FLUOROQUINOLONES


Ohio Product Liability Lawyer representing plaintiffs nationwide in Pharmaceutical Litigation and drug injury cases
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The U.S. Food and Drug Administration (FDA) recently released new warnings on the “disabling” side effects from the commonly used class of antibiotics called fluoroquinolones. The agency says the drugs can be dangerous and their use should be restricted.

The FDA’s warnings, placed on the drugs’ labels and warning inserts, aim to inform patients that the serious side effects of these medications generally outweigh the benefits, particularly if patients have other treatment options.
The most severe side effects can involve damage to tendons, muscles, joints, nerves and the central nervous system.

Some of the most dangerous of the antibiotics have already been removed from the market because of their side effects, but the FDA has stopped short of a complete ban on some popular drugs.

This class of drugs include large brand names include Bayer AG’s Cipro (ciprofloxacin) and Johnson & Johnson’s Levaquin (levofloxacin) along with Merck’s NoroxinMoxifloxicin and numerous others.


Aortic Dissections & Aortic Aneurysm Risk


Recent studies, published by the American Medical Association and numerous medical journals, show a link between the use of fluoroquinolone antibiotics and a substantial risk for aortic aneurysms and aortic dissections. The 2015 studies identify a logical “association” between fluoroquinolone use and the development of severe aortic disorders, including fatal aortic ruptures.

According to the most recent annual statistics from the U.S. Center for Disease Control and Prevention (CDC), aortic aneurysms were the primary cause of almost 10,000 deaths in the United States.

When an aorta ruptures, blood can push through and separate (dissect) the middle layer of the wall from the outer layer. As a result, a new, false channel forms, and causes a dangerous emergency situation.

Symptoms of aortic dissection may mimic those of other diseases, often leading to delays in diagnosis. Over time, the amount of oxygen and nutrients available for the organs of the body is diminished. Without treatment, about 80 percent of people who have an aortic dissection will die within two weeks.

Aortic dissection is a life-threatening condition that occurs when the lining of the aorta—the primary artery in the body—is broken down under distress, causing debilitating complications that often lead to death. These conditions are called silent killers as without regular monitoring there is often no warning that the aorta has been compromised.

Medical scientists compiled data that shows the incidence of aortic dissection and aortic aneurysm in America has risen over the last 30 years, a primary cause of death each year for thousands of unknowing patients.

Joe Lyon is a highly-rated Cincinnati, Ohio pharmaceutical product liability attorney, representing plaintiffs nationwide in a wide variety of wrongful death and injury claims related to dangerous pharmaceutical products.  


Fluoroquinolone Permanent Nerve Damage


The FDA’s recent action follows a study by its Office of Surveillance and Epidemiology, which found “an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy.”

In 2013, the FDA issued a warning about permanent nerve damage as a possible fluoroquinolones injury, such as Cipro and others. The agency said the damage “may occur rapidly,” and could be “potentially permanent.”

In the FDA Adverse Event Reporting database, there are over 1,000 reports of nerve damage after fluoroquinolone use, and only 10 percent reported improvement or recovery. In some cases, disability was so severe that continued employment was not possible.


Antibiotic Tendon Damage


As far back as 2008 the FDA knew about major concerns and risks for this class of antibiotics. That year they added the “black box” warning to seven fluoroquinolone drug labels and prescribing information, primarily because of the added risk of tendon rupture. The drugs named in the warning included:

•    Ciprofloxacin
•    Gemifloxacin
•    Levofloxacin
•    Moxifloxacin
•    Norfloxacin
•    Ofloxacin


By 2008, there had been over 400 reports of tendon rupture and about 340 cases of tendinitis in patients using fluoroquinolone antibiotics. At the time, the agency recommended that patients be switched to alternative treatments before tendons ruptured.


