Symbicort Lawsuits – Outlook and Updates

What is Symbicort?

Symbicort is a medication composed of Budesonide (a corticosteroid) and Formoterol (a bronchodilator). These medications are inhaled and are used to control the symptoms of Asthma and COPD.

What are Symbicort’s side effects?

Common side effects of using Symbicort include headaches, nausea and sore throat. In rare cases patients may experience sudden worsening of their breathing immediately after use. If your breathing worsens after taking Symbicort, you should seek medical help.

Have there been any class action lawsuits against Symbicort?

Symbicort has been at the center of multiple lawsuits in recent years. Lawsuits have emerged both from the side effects of using Symbicort and from issues related to its manufacturing and marketing.

In a significant development, Viatris Inc., a global healthcare company, along with Kindeva Drug Delivery L.P., won a court decision that invalidated AstraZeneca’s Symbicort patent, U.S. Patent No. 10,166,247. The district court determined that the patent was invalid due to a lack of written description and lack of enablement​​. This decision marks the fourth Symbicort patent found either not infringed or invalid. Earlier in May, Viatris and Kindeva had won an appeal leading to AstraZeneca stipulating that the companies’ budesonide/formoterol fumarate dihydrate products would not infringe U.S. Patent Nos. 7,759,328, 8,143,239, and 8,575,137​.

As a result of this court decision, Viatris, via its subsidiary Mylan Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Breyna™, the first approved generic version of AstraZeneca’s Symbicort​. This will likely increase access to this important medication for many American patients.

However, it is important to note that AstraZeneca has filed a new complaint asserting infringement of a fifth Symbicort patent, which shares the same specification and named inventors as the previously mentioned patents. A trial on U.S. Patent No. 11,311,558 is currently scheduled for December 13, 2022​.

In another legal arena, a former AstraZeneca employee, Suzanne Ivie, was awarded $2.4 million in a federal whistleblower lawsuit. She was fired after revealing inside information about the company’s alleged illegal advertising of drugs for unapproved uses, including Symbicort. Ivie claimed her whistleblower rights were violated, her authority in the company reduced, and bonuses slashed, leading ultimately to her termination​.

AstraZeneca disputed these claims, stating there was no criminal activity and that Ivie was fired for failing to perform her work duties adequately​²​. In a recent trial, the jury found that Ivie made a good faith effort to report suspected criminal activity and faced illegal retribution for doing so. However, the jury did not agree with Ivie’s claim that the company’s marketing practices were actually illegal. It also did not agree that she was the victim of ageism​.

Finally, In another series of lawsuits, patients who suffered a heart attack, stroke or other cardiovascular event within the first 30 days of initiating treatment with Symbicort have filed legal actions. A study published in JAMA Internal Medicine in January 2018 revealed that patients who started using certain long-acting inhalers, including LABAs such as formoterol, a component of Symbicort, were more likely to experience serious cardiovascular events within the first 30 days of treatment initiation​.

Pharmaceutical companies have a legal duty to warn patients about the risks and side effects associated with their medications. By filing a Symbicort lawsuit, individuals who may have been injured by this drug, and their surviving family members, could potentially obtain compensation for physical, financial, and emotional damages associated with their injury, such as medical bills, lost wages, emotional distress, disability, and more​.

More information about Symbicort

Please visit these sites for more information about Budesonide Formoterol.

• MySymbicort.com – official website
• Budesonide Formoterol – Wikipedia entry
• Web MD – Symbicort