The widely used drug fluoroquinolone has recently been the focus of multiple mass tort cases because the manufacturers failed to give proper warnings about the adverse effects of the antibiotic. I want to set the stage for the medical record review, which is crucial to the result of your fluoroquinolone litigation, before getting into the specifics of fluoroquinolone.
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Here in this blog, you will learn more about the fluoroquinolone antibiotic, some of its powerful generic brands, and the legal troubles those medications manufacturers are currently facing.
What antibiotics are fluoroquinolone?
The FDA (Food and Drug Administration) has licensed fluoroquinolone antibiotics to prevent several bacterial illnesses, including
- Gonococcal diseases
- Infections with gastroenteritis
- Infections of the urinary tract
- Infections inside the abdomen and septicemia
- Infections in the bones and joints
- Skin and soft tissue infections.
The FDA additionally suggested using this medicine only for severe problems. Quinolones are strong antibacterial agents having a basic bicyclic ring chemical structure. Fluoroquinolones are generated by adding a fluorine atom at position C-6 and making other replacements to the basic quinolone structure. It comes in over 60 generic versions. Several well-known fluoroquinolone antibiotics consist of
- Avelox (moxifloxacin hydrochloride)
- Maxaquin (lomefloxacin hydrochloride)
- Noroxin (norfloxacin)
- Raxar (grepafloxacin hydrochloride)
- Cipro (ciprofloxacin)
- Proquin XR (ciprofloxacin hydrochloride)
- Zagam (sparfloxacin)
- Factive (gemifloxacin mesylate)
Who discovered fluoroquinolones?
Lesher made modifications to a molecule that was identified in the manufacturing of the antimalarial medication chloroquine in 1962, leading to the discovery of nalidixic acid, the first clinically effective quinolone.
Numerous fluoroquinolones have been formulated for application in human and veterinary medicine over the past 40 years.
Even though more than 10,000 compounds have already been synthesized around the world, only 2% of them have been developed and tested in clinical studies. Moreover, only twenty of these compounds have been officially launched onto the market.
If quinolones are to attain their full potential in the medical world, their future in pharmaceuticals must be handled with extreme care.
How fluoroquinolones work?
The more recent fluoroquinolones constitute significant progress in antimicrobial chemotherapy. They prevent the DNA gyrase enzyme from supercoiling.
DNA gyrase, topoisomerase IV, and type II DNA topoisomerases are a few examples of the enzymes that fluoroquinolones disrupt to function (which are required for the synthesis of bacterial mRNAs and DNA replication).
Why are fluoroquinolones dangerous?
When fluoroquinolones first appeared on the market in the 1980s, doctors were amazed by their capacity to treat a vast spectrum of common and serious infections. Regrettably, reports of dangerous and even life-threatening side effects have grown along with the usage of strong medications.
Fluoroquinolones are only recommended for severe conditions, but patients who tried to take them for minor ailments developed permanent and disabling side effects.
Severe side effects on the hamstrings, muscles, joints, nerves, and central nervous system may occur in the same patient.
How long do the adverse effects of fluoroquinolones last?
The majority of victims (90%) of fluoroquinolone antibiotic side effects are treated non-surgically, with recovery taking an average of one month. For 10% of patients, long-term effects can include pain, a reduced range of motion, and problems with walking.
Fluoroquinolone antibiotics in pregnancy
More studies are required before safety is verified, but quinolones are not linked to poor pregnancy outcomes. It is advised that quinolones not be used as the first-line treatment during the first trimester till then.
Antibiotics were often recommended for pregnant women up to 80% of the time. It’s crucial to know which ones can be used properly because they’re so common. If you’re unsure whether taking an antibiotic while pregnant is safe, be certain to speak with your doctor.
Fluoroquinolones black box warning 2021
Fluoroquinolone manufacturers have been ordered by the US Food and Drug Administration to warn doctors and patients about the increased risk of their drugs.
Drug labels and prescribing information should include the most stringent “black box” warning, and manufacturers must also create a treatment guide for patients.
On July 8, 2008, the FDA stated that these actions would strengthen existing warnings in fluoroquinolone prescribing information. The precautions apply only to systemic tablets, capsules, and injectable formulations, not to the eye and ear drops.
The FDA added a warning about the possibility of developing myasthenia gravis while taking the medication in 2011. This neuromuscular disease results in significant weakness. Two years later, they added a new warning about the significantly increased risk of peripheral neuropathy.
