>>MORE INFO: Fosamax Fracture Lawsuits

For the past three years, Saiontz & Kirk, P.A. has been investigating potential product liability lawsuits for users of the popular osteoporosis drug who have experienced a sudden femur fracture on Fosamax, which typically occur with little or no trauma. Complaints that are being pursued throughout the United States allege that Merck & Co. failed to adequately warn about the risk of Fosamax fracture problems, and has not taken sufficient steps to minimize the risk for users of the medication.

Fosamax (alendronate sodium) has been prescribed to millions of people in the United States since it was approved in 1995. It is the most popular seller in the family of bone-strengthening drugs known as bisphosphonates, which are the subject of the FDA advisory panel meetings set to begin on Friday.

Merck has promoted and encouraged the long-term use of Fosamax for treatment of osteoporosis and Pagets disease of the bone. However, Fosamax has an extremely long half-life, which means that it remains in the system for years and there can be a dose accumulation effect the longer it is taken.

Side effects of Fosamax long-term use have been linked to a number of serious, painful and potentially disabling problems. In addition to an association with low-trauma femur fractures, it has also been associated with decay or deterioration of the jaw bone, known as Fosamax jaw necrosis.

The FDA advisory panel will make recommendations to the FDA about regulatory options that could be enforced to minimize the risk of Fosamax problems. The panel will likely discuss potential limits on the number of years that women should take Fosamax and whether doctors should be told to have their patients take temporary breaks from using Fosamax, known as a “drug holiday” to reduce the risk of jaw decay and femur fracture problems with Fosamax.

FOSAMAX LAWSUIT FOR FAILURE TO REDUCE RISK

Although information has been available to Merck for some time about the risks associated with their blockbuster medication, they failed to take steps that could have been taken to reduce the risk of femur fractures or jaw necrosis from Fosamax. In fact, while providing inadequate warnings, Merck has encouraged the long-term use of the medication, rather than recommending limits on use or drug holidays, which would have negatively impacted sales of the blockbuster medication.

Individuals who have experienced problems may be entitled to financial compensation through a Fosamax lawsuit. To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

>>MORE INFORMATION: Fosamax Lawsuit over Fractured Femurs

According to a study published on May 5 in the New England Journal of Medicine, women were found to be face a 47.3% relative risk of suffering an atypical fracture of the femur with use of Fosamax or other bisphosphonate medications. Although the overall risk remains low, this does provide further support for our clients who are pursuing a Fosamax fractured femur lawsuit.

We first wrote about the potential link between Fosamax and femur fractures in June 2008, after a small study was published that identified a fracture pattern that was 98% specific to users of Fosamax. These atypical thigh bone breaks can occur with little or no trauma at all, typically while taking a step or falling from standing height or less.

Although information has been available for some time about the risk of fractured femurs from Fosamax side effects, Merck failed to properly warn consumers or the medical community. Last year, in October 2010, the FDA required new warnings about the potential risk of bisphosphonate femur fractures, but indicated at that time that no causal link between femur fractures and Fosamax or other bisphophonate medications had been identified.

If better warnings and information had been provided earlier, thousand of women may have avoided a Fosamax fractured femur if they had known to seek immediate medical attention if they experienced sudden groin or thigh pain, which may occur before a complete break occurs.

LAWSUITS FOR FOSAMAX FEMUR FRACTURES

Potential Fosamax lawsuits over femur fractures are being reviewed for women throughout the United States. All cases are being pursued under a contingency fee agreement, which means that there are no fees unless a recovery is obtained and there is no obligation to pursue a claim after contacting one of our lawyers for a free consultation.

To review a potential case for yourself, a friend or family member who suffered a femur fracture on Fosamax, request a free consultation and claim evaluation.

The Fosamax lawyers at Saiontz & Kirk, P.A. have been representing individuals since 2006 who experienced problems from the popular osteoporosis drug. Most of the lawsuits involve claims for osteonecrosis of the jaw from Fosamax, a painful and debilitating condition where portions of the jaw decay and die. However, recently, there have been a growing number of claims over unexplained, low-trauma femur fractures caused by Fosamax.

