The judge overseeing litigation over Merck's bone drug Fosamax needs more tea leaves to read. Judge John Keenan originally thought a half-dozen bellwether cases would be enough to outline the arguments on both sides so he could decide whether to send the 900-odd lawsuits remaining back to their home courts for trial. But he's now asking for two more.
Plaintiffs have claimed Fosamax caused their jawbone tissue to deteriorate, a condition known as osteonecrosis. Back in July 2005, the FDA asked makers of bisphosphonate drugs--Fosamax's class--to warn patients that some who used this type of med had developed the degenerative bone disorder.
As the Wall Street Journal Law Blog reports, Keenan wants to hear one case whose plaintiff was using Fosamax before Merck added the osteonecrosis warning to the drug's label, but did not develop the condition until after the label change. The other case, Keenan ordered, should involve a patient who both used Fosamax and developed jawbone trouble after the change. These cases would be in addition to the two already scheduled for trial later this year.
So far, three cases have gone to trial. Merck prevailed in two of them; in the other, the jury awarded $8 million in damages, an amount the judge later deemed excessive. The company maintains that it "acted responsibly" in monitoring Fosamax after it made its debut and provided "appropriate and timely information" about the drug to doctors, regulators and patients.
- read the Law Blog piece