Find Legal Topics > Drugs Laws > Aredia Lawsuit

Aredia Lawsuit


A brief guide to filing an Aredia lawsuit

Cancer patients with osteoporosis or other bone density issues are sometimes prescribed the medication Aredia--a biophosphonate. However, Aredia is accompanied by numerous side effects including a condition known as "osteonecrosis of the jaw," or "ONJ." Left untreated, this condition can lead to severe repercussions, such as a full removal of the jaw. Because of this gruesome side effect, at least 750 people are seeking an Aredia settlement through litigation.

Reports of the development of ONJ prompted the FDA to issue an update concerning Aredia side effects. In response to reports of this complication, warnings were issued to caution patients about a recommended dental examination prior to treatment. In 2011, a study published in the Journal of the American Medical Association reported that women who take biophosphonates for an extended period of time are at greater risk for unusual bone fractures, especially of the femur. These potential Aredia side effects led to another FDA update in 2012 that proposed limiting a course of treatment with this or similar medications to no more than five years.

The majority of people who filed an Aredia lawsuit were suing over the development of ONJ. In response to the volume of litigation seeking an Aredia settlement, the cases were consolidated in a procedure known as "multidistrict litigation." This involves trying a number of similar cases in a single court. In this case, the federal district court of Nashville is hearing nearly all lawsuits concerning Aredia side effects.

In 2009, the first Aredia lawsuit heard resulted in a $3.2 million verdict being awarded to the plaintiff. In this case, a woman who was prescribed the medication during a course of cancer treatment, sued over jaw damage. Her lawyers argued that the medication sufficiently warned of such a risk, justifying an Aredia settlement.

The next two cases concerning Aredia side effects followed in 2010. The second case did not result in an Aredia settlement for the plaintiff. However, the third Aredia lawsuit ended with a $12.8 million settlement being issued to the survivors of a woman who died while taking the drug. Defense attorneys presented an internal company memo suggesting that manufacturer Novartis was aware of such dangerous potential Aredia side effects by 2001 but deliberately suppressed them from public knowledge.

Subsequent cases seeking an Aredia settlement have been resolved in favor of both plaintiffs and the manufacturer. The success of every Aredia lawsuit is dependent on several factors, including your state's statute of limitations, your ability to prove that Aredia was responsible for your injury or illness and proof that you took the medication as prescribed.

Many attorneys may still be interested in seeking Aredia settlements for bone fractures. An Aredia lawsuit would proceed on the grounds that Novartis has not provided sufficient warning of this risk. Because of similar side effects, those seeking an Aredia settlement commonly will also litigate over the drug Zometa. Consult with an attorney about a Zometa or Aredia lawsuit as soon as possible if you believe you have a strong case.


Other Aredia Side Effects:


Some common Aredia side effects include: fatigue, nausea, vomiting, anemia, skeletal pain and fever. Also, some patients report joint and muscle pains within 1 to 3 days after their second or third treatment.



Aredia FDA Warnings:


The United States Food and Drug Administration notified dental healthcare professionals of revisions pertaining to osteonecrosis in cancer patients receiving Aredia. The FDA recommends that cancer patients who are administered this drug receive a dental examination prior to engaging in therapy with bisphosphonates.



Sources:


1.) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152862.htm


2.) http://www.chemocare.com/faq/aredia__use_and_side_effects_information.asp


3.) United States National Library of Medicine Pamidronate Injections retrieved from: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000135/


4.) Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates". Postmarket Drug Safety Information for Patients and Providers. Food and Drug Administration (United States). October 2008.

 

Related Topics