Valsartan Cancer Lawsuit – MDL 2875
Valsartan is a common drug for treating high blood pressure and heart disease. Valsartan was sold under the brand name Diovan, manufactured safely by Novartis Pharmaceuticals Corp. for decades. The valsartan lawsuits do not cover claims related to the name brand Diovan. Around 2012, many generic drug manufacturers, such as Zhejiang Huahai Pharmaceutical Co., Ltd.; Hetero Drugs Limited; Aurobindo Pharma Limited; Mylan; Torrent Pharmaceuticals Limited; and Teva Pharmaceutical Industries began selling valsartan after it went off patent. The active ingredient for generic valsartan was primarily manufactured in China and India. The generic drug companies utilized a cheap manufacturing process that resulted in the formation of potent genotoxic carcinogens called nitrosamines. The valsartan lawsuits allege that the two most common nitrosamines in the contaminated valsartan are NDMA (N-nitrosodiethylamine) and NDEA (N-nitrosodimethylamine). Companies and the FDA began recalling contaminated valsartan and losartan in July of 2018. However, many individuals that ingested contaminated valsartan will not develop cancer for years after exposure.
Valsartan MDL 2875 Court Appointed Leadership
The attorneys at Nigh Goldenberg Raso & Vaughn make up a large portion of the court appointed leadership in the valsartan litigation. Daniel Nigh is co-lead counsel and a member of the Plaintiffs’ Executive Committee of the valsartan lawsuit MDL 2875. Marlene Goldenberg is on the Plaintiffs’ Executive Committee and discovery committee of the valsartan lawsuit MDL 2875. Brett Vaughn is also on the Plaintiff’s Executive Committee and is co-chair of the science and expert committee of the valsartan lawsuit MDL 2875. And Ashleigh Raso is on the Plaintiffs’ Steering Committee of the valsartan lawsuit MDL 2875. The valsartan attorneys at NGRV have extensive experience in MDL 2875.
What Types of Cancers Can Contaminated Valsartan cause?
The valsartan lawsuits allege that valsartan contaminated with nitrosamines can result in the formation of numerous types of cancer, even years after taking contaminated valsartan. The types of cancer supported in the valsartan lawsuit MDL 2875 include:
- Blood Cancer
- Liver Cancer
- Colorectal Cancer
- Intestinal Cancer
- Gastric Cancer
- Lung Cancer
- Pancreatic Cancer
- Pharyngeal (throat) Cancer
- Prostate Cancer
- Bladder Cancer
When patients have been exposed to a potent carcinogen, such as contaminated valsartan, cancer of numerous organs becomes more common. This is different than cancer metastasis, which is cancer moving from one organ to another (which contaminated valsartan also increases the risk of). Multisystem cancer is supportive of exposure to a carcinogenic agent.
How Did Valsartan Get Contaminated with NDMA and NDEA?
The valsartan lawsuits allege that NDMA is formed in part because nitrites are utilized in the valsartan manufacturing process. Furthermore, the valsartan attorneys assert that NDMA can also be present in recycled solvents, which some of the generic valsartan manufacturers utilized.
How To Know If Your Valsartan Was Contaminated?
If you took generic valsartan between 2012 and 2019, it’s possible that you’re eligible to file a valsartan lawsuit against the manufacturer of your valsartan. A substantial amount of all generic valsartan on the market between 2012 and 2019 was contaminated with unsafe levels of carcinogens. All you need to do is fill out an online form or contact one of our valsartan attorneys at 202-792-7927 to get started.
Valsartan Recall Letters
Many patients that took contaminated valsartan never received a valsartan recall letter from the generic drug manufacturer or from their pharmacy. Unless the patient was taking contaminated valsartan at the time of the recall, it is unlikely that the patient was ever notified that they consumed valsartan contaminated with dangerous carcinogens.
