Valsartan Lawsuit News and Updates
The latest lawsuit news and updates for the recalled drug Valsartan.
Valsartan Lawsuit News Update: Valsartan Users And Providers Say They Have Paid The Price For Contamination Recalls, Sue For Reimbursement
February 7, 2019
Author: Daniel Gala
The Maine Automobile Association Inc. Insurance Trust has become the latest plaintiff to sue for reimbursement of additional costs it says it incurred due to recent recalls of Valsartan, a popular blood-pressure medication, according to a report by Law360. The lawsuit, filed January 30 in New Jersey federal court, alleges that the insurance trust, like other third-party payers, incurred vastly increased costs related to Valsartan and similar drugs as a direct result of global voluntary recalls that began in mid-2018. The recalls, issued after many forms of valsartan had been found to be contaminated with known human carcinogens, resulted in vastly diminished supplies of the drug worldwide.
The claims raised by the insurance trust are similar to those made in a putative consumer class action suit filed in Massachusetts federal court in November 2018. In that case, the plaintiffs accused generic drug makers Camber Pharmaceutical Inc. and Hetero Drugs Ltd. of willfully ignoring concerns about overseas manufacturing facilities, which the complaint alleges allowed the contamination to occur.
In the instant case, the Maine Automobile Association Inc. Insurance Trust says that the Valsartan recalls resulted in its expenditures related to the drug doubling. According to the lawsuit, these additional recall-related costs include increased drug prices due to diminished supply, as well as additional doctor’s visits for patients exploring other medication options and/or concerned about their exposure to contaminated pharmaceuticals.
Seeking recourse under the New Jersey Consumer Fraud Act among other claims, the insurance trust claims that the defendant drug makers were aware of the risk of contamination for years, yet continued to push their unsafe products onto the market.
“[D]efendants placed these drugs in the market and sold them to an unsuspecting public for four years,” the complaint says, per Law360. “Plaintiff and similarly situated [third-party payers] paid for these contaminated pharmaceuticals during the entire period.”
In addition to Valsartan, the lawsuit also seeks reimbursement for additional expenses the insurance trust says it incurred over the medications Irbesartan and Losartan, which also have faced similar contamination concerns.
O’Sullivan, J. (31 January 2019). Blood Pressure Med Recalls Cost Us Double, Payers Say. Law360
Leibowitz, A. (8 November 2018). Blood-Pressure Drug Cos. Hit With Suit Over Contamination. Law 360
Valsartan Lawsuit News Update: JPML likely to approve multidistrict litigation
February 4, 2019
Author: Daniel Gala
The judicial body responsible for approving or rejecting requests to consolidate multiple lawsuits into multidistrict litigation (MDL) appeared poised to approve an MDL over contamination of the blood-pressure medication valsartan, though the scope and ultimate location of the litigation remain in question, Law360 reported January 31.
Valsartan has become the subject of much concern after evidence was discovered in 2018 suggesting that ingredients used by certain manufacturers of valsartan had become contaminated with known carcinogens due to a problem with the manufacturing process.
Opponents of consolidation argued that the Judicial Panel on Multidistrict Litigation (JPML) should deny the MDL because the number of valsartan personal injury claims was relatively small compared to the thousands of cases contained in other MDLs. According to Law360, only 18 such cases had been filed as of late January 2019.
However, U.S. District Court Judge Lewis A. Kaplan of the Southern District of New York, a member of the JPML, expressed confidence that the number of cases will inevitably grow.
“It’s going to happen. We all know it’s going to happen,” Judge Kaplan said regarding the inevitability of additional cases being filed.
Judge Kaplan’s colleague, U.S. District Court Judge Ellen Segal Huvelle of the District of Columbia, agreed.
“The writing is on the wall,” Judge Huvelle said, referencing comments from attorneys who had informed the panel that, while the present number of cases was small, hundreds of additional valsartan cases presently were being vetted.
