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A growing number of individuals have filed Levaquin lawsuits that allege the manufacturers of the popular fluoroquinolone antibiotic failed to provide adequate warnings about its association with permanent peripheral neuropathy, a type of serious nerve damage that can result in pain, burning, and numbness in the extremities, loss of reflexes, and even paralysis. In 2013, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of Levaquin, Cipro, Avelox and other fluoroquinolones to include stronger warnings about the potential for nerve damage among patients treated with these powerful medications. Plaintiffs who have filed Levaquin peripheral neuropathy claims contend that drug makers were actually aware of this risk for years, but continued to aggressively market fluoroquinolones as safe medications.
Individuals who were prescribed Levaquin or any other brand-name fluoroquinolone drug to treat non-life-threatening conditions, such as sinus infections, ear infections, skin infections, or pneumonia, may be entitled to financial compensation if they were diagnosed with peripheral neuropathy related to its use. Read on to learn more about this growing litigation, and to determine if you might be eligible to file your own Levaquin lawsuit.
BREAKING NEWS ALERT: Bernstein Liebhard LLP Files 13 Levaquin Lawsuits, More Filings Expected
During the first two weeks of August 2016, the nationwide law firm of Bernstein Liebhard LLP filed 13 Levaquin lawsuits in New Jersey federal court. All of the cases involve clients who developed peripheral neuropathy allegedly due to their use of the fluoroquinolone antibiotic. The Firm expects to file at least 10 additional lawsuits in the near future.
Plaintiffs being represented by Bernstein Liebhard claim that Johnson & Johnson and its Janssen Pharmaceuticals unit failed to provide doctors and patients with adequate warnings regarding the serious risks associated with Levaquin. Among other things, the complaints assert that information added to the drug’s label in 2004 wrongly characterized peripheral neuropathy as a rare side effect, and one that could be avoided by discontinuing Levaquin should certain symptoms appear. They also maintain that modifications made to the label in 2013 were “inadequate and confusing.” Read More
Levaquin and Peripheral Neuropathy
Levaquin was approved by the U.S. Food & Drug Administration (FDA) in 1996, and now ranks as the top-selling medication in the fluoroquinolones class. Prior to the introduction of the first generic version in 2011, Levaquin generated over $1.3 billion in annual sales. It and similar antibiotics, such as Cipro and Avelox, are indicated to treat serious bacterial and skin infections, pneumonia, and even the bubonic plague. However, plaintiffs who were allegedly injured by these medications assert that fluoroquinolones are often prescribed for minor infections or even when there is no clear demonstrable need. Studies have linked drugs like Levaquin to a number of major side effects, including tendon damage and a serious eye disorder called retinal detachment.
Suspicions regarding Levaquin and peripheral neuropathy began to grow in 2001, after a study published in the Annals of Pharmacotherapy detailed 45 cases of the condition among people treated with fluoroquinolones. At least 84% of the cases were characterized as “severe,” while more than half persisted for a year or more. In 2004, information about peripheral neuropathy was added to all fluoroquinolone labels, including Levaquin.
In 2013, the FDA requested that the labels for Levaquin and other fluoroquinolones be updated to include clearer warnings about the potential risk of serious nerve damage in patients being treated with the medications. Among other things, the FDA said its review of dozens of adverse event reports had determined that the “potential rapid onset and permanence” of peripheral neuropathy was not adequately described on the current labeling. It also required that statements characterizing peripheral neuropathy as a “rare” occurrence be removed.
According to the Mayo Clinic, symptoms of peripheral neuropathy will vary depending on the nerves affected, and may include:
- Gradual onset of numbness and tingling in feet or hands, which may eventually spread to the legs or arms
- Burning, sharp, or electric-like pain
- Extreme sensitivity to touch, even light touch
- Changes in the skin, hair or nails
- Lack of coordination
- Muscle weakness or paralysis
- Intolerance to heat
- Bowel, bladder or digestive problems
- Changes in blood pressure, causing dizziness or lightheadedness
The FDA advises Levaquin patients to seek medical assistance if they experience any signs or symptoms associated with peripheral neuropathy or serious nerve damage. According to the Mayo Clinic, early diagnosis and treatment of peripheral neuropathy offers the best chance for controlling symptoms and preventing further damage.