Last October, the FDA required the drug maker, Merck, to add new warnings to the drug label about the risk of Fosamax fracture problems. However, for years consumers were not adequately warned that they should seek immediate medical attention if they experience groin pain or thigh pain on Fosamax, as that may be a sign that appears weeks or months before a complete fracture of the femur on Fosamax occurs.

A Fosamax MDL is already pending in the U.S. District Court for the Southern District of New York for the jaw cases. However, Merck filed a motion on March 23 to establish a new MDL for the Fosamax femur fracture litigation. It is expected that the MDL panel will hear arguments on the motion for May 16, at the next scheduled session.

According to documents filed by Merck, more than 100 people have already filed a Fosamax broken femur lawsuit in federal district courts throughout the United States. However, based on the number of cases being investigated nationwide, attorneys involved in the litigation expect the filings will increase substantially in the coming months and years.

All of the cases involve similar allegations that side effects of Fosamax increase the risk of sudden fractures of the femur or thigh bone. These Fosamax broken bones typically occur with falls from standing height or less, and may occur without any trauma at all.

If the new MDL is formed, as is widely expected, the cases will be assigned to one judge during pretrial litigation, eliminating duplicative discovery in hundreds of different cases and avoiding inconsistent rulings by judges in different districts throughout the United States.

While most consumers consider MDL consolidation the same as a Fosamax femur fracture class action lawsuit, the cases are not permanently combined and do remain individual claims. Unlike a class action, each plaintiff’s damages are unique and they each still must established that their bone fracture was caused by side effects of Fosamax.

If a Fosamax femur fracture settlement agreement is not reached during pretrial proceedings, each case will be returned back to the federal district court where it was originally filed for an individual trial.

FOSAMAX FRACTURE CLASS ACTION LAWYERS

Potential claims are continuing to be reviewed by our Fosamax fracture lawyers for individuals throughout the United States. All cases are pursued on a contingency fee basis, which means that there will be no fees or expenses until a recovery is obtained, and nothing is owed if compensation is not secured.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

>>REVIEW A POTENTIAL FOSAMAX BONE FRACTURE LAWSUIT<<

According to a report by the Institute of Safe Medication Practices (ISMP) [PDF], during the second quarter of 2010 there were at least 126 reports submitted to the FDA’s MedWatch adverse event reporting system involving low-trauma or no-trauma bone fractures with Fosamax. That compares to only 53 reports that linked the osteoporosis drug to incidents of jaw bone decay during the same period.

While most of the attention in recent years surrounding Fosamax side effects have focused on decay of the jawbone, more and more people are becoming aware that an atypical bone fracture may be from Fosamax.

Although Merck continues to deny that there is a connection between Fosamax and bone fractures, according to the ISMP report:

In our [Fosamax] alendronate data, a lower limb fracture was 50 times more likely to be reported than would be expected for the drug given the total number of reports for all types of possible injury.

The FDA announced in October 2010 that it was requiring new label warnings on about the risk of Fosamax femur fracture side effect. However, as of last month, those new warnings have not been implemented.

FOSAMAX BONE FRACTURE LAWSUITS

The Fosamax lawyers at Saiontz & Kirk, P.A. provide free claim evaluations to help individuals determine whether they may be entitled to compensation as a result of Merck’s failure to warn about the risk of Fosamax side effects. If you, a friend or family member have experienced a bone fracture on Fosamax or developed jaw problems, request a free consultation.

While there has been a good bit of media attention surrounding Fosamax lawsuits in recent years, most of this coverage has involved the risk of jaw problems from Fosamax. Very little attention has been paid to the mounting number of Fosamax fractured femur cases, but that now appears to be slowly changing.

Fosamax is a widely used drug for treatment and prevention of osteoporosis, which has been prescribed to millions of people throughout the United States. While the medication is designed to strengthen the bones, side effects of Fosamax appears to increase the risk of a rare type of low-impact fracture of femur bones. These femur fractures on Fosamax typically occur as a result of falls from standing height or less, or can occur with no impact at all.

We first wrote about the Fosamax femur fracture risk in June 2008. A study published around that time identified a low-energy femur fracture pattern that was 98% specific to users of Fosamax. Although Merck, the drug’s manufacturer, knew about the mounting number of Fosamax fracture femur reports, they have denied or minimized the risk and failed to take steps to ensure that doctors and consumers were aware of the possible risk of femur fractures.

