"The Fosamax case is far more important than most drug litigations because Fosamax is still being sold and still causing extraordinary harm to innocent women," says Grossman, a partner in the Sanders Firm on Long Island. "I have met with over 50 Fosamax victims and many of their doctors. These women are suffering dearly."

Dead jaw is as horrific as it sounds. According the medical literature, many Fosamax users experience negative affects after dental surgery. Their gums may become infected, swell and bleed and refuse to heal. Victims often report a numb feeling in their jaw. Ultimately, the jawbone begins to decay, resulting in so-called dead jaw. The condition is usually permanent and can be disfiguring.

Fosamax dead jaw victims are often so debilitated that they have to sip their food through a straw. "Can you imagine your doctor telling you that you will never experience another meal again?" says Grossman. "Obviously, this is difficult to deal with and has also led to severe depression in some of our clients."

The suit filed by Grossman alleges that Merck knew of the risks associated with Fosamax and failed to warn users or advise them take a "drug holiday" prior to any dental procedures.

Thousands of Fosamax users have litigation pending against Merck, but Grossman's client's case will be the first to come trial. The trial begins on July 10, 2010, and Grossman expects it to serve as a bellwether event that will determine the course of further legal action against the company and the future of Fosamax.

Meanwhile, the Food and Drug Administration has recently issued a Drug Safety Communication raising concerns about the use of Fosamax and the increase in femur fractures in women. The Sanders Firm is currently reviewing information and preparing to file Fosamax femur fracture suits against Merck.

A straight-talking lawyer, Grossman has spent most of career fighting insurance companies and drugmakers. "It is mostly because these industries have been the most overtly driven by profits at the expense of the safety of the American people," says Grossman.

Right now, it is Merck and its drug Fosamax that Grossman has in his sights. "You and I shouldn't have to send this message to Fosamax users," he says. "Merck needs to pull this drug off the market and stop putting profits over safety."

Marc Grossman graduated from The University of Michigan in 1989 and subsequently completed a J.D./MBA at Brooklyn Law School and Baruch Business School. Grossman is a senior partner at Sanders, Sanders, Block, Woycik, Viener & Grossman, a firm that has earned millions in settlements and verdicts for clients over the last two decades.

The Atlantic County Superior Court has set the first jury trial concerning Fosamax for July 12, 2010, with the case meant to serve as a "bell-weather" for thousands of others pending before the court. The plaintiff is an osteoporosis sufferer that used the drug for approximately 4 years before she developed severe osteonecrosis of the jaw, a debilitating side-effect suffered by thousands of other women who used Fosamax. Osteonecrosis of the jaw is the permanent death of living bone tissue that requires extensive treatment to correct and causes considerable pain and disfigurement.

Marc Grossman, a New York attorney that represents the plaintiff in the bell-weather case, as well as hundreds of former Fosamax users, states "We are ready and eager to have our day in court and hold Merck responsible for the suffering it caused to thousands of women. Merck marketed this drug as a treatment for osteoporosis, when it knew the drug caused the death of bone tissue in the jaw. It's a blatant example of the drug industry putting increased profits before the safety of people"

Fosamax belongs to a class of drugs called biphosphonates and is the most widely prescribed of the class. In 2005, Merck succumbed to increasing pressure from the Food and Drug Administration and the medical community to add a warning on the Fosamax label that osteonecrosis of the jaw was a known risk of the drug. In a January, 2009 article published in the Journal of the American Dental Association, several dentists from the University of Southern California have recommended that all dental professionals warn their patients that "Because you are taking a type of drug called bisphosphonate, you may be at risk for developing osteonecrosis of the jaw and certain dental treatment may increase that risk."

Marc Grossman is a Senior Partner at The Sanders Firm, a National Law Firm with almost fifty attorneys, one-hundred and twenty staff members and clients in all fifty States. For the past forty-three years, The Sanders Firm has successfully represented thousands of victims of defective drugs and products and has recovered over $500 Million for its clients. For further information or press inquiries, please contact Marc Grossman at 1-800-FAIR-PLAY or visit us at www.thesandersfirm.com or via email at mgrossman@thesandersfirm.com.

New research suggests that Fosamax could contribute to broken bones.Common brand names of these medications, known as bisphosphonates, include Fosamax, Actonel, Boniva and Reclast.

"Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications," the FDA said today in its drug safety communication.

"At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures," the statement said. "FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue."