In May 2016, the FDA modified the boxed warning for Levaquin and other systemic fluoroquinolones after the agency concluded that the drugs are generally too dangerous for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. Their risks include potentially permanent complications involving the tendons, muscles, joints, nerves and central nervous system that can occur together. Read More
- October 2016: The federal court overseeing hundreds of Levaquin lawsuits and other legal claims involving fluoroquinolone antibiotics and peripheral neuropathy has scheduled a Science Day for January 17, 2017. The event will allow plaintiffs and defendants to bring the Court up to speed on the medical and scientific issues central to the litigation. Read More
- August 2016: A Defendant fact sheet has been approved for use in the federal fluoroquinoline litigation. Such documents are utilized in large, centalized proceedings to standardize discovery, and generally takes the place of written interrogatories. A similar Plaintiff’s’ Fact Sheet was approved by the Court in April 2016. Read More
- August 2016: The federal court overseeing hundreds of peripheral neuropathy lawsuits involving Levaquin and other fluoroquinolone antibiotics has declined to rule on a remand motion filed by a group of California plaintiffs. According to an Order issued in the U.S. District Court, District of Minnesota , the judge presiding over the centralized proceeding deferred his decision until he can review information underlying the plaintiffs’ pleadings against McKesson Corp., a California-based pharmaceutical distributor. Read More
- June 2016: Plaintiffs who have filed cases in the federal fluoroquinolone litigation underway in Minnesota have been granted leave to amend their Master Complaint to reflect the latest FDA label update. According to Minutes from the proceeding’s June 21st Status Conference, the Court found that doing so would not greatly expand the scope of the litigation. Read More
- June 2016: A Florida man has become one of the first plaintiffs in the country to file an aortic aneurysm lawsuit involving the antibiotic Levaquin. He also claims that he developed peripheral neuropathy due to the antibiotic. The case was filed on June 8th in the U.S. District Court, Middle District of Florida. Read More
- May 2016: A Status Conference was convened in the federal fluoroquinolone litigation on May 18th, at which time it was reported that more than 400 peripheral neuropathy lawsuits involving Levaquin, Avelox and Cipro had been filed nationwide. These included 383 cases pending in the U.S District Court, District of Minnesota, and an additional 39 claims that have been filed in the Philadelphia Court of Common Pleas. Minutes from the conference indicate that the Pennsylvania judge overseeing those lawsuits would be interested in coordinating with the federal multidistrict litigation. Read More
- April 2016: An Intitial Case Management Plan issued in the federal multidistrict litigation on April 26th sets forth protocols and limitations for discovery during the early stages of the proceeding. Among other things, the plan require that fact discovery in Levaquin lawsuits be completed by May 31, 2017. Read More
- April 2016: The federal litigation involving Levaquin and other fluoroquinolone antibiotics convened a Status Conference on April 21st, at which time the Court addressed an initial case management plan, the scheduling of Science Day, and matters related to bellwether trials. Nearly 400 cases have been filed in the U.S. District Court, District of Minnesota, on behalf of patients who developed peripheral neuropathy, allegedly due to their use of Levaquin and similar antibiotics. Read More
- February 2016: The federal fluoroquinolone litigation convenes a Status Conference on February 24th. Minutes from the meeting indicate that 425 peripheral neuropathy cases have been filed in the U.S. District Court, District of Minnesota, including 289 involving Johnson & Johnson, the manufacturer of Levaquin; 136 related to Bayer, which markets Avelox and Cipro; and 58 that pertain to both companies. The Court also issues a third Pretrial Order that sets forth procedures for the use of Master Pleadings. Read More
- February 2016: The first Pretrial Order has been issued for the multiditrict litigation established in the U.S. District Court, District of Minnesota, for federally-filed peripheral neuropathy lawsuits involving fluoroquinolone antibiotics. More than 300 cases are now pending proceeding against the manufacturers of Levaqauin, Avelox and Cipro. Read More
- February 2016: A Pennsylvania state court has rejected a motion to have all peripheral neuropathy lawsuit filed in the state against the manufacturers of Levaquin and other name-brand fluoroquinolones centralized in a single mass tort proceeding. Read More
- January 2016: A Levaquin lawsuit filed under the federal RICO act accuses Johnson & Johnson and Janssen Pharmaceuticals of conspiring with other defendants to conceal the drug’s serious side effects for financial gain. Read More
- December 2015: A petition is filed in Pennsylvania to create a mass tort program in the Philadelphia Court of Common Pleas for all fluoroquinolone peripheral neuropathy lawsuits filed in the state. Meanwhile, the federal multidistrict litigation in the District of Minnesota is set to hold its Initial Status Conference in January 2016. Read More
- August 2015: The U.S. Judicial Panel on Multidistrict Litigation (JPML) has centralized all federal fluoroquinolone lawsuits involving peripheral neuropathy in the U.S. District Court, District of Minnesota. Read More
- July 2015: Oral arguments are heard on a motion to transfer all federal product liability lawsuits involving Levaquin and other fluoroquinolones to a single multidistrict litigation. Plaintiffs who favor the proposal assert that hundreds of similar lawsuits will eventually be filed, and argued that consolidation of the docket would reduce duplicative discovery, avoid conflicting pretrial rulings and better serve the convenience of the parties, witnesses and the courts. Read More.
Legal Help for Those Harmed by Levaquin
If you were diagnosed with permanent peripheral neuropathy after treatment with a fluoroquinolone antibiotic, filing a Levaquin lawsuit may enable you to obtain compensation for your injury-related damages, including:
- Medical bills
- Lost wages
- Pain and suffering
- Emotional distress
- Permanent disability
Lawyers around the country are currently providing free legal evaluations to victims of serious nerve damage allegedly associated with Levaquin. If you would like to obtain more information about pursuing a lawsuit, or to determine if you might be eligible to file a case of your own, please call Rx Injury Helpto be put in touch with an attorney today.
Last Modified: November 8, 2016