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Fosamax, a bisphosphonate drug manufactured by Merck; gained FDA approval on September 29, 1995. It generated three billion dollars of revenue for Merck in 2006. In 2004, the FDA and Merck, as well as the manufacturers of other bisphosphonates, updated the drugs labels to warn about osteonecrosis of the jawbone. In Osteonecrosis of the jawbone, parts of the jawbone rot and may fail to heal following oral surgery or dental work.

On June 25, 2010, a jury awarded $8 million in compensatory damages to a Florida woman who sued Merck & Co, alleging the company’s osteoporosis drug Fosamax damaged her jaw, nine months after the first lawsuit ended in a mistrial.

The plaintiff sued Merck in 2006, claiming she suffered dental and jaw problems because she took Fosamax from 1997 to 2006.

A month-long trial in Manhattan federal court in August and September last year was Merck’s first out of some 1,280 plaintiff groups involving almost 900 U.S. lawsuits by patients who claim Fosamax caused the condition known as osteonecrosis of the jaw, or death of jawbone

On January 29, 2010, a Manhattan federal judge refused to reject a lawsuit alleging that Merck & Co Inc’s osteoporosis drug Fosamax caused jaw damage to an Indiana woman during the nearly eight years she took the pill. According to a Reuters report, Merck submitted a motion seeking to dismiss all claims filed by the Indiana plaintiff. The trial is scheduled to begin on April 19, 2010.

U.S. District Judge John Keenan described the case involving the plaintiff Louise Maley, as one of the “bellwether” trials in nationwide litigation over Fosamax, which has spawned close to 900 lawsuits. The judge is handling many of the cases.

Keenan in November dismissed a lawsuit alleging that Fosamax causes jaw damage, two months after a jury deadlock led to a mistrial in a similar case.

Fosamax is part of the bisphosphonate family of osteoporosis drugs that include Procter & Gamble Co’s Actonel and Roche Holding AG’s Boniva. This class of drugs is designed to prevent bone fractures and help offset bone loss associated with menopause. Fosamax has been linked to Osteonecrosis of the Jawbone, which overtime the bone tissue in the jaw roots and dies.

On August 11, 2009, the first of many lawsuits brought by patients who claim they suffered jaw damage from Fosamax began.  An estiamted 1280 plaintiff groups, involving almost 900 cases, have alleged jaw problems due to Fosamax.

U.S. District Judge John Keenan of Manhattan Federal Court heard arguments from attorneys for Shirley Boles, a 71-year-old plaintiff from Walton Beach, Florida, who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006.

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” Merck said in a statement on August 10, 2009.

Fosamax, made by Merck, was approved in the United States in 1995, and belongs to the bisphosphonate family of osteoporosis drugs that include Actonel and Boniva. The pills prevent bone fractures particularly in postmenopausal women by helping to increase bone mineral density.

In 2003, reports initially emerged linking intravenous bisphosphonate treatments with jaw osteonecrosis, meaning death of jawbone tissue that can include symptoms such as pain, swelling or infection of the gums and jaw, gums that don’t heal, and loose teeth.

Intravenous bisphosphonates, which are not made by Merck, involve higher concentrations of medication that are typically used to treat patients with cancer that has spread to the bones.

Oral versions of the class of drugs were initially thought to be safe until a report came out in May 2005 showing that 7 of 63 bisphosphonate users who developed the condition had been using oral forms.

But an informal review in the Journal of the American Dental Association in early 2008 suggested that oral treatments instead reduced risk of inflammatory deterioration of the jaw in patients with osteoporosis. By contrast, the report suggested a 4-fold increase in such risk among patients taking intravenous bisphosphonates.

Merck said two other Fosamax lawsuits are slated to go to trial later this year, one in federal court and another in a state court in Alabama.