Valsartan Lawsuit Status

Valsartan Lawsuit Status: July to September 2019

October 28, 2019
The third quarter of 2019 saw more questions raised and few answers delivered as authorities and drugmakers continued to grapple with the scope and complexity of carcinogenic contamination in the US pharmaceutical supply. Originally limited to a single contaminant that had been detected in certain batches of generic valsartan, the ongoing recalls have grown to include other contaminants and other angiotensin II receptor blockers (ARBs) such as losartan and irbesartan.

Further yet, during July to September 2019, the carcinogenic contamination fiasco reached a worrying milestone when nitrosamines, the same form of carcinogenic contaminants found in recalled valsartan and other ARBs, were detected in an unrelated heartburn medication. Meanwhile, in the District of New Jersey, multidistrict litigation (MDL) over valsartan contamination continued to ramp up as hundreds of new cases were added.

Here’s a look back at the major developments in the valsartan recall saga that took place during the third quarter of 2019:

Q3 Developments In Valsartan MDL

Established February 14 by order of the Judicial Panel on Multidistrict Litigation (JPML), multidistrict litigation (MDL) over valsartan contamination continued to ramp up during the third quarter of 2019. Located in the District of New Jersey, the MDL includes cases filed by plaintiffs alleging bodily injury as a result of taking contaminated valsartan, as well as plaintiffs claiming economic injury.

According to the court’s list of member cases, as of October 11, roughly 145 valsartan lawsuits had joined the MDL, with thousands more expected.

Source:

United States District Court District of New Jersey. (Accessed 11 October 2019). Member Cases. Civil Docket For Case #: 1:19-md-02875-RBK-JS. MDL 2875. Valsartan N-Nitrosodimethylamine (NDMA) Products Liability Litigation

June-July: House Committee Voices Valsartan Concerns To GAO and FDA

The second quarter of 2019 closed and the third quarter opened with the House Energy and Commerce Committee voicing renewed concerns to both the Government Accountability Office (GAO) and the Food and Drug Administration (FDA) over the ongoing, and still expanding, valsartan recalls. In a pair of bipartisan letters dated June 28, lawmakers gave the FDA until July 12 to provide additional information about the carcinogenic contamination in particular and the FDA’s international monitoring program in general.

“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,” stated a press release issued by the committee. “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 Committee’s letter to the GAO voiced concern about the FDA’s ability to properly oversee an increasingly global pharmaceutical supply chain, citing a January 2019 report by Bloomberg, which found that FDA inspections had actually declined since the beginning of the valsartan recalls.

“Treatments made by Chinese companies now account for almost one of every 10 generic drugs cleared by the FDA for sale,” the Bloomberg report found. “But agency inspections meant to ensure that approved drugs are meeting US standards fell almost 11 percent, to 125, in China for the fiscal year that ended Sept. 30 [2018], compared with the previous year, according to data obtained by Bloomberg through public-records request.”

Why the congressional committee charged with FDA oversight had to learn of this troubling data though the news media is another question unto itself.

Sources:

Edney, A. (29 January 2019). How a Tainted Heart Drug Made in China Slipped Past the FDA. Bloomberg

August: Defense Logistics Agency Says It Purchased Valsartan For Troops That Was Later Recalled

As the valsartan recalls continued into their second year, military experts increasingly voiced concern over the potential impact that drug contamination and over-reliance on foreign drug manufacturing could have on national security, with the Defense Logistics Agency (DLA), the entity responsible for procuring medications for armed-services medical facilities, telling Bloomberg that it had procured valsartan that later had been subject to recall.

“This affects the readiness of the troops,” Larry Wortzel, a military retiree and member of the US-China Commission, told Bloomberg for a piece published August 5.

US military experts further warned that an over-reliance on drugs made overseas could impact available supplies in times of conflict.

“We wouldn’t have our aircraft carriers and nuclear submarines made in China, and for very important medications, we should look at what it takes to purchase based on value and not just price,” author Rosemary Gibson, whose book "China-Rx” examined the growing dominance of China in manufacturing drugs sold in the US, told an advisory panel in Washington.