Fosamax is supposed to make bones stronger, but now there's mounting evidence that for some women, taking Fosamax or its generic alendronate for more than five years could cause spontaneous fractures.

Sales of the popular drug increased when doctors began prescribing it not only to women showing signs of osteoporosis, but also those who were osteopenic, and thus, at risk for the disease. Now some doctors worry that staying on the drug for more than five years can cause some women's bones to become more brittle.

This is not the first time that many doctors have reported an opposite effect for many people taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as well as to a serious bone-related jaw disease called osteonecrosis.

"In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown," Merck responded in a written response to the suggested link. "Rare cases of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines."

In 2008, the FDA reached out to the pharmaceutical company Merck about the reports of femur fractures. After 16 months, Merck added patients' reports of femur fractures to the list of possible side effects reported by patients included in the drug's package insert.

"It took Merck an entire year to respond," ABC News senior health and medical editor Dr. Richard Besser said. "Just six words: 'low energy femoral shaft and subtrochanteric fractures.'"

The FDA has also never made an effort to inform the public or doctors across the country who prescribe bisphosphonates of the possible side effect, Besser said.

A causal relationship between Fosamax and these fractures has not been established, according to Merck.

Many studies suggest an overall benefit from taking the medication for women who are at risk for osteoporosis. In fact, bisphosphonates can help prevent hip and spine fractures, which for many women may lead to death.

In 2008, bisphosphonate sales exceeded $3.5 billion according to data from IMS Health. In 2008, over 37 million prescriptions were written for the osteoporosis medication.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

"Rosiglitazone should be removed from the market," one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that "scientific evidence simply does not establish that Avandia increases" the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug's potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night. "Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."

The bipartisan multiyear Senate investigation -- whose results are expected to be released publicly on Monday but which were also obtained by The Times -- sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

"Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, "Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust."

In response, GlaxoSmithKline said that it disagreed with the Senate investigation's conclusions. The company said that it could not comment on internal F.D.A. documents but that "the official ruling from F.D.A. is that Avandia remain on the market."

In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.

But Dr. Graham and Dr. Gelperin, working in the F.D.A.'s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is "unethical and exploitative" because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia's use by precisely such patients, the reports note.

"Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable," one of the reports concludes.

These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company's patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.

In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked "what steps the F.D.A. has taken to protect patients in the TIDE trial" and said the trial's patients had never been told about the concerns raised by the agency's own safety officers.

Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.

"It doesn't make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision," Mr. Grassley said. "The Avandia case may be the most alarming example of the problem with this setup."

The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems -- including 304 deaths -- reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.

But companies say that such reports do not offer proof of a problem and that highlighting them can scare patients away from needed treatment, so they often argue that more certainty is needed before alarms are raised. GlaxoSmithKline said a "vast majority" of the recent reports regarding Avandia was related to litigation.

The Senate investigation -- the result of years of digging through more than 250,000 internal company documents -- concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company's Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.

European regulators had earlier ordered GlaxoSmithKline to conduct a study -- called the Record trial -- to examine Avandia's heart risks because hints of these problems appeared in the company's earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.

So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.

In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.

Two large company-sponsored trials -- called Dream and Adopt -- were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company's Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies "disquieting." Negotiations with agency officials about how and whether to alert the public continued.

Meanwhile, the company continued to market and advertise Avandia aggressively. The Senate inquiry concludes that the company threatened doctors who suggested in public that Avandia might have serious risks.

In 1999, for instance, Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania.

GlaxoSmithKline said that it "does not condone any effort to silence" scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation "could have been handled differently."

A recent study by Harvard researchers slated for publication by the American Diabetes Association found twice the number of heart attacks among 26,375 diabetic patients in patients studied between 2000 and 2006 who took Avandia, compared with diabetic patients in the same time period who took a different oral diabetic medication.

A separate study sponsored by GlaxoSmithKline - the manufacturer of Avandia - and i3 Drug Safety, an independent drug safety firm, found that Avandia users have a 35 percent to 41 percent increased risk of heart attack over users of Actos, Avandia's main competitor.

The Harvard group analyzed clinical care data taken from the electronic medical records of patients at several Boston area hospitals and clinics associated with Harvard Medical School. All 26,375 patients' records reviewed included a diagnosis of diabetes and the use of at least one oral diabetic medication used between years 2000 and 2006.

The researchers then reviewed the records to find all patients who suffered "myocardial infarction" or heart attack. The incidence of heart attack was more than double for Avandia compared with its main competitor Actos.