On September 25, 2013, the California Supreme Court denied the generic Fosamax manufacturers petition for review thereby upholding the June 13, 2013 Court of Appeal decision allowing people injured by generic Fosamax to go forward in the Courts and hold the generic manufacturers responsible. In denying the generic manufacturers Petition, the Supreme Court let stand the June 13, 2013 the California Court of Appeal, Fourth Appellate District, Division Three ruling that people who used the generic Fosamax were not preempted by Federal law and the decision in PLIVA, Inc. v. Mensing (2011) 131 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, a 5-4 decision authored by Hon. Clarence Thomas, 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.
The practical effect of Mensing is, to quote the dissenting opinion of Justice Sotomayor, at 2581;
“As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: This outcome “makes little sense.”
However, in the case of Olga Pikerie, the California 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.
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.