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Valsartan Recall, Lawsuit and Side Effects

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In a matter of mere months, the previously little-known pharmaceutical ingredient valsartan has gone from relative obscurity to being at the center of multiple drug recalls and at least one potential class-action lawsuit. Since 1996, valsartan, marketed by Novartis under the brand name Dioval, has been approved in the United States for the treatment of high blood pressure and, later, heart failure. However, beginning in July 2018, products containing valsartan were subject to a series of drug recalls over contamination concerns, developments that already have yielded at least one federal lawsuit seeking class-action status.

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Valsartan Recalls

In mid July 2018, the US Food and Drug Administration (FDA) announced a voluntary recall of some, but not all, products containing the active pharmaceutical ingredient valsartan, citing evidence that the drugs had been contaminated with a probable human carcinogen. Thought to be a result of changes in manufacturing methods, the “impurity” involved the presence of the substance N-nitrosodimethylamine (NDMA), which was traced back to valsartan manufactured by Zhejiang Huahai Pharmaceuticals of Linhai, China and later sold to manufacturers of generic valsartan. Based on laboratory studies conducted on animals, the US Environmental Protection Agency (EPA) has classified NDMA as “a probable human carcinogen”.

According to the FDA press release, the July 2018 valsartan recall included generic forms of valsartan sold by:

• Major Pharmaceuticals
• Solco Healthcare
• Teva Pharmaceuticals Industries Ltd.

In late July 2018, the FDA expanded its list of valsartan products to be recalled of recalled due to the presence of NDMA to include drugs sold by:

• Prinston Pharmaceuticals
• Bryant Ranch Prepack Inc.
• H. J. Harkins Company Inc.
• Lake Erie Medical, doing business as Quality Care Products LLC
• NuCare Pharmaceuticals Inc.
• Northwind Pharmaceuticals
• Proficient Rx

The FDA’s valsartan recall list was further augmented throughout August 2018 to include valsartan manufactured in India by Hetero Labs “using a process similar to Zhejiang Huahai Pharmaceuticals”, the source of other NDMA-contaminated valsartan. Additional companies subject to the recall were:

• Camber Pharmaceuticals
• Torrent Pharmaceuticals Limited

According to the FDA, its investigation into valsartan contamination remains ongoing, and additional information will be provided as it comes available. For the FDA’s up-to-date list of drugs included in the valsartan recalls, click here.

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Valsartan Lawsuit

On August 16, 2018, plaintiffs Elizabeth Duffy and John Duffy filed a federal complaint in the Southern District of New York against two drug makers and two drugstore chains for their role in manufacturing, distributing, and selling generic valsartan-containing drugs that were contaminated with NDMA, a substance the US Environmental Protection Agency (EPA) has categorized as a “probable human carcinogen”. The lawsuit, which was filed on behalf of the plaintiffs and all similarly situated consumers, accuses Solco Healthcare and Prinston Pharmaceutical of manufacturing and distributing the potentially harmful drugs and blames drugstores Walgreen Co. and Throggs Neck Pharmacy of selling the drugs to consumers.

If you or a loved one has taken a recalled version of valsartan, contact the experienced team of attorneys at TheLawFirm.com today for a free consultation with a licensed attorney!

What is NDMA, the substance found to have contaminated many forms of valsartan?

According to the United States Environmental Protection Agency (EPA), N-Nitrosodimethylamine, or NDMA, is a “contaminant” that “forms in both industrial and natural processes.” Although NDMA presently is not commercially produced in its pure form in the United States, it previously has been used in the production of such wide-ranging products as “liquid rocket fuel, antioxidants, additives for lubricants, and softeners for copolymers.”

Nowadays, except for research purposes, NDMA no longer is produced for its own sake, but instead is formed as a byproduct of chemical reactions used in various industrial processes. An EPA list of potential NDMA sources in the modern world implicates a variety of large global industries, including “amine manufacturing plants, tanneries, pesticide manufacturing plants, rubber and tire manufacturers, fish processing facilities, foundries, dye manufacturers, and surfactant industries.” NDMA can even result from certain water-purification techniques that use chloramines to disinfect wastewater.

Once introduced into the environment, NDMA is incredibly pervasive, with NDMA contamination having been identified in the air, water, and soil. In humans, exposure primarily takes place through the oral consumption of contaminated food and beverages. the EPA warns that certain everyday items may contain NDMA, increasing the risk of human exposure.

These items include:

• Smoked meats or fish
• Contaminated water
• Malt beverages (such as beer and whiskey)
• Toiletry and cosmetic products (such as shampoos and cleansers)
• Cigarette smoke

What are the health risks associated with NDMA?

The United States Environmental Protection Agency EPA has identified a number of health risks associated with exposure to NDMA. Most seriously, based on animal studies conducted on a variety of mammal species, the EPA has classified NDMA as a B2 carcinogen, meaning it is a “probable” human carcinogen.

The US Department of Health and Human Services (DHHS) similarly has concluded that NDMA “is reasonably anticipated to be a human carcinogen” after having identified tumors in the livers, respiratory tracts, kidneys, and blood vessels of experimental animals exposed to NDMA.

