Fluoroquinolone Antibiotics: Levaquin
Commonly asked questions about Levaquin:
- What is Levaquin?
- Is nerve damage or peripheral neuropathy a side effect of Levaquin?
- Does Levaquin cause aortic aneurysms?
- What is important Levaquin lawsuit information?
- Is there important information regarding a Levaquin multidistrict litigation?
- Will Levaquin face a recall from the FDA or Johnson & Johnson?
- What is the first step I need to take to start a Levaquin lawsuit claim?
Levaquin (levofloxacin) is a member of antibiotic drug class known as fluoroquinolones. The drug was developed by Johnson & Johnson subsidiary Janssen Pharmaceutica and received approval from the U.S. Food and Drug Administration in 1996 as a drug to combat a large range of bacterial infections.
However, following suit with other fluoroquinolones, studies conducted over the next decade discovered that Levaquin use was frequently associated with the development of several health complications ranging from aortic aneurysms to peripheral neuropathy.
These side effects have become so prominent that medical professionals have begun treating Levaquin as a last resort drug – only using it on patients who have exhausted all other medical options and are in dire need. However, while the medical community has adjusted their view of Levaquin, Johnson & Johnson still stands by their drug and refuses to admit that the negative side effects of Levaquin use may frequently outweigh the benefits.
Of the various health complications that have been associated with Levaquin use over the last decade, nerve damage and peripheral neuropathy have been the most frequently reported and studied.
While initial warnings regarding overall fluoroquinolone use and nerve damage covered only minor ailments, recent years have seen warnings issued regarding the possibility of fluoroquinolone users developing crippling nerve complications.
In fact, reports detailing the devastating effect of fluoroquinolones on users nervous system have become so prominent since Levaquin’s release in 2004 that the FDA has taken multiple explicit actions solely to warn the public of these dangers. One of these actions came in 2013 with the FDA issuing a label requirement regarding all fluoroquinolone drugs – including Levaquin.
The FDA label requirement ensured that all future Levaquin containers would be outfitted with information detailing the severity and fast acting nature of permanent nerve damage, including peripheral neuropathy, regardless of the drug dosage amount.
However, multiple studies and consumer reports of widespread Levaquin nerve damage led to a 2016 FDA Drug Safety Communication. The communication issued a warning that “fluoroquinolones should be reserved for those who do not have alternative treatment options.”
The communication marked the first time the FDA had formally acknowledged that the side effects of Levaquin and other fluoroquinolones far outweigh the benefits in many of their situations of use.
These FDA warnings came following the publishing of major studies indicating that Levaquin and other fluoroquinolones posed an unnecessary danger to many of the patients who used them.
These studies have been prominent since 1995 when the Swedish Adverse Drug Reactions Advisory Committee conducted a study in which a majority of subjects suffered from nerve complications while using fluoroquinolones. Studies conducted by prominent medical entities continue to publish results, some of these published studies include:
- Neurology: The Official Journal of the American Academy of Neurology (2014)
- Sage Journals: Annals of Pharmacotherapy (2001)
- Annals Of Epidemiology: The Official Journal of the American College of Epidemiology (2014)
While exact data differed, every study was able to report a notable peripheral nueropathy risk increase in Levaquin users. In most studies, published data indicated an increased risk factor of nearly two times the former amount.
While peripheral neuropathy rarely leads to fatalities, the nerve complication poses a major quality of life challenge regardless of the conditions stage of development as Levaquin triggered nerve damage can often persist for years even after drug use has been halted.
The symptoms of these persistent complications include:
- Burning Throughout Body
- Sharp/Shooting Pain Throughout Body
While at first glance these symptoms may not appear to pose a major risk, the longevity and suddenness of the complications are worrying. Some cases have even reported the development of these symptoms overnight after less than five instances of Levaquin use.
Those suffering from peripheral neuropathy or other Levaquin related nerve complications often report that they are unable to take part in exercise, social, or work activities because of the debilitating pain that follows. With thousands of consumers prescribed Levaquin every year, the high development rate of nerve complications in Levaquin users suggest that this dangerous drug could lead to thousands of people developing this crippling side effect every year.