A study published in Neurology in 2014 echoed the FDA’s position on an increased risk of peripheral neuropathy, while a study published in BMJ in 2015 linked the drugs to an increased risk of aortic aneurysm.
As of August 2017, the FDA advises doctors to only use fluoroquinolones for bacterial infections when no safer alternative treatment is available. It is not recommended for sinus infections, chronic bronchitis, or uncomplicated urinary tract infections unless all other options have been exhausted.
Many individuals who have taken fluoroquinolone drugs have encountered adverse effects. Most of these suits claim that the manufacturers knowingly hid information regarding the safety of these drugs from the general population.
The United States Judicial Panel on Multidistrict Litigation ordered in August 2015 that all federal neurological cases be transferred to the District of Minnesota for consolidated pretrial proceedings. The cases were assigned to U.S. District Judge John R. Tunheim by the panel.
Approximately 80 actions were pending in nearly 40 federal districts at the time. Additional cases were pending in state courts in California, Pennsylvania, New Jersey, and Oklahoma (some of which were transferred to the MDL).
In the mass litigation, over 1,260 actions have been filed. According to court documents, several have been settled for undisclosed sums. Only 471 lawsuits remained pending in the MDL as of July 2019.
The FDA recently limited the use of fluoroquinolones to only the most serious bacterial infections because the serious side effects outweighed any potential benefit. As a result, a large number of fluoroquinolone antibiotics lawsuits were filed against its manufacturers.
Fluoroquinolone antibiotics class action lawsuit
The risk for almost any complications or side effects related to a drug’s consumption is also a fact that drug manufacturers are supposed to state very clearly.
Unfortunately, until the U.S. Food and Drug Administration (FDA) amended its safety guidelines and required new labeling, the makers did not alert medical professionals or patients to any potential risks.
The first bellwether trial took place against Ortho-McNeil Pharmaceutical Inc. in November 2010 and tends to result in a jury verdict in favor of the appellant.
The jury awarded the plaintiff $700,000 in compensatory damages, which was later reduced to $630,000. The jury also awarded $1,115 000 in civil penalties.
The second and third bellwether trials were taken place in June 2011 and January 2012, respectively. Jury verdicts in favor of Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc. were obtained in both cases.
The MDL received approximately 2,049 total actions. Hundreds of cases have been settled, according to records. Others were transferred or remanded and later discharged.
As of March 2017, only ten pending cases remained. The MDL was officially closed in July 2017 by the United States Judicial Panel on Multidistrict Litigation.
Top manufacturers with lawsuits
Almost every major pharmaceutical company has at least one fluoroquinolone antibiotic on the market, and many are facing legal action due to potential side effects. They are as follows:
- The Bayer Company
- Bayer Healthcare Pharmaceuticals
- Merck & Co., Inc.
- Johnson & Johnson
- Janssen Research & Development.
Cipro, Levaquin & Avelox lawsuits
Cipro (Ciprofloxacin) by Bayer HealthCare Pharmaceuticals, Inc., Avelox (Moxifloxacin) by Merck & Co., Inc., and Levaquin (Levofloxacin) by Johnson & Johnson are the top fluoroquinolone brands, with numerous lawsuits against them. They were also the most commonly used antibiotics in the United States.
Cipro lawsuits and Cipro lawsuit settlement amounts
December 2010 – An 82-year-old Minnesota man who experienced tendon damage led on by the treatment of a fluoroquinolone antibiotic received $1.8 million in damages from the jury hearing his case.
October 2012 – A settlement was reached in 845 lawsuits involving tendon damage caused by fluoroquinolone antibiotic medications that were filed in federal court in Minneapolis.
May 2013 – Overall, 1,182 of the 1,879 cases in a federal MDL for fluoroquinolone antibiotic cases have been resolved, and 153 are in settlement negotiations. Additionally, there are 1,228 ongoing cases in New Jersey state court, of which 898 are likely to be dismissed as a result of a settlement.
August 2014 – A woman who was prescribed a fluoroquinolone antibiotic filed a lawsuit in California state court, alleging that her nerve damage was a “direct and imminent result” of the prescription medication.
December 2014 – Another product liability lawsuit was filed in California state court on behalf of a woman who took a fluoroquinolone antibiotic and developed peripheral neuropathy.