Source:

Edney, A. (5 August 2019). Pentagon Sees Security Threat in China’s Drug-Supply Dominance. Bloomberg

August 8: FDA Sends Warning Letter To Indian Solvent Recovery Company Over Valsartan Contamination

Lending further credence to suspicions that the nitrosamine contamination found in valsartan and other ARBs is related to the use of solvents in the manufacture of the drugs’ active pharmaceutical ingredients (APIs), the FDA on August 8 sent a warning letter to an India-based solvent recovery firm over alleged violations of industry best practices. In particular, the warning letter said that a client of the solvent recovery company had detected nitrosamine contamination in solvent recovered by the company, the same nitrosamines later discovered in some of the recalled medications.

“This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API),” the FDA warning letter reads. “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].”

Source:

United States Food and Drug Administration (FDA). (8 August 2019). Warning Letter 320-19-34. Lantech Pharmaceuticals Limited. FDA Website

August 28: FDA Issues First Public Valsartan-Related Update In Nearly Two Months; Provides No New Information

While media reports had been updating and expanding the valsartan-recall story in several important directions, the FDA itself for months had remained largely silent on the issue, despite setting up a website dedicated to provide the public with up-to-date information on the carcinogenic contamination infecting the nation’s pharmaceutical supply.

Finally, on August 28, the nation’s purported chief pharmaceutical watchdog broke its silence with a largely self-serving statement that contained little in the way of useful, new information for patients or their prescribing physicians.

“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., began, 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.”

Given the FDA’s apparent inability to get a handle on the valsartan-contamination crisis and the number of outstanding questions unaddressed in the FDA's statement, one could be forgiven for having less than full confidence in such proclamations.

Source:

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

September 13: FDA Announces Nitrosamine Found In Non-Valsartan-Related Drugs

In an enormous development in terms of the scope of the pharmaceutical-contamination crisis, and one many observers had feared for months, the FDA announced September 13 that a nitrosamine contaminant had been detected in a non-valsartan-related drug, with the carcinogen NDMA having been identified in certain batches of ranitidine, a heartburn medication sold under the brand name Zantac. The discovery suggested that the carcinogenic contamination may be much more widespread than previously known, enhancing concerns that the FDA is not up to the task of regulating an increasingly global pharmaceutical supply chain.

“Valsartan is just the one we caught,” former FDA medical officer David Gortler presciently told Bloomberg for a report published September 12, the day before the FDA’s announcement that NDMA had been found in Zantac. “Who knows how many more are out there?”

More worrying still, the Zantac contamination wasn’t even detected by the FDA itself, but by third-party Valisure, a pharmacy that conducts independent screenings of the drugs it sells, which alerted the nation’s top pharmaceutical regular to the problem, according to Reuters.

“It seems that there’s an inherent problem with the drug itself,” Valisure CEO David Light told Reuters. “There’s a lot of concern that, in our mind, justify completely recalling this product.”

At the time, FDA did not announce any recalls of ranitidine, though some drugmakers subsequently have voluntarily pulled their ranitidine products from the market.

Sources:

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

September 25: FDA Announces First Recalls Of Non-Valsartan-Related Drugs Due To Nitrosamine Contamination

Finally, nearly two weeks after announcing that a probable human carcinogen had been detected in the common heartburn medication ranitidine, sold under the brand name Zantac, the FDA announced the first recalls of non-valsartan-related drugs due to nitrosamine contamination, signaling a frightening new escalation in the valsartan-recall issue.

Source:

United States Food and Drug Administration (FDA). (25 September 2019). Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tables 75 mg and 150 mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) Impurity in the product. Company Announcement. Recalls, Market Withdrawals, & Safety Alerts

Looking Ahead: Q4 2019 And Beyond

With the ongoing valsartan recalls well into their second year, the scope of the contamination crisis appears to be growing rather than receding. With new ARBs still being identified for voluntary recall over nitrosamine contamination and the same contaminants having now been discovered in the heartburn medication Zantac (ranitidine), the United States FDA increasingly is raising questions of whether it is up to the task of ensuring the safety of the US drug supply. It is anybody’s guess how widespread the contamination issues ultimately will be found to be.

Meanwhile, multidistrict litigation (MDL) over the valsartan recall will continue to ramp up, though it could easily be years before the first bellwether trials take place. Who knows how massive the crisis that began as the valsartan NDMA recalls will have become by then?