While multiple studies have reported findings indicating an increasingly prominent correlation between Levaquin use and aortic aneurysms, the FDA has yet to take any actions regarding Levaquin triggered aortic aneurysms.
Two studies that are frequently used by medical professionals when discussing the possibility of aortic complications in Levaquin users were published in 2015. While each study was conducted independently of each other and in different countries, they both reported strikingly similar results.
The first of these studies was conducted by a team of medical researchers based at the National Taiwan University Hospital and published in the November 2015 issue of the JAMA Internal Medicine Journal.
The study involved pairing each of the 1,477 selection aortic aneurysm victims with 100 control cases to analyze the factors and rates involved with Levaquin and other fluoroquinolone use as opposed to non-drug use.
To qualify for the study instances of aortic aneurysms had to have occurred between 2000 and 2011 with the loosest requirement in defining a fluoroquinolone related aortic aneurysm being “having a fluoroquinolone prescription filled for 3 or more days anytime during the 1-year period before the aortic aneurysm or dissection.”
When the study concluded, it reported that the fluoroquinolone users faced a rate of aortic aneurysms over two times greater than non-users. It must be noted that along with the published data, the researchers explicitly indicated that the study “cannot establish cause and effect.”
However, the study was also explicit in identifying the issue that “it is not likely that more detailed information on a larger population at relatively high-risk of aortic aneurysm or dissection will be available in the immediate future.”
The second major study was published in The BMJ in their November 2015 publication.
Similar to the JAMA study, The BMJ study reported a significant aortic aneurysm risk increase in Levaquin users. However, unlike the JAMA study which reported a risk increase of 200%, The BMJ study reported a risk increase of nearly 300% in drug users.
The aortic aneurysm occurrence rate for the control group was .13 per 100 people while the rate for the fluoroquinolone user group was .35 per 100 people .
While the risk of developing an aortic aneurysm even when taking Levaquin may by minute, the substantial risk increase the drug carries and the dangerous nature of the complication still poses a major drug safety risk.
Aortic aneurysms are incredibly dangerous regardless of their stage of discovery, although much of the time they are discovered after a rupture has occurred. Aortic aneurysms find the cause of their danger in the aortas role as the largest artery in the human body.
The aorta is not only the largest artery in the human body, but it is responsible from pumping blood from the heart all throughout the lower body.
Levaquin aortic complication can take two different forms, each extremely deadly if preventative measures are not taken. The first of these conditions is known as an aortic dissection.
An aortic dissection is characterized by the weakening of the aortic wall. However, unlike an aneurysm, this complication involves the weak wall immediately tearing. Once the tear is made, blood will rush through it, separate the aortic layers, and eventually lead to an aortic outer wall rupture.
The other more common aortic condition associated with Levaquin use is an aortic aneurysm. Unlike a dissection, while the aortic wall weakens, it does not break until a bulging aneurysm has developed within the artery.
The aneurysm stretches out the already weak aortic wall and continues to do so until the walls are unable to take the pressure and rupture.
Once the aortic wall ruptures, an aortic aneurysms follows the same process as an aortic dissection. It also has the same grim outlook in which the internal bleeding is incredibly difficult to stop once it has begun.
Another feature that an aortic aneurysm shares with a dissection is the difficulty in pre-rupture detection. Both conditions can have no symptoms whatsoever until they rupture or in other cases they will carry symptoms that don’t indicate a serious threat to medical professionals.
In regards to fatality risk, an aortic complication poses the most dangerous side effect that has been reportedly associated with Levaquin use. The high mortality rate of these conditions is why the marginal risk of development that Levaquin carries is a cause for major concern from consumers and medical professionals.
News coming in the form of medical studies, FDA resources, and victim claims has led to a constant stream of information being disclosed to the public regarding Levaquin. A vast majority of this information has been on the topic of Levaquin’s relationship with the development of severe nerve damage that can oftentimes result in peripheral neuropathy.
