As of August 2017 there were 755 fluoroquinolone lawsuits pending against Bayer Healthcare Pharmaceuticals Inc, Merck & Co Inc., Johnson & Johnson, Janssen Research & Development LLC. The antibiotics classified as fluoroquinolones are Cipro, Levaquin and Avelox. The lawsuits allege that companies provided inadequate warnings about potential side effects, including 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 August 2017 there are 755 cases pending under Multidistrict Litigation (MDL) (IN RE: Fluoroquinolone Products Liability Litigation – MDL 2642) in federal court in the District of New Jersey. Fluoroquinolone cases were combined for the purpose of MDL in August 2015 to simplify and consolidate the litigation process. As of June 2017 there were approximately 260 cases involving Bayer or Bayer and Johnson & Johnson pending in the MDL.Bellwether cases are expected to proceed in 2018 and 2019.
Cases from around the country may be combined in a single court and judge in multidistrict litigation in order to combine and simplify pretrial discovery. If the cases are not settled or dismissed the presiding judge and parties involved may choose one or more representatives case to litigate. These “bellwether” cases offer guidance to other plaintiffs about if and how to continue.
The plaintiffs allege that “Invokana may cause a variety of injuries, including diabetic ketoacidosis and kidney damage, and that defendant Janssen Pharmaceuticals, Inc. (Janssen) [a subsidiary of Johnson & Johnson], which developed and manufactured the drug, failed to adequately test the drug and warn of its risks.”
Fluoroquinolones are a class of antibiotics that are used to treat bacterial infections.