Zometa is a brand name for the medication zoledronic acid, which is used to treat various conditions, including osteoporosis and certain types of cancer. Zometa was targeted for a small but signfiicant number of lawsuits alleging that it causes osteonecrosis of the jaw (ONJ).
How Does Zometa Work?
Zometa, known generically as zoledronic acid, is a medication classified as a bisphosphonate. It works by inhibiting the activity of osteoclasts, which are the cells responsible for breaking down bone tissue. This action helps to slow bone loss and maintain bone density. By reducing the activity of these cells, Zometa can help prevent complications associated with excessive bone breakdown.
Zometa is commonly used to treat conditions where bone loss or abnormal bone activity is a concern. In patients with osteoporosis, it helps strengthen bones and reduce the risk of fractures. In cancer patients, Zometa is often prescribed to manage hypercalcemia, a condition characterized by elevated calcium levels in the blood, which can occur due to cancer spreading to the bones. It is also used to treat bone metastases, where cancer cells affect bone tissue, causing pain and an increased risk of fractures. Through its mechanism of action, Zometa plays a crucial role in managing these conditions and improving patients’ quality of life.
What Is ONJ?
ONJ is a condition where the jawbone begins to die due to a lack of blood supply. The biggest symptoms of OJN are pain and difficult eating or even speaking. ONJ is linked to the use of bisphosphonates, a class of drugs that includes Zometa. The first reports of ONJ in patients taking bisphosphonates appeared in the early 2000s. Hundreds of lawsuits have been filed against Novartis, the manufacturer of Zometa, claiming Zometa caused their ONJ.
Like most drug lawsuits, the plaintiffs did not argue for a Zometa recall. The majority of these lawsuits wered filed by patients or their surviving families who claim that drugmaker failed to adequately warn about the risk of ONJ that traveled with Zometa. They argue that Novartis either knew or should have known that bisphosphonates could cause ONJ that it should have passed along to doctors and patients.
Why? Because they did not want people to stop buying Zometa. Keep in mind that Novartis, at one point, agreed to pay $250 million to settle allegations that it provided kickbacks to doctors and hospitals to promote Zometa and other drugs. The US Department of Justice also fined the company for illegal marketing practices. So the allegation that Novartis put profits over people is not exactly out of left field, right?
Who Is at Risk for ONJ?
Therw is no question that Certain factors can increase a patient’s risk of developing ONJ. One of the most significant risks is undergoing invasive dental procedures, such as tooth extractions or root canals, which can disrupt blood flow to the jawbone. Patients with pre-existing dental issues, including gum disease or poorly fitting dentures, are at higher risk. Additionally, prolonged use of bisphosphonates, particularly over several years, has been linked to an increased likelihood of ONJ.
To reduce the risk of developing ONJ, patients are advised to address any dental problems before starting Zometa or similar treatments. Routine dental care, including regular check-ups and good oral hygiene practices, is crucial. It is also important to inform healthcare providers and dentists about Zometa use before undergoing any dental procedures.
Symptoms and Diagnosis of ONJ
Early detection of ONJ is important for effective management. Common symptoms include persistent jaw pain, swelling, or redness in the gums. Some patients may experience loose teeth, exposed bone in the mouth, or difficulty chewing and speaking. If these symptoms occur, you want to get medical or dental evaluation promptly.
Diagnosing ONJ typically involves a thorough dental examination. You dentist or oral surgeon will look for exposed bone or other abnormalities. Imaging studies, such as X-rays or CT scans, help confirm the diagnosis by revealing bone damage or changes in the jaw. Early intervention can help manage the condition and reduce its impact on a patient’s quality of life.
ONJ Warning History
The story of the Zometa OMJ warning is one of incrementalism.
Early Years (2001–2004):
- Limited Awareness: When Zometa was first approved by the FDA in 2001, the prescribing information did not include any mention of ONJ, as the condition was not yet widely recognized as a potential side effect.
- Initial Reports: By the early 2000s, sporadic reports of ONJ began to emerge, particularly in patients undergoing dental procedures while receiving bisphosphonate therapy.
2004–2005:
- First Warnings Issued: Novartis updated Zometa’s labeling to include a precaution about ONJ after accumulating evidence linked bisphosphonates to jawbone issues. The warning was initially brief, noting the potential for ONJ, particularly in cancer patients receiving high doses of the drug.
