Doctors prescribe fluoroquinolone antibiotics like Cipro and Levaquin to thousands of Americans each year to treat infections and in some cases, save lives. But makers of these drugs also face a growing number of lawsuits filed by patients who say these medications caused them debilitating, permanent nerve damage called peripheral neuropathy.
After several months and doctor’s visits, Myers discovered she had peripheral neuropathy and tendinopathy, which she said stemmed from taking Levaquin. Now she endures physical therapy several times a week to keep the muscles in her legs from wasting away and struggles to walk.
In August 2103, 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.
This reinforces the necessity for people to find the best local doctors. It can be hard to find an honest local primary car physician or a transparent number of local surgeons to be your healthcare provider.
Status of Lawsuits
Several state and federal lawsuits related to fluoroquinolones 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.
Why People Are Filing Lawsuits
Although, drug companies claim their products are “safe and effective,” several medical studies linked fluoroquinolones to an increased risk of 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.
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, these include:
- Strict Liability. 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.
- Failure to Warn. 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.
- Negligence. 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.
- Fraud. Drug companies misrepresented the safety and effectiveness of fluoroquinolones they manufactured. They actively concealed the dangers of the drugs, specifically irreversible peripheral neuropathy.
Individual Nerve Damage Lawsuits
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.
Kellerman v. Bayer
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.
Grossman v. Johnson & Johnson
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.