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Our lawyers can help you bring a Valsartan cancer lawsuit in all 50 states.
Valsartan is a popular blood-pressure drug used by millions of people in the U.S. and sold under the brand names Diofan and Exforge. But Valsartan was recalled after it was discovered that the drug was contaminated with dangerously high levels of a carcinogenic chemical called NDMA.
This has prompted thousands of Valsartan lawsuits by individuals who developed certain types of cancer after prolonged use of Valsartan.
Our law firm handles valsartan cancer lawsuits in all 50 states. We are still taking new claims. If you used Valsartan for an extended period, it may have significantly increased your chance of developing certain types of cancer. Get a free online consultation or call our lawyers at 800-553-8082.
Valsartan News and Updates 2024
Below are updates from the Valsartan MDL:
October 28, 2024 – The First Valsartan Lawsuit to Go to Trial (seriously this time)
October 20, 2024 – New and Probably Smarter Plan
The U.S. District Judge overseeing federal Valsartan lawsuits has postponed the first bellwether trial, originally set to begin this month. The first trial was set to be a third-party payor claim, which is a claim without an actual personal injury plaintiff who was diagnosed with cancer. That never really made a ton of sense and the judge is belatedly fixing it. The new plan is to select a new personal injury case for the first trial, involving a plaintiff diagnosed with cancer after exposure to recalled Valsartan.
October 1, 2024 – MDL Cases Totals
In September, just six new cases were added to the Valsartan class action MDL, bringing the total number of pending cases to 1,270.
September 9, 2024 – Where the Fees for Sanctions against ZHP Will Go?
Plaintiffs were awarded monetary sanctions against ZHP, totaling $309,130 in attorneys’ fees and $41,399.20 in costs, for time spent addressing issues related to the Baohua Chen deposition and missing document production. These funds are intended for the reimbursement of common benefit time rather than work on any individual plaintiff’s case.
As a result, plaintiffs’ lawyers plan to file a motion requesting that the awarded fees and expenses be designated as common benefit reimbursement, to be managed by the Plaintiffs’ Executive Committee for the benefit of all plaintiffs involved.
September 8, 2024 – Trial Length
Plaintiffs’ attorneys are concerned that the current trial schedule (3.5 weeks) is inadequate due to the complexity of the case. They propose starting the trial earlier or allowing more time to accommodate witness testimonies and defense arguments.
September 3, 2024: 7 New Cases Added to MDL
Only 7 new cases were added to the Valsartan MDL during the last month. That brings the total number of pending case in the MDL up to 1,264.
August 26, 2024: Modifications to Special Master Order No. 100
After reviewing the motions and the Special Master’s findings de novo, the court made the following decisions: Zhejiang Huahai Pharmaceutical’s motion was denied, while the plaintiffs’ motion was granted in part and denied in part. Additionally, the motions filed by Teva and Torrent were granted, as we predicted in our August 3 update.
The jury instructions were altered to address issues related to the deposition of Baohua Chen, President of Zhejiang Huahai Pharmaceutical, who did not appear for a deposition as ordered by the court. The revised instructions allow the jury to infer that Chen’s deposition testimony might have been unfavorable to the defendants, especially regarding their knowledge of the contamination in Valsartan, a key issue in the case. See the July 24 update below for more on the order.
August 20, 2024: Hearing
There is a hearing on Friday to resolve various disputes between the parties.
August 15, 2024: Trial Is Focus
This litigation is now focused on the first bellwether trial in November.
August 5, 2024: Zhejiang Tries to Fight Sanctions Ruling
Zhejiang Huahai Pharmaceutical is having a freak out of the sanctions order, manifested in a 31 page motion.
The gist of their argument is that the jury should determine the appropriateness of the discovery violations, which contradicts the court’s prior conclusive rulings on these issues.
It also argues that the impact of these sanctions will complicate the legal proceedings and might necessitate a mini-trial on matters already settled by the court, thus potentially prolonging the litigation and detracting from the main issues at trial. The logic of why that would be is a little confusing.
