New York Boniva Attorneys
Experienced in Litigating Boniva Cases
With Rheingold, Valet, Rheingold, McCartney & Giuffra LLP you are getting a firm who has represented Boniva since before femur fracture were highly publicized. Our firm has one of the few "bellwether" femur fracture cases in the Fosamax litigation (Fosamax is a bisphosphonate just like Boniva). These are hand-picked cases from the thousands of pending suits which are chosen to be prosecuted as one of the first trials. As of early 2012, our firm is conducting deposition discovery of our client, a woman for South Carolina who has suffered from a femur fracture in each leg.
Aside from our firm prosecuting hundreds of individual claims, litigation involves review of millions of corporate documents. Perhaps these documents will reveal that bisphosphonate's benefits were significantly more narrow than promoted, and that the dangerous side effects were much more severe. Sadly, some of our femur fracture clients have not fully healed even after two years of recovery!
The drug Boniva uses bisphosphonate to treat symptoms of bone disease and bone degeneration like osteoporosis. Unfortunately, a side effect of bisphosphonate and Boniva is damage to bones. Specifically, Boniva can lead to:
- The fracturing of the femur
- Damage to the jaw bone (often referred to as osteonecrosis of the jaw [ONJ])
Boniva and bisphosphonate's damage is usually limited to the jaw and femur because it tends to "target" bones that have been subjected to heaviest impact, namely our femurs/hips (from walking) and jaws (from chewing).
Boniva can damage femurs to such an extent that femur/hip breaks caused by Boniva usually occur during normal activities like walking up the stairs or standing. If you suspect that you or a loved one has experienced a fractured or broken femur following the use of Boniva, contact the New York pharmaceutical law firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP.
Our firm filed one of the first bisphosphonate femur fracture cases in February, 2009, almost two years before the FDA required warnings about the injury (see below). We continue to review and file cases in a coordinated action with other firms in order combine forces for the strongest possible litigation. Drug companies like Hoffman-LaRoche who are selling bisphosphonates have attempted to thwart litigation, but our firm and the courts are now pushing the litigation based on the continued findings of medical studies. Through written discovery demands on the drug companies, we will learn more about what their actual knowledge was of the nine femur fracture victims reported in 2005 (some of which obviously happened before 2005), which is five years before the warning was added. Some have reported that the drug companies like Merck knew of an increased fracture risk before the drug was even approved in 1995
For knowledgeable legal help in New York regarding Fosamax femur and bone injuries, contact the lawyers of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP at 888-335-9457.
Boniva injuries can strike any Boniva user but most often affects older, female users. We regularly meet both with victims of Boniva and the adult children of Boniva users who are concerned about a parent's health.
More Information About Boniva, Fractured Femurs and Rheingold, Valet, Rheingold, McCartney & Giuffra LLP
The FDA is mandating a warning about femur fractures. See below for more information.
Research demonstrates that use of Boniva may increase the risk of a rare type of femur fracture due to impacting the ability of the bone to repair damage to the femur.
The study is published in the May/June 2008 issue of the Journal of Orthopedic Trauma. Researchers performed a review of femur fractures which resulted in emergency room treatment between January 2002 and March 2007. The fractures reviewed in the observational study involved injuries typically caused by the impacts of falls from a standing height or less.
Researchers identified a fracture pattern that was 98% specific to users of bisphosphonates, and the average duration of bisphosphonateuse was longer among those who had the pattern than those who did not. 25 involved users of v and 76% of the bisphosphonate femur fractures involved the distinct characteristics identified in the fracture pattern.
We are actively pursuing these cases, and please feel free to call us for a free and confidential consultation. We can handle cases in any state, and are already involved in the consolidated litigation against Hoffman-LaRoche for their Boniva drug.
For many of our Boniva patients a lawsuit is an opportunity to hold negligent doctors and drug manufacturers responsible for their carelessness. If you have questions regarding medical malpractice law and Boniva litigation, contact a medical malpractice attorney in New York City by calling Rheingold, Valet, Rheingold, McCartney & Giuffra LLP.
Contact Us
Rheingold, Valet, Rheingold, McCartney & Giuffra LLP offers free initial consultations, works on a contingency fee basis and is conveniently located in Midtown Manhattan. To contact us, call 888-335-9457.
Contact our firm and we would happily provide you with most recent medical literature involving bisphosphonates (like Boniva) and their relationship to atypical femur fractures.
Breaking News!
September 9, 2011 - The Bisphosphonate panel for the US Food and Drug Administration (FDA) voted 17 to 6 to recommend that the labeling for bisphosphonates for the treatment of osteoporosis specifically state about how long the drugs should be used.
Prior News: The FDA is mandating femur fracture warnings. Below are excerpts from the 10-13-10 announcement
FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
Safety Announcement
[10-13-2010] The U.S. Food and Drug Administration (FDA) is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis. Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.
The bisphosphonates affected by this notice are only those approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic products).
Although the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term term bisphosphonate use. FDA will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs. This statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.
A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription. This Medication Guide will describe the symptoms of atypical femur fracture and recommend that patients notify their healthcare professional if they develop symptoms..
groin pain, duration of bisphosphonate use, relevant medical history, and concomitant use of other medications.
Data Summary
FDA has reviewed all available data, including data summarized in the American Society for Bone and Mineral Research (ASBMR) Task Force report regarding bisphosphonates and atypical subtrochanteric and diaphyseal femur fractures, released on September 14, 2010. These atypical femur fractures can occur anywhere in the femoral shaft, from just below the lesser trochanter to above the supracondylar flare, and are transverse or short oblique in orientation without evidence of comminution. The fractures can be complete (involving both cortices) or incomplete (involving the lateral cortex only), and may be bilateral. Many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. The exact incidence of atypical femoral fractures is unknown but appears to account for less than one percent of hip and femoral fractures overall. Therefore, atypical fractures are very uncommon. Although atypical femoral fractures have been predominantly reported in patients taking bisphosphonates, they have also been reported in patients who have not taken bisphosphonates.
The optimal duration of bisphosphonate treatment for osteoporosis is unknown. Bisphosphonate medications approved for the prevention and/or treatment of osteoporosis have clinical trial data supporting fracture reduction efficacy through at least 3 years of treatment and, in some cases, through 5 years. The FDA is continuing its evaluation of data supporting the safety and effectiveness of long term use (greater than 3 to 5 years) of bisphosphonates for the treatment and prevention of osteoporosis and will provide additional guidance at the completion of our review.
In summary, FDA is continuing its ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. As of this notice, the FDA is notifying patients and healthcare professionals of new Warnings and Precautions information that is being added regarding this risk to the labels of all bisphosphonate products approved for the prevention or treatment of osteoporosis. A new Limitations of Use statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis. In addition, the FDA will require that a Medication Guide be included with all bisphosphonate medications approved for osteoporosis indications to better inform patients of the risk for atypical femur fracture.
