Bellwether Fosomax trial starts today

In drug liability litigation, the first case to come to trial always is closely watched. Lawyers, plaintiffs and companies alike want to know their opponents' strategies. And perhaps most importantly, they want to know how jurors respond to testimony. The inaugural trial in Merck's defense of its Fosamax bone drug is no exception.

Merck faces some 900 lawsuits over claims that the drug causes a painful and irreversible decay of the jawbone. In this first case, Shirley Boles, 71, claims that Fosamax caused her osteonecrosis of the jaw--essentially, death of jawbone tissue--and that Merck knew about the risks as early as 1996. The company should have warned patients and doctors earlier than it did, Boles alleges.

Merck and other makers of bisphosphonates changed the drugs' labeling in 2005 to warn about the risks. But Boles' lawyer says Merck didn't use the label language requested by the FDA as the other companies did. For its part, Merck says it acted appropriately and provided the proper information. And the company disputes the idea that Fosamax causes the condition. "We're going to demonstrate that there's no causal link between Fosamax and the plaintiff's injury," a Merck lawyer told Bloomberg. "There isn't any scientifically reliable evidence of causation." We'll see what the court thinks.

- read the Bloomberg piece [1]

Related Articles:
Study links Fosamax to jawbone problems [2]
FDA calls 'all clear' on bone meds [3] (2008)
Bisphosphonates may weaken bones [4] (2008)
Safety questions on Fosamax, Actos, et al. [5] (2008)