Fluoroquinolone Antibiotics: Cipro
Below are questions pertaining to Cipro:
- What is Cipro?
- Are aortic aneurysms a side effect of taking Cipro?
- Is nerve damage or peripheral neuropathy related to Cipro use?
- What is important Cipro lawsuit information?
- Has a Cipro multidistrict litigation been created?
- Has the FDA or Bayer AG issued a Cipro drug recall?
- How can I start my Cipro lawsuit claim?
Cipro (ciprofloxacin) is fluoroquinolone class drug manufactured by Bayer AG to combat various types of infections including urinary tract infections. The drug was promoted extensively by the U.S. government in the early 2000’s as a suitable method to combat the effects of anthrax.
An immensely popular drug, Cipro and other drugs in its class are the most popular antibiotics on the market but are often used for unnecessary purposes that expose consumers to dangerous health complications. At it’s peak, Cipro held 62% of the market share for the fluoroquinolone market. Studies have been published beginning in 1995 continuing to this day.
These studies have routinely issued warnings that Cipro should only be used as a last result for the most serious of infections due to the severity of the health complications it can trigger.
These reports has led to Cipro and other fluoroquinolones to be characterized as “big guns” with “the bigger the gun you use, the more damage you can expect as collateral.”
While the U.S. Food and Drug Administration has not issued any information, findings, or warnings regarding a connection between aortic aneurysms and Cipro use, multiple studies have reported findings that heavily suggest a connection.
Two of the most well known and respected studies regarding this issue were published in 2015. Both of these findings reported that Cipro subjects users to a significant increased risk of aortic aneurysms – although the overall risk may still by minimal.
One of the studies published in JAMA Internal Medicine, broke down data from 1,477 patients who reported aortic aneurysms and matched them up with 100 control cases for study.
Their study revealed that those who were prescribed fluoroquinolone carried a risk for aortic aneurysms twice as great as non-users. While the study was explicit in stating that their “results cannot establish cause and effect,” they went on to say 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.”
While a conclusive cause and effect relationship between Cipro and aortic aneurysms may never be established, a study published the same month as the JAMA study reported similar results.
The second study was published in The BMJ, formerly known as the British Medical Journal or BMJ, in November 2015.
Their study recorded an aortic aneurysm rate increase of almost three times that of the control group. Their study reported that the control group exhibited an occurrence rate of .13 per 100 people with Cipro/fluoroquinolone users having a rate of .35 per 100 people.
As both studies indicated, the risk of developing an aortic aneurysm even when taking Cipro may be minimal but it is far greater than the risk associated with non-Cipro users.
A decade of research focusing on fluoroquinolone class drugs and their relationship with aortic aneurysms have yielded some startling results as to just how prominent this side effect may be in drug users.
Aortic aneurysms are extremely dangerous no matter when they are discovered and treated by medical professionals. This danger comes from the aorta’s status as the largest artery in the human body, responsible for transporting blood from the heart throughout the entire lower body.
The first stage in an aortic aneurysm development is the weakening of the aortic wall. This weakening of the aortic wall can can lead to an aneurysm or if initially severe enough can lead to the wall simply tearing, a condition known as aortic dissection. An aortic dissection alone can often prove fatal as blood can rush through the tear, separate the aortic layers, and lead to an aortic outer wall rupture.
This rupture will lead to extreme internal bleeding that is difficult to stop once it has begun. Adding danger to this condition is that its symptoms mimic other diseases, leading to delayed diagnosis in most cases.
When the internal aortic wall does not tear but instead weakens, an aortic aneurysm enters the main stage of its development. This stage is characterized by the stretching and bulging of the aorta. The stretching and bulging of the artery continues until the weakened walls burst.
Similar to an aortic dissection, an aortic aneurysm results in severe internal bleeding that is difficult or impossible in some cases to stop.
Another feature that the two aortic conditions share is the difficulty in detecting them as their symptoms are often assumed to be the result of other conditions. In fact, sometimes it is impossible to self detect these conditions as symptoms may not be present at all.
Unlike the the connection between Cipro use and aortic aneurysms, the connection between Cipro and various stages of nerve damage has been acknowledged by not only independent studies but the U.S. Food and Drug Administration.
The first of these acknowledgments by the FDA came in 2001 when Cipro was a recommended drug to combat the potential effects of anthrax exposure. At the time though, the warning only came as a blanket statement warning of minor effects on a users central nervous system.
While other warnings and reviews by the FDA have taken place since 2001, the most explicit of these came in 2013 as the FDA issued a requirement that all fluoroquinolones, including Cipro, would need to carry a label warning of the drugs connection to peripheral neuropathy.
A later FDA Drug Safety Communication issued in 2016 went beyond requiring a label change and declared that all fluoroquinolones should be avoided whenever possible and only used when patients “do not have alternative treatment options.”
