Valsartan Lawsuit Status

Valsartan Lawsuit Status: April to June 2019

July 4, 2019
July 13 marks the one-year anniversary of the first valsartan recalls announced by the FDA (US Food and Drug Administration), and yet the scope of the problem continues to expand, with the FDA announcing additional recalls of valsartan-related drugs as recently as June 26.

The ongoing nature of the valsartan fiasco increasingly raises questions about the FDA’s ability not only to grapple with the scope and complexity of the yet-to-be-resolved valsartan-contamination issue, but to properly oversee an increasingly global pharmaceutical supply chain in a manner that ensures the safety of American patients.

With the inglorious one-year anniversary of this continuing saga upon us, before we take our usual look back at the events of the last three months, let’s do a quick rundown of how we got here in the first place.

One Year Of Valsartan Recalls

It was on July 13, 2018 that the US Food and Drug Administration (FDA) announced the first valsartan recalls.

“The US Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure,” the FDA press release read. “This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products….NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on laboratory tests.”

The FDA said it had traced the contamination to a manufacturing facility in Linhai, China, where an active pharmaceutical ingredient (API) in the recalled valsartan had originated. However, as additional recalls were announced over subsequent weeks and months, contaminated APIs were traced to an additional facility in India operated by a different drug manufacturer.

Meanwhile other nitrosamines in addition to NDMA were being detected in valsartan and other angiotensin II receptor blockers (ARBs), including losartan and irbesartan, and the scope of the recalls continued to expand.

Source:

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 Release

April to June 2019: Valsartan Recalls Continue, the Valsartan MDL Gets Underway, And New Concerns Are Raised By A Third Party

April 2, 2019: Judge Issues Scheduling Order In Valsartan MDL

Multidistrict litigation (MDL) over contaminated valsartan slowly began to get underway at the beginning of the second quarter of 2019, with the judge overseeing the centralized claims issuing on April 2 a scheduling order laying out preliminary matters such as the timing of bi-weekly status conferences. The order was a reminder that the MDL remains in its very early stages and is likely to last for years.

Source:

The 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

April 4, 2019: FDA Offers A Half-Hearted PR Response To Ongoing Recalls

With the pressure on the agency to get a handle on the valsartan issue mounting, then-FDA Commissioner Scott Gottlieb MD (who has since left the nation’s pharmaceutical watchdog to join the board of Big Pharma giant Pfizer and Director of the FDA Center for Drug Evaluation and Research Janet Woodcock MD issued a joint statement aimed at demonstrating that the FDA was on the job and up to the task.

“Our response to this issue has been comprehensive and constant,” the statement claims. “Although we still have more work to do, we’re making significant advances in our efforts to protect patients from unnecessary exposure to these impurities.”

The statement outlined the various steps the agency claimed to be taking to minimize risk to patients while also ensuring that adequate supplies of the important medications remain available. The steps cited include a temporary suspension of the FDA’s own limits on acceptable levels of contamination.

“Currently, valsartan products are in shortage, and we know that other types of products have the potential to fall into shortage soon,” the April 4 statement explains. “In anticipation, the agency is not objecting to temporary distribution of specific lots of losartan [an ARB like valsartan] that contain impurities above the interim acceptable intake limit, for a short period of time.”

In addition, the FDA said it was putting out a list of supposedly “clean” valsartan in which the agency had not detected any nitrosamines, such as NDMA.

“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 FDA statement reads.

While aimed at helping patients and health-care providers determine which lots of valsartan had been declared non-contaminated, this approach by the FDA would prove reliable only so long as nitrosamines remained the only dangerous contaminants to be detected in valsartan and other ARBs.

Sources:

Gottlieb, S. And Woodcock, J. (4 April 2019). FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue. United States Food and Drug Administration Press Announcements

LaVito, A. (27 June 2019). Former FDA Commissioner Scott Gottlieb joins Pfizer’s board of directors. CNBC

May 2, 2019: FDA Releases New Test Results And Assessment Of Cancer Risks

Seeking to downplay the risks of contaminated valsartan and other ARBs, the FDA released on May 2 what it described as “additional test results…showing NDMA and NDEA levels in recalled valsartan” along with statistical interpretations on what that meant for individuals having been exposed to the contaminated drugs.

