A federal judge in New Jersey recently ruled that Valsartan emails from Torrent Pharmaceuticals are not confidential and can therefore be used during Valsartan lawsuit litigation.

Valsartan Emails Deemed Non-Confidential

U.S. Magistrate Judge Joel Schneider determined that certain emails about Valsartan from Indian drug manufacturer Torrent Pharmaceuticals are not confidential since they do not contain proprietary information which could give other companies a competitive advantage. Instead, the five chains of emails from Torrent to customers reportedly center around the company’s response to valsartan contamination and recalls.

“At bottom, Torrent’s emails involve what appears to be routine business communications,” Judge Schneider wrote. “Albeit, the emails were prepared in response to what appears to be an unprecedented situation.”

Torrent had argued that these emails shouldn’t be considered in the multidistrict litigation surrounding valsartan contamination, but the court disagreed. Although the company may not want the details of the situation to become public, Judge Schneider ruled that none of the details from the valsartan emails reveal any proprietary information, company secrets, or information about business plans, profits, and revenues which could be sensitive.

The judge also shot down arguments that the emails should be considered confidential based on the wishes and expectations of Torrent’s clients.

“This is not an acceptable basis to justify the confidential designation of a routine business communication,” Judge Schneider said. “Otherwise, large swatches of routine emails would be kept under wraps.”

Valsartan Contamination & Recalls

Plaintiffs in the valsartan MDL challenge serval companies’ roles in the contamination of blood pressure medications which featured prominently in the news in 2018 and 2019.

In July 2018, it was first revealed that several lots of valsartan – an angiotensin II receptor blocker (ARB) prescribed to treat high blood pressure – was contaminated with N-nitrosodimethylamine (NDMA) – a potential carcinogen. This contamination prompted a recall and was followed by numerous other recalls of ARBs such as valsartan, losartan, and irbesartan due to contamination with NDMA and other nitrosamine impurities.

After further investigation, the FDA has traced the widespread NDMA contamination in ARBs to the active pharmaceutical ingredients used to make high blood pressure medications. As a result, countless lots of ARBs from numerous manufacturers were included in the widespread recalls. This is due to the fact that one manufacturer of APIs may supply numerous drug manufacturers who may then sell their stock to other companies such as pharmaceutical repackagers.

NDMA is an environmental contaminant which may appear in water or certain foods at low levels. However, NDMA and other nitrosamine impurities may also be produced during chemical processes – including those seen during pharmaceutical manufacturing. These chemicals may be produced if sterilization of manufacturing equipment is subpar or if certain solvents are reused.

In August 2019, the FDA detailed their response to this epidemic of contamination. Although the FDA’s regulations already aim to reduce the risk of impurities through best manufacturing practices, the agency has reportedly worked to improve their regulations and crack down on violations, as well as provide guidance over impurities in an attempt to reduce recalls. The FDA has reportedly cited several companies for violations which could lead to similar contamination.

“We are working to incorporate what we have learned about the process risks that caused these impurities into our oversight of drug manufacturing, which includes how we assess applications and changes to applications, as well as enhancing our inspection coverage to evaluate the controls in place to prevent unacceptable levels of nitrosamine,” the FDA revealed in their August 2019 press release.

Although regulators around the world are working to stop similar contamination from occurring on such a wide scale, consumers can still take matters into their own hands by joining or filing a valsartan contamination lawsuit.

The Valsartan Contamination MDL is In re: Valsartan Products Liability Litigation, Case No. 1:19-md-02875, in the U.S. District Court for the District of New Jersey.