Valsartan Lawsuit News and Updates
The latest lawsuit news and updates for the recalled drug Valsartan.
Valsartan Recall News: Bloomberg Exposé Examines Massive Failures Behind Handling of Valsartan Recall Crisis
September 15, 2019
Author: Daniel Gala
In an in-depth exposé published September 12, the publication Bloomberg reports on the findings of its probing investigation into the failures behind the ongoing recalls of the generic medication valsartan and related drugs, casting new light on a years-long saga that oftentimes has gotten lost in the shuffle of the 24-hour news cycle.
Using graphic imagery and individual stories to illustrate the human toll behind the valsartan recalls, Bloomberg exposes the repeated failings of regulators, manufacturers, and distributors to maintain adequate oversight of an increasingly global pharmaceutical supply change, resulting in what appears to have an been an all-too-preventable crisis, the full scope of which we likely will not know for years to come.
NDMA Is An Industrial Poison With A Sketchy Past
“The chemical N-Nitrosodimethylamine, or NDMA, is a yellow liquid that dissolves in water,” the Bloomberg piece reads, referring to the contaminant that has been discovered in valsartan distributed in the US, prompting voluntary recalls of valsartan beginning in July 2018. “A single dose of less than a milligram can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days.”
Bloomberg continues, providing further context:
“An Oklahoma man poisoned the family of an ex-girlfriend in 1978 by pouring a small vial of NDMA into a pitcher of lemonade. In 2018 a graduate student in Canada sickened a colleague by injecting the chemical into his apple pie.”
Now, that dangerous poison, once used as an additive to rocket fuel but now present mostly as a byproduct of industrial processes, has somehow made it into the global pharmaceutical supply chain.
“Drugs sold to millions of people in 30 countries could be tainted,” Bloomberg reports, outlining the enormous scope of the problem.
Rather Than Protect The Public, FDA Has Downplayed Risks In Misleading Ways
Meanwhile, one tactic adopted by the United States Food and Drug Administration (FDA), purportedly the nation’s chief pharmaceutical watchdog, has been to downplay the significance of the contamination by noting that NDMA is present in everyday foods such as cured meats. While conceding that the FDA’s own researchers estimate that for every 8,000 people taking the contaminated valsartan for four years there would be one additional case of cancer, FDA execs have tried to paint these figures as somewhat misleading. (European researchers peg the risk at one additional cancer case in roughly every 4,000 patients.)
“We had to be honest about that [estimate of one new cancer case for every 8,000 patients taking contaminated valsartan], but that’s not a great message for the consumer,” said the director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock, per Bloomberg. “Throw a couple of lamb chops on the barbecue and you’d find nitrosamine after a good grilling. You have to put this in perspective.”
The FDA even went so far as to provide, on a webpage purportedly devoted to providing important information to the public about this ongoing health crisis, bullet points identifying the levels of NDMA contamination found in common foods, such as cured meat, smoked meat, grilled meat, and bacon, presumably in an effort to downplay the significance of the carcinogenic contaminant in a prescription medication. According to the FDA, the “Estimated Range of Daily NDMA Consumption for certain foods” ranged from 0.004 to 1.02 micrograms.
However, as Bloomberg points out, this is hardly equivalent to taking the 17 micrograms of NDMA that have been detected in a single pill of valsartan.
“That’s the equivalent of eating 48 pounds of bacon,” Bloomberg notes.
Further, by pointing to the presence of NDMA in certain meats, the FDA obscures the fact that, regardless of its presence elsewhere in the world, the carcinogenic contaminant had no business being present in prescription pharmaceuticals in any amount, and that the existence of NDMA in contaminated valsartan is directly attributable to the FDA’s own shortcomings.
The FDA Identified Problems At The First Plant Where Contaminated Valsartan Was Discovered, But Failed To Act
The Bloomberg report describes how the FDA itself had identified significant issues at the Chinese manufacturing facility first implicated in the NDMA contamination at least as early as May 2017, more than a year before the first valsartan recalls were issued in the US in July 2018. However, neither the FDA nor the owner of the facility appears to have taken any action at that time.
“When an FDA inspector visited [a Huahai manufacturing facility in China] in May 2017, he was alarmed by what he saw: aging, rusty machinery; customer complaints dismissed with no reason; testing anomalies that were never looked into,” Bloomberg states. “He reported that the company was ignoring signs its products were contaminated.”
However, the FDA failed to act, not even bothering to test any of the drugs produced by this facility at the time. Such testing may have revealed the presence of NDMA contamination, perhaps giving regulators an earlier start on taking action to protect public health.
“Senior FDA officials didn’t reprimand Huahai; they expected the company to resolve the problem on its own,” Bloomberg reports. “Huahai didn’t. The agency didn’t try to identify any impurities at that point, and Huahai didn’t either. It wasn’t until a year later that another company—a customer of Huahai’s—found an impurity in Huahai’s valsartan and identified it as NDMA. That was when the FDA demanded drugmakers begin looking for NDMA in their valsartan. They found it again and again.”
The FDA and the elected representatives in Congress responsible for its oversight have known for years that the agency is far from up to the task when it comes to properly regulating an increasingly international pharmaceutical supply chain and ensuring the safety of drugs entering the US market. On June 28, the House Committee on Energy & Commerce, which oversees the FDA, sent a bipartisan letter to the Government Accountability Office (GAO) requesting that “GAO conduct a review of FDA’s drug inspection program.” At the same time, the Committee sent a follow-up letter to the FDA expressing that “FDA’s oversight of foreign drug manufacturing is a longstanding area of concern for the Committee.”
A previous GAO investigation into the FDA’s foreign drug inspection program, the results of which were detailed in a report published in January 2017, found that, despite quantifiable improvements, significant gaps remained in the FDA’s foreign drug oversight.
For example, the GAO found that “46 percent of the positions at the FDA foreign offices are vacant and that the vacancies have been a persistent problem,” according to a press release issued by the Committee on Energy & Commerce at the time of the GAO report’s release.
Additionally, the GAO report found that nearly 1,000 out of roughly 3,000 total foreign establishments involved in the production of pharmaceuticals for the US market had “no inspection history” whatsoever. Though down from a staggering 64% in 2010, to have approximately one-third of overseas manufacturing facilities having never been visited by an FDA inspector marks a significant hole in its regulatory oversight.
Meanwhile, overseas production of drugs sold in the United States has only been growing.
“At least 80% of all active pharmaceutical ingredients, or APIs, for all drugs are made in Chinese and Indian factories that U.S. pharmaceutical companies never have to identify to patients, using raw materials whose sources the pharmaceutical companies don’t known about,” the Bloomberg exposé states, raising the prospect the full scope of the problem may be much larger than presently is known.
The Valsartan Contamination Crisis Might Be Only The Tip Of The Iceberg
Perhaps most concerning of all, the valsartan contamination fiasco might only be the tip of the iceberg when it comes to the contamination of prescription drugs on the US market. As the 2017 GAO report discovered, FDA oversight of overseas manufacturing facilities remains grossly inadequate. And, as the Bloomberg exposé identifies, even when FDA inspectors reported back problems at the foreign manufacturing facilities that they had actually investigated, the FDA did little, if anything, to enforce compliance and follow up on the situation.
With such shoddy practices apparently so widespread, and accountability practically nonexistent, it is almost inevitable that other drug safety issues exist that simply have not yet been detected.
“Valsartan is just the one we caught,” David Gortler, a former FDA medical officer, told Bloomberg. “Who knows how many more are out there?”
Patients Can Do To Fight Back
With the nation’s purported pharmaceutical watchdog and the elected representatives that oversee it apparently not up to the task of taking the drastic steps necessary to adequately ensure the safety of our nation’s drug supply, patients increasingly are taking the law into their own hands and filing lawsuits against the generic drug companies that sold them contaminated medication, in some cases for years.
Thousands of valsartan-related lawsuits having been filed to date, and federal valsartan products liability claims have been centralized as multidistrict litigation (MDL) in the District of New Jersey. With the prospect of regulatory oversight apparently not enough to get drug manufacturers and distributors to (literally) clean up their collective act, patients and their advocates now are trying a different approach by hitting these companies and their execs where it really counts: in their pocketbooks.