Valsartan Lawsuit MDL 2875 Update / History
February 2019
The United States Judicial Panel on Multidistrict Litigation (JPML) entered a transfer order consolidating all valsartan lawsuits filed in federal court into MDL 2875 in the District of New Jersey before the Honorable Robert Kugler. Many of the valsartan defendants have their U.S. headquarters in New Jersey. The JPML also noted that, “Judge Robert B. Kugler is an experienced transferee judge with the willingness and ability to manage this litigation. We are confident that he will steer this litigation on a prudent course.” At the time of consolidation there were 30 valsartan related lawsuits on file, including 17 valsartan personal injury lawsuits and the remainder being putative class actions on behalf of consumers and third-party payors. Just a few days after the JPML created the valsartan lawsuit MDL 2875, Judge Kugler entered the first case management order (CMO) in MDL 2875. Judge Kugler set the first valsartan case management conference for all valsartan attorneys to be held on March 27, 2019.
April 2019
Case management order #2 was entered in MDL 2875, establishing monthly in-person valsartan status conferences with Judge Kugler and monthly follow-up conferences by telephone with the magistrate judge.
May 2019
Case management order #6 was entered in the valsartan lawsuit MDL 2875, appointing leadership of the valsartan litigation. NGRV attorneys Daniel Nigh, Marlene Goldenberg, Brett Vaughn, and Ashleigh Raso were all appointed to valsartan leadership positions.
September 2019
The valsartan attorneys Short Form Complaint (SFC) was approved via case management order #13. All future personal injury valsartan lawsuits transferred into MDL 2875 were ordered to file a short form complaint within 30 days of transfer.
October 2019
The valsartan court approved the Plaintiff’s Fact Sheets for the respective classes of valsartan Plaintiffs as follows:
- Valsartan Personal Injury Plaintiffs
- Valsartan Medical Monitoring Class Representative Plaintiffs
- Valsartan Economic Loss Plaintiffs
All plaintiffs with a valsartan lawsuit on file were ordered to have a Plaintiff’s Fact Sheet on file within sixty days of filing their Short Form Complaint. Furthermore, the valsartan defendants are allowed to bring Show Cause orders for valsartan plaintiffs that do not adequately complete their valsartan Plaintiff’s Fact Sheet.
December 2019
The JPML expanded the valsartan lawsuit MDL 2875 to also include losartan and irbesartan personal injury lawsuits, which are similar types of blood pressure medications that were also contaminated with nitrosamines. Many of the generic valsartan manufacturers were also manufacturing irbesartan and losartan. Furthermore, many patients with a valsartan lawsuit filed also took contaminated losartan or irbesartan at some point. Some patients were transitioned from valsartan to losartan after the valsartan recall, but it was not yet known that losartan was also contaminated with deadly carcinogens.
November 2020
The valsartan court addresses depositions going forward in the fact of Covid-19 in case management order #20. The court noted that all depositions in the valsartan lawsuit MDL 2875 could be noticed to take place remotely via Zoom. The court also entered case management order #21, approving the request for production of documents (RFP) related to the following:
- Valsartan Medical Monitoring Class Action Plaintiff Class Representatives
- Valsartan Economic Loss Class Action Plaintiff Consumer Class Representative
- Valsartan Economic Loss Class Action Plaintiff Third-Party Payor Class Representative (MSPRC)
- Valsartan Economic Loss Class Action Plaintiff Third-Party Payor Class Representative (Main Automobile Dealers Association, Inc. Insurance Trust)
January 2021
The valsartan court set the following deadlines in case management order #22:
- April 1, 2021: Complete first phase of fact discovery, including deposition of valsartan manufacturing defendants and at least 10 valsartan personal injury bellwether plaintiffs.
- May 3, 2021: Plaintiff serve valsartan expert reports addressing general causation.
- June 1, 2021: Defendants serve valsartan expert reports addressing general causation.
- July 1, 2021: Complete depositions of plaintiff’s valsartan general causation experts.
- August 2, 2021: Complete depositions of defendant’s valsartan general causation experts. All valsartan bellwether depositions should have been completed by this date as well.
- August 31, 2021: File Daubert motions regarding valsartan general causation experts.
- October 1, 2021: Responses to Daubert motions regarding valsartan general causation experts.
- November 1, 2021: Replies to responses to Daubert motions regarding valsartan general causation experts.
May 2022
Via case management order #25, the valsartan court ordered the parties to appoint settlement counsel. The valsartan court order read, “it appearing to the court that a fair and equitable way to advance settlement negotiation sin this Multi-District Litigation[“MDL”] is to ask each party to nominate settlement counsel to represent it in MDL settlement negotiations conducted by the Settlement Special Masters: the Honorable (Ret.) Gregory M. Sleet, and the Honorable (Ret.) Lawrence F. Stengel”.
