We all know that doctors prescribe Valsartan to patients battling high blood pressure. This medication has undoubtedly proven highly effective in managing hypertension. It also improves overall cardiovascular health.
Do you know that numerous Valsartan medication lawsuits have emerged? These lawsuits aim to recover damages for individuals and companies affected by the contaminated drugs. Strict quality control must be applied to pharmaceutical production to ensure patient safety and medication trust.
What Is Valsartan?
Valsartan is a medication used alone or in combination with other drugs to treat hypertension. In the U.S., it is sold under brand names such as Diovan and Prexxartan. Several legal generic versions are available as well. The drug valsartan acts as an angiotensin II receptor blocker (ARB). It prevents blood vessels from tightening in the body and lowers blood pressure.
Now the question arises why is high blood pressure a concern? High blood pressure forces the heart, arteries, and other organs to work harder, leading to increased risks such as:
- Heart failure or heart attacks
- Stroke
- Kidney failure
- Pooling of blood in the lungs
In addition to reducing blood pressure, Valsartan increases oxygen supply to the heart, brain, and other organs. Primary Uses of Valsartan include:
- Lower high blood pressure (hypertension)
- Treat heart failure
- Reduce hospitalization risk from heart failure
- Improve post-heart attack survival rates
- Manage diabetic kidney disease
Patients must be eager to know about the workings of this drug. So, here it is. Valsartan actually relaxes blood vessels. Consequently, this reduces blood pressure and increases blood and oxygen supply to the heart. The medication begins working almost immediately. About two hours after intake, it starts lowering blood pressure. It reaches full effectiveness within two to four weeks.
Now let’s talk about the Side Effects of Valsartan. Common side effects include:
- Fatigue and dizziness
- Fever
- Body aches
- Abdominal pain
- Headaches
- Diarrhea
- Back or joint pain
- Rashes
It is noteworthy that the most serious side effects can occur in patients with pre-existing kidney disease.
Novartis markets Valsartan, which was first approved by the US Food and Drug Administration in 1996 under the brand name Diovan. After the patent expired in 2012, generic versions were produced, primarily overseas. Nearly two dozen pharmaceutical companies manufacture Valsartan-containing ARBs.
The FDA recalled many generic versions due to unacceptable levels of impurities in 2019. This led to the FDA fast-tracking a new generic version to mitigate shortages caused by these recalls.
Millions of people use Valsartan, especially its generic forms, to manage high blood pressure and associated conditions. Its comprehensive angiotensin II antagonism offers significant
benefits in treating hypertension. It also provides notable advantages in managing heart failure and diabetic kidney disease.
Why Are Valsartan Medication Lawsuits Filed?
There have been numerous Valsartan lawsuits filed after contaminated batches of the drug were discovered. As of 2024, over 1,400 cases have been filed, with the first bellwether trial scheduled for 2022. The case has seen notable developments including Retired judges appointed for settlement negotiations.
Manufacturers attempting to exclude expert testimony. Three classes of plaintiffs were certified in December 2023. An MDL is not similar to a class action lawsuit. In an MDL, lawsuits are pursued independently. A win for the initial lawsuit does not guarantee similar results in later trials.
Valsartan lawsuits have been filed due to the contamination of Valsartan-based drugs with N-nitroso dimethylamine (NDMA) and N-nitroso diethylamine (NDEA). The FDA discovered the contamination in 2018 and estimated that 1 in 8,000 people could develop cancer due to these drugs. Patients are seeking compensation for medical bills and suffering, as well as for loss of quality of life. Moreover, third-party payors are seeking compensation for unsafe products.
ARE YOU AWARE?
The Environmental Protection Agency (EPA) states that NDMA is not currently produced in pure form or commercially used in the United States, except for research purposes.
What Are the Latest Updates on the Valsartan Medication Lawsuit?
July 2018: Some generic versions of valsartan are recalled due to potential cancer-causing impurities. As a result, this leads to investigations and lawsuits.
March 2022: Judge Kugler appointed retired judges Gregory M. Sleet and Lawrence F. Stengel to negotiate valsartan settlements.
December 2022: Judge Kugler denied the defendant’s motion to exclude expert testimony. The judge allowed the trials to proceed with scientific evidence linking contaminated valsartan to cancer.
January 2023: Approximately 1,072 ongoing valsartan lawsuits.
February 2023: Judge Kugler certified multiple MDL classes against manufacturers and distributors/retailers of cancer-causing valsartan pills. In addition, MDL plaintiffs requested medical monitoring.
April 2023: The Third Circuit Court denied the defendant’s motion for interlocutory appeal of Judge Kugler’s Class Certification ruling. Hence, allowing economic cases to proceed at the end of 2023 or early 2024.
July 2023: 1,223 cases pending in MDL 2875.
August 2023: 1,230 cases pending in the MDL.
October 2023: U.S. Magistrate Judge Singh signed a pretrial scheduling order on Oct. 19. The deadline for fact discovery is 30 Sept 2024, with a telephone status conference scheduled for 22 Jan 2024.
December 2023: The judge in the Valsartan MDL has certified three classes: Consumer Economic Loss, Medical Monitoring, and Third Party Payor (TPP), along with some subclasses. No decision yet on the Defendant’s wrongdoing or the Plaintiff’s injury claimed.
February 2024: Motions filed to exclude certain experts from depositions and plaintiffs’ fact sheets.
