Victoza

  • Victoza Medical Record Review & Outsourcing Services

Victoza (Liraglutide) is a long-acting glucagon-like peptide-1 receptor agonist. The U.S. Food and Drug Administration (FDA) approved it on January 25, 2010. It is manufactured by Danish drug maker Novo Nordisk and was launched in the U.S. in February 2010 and in the EU in July 2009.

It acts by binding to the same receptors as does the endogenous metabolic hormone GLP-1 that stimulates insulin secretion. It mimics the GLP-1 (glucagon-like peptide-1) hormone and controls the blood glucose level when given along with diet and exercise, in adult patients with Type 2 diabetes mellitus. The injectable form works by stimulating insulin production.

Serious Alleged Injuries may include:

  • Hypoglycemia
  • Kidney failure
  • Severe allergic reaction
  • Pancreatitis
  • Pancreatic cancer
  • Thyroid cancer

FDA Safety Warnings:

  • On June 14, 2011, the warning had been issued by the FDA for Victoza about the risks of thyroid cancer and pancreatitis. The agency also highlighted the contraindication for liraglutide in patients with a personal or family history of medullary thyroid cancer or a personal history of multiple endocrine neoplasia syndrome type 2.

  • On April 9, 2012, the FDA approved updating the label regarding the superior blood glucose control when compared to Januvia.

  • In April 2013, warnings and precautions included acute pancreatitis, fatal and non-fatal hemorrhagic and necrotizing pancreatitis.

  • In March 2015, black box warning and precautions were modified, adding the risk of thyroid C- cell tumors, including medullary thyroid carcinoma (MTC).

Legal Updates:

Defendants: Merck Sharp & Dohme Corp., Eli Lilly & Co., Novo Nordisk Inc. and Amylin Pharmaceuticals LLC.

Defendant Law Firm:  Kannon K. Shanmugam of Williams & Connolly LLP.

Allegations: Allegations include that the manufacturers failed to warn consumers about pancreas problems from Type 2 diabetes drugs.

Plaintiff Steering Committee:

  • Michael Goetz, Morgan & Morgan

Lawsuit Status:

  • 2013: Victoza lawsuits along with several diabetes medications (Byetta, Januvia, and Janumet) were centralized in a multidistrict litigation MDL 2452 (In Re: Incretin Mimetics Products Liability Litigation) in the Southern District of California. Lawsuits filed alleged that though the manufacturers knew about the link of their product to cancer side effects in several studies, the details were not made public. Victoza thyroid lawsuits were filed across the nation, claiming that the drug caused patients to develop thyroid and pancreatic cancer.
  • November 2015: Judge Battaglia, granted summary judgment in favor of the defendants, following a preemption protocol dismissing all the cases in the MDL.
  • September 2016: Plaintiff attorneys filed an appeal to the Ninth Circuit U.S. Court of Appeals on behalf of the MDL stating that Judge Battaglia misinterpreted the U.S. Supreme Court preemption law.
  • November 2017: The U.S. Court of Appeals for the Ninth Circuit reversed and vacated the Federal District Court Judge’s ruling, thereby reinstating the dismissed federal lawsuits and sending them back to the Federal District Court in California for further proceedings.

Evidence:

  • Usage of Victoza in Pharmacy Records
  • Duration of Victoza usage
  • Indications for usage of Victoza in Medical Records
  • Complications and their treatment after Victoza Intake

Medical Record Review and claim validation of Victoza 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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