Armed with information about the risk of a femure fracture from Fosamax, many serious and debilitating injuries could have been prevented.

Only recently have warnings been provided about the potential link between Fosamax and femur fractures. In October 2010, the FDA required the manufacturer to update warning information on about these atypical fractures of the femur with Fosamax and other bisphosphonate medications.

New information is now provided to physicians and to consumers in a Medication Guide that will be distributed with each prescription. To reduce the risk of injury for consumers, healthcare professionals are now being informed that they should:

• Be aware of the possibility of atypical femur fractures with Fosamax and other bisphosphonates
• Rule out femoral fracture from Fosamax if a patient develops new thigh or groin pain, and to discontinue the medication if a patient has evidence of a femur fracture.
• Consider periodically re-evaluating whether continued use of Fosamax or another bisphophonate medication is needed, especially in patients taking the drugfor more than five years.
• Discuss the benefits and risks with patients and instruct them to seek immediate medical attention if they experience few groin pain or thigh pain, which is often described as dull or aching. This pain can occur weeks or months before a complete Fosamax fracture occurs.

FOSAMAX FRACTURED FEMUR LAWSUIT EVALUATIONS

As a result Merck’s failure to adequately warn about the Fosamax fracture femur risk earlier, consumers and the medical community were unaware of the risk associated with the medication and failed to take steps that could have reduced the risk of serious and permanent injuries.

The Fosamax femur fracture lawyers at Saiontz & Kirk, P.A. are providing free consultations for individuals who have suffered a sudden, low-trauma fracture of the femur while taking Fosamax. To review a potential Fosamax fracture lawsuit on behalf of yourself or a family member, request a free claim evaluation.

>>MORE INFO: Fosamax Thigh Fracture Lawsuit

Fosamax (alendronate sodium) is a popular medication prescribed to treat osteoporosis and reduce the risk of fractures by preventing bone turn-over. However, side effects of Fosamax have been linked to decay of the jaw bone, known as osteonecrosis of the jaw from Fosamax, and reports of low-energy femur fractures, typically occurring with falls from standing height or less.

On October 13, the FDA announced that a thigh fracture warning will be added to all bisphosphonate medications like Fosamax, though they stopped short of decaring the there was a cause and effect relationship between the drugs and femur fractures.

During their review of the Fosamax fractures of the thigh, the FDA discovered that they all appear to be atypical subtrochanteric and diaphyseal femur fractures. These only accounted for 1% of all thigh fracture reports, but when FDA researchers looked into that group, the found that they are predominantly reported by people who have been taking Fosamax or another bisphophonate. The review also suggests that the fractures of the thigh from Fosamax may be connected to long-term use of bisphosphonates.

Although evidence has suggested that there is a connection between Fosamax and a fracture risk for some time, the drug maker has failed to adequately warn consumers.

>>PRIOR POST (3/9/2010): Report on Fosamax Broken Thigh Bones

According to recommendations posted by the FDA (pdf) for consumers taking Fosamax or other bisphosphonate medications for osteoporosis, users should:

• Review the new medication guide, which will describe symptoms of atypical femur fractures from Fosamax
• Notify your healthcare provider if you experience symptoms of a Fosamax fracture
• Notify your healthcare provider if you develop new hip or thigh pain, which is commonly described as dull or aching pain

The FDA is continuing to review the connection between Fosamax and thigh fractures, and recommends that individuals continue to take their medication unless they are told by their doctor to stop. In addition, the agency is urging individuals to report any Fosamax thigh fracture side effects through the FDA’s MedWatch program.

PROBLEMS WITH FOSAMAX FEMUR FRACTURES

The Fosamax lawyers at Saiontz & Kirk, P.A. are providing free consultations and claim evaluations for individuals who believe they may have suffered a thigh fracture from Fosamax. Lawsuits are also being reviewed for individuals who have developed osteonecrosis of the jaw, osteonecrosis of the hip, osteonecrosis of the knee or osteonecrosis of the shoulder.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

>>INFORMATION: Fosamax Osteonecrosis of the Jaw Lawsuits

This case, which involved a Fosamax lawsuit filed by Shirley Boles, originally went to trial last September, but ended in a mistrial after jurors could not agree on a verdict. The retrial began in May, and the jury came back with a plaintiff’s verdict last week awarding $8 million. The case was tried by Gary Douglas of Douglas & London and Timothy O’Brien of Levin Papantonio.

