Merck has been litigating product liability lawsuits over the osteoporosis drug Fosamax for years, including claims that side effects of Fosamax caused users to suffer severe jaw problems, spontaneous femur fractures and other injuries. There does not appear to be a quick end in sight for the cases, and the drug maker could soon face hundreds of individual trials in courts throughout the country.
Fosamax (alendronate sodium) is a blockbuster medication that was 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
There are nearly 5,000 Fosamax lawsuits pending in state and federal courts throughout the country, with some of the earliest cases filed more than seven years ago.
The litigation began in 2006, with claims filed by former users of the oral bisphosphonate medication who allege that they developed osteonecrosis of the jaw from Fosamax. Also known as ONJ or “dead jaw”, the painful and debilitating condition is associated with the decay and deterioration of the jaw bone, often resulting in exposed areas of bone inside the mouth that cause infection and may require surgery to remove portions of the jaw.
Several early trial dates involving Fosamax jaw problems have gone before state and federal court juries with mixed results.
After the parties failed to reach any agreements to settle Fosamax cases during a recent medication, the judge presiding over all federal cases involving jaw injuries indicated that he may start remanding lawsuits back to the U.S. District Courts where they were originally filed for individual trial dates.
Recently, most of the new cases brought have involved former users who allege that Merck failed to adequately warn risk of suffering atypical femur fractures from Fosamax, which can occur after long-term use. Users have reported suffering femur fractures following little or no trauma, such as falling from standing height or less.
The first “bellwether” trials involving femur fractures from Fosamax are just beginning, with a federal court jury returning a defense verdict earlier this year and a New Jersey state court jury scheduled to hear a case early next year.
Fosamax Jaw Lawsuits May Be Remanded to Courts Nationwide
In August 2006, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established consolidated proceedings for all Fosamax jaw lawsuits filed in the federal court system. The litigation has been centralized for coordinated pretrial proceedings before U.S. District Judge John Keenan in New York.
As part of the Fosamax MDL proceedings, Judge Keenan has held several early trials, known as “bellwether” trials, which are designed to help the parties gauge how juries may respond to evidence and testimony that is likely to be repeated throughout the litigation.
According to an updated case list (PDF) provided by the U.S. JPML on August 15, there are still 978 lawsuits pending in the Fosamax jaw MDL, out of 1,120 total cases that have passed through Judge Keenan’s court.
Because the parties have been unable to reach Fosamax settlement agreements to resolve the cases, Judge Keenan has indicated that he will start remanding cases back to the U.S. District Courts where they were originally filed for individual trial dates before judges throughout the United States. This means that Merck could soon face simultaneous litigation throughout the country.
Plaintiffs have proposed that Judge Keenan begin remanding about 300 cases every four months to move forward with individual trial dates, while Merck is still attempting to slow the litigation down, arguing that Judge Keenan preside over case-specific discovery in the 100 oldest cases while the rest of the litigation remains stayed. The drug maker proposes that following case-specific discovery designed to identify strengths and weaknesses in this small group of cases, then the Court could evaluate how it is best to handle the remaining cases.
Fosamax Femur Fracture Litigation
In addition to the jaw cases, Merck faces a separate track of litigation involving femur fractures following long-term use of the medication.
Most of these complaints have been filed since late 2010, when the FDA required Merck to add new warnings about the risk of bone fractures from Fosamax. These warnings provided new information for consumers and the medical community about the importance of identifying symptoms of new hip or groin pain, which could occur before an atypical fracture of the femur.
The lawsuits allege that Merck knew or should have known about these risks long before the warnings were provided, and claim that if adequate information had been provided to users and the medical community plaintiffs could have avoided suffering complete fractures on Fosamax by avoiding the medication or stopping use earlier.
Last year, the FDA issued new recommended guidelines for taking Fosamax and other similar oral bisphophonate medications, such as Actonel and Boniva. The agency suggested that users should consider limiting the medications to a three to five year period, which may allow individuals to reduce the risks of side effects associated with long-term use, while continuing to receive benefits for osteoporosis.
In May 2011, the U.S. JPML established a separate MDL proceeding for all Fosamax fracture lawsuits, which have been assigned to U.S. District Judge Garrett E. Brown, Jr. in the District of New Jersey. There are currently about 1,100 cases pending before Judge Brown.
The first Fosamax trial involving a femur fracture was held in the federal court system earlier this year, with the jury returning a defense verdict. The case involved a complaint brought by Bernadette Glynn and her husband, Richard, who claimed that side effects of Fosamax use for seven years caused Bernadette to fracture her femur suddenly in April 2009, more than a year before warnings were added to the medication. However, the jury found that the drug maker was not responsible for Glynn’s injury.
A large number of cases are also pending in the New Jersey state court system, where they have been centralized as part of an MCL or Multi-County Litigation before Judge Carol Higbee in Atlantic. There are currently more than 2,800 lawsuits pending in New Jersey state court, including both femur fractures and jaw injuries.
An initial group of about 30 femur fracture cases have been prepared for early trial dates before Judge Higbee, with case-specific discovery completed. Following a mistrial granted in a case that went before a jury in March, due to an unrelated health problem suffered by the plaintiff during trial, the next case is scheduled to begin in early 2014.