Lawsuits over fluoroquinolone antibiotics Cipro, Levaquin and Avelox say patients suffered aortic dissection or aortic aneurysm that required overnight hospitalization or surgery, or resulted in death, within one year of taking the prescription drugs.
If you're suffering from heart problems after taking a fluoroquinolone antibiotic like Cipro, Levaquin or Avelox, you could be eligible for compensation.
Fluoroquinolone antibiotic lawsuits accuse manufacturers Johnson & Johnson, Bayer AG and Merck & Co., among others, of failing to warn consumers that use of these drugs could lead to aortic aneurysms and dissections.
Recent studies reveal taking fluoroquinolones doubles a person’s risk of developing major, life-threatening aortic injuries.
Attorneys are currently accepting cases on behalf of people who took fluoroquinolone antibiotics, such as Cipro, Levaquin and Avelox, and then suffered aortic rupture, dissection or aneurysm.
They are also interested in talking with surviving spouses or relatives of people who took these drugs and then died as a result of aortic side effects.
These lawsuits are in the early phase of the legal process, so there are no known major settlements or verdicts as of yet. To date, no class action or multidistrict litigation has been established.
Fluoroquinolone lawsuits filed in the past resulted in settlements and a $700,000 jury verdict.
People who believe they suffered aortic injuries as a result of taking fluoroquinolones can still sue the drugs’ makers.
Lawsuits that allege aortic injuries are in the early stages of the legal process.
People have filed complaints in federal courts in different states, including Florida and New York.
It’s possible that as more people file lawsuits, the cases will be grouped together in one federal court.
One federal New York case filed by a Pennsylvania man accuses Johnson & Johnson of negligence, fraud, failure to warn, among other wrongdoings. Benn Prybutok was prescribed Levaquin in May 2007. He later suffered aortic dissection that required surgical repair, according to his complaint.
Another man, Robert Vaughn, filed his lawsuit against Johnson & Johnson in federal court in Florida. He claims he took Levaquin and later suffered aortic aneurysm.
Drugwatch’s expert legal partners are currently accepting cases on behalf people who took a fluoroquinolone antibiotic as prescribed by a doctor and sustained an aortic injury that required surgery or an overnight stay in a hospital, or that resulted in death.
The aorta is the body’s largest artery. It carries oxygenated blood from the heart to the rest of the body. Aortic aneurysm and dissection are major, life-threatening injuries.
Those diagnosed with an aortic injury or admitted to the hospital after 2000 and within one year of taking a fluoroquinolone antibiotic may have a legal claim against the drug’s manufacturer.
These injuries can be abdominal (in the stomach region) or thoracic (in the chest). They may have resulted in diminished quality of life, physical impairment, mental anguish, hospital and medical expenses and loss of earnings — all damages that can result in compensation.
Cipro (ciprofloxacin), Avelox (moxifloxacin) and Levaquin (levofloxacin) are brands of fluoroquinolones most often named in lawsuits. They are also the most widely used antibiotics in the U.S.
These drugs are strong prescription antibiotics used to treat bacterial infections, including respiratory and urinary tract infections. Doctors administer the medications as pills or intravenously.
All but six of these brands are discontinued in the U.S. However, pharmacies still dispense brand-name prescriptions as well as generic versions of the drugs.
Bayer AG, Johnson & Johnson, and Merck & Co. are among the manufacturers fighting lawsuits over allegations that they failed to warn of aortic risks associated with their fluoroquinolone antibiotics. Companies being sued are those that developed, manufacture and market the drugs.
Bayer HealthCare Pharmaceuticals, Inc. manufactures Cipro. The company also partners with Merck Sharp & Dohme Corp. to make and sell Avelox. Both companies are subsidiaries of pharmaceutical giants: Bayer HealthCare Pharmaceuticals is part of Bayer AG, and Merck Sharp & Dohme Corp. is part of Merck & Co.
Janssen Pharmaceutical Companies makes Levaquin. Janssen is part of Johnson & Johnson. The company announced in October 2017 that it had made $15.7 billion in U.S. pharmaceutical sales since January of that same year.
Other companies being sued include distributors McKesson Corporation and Schering Corporation.