May 2024: Plaintiff’s attorneys requested a status conference with Judge Renee M. Bumb.
DO YOU KNOW?
About 3 million people in the U.S. take valsartan each year, and over 1 million may have taken contaminated versions in 2018. More plaintiffs are expected as the litigation progresses.
What was the Valsatran Response?
The Valsartan lawsuit involves around 20 companies, with Hetero Labs and Zhejiang Huahai Pharmaceutical Co., Ltd. being the primary defendants. Companies that created uncontaminated Valsartan drugs (Novartis) have accelerated the lawsuit. Other generic Valsartan drug companies have also avoided being named. In addition, during the pre-trial process, companies have also challenged expert evidence.
Defendants in Valsartan lawsuits include:
- Actavis LLC
- A-S Medication Solutions LLC
- AvKARE Inc.
- Bryant Ranch Prepack Inc.
- Camber Pharmaceuticals Inc.
- Hetero Labs Ltd.
- H.J. Harkins Company Inc. (Pharma Pac)
- Major Pharmaceuticals
- Northwind Pharmaceuticals
- NuCare Pharmaceuticals Inc.
- Preferred Pharmaceuticals
- Prinston Pharmaceutical Inc.
- RemedyRepack Inc.
- Solco Healthcare, U.S. LLC
- Teva Pharmaceutical Industries Inc.
- Teva Pharmaceuticals USA Inc.
- Throggs Neck Pharmacy
- Torrent Pharmaceuticals
- Walgreens
- Zhejiang Huahai Pharmaceutical Co. Ltd.
How to File a Valsartan Medication Lawsuit?
If you took Valsartan and were later diagnosed with cancer, you might be eligible for a lawsuit. But first, let’s break down what that means and how the process works. Valsartan is a drug used to treat high blood pressure and heart failure. Surprisingly, from 2014 to 2018, about three million people took it.
However, only about a third were exposed to contaminated versions. That contamination is key because it contains a carcinogenic substance linked to certain cancers and liver injuries. So, what does it take to qualify for a Valsartan lawsuit? Here are the main criteria:
- You took Valsartan, or a combination of Valsartan with HCTZ and Amlodipine, for at least six months between 2015 and 2018.
- You used Valsartan for at least six months before your cancer diagnosis.
- Your cancer diagnosis came after 2017.
- You have not hired an attorney for this specific issue.
Your diagnosis is for a type of cancer associated with Valsartan contamination. This includes colorectal, intestinal, stomach, liver, esophageal, prostate, blood, bladder, and lung cancer.
Therefore, it is likely to act quickly, because you need to file within your state’s statute of limitations. An attorney can help you determine your eligibility and navigate the process. Moreover, they will file a lawsuit in your state. They are seeking to join the Multi-District Litigation (MDL) as well.
Is there anything else you need to do? Certainly, you need to gather medical records. You also need to collect proof of Valsartan use and obtain cancer diagnosis details. Thus, contact an attorney as soon as possible to discuss your options.
What is the Possible Compensation from a Valsartan Lawsuit?
Valsartan lawsuits can result in compensation for injuries and financial losses. Settlements typically cover medical costs, lost wages, and ongoing care related to cancer treatment. If a long-term or permanent disability impacts an individual’s ability to work, they may be entitled to compensation. This compensation may include:
- Loss of future earning potential
- Physical pain
- Mental stress
- Decreased quality of life due to serious side effects
We have already mentioned that an experienced attorney can help navigate the process and fight for fair compensation. In addition, surviving family members may have grounds for a wrongful death lawsuit in tragic cases. Compensation for product liability cases depends on the degree of harm the plaintiff has endured.
Those with advanced cancer may be eligible for great compensation. This compensation can cover extensive medical treatments. It can also cover lost income and related expenses. Plaintiffs, however, will not be compensated if manufacturers or other responsible parties receive a trial verdict or settlement. Therefore, a skilled attorney is crucial to building a strong case and protecting your rights.
Has a Recall Been Issued for Valsartan?
Here is a timeline summarizing key events related to the recall of contaminated valsartan:
| DATE | EVENT |
| July 2015 | The recall began after NDMA was detected in multiple batches of valsartan. |
| May 2018 | European Medicines Agency started reviewing medicines containing valsartan from Zhejiang Huahai Pharmaceuticals due to NDMA detection. |
| August 2018 | FDA announced recalls of valsartan from Zhejiang Huahai and Hetero Labs. |
| November 2018 | Teva Pharmaceuticals recalled combination tablets after detecting NDEA. |
| 2018 (general) | FDA issued a recall of all NDMA and NDEA-contaminated drugs. |
| Since 2018 | Numerous Valsartan/Amlodipine/HCTZ tablets have been recalled for contamination with NDMA, NDEA, and NMBA. |
Final Words
Hence, we can conclude that the wrong conditions can make any drug dangerous. Likewise, Valsartan can cause serious complications, such as breathing difficulties and dangerous swelling, especially in people with kidney disease. These are known side effects and are considered acceptable risks given the drug’s potential life-saving benefits.
However, the presence of a carcinogen in Valsartan is different because the drug can be made without this harmful substance. This issue has led to over 1,000 active Valsartan medication lawsuits in the U.S. The legitimacy of these claims has yet to be determined. In a few months, the first case going to trial will provide answers. Current and potential claimants are expected to have a better understanding of these concerns by the end of 2024.