With consumers suddenly well informed of Levaquins dangers, many are beginning to realize that they may have been victims of a Levaquin side effect. This self awareness has led to victims coming forward in the hopes of seeking justice against Johnson & Johnson and subsidiary Janssen Pharmaceutica.
The most common method of this pursuit of justice has come in the form of dangerous drug lawsuits naming the manufacturers as responsible for exposing their consumers to severe health risks.
Levaquin lawsuits were first filed in large numbers beginning in 2015. The lawsuits filed against the drug manufacturer had wide ranging allegations and quickly gained prominence in the pharmaceutical news circuit with several outlets picking up the stories.
Johnson & Johnson continues to defend their drug under the claim that any negative side effects that are associated with use is greatly outweighed by its health benefits.
All Levaquin victims should also be aware of the controversial 2015 decision to create a fluoroquinolone multidistrict litigation (MDL).
While the creation of an MDL is typically perceived as a good sign for dangerous drug lawsuit defendants, this instance differed as defendants were unhappy that lawsuits against different companies over different drug brands were being consolidated and treated as uniform.
While uncommon for an MDL to incorporate lawsuits against different plaintiffs, the similar nature of allegations and composition of all fluoroquinolone drugs was seen as a suitable basis for consolidation.
Before attempting to file a lawsuit against Johnson & Johnson, all potential defendants should be aware of the rigid set of criteria associated with filing a Levaquin lawsuit.
The criteria that all Levaquin users must satisfy to be deemed eligible to file a lawsuit as a dangerous drug victim includes:
- Drug Usage Between 2002 And 2013
- Latency Of 90 Days Or Less
- User Subjected To Peripheral Neuropathy Or Related Symptoms
- User Had No Prior Peripheral Neuropathy Or Diabetic History
- Levaquin Not Used For Serious Infection (MRSA, etc.)
- Levaquin Was First Prescribed Choice
- User Had No Antibiotic Allergies
- No Established Confounders (HIV, Alcoholism, etc.)
A Levaquin user cannot self-review their eligibility as this process must be done by a qualified Levaquin dangerous drug attorney. Once a user contacts an attorney, the process to confirm their eligibility under the criteria guidelines will begin.
Eligibility is determined by executing a thorough investigation of a users medical records to determine where the drug use and health complication development falls into their overall medical history. These investigations are handled by medical professionals who report directly to the attorney as to whether medical records meet the necessary requirements for lawsuit filing.
In addition to the criteria list, a medical record examination also seeks to determine if the drug complication occurred within the necessary state deadlines.
Missing state deadlines is among the most common reason a dangerous drug victim is unable to pursue a compensatory settlement, so beginning your process immediately is very important.
Consumers who were prescribed Levaquin and subjected to major undisclosed health risks will always have the ability to investigate their eligibility to file a lawsuit. However, for a wide variety of reasons, victims often do not come forward to pursue justice against a neglectful drug manufacturer.
The varying reasons that are cited cover fears ranging from further financial ruin to being unable to focus on their personal health recovery. With our legal team being driven by our clients best interests, it has become our goal to quell as many victim fears as possible. After discussion within our legal team, we have determined what we believe to be the top reasons for all potential Levaquin victims to come forward and file a lawsuit.
1. Johnson & Johnson Was Neglectful With Levaquin: With studies and FDA reports reporting connections between Levaquin and various health complications, allegations that Johnson & Johnson either hid information regarding or failed to test Levaquin health risks are growing. This neglect has led to thousands of consumers to be unnecessarily subjected to health complications.
2. No-Fee Guarantee: Too many victims never come forward because they worry that an unsuccessful lawsuit could result in further ruin of their finances. Victims should never let those fears get in the way of seeking justice, so our legal team guarantees all our clients that they will never be charged any fee unless they win a financial settlement.
3. Disastrous Levaquin Health Effects On Victims: No matter the health complication suffered, victims of Levaquin health complications must face physical, emotional, and mental pain as they fight for their recovery. A Levaquin settlement will not heal these injuries but it gives our clients the ability to focus on their recovery without needing to worry about deteriorating financial abilities.
