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More than 26 million Americans receive a prescription for a fluoroquinolone antibiotic like Cipro, Levaquin or Avelox each year. These drugs treat a wide variety of infections. But, they are also linked to dangerous side effects like nerve damage, aortic aneurysms (bulges) or dissections (tears). Damage to the aorta, the largest blood vessel in the body, can lead to strokes, heart attacks and even death. People who suffered these side effects are filing lawsuits against the drug makers.
Medical studies and patient accounts also link these drugs to permanent nerve damage called peripheral neuropathy.
After being diagnosed with nerve damage, patients and families of patients filed lawsuits against the makers of drugs. According to evidence presented in court documents, many of these drug manufacturers knew as early as 1996 that fluoroquinolones increased the risk of irreversible peripheral neuropathy, but they concealed the risks.
In August 2013, the U.S. Food and Drug Administration (FDA) required all makers of these medications to add additional warnings to the labels for peripheral neuropathy. According to the new warning, nerve damage can begin almost immediately after taking the drug and may be permanent.
Unfortunately, this warning came too late for many patients who suffered nerve damage that will last the rest of their lives. The FDA or drug makers have yet to warn the public about aortic dissection or aneurysm, conditions that can cost thousands of dollars in lifetime treatment. Sometimes, they are fatal.
Attorneys are now accepting cases from people who suffered aortic dissection and aortic aneurysm after taking a fluoroquinolone and expect the case count to rapidly grow.
Several state and federal lawsuits related to fluoroquinolone nerve damage are pending across the country. At one time, more than 2,000 Levaquin cases against Johnson & Johnson sat before U.S. District Judge John R. Tunheim in multidistrict litigation (MDL) in Minnesota. Several were settled for confidential amounts, according to court documents. As of March 2015, about 100 were pending in the federal MDL.
Lawsuits continue to mount against Bayer, the maker of Avelox. These cases remain in state courts, however. Attorneys expect more patients to file cases.
|Drugs included in litigation:|
|Avelox (moxifloxacin hydrochloride)||Cipro (ciprofloxacin)||Cipro XR (ciprofloxacin)|
|Factive (gemifloxacin mesylate)||Floxin (ofloxacin)||Levaquin (levofloxacin)|
|Maxaquin (lomefloxacin hydrochloride)||Noroxin (norfloxacin)||Proquin XR (ciprofloxacin hydrochloride)|
|Raxar (grepafloxacin hydrochloride)||Zagam (sparfloxacin)|
|Drugs included in litigation:|
|Avelox (moxifloxacin hydrochloride)|
|Cipro XR (ciprofloxacin)|
|Factive (gemifloxacin mesylate)|
|Maxaquin (lomefloxacin hydrochloride)|
|Proquin XR (ciprofloxacin hydrochloride)|
|Raxar (grepafloxacin hydrochloride)|
Although, drug companies claim their products are “safe and effective,” several medical studies linked fluoroquinolones to an increased risk of aortic dissection and aortic aneurysm. They are also linked to possible long-term or permanent peripheral neuropathy. According to lawsuits filed by plaintiffs, manufacturers of these antibiotics claimed the risk was rare and failed to warn patients and doctors that the nerve damage could be permanent. Attorneys are also accepting cases from people who suffered aortic dissection and aneurysm.
Peripheral neuropathy lawsuits claim drug labels misled patients and purposely used confusing language to hide the truth about permanent nerve damage. It wasn’t until August 2013 – after the FDA released an updated warning – that drug makers finally added information about rapid onset, irreversible peripheral neuropathy. The new label also removes the word “rare” from the warning about risk.
Court filings accuse defendants of several counts of wrongdoing. Most cases of this type claim negligence and failure to warn, other counts include:
Defendants knew these drugs posed unreasonable risks, but failed to include adequate warnings in labeling to warn patients and doctors.
At all times, defendants knew their products could cause harm, but continued to sell it.
Defendants “negligently and recklessly failed to warn of the nature and scope of the side effects” associated with fluoroquinolones like Cipro, Levaquin and Avelox. In particular, irreversible peripheral neuropathy. The risk of aortic dissection and aneurysm is also not included in warnings.
Drug companies have a duty to make sure that their products are safe before selling them. Defendants breached their duty when they negligently promoted, distributed, marketed and labeled the fluoroquinolone antibiotics. They failed to conduct appropriate pre and post-marketing tests and surveillance to make sure the drug was safe.
Drug companies misrepresented the safety and effectiveness of fluoroquinolones they manufactured. They actively concealed the dangers of the drugs, specifically irreversible peripheral neuropathy. Attorneys also found that drug makers may have actively concealed the risk of aortic dissection and aneurysm.
Plaintiffs claim after they took one or more of these powerful antibiotics, they were left with debilitating nerve pain. Some patients took antibiotics for illnesses like simple sinus infections that could have been treated by other types of antibiotics.
Sherri Kellerman filed a lawsuit against Bayer after she took Avelox and developed peripheral neuropathy. The lawsuit says her nerve damage was a “direct and proximate result of being prescribed and ingesting Avelox.” Kellerman’s complaint states that “Avelox is defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings and directions as to the dangers associated with its use.” The case is currently pending in The Northern District of California.
According to her lawsuit, Karyn Joy Grossman took Levaquin – manufactured by Johnson & Johnson – and developed peripheral neuropathy. According to Grossman’s complaint, the defendant marketed and sold Levaquin even though they knew it could cause peripheral neuropathy but did not warn patients and doctors. She seeks punitive damages because of the defendant’s “deliberate disregard for the rights and safety of their consumers.”
These cases are pending in California State Court.
In 2016, five individuals sued former FDA Commissioner Margaret A. Hamburg. They claimed Hamburg, her hedge fund executive husband and Johnson & Johnson (J&J) conspired to increase profits by failing to warn about "the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin."