By: Austin Kirk | Published: September 21st, 2012
The number of lawsuits over Fosamax filed in the New Jersey state court system continues to increase, with more than 2,000 complaints now filed by individuals who have suffered sudden femur fractures, jaw problems or other injuries allegedly caused by side effects of the osteoporosis drug.
Fosamax (alendronate sodium) is a popular medication introduced by Merck in 1995 for treatment and prevention of osteoporosis. Before it became available as a generic in 2008, the medication generated over $3 billion in annual sales and was used by millions of Americans.
All Fosamax lawsuits filed in New Jersey state court have been consolidated as part of a “mass tort” or “multi-county litigation”, which is centralized before Judge Carol Higbee in the Superior Court of New Jersey for Atlantic County.
According to the most recent case list (PDF) issued by the court, there were at least 2,067 complaints filed in New Jersey state court on September 13. While the earliest lawsuits were filed in 2006, the number of cases has dramatically increased since 2010 and nearly half of all complaints pending in the state having been brought over the past year.
All of the complaints involve similar allegations that Merck failed to adequately research their popular medication or warn about the potential side effects of Fosamax.
While the early lawsuits were filed by individuals who suffered a rare form of jaw damage from Fosamax, known as osteonecrosis of the jaw, most of the complaints now involve allegations that plaintiffs sufferd a spontaneous femur fracture on Fosamax, which typically occurs with little or no trauma at all.
Fosamax is a member of the class of medications known as bisphophonates, which are designed to strengthen bones and reduce the risk of fractures associated with osteoporosis. However, long-term use of Fosamax and other medications in this class have been linked to an increased risk of low-trauma bone fractures, where the femur may completely fracture while taking a step or falling from standing height or less.
In October 2010, the FDA required Merck and manufacturers of other oral bisphophonates, such as Actonel and Boniva, to add new warnings about the risk of bone fractures, providing new information to users that they should contact their doctors if they experience groin pain, which may be a sign of problems before one of these atypical fractures occur.
Earlier this year, the FDA issued new guidance for individuals taking Fosamax and other similar osteoporosis drugs, now indicating that women may be able to stop taking the drug after 3 to 5 years. FDA officials have suggested that it is difficult to determine whether the benefits of the drug outweigh the risk after that period of time.
The five-year time limit was first suggested by a September 2011 FDA report, which noted that there appears to be no benefit to taking the drugs longer than five years. That report was issued before an FDA advisory committee was convened to review the risks associated with the long-term use of the medications. The panel ultimately voted to place stronger bone fracture label warnings on the popular medications, but did not go as far as finalizing any length-of-use recommendations.
In a letter sent to lawyers involved in the New Jersey Fosamax litigation in June, Judge Higbee indicated that the next trial date scheduled will involve a femur fracture from Fosamax, as opposed to a plaintiff who suffered jaw damage, even though those cases are older.