“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 of the lifetimes of the 8,000 people,” the FDA statement said, failing to mention that potentially millions of patients were exposed to the contaminated drugs and even one case of cancer is one case too many when caused by contamination that was never supposed to be there in the first place.

The statement placed the cancer risk of NDEA contamination at one case per 18,000 patients exposed to the contaminated drugs.

Source:

United States Food and Drug Administration (FDA). (2 May 2019). Laboratory analysis of valsartan products. Drug Safety and Availability

May 14, 2019: New Book Highlights Same Overseas Drug Manufacturing Conditions Behind Valsartan Recalls

Though not directly related to the valsartan recalls, the May 14 release of the journalistic exposé Bottle of Lies: The Inside Story of the Generic Drug Boom by investigative reporter Katherine Eban brought a new level of public attention to the FDA and its failure to properly regulate active pharmaceutical ingredients (APIs) and finished drugs manufactured at facilities overseas.

“A generic drug executive contacted me anonymously under the pseudonym ‘4 Dollar Refill,’” wrote Eban in the book’s Author’s Note, dated March 2019. “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.”

The conditions described by Eban are exactly those suspected to be behind the valsartan contamination and subsequent recalls, suggesting that the problem may not be limited to valsartan and other ARBs but may be an issue for generic drugs as a whole.

“‘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.”

Source:

Eban, K. Bottle of Lies: The Inside Story of the Generic Drug Boom. HarperCollins, 2019.

May 16, 2019: Bloomberg Reports That FDA Investigators Had Identified Violations At Companies Tapped By FDA To Produce Emergency Supplies Of Valsartan

In March, the FDA attempted to alleviate the recall-induced shortages of valsartan by approving two new manufacturers for production of the drug. However, according to a May 16 report by Bloomberg, these two drug makers previously had been identified by the FDA’s own investigators for many of the same violations and shoddy practices believed to be at the center of the valsartan-contamination scandal in the first place.

“Workers ignored testing data showing product flaws; destroyed records indicating that drugs were failing key quality measures; and didn’t properly clean equipment, FDA inspection reports stated,” Bloomberg reported. “Inside one factory, inspectors said they saw swarms of insects.”

The report further underscored the lack of control the FDA has over the valsartan-recall crisis and its failure to properly execute its broader regulatory responsibilities.

Source:

Edney, A. (16 May 2019). Heart-Drug Suppliers for Millions Faulted Over Data, Bugs, Dirt. Bloomberg

June 13, 2019: Online Pharmacy Says It Has Detected A New, Non-Nitrosamine Carcinogen in Valsartan

In a Citizen Petition to the US FDA dated June 13, 2019, online pharmacy Valisure warned that it had detected a new carcinogenic contaminant in certain batches of valsartan. Unlike the previously discovered contaminants, the new carcinogen was not a nitrosamine, raising fresh concerns about what untested-for contaminants might be present in valsartan and other of today’s pharmaceuticals.

“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 petition stated. “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’).”

In response to this discovery, Valisure requested that the FDA take a number of significant steps, including “review and significantly lower the acceptable intake/permitted daily exposure limit of DMF.”

As of the close of the second 3 month segment of 2019 on June 30, the FDA had not made any public pronouncements in response to the Valisure Citizen Petition, nor has any reference to the petition or its contents been included on the website the FDA set up to keep patients informed of the latest developments in the valsartan and ARB recalls.

Source:

Valisure, LLC. (13 June 2019). Valisure Citizen Petition. United States Food and Drug Administration (FDA)

Looking Ahead: Entering the Second Year of Valsartan Recalls

As we enter the second year of the valsartan recalls, things unfortunately only appear to be getting started. With the Valisure Citizen Petition alleging that the company had detected new carcinogenic contaminants in some batches of valsartan, new questions continue to be raised about whether government watchdogs like the US Food and Drug Administration (FDA) are capable of properly overseeing an increasingly global and complex pharmaceutical supply chain.

Things are only beginning on the legal front as well. Investors have sued the makers of contaminated valsartan alleging that the leaders of those companies knew or should have known of the problems with the overseas providers of active pharmaceutical ingredients (APIs). And multidistrict litigation (MDL) centralizing federal valsartan lawsuits brought by patients exposed to the contaminated drugs is likely to be ongoing for years to come.