However, the risks of nerve damage and peripheral neuropathy stemming from Cipro use is so great, that not only has the FDA extensively covered it but so too have dozens of independent studies.
Some of the most prominent studies regarding this drug-complication relationship have been published by major sources including:
- Sage Journals: Annals of Pharmacotherapy (2001)
- Oxford Journals: Journal of Antimicrobial Chemotherapy (1995)
- Neurology: The Official Journal of the American Academy of Neurology (2014)
These studies all reported data indicating strong correlations between Cipro and other fluoroquinolone use and the development of severe nerve damage that often included peripheral neuropathy.
Many of the studies came to conclusions that are closely related to “the link between fluoroquinolones and PN and shows the potential association with more severe forms of nerve damage,” in addition to the idea that “Unless the benefit of fluoroquinolone therapy (e.g., overwhelming infection or development of bacterial resistance) outweighs PN risk, treatment with alternative antibacterial agents is recommended.”
The dangers of Cipro related peripheral neuropathy and other nerve complications find their base in two factors.
The first factor is actual symptoms these complications lead to, which can include:
- Burning Throughout Body
- Sharp/Shooting Pain Throughout Body
These symptoms can develop almost overnight depending on your susceptibility to the fluoroquinolone base of Cipro.
On initial read or research of the common symptoms associated with peripheral neuropathy and other forms of nerve damage, they might not appear to be as dangerous as other Cipro complications like an aortic aneurysm.
While this may be true regarding the chance of suffering a fatality from the side effect, it must be noted that these symptoms can persist for years after only taking a few pills and become constants in victims lives.
Oftentimes, peripheral neuropathy leads to many victims needing to embark on significant lifestyle changes as they are no longer able to remain active for any period of time without suffering intense, debilitating pain.
The second factor that works to make peripheral neuropathy and additional nerve complications dangerous is the high development rate in the millions of consumers that are prescribed Cipro every year.
While concrete percentage totals are unavailable due to conflicting reports and studies, it is widely established that consumers of Cipro face a risk of developing nerve complications that dwarfs most other drug complication rates.
The sheer number of consumers and likelihood of developing one of these Cipro related nerve complications creates a rare dimension of drug danger not often faced with other dangerous drugs.
As more information was disclosed to the public regarding Cipro regarding health risks – especially nerve damage and peripheral neuropathy – more and more Cipro users who fell victim to these complications began coming forward demanding justice. As is the most common method for all instances of dangerous and defective drugs, pursuing legal action against drug manufacturer Bayer AG became the most prevalent form of pursuing justice.
Lawsuits against various drug manufacturers regarding their own respective fluoroquinolone drug gained prominence in 2015 as several major pharmaceutical companies were named as the responsible plaintiffs for a bevy of charges that at times included the rare charge of racketeering.
As lawsuits began mounting against companies like Bayer AG, pharmaceutical companies began publicly defending their drugs claiming that any negatives associated with their use were far outweighed by the drugs positive effects.
However, perhaps the most important piece of information to note about the status of Cipro lawsuits is the controversial 2015 creation of a fluoroquinolone multidistrict litigation (MDL).
This move was perceived as controversial due to the unique nature of fluoroquinolone dangerous drug lawsuits. Unlike typical dangerous drug MDL’s, this MDL encompasses multiple different drug brands produced by multiple pharmaceutical companies.
Defendants in filed lawsuits expressed disdain with this decision as they felt that lumping together lawsuits against different companies under one MDL was unfair to victims of this dangerous drug class.
While the MDL began with less than 100 cases, it has since grown well into the hundreds with those numbers likely to continue to grow.
With millions of prescriptions issued for Cipro every year, there are thousands of former and active consumers who are now just beginning to become aware of their ability to pursue legal action against Bayer AG. While the legal process is similar to all standard dangerous drug lawsuits, those who wish to pursue legal action against Bayer AG need to meet a unique set of criteria to be deemed eligible.
The criteria for Cipro lawsuits include the following:
- 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
- Cipro Not Used For Serious Infection (MRSA, etc.)
- Cipro Was First Prescribed Choice
- User Had No Antibiotic Allergies
- No Established Confounders (HIV, Alcoholism, etc.)
Once a Cipro dangerous drug victim contacts a dangerous drug attorney, the process to prove their situation meets all the necessary criteria points will begin.
This process mostly encompasses the ordering and subsequent investigation of a victims full medical record history. These investigations are executed by licensed medical professionals who can identify drug and complication correlations to offer a conclusive determination of a victims lawsuit eligibility.
If a victim is deemed eligible to proceed with legal action after being subjected to the preceding points of criteria, a Cipro attorney will begin working to create the strongest case against Bayer AG possible.
Victims of Cipro related health complications are often able to seek eligibility to file a dangerous drug lawsuit. However, in similar fashion to many victims of dangerous drugs, Cipro victims do not always come forward to seek justice against Bayer AG in the form of a lawsuit.