Edney, A., Berfield, S. and Yu, E. (12 September 2019). Carcinogens Have Infiltrated the Generic Drug Supply in the U.S. Bloomberg
House Committee on Energy & Commerce. (28 June 2019). Letter from House Committee on Energy & Commerce to the Comptroller General of the United States, U.S. Government Accountability Office
House Committee on Energy & Commerce. (28 June 2019). Letter from House Committee on Energy & Commerce to the Acting Commissioner of the U.S. Food & Drug Administration
House Committee on Energy & Commerce. (17 January 2019). Nonpartisan Watchdog: FDA Still Lacks Inspection Data On Almost 1,000 Foreign Drug Firms Shipping To U.S. Press Release
Valsartan Recall News: Fears That Valsartan Contamination Was Only Tip Of Iceberg Confirmed As FDA Reports NDMA Found In Zantac
September 15, 2019
Author: Daniel Gala
As the United States Food and Drug Administration (FDA) has struggled to grapple with ongoing recalls of the popular heart and blood-pressure medication valsartan and other angiotensin II receptor blockers (ARBs) following the discovery that certain batches of the drugs had been contaminated with probable human carcinogens, outside observers have voiced concern that the valsartan recalls may represent only the tip of the iceberg when it comes to contamination and other safety issues within the increasingly global pharmaceutical supply chain.
“Valsartan is just the one we caught,” David Gortler, a former FDA medical officer, told Bloomberg for a report published September 12. “Who knows how many more are out there?”
The warnings of Gortler and other experts unfortunately now have been proven all too prescient, as the FDA announced on September 13 that NDMA, the same carcinogenic contaminant that prompted the first valsartan recalls in July 2018, had been discovered in some ranitidine medicines, as well, including the medication sold under the brand name Zantac.
“The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” read the September 13 statement from Dr. Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Ranitidine drugs, including Zantac, are most often prescribed for the treatment of heartburn and are available in both prescription and over-the-counter varieties.
In the statement's second paragraph, the FDA statement ties the discovery of NDMA to the ongoing valsartan recalls.
“The FDA has been investigation NDMA and other nitrosamine impurities in blood pressure and heart failure medications called Angiotensin II Receptor Blockers (ARBs) since last year,” the statement reads. “In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”
Despite the contamination concerns, the statement does not make any reference to potential recalls of Zantac or other ranitidine medicines.
Further, “[t]he FDA is not calling for individuals to stop taking ranitidine at this time.”
Because of significant regulatory and bureaucratic hurdles, it is extremely rare for the FDA to issue an involuntary recall of a pharmaceutical product. All recalls of valsartan and other contaminated ARBs have been voluntary recalls initiated by the manufacturers and/or distributors in coordination with the FDA.
Meanwhile, the FDA says it is investigating the cause of the contamination and will consider taking further action as more information comes to light.
“The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine,” the statement reads. “The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients.”
While the FDA has consistently attempted to downplay the danger of NDMA, noting its presence in small amounts in common foods such as cured meats, as Bloomberg reports in its September 12 exposé on the valsartan recalls and the contamination behind them, NDMA for years has been known as a dangerous poison.
“[NDMA]’s known to cause cancer in animals and is classified as a probable carcinogen in humans—it’s most toxic to the liver. A single dose of less than a milligram can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days,” Bloomberg reports. “An Oklahoma man poisoned the family of an ex-girlfriend in 1978 by pouring a small vial of NDMA into a pitcher of lemonade.”
“[NDMA]’s in tobacco smoke, which is one reason secondhand smoke is dangerous.”
However, from its opening paragraph, the FDA statement attempts to downplay the fact of this dangerous poison’s presence in the nations drug supply.
“NDMA is a known environmental contaminant found in water and foods, including meat, dairy products, and vegetables,” the statement’s first paragraph concludes.
“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” the FDA adds later in the statement, obscuring the fact that this dangerous substance should not be present in any amount in the nation’s drug supply and that its presence, coupled with the FDA’s continuing failure to adequately address the ongoing valsartan recalls, represents an abject failure of the FDA as the nation’s purported pharmaceutical watchdog.
Bloomberg, by contrast, describes NDMA in terms that make it sound less natural and less innocuous:
“NDMA no longer has industrial uses—it was once added to rocket fuel—but it can form during industrial processes at tanneries and foundries as wells as at pesticide, dye, and tire makers.” Additionally, the FDA statement fails to mention that it was not the FDA itself but an independent third-party pharmacy that initially discovered the NDMA contamination in the ranitidine drugs.
According to Reuters, the NDMA contamination in Zantac and other ranitidine medicines was not first detected by any governmental regulatory body but by Valisure, an online pharmacy.
“It seems to be that there’s an inherent problem with the drug itself,” Valisure CEO David Light told Reuters. “There’s a lot of concerns that, in our mind, justify completely recalling this product.”
However, rather than follow the advice of the company that discovered the contamination, the FDA has explicitly adopted a wait-and-see approach to yet another potential national health crisis.
United States Food and Drug Administration (FDA). (13 September 2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. FDA Statement. Dr. Janet Woodcock, MD. Director Center for Drug Evaluation and Research
Edney, A., Berfield, S. and Yu, E. (12 September 2019). Carcinogens Have Infiltrated the Generic Drug Supply in the U.S. Bloomberg
Erman, M. (13 September 2019). U.S. and European regulators reviewing safety of heatburn drugs like Zantac. Reuters
Valsartan Recall News: FDA Releases Statement On Valsartan Recalls, First Update In Two Months
September 9, 2019
Author: Daniel Gala
In a statement released August 28, the United States Food and Drug Administration (FDA) broke nearly two months of public silence on the urgent and ongoing recalls of important heart and blood-pressure medications, including the generic drug valsartan and other angiotensin II receptor blockers (ARBs). However, the statement provided little by way of new information or other assurances that might indicate that the agency, the nation’s chief pharmaceutical watchdog, has made any significant progress in addressing a crisis that has raised serious concerns about the agency’s broader ability to effectively oversee an increasingly international pharmaceutical supply chain.
“Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves,” the statement from the director of FDA's Center for Drug Evaluation and Research, Dr. Janet Woodcock, M.D., begins, adding later in the paragraph, “Millions of people benefit from the high-quality products that the FDA regulates, and the U.S. has the most robust drug supply in the world, with strict standards for safety, effectiveness and quality.”
However, an objective examination of the information contained in the FDA statement does little to support these statements, particularly when placed in the broader context of recent media reports and other developments. In fact, the content of the FDA statement reads more like a public-relations exercise intended to quiet public concerns over the ongoing recalls of valsartan and other ARBs rather than address the causes of the crisis itself.
“As part of our efforts to be transparent regarding the impurities in ARBs, we want to make sure patients have a full understanding of how these impurities may affect them,” the statement reads in its second paragraph. “Notably, we would like to stress that the actual risk to patients is likely much lower than our estimates, which reflect a scientific assessment of the highest possible exposure.”
Amidst the reassurances that the risk probably is not even as bad as the FDA itself previously had stated and the reiterations of already-released information aimed at making it look like the FDA is taking urgent action to address the situation, the agency’s statement ignores a great deal of information that has become public knowledge since its previous valsartan < href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan">update on June 26.
For example, throughout the FDA statement, the agency largely restricts the scope of its valsartan-contamination discussion to “nitrosamine impurities”.
However, in a citizen petition submitted June 13, the pharmacy Valisure, living up to its branding as “the pharmacy that checks”, identified a different form of dangerous contaminant in some batches of valsartan it had tested. In its petition, Valisure urged the FDA to take urgent action to address the alleged contamination with the chemical DMF by, among other things, vastly lowering the agency’s existing safety levels for the contaminant.
“Valisure has tested and detected high levels of N, N-Dimethylformamide (“DMF”) in specific lots of the drug valsartan,” the citizen petition states. “DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (“WHO”) and the International Association for Research of Cancer (“IARC”).”
Despite these concerns having been raised months ago, the FDA has yet to speak publicly about the alleged DMF contamination. In fact, the FDA explicitly continues to screen valsartan and other ARBs only for nitrosamine contamination.
“Ultimately, our goal is to be certain that no ARBs with unacceptable impurity levels reach patients,” the statement reads as it nears its conclusion. “Based on our assessments, with current lab testing, the agency has identified 43 ARB medications that have been determined not to contain any nitrosamine impurities.” (Emphasis added.)
But what, one might ask, of the other impurities identified by reputable third-party labs?
“The FDA has ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, effective, and quality drug products for the American public,” the statement claims. Given the agency’s refusal to date to address many of the outstanding concerns regarding the valsartan recalls or their implications for the FDA’s broader pharmaceutical regulatory regime, one might justifiably question just how “transparent” the agency actually is being.
