As of August 2017 there have been 755 fluoroquinolone lawsuits pending against Bayer Healthcare Pharmaceutica Inc, Merck & Co Inc., Johnson & Johnson, Janssen Research & Development LLC. The antibiotics categorized as fluoroquinolones are Cipro, Levaquin and Avelox. The lawsuits allege that firms provided insufficient warnings about possible side effects, such as nerve damage, tendon ruptures and aortic aneurysm and dissection.
The FDA has released numerous warnings about the use of Fluoroquinolones:
- Warning for Tendonitis and Tendon Rupture: In July 2008 the FDA notified manufacturers that Fluoroquinolone must include its “most prominent” warning, a black box warning, on product packaging. They also required publication of a Medication Guide for consumers. The FDA stated,“Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy.”
- Upgraded Warnings: The FDA issued upgraded warnings were issued in May and July, 2016. The Agency stated that fluoroquinolones should not be used in cases where alternative treatments were readily available. “Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients.”
- Warnings for Nerve and Muscle Side Effects: The upgraded warnings added muscles, joints, nerves, and the central nervous system as susceptible to suffering side effects. “Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.”
- Update on Aortic Aneurysm and Dissection: In May 2017 the FDA stated that it had not found a link between fluoroquinolines and aortic aneurysms and dissections: “As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection.”
Multidistrict Litigation in Fluoroquinolone Lawsuits
As of June 2017 there have been roughly 260 cases between Bayer or Bayer and Johnson & Johnson impending from the MDL. Fluoroquinolone cases were united with the intention of MDL in August 2015 to simplify and combine the lawsuit procedure.
Bellwether instances are expected to move in 2018 and 2019. Examples from around the state could be united in one courtroom and one Judge in multidistrict litigation so as to unite and simplify regeneration. If the cases aren’t settled or ignored the presiding judge and parties involved might select one or more representatives’ case to litigate. All these “bellwether” instances provide advice to additional plaintiffs about if and how to continue. The plaintiffs allege that “Invokana can cause an Assortment of Accidents, such as diabetic ketoacidosis and kidney impairment, which defendant Janssen Pharmaceuticals, Inc. (Janssen) that developed and fabricated the Medication, failed to adequately test the medicine and warn of its own dangers.”
Fluoroquinolones are a class of antibiotics that are used to treat bacterial infections.