The could will hold a hearing on September 3 to hear ZHP out. But I would bet against it. The court did not sanction this defendant lightly. You do not issue that type of order unless you have thought how to best address ZHP’s non-compliance.
August 3, 2023: Correcting the Record
Defendants Teva Pharmaceuticals, Actavis and Torrent are requesting a minor revision to the adverse inference jury instruction related to Zhejiang Huahai Pharmaceutical that we discussed in the July 24 update.
This instruction was part of the sanctions imposed on ZHP due to their failure to make Baohua Chen, ZHP’s CEO, available for a deposition as ordered by the court. The existing instruction allows the jury to infer that Mr. Chen’s absent testimony would have been unfavorable to the defendants if they find he could have been produced and his testimony would have been relevant.
Teva and Torrent are specifically requesting that references to “defendants” in the jury instruction be changed to “ZHP” to prevent confusion and potential prejudice against them, as they were not involved in the discovery disputes that led to this sanction against ZHP.
This motion should be and will be granted.
August 2, 2024: Valsartan MDL Case Count
The Valsartan, Losartan, and Irbesartan Products MDL-2875 experienced a slight percentage increase in active cases from July to August 2024. The number of active cases is now 1,257, up three from last month. This is mature litigation that is unlikely to have any big jumps in case counts.
July 24, 2024: Big Valsartan Sanctions Ruling
The court finally addressed the sanctions motion against Zhejiang Huahai Pharmaceutical Co., Ltd. (ZHP) for violating discovery orders. ZHP failed to comply with orders to produce documents and allow the deposition of its CEO, Baohua Chen.
It was worth the wait. Of course, the MDL judge did not grant the harshest penalties, such as default judgment, but will instruct the jury that they may infer the missing testimony and documents would have been unfavorable to ZHP. That is huge for plaintiffs.
Two key jury instructions come out of this that the judge has already written out:
- Jury Instruction on Missing Testimony: The jury will be instructed that they may infer that Baohua Chen, CEO of ZHP, ‘s missing deposition testimony would have been unfavorable to the company. This inference is based on the assumption that Mr. Chen’s testimony would have provided relevant information regarding ZHP’s handling of the contamination and recall of its Valsartan product.
- Jury Instruction on Missing Documents: The jury can also infer that missing documents, including a crucial email and internal report about contamination, would have been unfavorable to ZHP. The jury can consider whether these documents were under ZHP’s control and relevant to the case.
The presumption that the missing testimony and documents would have been unfavorable to ZHP is a significant advantage for the plaintiffs because it allows the jury to draw adverse inferences against ZHP based on the absence of this crucial evidence.
This can be particularly powerful in shaping the jury’s perception. It strongly suggests that the withheld evidence was potentially damaging and could have supported the plaintiffs’ claims. It also gives the jurors an idea of who the good guys and who the bad guys are at trial.
This instruction essentially shifts part of the burden onto the defendants. Now they must counter the negative implications of the missing evidence which seems like a hard make in this case.
ZHP is also ordered to pay $309,130 in attorneys’ fees and $41,399.20 in expenses to the plaintiffs.
Zhejiang’s lawyers will now start the first Valsartan trial behind the 8 ball which is 100% something that could have been easily avoiding by showing even a little respect for the rules of discovery.
July 17, 2024: New Valsartan Lawsuit
A new Valsartan lawsuit was filed in the MDL on behalf of a New Jersey man who is suing Zhejiang and Aurobindo, among others.
This litigation generally involves seven types of cancer: liver, kidney, stomach, colorectal, pancreatic, esophageal, and small intestine. But there is no question there is science that supports colon cancer claims, which is the injury this man is claiming.
July 14, 2024: Not Looking Back on Old Rulings
Judge Bumb’s new order is clear that the court intends to follow Judge Kugler’s decision to proceed with the TPP class trial, dismissing defense arguments for reconsideration. The court found the defense’s claims, such as the assertion that a trial would “end in reversible error,” to be unconstructive.