Woodcock, J. (28 August 2019). Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications. Director - Center for Drug Evaluation and Research. United States Food and Drug Administration. Press Announcements
Valisure Pharmacy. (13 June 2019). Valisure Citizen Petition. Division of Dockets Management. United States Food and Drug Administration (FDA)
Valsartan Recall News: ‘Your API Are Adulterated’: FDA Sends Stern Warning Letter To Indian Solvent Company Tied To Valsartan Recalls
August 26, 2019
Author: Daniel Gala
In a somewhat novel approach that represents a further expansion of its efforts to address ongoing recalls of the popular blood-pressure medication valsartan and similar drugs, the United States Food and Drug Administration (FDA) has sent a warning letter to an Indian solvent recovery and manufacturing company involved in the overseas manufacture of drugs found to be contaminated with probable human carcinogens. The FDA letter, dated August 8 details Lantech Pharmaceuticals Limited’s alleged failure to adhere to industry best practices in recovering and manufacturing solvents used in the drug manufacturing process.
According to the letter, the FDA’s claims are based on FDA inspections that took place in India from March 6 to 15, 2019.
“This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API),” the FDA letter states. “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of [US law].”
Of the many allegations contained in the FDA’s warning letter, among the most serious is the claim that, once informed of the contamination problem, Lantech’s efforts to investigate and remedy the problems were severely lacking in a number of key ways. According to the FDA, in December 2018, Lantech was informed by a customer (identified in the letter only as “b(4)”) that it had “identified the potential mutagenic impurity N-Nitrosodiethylamine (NDEA) in samples collected from [Lantech] equipment.”
However, although customer b(4) told Lantech of potential impurities of the related contaminant NDMA as well as NDEA, the FDA alleges that Lantech’s investigation focused only on NDEA contamination.
Further, the FDA found gross inadequacies with Lantech’s record keeping, particularly with regards to the company’s use of its storage tanks.
“Given that your firm does not maintain logbooks or documentation demonstrating product use or cleaning associated with the use of these tanks, there is a a potential for all products manufactured at your facility to contain nitrosamines through mix-ups or cross contamination,” the FDA asserts, adding later, “Your firm failed to adequately evaluate the potential of these ARBs to form nitrosamines and identify potential cross contamination risks for drugs manufactured made [sic] using non-dedicated equipment shipped into the U.S. supply chain.”
With the FDA’s previous enforcement efforts related to the ongoing valsartan crisis having focused primarily on overseas drug manufacturers and the generic-drug companies that import these pharmaceuticals onto the US market, the focus on a solvent recovery and manufacturing company represents an expansion of the FDA’s response. However, with solvents having been identified as the cause of the carcinogenic impurities, it represents a necessary response to addressing the issue and preventing further contamination in the future.
The fact that FDA must now also keep tabs not only on overseas drug manufacturers but also on the companies that provide them with solvents to use in the drug-making process shows the staggering scope of the enforcement problem facing the agency, which has flatly admitted it lacks the resources to adequately inspect all foreign drug-making facilities that produce pharmaceuticals bound for the US market.
The first valsartan recalls were announced in July 2018, more than six months after Lantech first was informed by the anonymous customer that it had detected NDEA and NDMA in Lantech solvents.
Federal products liability lawsuits filed against generic-drug makers by patients alleging they were exposed to contaminated valsartan or otherwise negatively impacted by the recalls have been centralized as multidistrict litigation (MDL) in the US District Court for the District of New Jersey.
United States Food and Drug Administration (FDA). (8 August 2019). Warning Letter 320-19-34. Lantech Pharmaceuticals Limited. FDA Website
United States Food and Drug Administration (FDA). (Updated 26 June 2019). FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). Drug Safety and Availability
United States District Court District of New Jersey. (Accessed 25 August 2019). Valsartan MDL 2875
Valsartan Recall News: Despite Nearly Two Months With No FDA Updates On Valsartan Recalls, Many Questions Remain
August 19, 2019
Author: Daniel Gala
While the United States Food and Drug Administration (FDA), the nation’s purported pharmaceutical watchdog, has gone nearly two months without issuing new recalls or providing updated public information pertaining to the ongoing crisis over contamination of the generic heart and blood-pressure medication valsartan, a number of serious questions continue to linger about the valsartan recalls themselves as well as what they have revealed about the FDA’s potential inability to properly oversee an increasingly global pharmaceutical supply chain.
Chief among these open questions are if, when, and how the FDA will respond to two pieces of official correspondence directed at the agency. First, on June 28, the House of Representatives Committee on Energy and Commerce issued a letter seeking additional information pertaining to the committee’s investigation into “the Food and Drug Administration’s (FDA) ability to ensure the safety of the nation’s drug supply.”
The June 28 letter was a follow-up to the committee’s February 2019 correspondence expressing concern over the valsartan recalls and the broader implications for the safety of pharmaceuticals sold and consumed in the United States.
“Beginning in July 2018, there have been at least 15 recalls issued for a variety of angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure,” the committee’s February letter, addressed to then-FDA Commissioner Scott Gottlieb, MD, states. “The roots of this ever-expanding series of recalls appear to be related to at least two foreign drug manufacturing facilities: Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India. Inspection reports from these two factories indicate serious problems at both factories, even before the carcinogens were detected.”
While the committee’s June correspondence indicates that FDA had provided a “staff briefing” it further states that those same members “remain concerned about whether FDA has the appropriate resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing.”
While the June 28 letter requests additional information be furnished to the committee by July 12, the committee has not issued a public statement [https://energycommerce.house.gov/newsroom] confirming whether or not any such information was received and, if so, what its contents consist of, leaving the matter of congressional oversight and the potential ramifications for FDA a huge open question in the valsartan recalls.
Secondly, the FDA has yet to respond publicly to a citizen petition dated June 13 submitted by Valisure online pharmacy informing the agency that “Valisure has tested and detected high levels of N,N-Dimethylformamide (‘DMF’) in a specific lot of the drug valsartan…DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (‘WHO’) and International Association for Research of Cancer (‘IARC’).”
The citizen petition requests that the FDA Commissioner: “review and significantly lower the acceptable intake/permitted daily exposure limit of DMF”; “request a recall of identified lots of valsartan”; “conduct examinations and investigation [sic]…regarding these products, their manufacturing processes, and the manufacturer submissions made for FDA approval”; “provide information to the public regarding these products”; and “promulgate regulations requiring robust independent chemical batch-level testing and verification of the chemical content of batches of pharmaceuticals.”
To date, the FDA does not appear to have taken any of the requested actions. The FDA website devoted to providing the public with regular updates on the valsartan recalls makes no mention of the Valisure citizen petition or of potential contamination with the carcinogen DMF, and no valsartan recalls, voluntary or mandatory, have been issued over the alleged DMF contamination.
With so many questions left unanswered, it is a bit puzzling that the FDA now has gone silent for nearly two months on the valsartan recalls, having not posted a public update since June 26.
House Committee on Energy & Commerce. (28 June 2019). Letter to Acting FDA Commissioner Dr. Norman E. Sharpless, M.D. Committee Website
House Committee on Energy & Commerce. (13 February 2019). Letter to FDA Commissioner Dr. Scott Gottlieb, MD. Committee Website
Valisure Pharmacy. (13 June 2019). Valisure Citizen Petition. Division of Dockets Management. United States Food and Drug Administration (FDA)
United States Food and Drug Administration (FDA). (Last Updated 26 June 2019). FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). Drug Safety and Availability. FDA Website
Valsartan Recall News: “This Affects The Readiness Of Our Troops”: Valsartan Recalls Raise National Security Concerns
August 7, 2019
Author: Daniel Gala
With the ongoing recalls of generic valsartan highlighting both the US pharmaceutical industry’s over-reliance on Chinese drug manufacturers and the potential risks of such an arrangement, US military officials increasingly are voicing concerns that the issue holds ramifications for national security, as well.
“This affects the readiness of our troops,” Larry Wortzel, military retiree and a member of the U.S.-China Commission, told Bloomberg. Wortzel takes a generic form of the blood-pressure medication valsartan, and his pills were recalled four times over a three-month span as a result of ongoing recalls issued by the US Food and Drug Administration (FDA).
“They were contaminated with rocket fuel,” Wortzel said, per Bloomberg, referring to the probable human carcinogen NDMA, which has been identified in some lots of recalled valsartan. NDMA is indeed found in rocket fuel, as well as certain foods such as grilled meats.
The Defense Logistics Agency (DLA), which manages the supply chain for the US military, is responsible for procuring the medications that supply military medical facilities. A DLA spokesperson told Bloomberg that DLA had purchased valsartan that later had been subject to recall.
The ongoing valsartan recalls, which date back to July 2018, began when active pharmaceutical ingredients (APIs) used in the manufacture of generic valsartan were found to be contaminated with probable human carcinogens. The contamination is believed to be the result of the manufacturing processes used at the overseas facilities where the APIs were made. The contamination first was traced to a facility in China and later to an additional facility in India.
