Lawsuit claims widely-prescribed antibiotics caused permanent injury
Published 4:03 pm Friday, March 11, 2016
A lawsuit claiming that popular antibiotics can cause nervous system damage has been moved to federal court.
Cipro, Avelox and Levaquin – all members of the fluoroquinolone family – are popular prescription drugs used in adults to treat bacterial infections.
The suit, filed against two major drug companies and their subsidiaries, claims about 300 patients suffered from peripheral neuropathy — a condition that damages the peripheral nervous system and can lead to permanent and long-lasting injuries — after taking those drugs. The suit also contends that the drugs lacked proper directions and warning labels about the potential risks, and it seeks more than $350,000 in damages per patient.
Filed by the Sill Law Group in Edmond, Oklahoma, the suit had been sitting at the Stephens County Courthouse since August, but was moved to a federal court in Minnesota on Monday.
Tara Tabatabaie, a partner of the firm, said her firm might not oppose the move as they prepare to join other law firms as the suit progresses, a process that will take at least two to three years.
The 40-page lawsuit claims Bayer and Johnson & Johnson and several of their subsidiaries and distributors – McKesson, Janssen, Merck & Co, Schering and Ortho-McNeil-Jansenn – “failed to appropriately and adequately inform and warn” users and physicians of serious and dangerous risks associated with the drugs.
The U.S. Food and Drug Administration (FDA) Advisory Committee met last November to discuss the popular family of antibiotics. Documents obtained from the meeting show a list of about 139 side effects. The committee recommended the FDA take a deeper look into prescribing these drugs for a variety of common infections, such as routine acute bacterial sinusitis and uncomplicated urinary tract infections.
“When considering the potentially modest treatment benefits of antibacterial drugs for these three indications, the risks of the fluoroquinolone antibacterial drugs should be taken into consideration,” stated the documents. “While the actual incidence of each adverse reaction is difficult to ascertain, the seriousness of certain uncommon adverse reactions deserves attention.”
FDA documents state in 2014, 22 million unique patients received a prescription for fluoroquinolones.
Tabatabaie says side effects from the drug have been reported for more than 23 years, but the warning labels have been misleading.
“Rather than warning patients and physicians that the use of fluoroquinolones may result in permanent nerve damage, the drug makers instead adopted a warning that misleadingly indicated such damage was rare and in any event could be avoided by simply discontinuing the drug upon the onset of certain symptoms,” she said. “In August of 2013 … the FDA determined that the existing warning … was inadequate. On Aug. 15, 2013, an updated warning was issued in which the risk of rapid onset of irreversible peripheral neuropathy was finally included. The updated warning also removed the statement that nerve damage occurred only in rare cases.”
Tabatabaie also noted that the drugs were originally approved as a second-line therapy — something given after the initial treatment hasn’t worked — but that “aggressive advertisement by the drugs’ makers” have led to increased prescriptions.
“Cipro and its generic versions were the most commonly prescribed antibiotic in uncomplicated urinary tract infections in 2014,” she said.
According to documents obtained from the FDA’s November meeting, an estimated 168 million prescriptions for the drugs were issued from 2010 to 2014, with 33 million happening in 2014. Family practice doctors were the top prescribers, with about 20 percent of the total, followed by internal medicine doctors at 19 percent.
Documents obtained from the FDA also show reports of peripheral neuropathy caused by the drug from 2003 to 2012 but had no specific percentages.
Jennifer Norton, spokeswoman for Janssen, pharmaceutical companies of Johnson & Johnson, said the company is aware of the lawsuit and will vigorously defend against the claims in litigation.
“Ever since it was first approved by the FDA in 1996, the Levaquin label has provided information to physicians on the risks and benefits associated with the medication, including warnings and precautions,” she said. “Since 2004, the Levaquin label has informed physicians and patients about possible side effects related to peripheral neuropathy.”
Rosemarie Yancosek, spokeswoman for Bayer pharmaceuticals echoed these sentiments pointing to patient safety as Bayer’s first priority.
“At Bayer, patient safety is our top priority and we have sympathy for anyone experiencing medical problems, regardless of the cause,” she said. “Bayer believes it has meritorious defenses and intends to defend itself vigorously against plaintiffs’ claims.”
Chief Compliance Officer for the Oklahoma Pharmacy Board Cindy Hamilton said pharmacies will at times buy large supplies of antibiotics that already come with a warning label issued by the FDA.
“There’s antibiotics that are sitting on a shelf of a pharmacy for a couple of years and the labels are still the same,” she said.
She added that even if new warning labels are issued, pharmacies are not responsible for adding new labels to in-stock drugs. New stocks of the drugs would have the new warning labels.
Details for this story were provided by the Duncan, Oklahoma Banner.