In human health, bone density is a crucial factor for physical flexibility. Osteoporosis, affecting both men and women, underscores the importance of bone health. Fosamax, a medication designed to control osteoporosis, has proven effective for many patients. However, concerns have emerged regarding the serious side effects associated with its long-term use.
The Fosamax lawsuit raises questions about the drug’s safety and potential side effects and seeks compensation for affected people. This blog explores osteoporosis, its impacts on people, and delves into the controversies surrounding Fosamax along with the legal issues involved.
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What is Fosamax?
Fosamax, a brand name for alendronate, belongs to the bisphosphonate group of drugs used to treat osteoporosis. Bisphosphonates strengthen bones by slowing or halting bone loss, reducing the risk of hip and spine fractures.
Fosamax is prescribed for treating osteoporosis caused by steroid use. It is also used to prevent osteoporosis in women experiencing menopause. Additionally, Fosamax is helpful in treating Paget’s disease of the bone in both men and women.
The United States approved the commercial sale of Fosamax in 1995.
Osteoporosis
Osteoporosis is a common bone disease caused by excessive bone loss, insufficient bone formation, or a combination of both factors. This leads to weakened bones that are more susceptible to fractures, even from minor incidents.
Each bone consists of two types of bone tissue for strength: compact bone, forming a hard outer layer, and trabecular bone, a softer, spongier mesh with a honeycomb structure found inside the bone. In osteoporosis, the honeycomb spaces and holes become significantly larger compared to a healthy bone. This results in an abnormal tissue structure and a loss of mass or density in the bones. As bone density decreases, bones become more fragile and prone to fractures.
Fosamax Side effects
Fosamax can lead to serious adverse effects, although these are rare. Here’s an overview of the side effects, highlighting the need for immediate medical attention if they occur.
Low Blood Calcium Levels
Fosamax can cause a decrease in blood calcium levels. This condition requires monitoring and possible intervention by healthcare professionals. Symptoms may include muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth; and, in severe cases, confusion or memory loss.
Osteonecrosis of the Jaw (ONJ)
A critical condition linked to Fosamax is osteonecrosis of the jaw (ONJ). This occurs when bone tissue in the jaw dies, leading to pain and the weakening of the jawbone. It’s more commonly seen in people who have dental surgeries or extractions while on Fosamax.
Symptoms include an exposed jawbone, pain, swelling, numbness, redness, loose teeth, bad breath, and signs of gum infection. In severe cases, tooth extraction might be necessary due to jawbone loss.
Femur Bone Fractures
Researchers have reported a safety concern regarding the long-term use of the osteoporosis medication Fosamax. A study revealed an association between prolonged Fosamax use and atypical femur fractures.
Approximately one-third of women who experienced such fractures were undergoing long-term osteoporosis prevention therapy, with two-thirds of them having used Fosamax for an average of over seven years. The average duration of Fosamax use before experiencing these fractures was around 5.4 years in the studied group.
These results suggested a link between Fosamax use and low-energy femur fractures. However, the authors acknowledged the retrospective nature of their analysis and called for further confirmation through studies.
The study emphasizes that while bisphosphonates, such as Fosamax, remain beneficial for osteoporosis treatment, their long-term use beyond the recommended guidelines may pose risks. Accordingly, the Food and Drug Administration (FDA) recommends a reassessment of bisphosphonate therapy after three to five years of use.
Fosamax plaintiffs should report any new thigh or groin pain to their doctor, as this may be an early symptom of a fracture. The Fosamax femur fracture lawsuit involves claims that the osteoporosis drug Fosamax causes atypical femur fractures.
Esophagus or Stomach Problems
Fosamax can irritate the esophagus and stomach lining, causing inflammation, ulcers, or bleeding. There have been reports of esophageal cancer in patients taking Fosamax. A 2009 FDA investigation cited 23 incidents of such cancer linked to Fosamax use. This shows the importance of monitoring for any esophageal or stomach-related issues during treatment.
Atrial Fibrillation
A recent study aimed to better understand the connection between drugs for osteoporosis and atrial fibrillation (AF).
Atrial fibrillation is a heart condition where the upper parts of the heart beat very quickly and irregularly. Symptoms can include feeling your heart race or flutter, chest pain, dizziness, lightheadedness, tiredness, difficulty exercising, trouble breathing, and overall weakness.
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FDA Warnings on Fosamax
The U.S. Food and Drug Administration (FDA) has issued multiple warnings regarding Fosamax. In 1997, the FDA criticized Merck for misleading marketing practices. Later, in 2004, the FDA highlighted the risk of bisphosphonates, including Fosamax, causing osteonecrosis of the jaw, commonly known as “dead jaw syndrome.” However, immediate action was not taken.
In 2008, the FDA urged Merck to investigate reports of femur fractures. Despite these warnings, efforts to inform the public and the medical community were deemed insufficient. Research published in journals like the Journal of Orthopedic Trauma and the Journal of Bone and Mineral Research has established a connection between Fosamax and rare femur fractures, particularly in long-term users.
Is there a lawsuit against Fosamax? Let’s see below.