With several of the panel’s members making comments suggesting that they favored consolidation, many of the arguments involved the MDL’s eventual venue. The District of New Jersey was the most popular venue among the parties, though other possible locations included the Northern District of California, the Southern District of Florida, Massachusetts, Minnesota, and the Eastern District of Texas, Law360 reported.
Valsartan is the generic form of Novartis AG’s Diovan, a popular blood-pressure medication also used in the treatment of congenital heart defect. In July 2018, manufacturers of valsartan around the globe began issuing voluntary recalls after their drugs were found to be contaminated with known carcinogens NDMA and NDEA.
The contamination ultimately was traced back to a manufacturing facility in China, with later reports that contaminated valsartan also had been connected to an additional plant in India. Both facilities had been involved in the manufacture of an active ingredient used in many brands of generic valsartan. It is believed that a change in manufacturing methods resulted in the contamination.
Hale, N. (2019 January 31). Panel Leans Toward Valsartan MDL, But Grapples With Scope. Law360
Valsartan Lawsuit News Update: Walmart has been sued along with three pharmaceutical companies over a contaminated medication
December 5, 2019
In a sign of what could be to come in the Valsartan litigation, Walmart has been sued along with three pharmaceutical companies over a contaminated medication. The suit alleges that the companies all contributed to the production and sale of contaminated batches of a drug used to treat high blood pressure and diabetes.
The batches of irbesartan, a generic version of the drug Avapro, were contaminated with the known carcinogen N-Nitrosodimethylamine, or NDEA, due to manufacturing defects at the manufacturers production facility in India.
This is very similar to what is happening with the high blood pressure drug Valsartan. The Chinese manufacturing plant allowed the drug to be contaminated with a cancer causing substance.
The lawsuit alleges that the patients who purchased the contaminated pills face an increased risk of cancer and disease. The companies have been accused of negligence, breach of contract, strict product liability and violation of consumer protection laws.
Many times it is simply the manufacturer of a contaminated drug who is sued. However, some States allow the pharmacy to be sued as well. In fact, there are a number of potential defendants in a drug-related products liability claim. An attorney faced with a client injured by a defective drug will often consider everyone in the "chain of distribution" of a drug -- that is, the path the drug takes from the manufacturer to the consumer. This path could include the following:
Manufacturer. This is often the starting point for litigation. Pharmaceutical manufacturers are typically large companies, with the ability to pay compensation. However, many manufacturers delay these lawsuits for many, many years.
Testing laboratory. The drug that injured you should have been tested before going to market. If the labs were independent of the manufacturer, they can also be sued.
Pharmaceutical sales representative. A pharmaceutical sales rep may be liable if they recommended the drug that injured you.
Doctor. The doctors who prescribed the drug that injured you may also be liable for your injuries because they are part of the chain of distribution of the drug. The doctors may be liable based on their failure to warn you about potential side effects or to provide adequate instructions regarding the proper use of the drug. It is not the general practice of TheLawFirm.com to sue doctors but they are a potential defendant.
Hospital or clinic. A hospital or a clinic, if it was part of the chain of distribution between the manufacturer of the drug and you may be liable for your injuries.
Pharmacy. Your pharmacy is the final point in the chain of distribution of a drug from the manufacturer to you. The pharmacist's counseling regarding use of the drug that injured you may constitute an additional basis for the pharmacy's liability. As well, pharmacies have the ability to test drugs so they can be sued if they sell contaminated drugs.
At the current time, TheLawFirm.com is concentrating on the manufacturer of Valsartan but we are always mindful that other parties may end up bearing some responsibility for the sale of this cancer causing medicine.
Valsartan Lawsuit News Update: More foreign made drugs are now tainted
November 29, 2018
It appears that more foreign made drugs are now tainted. Americans were made aware that a suspected carcinogen was found in the blood pressure drug Valsartan, a product produced in China. Now the FDA has learned the problem is much broader, with two of the largest generics drugmakers now recalling dozens of lots after drug maker Mylan found also a suspected carcinogen.
Mylan just announced that a drug manufactured at one of its plants in India was tainted with N-nitrosodiethylamine (NDEA), one of two probable carcinogens the FDA has been tracking. 15 lots of valsartan products have been recalled.