Lawsuits accuse manufacturers and distributors of Cipro, Levaquin and Avelox of selling products that are defective and dangerous to human health. Attorneys representing patients say the drugs’ manufacturers knew or should have known of the aortic risks but failed to properly warn of the dangers associated with all of the drugs’ uses. They call the drugs “unfit and unsuitable,” and accuse companies of marketing and selling them to treat infections for which they were not required.
As a result of these wrongdoings, patients (through no fault of their own) experienced permanent and/or long-lasting side effects.
Because the companies failed to adequately warn doctors of the risks, doctors could not inform and instruct patients about the risk of aortic aneurysm or dissection injuries associated with the drugs. The companies’ failure to warn also led to patients’ receiving fluoroquinolones instead of other adequate antibiotics, according to complaints filed in federal court.
The drug companies are also accused of failing to include appropriate warnings in their products’ labels published to the medical community. This allegedly means patient information presented directly to consumers — either as part of sample packages or as part of the prescription they received at the pharmacy — lacked adequate warnings.
Currently, no class action lawsuits exist for fluoroquinolone-induced aortic injuries. However, lawsuits claiming these drugs caused other serious side effects have been consolidated into multidistrict litigations — another type of legal process used when there are many cases with similar allegations against the same companies.
Class action lawsuits are actually on the decline, but multidistrict litigations, or MDLs, are becoming more common. MDL cases stay separate but are transferred to a single court to streamline the pretrial proceedings. Unlike in class actions, plaintiffs in MDLs do not all share in the same settlement or verdict.
There are currently no publicized verdicts or settlements for aortic injury lawsuits associated with fluoroquinolones. However, these injuries are not the only reported side effects of fluoroquinolones that have prompted lawsuits.
People who took Cipro, Levaquin or Avelox and subsequently suffered from peripheral neuropathy and tendon ruptures have also sued the drugs’ makers. Some of these cases ended in settlements. One resulted in a $700,000 jury verdict.
Drugwatch’s legal partners are not currently accepting peripheral neuropathy or tendon rupture cases, though other law firms might.
Nearly 800 cases are currently pending in federal and state court involving allegations that fluoroquinolone use causes peripheral neuropathy, a condition that develops as a result of damage to the peripheral nerves.
These lawsuits claim the defendants — namely Bayer Healthcare Pharmaceuticals Inc., Merck & Co Inc., Johnson & Johnson, Janssen Research & Development LLC, and Bayer Corporation — failed to adequately warn patients of this alleged side effect.
The defendants, who developed, manufacture and market fluoroquinolones, deny that the drugs are defective or unreasonably dangerous. They also deny that their warnings were inadequate.
In August 2015, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal neuropathy fluoroquinolone cases be transferred to the District of Minnesota for consolidated pretrial proceedings. The panel assigned the multidistrict litigation to U.S. District Judge John R. Tunheim.
At the time, about 80 actions were pending in nearly 40 federal districts. Additional cases (some of which were transferred to the MDL) were also pending in state court in California, Pennsylvania, New Jersey and Oklahoma. At its peak, the federal MDL consisted of 1,036 total actions. Several were settled for confidential amounts, according to court documents.
As of October 2017, 769 cases remained pending in the MDL. About 250 cases involve Bayer or Merck entities, and between 90 and 100 of those cases also involve a Janssen entity, according to court documents. An additional 17 cases were pending in Pennsylvania state court.
The federal court has scheduled bellwether trials in 2018 and 2019. These trials are intended for both sides to test their arguments, with the goal of moving the overall litigation toward resolution.
During a February 21, 2017 status conference, counsel told the court that both sides made their bellwether selections, including four cases each involving Avelox and two cases each involving Cipro. Both parties selected the same two Cipro cases and agreed that they would proceed with 10 bellwether cases, including eight Avelox cases and the two Cipro cases.
The litigation is now in the discovery phase, which is when both sides disclose all relevant facts and documents to one another prior to trial.
Judge Tunheim also oversaw pretrial proceedings for a separate MDL involving the fluoroquinolone Levaquin. Plaintiffs in that MDL were prescribed Levaquin and allege that it causes tendon rupture. As with the neuropathy MDL, plaintiffs in the tendon rupture MDL claim the defendants, Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc., failed to adequately warn of the side effect.