“We wouldn’t have our aircraft carriers and nuclear submarines in China, and for very important medications, we really should look at what it takes to purchase based on value and not just price,” Rosemary Gibson, author of the book “China-Rx”, recently told a US-China advisory panel in Washington, according to Bloomberg.
Christopher Priest, acting deputy assistant director for health-care operations and Tricare for the Defense Health Agency, expressed similar concerns, telling the panel, “The national security risks of increased Chinese dominance of the global API market cannot be overstated.”
Aside from the potential of drug-quality issues such as those that sparked the valsartan recalls to impact military readiness, national security experts also have voiced concern that China’s dominance of the market could put the US at a disadvantage in the event of conflict, giving China the ability to effectively shut off US pharmaceutical supplies.
“If China shut the door on exports, our hospitals would cease to function, so this has tremendous urgency,” said Gibson.
Edney, A. (5 August 2019). Pentagon Sees Security Threat in China’s Drug-Supply Dominance. Bloomberg
Valsartan News: House Committee Voices Renewed Concerns Over FDA’s Handling Of Valsartan Recalls
July 8, 2019
Author: Daniel Gala
On Friday, June 28, the House Energy and Commerce Committee’s top members sent bipartisan letters to the Government Accountability Office (GAO) and the US Food and Drug Administration (FDA) voicing renewed concerns over the FDA’s handling of the ongoing valsartan recalls as well as the agency’s ability to properly oversee the global pharmaceutical supply chain more broadly.
“A bipartisan group of Energy and Commerce Committee leaders sent a letter to the Government Accountability Office (GAO) today requesting a review of the Food and Drug Administration’s (FDA) drug inspection program following a series of recent recalls of contaminated blood pressure medications that were manufactured in China and India,” a June 28 press release states, referring to the recalls of valsartan and other angiotensin II receptor blockers (ARBs) such as losartan and irbesartan. “The lawmakers also sent a letter to FDA following up on an earlier request for information on the agency’s ability to ensure the safety of the drug supply chain following a series of recalls involving drugs manufactured overseas.”
The lawmakers have requested that the FDA provide responses to the questions stated in the committee’s letter by July 12.
The committee’s letter to the GAO requests that the government watchdog take another look at the FDA’s oversight of overseas pharmaceutical production. The correspondence, signed by a bi-partisan group of lawmakers including Chairman Frank Pallone, Jr., a New Jersey Democrat, and Ranking Member Greg Walden, a Republican representing Oregon, cites a January 2019 report by Bloomberg , which found that FDA inspections of foreign manufacturing facilities actually haddeclined in the midst of the ongoing valsartan recalls, the first of which were announced in July 2018.
“Treatments made by Chinese companies now account for almost one of every 10 generic drugs cleared by the FDA for sale,” Bloomberg reported. “But agency inspections meant to ensure that approved drugs are meeting U.S. standards fell almost 11 percent, to 125, in China for the fiscal year that ended Sept. 30 , compared with the previous year, according to data obtained by Bloomberg through public-records requests.”
Perhaps more worrying than the drop in overall inspections, the Bloomberg investigation cited by lawmakers also found that, even when investigations did take place and uncovered violations, FDA inspectors often clashed with FDA management over what should be done about it.
Shockingly, the China-based manufacturing facility originally at the center of the valsartan recalls was the subject of one such controversy over a year before the first recalls were announced.
“At the plant that set off the heart-drug recall in July of last year, an FDA inspector had determined in May 2017 that some of the drugs it was supplying to the American market might be substandard, according to an inspection report obtained by Bloomberg,” the investigation found. The report continued:
The FDA inspector’s 2017 visit had turned up a number of problems. The Chinese drugmaker, Zhejiang Huahai Pharmaceutical Co. Ltd., had omitted from official records quality-test results that showed unnamed drugs failed to meet U.S. standards, and instead recorded passing grades, the FDA inspector wrote in his report. The inspector recommended that the agency send Zhejiang Huahai, one of China’s largest exporters of pharmaceuticals, a warning letter that likely would have meant it couldn’t gain approval to make any new generic drugs in that factory until it cleared up the list of problems.
But four months later, FDA managers at the agency’s Silver Spring, Maryland, headquarters overruled the inspector. Zhejiang Huahai Pharmaceutical was allowed to avoid those penalties and address the problems itself—possibly missing a chance to detect the cancer causing contaminant more than a year earlier than it was.
In response, the congressional lawmakers are asking the GAO to take another look at the FDA’s oversight mechanisms including “[t]o what extent...FDA’s efforts [are] adequate to oversee the drug product supply chain.”
The GAO initially included the FDA’s ability to ensure the safety of medical products in the United States in its “High-Risk Series” in 2009, culminating in a GAO report released December 2016 which “found that FDA had increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection,” according to the committee’s letter to the GAO.
However, the Bloomberg report suggests a significant backslide may have taken place since that time, prompting the lawmakers’ request for a fresh review of FDA practices.
The original recalls of valsartan, a popular blood-pressure medication, date back to July 2018, when the FDA announced that it had detected a carcinogenic contaminant in certain batches of the drug. The ongoing recalls continue to expand, with the most recent related recalls announced June 26.
House Energy and Commerce Committee. (28 June 2019). Bipartisan E&C Leaders Request GAO Review Of FDA’s Foreign Drug Inspection Program. Press Releases
House Energy and Commerce Committee. (28 June 2019). Letter to The Honorable Gene L. Dodaro, Comptroller General Of the United States, US Government Accountability Office. EnergyCommerce.House.gov
Edney, A. (30 January 2019). How a Tainted Heart Drug Made in China Slipped Past the FDA. Bloomberg
United Stated Food and Drug Administration. (Last updated 26 June 2019). FDA Updated and Press Announcements On Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). FDA Website
Valsartan News: Online Pharmacy Tells FDA It Has Found Another Carcinogen In Valsartan
June 19, 2019
Author: Daniel Gala
In a citizen petition to the United States Food and Drug Administration (FDA) dated June 13, the online pharmacy Valisure reported that its tests had revealed the presence of yet another carcinogen in generic forms of valsartan, a popular heart and blood-pressure medication that already had been subject to ongoing recalls over contamination concerns. The carcinogenic contaminant, a solvent often used in pharmaceutical production, was identified in valsartan sold by multiple companies, including Swiss pharmaceutical giant Novartis AG, maker of the original non-generic valsartan branded as Diovan.
News of the Valisure citizen petition was first reported by Bloomberg in an articles posted June 18.
The petition raises fresh concerns over the FDA’s ability not only to effectuate the valsartan recalls, which continue to broaden in scope despite having been ongoing since July 2018, but to properly oversee an increasingly global pharmaceutical supply chain in general.
“Valisure has tested and detected high levels of N,N-Dimethylformamide (‘DMF’) in specific lots of the drug valsartan, an angiotensin II receptor blocker (‘ARB’),” the Valisure citizen petition states. “DMF is a chemical that was reclassified in 2018 as a Group 2A probable human carcinogen by the World Health Organization (‘WHO’) and International Association for Research of Cancer (‘IARC’).”
Certain lots of generic valsartan previously had been found to be contaminated with the carcinogenic nitrosamines NDMA and NDEA, both of which also are classified as Group 2A probable human carcinogens, according to the Valisure petition.
The petition urges the FDA to take a number of drastic steps in response to the company’s findings, among them requesting a recall of the affected lots of valsartan. (Existing law makes it so onerous for the FDA to order involuntary recalls that essentially all recalls in the United States are voluntary on the part of drugmakers.)
Additionally, Valisure calls for the FDA to “review and significantly lower the acceptable intake/permitted daily exposure limit of DMF…from its current level of 8,800,000 nanograms to less than 1,000 nanograms (and potentially as low as 96 nanograms).”
Later Valisure explains its reasoning based on comparisons to the FDA’s permissible levels of similar carcinogens. According to the Valisure petition, the permissible levels of DMF are “9,166,667% higher than the acceptable intake limit of NDMA,” which also has been found in contaminated valsartan and which also is classified as a Group 2A carcinogen.
This makes the FDA’s response to the petition particularly troubling, with the purported industry watchdog stating that “it is important to note that the amounts of DMF being reported are more than 100 times less than those determined by international standards as the level of concern to patients,” according to Reuters.
The DMF levels detected ranged widely, according to the petition, with Valisure discovering contamination of as little as 8 nanograms per pill to as much as 100,000 nanograms per pill.
As of the close of business on June 18, an FDA webpage set up to provide the public with updates about the ongoing recalls of valsartan and other ARBs did not contain any mention of the Valisure petition or concerns over additional lots of valsartan being contaminated with a probable human carcinogen.
In its citizen petition, Valisure suggests that the discovery of DMF may be related to the presence of the carcinogenic nitrosamines.
