Boniva Lawsuit

A Brief Guide to Filing a Boniva Lawsuit

As a popular biophosphonate, Boniva is issued to post-menopausal women to protect against the risk of developing osteoporosis. Although effective, Boniva may produce rare side effects including an increased risk of developing unusual bone fractures.

Because of these reactions, the FDA in 2010, requested further review to affirm the link between biophosphonates and the development of unusual fractures, particularly in the femur. The results of the study, offered by the American Society for Bone and Mineral Research, showed 291 out of the 330 patients developed atypical fractures as a result of boniva use.

Bearing these risks in mind, the FDA ordered a 2010 update of warning label information concerning these potential Boniva side effects. Similar warnings were included in the labeling information of all biophosphonates. To date, this finding has not produced any notable Boniva lawsuit; no patient suffering from an atypical fracture has sought compensation from Boniva’s manufacturer.

The FDA is still considering what steps to take to minimize Boniva side effects. Currently, the agency recommends that a course of Boniva treatment be capped at five years; studies reveal that the risk of Boniva side effects increased with multi-year use.

In addition to abnormal fractures, patients should be alert to the possibility of developing osteonecrosis of the jaw (ONJ). One study found that slightly more than 120 patients taking biophosphonates reported developing this condition between 2001 and 2006. While patients are cautioned of such Boniva side effects in the prescription information, it may still be possible to pursue litigation in such cases.

Famous Boniva Lawsuits:

To date, no notable successful Boniva lawsuit concerning adverse effects has been reported. However, litigation was filed against manufacturer Roche Laboratories in 2006. In this Boniva lawsuit, competitors Proctor & Gamble and SanofiAvents accused the company of selling the drug under false pretenses. The case was eventually thrown out by the U.S. District court. In their decision, the court concluded that the Boniva lawsuit stemmed from a desire to weaken the drug's share of the marketplace.

Filing litigation over Boniva side effects may be difficult, since no significant Boniva lawsuit has been reported. While mounting clinical data over Boniva side effects and bone fractures can help provide the foundation for such a case, an attorney must be hired to demonstrate that a patient was not sufficiently warned of these dangers.

As the FDA considers how to make the drug safer, legal action against Roche Laboratories has not been currently reported. Multiple patients experiencing bone fractures may pursue a class action Boniva lawsuit. This will require the hiring of a lawyer to assemble multiple plaintiffs' complaints and demonstrate manufacturer negligence. Since no Boniva lawsuit on such grounds has reached a public resolution, it is difficult to know whether such actions would result in compensation.

Boniva and the FDA:

In October of 2010, the United States Food and Drug Administration issued warnings on Boniva. The agency linked use of Boniva—as well as other popular osteoporosis drugs—to the development of the aforementioned fracture of the thigh bone. The agency issued this warning in response to an ongoing agency review of the effectiveness and safety of biophosphonates to treat or prevent osteoporosis.

Although this review altered the prescription warning found on Boniva’s product label, the FDA advised patients to keep taking the drugs unless specifically told by their doctors to discontinue use.

Sources:

1. FDA Issues Warning on Bone Drugs New York Times October 13th 2010, by Duff Wilson, retrieved from:

http://prescriptions.blogs.nytimes.com/2010/10/13/f-d-a-issues-warning-on-bone-drugs/

2. http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm101551.html

3. http://www.dailyfinance.com/2010/10/13/fda-warns-about-boniva-fosamax-and-other-osteoporosis-drugs/

4. United States National Library of Medicine "Ibandronate" retrieved from:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000318/