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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. 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:
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 23, 2024 – Revised Scheduling Order
| Date | Action | Notations |
|---|---|---|
| January 26, 2024 to February 5, 2024 | New Deadline |
|
| February 5, 2024 to February 12, 2024 | New Due Date | Parties’ opening Rule 702/Daubert motions to preclude reports of the damages experts |
| February 19, 2024 to February 26, 2024 | New Due Date | Parties’ Oppositions to these Rule 702/Daubert motions |
| February 28, 2024 to March 6, 2024 | New Due Date | Parties’ Replies to the Rule 702/Daubert Oppositions |
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 News and Updates 2023
Valsartan Update: August 2023:
With the opening round of bellwether trials only 7 months away, the Valsartan class action lawsuit continues to grow at a snail pace. Last month, just 5 new plaintiffs were added to the MDL, bringing the current total up to 1,216.
Valsartan Update: June 2023
This litigation continues to move along. There are now 1,211 plaintiffs. So there is more case subtraction at this point than addition. The next Case Management Conference will occur Wednesday, June 7, 2023.
Valsartan Update: February 2023:
In the wake of the depressing ruling in Zantac, another NDMA lawsuit, defendants in the Valsartan class action MDL filed a motion asking the MDL to reconsider its earlier ruling on the validity of the plaintiffs’ causation evidence. Nope. Instead, Judge Kugler certified not one, not two, but a whopping four class actions were greenlit: economic loss, third-party payers, and two flavors of medical monitoring (remedy and independent claim). He also looked favorably on most plaintiffs’ experts’ opinions. The reality is that the science of the Valsartan litigation is very different than the Zantac cases.
Valsartan Update: December 2022
In the wake of the recent ruling dismissing all of the Zantac lawsuits, defendants in the Valsartan class action MDL filed a motion asking the MDL to reconsider its earlier ruling on the validity of the plaintiffs’ causation evidence. The defendants were hoping that the Zantac ruling would lead to a similar result in their cases.
However, the Valsartan MDL Judge rejected this request. In an Order issued last week, Judge Kugler explained that the scientific issues in the Zantac lawsuits were significantly different and, therefore, the ruling in that litigation had no application to the Valsartan cases. Judge Kugler’s ruling now leaves the path clear for the Valsartan cases to go to trial.
This is good news. The shadow of the December dismissal of the Zantac NDMA claims hovered over this litigation. Yes, different judges, different science, many different things. But you cannot seriously pretend that the dismissal of the Zantac class action lawsuit did not send shockwaves through the Valsartan litigation, even if it is just a reflex. Still, it is all systems go toward the first Valsartan trial.
Valsartan Update: November 2022
We will not see many more new Valsartan lawsuits. Only 15 new cases were added to the Valsartan class action MDL over the last month. Since the start of the year, only 116 new Valsartan cancer lawsuits have been added to the MDL class action. Most of those were filed before April. The monthly totals have been steadily decreasing since then, which could indicate that the field of prospective plaintiffs may be close to fully exhausted.
Valsartan Update: October 2022
There are now 1,155 plaintiffs with pending cases in the Valsartan MDL alleging that NDMA in the popular drug caused them to develop cancer. This means that the Valsartan MDL has only added 120 new cases over the last six months.
One of the primary reasons that the Valsartan class action has remained so small compared to its class action “cousin” Zantac is that the NDMA contamination in Valsartan was a limited event that occurred in only certain batches of the drug. It is also a reflection of the more limited size of Valsartan users compared to Zantac.
Valsartan Settlement Update: August 2022
There has not been much to update in the Valsartan class action lawsuit in the last few months. Forty new Valsartan NDMA cancer cases have been transferred into the MDL since April.
During that same time, around half a dozen cases have been voluntarily dismissed. So the current number of Valsartan lawsuits in the class action is 1,110 as of June 15.
Our lawyers’ general expectation is that the Valsartan cases will eventually be resolved in a global settlement. But it has been a slow – very sloooowww – grind.
The minutes of the last status conference with the MDL judge on June 29, 2022, underscore this reality. Instead of hammering away to find common ground on Valsartan lawsuit settlement amounts that would resolve these cases, the parties are still discussing the same preliminary discovery matters that were at issue five months ago. It is like Groundhog Day.
No bellwether trials have been scheduled, and we don’t even have a selection process for bellwether cases. Hopefully, things will heat up soon. There is a good judge in these cases, and Valsartan lawyers on both sides are good, competent lawyers.
One more thing to keep in mind if you are reading these updates but you are sitting on the sidelines with a potential claim. Once there is an agreement on settlement compensation amounts, it may become hard to find a lawyer. Our law firm, for example, will likely stop taking new cases after a Valsartan settlement. So, if you have a claim, call us or another Valsartan lawyer today.
Valsartan Settlement Update: April 2022
As settlement efforts continue, the Valsartan class action lawsuit balloons to 1,072 plaintiffs. Judge Kugler will hold the monthly status conference in the Valsartan MDL today (April 13, 2022). The main agenda item for the conference today is boring but important: a lingering discovery dispute regarding document requests from the plaintiffs’ lawyers.
Valsartan Settlement Update: March 2022
A pair of former judges have been appointed as settlement counsel in the Valsartan MDL. Their job will be to help facilitate some type of global settlement that will resolve over 1,000 cases currently pending. If a settlement cannot be brokered, the opening round of bellwether trials will move forward. Here is the number if you want to follow the litigation in Pacer: 1:19-md-02875
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.
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.
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.