“In the recent wave of ARB recalls due to the discovery of probably human carcinogens, it has become apparent that the switch in the manufacturing industry to the use of the DMF solvent may be largely responsible for the formation of nitrosamine carcinogens,” the petition states.
This increased use of DMF has come despite recognition of its potential dangers by the FDA itself.
“DMF is classified by the FDA as a Class 2 solvent and is commonly used in the production of pharmaceutical active ingredients,” Valisure states in its petition. “According to the FDA, Class 2 solvents ‘should be limited in pharmaceutical production because of their inherent toxicity.’”
The makers of recalled valsartan already face thousands of lawsuits filed by patients, investors, and insurance companies over the contamination fiasco, and, with the scope of the ARB recalls only growing, thousands more are likely to follow. Federal products liability claims filed by patients exposed to contaminated valsartan have been centralized as multidistrict litigation (MDL) in the District of New Jersey.
Valisure, LLC. (13 June 2019). Valisure Citizen Petition. United States Food and Drug Administration (FDA)
Edney, A. (18 June 2019). Fourth Carcinogen Discovered in Heart Pills Used by Millions. Bloomberg
United States Food and Drug Administration (FDA). (Accessed 18 June 2019). FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan). FDA Website
Valsartan News: New Book Takes In-Depth Look At Overseas Drug Manufacturing Flaws Like Those That Led to Valsartan Contamination
May 22, 2019
Author: Daniel Gala
In her new book Bottle of Lies: The Inside Story of the Generic Drug Boom, released May 14 by HarperCollins, the investigative reporter Katherine Eban takes an in-depth look at many of the same issues that led to ongoing recalls of the generic blood-pressure medication valsartan over contamination concerns. The release of the book, along with Eban’s associated publicity tour, which has included interviews at a number of top media outlets, have increased public scrutiny over the United States Food and Drug Administration’s (FDA’s) ability to properly oversee an increasingly global pharmaceutical supply chain.
The details contained in the book also suggest that the ongoing recalls of valsartan found to be contaminated with human carcinogens may represent only the tip of the iceberg in terms of concerns over the safety of generic drugs sold on the US market.
According to Eban, what began as an investigation into why people taking widely different generic drugs seemed to complain about similar side effects ended up as a scorching exposé of the generic drug industry as a whole. With help from sources both inside the industry and from within regulatory agencies like the FDA, Eban exposes outright fraud committed by overseas manufacturers of active pharmaceutical ingredients (APIs) and final drugs sold on the US market.
“A generic drug executive contacted me anonymously under the pseudonym ‘4 Dollar Refill,’” Eban shares in the Author’s Note, written in March 2019, continuing:
He explained that there was a gulf between what the regulations required of generic drug companies and how those companies behaved. To minimize costs and maximize profit, companies circumvented regulations and resorted to fraud: manipulating tests to achieve positive results and concealing or altering data to cover their tracks.
To those who have been following the valsartan recalls, which date back to July 2018, the book is not so much shocking in that it draws concerns to the overseas manufacturing of generic drugs—much of which mirrors information that already had been known publicly if not widely publicized—but in its simultaneous revelations of both the massive scope and revolting particulars of the situation.
“‘It’s like it was at the turn of the twentieth century,’ a Dutch pharmaceutical executive, who encountered a frog infestation at a manufacturing plant in China, told me,” Eban writes. “‘It’s like The Jungle,’ he said, referring to the book by Upton Sinclair that exposed gruesome conditions in America’s meatpacking plants.”
In the United States, thousands of lawsuits have been filed against the sellers and manufacturers of contaminated valsartan, with plaintiffs including patients exposed to the contaminated drugs, insurance companies forced to pay increased prices due to diminished supplies resulting from the recalls, and investors who say that company executives knew or should have known about the contamination problems and failed in their fiduciary duties by not doing anything about it.
Federal products liability claims over contaminated valsartan have been centralized as multidistrict litigation (MDL) in the District of New Jersey.
Eban, Katherine. Bottle of Lies: The Inside Story of the Generic Drug Boom. HarperCollins, 2019
Valsartan FDA Update: FDA Says Valsartan Could Have Been Contaminated For Up To Four Years
May 8, 2019
Author: Daniel Gala
“Based on FDA laboratory testing results and records from manufacturers of the recalled valsartan lots, the impurities may have been present in valsartan-containing finished drug lots for up to four years.”
Thus states a new laboratory analysis of valsartan products released by the United States Food and Drug Administration (FDA) on May 2, confirming that the contamination went undetected for years before regulators took action.
The concession that contaminated medications could have been sold on the US market for approximately three years before being recalled serves as a stern reminder that, nearly a year since the first valsartan recalls in July 2018, the FDA still is learning new information about the scope of the contamination that prompted those recalls.
Worldwide recalls of contaminated valsartan and other generic angiotensin II receptor blockers (ARBs) such as losartan and irbesartan have resulted in drug shortages, price spikes, and thousands of lawsuits filed by patients, health insurance providers, and investors.
Federal products liability lawsuits filed by patients exposed to contaminated valsartan have been centralized as multidistrict litigation (MDL) in the District of New Jersey. The revelation that these patients may have been unwittingly exposed to contaminated medications for years likely will only bolster their claims.
It also raises further questions about the FDA’s ability to properly oversee the 21st-century global supply chains used by drug manufacturers, with the majority of active pharmaceutical ingredients (APIs) used in medications sold in the US today being manufactured at facilities overseas.
The carcinogenic compounds found to have contaminated valsartan and other ARBs have been traced back to facilities in China and India, where a change in manufacturing techniques is suspected to have resulted in the contamination.
In addition to new laboratory analysis about the levels of nitrosamine contamination in recalled lots of valsartan, the FDA release also included an update on the estimated risk of these exposure levels.
“FDA 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,” the FDA release states regarding contamination with the nitrosamine NDMA, which is believed to be carcinogenic in humans.
“FDA scientists estimate that if 18,000 people took valsartan at the highest dose (320 mg) containing NDEA from recalled batches for four years, there may be one additional case of cancer over the 18,000 people,” the release continues. “NDEA has a marginally lower cancer risk estimate than NDMA because NDEA levels were lower than levels of NDMA in drug samples.”
Though these figures may make the risk sound small, with millions of people potentially having taken the popular blood pressure medication on a regular basis, the contamination could result in hundreds if not thousands of additional cancer diagnoses. And one might hope that the FDA would consider even one case of cancer caused by contaminated medication to be one case too many.
United States Food and Drug Administration (FDA). (2 May 2019). Laboratory analysis of valsartan products. FDA Website
Valsartan FDA Update: Defendants Must Hand Over All Communications With FDA, Valsartan MDL Judge Orders
May 4, 2019
Author: Daniel Gala
Defendants in multidistrict litigation (MDL) over the generic blood-pressure medication valsartan have until June 17 to hand over all communications with the United States Food and Drug Administration (FDA) over valsartan recalls and contamination, the presiding magistrate judge demanded in an April 29 order addressing what he termed “core” discovery matters in the relatively young litigation.
The order limited the scope of the required production to valsartan, omitting the related drugs losartan and irbesartan for the time being.
The defendants covered by the order include manufacturers of active pharmaceutical ingredients (APIs) used in contaminated valsartan, suppliers of contaminated valsartan in the United States, and “finished product/dose manufacturer defendants.”
The order requires that each of these defendants produce their communications with the FDA about the valsartan recalls and contamination, as well as materials relating to the abbreviated new drug application (ANDA) for valsartan. In addition, API manufacturer and supplier defendants hand over their valsartan master drug files.
The Valsartan MDL arises from worldwide recalls of generic valsartan that had been found to be contaminated with probable human carcinogens. In the United States, the FDA announced the first voluntary recalls in July 2018, and new recalls of valsartan and other angiotensin II receptor blockers (ARBs), such as losartan and irbesartan, continue to be announced.
Established earlier this year by the Judicial Panel on Multidistrict Litigation (JPML), the valsartan MDL centralized in the District of New Jersey federal products liability lawsuits filed by patients who claimed to be injured by contaminated valsartan. Makers and sellers of contaminated valsartan also face lawsuits from health insurance companies seeking compensation for the steep rise in drug prices that resulted from the recalls and from investors who claim company executives knew or should have known about the contamination and done something to prevent it.
Following an FDA investigation, the contamination of valsartan and other ARBs with carcinogenic nitrosamines ultimately was traced back to active pharmaceutical ingredients manufactured at a facility in China and, later, one in India.
The complexity of the recall situation has been compounded by the known risks of abruptly stopping taking valsartan, including stroke.
Per the April 29 order, the next telephonic status conference is scheduled to take place May 8, and the next in-person status conference is scheduled for May 29.