And now, Teva Pharmaceuticals said it is recalling 49 lots of valsartan products in the U.S. because they had been made with the Mylan product.
The global recall of valsartan drugs began in the summer of 2018 when the FDA and EU learned that China’s Zhejiang Huahai Pharmaceuticals made drugs containing potential carcinogens NDEA and N-nitrosodimethylamine (NDMA).
The FDA has banned certain drugs coming out of Huahai’s manufacturing site in China.
However, for years, it is likely that many Americans regularly consumed a medication that contained a probably carcinogen. If you took a Valsartan product and developed cancer, call the attorneys at TheLawFirm.com for a case review.
Valsartan Lawsuit News Update: Valsartan Update: FDA Expands Contaminated ARB Recalls Beyond Valsartan
October 31, 2018
According to an update posted to its website October 30, the United States Food and Drug Administration (FDA) has issued its first recall of a non-valsartan drug found to be contaminated with the impurity N-Nitrosodiethylamine (NDEA), a probable human carcinogen. The voluntary recall involves certain lots of irbesartan sold by ScieGen under the brands Westminster Pharmaceuticals and Golden State Medical Supply. Aurobindo, which manufactures the active pharmaceutical ingredient (API) used in ScieGen’s irbesartan, also has issued a voluntary recall.
Like valsartan, which has been the subject of numerous FDA recalls over the past several months due to contamination concerns, irbesartan is an angiotensin II receptor blocker (ARB) used in the treatment of high blood pressure. Numerous brands of generic valsartan have been recalled after they were found to be contaminated with the impurity N-Nitrosodimethylamine (NDMA), which was traced back to a Chinese facility that had manufactured the API used in the drugs.
“To date, ScieGen is the only manufacturer of irbesartan drug products found to contain NDEA,” the FDA announcement states. “FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities.”
For patients presently taking valsartan or irbesartan from lots that have been subject to recall, “FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option.”
At least one proposed class-action lawsuit has been filed in the United States against manufacturers of generic valsartan subject to recall. In early October, a plaintiff filed a complaint in New Jersey federal court against generic drug makers Solco Healthcare US LLC and Prinston Pharmaceutical Inc., alleging that the companies “willfully ignored warnings [sic.] signs regarding the operating standards of the Zheijang Huahai Pharmaceuticals manufacturing plant in China,” which has been identified as the source of the contaminated valsartan.
The FDA’s complete, up-to-date list of Irbesartan products under recall can be found here.
A complete, up-to-date list of valsartan subject to FDA recall can be found here
United States Food and Drug Administration (FDA)
Valsartan Lawsuit News Update: EU to Increase Scrutiny of Chinese Drug Maker Behind Contaminated Valsartan
October 31, 2018
All drugs containing active ingredients manufactured by embattled Chinese firm Zhejiang Huahai Pharmaceuticals Co. Ltd. will receive greater scrutiny from European regulators, EU authorities announced October 15. The move follows recalls in Europe and the United States of the blood-pressure medication valsartan, some of which was found to be contaminated with a probable carcinogen that has been traced back to a Zheijang Huahei facility in China.
Relatedly, on October 24, the US Food and Drug Administration (FDA) released a brief update on the valsartan recalls, announcing that it continues to look into the matter and that it has added an additional lot of Remedy Repack valsartan to its list of recalled products. (The FDA’s complete, up-to-date list of generic valsartan products subject to the recall can be found here.)
Generic forms of valsartan not subject to recall have seen a massive price increase as a result of the sudden reduction in supply, with the cost of two doses of valsartan in the United States increasing more than any other drug during the month of September, according to a National Average Drug Acquisition Cost (NADAC) survey.
The NADAC survey for September showed that the cost of 160 milligram and 80 milligram valsartan tablets increased by more than double from August to September 2018. Where a 160 mg tablet of generic valsartan cost approximately 14 cents in August, by September that price had reached 31 cents, the survey found.
