Fosamax Lawsuits for Jaw Problems with Under 3 Years of Use Will Proceed

A federal judge in New York has rejected a motion filed by Merck & Co. to dismiss 24 Fosamax lawsuits that claimed side effects of their osteoporosis drug caused severe and debilitating jaw problems after less than three years of use, finding that sufficiently reliable evidence exists that could allow a rational jury to find such a connection after short-term use.

The ruling was released yesterday by U.S. District Judge John Keenan, as a jury was deliberating over the first Fosamax trial out of more than 900 cases involving allegations that users developed osteonecrosis of the jaw, or ONJ. While the vast majority of the cases involve plaintiffs who used Fosamax for more than three years, the cases at issue in Merck’s motion involved allegations of jaw damage that developed after the drug was taken for shorter periods of time.

Fosamax (alendronate sodium) is a member of a class of drugs known as bisphosphonates, which have been associated with decay of the jawbone when taken long-term or at high doses. With a very long half-life of 10 years, most of the Fosamax claims argue that dose accumulation over time increases the risk of ONJ. However, some research has indicated the potential Fosamax side effect can occur after use as short as one year.

Merck & Co. faces more than 900 lawsuits over Fosamax jaw problems, which cause the bone to decay and die, potentially resulting in infection and portions of bone becoming exposed inside the mouth. The jaw damage is irreversible, and in many cases individuals are left with deforming injuries.

Judge Keenan’s ruling came as heated jury deliberations continued in the first Fosamax trial, which was selected as a “bellwether” case because it is representative of issues common throughout other lawsuits in the litigation. In that case, the plaintiff, Shirley Boles, alleged that she developed osteonecrosis of the jaw after using Fosamax for parts of 10 years, between 1997 and 2006.

While the plaintiff’s lawyers argued that Merck failed to properly research their popular drug and warn about the risk of jaw damage, Merck denied that there is any evidence their drug caused the plaintiffs injuries or that they could have known about the potential risk before she first experienced jaw problems in 2003.

On Wednesday, Judge Keenan called for a “cooling off” period in deliberations, after jurors indicated that discussions became heated. Earlier this week, jurors submitted notes to the judge indicated that they did not think an agreed verdict could be reached. However, Judge Keenan indicates deliberations will resume Friday, and a mistrial will likely be granted if a verdict is not returned by the end of the day.