Makers of the asthma drug Xolair received an FDA safety warning that the medication may increase the risk of heart and blood vessel problems including deadly blood clots in the lungs. Lawyers are evaluating the potential for lawsuits.
Xolair is a popular asthma drug manufactured and marketed by Genentech Inc. and Novartis Pharmaceuticals Corp. It is consistently one of the highest grossing drugs in the U.S. and in 2013 it made over $820 million. But, current medical studies link the medication to some potentially life-threatening complications, leading to lawsuits.
Litigation related to the marketing of Xolair (omalizumab) dates back to 2009 but was re-started in 2014 after a long hiatus after the U.S. Food and Drug Administration (FDA) issued a warning that Xolair may cause an increase in problems of the heart and blood vessels leading to the brain.
Attorneys are currently evaluating the potential for Xolair lawsuits on behalf of patients who suffered: pulmonary hypertension, deep-vein thrombosis and heart issues after taking the asthma drug.
One of the most recent lawsuits filed in U.S. District Court of Massachusetts, brought by a whistleblower against Novartis Pharmaceuticals Corp. and Genentech Inc., accused the defendants of fraud, improperly marketing the medication and providing kickbacks to sell the drug.
Three former Novartis employees filed whistleblower claims against the company. In her filing, Allison Kelly said that Novartis had hoped that Xolair would garner approval from the FDA for “much wider use, including the treatment of mild asthma.” The other plaintiffs are Frank Garcia and Stephen Fauci.
After it received a more narrow approval, Novartis marketed the medication in an “off-label” way, according to the lawsuit. That is, it promoted its use for purposes other than what the FDA said was OK. The intent of the marketing was to broaden the pool of patients who could use – and pay for – Xolair.
Novartis reps told doctors, pharmacists and other health care providers that the medication gave relief to people battling mild asthma, to allergic asthma patients and to people who have allergic reactions not related to asthma, "like 'peanut allergy,'" according to the lawsuit. Reps also gave gifts, free medical equipment, free services and financial kickbacks to health care providers.
Although Xolair is not approved for use in children younger than 12, plaintiffs said Novartis and Genentech instructed their sales reps to encourage the drug's use in children.
These tactics worked. Xolair generated about $2 billion in sales from 2003-08, and the drug continues to generate hundreds of millions of dollars in annual revenue.
In addition to these claims, the plaintiffs say that Norvartis “induced” doctors and hospitals to upcode for distributing Xolair, allowing the providers to collect high payments from the federal government through Medicare, Medicaid, Tricare and the Veterans Administration.
In March 2015, the lawsuit was dismissed by U.S. District Judge William G. Young. According to Young, there was not enough evidence to charge defendants with fraud.
"Kelly’s allegations suggest that fraud was probable," Young said in court documents. "But the factual and statistical evidence resulting from the information she gives in support of these allegations . . . is not sufficient to strengthen the inference of fraud beyond possibility."
Warnings and Non-Warnings about Xolair
Product liability lawyers are reviewing cases for potential Xolair lawsuits. If you or a loved one took Xolair and suffered from pulmonary hypertension, deep vein thrombosis, mini-stroke, heart attack or any other injury it is important to contact a lawyer immediately.
The main claim is that Genentech knew about the serious risks associated with Xolair but did not provide enough warnings, which put all of the uses at risk.
Lawyers feel that Genentech seems to have placed their desire for profits in front of consumer safety. Similar product liability lawsuits against other drugmakers accuse drug companies of:
- Failure to warn
- Manufacturing a faulty product
New studies also cannot rule out the link between Xolair and an increased risk of certain cancers. The FDA required the new label to include information about the asthma drug and cancer.