Merck & Co. faces multiple lawsuits

According to Consumer Drug Report, a drug information resource, pharmaceutical company Merck & Co. is currently facing multiple lawsuits. Two women claim to have suffered osteonecrosis of the jaw (ONJ), or “dead jaw”, after taking Fosamax® and have filed lawsuits against Merck. Opening statements were heard on March 1, 2012.

According to Merck, the two women suffered from medical conditions that cause jaw injuries prior to taking Fosamax and maintain that Fosamax did not cause their injuries.

In addition to the claims brought forth by women who have suffered osteonecrosis after taking Fosamax, women have made claims that Fosamax causes atypical femur fractures. According to their complaints, spontaneous femur fractures would occur during normal activities such as walking or jogging.

There are two separate multidistrict litigation trials for Fosamax lawsuits. All femur fracture lawsuits are currently consolidated in the U.S. District Court for the District of New Jersey and all osteonecrosis lawsuits are consolidated in the U.S. District Court for the Southern Court for the Southern District of New York.

Merck introduced Fosamax in October of 1995 for the treatment of osteoporosis, a chronic bone condition that causes bones to become weak and fragile. Fosamax is included in a class of drugs known as bisphosphonates, which are bone strengthening medications.

In addition to Fosamax, Merck also manufactures a drug known as Vytorin® which helps lower the amount of cholesterol and involves a combination of Zocor® and Zetia®. Vytorin is a competing drug to Zocor and is much more expensive.

A shareholder lawsuit was filed against Merck claiming that Merck jointly marketed Vytorin, with the help of Schering-Plough Corp., as being more effective than Zocor and concealed the results of a study that showed otherwise. The lawsuit was settled and Merck agreed to pay $5.1 million to cover plaintiff fees.

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Fosamax® lawsuit attorneys actively pursue Fosamax injury claims

Fosamax lawsuit attorneys are actively pursuing claims against drug manufacturer Merck & Co. for reported adverse side effects associated with prescription drug Fosamax. Currently, the pharmaceutical giant faces a large number of lawsuits filed by individuals who claim to have suffered femur fracture injuries among other injuries.

In 1995, the Food and Drug Administration (FDA) approved Fosamax use to treat a chronic condition known as osteoporosis. The drug works by strengthening bones and preventing breakage. However, claims have been reported to the FDA stating that Fosamax and other bisphosphonate drugs cause atypical femur fractures.

A causal linkage between long term use (considered to be 12 months or more) and femur fractures were determined in recent studies conducted by researchers of bisphosphonates. It was shown that drugs like Fosamax tend to slow down the rate at which the body replaces old bone with new bone leading to possible fractures which may be serious and life threatening. Some patients claim that femur fractures would occur spontaneously, especially during running or jogging.

The FDA issued a warning to consumers and health professionals regarding the increased risk for suffering femur fractures in 2008. In 2010, the FDA mandated that all bisphosphonate manufacturers update their warning labels to include the increased risk for fracture with long term use.

Other injuries allegedly caused by Fosamax include osteonecrosis of the jaw (ONJ) or “dead jaw,” atrial fibrillation, and esophageal cancer. Currently all femur fracture lawsuits have been consolidated and centralized in the U.S. District Court for the District of New Jersey.

U.S. District Judge John Keenan ordered three Fosamax bellwether trials to occur this year, one in May, September, and November. Each Fosamax lawsuit against Merck alleges that the company failed to properly issue sufficient warnings regarding the risk for femur fracture injuries.

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Victims continue to sue Merck for Fosamax® femur fractures

Consumer Drug Report recently reported a case filed by another victim of Fosamax femur fracture injuries. According to the drug risk information resource, a woman by the name of Reba Inez Patton and her husband Patrick Patton filed a claim alleging that bisphosphonate medication, Fosamax and Boniva®, caused her to suffer from a low-energy femur fracture in December 2010. The fracture is a rare form of bone injury which may occur with little or no trauma to the victim.

The Fosamax lawsuit was filed on December 15, 2011 against drug maker Merck & Co., maker of Fosamax, and GlaxoSmithKline (GSK), maker of Boniva, in the Superior Court of New Jersey.

The complaint filed by the Patton’s alleges that both Merck and GSK falsely marketed the medications, which are designed to strengthen bones in women diagnosed with osteoporosis, claiming that the companies failed to provide sufficient warnings of the femur fracture risks.