The first Valsartan trial is set for November 2024. Judge Blumb instructed the parties to come to the next conference prepared to discuss in limine motions and the implications of the Mansouri study, noting a significant disconnect between the parties on this issue. This study, titled “N-nitrosodimethylamine-Contaminated Valsartan and Risk of Cancer,” conducted by Imène Mansouri and colleagues, was published in the Journal of the American Heart Association. Defendants think the study is reason to reopen Daubert hearings; plaintiffs roll their eyes at this because the study actually found that patients exposed to contaminated valsartan had a higher risk of liver cancer and melanoma.
It is clear the first case is going to trial unless the defendants step up and make a reasonable settlement offer.
July 7, 2024 – Valsartan Settlement Negotiations with Teva and Torrent
Plaintiffs have had direct settlement talks with Teva and Torrent and attended an in-person mediation with the Special Masters on January 26, 2024, which was unsuccessful. Plaintiffs are ready to resume talks with Teva and Torrent.
Settlement talks with the ZHP defendants, who are the big defendants in these cases, has gone nowhere. It is hard to imagine a reasonable Valsartan settlement with them without a few big verdicts at trial.
July 5, 2024 – Valsartan Case Count
There are 1,254 Valsartan lawsuits pending in the MDL.
June 26, 2024 – Plaintiffs’ Seek Financial Information for Punitive Damages
As we head into tomorrow’s case management conference, plaintiffs request that defendants produce financial information relevant to punitive damages for the Valsartan case. On February 20, 2024, the plaintiff’s lawyers learned that defense counsel would not seek to bifurcate punitive damages at trial, prompting plaintiffs to promptly request financial documents on February 23, 2024.
The documents requested include financial statements, tax returns, bank statements, asset and income documentation, liabilities, and information on trusts and other entities. Defendants have refused, claiming the request was not timely. Plaintiffs argue that financial information is crucial for determining punitive damages, as required by the New Jersey Punitive Damages Act. The request is timely and necessary for providing up-to-date financial data for trial.
Plaintiffs seek a court order for Defendants to produce the documents at least 30 days before each trial or, at minimum, provide updated net worth and gross revenue data with currency conversions.
The defendants are fighting this tooth and nail because they fear – with good reason – punitive damages in this litigation.
June 15, 2024 – Sanctions Hearing
A hearing on June 25th will determine whether sanctions should be awarded for the failure to produce Baohua Chen, the CEO of ZHP, for a deposition.
This is an important deposition. Chen was directly involved in the core issues of the case – the development, manufacture, sale, and recall of ZHP’s Valsartan. Plaintiffs’ lawyers also say that ZHP also failed to comply fully with court orders to produce relevant documents, including an email from July 27, 2017, which discussed contamination issues and an internal report on nitrosamine impurities. One of the core allegations in this case – one that could result in punitive damages – is that ZHP, under Chen’s direction, covered up their knowledge of the contamination from July 27, 2017, until Novartis discovered it in June 2018.
June 12, 2024 – New Prostate Cancer Case Filed
A man from Navajo, Arizona, became one of the most recent plaintiffs to file a case in the Valsartan class action MDL. The Complaint alleges that the plaintiff took generic Valsartan manufactured by Hetero Drugs, Ltd. And distributed by NuCare Pharmaceuticals. The lawsuit asserts that the plaintiff developed prostate cancer as a result of NDMA contamination in the Valsartan and asserts ten separate causes of action. The case was filed directly in the MDL using the Short-Form-Complaint.
June 6, 2024 – Settlement Rumors
There is a lot of buzz about Valsartan settlements. There have been settlements with Hetero, a relatively small defendant who only sold contaminated Valsartan for two months and had lower levels of MDMA contamination. This is not a new development. Will there be settlements with the larger defendants in the near future? You never know when a settlement will break, but this is one of those pieces of litigation where a few verdicts might be necessary to get the defendants to offer fair settlement amounts.
