Le Lézard
Classified in: Health
Subject: LAW

Voluntary dismissal of Norris case


MONROE TOWNSHIP, N.J., Jan. 16, 2020 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, does not comment on pending litigations per its corporate policy.  However, Bracco is pleased to announce today that the lawsuit filed by Chuck and Gena Norris, in which Mrs. Norris alleged injury from Bracco's magnetic resonance (MR) contrast agent MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL, has been voluntarily dismissed by Mr. and Mrs. Norris.  The case is now closed.  The decision to dismiss the lawsuit was entirely that of Mr. and Mrs. Norris and their attorneys.  No settlement payment was made and each party paid their own costs.

Bracco Diagnostics Inc. (PRNewsfoto/Bracco Diagnostics Inc.)

Bracco takes patient safety very seriously and stands behind the safety of all of its products, including the MR contrast agents ProHance® (Gadoteridol) Injection, 279.3 mg/mL and MultiHance.  For further information, please refer to the Bracco November 2, 2017 press release at https://imaging.bracco.com/us-en.

Indications and Usage for MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL:
MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL is a gadolinium-based contrast agent indicated for intravenous use in:

Indications and Usage for ProHance® (Gadoteridol) Injection, 279.3 mg/mL:
CENTRAL NERVOUS SYSTEM
ProHance® (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine, and associated tissues.

EXTRACRANIAL/EXTRASPINAL TISSUES
ProHance (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults to visualize lesions in the head and neck.

IMPORTANT SAFETY INFORMATION for MultiHance and ProHance:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

 

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with: 
    • chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or 
    • acute kidney injury. 
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. 
  • For patients at highest risk for NSF, do not exceed the recommended MultiHance/ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration. (see WARNINGS)

MultiHance (gadobenate dimeglumine) injection, 529 mg/mL
Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations ranging from mild to severe. The possibility of a reaction should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders. Trace amounts of gadolinium may remain for months or years in the body organs including bone (highest concentration), brain, liver, spleen, kidneys and skin. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of retention in skin and other organs have been established in patients with impaired renal function. Minimize repetitive GBCA imaging studies, particularly close spaced studies when possible.

ProHance (Gadoteridol) Injection, 279.3 mg/mL
As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes and renal insufficiency with or without hepatic impairment. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders. Trace amounts of gadolinium may remain for months or years in the body organs including bone (highest concentration), brain, liver, spleen, kidneys and skin. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of retention in skin and other organs have been established in patients with impaired renal function. Minimize repetitive GBCA imaging studies, particularly close spaced studies when possible.

Please see full Prescribing Information and Patient Medication Guide for additional important safety information for/regarding MultiHance (gadobenate dimeglumine) injection, 529 mg/mL at https://www.braccoimaging.com/us-en/products/magnetic-resonance-imaging/multihance

Please see full Prescribing Information and Patient Medication Guide for additional important safety information for/regarding ProHance (Gadoteridol) Injection, 279.3 mg/mL at https://www.braccoimaging.com/us-en/products/magnetic-resonance-imaging/prohance

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH ? 78224 Singen (Germany) and by Patheon Italia S.p.A, Ferentino, Italy.

ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH ? 78224 Singen (Germany).

MultiHance is a registered trademark of Bracco International B.V.

ProHance is a registered trademark of Bracco Diagnostics Inc.

About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.

Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.

The company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.

Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and the USA.

To learn more about Bracco Imaging, visit www.braccoimaging.com.

Press contact:
Kimberly Gerweck
Bracco Diagnostics Inc. Media Relations
BDIMediaContact@diag.bracco.com
+1 609-524-2777

SOURCE Bracco Diagnostics Inc.


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