Due to the femur fracture injuries, Mrs. Patton suffers severe and permanent damage requiring ongoing medical care.

Thousands of Fosamax femur fracture lawsuits have been filed against Merck & Co. all of which make similar allegations that the drug company failed to properly warn of the risks associated with long term use of Fosamax.

Fosamax was designed to treat osteoporosis, a chronic condition in which bones become brittle and break. The Food and Drug Administration approved Fosamax in October of 1995. Since its approval, over 20 million patients have taken the medication. The drug grew in popularity and prior to the release of a generic, Fosamax brought in revenues of $3 million.

All lawsuits filed against Merck have been consolidated as part of a multidistrict litigation and is centralized in the U.S. District court for the District of New Jersey.

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Fosamax® linked to multiple side effects

Fosamax is now being linked to multiple side effects according to the resource for drug information site Consumer Drug Report. According to the report, Fosamax, a bisphosphonate drug designed to treat osteoporosis, is being linked to a number of adverse side effects.

Victims who have taken the medication say that injuries associated with Fosamax use include osteonecrosis (ONJ), also known as “dead jaw”, atypical femur fracture injuries, atrial fibrillation, and esophageal cancer.  

Merck & Co., manufacturer of Fosamax, claims that these side effects were questionable during their own clinical trials. The company also released a statement, countering arguments that the drug causes ONJ, which said “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 or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown."

Fosamax attorneys have filed Fosamax lawsuits on behalf of victims affected by the injuries allegedly caused by Fosamax. Merck now faces thousands of lawsuits all involving similar allegations that the manufacturer failed to properly warn about the risks associated with the medication. The company is also accused of falsely marketing Fosamax for the treatment of osteoporosis.

These lawsuits have been consolidated into a multidistrict litigation and centralized in the U.S. District Court for the District of New Jersey.

In October 2010, the Food and Drug Administration mandated that Merck update the product with new warning labels displaying the risk of femur fractures associated with Fosamax use.

Fosamax was approved by the Food and Drug Administration in October of 1995. It was approved to treat osteoporosis in postmenopausal women. Over 20 million patients have been prescribed Fosamax since its approval and it generated $3 million per year in sales prior to the release of a generic version.

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Merck to battle three Fosamax® lawsuits in 2012

According to Consumer Drug Report, a resource for drug risk information, Merck is scheduled to have three initial Fosamax lawsuits, also known as bellwether trials, this year. The pharmaceutical giant and manufacturer of Fosamax is being sued by hundreds of individuals for adverse effects allegedly caused by the Fosamax drug.

Fosamax was designed to treat osteoporosis, a chronic condition which may cause bones to become fragile and break. However, according to numerous reports, the drug has been linked to adverse side effects.

The Food and Drug Administration (FDA) approved of Fosamax in October of 1995. Since then, approximately 20 million people have taken the medication. Prior to the release of a generic version of Fosamax, Fosamax brought in annual revenues of $3 million.

Each claim brought against Merck involves similar allegations that Fosamax causes osteonecrosis (ONJ) or “dead jaw,” a condition in which the jaw bone starts to deteriorate and may cause the jaw to show through the skin. As a result of this condition, full or partial jaw removal is often required. Other allegations against the company include claims that Fosamax causes atypical femur fractures. These femur fracture injuries are said to occur during normal activities such as walking or jogging.

Merck currently faces approximately 1,000 product liability lawsuits. Some claims state that the drug causes ONJ while others claim that the drug caused them to suffer atypical femur fractures. All federal cases filed by plaintiffs who claim Fosamax causes ONJ are consolidated before Judge Keenan in the U.S. District Court for the Southern District of New York as part of multidistrict litigation (MDL). All cases filed by plaintiffs who claim Fosamax causes atypical femur fractures have been consolidated as part of a different MDL and is centralized in the U.S. District Court for the District of New Jersey.

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Researcher With Financial Interest In Bisphosphonates Verifies Increased Risk Of Atypical Femur Fractures With Bisphosphonates Like Fosamax, Reclast

A researcher with financial ties to a company that hopes to commercialize a bisphosphonate product (and to which he holds the patent) has confirmed that bisphosphonates like Fosamax and Reclast increase the risk of an atypical femur fracture. (what is a femoral shaft fracture?) Bisphosphonates are a class of osteoporosis drugs—including the very-popular drug Fosamax—that have been linked to increased risk of bone breaks like femur fractures as well as other potential Fosamax injuries.