4. Ability To Recover Financial Compensation: Levaquin health complication recovery is often an expensive endeavor. Proper recovery may require hospital stays, medication, and missing of work among other costs. A settlement can offset all these costs for our clients, you shouldn’t need to pay for the neglect of a drug manufacturer.
5. Skill Of Legal Network: Our legal network has developed the skills over 50 years of filing dangerous drug lawsuits to ease the burden levied on our clients. Our clients don’t need to worry about being unable to sacrifice the time and effort needed to file a lawsuit because our legal team handles the process every step of the way.
With most Levaquin lawsuits being filed in mass numbers only in the last year, there have been no reported settlements publicly offered or issued as of this post – June 2016.
Lawsuits against Johnson & Johnson alleging that they acted neglectfully in Levaquin’s development and distribution are currently not taking part in active trials. With an uncertain timetable regarding when lawsuits may go to trial, it is difficult to determine when settlement offers may be fielded.
However, when looking to settlements regarding drugs of a similar magnitude, legal experts may not be able to accurately predict concrete settlement figures but they have been able to identify what settlement offers would likely provide compensation for:
- Pain And Suffering
- Psycological Damage
- Medical Expenses
- Lost Wages
With experts unable to predict when cases may go to trial or when settlements may be issued, it is recommended that potential Levaquin lawsuit plaintiffs begin the legal process as soon as possible to avoid any issues in receiving a future settlement.
With class action lawsuits against major corporations often comprising the main legal news that reaches the vast majority of the public, dangerous drug victims are often surprised to learn that a dangerous drug class action is a rare occurrence.
For this reason, a class action lawsuit regarding Levaquin allegations has yet to be created as of June 2016 and there are no indications that the creation of one is imminent.
Defendants in Levaquin dangerous drug lawsuits will instead pursue consolidation under multidistrict litigation if it is decided that it provides a greater chance at being awarded a settlement than a standard lawsuit.
As detailed previously in this article, a fluoroquinolone MDL was first created in late 2015 and was met with defendant controversy.
The process of MDL creation was jump-started by a request from major pharmaceutical companies to consolidate all the cases against them under one common legal process. A federal panel reviewed the request and decided in favor of creating the MDL in the hopes that it would provide both defendants and plaintiffs with an equal ability to appropriately execute all legal actions.
The MDL is currently active in the U.S. District Court of the District of Minnesota under the supervision of Chief Justice John R. Tunheim.
When the MDL was first created it only covered 78 cases but the last year has seen its numbers grow to nearly 383 cases. Additionally, it is reported that there may be 40 pending cases that will soon be consolidated under the MDL with more on the way.
While the MDL has not entered the phase of handling active cases, it is currently deciding on whether to enter a trial selection phase of potential bellwether trials.
Fluoroquinolones have been top selling antibiotics for over 50 years but have only seen extensive studies regarding their dangers published in the last two decades. Their prominence in modern medicine in addition to their effectiveness where other antibiotics may fail makes it extremely unlikely that a drug recall will be issued by either able party.
The FDA has issued several severe warnings, even going as far as telling medical professionals to only use Levaquin as a last resort for patients. Currently, it appears that those efforts are as far as the FDA will be willing to go. While it is impossible to determine with certainty, the rare nature of an FDA drug recall as well as the steps already taken means it will likely not happen in the future.
Additionally, Johnson & Johnson continues to stand by their drug with claims that any possible negative side effect of its use is outweighed by the immense positive health benefits. With the company still selling thousands of units a year, there is virtually no chance that Johnson & Johnson will self enforce a drug recall.
The first step in pursuing a Levaquin dangerous drug lawsuit is contacting a qualified Levaquin dangerous drug attorney. This first step can be accomplished by:
- Submitting the Free Case Review Box on this page, or
- Calling (866) 280-3417 any time of day to tell us about your case.
Our attorneys have been filing dangerous drug lawsuits for over 50 years and have gained a reputation for pursuing legal action with only the best interests of their clients in mind.
With an MDL now active and the threat of missing strict state deadlines present, it is recommended that all Levaquin victims contact an attorney immediately to begin the legal process.