United States District Court for the District of New Jersey. (29 April 2019). Order. MDL 2875. In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation
Valsartan FDA Update: FDA Reveals New Methods For Detecting Carcinogenic Impurities Found In Valsartan
April 21, 2019
Author: Daniel Gala
On April 19, the United States Food and Drug Administration FDA released two new testing techniques for detecting the carcinogenic impurities that have been found in the generic blood-pressure medication valsartan and similar drugs, resulting in ongoing voluntary recalls dating back to July 2018. The announcement came just one day after the FDA declared additional recalls related to the contamination.
The recalls have affected valsartan and other angiotensin II receptor blockers (ARBs) that contain active pharmaceutical ingredients found to be contaminated with various nitrosamines, substances believed to cause cancer in humans. The contamination in valsartan and other ARBs has been traced to new manufacturing techniques used in overseas facilities that produced active pharmaceutical ingredients used in the drugs, which were then sold in countries around the globe, including the US.
The new tests are aimed at aiding regulators, manufacturers, and distributors in identifying nitrosamine contamination before the medication reaches patients. One of the new methods, a headspace GC-MS method, is capable of detecting the nitrosamines NDMA, NDEA, NDIPA, and NEIPA, while the other, a direct injection GC-MS method, is able to detect those four nitrosamines in addition to NDBA.
One of the challenges facing regulators dealing with the valsartan contamination has been the lack of effective testing techniques for identifying the nitrosamine impurities, raising the question of what other contamination might be present but is simply going undetected using existing methods.
The ongoing recalls of valsartan and other ARBs already has resulted in thousands of lawsuits filed by plaintiffs ranging from patients who were exposed to the dangerous carcinogens in their medications to investors who claim that executives at companies selling the contaminated drugs violated their fiduciary duties by allowing the fiasco to negatively impact shareholder value.
Federal valsartan products liability claims in the US have been centralized as multidistrict litigation (MDL) taking place in the District of New Jersey.
United States Food and Drug Administration. (Updated 19 April 2019). Torrent further expands its voluntary recall of losartan; FDA posts new nitrosamine testing methods. FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan, and Irbesartan
United States Food and Drug Administration. (18 April 2019). Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP. Company Announcement
Valsartan Lawsuit (MDL) Update: Valsartan MDL Judge Lays Groundwork For Direct Filing Of Cases
April 12, 2019
Author: Daniel Gala
The judge overseeing multidistrict litigation (MDL) over contaminated batches of the generic blood-pressure medication valsartan issued on April 9 an order allowing cases to be filed directly with the MDL, paving the way for new cases to join the centralized litigation without first having to file their cases in a different district.
“In order to eliminate delays associated with the transfer to this Court of actions filed in or removed to other federal district courts and to promote judicial efficiency…any plaintiff whose action would otherwise be subject to transfer to MDL No. 2875 may hereinafter file his or her complaint against all defendants directly into docket matter No. MDL No. 2875 [sic] in the District of New Jersey,” the order, issued by District Judge Robert B. Kugler for the District of New Jersey, states.
The case management order further reports that defendants have stipulated not to argue improper venue against plaintiffs filing directly with the District of New Jersey, with any venue challenges to be addressed at the conclusion of the centralized pretrial proceedings. Meanwhile, defendants also have been stayed, for the time being, from issuing any responses to new complaints filed with the MDL.
The litigation stems from ongoing voluntary recalls issued by the United States Food and Drug Administration (FDA) over concerns that some batches of valsartan and related drugs have been contaminated with probable human carcinogens due to flaws in the manufacturing process. The MDL has centralized federal claims brought by patients who were exposed to the contaminated medications.
Only the third case management order issued in the nascent MDL, the order demonstrates that, though the litigation continues to move forward, it remains quite early in the proceedings.
The United States District Court For the District of New Jersey Camden Vicinage. (9 April 2019). Case Management Order No. 3 (Direct Filing Order – Stipulated). Master Docket No. 19-2875 (RBK/JS). In Re: Valsartan NDMA Products Liability Litigation
Valsartan FDA Update: Amid Valsartan Shortages, FDA Suspends Own Contamination Standards
April 11, 2019
Author: Daniel Gala
Citing ongoing drug shortages and the potential for further shortages in the future, the United States Food and Drug Administration (FDA) announced in a statement released April 4 that it would be temporarily suspending its own standards for drug contamination levels, allowing drugs that ordinarily would be barred from sale in the US to instead be distributed to patients. The announcement applied to the widely used blood-pressure medication valsartan and other angiotensin II receptor blockers (ARBs), such as losartan and irbesartan, some lots of which have been found to be contaminated with probable human carcinogens.
“Removing the affected medications from the market has led to shortages, and since then we’ve been working to mitigate and prevent shortages as often as possible,” the FDA statement reads. “Currently, valsartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon,. “In anticipation, the agency is not objecting to temporary distribution of specific lots of losartan that contain impurities above the interim acceptable intake limit, for a short period time.”
The admission that the agency would be suspending its own safety standards to allow manufacturers of medications found to be contaminated with dangerous substances to continue to sell their products in the United States under the guise of helping to alleviate a drug shortage those very same manufacturers caused was buried after the announcement that the FDA had found 40 different medications that had not been contaminated.
“Today, for the first time since the first nitrosamine impurity was discovered last summer, we’re announcing that we so far have identified 40 ARB medications where our assessment concluded they do not contain any known nitrosamine impurities, with the expectation that this number will increase,” the statement, attributed to then-FDA Commissioner Scott Gottlieb, M.D. and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, says before delving into the suspension of the usual safety standards.
“Our scientists feel that this [suspension of FDA contamination standards with regards to nitrosamines] will not have a meaningful increased risk for cancer over the time it should take to get impurity-free losartan to the market,” the FDA explains. “We want to reassure patients that we strongly believe the risks, such as stroke, of abruptly discontinuing these important medicines far outweighs the low risk associated with continuing the medications with these impurities.”
The FDA says it expects the United States supply of affected medications to be replenished with contamination-free drugs within six months. The announcement does not address what the FDA plans to do if this expectation is not met.
The announcement is just the latest in a series of FDA communications regarding the ongoing recalls of valsartan and other ARBs, with the most recent recall having been issued on March 25. The voluntary recalls, the first of which was announced in July 2018, result from concerns that the drugs had been contaminated with probable human carcinogens known as nitrosamines. The contamination later was traced back to active pharmaceutical ingredients (APIs) manufactured in overseas facilities in China and India, which were then used in generic forms of valsartan and other ARBs, such as losartan and irbesartan, that were distributed in the US.
United States Food and Drug Administration (FDA). (4 April 2019). Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of the agency’s ongoing efforts to resolve ongoing safety issue. FDA Statement
Valsartan (MDL) Lawsuit Update: Valsartan MDL Judge Sets Schedule For Bi-Weekly Status Conferences
April 5, 2019
Author: Daniel Gala
In just the second case management order in multidistrict litigation (MDL) over contaminated valsartan, the presiding judge on April 2 laid out the court’s forthcoming schedule, addressing such preliminary matters as the timing of bi-weekly status conferences in a reminder that the nascent litigation is only beginning to get under way.
According to the order, issued by United States District Judge Robert B. Kugler for the District of New Jersey, monthly in-person status conferences will be held on the fourth Wednesday of each month, with a telephonic status conference to be conducted on the Wednesday two weeks later.
Each of the monthly, in-person status conferences will consist of two parts: a morning session devoted to discovery issues and an afternoon session concerning case management and scheduling matters.
Other topics addressed in the order issued by Judge Kugler include the nomination of attorneys for positions on the plaintiffs’ leadership committees; the reporting of common benefit fees and costs; the drafting of a Master Complaint, Short Form Complaint, and other documents for each class of plaintiff; and the parties’ submitting of an agenda for the next status conference.
The Valsartan MDL centralizes federal products liability claims over the generic blood-pressure medication valsartan, certain batches of which the United States Food and Drug Administration (FDA) has found to be contaminated with substances thought to be human carcinogens. The contamination has been linked to overseas manufacturing facilities where active pharmaceutical ingredients (APIs) used in generic valsartan were made, and valsartan has been subject to ongoing voluntary recalls.
In addition to products liability lawsuits filed by patients who have been exposed to the contaminated drugs, sellers of generic valsartan also face claims filed by investors alleging the companies’ executives knew or should have known of the risk presented by the contaminated medications and by insurance companies who have incurred additional costs due to price spikes resulting from the valsartan recalls.
