Fosamax, also known as a bisphosphonate, which is used to treat chemotherapy for metastatic cancers and non-cancerous conditions such as Osteoporosis, has been linked to Osteonecrosis of the Jaw (ONJ) – a debilitating process that is extremely painful. Lawsuits filed against Merck, the drug’s manufacturer, allege the company knew of the risks and dangers of Fosamax, but failed to warn consumers.

Consumers have a right to know

There are a number of different theories of liability, but one of the biggest issues is that Merck put this drug on the market and knew (or should have known) about the risks – but it didn’t warn consumers, doctors or the FDA (U.S. Food & Drug Administration) about those risks.

Dan Thornburgh, a Florida attorney whose practice focuses in pharmaceutical and medical device litigation, explained:

These consumers, some of whom have very mild cases of Osteoporosis, such as Ostiopenia or even pre-Ostiopenia, took these drugs without being fully informed and now they’re at an increased risk of suffering this terrible disease. Merck should have tested and adequately warned these consumers of the possible risks.

In my opinion, there’s clear evidence that Merck knew, or should have known, about the problem. They should have gone to the FDA and changed the label to apprise individuals of the risk. Consumers have the right to be fully informed of those risks.

Fosamax product liability lawsuit

We asked Thornburgh how many product liability lawsuits have been filed against Merck regarding Fosamax. He told us that there have been a lot and explained, “I can tell you I’ve filed at least 30 and have another 30 or so that I’m going to file soon. There’s an MDL (multi-district litigation) set up in the Southern District of New York before Judge John Keenan, a United States District Judge and he’s overseeing all the pretrial litigation associated with the Fosamax cases. There’s also state litigation going on in New Jersey before Judge Carol Higbey.”

Status of the litigation

Fosamax litigation is currently in the discovery and pretrial motion phase with the MDL, according to Thornburgh. “We are taking depositions of persons most knowledgeable about the marketing and science of the drug. The judge is currently ruling on motions filed by us and the defendants. So, it is certainly moving forward quickly. While the New Jersey litigation is a little behind, it was recently consolidated. We have fair judges in both the Southern District and in New Jersey and we expect fair results.”

FDA warns of Fosamax dangers

In addition to the litigation, the FDA has also been involved with the safety aspects of Fosamax. Thornburgh explained, “The FDA, as part of the agency that oversees drugs and the manufacturing process, has been involved. As you know, the FDA is overly burdened and under funded. However, they have been involved with reviewing the safety and efficacy of Fosamax. A warning was added to Fosamax in November of 2005.”

Merck’s follow-up studies

While Merck has done some follow-up studies regarding the safety of Fosamax, Thornburgh doesn’t think that any of the studies funded by Merck have conclusively come out with any sort of science that refutes the issue. “They argue that exposure to Fosamax has to be for a certain period of time before you’re at this increased risk. There have been studies where the findings have been consistent with respect to the increased risk, but inconsistent with respect to the duration of exposure before that risk is increased.”

To speak with an attorney involved in the Fosamax litigation, click here.