June 3, 2024 – MDL Has 1,200 Cases
As of June 1, 2024, there were 1,248 pending cases in the Valsartan class action MDL. At this time last year, there were 1,211 pending cases, so the MDL has not really grown much over the last year.
May 23, 2024 – New Judge
A new MDL judge, U.S. District Judge Renee M. Bumb, has taken over the litigation after Judge Robert B. Kugler retired.
Valsartan lawyers are still preparing groups of cases for trial to gauge jury responses to evidence and testimony and to help determine settlement amounts. Will we get that far, or will the cases all settle before that? It remains to be seen.
May 2, 2024 – Types of Cases Linked to Valsartan
These are the conditions our Valsartan lawyer are targeting:
- Bladder Cancer
- Liver Cancer
- Blood Cancer
- Non-Hodgkin’s lymphoma
- Multiple Myeloma, and Leukemia
- Colorectal/Colon/Rectal Cancer
- Gastric/Stomach Cancer
- Lung Cancer
- Pancreatic Cancer
- Intestinal Cancer
- Pharyngeal (throat)/Esophageal Cancer
- Prostate Cancer
April 25, 2024 – Where Are We on a Valsartan Settlement?
There have been some Valsartan settlements. Judge Kugler appointed two retired judges as mediators to resolve outstanding lawsuits. The hope is the rest of the lawsuits settle soon.
March 27 2024 – Valsartan Motions
The MDL judge ruled ahead of the bellwether trial that drug labels stating “valsartan” implied a promise about the safety of these generic blood pressure medications, which is good news. But it remains contested whether this assurance was broken due to alleged contamination with a carcinogenic substance.
We think these cases will settle before there is a trial. It is hard to imagine what good would come for the defendants in not settling these cases or at least settling the bellwether to buy time. But we will see.
January 16, 2024 – Fact Sheet
There is a dispute about plaintiffs’ fact sheets that will be decided at a hearing on January 24, 2024.
January 13, 2024 – Status Conference
There will be a status conference on February 1, 2024.
January 11, 2024 – How Many Valsartan plaintiffs in the MDL class action?
There are 1,226 plaintiffs in the Valsartan MDL in January 2024.
January 10, 2024 – Experts in the Valsartan Litigation
Here are the experts who have been named in the Valsartan MDL:
| Expert | Retained by Plaintiffs | Report Date |
|---|---|---|
| Ali Afnan, PhD | ZHP | Amended Report 11 Jan 2023 |
| Timothy Anderson, MS, MBA | Teva | 12 Jan 2022 |
| Steven Baertschi, PhD | Teva & ZHP | 19 Dec 2022 |
| Michael Bottorff, PharmD | Defendants | 12 Jan 2022 |
| John Flack, MD, MPH | Defendants | 19 Dec 2022 |
| Timothy Kosty, RPh, MBA | Defendants | 19 Dec 2022 |
| Akhilish Nagaich, PhD | Torrent | 22 Dec 2022 |
| Roger Williams, MD | Teva | Revised Report 28 Jan 2023 |
| Fengtian Xue, PhD | ZHP | 22 Dec 2022 |
| Expert | Retained by | Report Date |
|---|---|---|
| Susan Bain, DRsc | Plaintiffs | 31 Oct 2022 |
| Laura Craft, MPH, JD | Plaintiffs | 31 Oct 2022 |
| Stephen Hecht, PhD & Ramin Najafi, PhD | Plaintiffs | 6 Jul 2021 & 31 Oct 2022 |
| Kaliope Panagos, PharmD | Plaintiffs | 31 Oct 2022 |
| Laura Plunkett, PhD | Plaintiffs | 31 Oct 2022 |
| Philip Russ, BS | Plaintiffs | 31 Oct 2022 |
The court put this list together in its January 5th ruling.
January 5, 2024 – Expert Rulings
The court made a huge ruling on what experts can and cannot say at trial. The court used a knife, not a machete, and thin sliced the report. For most experts, the judge allowed some opinions and excluded some opinions.
