After three years, two jury trials and a mountain of red tape, pharmaceutical giant Merck has reportedly agreed to a damage award in a landmark Fosamax osteonecrosis of the jaw (ONJ) bellwether trial. ONJ occurs when the jaw bone is exposed and begins to starve from a lack of blood, resulting in infection of the gums, loosening of the teeth, tooth ache, and a numbness or feeling of heaviness in the jaw. In addition to the jaw damage cases, Merck faces an even greater number of femur fracture lawsuits filed on behalf of former Fosamax users who allegedly broke their femurs with little or no trauma at all.
What’s the problem?
Back in September 2009, a Fosamax jaw decay lawsuit filed on behalf of Shirley Boles was the first of several hundred similar complaints to be presented to a jury. Boles’ case was ultimately ruled a mistrial after jurors were unable to agree on a verdict. Following a re-trial the next year, Boles was awarded $8 million in the first ever successful Fosamax verdict, after a jury determined that Merck failed to adequately warn both the public and medical communities about their drug’s ability to cause osteonecrosis of the jaw.
Boles’ victory was short lived, however, after the judge that presided over the case subsequently ruled that the verdict was excessive. Rather than accepting a reduced award of $1.5 million, Boles requested a third trial. The case was set to be presented to a jury earlier this month to determine the amount of damages that would be awarded to the Estate of Shirley Boles, who died a short time after requesting a new trial. However, a confidential settlement was reached which involved a stipulation on the amount of damages.
First approved by the U.S. Food & Drug Administration (FDA) in October 1995, Fosamax (generic: alendronate sodium) belongs to a controversial class of medications known as bisphosphonates, which are prescribed for the treatment of osteoporosis. Since first being released, Fosamax has been prescribed to more than 20 million patients. Before it became available as a generic in 2011, Fosamax generated over $3 billion in sales for Merck each and every year.
Judge Keenan has indicated that at least two more bellwether trials will be conducted in the Fosamax jaw decay MDL to help determine how juries will respond to evidence that is likely to be repeated throughout many cases. Additionally, late last year, a prestigious law professor was appointed to oversee potential settlement negotiations before Keenan begins remanding Fosamax lawsuits back to their original districts for individual trial dates.