allowed carcinogenic substances to make their way into medications intended to improve patients' health, not put them at risk of developing cancer.
Valsartan lawsuit timeline
- July 2018: The FDA announces a voluntary recall of several valsartan-containing products after detecting the presence of a probable carcinogen, N-nitrosodimethylamine (NDMA).
- 2018: The first valsartan lawsuits are filed shortly after the FDA's recall announcement, as patients learn of the potential link between their cancer diagnosis and contaminated valsartan.
- February 2019: The U.S. Judicial Panel on Multidistrict Litigation consolidates all federally filed valsartan lawsuits into a multidistrict litigation (MDL) in the District of New Jersey.
- Early 2023: The first bellwether trial, which will serve as a test case for the larger group of plaintiffs, is initially set to begin but is pushed back due to delays related to the COVID-19 pandemic and other factors.
- 2024 Update: Valsartan lawyers have filed over 1,400 cases in the Valsartan MDL as the litigation unfolds.
The outcome of the bellwether trial will likely have a significant impact on how the remaining valsartan cases proceed.
Current Status of the Valsartan Recall
In response to the discovery of NDMA and NDEA contamination, the FDA has overseen a widespread recall of affected valsartan medications.
It's important to note that the Agency did not include all valsartan products in the recall - only those found to contain unacceptable carcinogenic impurity levels.
Government recall list
The FDA maintains an updated list of tainted valsartan products on its website and includes information to help patients identify whether their medication is in the recall.
If you're taking valsartan, check this list and consult your doctor about alternative treatment options if necessary.
What's Next for Valsartan Plaintiffs?
As valsartan cancer litigation progresses in 2024, affected patients and their families remain hopeful that the courts will hold the responsible parties accountable for the disregard for patient safety that allowed contaminated valsartan to cause harm to countless individuals.
Beyond seeking individual justice, the Valsartan class action lawsuit also serves as a powerful reminder of the importance of strict oversight and rigorous safety standards in the pharmaceutical industry.
By shining a light on the failures that led to this crisis, the litigation can drive meaningful change and prevent similar tragedies from occurring in the future.
Add Comment