Atlantic City, NJOpening statements in a Fosamax lawsuit last week accused Fosamax manufacturer Merck & Co. of hiding risks associated with Fosamax bisphosphonate and fractures of the femur. The four-week trial, which is the first complaint alleging a bisphosphonate association with brittle bones to reach trial stage, is being heard by a jury in Atlantic City.
According to Bloomberg News (3/12/13), attorneys for the plaintiff noted a 2006 e-mail from a Merck official based in Singapore warning Merck executives about reports of brittle bones amongst Fosamax users in Singapore. It is alleged that Merck ignored the red flag for another two years and only took serious notice of Fosamax and femur fractures in 2008, when Fosamax came off patent and began to face competition from generics.
Bisphosphonates - a class that includes Fosamax - has been historically prescribed to combat the brittle bones commonly associated with osteoporosis. However, various studies have surfaced over the last 15 years that suggest long-term use of bisphosphonates such as Fosamax, while generally minimizing the effects of osteoporosis overall, is associated with Fosamax femur fractures.
Staff with the US Food and Drug Administration (FDA) had, in fact, floated the position that Fosamax (bisphosphonates) should not be used continuously after five years - a position that some doctors are taking, putting their patients on a so-called Fosamax “holiday” for an undetermined time, after five years. The FDA report, prepared for an FDA advisory panel prior to a gathering in 2011, noted there appeared to be little significant benefit of Fosamax (bisphosphonate) treatment beyond five years. While the panel advocated beefing up Fosamax warning labels, the panel did not advocate for a recommendation to halt Fosamax treatment after five years.
In the Fosamax femur lawsuit currently underway, plaintiff Christina Su, 67, alleges her use of Fosamax was responsible for a femur fracture that occurred in 2009, six years after she began taking Fosamax. According to Bloomberg, the initial fracture involved Su’s right femur. However, later that year, doctors were compelled to insert a metal rod into Su’s left femur to address stress fractures.
Sales of Fosamax were sustained at about $3 billion per year until Merck lost patent protection, Bloomberg reported. While Merck has won five out of seven cases alleging Fosamax use was the underlying cause of Fosamax osteonecrosis of the jaw, legal experts speculate that femur fracture lawsuits may have a different track record.
And there are a lot of them. According to Merck’s own filings with the US Securities and Exchange Commission (SEC), the drugmaker is facing no fewer than 2,075 Fosamax femur lawsuits in New Jersey state court, 420 cases in California state court and another 850 cases consolidated before a federal judge in New York.
Among the more grievous of the basket of Fosamax side effects is Fosamax ONJ, also known as Fosamax dead jaw - a nasty condition characterized by the gradual breakdown of bone mass in the jaw, often triggered by dental work but suspected of being caused by Fosamax use.
The Fosamax lawsuit is Su v. Merck & Co., ATL-L-0789-11-MT, Superior Court of New Jersey (Atlantic City).
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