Fosamax lawsuits brought by Boles and other plaintiffs all include similar allegations that the osteoporosis drug causes osteonecrosis of the jaw (ONJ), a painful condition that results in jaw decay, loss of bone structure and in some cases may require portions of the jaw to be surgically removed. There is no cure for osteonecrosis of the jaw from Fosamax, leaving many sufferers with permanent disfiguration and diminished quality of life.

The Boles’ lawsuit was a particularly difficult case for plaintiffs, which makes the award an even stronger sign of the Fosamax problems Merck faces in continuing to defend these cases at trial. Judge John Keenan, who is overseeing all of the federal Fosamax litigation, limited the evidence Boles’ attorneys could introduce involving Merck’s actions after 2003, as it was determined that Boles developed ONJ no later than September 2003. This eliminated some of the most damaging evidence against the drug maker.

FOSAMAX LAWSUITS FOR OSTEONECROSIS OF THE JAW

Merck currently faces hundreds of other similar Fosamax osteonecrosis of the jaw lawsuits filed on behalf of individuals throughout the United States. In addition, given the cumulative effect that the drug can have as it is taken for long periods of time, individuals continue to develop this painful and disfiguring jaw problem as a result of Merck’s failure to adequately warn about the side effects of Fosamax.

The Fosamax osteonecrosis of the jaw lawyers at Saiontz & Kirk, P.A. are continuing to review new cases for individuals who have been diagnosed with ONJ or are experiencing symptoms of the jaw damage, such as:

• Jaw Pain
• Infection of the gums or jaw
• Loosening of the teeth
• Poor healing gums
• Numbness or feeling of heaviness in the jaw
• Exposed jaw bone in the mouth

To review a potential Fosamax lawsuit for osteonecrosis of the jaw on behalf of yourself, a friend or family member, request a free consultation and claim evaluation.

>>INFORMATION: Fosamax Fracture Lawsuits

Fosamax (alendronate sodium) is an osteoporosis drug prescribed millions of people to reduce the risk of fractures, primarily involving the hip. About 1,000 Fosamax lawsuits have already been filed by users of this drug who experienced a rare decay of the jawbone after taking the medication, known as osteonecrosis of the jaw or ONJ. However, more and more doctors and medical experts are now noticing a possible connection between non-impact femur fractures and broken bones from Fosamax.

An ABC News and World Report aired last night discussing the stories of several women who have experienced these spontaneous broken bones and fractures after using the Fosamax for several years. Research into the Fosamax femur fracture side effects suggest that prolonged use of the osteoporosis drug may overly suppress bone metabolism, impacting the ability of the bone to repair microdamage to the femur (thigh bone), which is one of the strongest in the body.

The ABC report highlights how users and the medical community have not been adequately warned about the risk of femur fracture from Fosamax. The FDA told ABC that they are looking into the reports of bone breaks with Fosamax, and Merck issued a statement for the report denying that any causal connection has been established.

Here is the Fosamax femur fracture video from ABC News:

Similar stories continue to turn up about these unexplained Fosamax thigh bone fractures, which can occur after no obvious trauma. The following news report by WCBD-TV, a local NBC Affiliate in Charleston, South Carolina, aired last month:

FOSAMAX FEMUR FRACTURE ATTORNEYS

If you, a friend or family member have suffered a broken thigh bone or femur fracture on Fosamax, you may have a case as a result of Merck’s failure to warn about the potential risk. Fosamax fracture lawsuits are reviewed for users of the drug throughout the United States, and there are no fees or expenses unless a recovery is obtained. To have a case reviewed by one of our Fosamax attorneys, request a free consultation and claim evaluation.

Following a three-week Fosamax trial in the U.S. District Court for the Southern District of New York in Manhattan, the case was submitted to the jury on September 2nd. When deliberations resumed after the Labor Day holiday weekend, several notes were passed to the judge indicating that jurors who sided with the plaintiff were being intimidated, threatened and insulted. Reports suggest that yelling was frequently heard in the hallway outside of the jury room, and one juror indicated that a chair was thrown.

