Fosamax Lawsuits

Since September 2005, four federal lawsuits have been filed against the pharmaceutical giant, Merck & Co., claiming that Merck?s top selling osteoporosis drug, Fosamax, causes an incurable and painful condition known as osteonecrosis of the jaw (ONJ). The most recent suit, filed in Florida on April 10, 2006, is seeking class action status. Lead counsel in the Florida action, Tim O?Brien, has already filed fifty claims and predicts hundreds of additional cases will be added against the pharmacuetical company. It is estimated that the class represents roughly 10 million Fosamax users who either suffer from ONJ or are at risk of developing the condition. He filed his first Fosamax lawsuit on behalf of sixty year-old Floridian, Linda Secrest, who had been taking the drug for six years before she noticed soft-tissue in her mouth deteriorating and eventually her jaw becoming exposed and rotting. The three other federal actions were filed in Tennessee and New York.

Contact us regarding Fosamax; attorney consultations are free.

The complaints against Fosamax seek damages for Merck?s negligence, strict liability, breach of express and implied warranty, fraudulent misrepresentation, and fraudulent concealment. The lawsuits are also asking for relief in the form of a program that would notify the millions of Fosamax users of the defects and potential medical harm associated with the drug, and funding for a program for surgical treatment of ONJ, a study on the long-term effects of Fosamax, and funds for physicians and dentists for the diagnosis and medical treatment of the condition. In addition, the plaintiffs seek a court order that will require Merck to change Fosamax's lengthy label format in a way that will adequately warn doctors and patients about the risk of ONJ associated with the drug.

In 2003, an independent research study revealed a possible link between the use of nitrogenous bisphosphonate drugs, such as Fosamax, and ONJ. More than a thousand cases of ONJ have been reported in patients taking bisphosphonates. The results of a study performed by the University of Texas M.D. Anderson Cancer Center and sponsored by the pharmeceutical company Novartis AG (manufacturer of the IV bisphosphonates marketed as Aredia and Zometa) showed that out of 63 patients who developed ONJ following oral surgery, about 10% had been taking Fosamax to prevent osteoporosis. Dentists and oral surgeons nationwide also began reporting a pattern of the otherwise rare jaw condition appearing in patients who had used Fosamax.

Contact us regarding Fosamax; attorney consultations are free.

The Fosamax lawsuits allege that Merck has misled both doctors and the public about the dangers of Fosamax. The plaintiffs claim that Merck ignored the numerous research studies, medical articles, and expert reports that have shed light on Fosamax?s sorrowing side effects. Unlike other manufacturers of bisphosphonate therapies, Merck neglected to perform any additional research on Fosamax in order to determine if the drug causes ONJ in its users.

Merck continues to state that it observed no incidents of ONJ in its clinical trials, which were performed prior to applying to the U.S. Food and Drug Administration (FDA) for Fosamax's approval in 1995. The trials were conducted over a ten-year period with 3000 participants taking Fosamax for 3 to 5 years and 800 participants taking the drug for 8 to 10 years. Dr. Robert E. Marx, Chair of the Oral and Maxillofacial Surgery Department at the University of Miami Medical School of Medicine who conducted the study that first noted the link between ONJ and bisphosphonates, told the Star Ledger in a July 2006 expose that he believes Merck's researchers didn?t anticipate the extent to which bisphosphonates can effect the jaw compared with other bones, but nevertheless, "the clinical trials should have looked for the problem.?

The lawsuits claiming Fosamax causes ONJ also involve complaints against, Novartis AG, as its IV bisphosphonate therapies are also linked to ONJ. O'Brien, however, clarifies that the reason for the focus on Fosamax is that it is prescribed for a noncritical condition, whereas Novartis's drugs are chemotherapy drugs that aim to save a patient's life.

Contact us regarding Fosamax; attorney consultations are free.

In a 2004 article in the Annals of Internal Medicine, researcher and orthopedic professor at the University of Washington, Susan Ott, M.D., stated, "Many people believe that these drugs are 'bone builders,' but the evidence shows they are actually bone hardeners." Ott and others in the orthopedic field assert that, although Fosamax is useful in blocking minerals from being taken out of bones and, therefore, helping add density to bones, the drug goes too far after three to five years of use- restricting new bone tissue from forming, thus causing bones with aged tissue to become weak and fracture.

Many orthopedic experts agree that Merck?s advertisements encourage Fosamax to be prescribed to people who simply do not need to resort to long-term, drug based osteoporosis prevention. "If you're a healthy 50 year-old - an average woman going through menopause - your chances of getting a fracture are very low," Dr. Ott told the Seattle Times last year, "Yet they are pushing the drug right at that age group." Seeger Weiss LLP partner, Christopher Weiss, observed that Merck was far too aggressive with its promotion for the drug, noting that "the FDA sent four letters to Merck between 1997 and 2001 for making misleading claims in in its consumer advertising regarding Fosamax."

Dr. Marx suggests that this dramatic change in those who are using Fosamax may account for why cases of ONJ linked to the drug are only now being diagnosed. ?The concentration in the bones begins to build up by the 3rd year [of treatment],? said Dr. Marx, ?so its not surprising that we?re starting to see more cases among people who take the pills.? Oral surgeons and dentists are increasingly worried that the number of cases will multiply, and warnings have been posted on numerous websites run by professional groups. Given that more prescriptions are written each year for the pills - 22.4 million Fosamax prescriptions written in 2005 - experts suggest the rate at which ONJ will be diagnosed is very likely to increase. Dr. Ken Hargreaves, who helped write the report on the University of Texas?s ONJ study, has expressed his heightened concerns over bisphosphonate therapies: ?Even if this is a rare condition, so many women now take bisphosphonates to prevent bone loss that the numbers could grow. We just became aware of this a few years ago, and it has been called a growing epidemic.?

Contact us regarding Fosamax; attorney consultations are free.

The Fosamax lawsuits blame Merck for failing to provide a formal warning that ONJ is linked to use of the drug. In February 2005, the FDA recommended that Merck change the twenty-two page Fosamax label to include warnings about ONJ. Merck revised the pill?s packaging information in July 2005, but the lawsuits allege that the label remains misleading. ?They never come out and say it?s a risk factor,? O?Brien has stated. ?You have to read between the lines and read the medical literature to understand what they actually are saying.? The label referred to is a lengthy document that is provided as an insert within the Fosamax packaging for pharmacists, prescribing physicians and patients. The ONJ information that Merck added to the label does not appear until page 13.

It is too early to speculate whether Merck plans to settle the Fosamax litigation before the cases are heard in court. With the existing Fosamax lawsuits having just been filed within the past year, formal trial dates have yet to be announced.

If you or a family member has been diagnosed with ONJ or suffered other adverse effects after using Fosamax, and you would like to discuss your rights with an attorney, please fill out this short form and an experienced member of Seeger Weiss's staff will contact you. Initial attorney consultations do not create an attorney-client relationship and require no obligation or fee on your part. Seeger Weiss LLP maintains offices in New York and New Jersey and its attorneys are admitted to practice throughout the United States.