The study, published on May 5, 2011 in the New England Journal of Medicine (“NEJM”), found that the increased risk of an “atypical” fracture in bisphosphonate-using women 55 and older was "higher with an increasing duration of bisphosphonate use, with an odds ratio of 1.3 . . . per 100 prescribed daily doses. This risk was approximately 10 times as high as a normal level of risk within the first 2 years of use and 50 times as high thereafter.”

Dr. Per Aspenberg and his associates conducted the study on 1,234 women 55 years and older who suffered from a femoral shaft fracture.

Dr. Aspenberg admitted in his disclosure form to the NEJM to “receiving consulting fees from [drug manufacturer] Eli Lilly and Amgen and grant support to his institution, Linköping University, from Eli Lilly and Amgen, as well as holding stock in AddBIO, a company trying to commercialize a method for bisphosphonate coating of implants to be inserted in bone, and holding a patent for this method.” Eli Lilly is not a current bisphosphonate manufacturer.

Common Bisphosphonates and their manufacturers include:

·       Fosamax (Merck & Company).

·       Boniva (Roche and GlaxoSmithKline) 

·       Actonel (Procter & Gamble Pharmaceuticals and Sanofi Pharmaceuticals).

·       Skelid (Sanofi Pharmaceuticals)

·       Didronel (Procter & Gamble Pharmaceuticals)

·       Reclast and Zometa (Novartis Pharmaceuticals)

The Spangenberg law firm has provided information on potential Fosamax lawsuits at www.my-fosamax-lawsuit.com. The website provides information on Fosamax femur fractures and other possibly Fosamax-related injuries. The Spangenberg law firm can also be reached at 1-877-696-3303.

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How Does Fosamax Work?

Fosamax and other bisphosphonates work by interrupting the normal process of bone formation and degradation. Your body builds bone with one type of cell (osteoblasts), and takes bone away with another type of cell (osteoclasts). As people age, the re-absorption (or degradation) of the bones by osteoclasts can outpace the creation of bone by osteoblasts.  Severe bone loss is referred to as "osteoporosis."  That's what drugs like Fosamax were supposed to fight.

Fosamax (alendronate) stops the cells that take bone away, leading to an increase in total bone mass. But studies are showing that Fosamax patients’ bones are actually weaker, despite Fosamax making them denser. As ABC news reported, this can lead to devastating bone injuries like femoral fractures:

"We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body."

Fosamax patients who have suffered these types of injuries are filing Fosamax femur fracture lawsuits.  Fosamax Injury Attorneys can help these people determine whether they have a valid Fosamax lawsuit or not.  If you or a loved one think you might have been injured by Fosamax, contact a Fosamax Injury Attorney for more information.

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What is A Femoral Fracture?

"Femoral" refers to the femur, or the thigh bone.  One of the strongest bones in the body, it usually requires a great deal of force in order to cause a femur fracture.  As the American Academy of Orthopedic Surgeons explain on their website:

To break the thighbone across its length (shaft) takes a great deal of force, as might occur in a motor vehicle accident or a fall from a high place. Because of this, a broken thighbone is often associated with potentially life-threatening injuries to other body systems.

Symptoms of a femoral fracture include severe pain,inability to move the leg, deformity, and swelling.  A broken femur can be life threatening.

As eMedicine explains:

The femur is the largest and strongest bone and has a good blood supply. Because of this and its protective surrounding muscle, the shaft requires a large amount of force to fracture. Once a fracture does occur, this same protective musculature usually is the cause of displacement, which commonly occurs with femoral shaft fractures.


As with many orthopedic injuries, neurovascular complications and pain management are the most significant issues in patients who come to the ED. The rich blood supply, when disrupted, can result in significant bleeding. Open fractures have added potential for infection.

While normally a large amount of force is required to break the bone, evidence suggests that patients taking the bisphosphonate Fosamax (R) can suffer abnormal, or "atypical" femur fractures.  These atypical femur fractures do not require much force, and otherwise healthy-seeming femurs break all too easily.

Learn more about Fosamax(R) and Fosamax Femur Fracture Lawsuits at our Fosamax Fracture Lawsuit website.

Have you or a loved one suffered from a femur fracture?  Please leave a comment and share your story below!

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