A New York federal jury on Tuesday, February 5th, ordered Merck & Co. to pay $285,000 in a lawsuit over the risks of its osteoporosis drug, Fosamax; the second loss for the company after several earlier trials.
The eight-person jury in U.S. District Court in Manhattan, New York, found that Merck & Co. failed to provide adequate warnings about the drug’s association with a bone-decaying jaw disorder and failed to warn plaintiff, Rhoda Scheinberg’s doctors of the risks associated with Fosamax. The jury rejected the plaintiff’s argument that Fosamax was a defective product.
Fosamax is a brand name for the drug alendronate sodium, prescribed for post-menopausal women and men with osteoporosis. Fosamax works by reducing bone degeneration, a process referred to as “resorption.”
According to Reuters, the lawsuit was just one of the thousands pending in a federal litigation underway in New York, alleging that Fosamax could cause osteonecrosis of the jaw (ONJ). More than 4,000 lawsuits are pending in federal and state courts, arising out of injuries allegedly caused by the one-time blockbuster medication, Fosamax. Seven cases have now gone to trial; of which Merck has won five and lost two.
The latest trial was one of the so-called “bellwether” cases in the Fosamax litigation. Judges order bellwethers in mass litigation to assess trends and outcomes that could play out in similar lawsuits. If there are a lot of plaintiff wins, for example, that could give them a stronger hand in settlement discussions with defendants to end the cases. Scheinberg, a 69-year-old New York resident, alleges that Fosamax caused her to suffer delayed healing following a tooth extraction, causing a bone disorder of the jaw. She alleged that Fosamax was defectively designed and that Merck failed to warn her or her doctor about the risks of ONJ.
The jury found that Merck’s failure to warn about the drug’s risks was a cause of her injuries. The jury also found that Fosamax was not defectively designed.
A plaintiff’s source told Mealey Publications that the jury’s $285,000 failure-to-warn award was for pain and suffering. Medical expenses and lost wages were not sought.
In pretrial filings, Merck argued that Scheinberg’s ONJ was not caused by Fosamax, but from her periodontal disease, her diabetes and her use of other prescription drugs.
Merck said in a statement that it disagreed with the verdict and noted that the jury returned a mixed verdict. “Merck provided appropriate warnings, and the plaintiff was at increased risk for dental and jaw problems regardless of whether she was taking Fosamax.”
Scheinberg’s lawsuit, filed in 2008, was one of 975 pending suits in U.S. District Court in New Jersey. Other lawsuits are pending in state courts.
The only other Fosamax case that Merck has lost at trial resulted in an $8 million verdict by a federal jury in Manhattan in June 2010 in the case of Shirley Boles, a Florida woman who alleged she developed osteonecrosis of the jaw after taking the drug.
In October 2010, Judge Keenan reduced the verdict to $1.5 million. Merck is appealing the case.
Since 2000, the U.S. Food and Drug Administration (FDA) has known about Fosamax’s tendency to cause ONJ, a painful, disfiguring bone disease. It wasn’t until recently that research has linked Fosamax to sudden, unusual bone fractures.
The FDA added new information to the Fosamax label in October 2010 following reports of a study that indicated that people taking bisphosphonates for osteoporosis are at risk of suffering atypical femur fractures. Because the risk for Fosamax femur fractures appeared to be associated with long-term use, the FDA advised doctors to consider periodic reevaluation of bisphosphonate therapy, particularly in patients who have been treated for more than five years.
In May 2012, an FDA commissioned analysis published in the New England Journal of Medicine raised additional concerns about the long-term risks associated with drugs such as Fosamax. Among other things, the study found that there was little benefit from taking bisphosphonates for longer than five years due to their association with serious side effects, including atypical femur fractures.
Approximately 842 Fosamax femur fracture lawsuits have been consolidated in a multidistrict litigation (MDL) underway in U.S. District Court, District of New Jersey, Products Liability Litigation, (MDL No. 2243, D.NJ). A consolidated proceeding has also been established for Fosamax lawsuits, including those individual femur fractures in New Jersey Superior Court, Atlantic County. Court documents indicate that the first Fosamax femur fracture claims will start going to trial this spring in both litigations.
Fosamax had annual sales of $3 billion prior to its U.S. patent lapsing in 2008 and the highly anticipated generic version becoming available to the public.
Merck shares were up 53 cents or 1.3 percent, at $41.38 on the New York Stock Exchange in late afternoon trading.
Merck’s blockbuster drug, Fosamax, was marketed to protect patients against osteoporosis, but now patients are at a greater risk for osteonecrosis. However, doctors were never warned about this risk before they prescribed this drug to their patients. The pharmaceutical manufacturers care more about their profits than the safety of the consumers.
Do you feel this was a fair settlement? Feel free to comment on this blog post. You can contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).