Tendon Damage Symptoms


Pain, swelling, inflammation, and tears of tendons are common in patients taking fluoroquinolone antibiotics. The Achilles tendon, at the back of the ankle, is a very commonly affected area. Signs or symptoms of tendon rupture include:

•    A snap or pop in a tendon area
•    Bruising right after an injury in a tendon area
•    Inability to move an affected area
•    Inability to bear weight


Antibiotic Injury Risk


Anyone who takes  like Cipro and Levaquin could be at risk of fluoroquinolones injury. Evidence suggests the duration of drug therapy is not a factor; side effects can begin even after the first dose.

Some reports describe young, healthy patients who take a fluoroquinolone and days later is unable to run or even walk without support. The FDA has said the risk of tendinitis and tendon rupture is even higher in people with the following factors:

•    Over 60 years of age
•    Taking steroids (corticosteroids)
•    Kidney, heart, or lung transplant recipient
•    History of tendon problems in the past (including rheumatoid arthritis)


Antibiotic Complications


The recent FDA review focused on the risks of nerve damage and tendon rupture with the use of antibiotics. However, patients may develop other serious adverse effects, including:

•    Aortic Dissections
•    Aortic Aneurysms
•    Aortic Rupture
•    Hallucinations
•    Depression
•    Vision problems
•    Cardiac issues
•    Convulsions
•    Muscle aches
•    Joint pain
•    Anxiety


Symptoms of Possible Tendon Damage


Pain, swelling, inflammation, and tears of tendons are common in patients taking fluoroquinolone antibiotics. The Achilles tendon, at the back of the ankle, is a very commonly affected area.

Signs or symptoms of tendon rupture include:

•    A snap or pop in a tendon area
•    Bruising right after an injury in a tendon area
•    Inability to move an affected area
•    Inability to bear weight


Risk of Antibiotics Injuries


Anyone who takes fluoroquinolones like Cipro and Levaquin could be at risk. Evidence suggests the duration of drug therapy is not a factor; antibiotics injuries and side effects can begin even after the first dose.

Some reports describe young, healthy patients who take a fluoroquinolone and days later is unable to run or even walk without support. The FDA has said the risk of tendinitis and tendon rupture is even higher in people with the following factors:

•    Over 60 years of age
•    Taking steroids (corticosteroids)
•    Kidney, heart, or lung transplant recipient
•    History of tendon problems in the past (including rheumatoid arthritis)


Overprescribed Antibiotics


Fluoroquinolones like Cipro and Levaquin are very commonly prescribed. Data supplied by IMS Health, the drug-research firm, said there were a total of more than 36 million prescriptions written in 2014. The Centers for Disease Control and Prevention (CDC) claims that 50 percent of these prescriptions may be “inappropriate.”

Patients are regularly prescribed fluoroquinolones for sinusitis, bronchitis or uncomplicated urinary tract infections, even though there are other safer options available. The class of antibiotic have become so popular in part because they resolve infections quickly, but that could be a shortsighted decision seeing as they come with more side effects than other drug options.

The FDA’s reporting database of complaints involving Cipro and Levaquin alone show almost 200,000 adverse reactions from 1997 to 2015. This could be a great underestimate of the issue, because only a small fraction of patients who experience side effects report them.


Fluoroquinolones Injury Lawsuits


New evidence of fluoroquinolone aortic rupture dictates that the drugs should be controlled more closely by doctors, and should not be used in patients at increased risk unless there are no other available treatment options. Patients at additional risk may include those with prior aortic aneurysms, high blood pressure, and the elderly.

The FDA added a Black Box warning to certain antibiotics as a result of serious aortic dissection risks as well as added warnings about fluoroquinolone aortic rupture in prescribing information and patient medication guides for all fluoroquinolones.

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A Voice for Those who have suffered 

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this related to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Settlements?

The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Why Hire the Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Pharmaceutical Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Pharmaceutical lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 

IN RE: VIOXX

Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.

IN RE: TRASYLOL

Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.

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