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Zometa /Aredia
Lawsuit Status


Our Legal Team
has been appointed to the Plaintiff Steering Committee.

This committee has
the power to determine:
-what legal theories to pursue,
-what depositions will be taken and how to conduct discovery.

   On March 30, 2006, our legal team argued that product liability actions against Novartis, makers of Zometa and Aredia, be tried as Multi-District Litigation (MDL) cases.
The Defendant Novartis opposed this motion.

On April 18, 2006, 
The Judicial Panel on
Multidistrict Litigation
granted the motion.
We argued for this because we believe that this process will save time and costs necessary to litigate these cases.





 

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Leading Legal Team for ONJ Cases
Our Legal Team has been appointed to
the Plaintiff Steering Committee for both
the Zometa/Aredia and Fosamax Litigation


This committee has
the power to determine:
-what legal theories to pursue,
-what depositions will be taken
 and how to conduct discovery.


Bisphosphonates Jaw Osteonecrosis Information

 
Symptoms of bone death in the jaw include:

  • pain
  • infection of the gums
  • loosening of the teeth
  • poor healing of the gums
  • numbness or a feeling of heaviness in the jaw
  • exposed bone



About Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the Jaw (ONJ) is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.

More Bisphosphonate Jaw Osteonecrosis Information

"Expert Panel Recommendations for the
Prevention, Diagnosis, and Treatment of
Osteonecrosis of the Jaws: June 2004"

http://www.ada.org/prof/resources/topics/
topics_osteonecrosis_whitepaper.pdf

This pamphlet outlines the symptoms of ONJ
and the different procedures doctors may
perform in order to make an accurate diagnosis.
The pamphlet also provides a list of factors
that may increase one’s risk of developing
ONJ, as well as how to manage the disease
and treat patients with ONJ.

 

Http://www.fda.gov/medwatch/SAFETY/
2004/safety04.htm#zometa

This website will direct you to the US Food
and Drug Administration’s Zometa Safety Alert,
first posted on September 30, 2004.

 

http://www.fda.gov/medwatch/SAFETY/
2004/ZometaHCP.pdf

This September 2004 letter was sent from
Novartis to doctors, making them aware of the
changes they recently made to the Aredia and
Zometa US package inserts, now including a
precautionary statement regarding a
possible risk of developing ONJ.

 

http://www.fda.gov/medwatch/SAFETY/
2004/Zometa_PI.pdf

(In particular pages 9-11, 20)
In August 2004, Novartis revised the product
information label for Zometa, adding the risk
of developing ONJ to their list of precautions,
as well as to their Post-Marketing Experience notes.

"Coping with Cancer: Dental Health and
Osteonecrosis of the Jaw"

 

http://www.us.novartisoncology.com/info/
coping/dental_health.jsp

The Novartis Oncology website provides an overview
of what a person’s dental hygiene
routine should include if he or she has cancer. It also
discusses the risk of developing osteonecrosis of the
jaw and the factors that may increase the risk. Finally,
it provides information regarding diagnosis and treatment.

 

"Pamidronate (Aredia) and Zoledronate (Zometa)
Induced Avascular Necrosis of the Jaws: A Growing Epidemic

Robert E. Marx, Letter to the Editor, Journal
of Oral Maxillofacial Surgery. 61:1115-1118, 2003

Robert E. Marx, Letter to the Editor.pdf

Dr. Marx’s letter describes his study of 36 ONJ cases.
He explains how he reached the conclusion that a connection
exists between ONJ and bisphosphonates.
He describes common ONJ symptoms and how
bisphosphonates may affect the jawbone’s ability to regrow.
He concludes his letter by discussing methods of
prevention and possible treatments for ONJ.


 



 

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Fosamax ® Information

 
Symptoms of bone death in the jaw include:

  • pain;
  • swelling;
  • infection of the gums;
  • loosening of the teeth;
  • poor healing of the gums;
  • numbness or a feeling of heaviness in the jaw; and
  • exposed bone.

Fosamax ® (generic name - Alendronate) is a type of drug known as bisphosphonates. Recently a link has been found between bisphosphonates and a serious bone disease called osteonecrosis of the jaw (ONJ). This important discovery clearly shows that Fosamax ® side effects may include osteonecrosis of the jaw.

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 Zometa ® is a type of drug known as bisphosphonates. Recently a link has been found between bisphosphonates and a serious bone disease called osteonecrosis of the jaw (ONJ). This important discovery clearly shows that Zometa ® side effects may include osteonecrosis of the jaw.

The discovery, published in the Journal of Oral and Maxillofacial Surgeons, prompted both the US, Food and Drug Administration (FDA) and Novartis, the manufacturer of bisphosphonates used in cancer chemotherapy, to issue a warning to health care professionals on September 24, 2004. The warning letter contained information about bisphosphonates and the risks of osteonecrosis in the jaw.

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Aredia ® is a type of drug known as bisphosphonates. Recently a link has been found between bisphosphonates and a serious bone disease called osteonecrosis of the jaw (ONJ). This important discovery clearly shows that Aredia ® side effects may include osteonecrosis of the jaw.

 

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Actonel Jaw Osteonecrosis Lawsuit

Bisphosphonates are commonly used in tablet form such as Fosamax ® (Alendronate Sodium) and Actonel ® to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonates are commonly used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously, and usually for longer periods of time.

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Bisphosphonate News

Drug linked to death of jawbone, USA TODAY
Salvatore Ruggiero was puzzled.Over a three-year period, the jaws
of dozens of patients who had undergone oral surgery
at his hospital had failed to heal properly.


Jaw Ailment Shows Industry Moves Slowly on Drug Warnings
THE WALL STREET JOURNAL,
December 8, 2004; Page B1
After eight operations on patients whose jawbones turned out to be dead, oral surgeon Salvatore Ruggiero began doing some research....


Bisphosphonates Can Cause Problems in Jaw,
cancerpage.com (March 15, 2005) - Cancer patients given drugs called bisphosphonates to control
hypercalcemia – too much calcium in the blood – or the growth of bone
metastases can develop bone death in the jaw the FDA warns.

The American Association of Oral and Maxillofacial Surgeons
Bisphosphonates Can Wreak Havoc in the Mouth and Jaws, Oral and Maxillofacial Surgeon Warns ... onset of osteochemonecrosis,
or "
bis-phossy jaw," a painful, potentially disfiguring jaw condition,
according ... increase the risk of
bis-phossy jaw, it is the injectable medications

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The most common signs and symptoms of ONJ include pain, soft-tissue and jaw swelling, loosening of teeth, drainage, exposed bone, and infection.
Numbness, heaviness and other
sensations in the jaw may also occur in some individuals.
In order to diagnose ONJ, doctors may perform panoramic and tomographic imaging. They may also take microbial cultures and tissue biopsies in order to rule out other kinds of infections. Early detection of ONJ is imperative to preserving the jawbone.