Some experts warn that such price surges can have lasting impacts on drug costs that far outlive the original cause of the price increase.
“If the price of valsartan jumps to two dollars and then three weeks later it comes back down to 20 cents, there will be consumers somewhere in this country on high-deductible plans still paying two dollars a pill three years from now,” Eric Pachman, co-founder of healthcare data firm 46brooklyn, told Reuters.
At least one proposed class action lawsuit has been filed in the United States against manufacturers of recalled valsartan. The suit, filed in early October by a Kansas resident suing in New Jersey federal court, alleges that Solco Healthcare U.S. LLC and Prinston Pharmaceutical Inc. “willfully ignored warnings [sic.] signs regarding the operating standards at the Zhejiang Huahai Pharmaceuticals manufacturing plant in China.”
Stay tuned to TheLawFirm.com for the latest developments involving the valsartan recalls.
US Food and Drug Administration (FDA)
Valsartan Lawsuit News Update: Chinese Drug Maker Receives $43Million from Government Amidst Valsartan Recalls
October 23, 2018
The Chinese drug maker at the center of recent worldwide recalls of the blood-pressure medication valsartan has received $43 million in “industrial development assistance funds” from a municipal government in China, Reuters has reported.
The United States Food and Drug Administration (FDA) banned the import of pharmaceutical ingredients made at a Chuannan-based facility operated by Zheijang Huahai Pharmaceuticals after an active ingredient manufactured for use in generic forms of valsartan was found to be contaminated with the substance N-nitrosodimethylamine (NDMA), a probable human carcinogen that also has been associated with severe liver damage. Beginning in July, the FDA issued a series of voluntary drug recalls for affected batches of generic valsartan. (A complete, up-to-date list of generic valsartan recalled by the FDA can be found here.)
Regulators for the European Union similarly have taken action, announcing in a press release on July 27 that they had suspended Zhejiang Huahai Pharmaceuticals’ certificate of suitability, which is “used by a manufacturer to demonstrate that the quality of their active substance…is in compliance with current regulatory requirements.”
At least one proposed class-action lawsuit has been filed in the US over the contaminated valsartan. In early October, a Kansas resident filed a lawsuit in federal district court in New Jersey, accusing Solco Healthcare U.S. LLC and Prinston Pharmaceuticals Inc., two manufacturers of generic valsartan, of having “willfully ignored warnings [sic.] signs regarding the operating standards at the Zheijang Huahai Pharmaceuticals manufacturing plant in China,” an apparent reference to the Chuannan factory that is subject to the FDA import ban.
Zheijang Huahai Pharmaceuticals received the $43 million in development funds from the city of Linhai, China, which distributed the money over the course several months spanning August, September, and October 2018, or almost immediately after the Chinese drug maker began to run afoul with overseas regulators.
Stay tuned to TheLawFirm.com for the latest developments in the legal fallout from the valsartan contamination fiasco.
United States Food and Drug Administration (FDA)
United States Food and Drug Administration (FDA)
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Valsartan Lawsuit News Update: FDA Releases Lab Results Showing Valsartan NDMA Contamination Levels
October 15, 2018
On October 5, the United States Food and Drug Administration (FDA) posted lab results lab results for several previously-recalled generic versions of the blood-pressure medication valsartan, revealing levels of the potentially harmful contaminant N-Nitrosodimethylamine (NDMA), which has been linked to liver damage and has been characterized by the FDA as a probable human carcinogen. Since July, over a dozen US distributors have voluntarily recalled scores of contaminated valsartan products that contain an active ingredient from a manufacturing facility in China.
(A complete list of valsartan products recalled in the US can be found here. A list of valsartan products NOT presently subject to recall.)
According to the lab results released on the FDA website, which cover eight different valsartan products distributed by four different companies, contamination levels per tablet vary widely. For example, while 320-miligram valsartan tablets sold by Prinston Pharmaceutical tested among the highest at 15-16 micrograms of NDMA per tablet, tablets in the same dosage from Torrent Pharmaceuticals showed only 0.5-0.6 micrograms of NDMA per tablet.
