Antibiotics belonging to the class of drugs called fluoroquinolones have played a big role in fighting infections and saving lives. These are broad-spectrum antibiotics, those that can fight a wide range of types of bacteria. This property makes fluoroquinolones a crucial part of modern medicine and more than 15 percent of all antibiotics used in the world belong to this group.
As important as fluoroquinolones have been, they have also caused some serious problems. While most people tolerate these medications well and experience either mild or no side effects, others have been severely harmed by them. Fluoroquinolones lawsuits have been filed by some of these patients who felt they weren’t adequately warned about the risks of aneurisms, nerve damage, ruptured tendons, and other problems associated with the antibiotics.
What Are Fluoroquinolones?
Fluoroquinolones are synthetic, or laboratory-made, antibiotics, drugs used to kill bacteria and treat infections. These are synthetic drugs, but they derive from natural compounds found in some animals and plants. These natural compounds are called quinolones. The earliest fluoroquinolones came on the market in the U.S. in the 1960s. Currently there are six generic forms of this antibiotic class that are approved for use by the U.S. Food and Drug Administration (FDA): ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.
Other fluoroquinolones developed over the years have been withdrawn from the market because of the potential for serious side effects or for high toxicity. Some of these former antibiotics caused kidney damage and failure, liver failure, and other issues. The fluoroquinolones still in use fight infections by targeting particular enzymes in a broad array of bacteria. In doing so, they prevent the bacterial cells from replicating and creating new cells.
Aneurisms
Most people experience only mild, uncomfortable side effects when taking fluoroquinolones. These include nausea, dizziness, drowsiness, vomiting, diarrhea, headaches, and insomnia. Others will experience much less common, but more serious and life-threatening complications, like aneurisms, nerve damage and tendon damage. It is these that have led to a number of lawsuits against the companies that make and sell fluoroquinolones.
Some of the withdrawn fluoroquinolones caused cardiovascular events, specifically by changing the electrical rhythm of the heart. Those still in use may not have as drastic an effect, but still have been found to increase the risk of certain adverse events, including aneurisms and aortic dissections. Studies have found that the risk is as much as double up to 60 days after taking a course of a fluoroquinolone antibiotic. Dissections and aneurisms are tears and ruptures in blood vessels, which can be sudden and fatal.
Peripheral Neuropathy
Another big risk with taking fluoroquinolones is the potential for serious nerve damage. The FDA warned about a condition called peripheral neuropathy, which may be caused by taking these antibiotics. All fluoroquinolones now have to carry a warning about this nerve damage, but only many years after they were already on the market. Some patients who had nerve damage feel that the drug manufacturers should have known about and warned against the risk.
The labels for the drugs did include nerve damage as a possible adverse event, but as evidence about how serious the damage could be mounted, the FDA finally decided the warning was not strong enough. Some patients on these drugs have experienced disabling damage along with symptoms like tingling, burning, pain, and numbness in arms and legs.
Tendon Damage
Finally, damage to tendons has also been reported with fluoroquinolones and is yet another reason people are filing lawsuits. The drugs have caused instances of tendinitis, an inflammation in the tendons, and even tendon ruptures. A tendon is a type of connective tissue and it is thought that fluoroquinolones may cause the breakdown of the collagen that makes up its structure.
The FDA has required that labels for fluoroquinolones include a black box warning about tendon ruptures and tendinitis. It states that patients over the age of 60, those using steroids, and those with organ transplants are at greatest risk. Many people experienced tendon damage before this warning went into place on labels and are suing because of it.
Levaquin Class Action Lawsuit and Settlement
Because of the serious harm that some people have experienced from taking fluoroquinolones, many individual and class action lawsuits have been filed against the drug manufacturers. A large class action suit filed against Johnson & Johnson, the makers of brand name antibiotic Levaquin, was settled in 2012.
The main complaint made by the 845 plaintiffs given settlement compensation was that the drug company failed to warn patients of the risks of tendon damage. The amount of the settlement wasn’t disclosed, but the company still faced thousands more cases based on tendon damage. In spite of the settlement the company did not admit to any wrong doing or failure to warn.
Peripheral Neuropathy Lawsuits
Tendon damage has been a major reason for lawsuits against makers of fluoroquinolones, but there have also been individual cases brought by people who suffered nerve damage. One case is against Bayer and their antibiotic Avelox. A plaintiff claimed that she developed neuropathy as a direct result of taking Avelox and that Bayer did not provide adequate warning about the possibility of nerve damage.
In another fluoroquinolones lawsuit, a woman used Levaquin and experienced neuropathy. In her suit she accuses Johnson & Johnson not only failed to warn patients of the risks, but also knowingly marketed and sold a drug known to carry these serious risks. The plaintiff is seeking punitive damages against Johnson & Johnson.
In addition to the cases against Bayer and Johnson & Johnson for Levaquin and Avelox, lawsuits have also been filed against several other brand name fluoroquinolones: Factive, Cipro, Floxin, Maxaquin, Raxar, Noroxin, Proquin, and Zagam. If you have taken any of these antibiotics and experienced serious and severe complications, you may have a case to make and you may be entitled to compensation. Let a lawyer guide you and help you decide what your options are, what steps to take, and how to proceed in filing a lawsuit.
Sources
- http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/?_r=0
- http://www.webmd.com/brain/news/20130826/fda-strengthens-fluoroquinolone-warning
- http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm
- http://www.bloomberg.com/news/articles/2012-11-01/johnson-johnson-reaches-settlement-in-845-levaquin-cases
- https://dockets.justia.com/docket/california/candce/3:2014cv03680/279929
- https://docs.justia.com/cases/federal/district-courts/maryland/mddce/1:2015cv01082/313254/64