Lawsuit against Fosamax
Merck has been involved in legal issues over its osteoporosis drug, Fosamax. The drug has been linked to unusual fractures, leading to over four thousand lawsuits against the company. In response to these allegations, Merck has offered Fosamax lawsuit settlement amounts ranging from $285,000 to $1.5 million to affected patients.
More than a thousand patients who took Fosamax have sued Merck, claiming the corporation tested the medication carelessly and neglected to inform patients of the true hazards associated with using Fosamax, especially if it was used for more than five years.
Fosamax Lawsuit Dismissal
Judge Joel A. Pisano, who presided over Fosamax cases, ruled in favor of Merck in 2014. He dismissed cases involving injuries before September 14, 2010. Judge Pisano stated that the plaintiffs had not provided sufficient evidence to support their claims against dismissal for these reasons.
About 510 cases were appealed to the Third Circuit Court of Appeals. In March 2017, the appeals court overturned Pisano’s decision. The panel determined that a jury could believe the FDA objected to the use of “stress fracture” in the label because it was misleading.
In June 2018, the U.S. Supreme Court agreed to hear Merck’s appeal concerning the Fosamax lawsuits. The company argued that they could not be held responsible for failing to warn the public about the drug’s potential risks, as the FDA initially rejected their proposed warning language.
However, plaintiffs argued that the FDA only objected to the wording, not the warning itself, and later approved an appropriately worded warning.
Merck has spent over a decade defending against claims that Fosamax causes unusual fractures. Despite facing numerous lawsuits, Merck had a significant victory in the Supreme Court in 2022.
Following this decision, approximately 500 Fosamax lawsuits were dismissed by a federal judge in New Jersey. The dismissal was grounded in the argument that federal law took precedence over state-law injury claims.
Merck maintained that it had attempted to include a fracture warning on Fosamax’s label, but this was rejected by the FDA. As FDA labels hold federal authority, Merck argued it shouldn’t be held responsible under state laws for not warning about the drug’s risks.
Despite the dismissal of several cases, Merck continues to face ongoing legal challenges. These include cases related to osteonecrosis developments in patients who used Fosamax. The federal lawsuits are consolidated into multidistrict litigation in the Southern District of New York, indicating that the legal issues related to Fosamax are still ongoing and unresolved.
Fosamax Lawsuit Settlements
On June 26, 2010, a jury granted $8 million in compensatory damages to Shirley Boles from Walton Beach, Florida. She had filed a lawsuit against Merck & Co., stating that their osteoporosis drug Fosamax caused damage to her jaw.
This decision came nine months after the initial trial ended in a mistrial. Boles had taken Fosamax from 1997 to 2006 and claimed it led to dental and jaw issues.
In February 2013, in New York, a federal jury decided that Merck & Co. Inc. must pay $285,000 because of the lawsuit about the dangers of osteoporosis medication, Fosamax. This is only the second time the company has lost in court after many trials.
In December 2013, Merck & Co.’s lawyers decided to resolve a legal issue regarding osteoporosis drug, Fosamax. The company agreed to pay $27.7 million to settle lawsuits from about 1,200 patients who experienced jaw bone damage while using the drug. This agreement, which covers cases in various courts, requires all affected patients to accept it.
Fosamax Lawsuit Update September 2024
Fosamax lawsuits have been ongoing for over 13 years and will return to the U.S. District Court in New Jersey. The lawsuits involve claims that Merck failed to warn users about the risk of sudden femur fractures linked to the osteoporosis drug.
Merck argued that federal law prevented them from updating the drug’s warning label on their own. However, the Third Circuit Court of Appeals ruled on September 20 that Merck was not blocked by federal law from changing the label and reinstated the lawsuits. This decision follows a history of legal challenges, including a 2019 U.S. Supreme Court ruling about drug warning claims and a dismissal of the lawsuits in 2022 by a federal judge.
The appeals court found that the district court made an error in dismissing the claims, and the lawsuits will now proceed. It is unclear if Merck will seek further review, attempt settlements, or proceed to trial.
As of December 2, 2024, there are 5 cases still pending in the MDL.
Fosamax Lawsuit 2025: What to do?
The dangers of Fosamax have gone unnoticed by millions of Americans who use the medication. You might be eligible for reimbursement for your medical bills and other expenses if this drug caused a major health issue for you or a loved one.
If you are having problems with Fosamax, a product liability lawyer can be a great help for you. An experienced attorney can research the facts of your case, assist you in negotiating a settlement, and represent you in court if you feel you have a legitimate legal claim. So, it’s advisable to seek legal consultation to understand your rights and the implications of the ongoing lawsuits.
If you or someone you know has been affected by Fosamax, it’s important to stay updated on the status of the lawsuit.
For further information and legal assistance, you may consider contacting law firms specializing in Fosamax lawsuits or personal injury, as they can provide more personalized guidance based on your situation.
The attorney had to analyze complex medical records to decide whether Fosamax directly caused the health issues. So medical record review plays an important role in this type of Fosamax lawsuit.
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Conclusion
Fosamax lawsuits centered on claims that Fosamax, a medication designed to strengthen bones and prevent osteoporosis, led to serious side effects in some patients. Medication must save people and not cause other side effects.
To stay informed about lawsuits similar to Fosamax and other trending lawsuits, it’s advisable to regularly check LezDo TechMed blogs. We provide timely updates on similar cases.