July 2022
The valsartan court entered case management order #28, setting the following deadlines related to valsartan liability expert reports:
- September 16, 2022: Plaintiffs’ serve valsartan liability expert reports.
- October 18, 2022: Defendants’ serve valsartan liability expert reports.
- November 19, 2022: Completion of valsartan liability expert depositions.
- December 13, 2022: Daubert motions filed regarding valsartan liability experts.
- January 6, 2023: Daubert responses on valsartan liability experts.
- January 20, 2023: Daubert replies on valsartan liability experts.
February 2023
On February 8, 2023, Judge Kugler excluded numerous defense experts. Judge Kugler granted Plaintiff’s motion to strike new and altered valsartan general causation opinions of Michael Bottorff, PharmD, in particular the following opinions of Dr. Bottorff:
- “Oral doses at the levels detected in the generic valsartan at issue in this litigation are metabolized in the liver almost completely, preventing exposure to other tissues and organs.”
- “NDMA/NDEA in valsartan will not reach systemic circulation”
- “DNA repair mechanisms in humans can be as much as 10 times higher than that in rats, indicating a more active DNA repair in humans compared to rats”
Judge Kugler also granted Plaintiff’s motion to preclude the valsartan class certification expert report of Jason Clevenger, PhD. Jason Clevenger is an employee of the company Exponent. Dr. Clevenger attempted to offer the following opinions regarding Aurobindo’s contaminated valsartan containing drugs:
- There is “no evidence that the rate / extent of the bioavailability of contaminated valsartan differs from that of the reference listed drug (RLD).” Further, plaintiffs state, Dr. Clevenger opines that recalled Aurobindo VCD products remained bioequivalent even with low levels of NDEA or NDMA.
- Using higher temperatures to make the Aurobindo finished drug product likely resulted in the volatilization of nitrosamines in the corresponding batches of the API. Dr. Clevenger opines this shows that Aurobindo finished drug product batches generally had lower nitrosamine levels than corresponding API batches.
Judge Kugler found that Dr. Clevenger’s opinions “rest on deficient scientific methodology”. Regarding opinion 1, it was explained that, “Dr. Clevenger’s one-eye-shut approach is not a scientifically valid methodology. Constituting neither proper scientific deduction, nor inductive research, nor testing to conclusion, nor full scientific literature review, Dr. Clevenger’s approach-to rely on an untested lack of evidence to aver the presence of a physical identicality-is sheer sophistry. And to the point, to opine that the absence of evidence demonstrates the presence of a physical property without checking other relevant information and data is a well-known error in logic and belies a reliable method.”
In regard to Dr. Clevenger’s second opinion, it was explained that Dr. Clevenger’s opinion relied solely, “on his interpretation of Aurobindo’s own, initial test results that show the manufacture of finished dose products at elevated temperatures reduced the concentration of nitrosamines, and particularly NDEA, in the finished dose when compared with the API by about 70%. These results were not replicated by a subsequent test done by Aurobindo or by a separate test done by the FDA. But, Dr. Clevenger’s methodology did not include a comparison of Aurobindo’s initial test results either with Aurobindo’s second results or with the FDA subsequent test results. For this reason, Dr. Clevenger’s opinion declaring lower nitrosamine levels in the relevant Aurobindo’s FD batches compared to those levels in Aurobindo’s relevant API batches is based on skewed results and not methodologically reliable.”
May 2023
On May 1, 2023, third circuit judges Patty Shwartz, Paul Matey and Peter Phipps denied the valsartan defendant’s petitions for permission to appeal and dismissed all pending motions. The valsartan litigation will continue towards trial.
Valsartan Attorney
The valsartan litigation is just the latest in a long line of pharmaceutical product liability cases. The drug companies behind these products have a duty to the public to ensure their products are safe and effective, and when they fail to live up to this standard we see cases like this one. If you’ve been harmed by contaminated Valsartan, contact an experienced valsartan lawyer today so they can guide you through the valsartan lawsuit process. Contact our our valsartan attorneys today at (202) 792-7927.
