Valsartan

  • Valsartan

Valsartan belongs to a class of drugs called Angiotensin II Receptor Antagonist and is used to treat high blood pressure (Hypertension), and Congestive heart failure.

Diovan (Valsartan) was manufactured by Novartis International AG and was approved by the FDA on August 14, 2002. Diovan lost its patent in September 2014. The launch of the generic drug had been on hold since patent expiry due to regulatory problems with the FDA. In 2014, a US-based Ohm Laboratories (Ohm), a subsidiary of Ranbaxy Laboratories, was the first to get the approval from FDA for generic Valsartan. Thereafter, many generic versions of Valsartan came into the market via many other pharma companies.

The usage of Diovan had no evidence of any adversity in its entire span, but the FDA did find that the generic versions of Valsartan were causing issues. The most serious issue reported was that it had the presence of an impurity called N-Nitrosodimethylamine (NDMA), which was believed to be formed as a byproduct through a chemical reaction. Not only was this an impurity, but a concern was also raised when it was detected that NDMA is carcinogenic and can lead to cancer in people consuming this drug for the long term.

Immediately, the FDA called for its largest recall of Class I drug, Valsartan on 13 July 2018. The following manufacturers recalled their Valsartan containing drugs.

Recalled Products:

Medicine Company Valsartan - Major Pharmaceuticals

Valsartan -  Solco Healthcare

Valsartan -  Teva Pharmaceuticals Industries Ltd

Valsartan/Hydrochlorothiazide (HCTZ) -  Solco Healthcare

Valsartan/Hydrochlorothiazide (HCTZ) - Teva Pharmaceuticals Industries Ltd

The exact nature of injuries and its effects on the human body is still being studied to derive any strong conclusions. Meanwhile, patients consuming these generic drugs and facing injuries are advised to come ahead.

Along with Valsartan, there are other generic drugs belonging to the same class which can come under the FDA radar due to similar issues, which are:

  • Irbesartan (Avapro)

  • Losartan (Cozaar)

  • Olmesartan (Benicar)

  • Candesartan (Atacand)

These above drugs are suspected to cause similar injuries because they share the same manufacturing process as that of Valsartan.

Serious Alleged Injuries may include:

  • Stomach cancer
  • Liver cancer
  • Colorectal cancer
  • Lymphoma
  • Esophageal Cancer
  • Bowel cancer
  • Liver failure

FDA Safety Warnings:

July 18, 2018: Teva Pharmaceuticals USA labeled as Major Pharmaceuticals,  Prinston Pharmaceuticals Inc. labeled as Solco Healthcare LLC, and Teva Pharmaceuticals labeled as Actavis LLC recalled because of related to the NDMA impurity detected in the valsartan API.

August 2, 2018: The recalled valsartan-containing product information is updated, and API (Active Pharmaceutical Ingredient) manufacturers are reminded to evaluate processes for unsafe impurities.

September 28, 2018: Zhejiang Huahai Pharmaceuticals is placed on import alert by the FDA.

October 30, 2018: An alert related to ScieGen’s irbesartan recall due to presence of NDEA (N-Nitrosodiethylamine , a known animal and suspected human carcinogen) is raised by the FDA.

November 9, 2018: One lot of Sandoz losartan potassium and hydrochlorothiazide was recalled due to NDEA.

November 21, 2018: Mylan’s valsartan products were recalled due to NDEA.

November 27, 2018: Teva’s valsartan products were recalled due to NDEA.

December 20, 2018: Torrent’s valsartan products were recalled due to NDEA.

January 2, 2019: Aurobindo recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of NDEA.

January 18, 2019: Solco Healthcare’s irbesartan products were recalled due to NDEA.

January 23, 2019: Teva voluntarily recalled losartan products. Torrent Pharmaceuticals expanded its voluntary recall to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets.

January 28, 2019: The FDA provided two possible reasons for the carcinogenic impurities in Valsartan. It suspects the impurities may be formed when specific chemicals and reaction conditions are present during the manufacturing processes and could result from the reuse of materials such as solvents.

March 12, 2019: The Food and Drug Administration (FDA) approved a new generic version of Valsartan (Diovan) to ease the recent shortage of blood pressure medicine owing to a series of safety recalls.

 

Legal Updates:

Defendants:

  • Zhejiang Huahai

  • Mylan Laboratories Ltd.

  • Princeton Pharmaceutical

  • Solco Healthcare US

  • Aurobindo Pharma

  • Walmart

Defendant Law Firm:

Zhejiang Huahai: Represented by Seth Goldberg of Duane Morris LLP.

Mylan Laboratories Ltd.: Represented by Clem C. Trischler of Pietragallo Gordon Alfano Bosick & Raspanti LLP.

Allegations:

Allegations include that generic valsartan pills were distributed for years with cancer-causing impurities, including NDMA and NDEA, which appear to be a by-product of the drug manufacturing process. Several lawsuits have been filed in recent months by individuals who indicated that they were left with different types of cancer, including liver cancer, kidney cancer, gastric cancer, pancreatic cancer, and other injuries following exposure to NDMA or NDEA.