After a “cooling-off” period on Thursday failed to lead any jurors to change their position, a mistrial was granted on Friday afternoon.

As would be expected, Merck has touted it as a victory that the Plaintiff was unable to convince all of the jurors that the she suffered jaw necrosis from Fosamax. However, the case will likely be rescheduled for a new trial next spring. In addition, Tim O’Brien, who was the attorney representing the plaintiff at trial, suggested that the split among the jurors may actually be more of a favorable forecast for plaintiffs in other cases.

The Fosamax trial was the first of more than 900 lawsuits against Merck over Fosamax jaw necrosis, and was selected as one of three “bellwether” trials that would help gauge how jurors would respond to certain evidence. However, this first case involved a plaintiff who developed ONJ no later than September 2003, and most of the damaging evidence about how Merck ignored the Fosamax jaw problems and failed to follow FDA recommendations occurred after that date.

U.S. District Judge John Keenan, who is presiding over the pretrial litigation for all of the Fosamax lawsuits pending in federal court, ruled before trial that the plaintiff in this first case would not be able to introduce evidence involving Merck’s actions after the plaintiff had already developed the jaw problems. However, most of the other Fosamax trials involve individuals who were diagnosed later, which will likely make those plaintiffs’ cases stronger.

FOSAMAX ATTORNEYS

The Fosamax attorneys at Saiontz & Kirk, P.A. represent women throughout the United States who have been diagnosed with osteonecrosis of the jaw after using the popular osteoporosis drug. The second and third “bellwether” Fosamax trials are currently scheduled for January and April 2010.

Although the early trials in the Fosamax litigation are already underway, our attorneys are continuing to review potential claims for individuals who have been diagnosed with ONJ or experienced symptoms, such as:

• jaw pain
• infection of the gums or jaw infection
• jaw swelling
• loosening of the teeth
• tooth ache
• poor healing gums
• numbness or a feeling of heaviness in the jaw (“Numb Jaw” or “Heavy Jaw”)
• exposed jawbone and drainage

Fosamax has a very long half-life, and since many users took the drug over a number of years, the consequence of Merck’s failure to warn continues to result in new cases. To review a potential Fosamax lawsuit for yourself, a friend or family member, request a free consultation.

>>INFORMATION: Fosamax Jaw Damage Side Effects

All federal lawsuits involving Fosamax have been consolidated in an MDL, or multidistrict litigation, in the U.S. District Court for the Southern District of New York before Judge John F. Keenan. As part of the pretrial proceedings, three cases were scheduled for early trials, known as “bellwether” cases.

The term “bellwether” refers to how the cases will serve to predict or forecast what may happen in the future. It is derived from the practice of placing a bell around the neck of a castrated ram (a wether) that is leading its flock of sheep, where the movements of the flock could be noted by hearing the bell before the flock was in sight.

The trial that starts today with opening statements involves the plaintiff Shirley Boles, who used Fosamax for a number of years. Boles claims that the build up of the drug in her system, since Fosamax has a long half-life, led to the permanent decay and destruction of her jawbone, known as osteonecrosis of the jaw.

Although Merck & Co., which manufactures Fosamax, indicates that they intend to defend itself in court in these cases, a similar early litigation strategy was employed in cases filed following the 2004 Vioxx recall, which ultimately resulted in a $4.85 billion global settlement for more than 30,000 lawsuits.

As of June 30, 2009, approximately 899 Fosamax lawsuits have been filed in state or federal courts throughout the United States on behalf of 1,280 plaintiff groups.

FOSAMAX LAWYERS

The lawyers at Saiontz & Kirk, P.A. are continuing to investigate potential Fosamax jaw lawsuits on behalf of users of the popular osteoporosis drug who have been diagnosed with osteonecrosis of the jaw (ONJ), or experienced symptoms like:

• jaw pain
• infection of the gums or jaw infection
• jaw swelling
• loosening of the teeth
• tooth ache
• poor healing gums
• numbness or a feeling of heaviness in the jaw (“Numb Jaw” or “Heavy Jaw”)
• exposed jawbone and drainage

To review a potential claim and determine if you, a friend or family member may be eligible to pursue a Fosamax case, request a free consultation and claim evaluation.