Reasons why victims do not come forward vary but oftentimes include the fear of what the future could hold in the event that they file a lawsuit. In an effort to convince more Cipro victims to come forward, our legal team has discussed and determined the top five reasons that victims should pursue legal action against Bayer AG.
1. Ease Of The Process: Unfortunately, a significant number of victims don’t come forward because they are worried that a lawsuit will require an effort and time commitment that they are unable to afford. Contrary to that belief, our legal team will work to handle the case in a manner that will allow our clients to not need to undergo further alterations to their lives.
2. Affliction Of Extreme Pain And Suffering: Whether victims suffered through aortic or nerve complications, they are often subjected to immense continuous physical pain in addition to emotional and psychological trauma. A lawsuit may not be able to correct those pains, but it can work to acquire settlements that allow our clients to focus on their recovery.
3. Growing Financial Damage: Cipro complications are frequently associated with extended medical care as victims attempt to regain their former quality of health. These efforts lead to mounting medical expenses in addition to wages lost from the need to miss work due to treatment, suffering, etc. A settlement can compensate you for those damages.
4. Bayer Failed To Disclose Health Risk Information: A major issue associated with Cipro complications has been the discovery that Bayer AG withheld data, public warnings, and testing efforts regarding Cipro health complications. This neglect on behalf of Bayer led to millions of consumers being subjected to life-threatening health risks.
5. No-Fee Guarantee: The fear that additional financial ruin could be incurred due to an unsuccessful lawsuit is perhaps the most commonly cited reason that victims do not come forward. However, to combat that fear our legal team guarantees our clients in writing that unless you win a settlement you will not be charged any fees whatsoever.
As of June 2016, there have been no settlements publicly awarded or offered to plaintiffs who have filed lawsuits against Bayer AG alleging that Cipro carried undisclosed and dangerous health complications.
With no lawsuits against Bayer entering trial in the immediate future, it is difficult to determine when settlement offers may begin to be fielded.
Although settlements are not yet being awarded to Cipro lawsuit plaintiffs, legal experts are recommending that Cipro victims begin pursuing legal action as soon as possible in order to maximize their ability to receive any future settlement offers.
While no predictions can be certain, it is likely that any awarded or offered settlement will seek to provide compensation for the following:
- Pain And Suffering
- Psycological Damage
- Medical Expenses
- Lost Wages
In similar fashion to settlements, as of June 2016 there have been no public records indicating that a class action lawsuit regarding Cipro is active or will soon go active.
Typically, class action lawsuits are not created to consolidate dangerous drug lawsuits. This precedent would indicate that it is increasingly unlikely that a Cipro class action lawsuit will be created, no matter how many lawsuits are filed against Bayer AG.
However, while a class action lawsuit is not a current factor in Cipro litigation, a federally appointed multidistrict litigation (MDL) has quickly become a major factor in litigation.
In late 2015, at the request of the major pharmaceutical companies listed in various Fluoroquinolone lawsuits including Bayer AG, a federal panel decided in favor of creating a multidistrict litigation that would handle all fluoroquinolone lawsuits, covering multiple brands and manufacturers.
The multidistrict litigation went active in the U.S. District Court of the District of Minnesota under the supervision of Chief Justice John R. Tunheim.
After the MDL being active for a year, its case numbers have swelled from an initial 78 to approximately 383, with 40 more pending as of a court update on May 18, 2016.
The purpose of this MDL is to consolidate all fluoroquinolone lawsuits to streamline the process. Currently, the MDL is not handling active trials as it is currently awaiting further decisions regarding potential bellwether trials.
Any lawsuits that are filed against Bayer will now have the ability to be consolidated under the MDL. While the MDL was met with initial controversy from defendants, it has the potential to provide benefits to victims as early trials with favorable defendant verdics often lead to a greater chance of plaintiff issued settlement offers.
While health complications, their severity, and their prominence are well documented by independent studies and the FDA, neither the FDA nor Bayer have issued a drug recall for Cipro.
FDA issued drug recalls are exceptionally rare and it is unlikely that a recall will occur in the future. However, the FDA has taken significant steps to warn consumers and medical professionals of the dangers than can be associated with Cipro use.
Additionally, it is also highly unlikely that Bayer self enforces a drug ban as they have continued to stand by their claim that any negative effects associated with Cipro are far outweighed by its positive effects.
Contacting a qualified dangerous drug lawyer should be the first step you take when pursuing legal action against Bayer. To contact one of our award-winning dangerous drug lawyers, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-4722 any time of day to tell us about your case.
Members of our legal team have gained a reputation over 50 years of dangerous drug litigation as attorneys who will always put the needs of our clients before anything else.
Remember, Cipro lawsuits are often ineligible due to strict state deadlines. Start your lawsuit claim today to maximize your chances of meeting all respective state deadlines.