- Focus on Risk Factors: These early warnings highlighted invasive dental procedures, poor oral hygiene, and cancer-related use as potential risk factors for ONJ.
2006–2010:
- Strengthened Warnings: As more cases of ONJ were reported, Novartis expanded the warning section of Zometa’s prescribing information. This included stronger language emphasizing the importance of preventive dental care and advising against invasive dental procedures during treatment whenever possible.
- Specific Recommendations: By 2007, the label recommended that patients undergo a dental examination prior to starting treatment, with a focus on identifying and addressing pre-existing dental conditions.
2010–2015:
- Black Box Warning Consideration: While Zometa never received a formal “black box warning” for ONJ, the warnings during this period became increasingly detailed. The labeling emphasized the link between high-dose, long-term bisphosphonate use and a higher risk of ONJ.
- Emerging Evidence: New data also suggested that even patients on lower doses for conditions like osteoporosis could develop ONJ, though the risk was lower than in cancer patients.
2015–2020:
- Comprehensive Guidelines: The FDA-approved labeling further refined its recommendations, incorporating guidance for healthcare providers to monitor patients regularly for oral symptoms and stressing the importance of avoiding dental surgery during treatment.
- Focus on Duration of Therapy: As evidence grew about the cumulative risk of bisphosphonates, warnings began to include recommendations for limiting treatment duration in some cases.
ONJ Warning in 2025
In 2025, the prescribing information for Zometa includes specific warnings regarding the risk of osteonecrosis of the jaw (ONJ). The U.S. Food and Drug Administration (FDA) labeling advises healthcare professionals to perform preventive dental examinations before initiating Zometa treatment and to avoid invasive dental procedures during therapy when possible. Patients are also encouraged to maintain good oral hygiene and receive routine dental care to mitigate the risk of developing ONJ.
The American Dental Association tells us that that ONJ typically occurs following tooth extractions or other dentoalveolar surgeries. But they can also develop spontaneously. Patients at increased risk include those receiving antiresorptive agents at dosages and treatment schedules associated with cancer-related indications, those receiving antiresorptive drugs for more than two years, and those with periodontitis or dentures. The ADA recommends that, prior to initiating antiresorptive therapy, patients undergo a thorough oral examination with radiographs and complete any necessary invasive dental procedures.
Zometa Lawsuits – The Theory of These Claims
There were six key allegation in Zometa lawsuits:
Failure to Warn
A core of every Zometa ONJ lawsutit hat was filed was that Novartis failed to provide adequate warnings about the risks associated with the drug, particularly the development of osteonecrosis of the jaw (ONJ). Plaintiffs argued that Novartis had knowledge of these risks based on early research, internal studies, and reports of adverse events. The suits allege the company drove past this information and told doctors and patients nothing. There was a warning but the warnings that were provided, such as those included in package inserts, was argued to be insufficient. The claim was that the company intentionally buried information doctors and patients need in in dense medical language and presented in a way that made them unlikely to be fully understood by anyone.
Negligence
Plaintiffs also accused Novartis of acting negligently in the development, testing, and marketing of Zometa. They claimed that the company failed to take reasonable steps to ensure the safety of the drug before bringing it to market. Additionally, Novartis was alleged to have inadequately monitored the drug’s safety after its release and to have ignored emerging evidence linking Zometa to serious side effects like ONJ. According to plaintiffs, this negligence exposed patients to unnecessary and preventable risks, causing significant harm.
Fraud and Misrepresentation
Another key claim in the lawsuits was that Novartis engaged in fraud and misrepresentation by actively concealing or downplaying the risks associated with Zometa. Plaintiffs pointed to internal documents and communications that, they argued, demonstrated an effort by the company to suppress unfavorable safety data and prevent the publication of studies linking Zometa to ONJ. These actions were portrayed as profit-driven decisions that put profits over people.
Breach of Duty
Zometa OMJ lawsuits further alleged that Novartis breached its duty of care to patients and healthcare providers by failing to act responsibly in addressing known risks. Plaintiffs contended that Novartis prioritized aggressive marketing and sales over transparency, ultimately violating its obligation to protect public health. This breach, according to the claims, directly resulted in the injuries and suffering experienced by the plaintiffs.
