The oral bisphosphonate (e.g. Fosamax) / osteonecrosis story continues to heat up. This past week Linda Secrest and her husband, Frank Secrest, filed a personal injury and product liability lawsuit against Merck & Co., the manufacturer of Fosamax. Class-action status will be pursued for similarly injured victims, O'Brien, her lawyer said. The lawsuit was filed in federal court in Fort Myers.
As described by Secrest, six or seven months after she started on Fosamax, Secrest underwent a root canal in September 2000. She had no inkling the medication can lead to infection and tissue loss after invasive dental procedures, including having cavities filled.
Secrest fell victim to a painful infection with swelling. The infection refused to heal and led to a jawbone tissue disease, called osteonecrosis of the jaw, referred to as ONJ, where tissue doesn't heal and becomes exposed after a minor trauma, such as invasive dental work.
"We have over 200 clients all over the U.S., but the majority are in Florida," Tim O'Brien, of the national firm Ennis & Ennis, said.
His law firm is among others nationwide working on negligence claims against Merck regarding Fosamax, following a similar course as the 9,000 lawsuits logged against the drug manufacturer for failure to warn of potentially deadly side effects from its painkiller Vioxx.
"Merck's problem is bigger here than with Vioxx," O'Brien said, adding that there is a clear link the jawbone tissue disease and Fosamax. "It is not that (the jaw tissue disease) is so uncommon. It is just that the causes are so few."
A top seller for Merck, bringing in more than $3 billion in sales, Fosamax was first approved by the Food and Drug Administration for osteoporosis in September 1995. The medication belongs to a class of drugs known as bisphosphonates, used for treating bone conditions and as chemotherapy for cancer patients.
During the late 1990s and later, cases were surfacing where cancer patients on bisphosphonates, namely intravenous drugs Aredia and Zometa, had developed jawbone deterioration.
In 2004 after seeing an increase of jawbone necrosis in patients on bisphosphonates, a group of oral surgeons published an article in the Journal of Oral and Maxillofacial Surgery relating their findings involving 63 patient cases. Novartis, the manufacturer of Aredia and Zometa, responded by issuing a warning to doctors in November 2004.
On the other hand, Merck did not take such action, although the company knew or should have known that Fosamax, as part of same class of drugs as the chemotherapy agents, inhibit blood flow and tissue growth, according to the lawsuit. That's despite the FDA recommendation that Merck should amend its labeling for Fosamax to specifically warn of the risk of the jawbone disease.
"As a result, a minor injury or disease can turn into a nonhealing wound," according to the lawsuit. "That in turn can progress to widespread necrosis (bone death) and osteomyelitis (inflammation of bone marrow)."
Merck did not undertake any further clinical studies on Fosamax to examine the risk of jawbone loss, and the pharmaceutical company did not warn the medical community or consumers of the risks, according to the lawsuit.
Merck spokesman Chris Loder issued a prepared statement in response to the lawsuit:
"The cause of osteonecrosis of the jaw (ONJ) is not well understood and is likely to include a number of conditions. In all of our controlled clinical trials, including the 10-year data with Fosamax, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax. Merck has received post-marketing reports described as osteonecrosis of the jaw occurring in patients taking Fosomax. Post-marketing reports do not necessarily indicate causality."
On Jan. 31, 2005, Merck received a request for data from the FDA to update the label for Fosamax to include bisphosphonate class labeling for the jawbone tissue disease, according to the statement.
"Merck submitted a draft to FDA on March 1, 2005," according to the statement. "FDA comments on this draft revised label were received in June 2005 and the new label was made publicly available in July, 2005."
Dr. Salvatore Ruggiero, lead author of the 2004 article that linked the class of drugs to jawbone necrosis, said Merck likely would not have known that Fosamax can lead to jawbone necrosis.
"The problem is the complications with the drugs, especially the oral form, will take many years to manifest, so you won't see it in phase one, phase two or phase three (clinical) trials," Ruggiero, chief of oral and maxillofacial surgery at Long Island Jewish Medical Center, said. "So I'm not surprised they did not know of this complication. When Merck became aware of the problem? I don't know."
The FDA did issue a broad warning covering the entire class of the drugs but he does not recall when that occurred and when Merck acted.
"The timing of it is what the lawyers are going nuts over," he said, adding that his focus was making oncologists, dentists and primary physicians aware of the medical complication.
The predicament now is that no studies are under way to further show the connection, although his clinic is following 155 patients with jawbone necrosis.
"Do we all think it is happening? Absolutely, but we need prospective studies," he said. "The association is very strong."
His theory is that the longer an individual is on this class of medications, the risk of jawbone necrosis increases following invasive dental work.
Dr. James Green, an oral surgeon with the University of Florida's College of Dentistry, said the dental community became aware of the incidence of jawbone death with bisphosphonates five or six years ago.
"My experience runs about three or four years," he said. "I don't know why we are seeing it now, all of a sudden we are seeing these cases now."
At the same time, Fosamax is responsible for many fewer cases of jawbone death than the chemotherapy medications of the same class of drugs.
"Fosamax is a little player, about 4 percent of the cases," Green said, adding that it is confusing why Fosamax is facing the personal injury attention unless Merck did not reveal the risks.
O'Brien, the plaintiff's attorney, said the reason for the focus on Fosamax is that it is prescribed for a noncritical condition, whereas the chemotherapy drugs aim to save a patient's life.
Secrest, the Naples plaintiff, and other defendants will need coninuing medical monitoring that goes beyond normal medical care, according to the lawsuit.
In Secrest's case, her non-healing infection led to teeth having to be removed and an attempt with dental implants which didn't take, O'Brien said. The couple have declined to comment about the lawsuit.
She had 60 treatments in a hyperbaric chamber, which stimulates blood vessel growth for tissue healing, to no avail.
"They were not much help," her attorney said. "She now has exposed jawbone, she has significant bone loss. It's very, very trying on her. If you look at her, you will see a ravaged mouth. It is very trying because there is no fix."
Source: Liz Freeman, NapleNews.com