In a major victory for consumers who used the generic form of Fosamax, (Alendronate sodium) on June 13, 2013 the California Court of Appeal, Fourth Appellate District, Division Three ruled that people who used the generic Fosamax were not preempted by Federal law and the decision in PLIVA, Inc. v. Mensing (2011131 S.Ct. 2567 but could proceed against manufacturers of generic version for failure to adequately warn of safety issues regarding the products (Teva Pharmaceuticals USA, Inc, et al vs. Superior Court of Orange County, OLGA PIKERIE, Real Party In Interest, G047134).
In Mensing, the US Supreme Court ruled that any claim a generic drug company should have used stronger warnings than those approved for use on the equivalent brand‑name drug are preempted by federal law. The court also held that a state could not require a generic drug manufacturer to provide information on its label in addition to information required on the brand‑name drug’s label, as that would make it impossible for the generic drug manufacturer to comply with both its duty under federal law to match the brand-name label and any claimed duty under state law to do more. As a result of this impossibility, such a state requirement would be preempted by federal law.
However in the case of Olga Pikerie, the Court stated: “In this case, in contrast, plaintiff alleged that the brand‑name drug label was updated, but the generic drug manufacturers failed to update their products’ labels accordingly. In other words, the generic drug labels did not match the brand‑name drug label. Consequently, we conclude, plaintiff’s claims in this regard are not preempted by federal law.”
Fosamax was under patent protection to MERCK until 2008. 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. For many, what was designed to make you stronger actually made you weaker.
When the patent expired, several other companies made the generic version (Alendronate sodium) including Teva Pharmaceuticals USA, Inc. (Teva), Barr Pharmaceuticals LLC (Barr), Barr Laboratories, Inc. (Barr Labs), Mylan Pharmaceuticals, Inc. (Mylan), Caraco Pharmaceutical Laboratories, Ltd. (Caraco), Sun Pharmaceutical Industries, Inc. (Sun), and NorthStar Rx LLC (NorthStar). Fosamax and alendronate sodium belong to the class of drugs known as bisphosphonates and they are indicated for the treatment and prevention of osteoporosis.
On October 13, 2010, the U.S. Food and Drug Administration 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 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.”
Olga Pikerie was prescribed and took Fosamax and/or alendronate sodium from 2006 to 2011 when she suffered a left femur fracture. Pikerie’s complaint alleged prolonged use of Fosamax and/or alendronate sodium might cause fractures of the femur due to suppression of bone turnover. Her suit claimed that “ the Teva Defendants’ alleged failures to (1) update the alendronate sodium labels to match the updated Fosamax label; (2) communicate the updated safety information to physicians and other health care professionals; (3) stop marketing alendronate sodium after learning about safety issues regarding the drug; and (4) request the FDA to order a change to the Fosamax label, which would have enabled the Teva Defendants to then update the alendronate sodium labels to match the Fosamax label.”
The Court concluded her case was not pre-empted under federal law and will allow her cases and those of other users of generic Fosamax to proceed. This case arose when the Teva Defendants filed a Demurer to the original complaint, lost, and asked the Appellate Court to overturn the Trial Court by way of Special Writ of Mandate/Prohibition claiming cases against generic manufacturers were barred by the legal doctrine of federal pre emption.
A 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”.
This decision will allow countless people who suffered atypical femur fractures on Fosamax or its generic equivalent to hold the manufacturers accountable. The Brandi Law Firm continues to represent a number of people who used Fosamax or its generic equivalent and suffered atypical femur fractures. We believe that ultimately Merck and the generic manufacturers will be held accountable in these cases. If you would like more information, check the video below or go to our website, or contact us.