Xolair is a drug made by Genentech and marketed in the U.S. by Novartis Pharmaceuticals used for the treatment of certain allergic conditions, including asthma. The U.S. Food and Drug Administration (FDA) approved it for treating asthma in 2003 and in 2014 expanded toe approval to include the treatment of chronic hives. It is typically only used in cases that are severe or in patients whose symptoms don’t respond to other treatments.
Since Xolair has been in use, Genentech and Novartis have come under fire for unethical and possibly illegal actions that put patients using the drug at risk. Severe allergic reactions, heart attack, stroke, and other serious complications are possible for people using Xolair and plaintiffs against the drug companies claim that the risks were downplayed or hidden in the marketing of it. Lawsuits are ongoing and those who were hurt by Xolair hope to recover damages.
Xolair for Allergies
The generic drug that makes up Xolair is called omalizumab and it was created, developed, and tested by Genentech. It is given to patients who have severe allergic asthma as an injection and is meant to be used in those whose asthma can’t be controlled with other medications. Ten years after its first approval the FDA decided Xolair could also be used to treat a condition called chronic idiopathic urticarial, essentially chronic hives that don’t respond to typical antihistamines.
Omalizumab is an antibody, which is a type of protein that immune system cells make to bind to target substances. Antibodies typically bind to invaders like viruses so that the immune system can attack and destroy them. When someone has an allergy, the immune system mistakenly attacks something harmless, like pollen. Omalizumab attacks the antibodies that attack these harmless allergens, thereby preventing the allergic reaction.
Complications of Xolair Spur Lawsuits
While for most people this can be a life saver, for others the complications from using Xolair have been serious and devastating. Although rare, it has been found that some people will have a severe allergic reaction to omalizumab. This reaction is called anaphylaxis and it is life-threatening. It causes the throat and mouth to swell up and makes breathing impossible. Emergency treatment is needed, otherwise this reaction can soon become fatal.
This is just one of the reasons that some plaintiffs have filed lawsuits against Genentech and Novartis. They did not expect to have a severe reaction to the medication that was supposed to be treating their allergies. The FDA only required that the companies put a black box warning about anaphylaxis on Xolair’s label in 2007, four years after it was already in use. Those who suffered from a severe reaction feel that they should have been warned sooner.
Two other possible complications that can come with using Xolair are having a heart attack or a stroke. The FDA only issued a warning about these risks in 2009. In this warning the FDA stated that there may be an increased risk of a heart attack or stroke, according to ongoing research. The agency also did not make a move to change labeling of the drug, but said that there was a need for more study. It wasn’t until 2014, which was more than ten years after Xolair came on the market that the FDA required that the label be changed to warn about this risk.
A Whistleblower Lawsuit
The risks associated with using Xolair may not be common, but they are deadly serious. A patient using Xolair who doesn’t understand those risks could potentially die from anaphylaxis, from a heart attack, or after suffering a stroke. Some people believe that these risks were not understood by patients, but that they should have been. One whistleblower even came forward and indicated that Genentech and Novartis had engaged in shady marketing practice to push Xolair towards bigger sales while leaving patients in the dark.
Although there have been others against Xolair, Genentech and Novartis, this whistleblower lawsuit has gotten the most attention. In fact there were three whistleblowers, all employees at Novartis who claimed that the company committed fraud, provided kickbacks to doctors to use Xolair, and marketed the drug unethically.
One whistleblower also claimed that Novartis was pushing the FDA to approve Xolair for much wider use. Instead of reserving it for severe cases of asthma, the company wanted to sell Xolair to people with even mild asthma that could be treated with another medication. This is while knowing that there are serious risks of complications associated with Xolair. When Novartis didn’t get its way, the whistleblower stated, it marketed the drug off-label, for non-approved uses, which is illegal.
Sales reps at Novartis were supposedly told to push doctors to prescribe Xolair to patients with just mild asthma and even to those with allergies not related to asthma at all. They gave doctors and medical centers gifts, free medical equipment, and other types of kickbacks to help push them into using Xolair for more patients and even for children under 12.
The accusation of fraud against Novartis also came from the whistleblowers who claimed that the sales reps also pushed doctors and hospitals to upcode Xolair. This meant that they could charge government programs like Medicare and Medicaid more money for the medication. The whistleblowers started a lawsuit against Novartis and Genentech, but unfortunately the judge had no choice but to dismiss it, citing lack of evidence even though he believed the companies probably did commit fraud and engaged in illegal, off-label marketing.
Because the whistleblower lawsuit was thrown out does not mean that future cases can’t be made against Genentech and Novartis. The companies clearly engaged in some unethical practices, and possibly even committed fraud. For patients, the consequences of all this action have potentially been severe and life-threatening. It may be that Novartis actively promoted a drug that can be harmful for unapproved uses, putting many more patients at risk of dying from anaphylaxis or suffering from a heart attack or stroke. If you think you have a case to make against Xolair, let a lawyer help guide your next steps.