March 2015 – Approximately 100 fluoroquinolone antibiotic lawsuits were filed in the federal MDL in Minnesota before the U.S. John R. Tunheim, District Judge.
May 2015 – A woman from North Carolina filed a fluoroquinolone antibiotic lawsuit alleging that the prescription drugs failed to warn her about the risk of peripheral neuropathy.
Johnson & Johnson and its subsidiaries, Ortho McNeil-Janssen, lost the first lawsuit filed due to a Levaquin injury in 2010.
Levaquin lawsuits 2016
There was a lawsuit filed against J&J, alleging that the manufacturer intentionally concealed safety information to defraud the public, and a new wave of medical injury lawsuits was expected against the company. Even though no announcements have been made regarding the outcome of these lawsuits or settlement offers, the company has decided to stop producing Levaquin.
A multidistrict litigation lawsuit has been filed for other fluoroquinolones, and legal experts are waiting to see how it will impact the ongoing Levaquin litigation.
December 2014 – Another Avelox peripheral neuropathy case was submitted against Merck & Co. and Bayer Healthcare, Inc., this time in the United States District Court for the District of Columbia by a patient who experienced permanent peripheral neuropathy after using the brand-name antibiotic Avelox.
According to the plaintiff, in 2013, her doctor gave her a prescription for Avelox to be taken over ten days. On the fourth day, she asserted that the drug left her feeling weak and in agony.
April 2015 – Another Avelox peripheral neuropathy case was launched against Merck & Company, Inc. and Bayer Healthcare Pharmaceuticals Inc., this time by a South Carolina woman who claims the well-known fluoroquinolone prescription antibiotic is to blame for her nerve damage.
According to the plaintiff, her doctors allegedly prescribed the quinolone antibiotic drug in 2013 for a seven-day course of treatment. The complaint states, it was at this point that she started experiencing side effects from her antibiotics, including peripheral neuropathy. Even though she no longer takes the prescription drug Avelox (moxifloxacin), lawsuit records show that she still has substantial and long-lasting peripheral nerve damage.
August 2016 – An Oklahoma couple claimed Avelox is defective and causes severe nerve damage. As an outcome, the plaintiffs have filed an Avelox lawsuit against Merck & Company for failing to warn them of the potential dangers and side effects. According to the lawsuit documents, the husband was prescribed Avelox in 2008, which he took under the guidance of his doctor.
March 2017 – Ten bellwether cases involving product liability claims filed by plaintiffs against Avelox pharmaceutical manufacturers were filed. The bellwether cases aided in the consolidation of rulings and provided access to resources for the more than 735 lawsuits currently pending in a quinolone MDL (multidistrict litigation) case on the floor.
Current status of the fluoroquinolones lawsuit
One of the most recent lawsuits was filed against Johnson & Johnson, the manufacturer of Levaquin, on behalf of five patients.
According to their claim, the company purposefully concealed or downplayed the potentially severe side effects and mislabeled and misbranded the drug. Separate claims have made similar allegations, including
- Fluoroquinolone antibiotic manufacturers were negligent in failing to conduct adequate and thorough testing of the drugs before making them available to the public
- The manufacturers failed to warn patients and healthcare providers adequately about the severe complications and side effects associated with fluoroquinolones.
- Cipro®, Levaquin®, and Avelox® manufacturers purposefully marketed their products as safe, concealing the medications’ risks.
Things to know before filing a lawsuit
You need to know the details regarding the manufacturer of the antibiotic drug you consumed before filing a lawsuit.
If you or a loved one has suffered a severe complication after being prescribed and taking a fluoroquinolone antibiotic such as Cipro®, or Avelox®, schedule a complimentary consultation.
Fluoroquinolone lawyers with extensive knowledge and transparent medical records can thoroughly review your claim.
They also assist you in choosing the best strategy to obtain legal compensation for your pain and suffering, as well as for your paid medical costs and lost wages.
You should be aware of LezDo TechMed’s medical record review if you are one of the people who are suffering from side effects from any fluoroquinolone antibiotic. Medical record review helps your attorney extensively analyze your medical records.
As a result, your complaint will be more substantial, and receive better compensation.
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To wind up, I strongly advise you to file a lawsuit against the manufacturer if you’ve been victimized by any antibiotic like fluoroquinolone, because it may help somebody else avoid using such drugs. Follow us on LinkedIn for more updates.