Fosamax Litigation Attorneys in California, Arizona and Nevada
Fosamax was heavily marketed following its introduction to the consumer market in 1999. Millions of patients were prescribed Fosamax to treat or prevent
Osteoporosis, especially in women going through menopause. However, there are potential dangerous side effects of Fosamax that Merck & Company (manufacturer of Fosamax) failed to alert the public about, especially atypical femur fractures.
At the Brandi Law Firm, we bring suit against defective drug manufacturers for their negligence in placing dangerous and defective drugs on the market. Our drug litigation attorneys are actively investigating claims involving injury from Fosamax. Contact us to speak with an experienced Fosamax lawyer about your claim.
Side Effects of Fosamax
Fosamax (generic name Alendronate Sodium) is in a category of drugs known as Bisphosphonates. Bisphosphonates are effective in preventing bone degeneration. Fosamax is given to Osteoporosis patients to reduce or prevent bone loss as the bones age and become susceptible to such loss. However, Fosamax has been linked to problems in the jaw, such as Osteonecrosis of the Jaw (ONJ or "dead jaw").
When Bisphosphonates, such as Fosamax, are in the body's system, the bone or tissue surrounding the bone fails to heal following a tooth extraction or jaw trauma. As a result, the patient may have exposed bone and may experience severe pain or infection. Often times, individuals are forced to undergo surgery to obtain a prosthetic jaw.
On October 13, 2010 the U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis, stating:
"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 fractures1, 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."
On October 123, 2010, in a letter to MERCK, the FDA wrote:
" Since Fosamax was approved on September 29, 1995, we have become aware of a possible increased risk of atypical subtrochanteric and diaphyseal femoral fractures in patients taking bisphosphonates, including Fosamax, for the treatment and/or prevention of osteoporosis. Recent publications, including the 2010 Report of a Task Force of the American Society for Bone and Mineral Research, suggest that the risk of atypical fractures and diaphyseal femoral fractures increases with increased duration of bisphosphonate exposure. We consider this information to be "new safety information" as defined in section 505-1(b)(3) of the FDCA.
Safety Labeling Change
In accordance with section 505(o)(4) of the FDCA, we are notifying you that, based on the new safety information described above, we believe that the information regarding possible increased risk of atypical fractures and diaphyseal femoral fractures should be included in the labeling for bisphosphonates approved for the treatment and/or prevention of osteoporosis as follows:
1. Add the following language (underlined) to the INDICATIONS AND USAGE section, Treatment and/or Prevention of Postmenopausal Osteoporosis section of the package insert: The safety and effectiveness of Fosamax for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
2. Revise the PRECAUTIONS section of the package insert to add the following paragraphs (underlined) following the Dental discussion:
Atypical Subtrochanteric and Diaphyseal Femoral Fractures:
Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These 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. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.
Atypical femur fractures most commonly occur with minimal or no impact to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture.
Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out a femur fracture. Subjects presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis."
Fosamax Litigation Information
Multidistrict litigation (MDL) is a federal procedure for consolidating complex civil cases involving one or more common questions of fact. While similar to class action lawsuits, each lawsuit consolidated into an MDL remains active and is decided on an individual basis.
On March 23, 2011 Merck asked the Judicial Panel on Multidistrict Litigation (JPML) to create a separate MDL for Fosamax femur fracture lawsuits. The JPML granted Merck's request for a new MDL and transferred all Fosamax femur fracture cases filed in federal courts to Judge Garrett E. Brown of the United States District Court for the District of New Jersey (MDL No. 2243).
California has its own version of the federal MDL called a Judicial Council Coordinated Proceeding (JCCP). On May 10, 2011, a JCCP comprised of Fosamax injury lawsuits was approved for coordination and assigned to Judge Ronald Bauer in Orange County Superior Court (JCCP No. 4644). Our office is currently representing numerous clients in the JCCP in California and the MDL.
Fosamax Again Linked to Rare Thigh Fractures
A new study published May 21, 2012 on line by the Archives of Internal Medicine said it found a link between bisphosphonate use (one of which is Fosamax) and atypical thigh fractures.
Of 477 patients fifty years and older hospitalized at one center for a subtrochanteric or femoral shaft fracture, 39 had atypical fractures and 438 had common fractures. The study examined patients between 1990 and 2010. Among those with atypical fractures, 82.1% had been taking bisphosphonates compared with just 6.4% of those with common fractures, Raphael P.H. Meier, MD, from University Hospitals of Geneva, and colleagues reported online in the Archives of Internal Medicine.
They also noted that the atypical-fracture group had a longer treatment period on bisphosphonates - including alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), and ibandronate (Boniva) - than the classic-fracture group, at a mean of 5.1 years versus 3.3 years (P=0.02). The study concluded that: "Atypical femoral fractures were associated with bisphosphonate use; longer duration of treatment resulted in augmented risk. The incidence of atypical fractures increased over a 12-year period, but the absolute number of such fractures is very small."
According to Douglas Bauer, MD, of the University of California San Francisco, in an accompanying commentary to the article the study "adds further data suggesting that the association between bisphosphonate use and atypical fractures is causal"
On October 13, 2010, the FDA warned patients and health care providers about the risk of an atypical thigh bone fracture, a rare but serious type of thigh fracture, in people who take Fosamax and similar drugs for the treatment of osteoporosis. The FDA stated that these fractures, called "atypical subtrochanteric" fractures, often appear in the bone just below the hip joint. These risks are increased in people using Fosamax for five years or more. These fractures, while rare, have been mostly reported in patients taking Fosamax or other drugs of this type.
A Tradition of Advocacy and Success
Lawsuits have been filed against Merck & Company throughout the nation involving the defective drug Fosamax. Our lawyers pursue overzealous drug companies like Merck & Company, which have placed profits ahead of the health and well being of patients taking these medications. If you or a loved one has suffered jaw damage while taking Fosamax, contact our lawyers at the Brandi Law Firm. We are committed to advocating for vulnerable clients facing powerful drug companies in drug litigation
Although most cases resolve in settlement, some case may result in trial. Our office works in a team approach with two lawyers and one paralegal working on every case with Mr. Brandi was lead trial attorney. On November 13, 2004 Mr. Brandi was named Trial Lawyer of the Year for the State of California by the Consumers Attorneys of California. He has been a finalist for Trial Lawyer of the Year for the Trial Lawyers of Public Justice (2004), Consumer Attorneys of California (2002, 2004) and San Francisco Trial Lawyers Association (1999, 2002, 2004, 2012), has been selected in the TOP 100 Super Lawyers every year since 2006, and in BEST LAWYERS IN AMERICA for over 15 years.