United States District Court for the District of New Jersey Camden Vicinage. (2 April 2019). Case Management Order No. 2. Master Docket No. 19-2875 (RBK/JS). In Re: Valsartan NDMA Products Liability Litigation
Valsartan FDA Recall News Update: FDA Updates Valsartan-Containing Meds Under Recall
March 25, 2019
Author: Daniel Gala
On March 22, the United States Food and Drug Administration (FDA) issued an update to its list of valsartan-containing medications under recall due to contamination concerns. According to the FDA, the list has been revised “to incorporate additional repackagers of Aurobindo’s valsartan-containing medicine.”
Aurobindo Pharma USA, Inc. presently has several different medications on the valsartan recall list, including drugs that combine valsartan with amlodipine and hydrochlorothiazaide (also known as HCTZ).
The March 22 update also included an expansion of recalls involving losartan-containing drugs. Losartan, like valsartan, belongs to the class of drugs known as angiotensin II receptor blockers (ARBs). The losartan recalls similarly were aimed at repackagers, in this case “repackagers of Torrent’s and Camber’s losartan-containing medicines.”
The valsartan recalls date back to mid 2018, when it was discovered that active pharmaceutical ingredients (APIs) manufactured overseas for use in the popular blood-pressure medication had been contaminated with probable human carcinogens. Contamination continues to be discovered in additional lots of valsartan as well as other ARBs including losartan and irbesartan.
United States Food and Drug Administration (FDA). (22 March 2019). FDA updates recalled valsartan-containing and losartan-containing medicine information. FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan, and Irbesartan. Drug Safety and Availability
United States Food and Drug Administration (FDA). (Updated 19 March 2019). Valsartan products under recall. Drug Safety and Availability
Valsartan FDA Recall News Update: FDA Expands Recalls Of Valsartan-Related Drugs Over Contamination Concerns
March 16, 2019
Author: Daniel Gala
As the one-year anniversary of the original valsartan recalls fast approaches, the United States Food and Drug Administration (FDA) continues to expand the scope of voluntary recalls related to the contamination of angiotensin II receptor blockers (ARBs) like valsartan over concerns that the medications, used to moderate high blood pressure and treat heart failure, have been contaminated with carcinogenic compounds.
On March 15, the FDA announced the additional recall of nearly four dozen lots of the generic ARB losartan due to tests revealing trace amounts of the substance NMBA, which the FDA describes as “a potential human carcinogen,” in the medication’s active pharmaceutical ingredient (API).
In two separate statements released simultaneously, the FDA announced the voluntary recall of nearly four dozen lots of Losartan Potassium USP tablets sold in the United States by Missouri-based Legacy Pharmaceutical Packaging, LLC. The recall covers tablets sold in 25 mg, 50 mg, and 100 mg doses.
The API in the recalled drugs was manufactured by India-based Hetero Labs, which has been implicated in a number of the previous ARB recalls. The recalls began in mid-2018 when it was discovered that valsartan using APIs manufactured at a facility in China had been contaminated with suspected human carcinogens. The contamination later was discovered to be present in other ARBs using APIs manufactured by Hetero Labs in India.
With this latest announcement of nearly four dozen additional lots being recalled, the scope of the valsartan-related recalls continues to grow. The situation already has led to numerous lawsuits filed by plaintiffs ranging from patients exposed to the contaminated medications to insurance companies who have incurred the costs of recall-related price increases. At least one congressional committee also has cited the valsartan recalls as a key reason for its investigating further the FDA’s practices regarding the inspection and regulation of overseas manufacturing facilities.
United States Food and Drug Administration (FDA). (15 March 2019).
Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical.
Recalls, Market Withdrawals, and Safety Alerts. Company Announcement
United States Food and Drug Administration (FDA). (15 March 2019).
Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API).
Valsartan FDA Recall News Update: FDA Announces Additional Valsartan Recalls Due to Contamination with Probable Carcinogen
March 9, 2019
Author: Daniel Gala
In a press release dated March 7, the United States Food and Drug Administration (FDA) announced the voluntary recall of an additional lot of the popular blood-pressure medication valsartan due to contamination concerns. The recall covers 160 mg Valsartan Tablets USP manufactured by Aurobindo Pharma USA, Inc. and sold by American Health Packaging.
According to the FDA, the recall is “due to the detection of trace amounts of an unexpected impurity found in the finished drug product.” The impurity, known as NDEA, is a naturally occurring substance that the International Agency for Research on Cancer (IARC) has classified as a probable human carcinogen.
The recall announcement is the latest of over two dozen spanning back to July 2018 that involve valsartan and other angiotensin II receptor blockers (ARBs) including losartan and irbesartan. In addition to NDEA, the medications also have been found to be contaminated with NMBA and NDMA, also believed to be human carcinogens.
Health investigators believe the contamination to be linked to new manufacturing processes used in the production of the drugs’ active ingredients. The recalls have led to drug shortages and price hikes.
Several manufacturers and sellers of generic valsartan already face lawsuits related to the alleged contamination. In addition to patients suing over their exposure to the contaminated drugs, insurance companies have sued over costs incurred over the resulting price increases, and investors have filed lawsuits saying the company knew or should have known about the contamination problems.
United States Food and Drug Administration (FDA). (7 March 2019). American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity. Recalls, Market Withdrawals, and Safety Alerts
Valsartan Recall News Update: New Democratic Majority in House Seeks FDA Briefing on Valsartan Recalls, Citing Overseas Inspection Concerns
March 9, 2019
Author: Daniel Gala
The freshly sworn-in Democratic majority in the United States House of Representatives has wasted little time using its newfound control over congressional committees to initiate a host of oversight actions on a wide range of matters, including an investigation into the Food and Drug Administration’s (FDA) practices pertaining to the inspection of overseas pharmaceutical manufacturing facilities, according to a letter sent to the FDA chairman by the House Committee on Energy and Commerce.
The letter, which requests that the FDA provide “a briefing on a series of recalls that appear to involve drugs manufactured overseas that may have been contaminated with trace amounts of known carcinogens,” specifically cites the ongoing recalls of valsartan and other angiotensin II receptor blockers (ARB) as the basis for its concerns.
“The roots of this ever-expanding series of recalls appear to be related to at least two foreign drug manufacturing facilities: Zheijang Huahai Pharmaceutical in China and Hetero Labs in India,” the letter to then-FDA commissioner Scott Gottlieb stated, reflecting what has been reported publicly. “Inspection reports from these two factories indicate serious problems at both factories, even before the carcinogens were detected.”
Signed by members of both parties, the letter goes into great detail regarding the committee’s concerns over the FDA’s overseas inspection practices, particularly given the large number of pharmaceuticals presently produced in whole or in part in facilities outside the United States. The committee cites the non-partisan Government Accountability Office (GAO), which ranked the FDA’s response to this globalization trend as a “High-Risk” area.
“For example, according to recent data, nearly 40 percent of all FDPs [Finished Drug Products] and nearly 80 percent of APIs [Active Pharmaceutical Ingredients] sold in the United States in 2016 were manufactured overseas,” the committee’s letter said, while at the same time, “the number of foreign drug surveillance inspections decline 10 percent to 778 in fiscal year 2018 from fiscal year 2017, which had a nine percent decline from fiscal year 2016.”
This worrying trend suggests that the recent valsartan recalls may represent only the tip of the iceberg when it comes to contamination and other concerns related to pharmaceuticals manufactured overseas. It remains to be seen whether the concerns stated by members of the committee will result in any concrete changes.
House Committee on Energy and Commerce. (13 February 2019). Letter to FDA Commissioner Scott Gottlieb
Valsartan FDA News Update: FDA Identifies Another Carcinogenic Impurity in Valsartan-Related Drugs
March 5, 2019
Author: Daniel Gala
In a press release posted March 1, 2019, the United States Food and Drug Administration (FDA) announced that it had identified a third carcinogenic compound contaminating generic angiotensin II receptor blocker (ARB) drug products, such as valsartan and losartan.
The impurities, which have been found in generic ARBs distributed in the United States by a number of different companies, have been traced back to manufacturing facilities in multiple countries, including China and India. The discovery that the drugs, used in the treatment of high blood pressure and heart failure, had been contaminated with known human carcinogens led countries around the world to announce recalls beginning in mid 2018. The recalls, in turn, led to shortages of the drugs, causing price spikes.
The news of a third type of known carcinogen contaminating ARBs was announced simultaneously with the revelation of a new voluntary recall, this time involving losartan potassium tablets manufactured by Hetero Labs Ltd and distributed by Camber Pharmaceuticals.
The losartan pills were found to be contaminated with the human and animal carcinogen NMBA. According to the FDA, “This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines.”
The first ARB recalls, announced in July 2018, involved generic forms of valsartan that had been contaminated with the carcinogen NDMA. Later, the even more dangerous carcinogen NDEA also was detected in some ARB drug products sold in the United States.
