A Fosamax lawyer can help

With thousands of Vioxx cases already in the courts, the drugmaker faces 15 suits over Fosamax, an osteoporosis drug blamed for rotting the jaw bone.

Merck, already in a long battle against thousands of Vioxx lawsuits, faces yet another war as plaintiffs begin to file suit over Fosamax.

Merck, the number 2 rated drugmaker in the U. S., will soon face a federal court suit from a Naples, Florida, wherein a woman blames the osteoporosis treatment for the necrosis that rotted her mouth and exposed bone in her jaw. Linda Secrest, 60, who took Fosamax for six years, filed the suit in Fort Myers, Fla. She accuses Merck of withholding information about the drug's health risks.

Could this possibly be another Vioxx? The plaintiffs in approximately 11,500 lawsuits blame the arthritis painkiller Vioxx for causing their heart attacks, and accuse Merck of purposely withholding information about the drug's health risks. Merck & Co. has consistently maintained the viewpoint that Vioxx didn't kill anyone and denied all charges of corporate wrongdoing.

Merck has made millions from Fosamax

Fosamax and Vioxx have been large contributors to Merck's earnings. Fosamax totaled $3.2 billion in 2005 sales, while Vioxx sales totaled $2.5 billion in 2003, its last full year on the market. Fosamax, which contains the active compound bisphosphonate, increases bone mass and reduces the risk of fractures in postmenopausal women, and also treats osteoporosis in men.

Merck dismisses comparisons between the two litigation battles, and there are some astute differences. Fosamax is still being sold, while Merck pulled Vioxx from the market on Sept. 30, 2004 after a study revealed that the risk of heart attacks and strokes increases in Vioxx patients after 18 months of use. Vioxx plaintiffs interpret the market withdrawal as an admission of guilt, while Merck’s defense lawyers use it to discount charges the company deliberately misled patients.

Yet there’s still another big difference: Merck says only 15 Fosamax suits have been filed against the company, versus the thousands of Vioxx cases. However, this low figure is expected to change.

Attorney Tim O'Brien, who represents Secrest and Carmen Carr, 57, of Pensacola, who blames her nine years of taking the drug for "significant bone loss in her jaw" as well as some teeth, expects to file some 300 more Fosamax cases.

In the Secrest case, O'Brien said ideally he is seeking "seven figures" for her personal injury claim, and in a class action suit he wants Merck to establish a fund to pay for a state education program about the drug's risks and for dental screening of Fosamax patients.

Fosamax is to blame

So why is Fosamax being blamed for causing the known as osteonecrosis, a rare yet serious disease of the jaw?

O’ Brien said he used a process of deduction to determine Fosamax as the cause of osteonecrosis in his plaintiffs. O'Brien said his plaintiffs never underwent radiation therapy or chemotherapy while taking bisphosphonate drugs like Fosamax, which he identified as the only other proven causes of the disease.

"Merck is going to have significant problems defending this case in the way they defend the Vioxx cases, by saying something else in the woman's past caused jaw necrosis, because so few things cause it," said O'Brien.

But Merck spokesman Ray Kerins rejects the theory by saying the "underlying cause" of osteonecrosis of the jaw is "uncertain," though it might be triggered by a traumatic event like tooth extraction or oral surgery.

Also, a Merck press release said the "post-marketing" reports of osteonecrosis of the jaw "do not necessarily indicate causality" in Fosamax patients, and that this condition never surfaced in 10 years of controlled clinical trials with 17,000 patients.

Thus, the plaintiffs in both the Vioxx and Fosamax litigations must prove the drugs caused their problems. Ultimately, the Fosamax patients may have a tougher time.

"Anybody could sue, and they will, but it doesn't seem like the prevalence is high and you still have to demonstrate cause and effect," said Barbara Ryan, analyst for Deutsche Bank North America. "I don't think it's a good thing, but I don't think it poses a significant financial risk to Merck."

