March has been a busy month for new filings in the national litigation efforts involving bisphosphonate drug-induced femur fractures. Currently, there are coordinated state court proceedings pending in Atlantic City, New Jersey as well as Southern California involving the manufacturers of Fosamax, Boniva, and other osteoporosis drugs. There are also coordinated proceedings in New Jersey federal court (also known as MDL No. 2243) which initially included mostly cases involving ingestion of Fosamax. However, it has now been expanded by the Judicial Panel on Multidistrict Litigation pursuant to a February 22, 2012, order to include the claims of plaintiffs who used Fosamax as well as Boniva and Reclast. We believe that the federal multi-district litigation will likely expand further as additional plaintiffs file claims involving use of multiple brand name osteoporosis drugs as well as the generic version of Fosamax (which is known as Alendronate).
The Mass Tort Unit of Searcy Denney Scarola Barnhart & Shipley has filed a number of new individual lawsuits over the past month on behalf of women who have suffered femur fractures because of their long-term ingestion of osteoporosis drugs:
- Lawsuit filed in Broward County, Florida on behalf of a Pennsylvania woman who suffered multiple bilateral fractures of her leg bones after long-term use of Fosamax and Zometa, a high-dose bisphosphonate drug that is given through an IV injection and most commonly used in conjunction with cancer treatments. This case will likely be transferred and included in the federal MDL proceedings pending in New Jersey.
- Complaint filed in New Jersey state court proceedings on behalf of a retired legal assistant from Tallahassee who suffered several drug-induced fractures, which required extensive surgery. She had taken Fosamax and Alendronate for more than seven years prior to developing her injuries, which manifested themselves in late 2009, when she developed pain and a limp. The FDA made its first announcement about concerns over the increased risks of atypical femur fractures in patients using these drugs on March 10, 2010. A more in-depth safety alert was published on October 13, 2010, after the FDA convened a panel of advisors to discuss emerging scientific data on the excessive rate of atypical femur fractures associated with long-term use of bisphosphonate drugs, a class which includes Actonel, Actonel with Calcium, Alendronate, Aredia, Atelvia, Bonefos, Boniva, Didronel, Fosamax, Fosamax D, Reclast, Zometa, and other generic and brand name formulations. Patients were urged to consult with their physicians to determine whether the benefits of these drugs outweighed the risks given their particular personal and family medical histories, and were also urged to consult with a physician, if they developed thigh pain or aching, which has been documented in numerous women for several months prior to their suffering a bisphosphonate-induced fracture or fractures.
- New case filed in New Jersey state court on behalf of an active Pittsburgh widow who suffered numerous injuries when her right femur spontaneously broke and caused her to fall in 2008. Since that injury, which has been attributed to her ingestion of Fosamax over a six-year period, she has experienced great difficulty with walking and has undergone numerous procedures to stabilize and rebuild her right leg and hip with implanted surgical hardware.
- Claims filed on behalf of an avid traveler from Jupiter, Florida, who sustained her drug-induced subtrochanteric hip fracture while visiting in Russia. Sadly, she has been required to undergo numerous medical treatments overseas as well as upon her return to Florida for complications stemming from the damage caused to her bones by her ingestion of Fosamax for more than a decade.
- A Holiday Florida resident filed her case against Merck Sharp & Dohme Corp., Barr Laboratories, and Caraco Pharmaceutical Laboratories after being diagnosed with injuries associated with her near-decade ingestion of Fosamax. This case may represent one of the few cases filed so far in the national bisphosphonate litigation against Caraco Pharmaceutical Laboratories, a generic drug manufacturer based in Detroit with ties to Sun Pharmaceutical Industries, Inc. (based in Michigan), Sun Pharmaceutical Industries, Ltd. (based in India), Sun Pharmaceutical (based in Bangladesh), Alkaloida Chemical Company Exclusive Group, Ltd. (based in Hungary), Chattem Chemicals (based in Chattanooga, Tennessee), and Taro Pharmaceutical Industries, Ltd (based in Israel, Canada, and the US).
- An individual lawsuit was filed in the coordinated Fosamax proceedings in Atlantic City on behalf of an active Tampa Bay resident, who suffered a drug-induced leg injury while hiking and camping. The retired school district employee ingested Fosamax and Alendronate for nearly a decade in order to improve her bone health, but suffered a stress fracture in her leg that required surgery and implantation of surgical hardware due to deterioration of the inner structures of her bone, which are now known to be caused by Fosamax and other bisphosphonate drugs.
- A disabled nurse from the Tampa area filed her lawsuit in the consolidated Fosamax proceedings in New Jersey state court before Judge Higbee against Merck, the manufacturer of Fosamax, as well as GlaxoSmithKline and Roche Laboratories (the manufacturers of Boniva). This fifty-eight year old plaintiff had taken Fosamax and Boniva for approximately six years prior to suffering a displaced femur fracture, that is consistent in presentation with those reported in the medical and scientific literature as being caused by long-term ingestion of these drugs. In September of 2010, a task force from the American Society for Bone and Mineral Research issued a report that has been very helpful in documenting the causal link between long-term ingestion of osteoporosis drugs and the onset of atypical femur factures. The task force report has also been helpful in providing treating physicians with the tools that they need in order to diagnose drug-induced femur fractures. A possible explanation for the increased risk of femur fractures associated with these drugs may be that the drugs cause micro-damage deep inside the bone that creates cracks as well as blocking the body’s mechanism for remodeling and turning over new bone (which is what the drug is supposed to do in order to theoretically provide short-term benefits in warding off osteoporosis). Another helpful study is one published in the Journal of the American Medical Association (JAMA) in February of 2011, a seven-year study of women aged 68 years or older who ingested bisphosphonates. This study noted a substantially increased risk of 2.7 times (or 270% increased risk) of femur fractures, which was most prominent among patients who ingested the drugs for more than five years.
It will be several weeks before the dust settles and the number of pending lawsuits involving Boniva, Fosamax, and other bisphosphonate drugs are known. Since the FDA has permitted the drugs to remain on the market, and many states statute of limitations periods far exceed two years, we anticipate that a number of additional lawsuits will be filed in the coming months and years on behalf of women who suffered the terrible irony of taking a medication to improve bone health and instead suffering significant bone injuries.