The EPA further cautions that NDMA exposure can cause liver damage in humans and reports other symptoms of NDMA exposure as including “headache; fever; nausea; jaundice; vomiting; abdominal cramps; enlarged liver; reduced function of liver, kidneys and lungs; and dizziness.”

If you or a loved one fears you have taken NDMA-contaminated valsartan and have suffered from any of the side effects listed above, contact the experienced team of attorneys at TheLawFirm.com now for a free legal consultation with a licensed attorney!

What is Valsartan?

Drug maker Novartis originally introduced valsartan into the United States pharmaceutical market under the brand name “Diovan” in 1996, when it was approved by the US Food and Drug Administration (FDA) for the treatment of hypertension, or high blood pressure. Subsequently, the FDA additionally approved Diovan (valsartan) for use in the treatment of heart failure as well as left ventricular dysfunction following myocardial infarction.

What are the health risks associated with Valsartan?

FDA Warnings and Adverse Reactions for Diovan (Valsartan)

From the time of its approval by the United States Food and Drug Administration (FDA) in 1996, Diovan (valsartan) was required to identify on its label a number of serious potential side effects associated with the drug, including a prominent warning to pregnant women that “[w]hen used in pregnancy during the second and third trimesters” drugs like valsartan “can cause injury and even death to the developing fetus.”

In addition to “Fetal/Neonatal Morbidity and Mortality”, the original prescribing information for Diovan (valsartan) also included a warning about the potential for “[e]xcessive reduction in blood pressure” as well as precautions involving impaired kidney and liver function. The revised 2018 labek notes adverse reactions such as headache, dizziness, viral infection, fatigue, and abdominal pain in patients taking Diovan (valsartan) to treat their hypertension.

Potential Link Between ARBs and Cancer

Valsartan is categorized as an “angiotensin II receptor blocker (ARB)”, a category of drug that has been the subject of enhanced scrutiny by the United States Food and Drug Administration (FDA) going back nearly a decade, long before concerns over NDMA contamination prompted recalls of generic valsartan in the summer of 2018. In a series of Drug Safety Communications dating back at least until 2010, the FDA reported that it was exploring potential links between ARBs like valsartan and an increased risk of cancer.

Writing in a Drug Safety Communication dated July 15, 2010 , the FDA announced that it was “conducting a review of the class of medications known as angiotensin receptor blockers (ARBs) after a recently published study suggested they may be associated with a small increased risk in cancer.”

The FDA followed up on the 2010 communication by declaring in June 2011 declaring in June 2011 that it had “completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs)” and had “concluded that treatment with an ARB medication does not increase a patient’s risk of developing cancer.”

Risks of Using ARBs with Other Medications

However, less than a year after it purportedly had cleared angiotensin receptor blockers (ARBs) like valsartan of a suspected increase in cancer risk, the United States Food and Drug Administration (FDA) issued in April 2012 another Drug Safety Communication involving ARBs, this time warning of risks associated with using ARBs in conjunction with other medications.

“The US Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren and other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment,” the agency announced April 20, 2012. “These drug combinations should not be used (are contraindicated) in patients with diabetes.”

Relying on data from a clinical trial known as “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)”, the FDA noted, an increased risk of “kidney (renal) impairment, low blood pressure (hypotension), and high potassium blood levels (hyperkalemia)” in diabetes patients taking aliskiren in conjunction with an ARB or ACEI. The Drug Safety Communication further warned that “preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke).”

Consequently, the FDA announced, that the warning labels for the relevant drugs would be “updated based on preliminary data” from the ALTITUDE study.

If you or a loved one fears you have taken NDMA-contaminated valsartan, contact the experienced team of attorneys at TheLawFirm.com now for a free legal consultation with a licensed attorney!

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Valsartan Lawsuit News and Updates

• October 31, 2018

Valsartan Update: FDA Expands Contaminated ARB Recalls Beyond Valsartan


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.

Sources:
United States Food and Drug Administration (FDA)
Law360

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Valsartan Lawsuit News and Updates

• October 31, 2018

Valsartan News: EU to Increase Scrutiny of Chinese Drug Maker Behind Contaminated Valsartan


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 RemedyRepack 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.

Sources:
US Food and Drug Administration (FDA)
Law360

Valsartan Recall News: Chinese Drug Maker Receives $43Million from Government Amidst Valsartan Recalls


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.

Sources:
Reuters
United States Food and Drug Administration (FDA)
United States Food and Drug Administration (FDA)
Law360
European Directorate for the Quality of Medicines & HealthCare (EDQM)

• October 15, 2018

Valsartan FDA News: FDA Releases Lab Results Showing Valsartan NDMA Contamination Levels


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!

Sources:
US Food and Drug Administration (FDA)
US Food and Drug Administration (FDA)
CNN

• October 15, 2018

Valsartan Lawsuit News: Proposed Class Action Suit Filed Over Contaminated Valsartan


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!

Sources:
US Food and Drug Administration
Law 360

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