Valsartan Recall
In 2018, the FDA announced a major recall of prescription blood pressure and heart drugs containing the active ingredient valsartan. Valsartan is widely used in several brand-name and generic drugs (Diofan, Exforge, etc.) to treat hypertension and heart failure. It was recently discovered that when valsartan is manufactured in a certain way, it can contain a dangerous impurity called N-nitrosodimethylamine (NMDA).
The drugs at issue are generic versions of certain blood pressure and heart failure medications. In July 2018, some companies started recalling these drugs after the FDA found tiny amounts of a harmful chemical called NDMA in some batches. NDMA is also found in water, food, and grilled meats. Later, in November 2018, more batches were recalled because of another harmful chemical, NDEA.
In October 2018, companies also recalled some batches of two other similar medications, losartan and irbesartan, due to possible contamination with NDEA. A few batches of losartan were recalled for containing another impurity, NMBA. These drugs are in the same class as valsartan but are made differently and had fewer recalls.
Known Carcinogen
NMDA is a known human carcinogen. The valsartan medications containing the dangerous NMDA impurity have been linked to a specific pharmaceutical ingredient distributed by a Chinese company — Zhejiang Huahai Pharmaceuticals. Zhejiang Huahai was manufacturing the contaminated valsartan component and selling it to several U.S. pharmaceutical companies, including Teva Pharmaceuticals Ltd. and Solco Healthcare. Zhejiang Huahai discovered NMDA impurities in its product which eventually led to the FDA recall.
All valsartan products manufactured with ingredients from the Zhejiang Huahai company were immediately recalled for safety reasons. According to the FDA, the NDMA impurities in the drugs were “totally unexpected” and believed to be caused by changes in the way certain ingredients were manufactured by the company in China.
The FDA followed up with a full investigation into the recalled products and the NDMA contamination. This investigation revealed that the NDMA contamination was more widespread than initially believed. At least one company in India that manufactures pharmaceutical ingredients was identified as a potential source of NDMA contamination.
List of Recalled Valsartan Drugs
Not all drugs containing Valsartan have been recalled. Only those drugs are made with ingredients from Zhejiang Huahai. The list of all recalled drugs is below:
Drug Name Manufacturer
Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.
What is NDMA?
NDMA is a type of chemical compound that is often created as a byproduct of chemical processes that are used to manufacture various products. NDMA is created in the manufacture of rubber tires, chemical pesticides, and the processing of fish for market sale.
A small trace amount of NDMA is often found in certain processed foods (again as the byproduct of the way the food is produced).
NDMA is classified as a human carcinogen (meaning it is believed to cause cancer in humans). Numerous animal studies have established that NDMA can cause cancer in the liver, gastrointestinal system, and kidneys.
Research indicates that NDMA forms during the manufacturing process under certain conditions, particularly when specific chemicals react under high temperatures. This issue in the Valsartan litigation is believed to stem from changes in manufacturing processes that increased NDMA levels beyond safe thresholds.
Potential Injuries from the Valsartan Products
It is very unclear how long the recalled Valsartan products may have been on the market while containing the dangerous NDMA impurities.
However, all of the recalled valsartan drugs are long-term “maintenance” medications that patients usually take every day for years. Therefore, it is very possible that many individuals could have been ingesting drugs contaminated with NDMA daily for many years. This sort of long-term exposure to a known carcinogen creates a very serious health risk. NDMA exposure is strongly linked to certain types of cancer, including:
- Bladder Cancer
- Stomach Cancer
- Liver Cancer
- Gastric Cancer
- Colorectal Cancer
- Kidney Cancer
- Pancreatic Cancer
Valsartan Class Action Lawsuit
The discovery of NDMA in Valsartan prompted a wave of product liability lawsuits. Since the 2018 recall, around 1,100 Valsartan lawsuits have been filed. Most of the Valsartan lawsuits ended up in federal courts and were eventually consolidated into a class-action MDL in the District of New Jersey (Valsartan MDL). There are currently over 1,000 active cases pending in the Valsartan MDL.