Ryan said that damages, if any, probably won't amount to much compared to the possible $30 billion damage tally related to Vioxx, and she does not believe that the Fosamax litigation poses any serious threat to Merck's stock price. However, only time will tell.

But the Fosamax verdict would come from a jury that could be swayed by disfigured plaintiffs suffering from osteonecrosis, and Merck has lost some Vioxx cases after arguing the same type of causality defense that it plans for Fosamax.

Contact a Fosamax lawyer today

So what's the best plan of action for Merck?

"The most risk-averse strategy of all is, of course, to pull it [from the market,] but then everybody who's on [Fosamax] will say there's a causal relationship and they'll pile on with more lawsuits," said Frances Miller, law professor at Boston University and expert in health care law and policy.

If you or a loved one has been harmed due to using the drug Fosamax, a Fosamax lawyer with Jim S. Adler & Associates can help. The law firm offers a free case review and works on a contingency basis, meaning you pay no retainer fees but only a percent of the recovery should your case prevail. Contact a Fosamax attorney with Jim S. Adler & Associates today.

FOSAMAX ARTICLES...

Fosamax patent regained

Despite mounting lawsuits and ongoing troubles with its osteoporosis drug Fosamax, Merck received some good news in March 2007 when its European patents were reinstated. The patent initially expired in 2004, but due to a loophole the wording of the drug’s purpose was changed slightly prompting the European Patent Office to make the extremely rare move of reinstating Merck’s patents.

Fosamax can be fatal

Fosamax was designed to help reduce bone loss, especially for people with osteoporosis. However soon after the Food and Drug Administration (FDA) approved it for use in 1995, doctors and dentists started to notice a rise in osteonecrosis of the jaw (ONJ) or “jaw bone death.” In this usually-rare disease, blood vessels in the jaw start to disappear literally killing the cells within the bone itself.

Fosamax can destroy blood vessels

Fosamax, a bisphosphonate drug manufactured by Merck, was designed to help rebuild bone density in people with osteoporosis and other bone-degenerating diseases. However in 2001, doctors and dentists started to notice that it caused another disease, osteonecrosis of the jaws (ONJ), also called “jaw bone death.” Despite this serious condition, the FDA did not send out its first warning to health professionals until three years later. And it was over four years later before Merck changed the labeling on Fosamax to include this serious side effect.

Actonel surpasses Fosamax

Both Actonel and Fosamax prevent bone loss after menopause. However, a study by leading osteoporosis experts say Actonel works faster than Fosamax.

Actonel (made by Procter & Gamble) and Fosamax (made by Merck) are both effective treatments for age-related osteoporosis. Age-related osteoporosis is a type of bone loss that is a particular problem for postmenopausal women.

Fosamax may do more harm than good

Millions of Americans rely on the medication Fosamax to stave off osteoporosis, a crippling disease that turns bones so brittle that someone can break a bone by doing normal everyday activities.

However a growing number of physicians and oral surgeons have heightened concerns that the long-term use of Fosamax, and similar "bisphosphonates," can lead to "dead jaw" syndrome, a painful condition that causes ulcers, tooth loss and exposed bone.

Fosamax can have dental impact

A tooth extraction generally involves mild but temporary pain, which diminishes in the short time it takes the wound in our mouth to heal from the procedure. But for people who are taking bisphosphonates, a relatively common class of drug, even a common tooth extraction can lead to painful jaw disease.

Bisphosphonates are drugs used to treat osteoporosis, malignant bone cancers, multiple myeloma and Paget's disease (a metabolic bone disorder). These drugs are very effective in controlling bone pain and preventing pathologic fractures in patients with these conditions. There are generally very few side effects associated with its use. But in a small number of patients taking bisphosphonates, tooth extractions or irritation from dentures can lead to exposure of the jaw bone, followed by infection and death of affected bone, known as osteonecrosis of the jaw.

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