Design Defect
Some lawsuits also asserted that Zometa’s design was inherently defective, arguing that its formulation and mechanism of action made the drug unsafe for certain patients. Plaintiffs maintained that safer alternatives or modifications to the drug’s design could have been pursued but were not. By failing to develop or implement these alternatives, Novartis was accused of unnecessarily endangering patients.
Causation and Damages
Plaintiffs claimed that Zometa directly caused their injuries, specifically ONJ, and sought compensation for the resulting physical, emotional, and financial harm. Many described how the drug’s side effects significantly impacted their quality of life, limiting their ability to perform everyday activities. In addition to compensatory damages, plaintiffs sought punitive damages, arguing that Novartis’ conduct was egregious and deserving of further penalties to deter similar actions in the future.
Zometa Litigation History
The Zometa litigation began in the early 2000s, following reports that the drug, manufactured by Novartis Pharmaceuticals, was linked to cases of osteonecrosis. Patients who had been prescribed Zometa for conditions such as osteoporosis, hypercalcemia of malignancy, and bone metastases started experiencing severe jawbone deterioration, prompting lawsuits against Novartis. Again, the central claims in these lawsuits focused on the company’s failure to warn patients and physicians adequately about the risk of ONJ. Plaintiffs argued that Novartis was aware of the risks associated with bisphosphonates, including Zometa, but failed to provide sufficient warnings or take steps to mitigate harm.
As the cases gained momentum, they were consolidated into an MDL. An MDL is sort of like a class action for pre-trial discovery but everyone maintains their own case. Evidence revealed during litigation, including internal company emails, suggested that Novartis may have suppressed unfavorable safety data and delayed efforts to disclose the risks of ONJ. This bolstered the plaintiffs’ claims that the company prioritized profits over patient safety.
Victories at Trial
Zometa plaintiffs scored some wins. In 2010, a jury in New Jersey awarded $8 million to a woman who claimed that Zometa caused her to develop ONJ. There was a $10 million verdict in New York; a $3 million verdictin Montana. In 2011, another jury in New Jersey awarded $285,000 to a man who claimed that the drug caused him to develop the condition. We mention another verdict in more detail below.
In 2012, A jury in New York ruled that Novartis Pharmaceuticals Corp. must pay $10.45 million to a woman who suffered side effects from using their drug Zometa. The jury decided on $450,000 in compensatory damages and $10 million in punitive damages for the plaintiff.
In that case, a plaintiff claimed that the drug caused osteonecrosis (bone death) in her jaw. During the trial, plaintiff pushed the narrative that Novartis was aware of the risk of jaw decay associated with Zometa long before they warned patients. There was reason to believe – there was an internal email from a Novartis marketing executive discussing efforts to prevent the publication of a report linking Zometa to jaw damage.
Zometa Settlement
In 2013, Novartis reached a settlement in the MDL, agreeing to pay $24 million to resolve the majority of the ONJ claims. The settlement included a framework for resolving remaining cases and provided compensation to eligible individuals who have suffered from ONJ as a result of taking Zometa.
Despite the settlement, a number of individual Zometa ONJ lawsuits have continued to be filed in the US. While some of these cases have been dismissed, others have gone to trial, with some resulting in substantial awards for plaintiffs and other were dismissed, settled, or Novartis won at trial.
Story of a Zometa Verdict
A terrific victory was achieved by plaintiff Peggy Stevens of Missouri in her quest to hold Novartis responsible for covering up the dangers of their osteoporosis drug Zometa. Like Fosamax and other bisphosphonate-drugs, Zometa can cause a condition known as osteonecrosis of the jaw, particularly when the patient undergoes invasive dental procedures (tooth extractions, root canals, etc.).
The jury of 12 deliberated for eight hours over two days in the Missoula District Court before concluding that Novartis was responsible for $822,000 in lost income and $2,378,000 in non-economic damages (pain, mental anguish, inconvenience, etc.), for a total verdict of $3.2 million.
Ms. Stevens showed the jury that Novartis hid relevant information and failed to appropriately and reasonably warn patients of the drug’s dangers. The only warning about osteonecrosis of the jaw was given in a 20-fold pamphlet inside the drug’s box, in tiny print. Look at the picture—is this something that should not be front and center? Additionally, internal company e-mails revealed that the company worked to suppress information on the dangers.
Zometa Lawsuits in 2025
We are unaware of any lawyers handling Zometa lawsuits in 2025. We are not.