“For reference, consuming up to 0.096 micrograms of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure,” the FDA explains in a description of its lab results.
Elsewhere, the FDA notes that NDMA is a “known environmental contaminant” that is “found in water and foods including meats, dairy products and vegetables.” For example, according to the FDA, “one pound of bacon may contain 0.303-0.354 micrograms of NDMA.”
(In other words, although small traces of NDMA might be found in other common, everyday products, one would have to eat more than 40 pounds of bacon to ingest the amount of NDMA contained in a single 320-miligram valsartan tablet distributed by Prinston Pharmaceutical.)
Despite the most contaminated tablets’ containing upwards of 150 times the FDA’s own daily safe-exposure level, the agency sought to downplay the resulting cancer risk, stating, “FDA previously estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people.”
While the FDA’s framing of the data seeks to downplay the cancer risk, multiplying even those conservative figures across one-million patients, the result is 125 cases of cancer that otherwise would not have occurred, not to mention the significant risk of liver injury.
According to CNN, 22 countries issued recalls of contaminated valsartan prior to the FDA’s announcing voluntary recalls in the United States last summer. The recalls issued outside the US involved some 2,300 different batches of valsartan that had been distributed to “Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta,” CNN reported.
If you took contaminated valsartan, contact the experienced team of lawyers at TheLawFirm.com right away for a free legal consultation with a licensed attorney!
US Food and Drug Administration (FDA)
US Food and Drug Administration (FDA)
Valsartan Lawsuit News Update: Proposed Class Action Suit Filed Over Contaminated Valsartan
October 15, 2018
Following a series of safety communications issued by the United States Food and Drug Administration (FDA) warning of potential contamination to generic forms of the blood-pressure medication valsartan, a Kansas resident has filed a proposed class-action lawsuit against two generic drug makers the plaintiff alleges are legally responsible for the presence of a probable human carcinogen in their products, Law 360 reported.
On October 11, Richard O’Neill filed in New Jersey federal court a complaint accusing Solco Healthcare U.S. LLC and Prinston Pharmaceutical Inc. of selling generic forms of valsartan that contained the substance N-Nitrosodimethylamine (NDMA), which has been linked to liver damage and has been identified by the FDA as a probable human carcinogen. O’Neill alleges that the companies knew or should have known that an ingredient they acquired from China-based Zhejiang Huahai Pharmaceuticals had been contaminated with NDMA.
“These medications are worthless, as they are contaminated with carcinogenic and harmful NDMA, and are not fit for human consumption,” O’Neill’s complaint asserted, according to Law 360. “Indeed, plaintiff and the class have been instructed to immediately stop using the medication, and have turned in their remaining medication for another, non-contaminated brand.”
Since July, the FDA has announced the voluntary recalls of generic valsartan distributed in the US by more than ten different companies, covering dozens of products. (A complete list of recalled valsartan is available.) Following an inspection of the Zhejiang Huahai Pharmaceuticals facility in China, the FDA banned all imports of valsartan containing ingredients manufactured there, though the agency concedes that the contaminated pharmaceuticals may have been distributed in the US for as long as four years prior to the recent recalls.
In his complaint, O’Neill claims that he took the contaminated drugs for over a year and that the alleged contamination dates back as far as six years. He says the drug companies that distributed contaminated valsartan in the US have violated several state laws, including consumer fraud statutes.
Though the FDA has said it believes the contamination is due to a change in manufacturing processes, it continues to investigate the situation.
If you or a loved one has been harmed by a dangerous prescription drug or a defective medical device, contact the experienced team of lawyers at TheLawFirm.com today for a free legal consultation with a licensed attorney!
US Food and Drug Administration
Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.
About TheLawFirm.com (TLF)
TheLawFirm.com is a group of award winning attorneys, paralegals and associates from the legal profession who’s main goal is to educate and represent their clients with the utmost expertise, respect and trust.
We also work closely with a large group of experts from the medical profession so we can draw upon their expertise, in order to present as much accurate information relating to various mass tort and personal injury lawsuits as we can.