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Recent research warns that the use of antibiotics like Noroxin (norofloxacin) could be associated with an increased risk for cardiac emergencies, even years after treatment.

Two new studies, published by the American Medical Association and other medical journals, are concerned that the use of fluoroquinolone antibiotics, like Noroxin, may be linked with an increased risk for aortic aneurysms and aortic dissections, which often lead to aortic rupture and death.

The recent studies, published in the Pharmaceutical Journal, claim they identified a definitive “association” between fluoroquinolone (Noroxin) use and developing emergency aortic disorders.

Data compiled by medical scientists show 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 American patients.

Aortic dissection is a cardiac disorder that occurs when the walls of the aorta break down, allowing blood to enter outside layers of tissue, depriving a victim of oxygen and rapidly causing debilitating complications like stroke, heart attack or death. When the aorta wall ruptures, patients have about a 50 percent chance of survival.

Joe Lyon is a highly-rated Cincinnati Noroxin lawyer and Ohio pharmaceutical attorney, representing plaintiffs nationwide in a wide variety of wrongful death and injury claims.  


FDA Warns of Noroxin Health Risks


Fluoroquinolone antibiotics are helpful in treating a wide variety of infections, but they also carry the potential to cause dangerous side effects like aortic aneurysms and dissections, and permanent nerve damage.

Common antibiotics concerned health professionals as early as 2008. At that time, the U.S. Food and Drug Administration (FDA) decided that the drug risks necessitated a “black box” warning, clearly stating the risks of tendinitis and tendon rupture on fluoroquinolone packaging. Noroxin, Cipro, Levaquin, and Avelox were among the specific drugs listed in that particular FDA warning.

As the number of complaints mounted, the FDA followed up in 2013 and issued another warning regarding peripheral neuropathy (permanent nerve damage) as a possible side effect of Noroxin and other fluoroquinolones.

The government agency warned the effects could be “disabling” and recommended to medical professionals to restrict their use. Your Noroxin lawyer can answer more questions regarding injury.

More recent studies, released in 2015, and published by the American College of Cardiology, are consistent with prior research. The newer studies build on evidence that these antibiotics induce aortic aneurysm and dissection in the same way they damage the collagen in tendons. The researchers explain: “…collagen is also a major component of the aortic wall.”


Aortic Dissection & Antibiotic Injury


research team from the University of Toronto found an association between fluoroquinolone use and an increased risk of aortic aneurysm. The team suggested more prudent use of the antibiotics could avoid countless aortic aneurysms. Their research concluded that “fluoroquinolone prescriptions can contribute acutely to aneurysm progression and rupture.”

Medical officials urge that aortic aneurysms and dissections be diagnosed quickly, and that victims seek immediate medical attention if they experience the following symptoms during or after treatment:

•    Sudden, intense and persistent abdominal, chest or back pain
•    Pain that radiates to the back or legs
•    Sweatiness
•    Dizziness
•    Nausea
•    Vomiting
•    Low blood pressure
•    Shortness of breath
•    Sudden difficulty speaking
•    Loss of vision
•    Weakness on one side of the body


Noroxin Injury & Aortic Rupture


Treating patients with fluoroquinolones like Noroxin (norfloxacin) has been associated with an increased risk for aortic aneurysm or dissection, and several other disorders, including the following:

•    Peripheral Neuropathy
•    Achilles tendon rupture
•    Retinal detachment
•    Vision deterioration
•    Hearing loss
•    Nerve damage
•    Convulsions
•    Cardiac issues
•    Hypersensitivity
•    Hallucinations
•    Depression and anxiety
•    Muscle aches and general fatigue
•    Joint pain
•    Hepatic failure
•    Renal failure


The public adverse reaction database on the FDA Web site shows numerous complaints involving Noroxin and other fluoroquinolones. Some other popular fluoroquinolones include:

•    Moxifloxicin
•    Cipro
•    Levaquin


Adverse Reactions & Noroxin Injury


The most recent warnings from the FDA and other medical outlets are somewhat predictable. These powerful drugs have a history of generating adverse health reactions. In 2013, the FDA warned that Noroxin treatment could lead to nervous disorders like irreversible peripheral neuropathy. The warning said permanent nerve damage was possible in the arms, hands, legs and feet of patients.

Other serious complaints in the last few years have included severe allergic reaction (DRESS), risk of tendon rupture, and muscle spasms.
For unstated reasons, Merck Co. discontinued some forms of Noroxin in 2014.


Noroxin Side Effects & Safety Risk


A 2015 study of nearly 2 million patients, published in the BMJ Open journal, found that within a month of finishing fluoroquinolone treatment, patients were more than twice as likely to experience aortic aneurysm as similar patients taking other courses of drugs.

Any person (all ages) treated with a short or long course could be at risk of developing cardiac disorders, including aortic dissection. Available data suggest the duration of treatment could be a likely factor, though adverse reactions have been reported even after the first dose. Contact a lawyer for a case review.


What is Noroxin Used for?


Noroxin (norfloxacin), manufactured and marketed by Merck Co., is a broad-spectrum antibacterial agent commonly used to treat bacterial infections, including the following:

•    Bladder infection
•    Kidney infection
•    Prostate infection
•    Urinary tract infection
•    Sexual transmitted diseases


Noroxin Injury Lawsuits


The U.S. Centers for Disease Control and Prevention (CDC) says at least 30 percent of antibiotics prescribed in the United States are “unnecessary.” Over 25 million Americans receive a prescription for a fluoroquinolone antibiotic like Noroxin, Cipro, Levaquin or Avelox each year. Public health officials note that the increased use of the drugs makes them a significant concern.

Although fluoroquinolones like Noroxin can be effective treatments for bacterial infections, alternate drugs or shorter courses should be considered. Patients receiving treatment should have been warned about a potentially lethal risk to the aorta.

photo of attorney Joe Lyon
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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