Plaintiff Steering Committee:

  • Ruben Honik - Golomb & Honik, P.C

  • Daniel Nigh - Levin, Papantonio, Thomas, Mitchell, Rafferty, Proctor, P.A

  • Adam Slater - Mazie Slater Katz & Freeman, LLC

  • Conlee Whiteley - Kanner & Whiteley, LLC

  • John Davis - Slack Davis Sanger, LLP

  • Marlene Goldenberg - Goldenberg Law

  • Behram Parekh - Kirtland & Packard, LLP

  • Andres Rivero - Rivero Mestre LLP

  • Mikal Watts - Watts, Guerra LLP

  • George Williamson - Farr Law Firm

  • Brett Vaughn - Hollis Law Firm

Lawsuit Status:

There are currently 10 class action lawsuits and one individual action pending in District Courts across the USA. Valsartan claims are consolidated under MDL No. 2875 (In re Valsartan Products Liability Litigation) in the United States District Court, District of New Jersey, presided by Judge Robert B Kugler, U.S.D.J and Hon. Joel Schneider, U.S.M.J. The number of cases filed is expected to increase with the spread of awareness.

April 9, 2019: A case management order was issued, in which Judge Robert B. Kugler, allowed the direct filing of new cases into the multidistrict litigation(MDL) established in New Jersey.

Important Legal Proceedings, Verdicts & Settlements:

Hundreds of product liability lawsuits have been filed due to side effects of recalled valsartan, losartan, and other blood pressure drugs, but no settlement has been made yet.

March 2019: The FDA approved a new generic version of valsartan (Diovan) to ease the recent shortage of blood pressure medicine owing to a series of safety recalls.

April 2019: U.S. District Judge Robert B. Kugler allowed the direct filing of new cases into the MDL established in New Jersey, where all similar claims are consolidated for pretrial proceedings.

April 2019: The FDA announced the recall of Teva Losartan Tablets due to the presence of cancer-causing Nitroso-N-methyl-4-aminobutyric acid (NMBA) in at least six lots of active pharmaceutical ingredient manufactured by Hetero Labs Limited in India.

May 2019: U.S. District Judge Robert B. Kugler appointed four plaintiffs’ attorneys to serve as Co-Lead Counsel, two attorneys as Plaintiffs’ Liaison Counsel, 11 attorneys to a Plaintiffs’ Executive Committee, 10 attorneys to a Plaintiffs’ Economic Reimbursement committee, and 16 attorneys to a Plaintiffs’ Personal Injury Committee.

June 2019: The FDA announced recall expansion of Teva losartan potassium tablets, indicating the presence of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).

June 2019: Macleods Pharmaceutical Limited initiated a voluntary recall over Losartan Potassium and Losartan Potassium/Hydrochlorothiazide combination due to the excessive presence of N-Nitroso-N methyl-4-aminobutyric acid (NMBA).

August 2019: The FDA issued a warning letter to Hyderabad-based Lantech Pharmaceuticals Limited after finding that the company failed to investigate complaints related to the blood pressure medicine Valsartan.

September 2019: The FDA expanded recall on three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets. 

October 2019: The FDA issued a warning letter to Torrent Pharmaceuticals over its manufacturing plant in India involving the active pharmaceutical ingredient (API) in losartan.

November 2019: Mylan Pharmaceuticals received a warning letter from the FDA with regards to “significant deviations” from good manufacturing practices at its plant in Andhra Pradesh, India.

January 2020: Attorneys representing plaintiffs in the federal valsartan litigation indicated that the drug makers did not preserve recalled pills properly, possibly spoiling or destroying important evidence about contaminated versions of the blood pressure drug.

September 2020: The FDA issued guidance recommending the manufacturers of active pharmaceutical ingredients and drug products to implement steps to avoid drug contamination with cancer-causing chemical by-products, such as N-nitrosodimethylamine (NDMA) and other nitrosamine impurities.

December 2020: U.S. District Judge Robert B. Kugler denied three dismissal motions filed by the defendants stating that claims by buyers and users of the drug are not preempted by federal law.

January 2021: Judge Robert B. Kugler said that consumers in the MDL cannot bring claims under the laws of states in which they don't reside in.

January 2021: Judge Robert B. Kugler rejected bids from the defendants over the dismissal of warranty claims.

February 2021: Judge Robert B. Kugler denied dismissing fraud-based claims against the manufacturers of the blood pressure drug.

February 2021: A group of 28 cases was selected from more than 600 complaints filed against manufacturers for the bellwether procedure of the recalled hypertension drug.

Evidence:

  • Usage in Pharmacy Records
  • Duration of Usage
  • Proof of Injury in Medical Records.

Medical Record Review and claim validation of Valsartan case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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