The plaintiffs in these Valsartan lawsuits are individuals who used prescription drugs containing valsartan to treat high blood pressure for extended periods and were subsequently diagnosed with one of the cancer types linked to NDMA. Plaintiffs in the Valsartan lawsuits are claiming that their cancer was directly caused by the NDMA in the Valsartan medication they were using. There is significant and reliable scientific evidence linking NDMA consumption to various cancers.
Who Are the Valsartan Defendants?
Defendants in this case are entities involved in the U.S. supply chain for generic medications Valsartan, Losartan, and Irbesartan. Specifically for Valsartan, they are categorized into six groups:
- Valsartan API Manufacturers: Zhejiang Huahai Pharmaceutical Co., Ltd.; Huahai U.S., Inc.; Hetero Labs, Ltd.; Hetero Drugs, Limited; Hetero USA Inc.; Mylan Laboratories, Ltd.; Aurobindo Pharma, Ltd.
- Finished Dose Valsartan Manufacturers: Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; Actavis LLC; Actavis Pharma, Inc.; Torrent Pharmaceuticals Ltd.; Aurobindo Pharma, Ltd.; Aurolife Pharma, LLC; Prinston Pharmaceutical Inc.
- Finished Dose Distributors: Aurobindo Pharma USA, Inc.; Solco Healthcare U.S., LLC; Torrent Pharma, Inc.; Camber Pharmaceuticals, Inc.
- Wholesalers: AmerisourceBergen Corporation (now Cencora, Inc.); Cardinal Health, Inc.; McKesson Corporation.
Valsartan Lawsuits
Plaintiffs’ lawyers in Valsartan lawsuits argue that the manufacturers failed to ensure the purity and safety of their products, thereby exposing consumers to harmful carcinogens. Legal strategies focus on proving negligence in quality control and lack of transparency in disclosing the potential risks associated with the drug.
A critical component of these cases involves demonstrating the causation between NDMA exposure and the specific cancers developed by plaintiffs. Lawyers rely on epidemiological studies, expert testimonies, and scientific data to establish a direct link between long-term exposure to contaminated Valsartan and the onset of cancer. The science is pretty strong for plaintiffs.
Plaintiffs’ lawyers also aim to show that the manufacturers had prior knowledge—or reasonably should have had knowledge—of the risks associated with NDMA but chose not to act swiftly or effectively to mitigate these risks. The main defendant in this litigation has dodged much of the discovery on this point which led to the court ordering sanctions as we discuss in the July 24, 2024 update above.
Settlement Value of Valsartan Lawsuits
None of the Valsartan cancer lawsuits have settled or gone to trial yet, so we don’t know exactly how much these cases could be worth. However, our attorneys can offer a reasonable estimate of their likely Valsartan settlement amounts by looking at payouts in prior cases. For purposes of valuing the Valsartan lawsuits, our lawyer focuses on average settlement values in other tort cases involving similar cancers and also prior mass tort settlements.
Based on these points of comparison, we think a reasonable estimate for the potential settlement value of valsartan cancer cases in the top settlement tier will be around $150,000 to $200,000.
The valsartan cases in the highest settlement tier will be those involving the worst types of cancer with the lowest survival rates (e.g., pancreatic cancer, stomach cancer, etc.) Valsartan cases involving somewhat more survivable types of cancer (kidney, colon, etc.) could end up in a second settlement tier with a possible value of around $90,000 to $125,000.
When Will the Valsartan Lawsuit Be Settled?
There has already been a Valsartan settlement with one of the smaller defendants. As of July 2024, there has not been meaningful settlement negotiations. There should be – we have said this before – a Valsartan trial in the MDL in November 2024. That may move the defendants to make reasonable settlement offers.
Contact a Lawyer If You Took Valsartan and Now Have Cancer
If you have been taking one of the recalled valsartan drugs and have been diagnosed with cancer, you should contact Miller & Zois to discuss whether you have a potential claim.
There is a class action lawsuit that we discussed above that may lead to financial settlements for Valsartan victims. Get a free online consultation or call 800-553-8082.