The plaintiffs began filing lawsuits in late 2006; the U.S. Judicial Panel on Multidistrict Litigation created the MDL in 2008. Around the same time the MDL began, the FDA first added a black box warning to fluoroquinolones for the increased risk of tendinitis and tendon rupture.
In November 2010, the first bellwether trial was tried against Ortho-McNeil Pharmaceutical Inc. and resulted in a jury verdict in favor of the plaintiff. The jury awarded the plaintiff $700,000 in compensatory damages, which was later reduced to $630,000. The jury also awarded punitive damages in the amount of $1,115,000. The second and third bellwether trials were tried in June 2011 and January 2012, respectively. Both resulted in jury verdicts in favor of Johnson & Johnson and Ortho-McNeil Pharmaceutical Inc.
About 2,049 total actions were filed under the MDL. Court records show hundreds of cases ended in settlements. Others were transferred or remanded and subsequently dismissed. Only 10 remained pending as of March 2017. The U.S. Judicial Panel on Multidistrict Litigation officially closed the MDL in July 2017.
The U.S. Food and Drug Administration requires all fluoroquinolones to carry the agency’s strongest warning — a black box warning — that advises patients of their heightened risk of developing permanent nerve damage (peripheral neuropathy), and tendinitis and tendon rupture.
Recent studies suggest that in the same way fluoroquinolones can weaken tendons — specifically the Achilles tendon — they can also weaken the aortic wall, leading to dissection or aneurysm.
An epidemiologic study published in the Journal of American Medical Association in 2015 found fluoroquinolones were associated with a two-fold increase in risk of dissection and aneurysm within 60 days of using the drug.
A second epidemiologic study published in BMJ in 2015 found a nearly three-fold increase in the risk of aortic aneurysm and dissection.
Researchers concluded that the results demonstrating a higher rate of aortic aneurysm and dissection within 60 days of fluoroquinolone therapy are consistent with the fluoroquinolone-associated tendon rupture findings.
Moreover, one of the studies revealed that risk of aortic aneurysm or dissection may still be significantly increased even a year after taking a fluoroquinolone.
According to the JAMA study’s authors, fluoroquinolones have been associated with collagen degradation. This raises safety concerns related to more serious collagen disorders with the use of these drugs.
Collagen degradation is recognized as a possible cause of tendon rupture. According to the BMJ study, the same collagen that makes up the majority of the Achilles tendon also makes up 80 to 90 percent of the aorta.
Lawsuits allege the drug makers should have known “the risk of tendinitis may cause or aggravate aortic aneurysm or dissection by a similar mechanism.”
“The Defendants’ failure to investigate or study the potential association between Levaquin and aortic rupture and dissection was not due to lack of awareness.”
“Defendants have for years had in their possession adverse event reports denoting patients who had received levofloxacin and suffered aortic aneurysm ruptures, aortic dissections and/or aortic ruptures following therapy,” according to one lawsuit.
“Despite their internal knowledge surrounding the collagen issue with their [fluoroquinolone] drug, Defendants failed to investigate or initiate any studies or testing regarding aortic aneurysm or dissection in association with [fluoroquinolone] use, much less update their Levaquin label to apprise the medical community or patients of this important safety risk.”
Although the FDA required fluoroquinolone manufacturers to update their drugs’ labels to include information on tendon rupture and other risks, the agency has yet to require a warning about aortic issues.
For years, fluoroquinolones have been linked to serious side effects. In fact, many fluoroquinolones have been removed from the U.S. market because of the risks they pose.
|Brand||Date Removed From Market||Risks That Prompted Removal|
|Omniflox® (temafloxacin)||June 1992||low blood sugar, kidney failure, rare form of anemia|
|Trovan® (trovafloxacin)||June 1999||severe liver toxicity|
|Raxar® (grepafloxacin)||October 1999||QT-interval prolongation|
|Zagam® (sparfloxacin)||July 2001||QT-interval prolongation|
|Tequin® (gatifloxacin)||May 2006||severe blood sugar reactions such as hyperglycemia and hypoglycemia|
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