That the scope of the recalls continues to expand nearly a year after the first valsartan recalls were announced suggests that regulators still do not yet fully understand the causes or the full extent of the issues. A statement by the FDA commissioner did little to allay such concerns, even leaving open the possibility of additional recalls in the future.
“Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products,” the FDA Commissioner, Dr. Scott Gottlieb, was quoted in the press release as saying, adding later, “We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products.”
The FDA says it has had to invent novel testing procedures in order to detect the carcinogenic impurities. The generic ARBs included under voluntary recall include valsartan, losartan, and irbesartan, though not all such drugs have been subject to recall.
United States Food and Drug Administration (FDA). (1 March 2019). FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall. FDA Newsroom
United States Food and Drug Administration (FDA). (13 July 2018). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. FDA Newsroom
United States Food and Drug Administration (FDA). (Last Updated 1 March 2019). FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan. FDA Drug Safety and Availability
Valsartan Lawsuit News Update: FDA Updates Recall List Of Contaminated Drugs Related to Valsartan
February 28, 2019
Author: Daniel Gala
On February 25, 2019, the United States Food and Drug Administration (FDA) updated its list of drugs subject to voluntary recall over contamination concerns to include batches of the pharmaceutical losartan distributed by Macleods Pharmaceuticals using an active ingredient manufactured by Hetero Labs Limited. The announcement marks the latest in an ongoing series of voluntary recalls of valsartan, losartan, and irbesartan dating back to July 2018 over concerns that the drugs had been contaminated with known human carcinogens due to flaws in the manufacturing process.
“FDA is alerting patients and health care professionals to a voluntary recall of one lot of losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods Pharmaceuticals,” the FDA announcement states. “The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.”
Valsartan, losartan, and Irbesartan all belong to a class of drugs known as angiotensin II receptor blockers (ARBs). The contamination issues first began to come to light in the United States in July 2018, when the FDA issued a press release announcing that “an impurity, N-nitrosodimethylamine (NDMA)…was found in the recalled products.”
According to the press release, “The presence of NDMA was unexpected and thought to be related to changes in the way the active substance was manufactured.” The initial valsartan contamination originally was traced back to a production facility in China, but active ingredients manufactured at other facilities in different countries later were discovered to suffer from similar contamination. The FDA subsequently has issued over two dozen updates on the recalls.
Although NDMA in particular is naturally occurring and can be found in common foods such as cured, smoked, and grilled meat, both NDMA and NDEA are classified as known human carcinogens, meaning that exposure at unsafe levels can lead to cancer.
United States Food and Drug Administration (FDA). (Last updated 25 February 2019). FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan, and Irbesartan. FDA Website
United States Food and Drug Administration (FDA). (13 July 2018). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. FDA News Releases
Valsartan Lawsuit News Update: JPML Approves Valsartan MDL, Sets NJ As Venue
February 24, 2019
Author: Daniel Gala
In a transfer order dated February 14, 2019, the Judicial Panel on Multidistrict Litigation (JPML) approved the creation of multidistrict litigation (MDL) to oversee claims that certain forms of the popular blood-pressure medication valsartan had been contaminated with known human carcinogens as a result of flawed manufacturing processes. The order establishes the MDL’s venue as the District of New Jersey.
“On the basis of the papers filed and the hearing held, we find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the Transfer Order states. “All actions involve common factual questions arising out of allegations that plaintiffs purchased or used general formulations of these valsartan medications containing the nitrosamine impurities NDMA and/or NDEA; and that defendants knew, or should have known, of the impurities as early as 2012.”
According to the Transfer Order, defendants differed in their views of centralization, with some defendants favoring centralization of consumer class action suits only, some urging for centralization in a venue other than an MDL, and others opposing their inclusion in centralization altogether.
The principal common defendants in the litigation who expressed positions in favor of centralization included Zhejiang Huahai Pharmaceutical Co., Ltd. and its US affiliates Prinston Pharmaceuticals Inc., Solco Healthcare U.S., LLC, and Huahai U.S., Inc., along with the pharmacies Walgreen Co. and Throggs Neck Pharmacy. Despite expressing fluctuating positions, according to the JMPL, these defendants ultimately favored centralization of consumer class actions only and joined a number of other defendants in urging the JMPL not to include personal injury actions in the MDL.
Ultimately, the JPML rejected the defendants’ arguments and included both consumer class actions and personal injury claims within the scope of the valsartan MDL.
“Based on this record, we believe that the centralized proceedings should include the related personal injury actions alleging that plaintiffs developed cancer as a result of using valsartan containing NDMA or NDEA impurities,” the panel concluded in the Transfer Order. “The core factual issues in the personal injury actions will be the same as in the consumer class actions – in particular, the cause of the alleged impurities; the nature and extent of the health risks posed by the NDMA and NDEA levels at issue; defendants’ knowledge of the alleged impurities; and the impact of any findings made by the FDA.”
The valsartan contamination originally was traced to a manufacturing facility in China operated by Zhejiang Huahai Pharmaceuticals but other facilities later were found to be sources of contamination, as well. The contamination is believed to be the result of new manufacturing processes used to produce a key active ingredient in valsartan.
Beginning in mid-2018, the discovery of potential contamination with known human carcinogens resulted in widespread recalls of valsartan around the globe, which in turn led to drug shortages and price spikes. Some healthcare providers have sued the makers and sellers of the contaminated drugs for costs incurred as a result of the recall, as well as for funds spent on potentially contaminated medication.
Not all valsartan products are subject to recall. A complete, up-to-date list of valsartan products under recall by the US Food and Drug Administration (FDA) can be found here. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf
Stay tuned to TheLawFirm.com for the latest developments in valsartan litigation.
Transfer Order. (14 February 2019). MDL No. 2875. In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination products Liability Litigation. Judicial Panel on Multidistrict Litigation
United States Food and Drug Administration (FDA). (Updated 6 February 2019.) Valsartan products under recall
Valsartan Lawsuit News Update: Valsartan Recalls Highlight Long-Standing FDA Blind Spot Over Foreign Drug Manufacturers, Lawmakers Say in Letter
February 19, 2019
Author: Daniel Gala
Prompted by recent wide-ranging recalls of the popular blood-pressure medication Valsartan, lawmakers in the United States have voiced their concerns over the Food and Drug Administration’s (FDA) ability to effectively regulate overseas pharmaceutical manufacturers. Most recently, these concerns were expressed in a bipartisan letter sent from the House Committee on Energy and Commerce to FDA Commissioner Scott Gottlieb, Law360 reported February 14.
According to reports, the letter from the House Committee on Energy and Commerce notes that, since 2012, the FDA has had the legal authority to inspect the manufacturing facilities of foreign companies manufacturing pharmaceuticals for sale and use in the United States. However, per the letter and a report by the nonpartisan Government Accountability Office (GAO), the backlog of un-inspected foreign facilities runs into the hundreds, at least.
Perhaps most concerning of all, the House Committee on Energy and Commerce had previously noted its concerns over this issue at least as far back as January 2017, well before the worldwide Valsartan recalls that began in mid-2018. In a press release dated January 17, 2017, the Committee drew attention to a then-recent GAO report highlighting the large number of un-inspected facilities overseas and the dangers such a backlog could pose to American pharmaceutical takers.
According to the Committee’s news release summarizing the GAO report, while the FDA had made some improvements in its oversight of foreign companies, the GAO still found that “46 percent of the positions at the FDA foreign offices are vacant and that the vacancies have been a persistent problem.”
The GAO report further stated that, while the FDA had significantly reduced the percentage of un-inspected foreign facilities from over 50% in 2010 to about 33% by the time of the report in late 2016, roughly 1,000 of the approximately 3,000 foreign establishments under FDA jurisdiction continued to have no inspection history at the time. According to the recent letter from the House Committee on Energy and Commerce, at least 400 such un-inspected foreign manufacturing facilities remained as of early 2019, even after the Valsartan recalls revealed the dangers of such lax regulatory oversight.
This is particularly troubling as, according to the House Committee’s 2017 press release, 80% of pharmaceutical ingredients used in the United States presently are manufactured overseas, with 40% of drugs completing the manufacturing process outside the US.
This means that a quite a large proportion of even prescription-strength drugs sold and consumed in the United States come from facilities that have never been inspected by the FDA. The Valsartan fiasco, which has led to drug shortages and price hikes, not to mention patients’ exposure to known human carcinogens, is just one example of what can go wrong when regulators become lax in their oversight of an area so important as drug manufacturing.
House Committee on Energy and Commerce. (17 January 2017). Press Release
Field, E. (14 February 2019). Reps Challenge FDA On Foreign Drug Monitoring After Recalls. Law360
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.
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