Any drug manufacturing involves research and trials of many years. After successful trials, a drug needs to get FDA approval before it can market its products out for patients. Even though many stringent rules and regulations are installed before drug approval, many reported drugs are causing severe health concerns. Instead of treating the primary issues, the drugs intensify the complications making the patients sicker and sicker. For example, Prolia is also a drug reported to have aggravated bone composition instead of improving it. Henceforth, a class action lawsuit against Prolia was filed to demand compensation.
Prolia-Use and Risks
Prolia, also known by the medical name denosumab, is a drug used to treat osteoporosis, bone loss, and tumors of bone. Prolia is marketed by a company named Amgen. Prolia was first sold in 2010 as an osteoporosis therapy. Also, it was the first time that FDA approved treatment medication for postmenopausal osteoporosis. However, since the initial days, it is related to a higher incidence of bone fractures.
Prolia is not recommended for persons who have low calcium levels in their blood. Joint and muscular discomfort in the arms and legs are the most common side effects. It lowers the incidence of fractures in postmenopausal osteoporosis patients, but it raises the risk of infection. Nevertheless, according to a 2013 study, it is a suitable treatment for this illness.
It’s not recommended for patients with hypocalcemia, and adequate calcium and vitamin D levels must be achieved before starting denosumab treatment. In addition, the medications fail to provide detailed information on interaction effects. Prolia works by reducing the hormonal activity that causes bone removal. This helps in retaining the bone mass and density in the body under healthy numbers. However, Prolia is active in the body for only six months. Over time, it has been noticed that Prolia causes distortion and disfigurement of jawbones known as ONJ( Osteonecrosis of Jaw). But, after six months, the effects fade away, and hence, dental procedures should be avoided during these six months.
Research and data have shown that the osteoporosis medicine Prolia’s adverse effects may raise the occurrence of multiple bone fractures like hip fractures, femur fractures, and other bone fractures, often occurring after minor trauma. Hence, this resulted in a class action lawsuit against Prolia
Causes of class action lawsuit against Prolia
The Prolia bone fracture warning letter, released in 2012 by Health Canada and Amgen, intends to alert Canadian patients about the increased risk of atypical femur fractures. The fractures could occur with little or no trauma to the thigh bone. This was seen as high risk and damaging medication contradictory to its claim. Damaging the thickest, largest, and strongest bones in the human body imply that other bones were at susceptible higher risk of irreversible damage.
Amgen issued a similar warning in Europe. Surprisingly, the same medication was sold in the US without any notice. Although the drug sold in other countries was the same, the warning intentions were not the same and elevated the misconduct on Amgen’sAmgen’s part. Over the years, Prolia was linked to multiple bone damaging effects similar to its counterpart Fosamax. Although the results were not as harmful, they were still considerably concerning. Prolia was added to Public Citizen’sCitizen’s list of medications to avoid in 2013, and the drug was labeled ”Do Not Use”. Prolia magnified the risk of hip fractures, femur fractures, and other bone disorders by multi-folds; it also raised concerns about infections and dermatologic side effects.
Despite the concerns, Amgen downplayed the side effects of earning profits from drug sales with the meager competition. Ironically, Prolia caused alarming damages to patients that the drug was initially created to prevent. This gave rise to more and more people filing in for class action lawsuits against Prolia.
What are class action lawsuits?
A class action lawsuit is a lawsuit brought by a group of people against a single defendant. It’sIt’s intended for cases in which multiple people have been injured in the same way due to the defendant’s defendants activities. When the damages claimed by each plaintiff—the person alleging wrongdoing—are too tiny for individual claims to be worthwhile, class action lawsuits are suitable.
Government bodies, financial institutions, manufacturers, retailers, and employers are frequently the targets of class action lawsuits. Many of them are based on faulty products, misleading advertising, discrimination, or unfair labor practices.
One or more “lead” plaintiffs represent a group or class of litigants. The lead plaintiffs’ injuries and allegations must be comparable to those of the rest of the class members.
Before a class action lawsuit may be filed, a court must certify the class. A lead plaintiff must show that the plaintiffs have a viable claim against the defendant and that all class members have identical claims. The lead plaintiff must also demonstrate that the lawsuit can appropriately represent all members of the group—all with the help of legal advice, of course.
The majority of class action lawsuits are settled outside of the courtroom. Each plaintiff receives a percentage of the settlement, which can be in the form of money, a refund, a service like credit monitoring, or anything else.
There are many advantages of filing a class-action lawsuit compared to an individual claim.
- It is a more straightforward way of filing a legal case against a more prominent defendant and compensation rather than no respite.
- Class action provides a controlled number of suits. Individual claims pointing to a single entity would cause a delay in judgment that might have a similar or identical verdict.
- The cost of litigation comes down considerably,
- The defendants are pressured to respond and compensate due to the high number of plaintiffs challenging the defendant’s defendants position.
Prolia caused fatal complications in many patients especially esophageal cancer, ONJ, and frequent bone fractures. Initially, it was projected as a safe treatment despite shown reports concerning health deterioration caused by the medication. To profit from the sales and drive a hidden warning marketing strategy brought more trouble to osteoporosis patients than without the medication.