The Daily Beast reported on the lawsuit involving the deadly antibiotic Levaquin. Plaintiffs filed the lawsuit against former Federal Drug Administration chief Margaret Hamburg and pharmaceutical giant Johnson & Johnson, accusing them of hiding the dangers of the antibiotic Levaquin to increase profits. Filed as a federal racketeering lawsuit, the complaint is salacious claiming that while heading the FDA, Hamburg conspired to “cover up” side effects to boost the profits of Johnson & Johnson (the drug’s maker) and her husband (whose firm allegedly owned stock in the company).
The man behind the conspiracy is Larry Klayman, a right-wing activist known as a “pathologically litigious attorney.” Hamburg’s attorneys called Klayman’s lawsuit “patently false,” “defective,” and lacking in factual evidence. “For nearly six years, Dr. Hamburg served alongside her FDA colleagues to help protect the health and safety of the American public. Mr. Klayman’s accusations concerning that work are reckless and offensive.”
Warnings surrounding the antibiotic Levaquin have been dangerously insufficient. The drug, capable of causing debilitating tendinitis, permanent nerve damage, ruptured tendons, and even psychosis, is meant to be reserved for severe life-threatening infections. It’s part of a family of antibiotics that, according to the Centers for Disease Control and Prevention (CDC), is the fourth-most prescribed nationwide, given to 33 million Americans in 2013 alone.
Levaquin (or levofloxacin) first entered the market in 1996 as the newest version of an old class of drugs known as fluoroquinolones. Synthetic broad-spectrum antibiotics, they attack bacterial DNA directly in a way that allows them to treat the severest infections. The strength with which Levaquin operates is a double-edged sword, leading to a host of side effects. These include nausea, vomiting, diarrhea, headaches, and insomnia as well as seizures, tendinitis, nerve damage, aortic aneurysms, cardiac arrhythmia, psychosis, vision loss, and renal failure.
When used for severe infections, the life-saving benefits of the drug far outweigh the risks. When used for uncomplicated urinary tract infections, a condition for which Levaquin is often prescribed, they do not. According to the 200,000 patients who have suffered serious side effects after being prescribed it for mild infections, that message is still not clear to some doctors. Without awareness, patients are prescribed the drug for mild infections, putting them at risk of permanent physical and psychological damage.
Levaquin began causing problems soon after hitting the market. Ten years after it was approved, the nonprofit consumer rights advocacy group Public Citizen released data showing that between November 1997 and December 2005 there were nearly 800 cases of tendon disorders from use of fluoroquinolones—61 percent of them from Levaquin.
In 2006, Public Citizen Research Group’s director, Dr. Sidney Wolfe, petitioned the FDA to add a black box warning to the label. “The numbers are startling,” Wolfe said in 2006. “Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals.”
In July of 2008, the FDA agreed to add a black box warning about the risk of tendinitis, but refused to notify doctors. The black box did little to curb prescriptions and by 2010 Levaquin was the best-selling antibiotic in America.
Patient complaints increased. In 2008, scientists at the National Center for Biotechnology Information studied the case of a healthy 42-year-old woman who suffered from an “acute-onset delirium” with “psychotic features.” Her symptoms dissipated when Levaquin was stopped, leading them to conclude that the drug caused the reaction.
In 2009, three separate plaintiffs from West Virginia who suffered from severe tendon injuries after taking the drug argued that the black box warning alone wasn’t enough. “Physicians will interpret the relative risk of a Levaquin-induced tendon injury inappropriately,” reads the complaint. “Defendants continue to market Levaquin as a first line therapy for the common bronchitis and sinusitis infections, and for which many other, safer antibiotics are available.”
In 2010, Johnson & Johnson settled its first major Levaquin lawsuit, shelling out $1.8 million in damages to a plaintiff who suffered a tendon rupture after taking the drug. By 2012, the company was facing upwards of 3,400 lawsuits from patients arguing that the warnings were not made clear enough to themselves or their doctors. In November of that year, the company settled 845 of them.
Those suffering from fluoroquinolones-related injuries began rallying together, nicknaming themselves “floxies,” and forming support groups across the Web. A Facebook page called Fluoroquinolone Antibiotic Toxicity boasts more than 7,300 members; another called My Quin Story (“Life After Levaquin”) has 3,179.
Dozens of doctors have spoken out against misuse of fluoroquinolones over the years, most while still affirming that the drugs do have benefits. The University of South Carolina’s Dr. Charles Bennett, who runs the Southern Network on Adverse Reactions, has filed two Citizen Petitions to the FDA about Levaquin—the first, asking for warnings about peripheral neuropathy; the other, mitochondrial toxicity.
In the petition, Bennett noted that more than 80,000 complaints about the drug had been filed to the FDA between 1997 and 2011 and that—due to the FDA’s weak reporting system—there were likely tens of thousands more. “We are talking about going into the physician’s office, having a little sniffle, walking out with an antibiotic and shortly after having these kinds of problems,” Dr. Bennett said.
A pharmacological epidemiologist named Mahyar Etminan told The New York Times that “lazy doctors” prescribing them for minor infections were “trying to kill a fly with an automatic weapon.” In July, a team at ABC acquired FDA documents showing that the number of serious adverse reactions to Levaquin has soared to 200,000—including at least 3,000 deaths.
This past November, in one of the biggest hearings on the drug to date, 30 patients suffering serious side effects went before a panel of experts at the FDA. The group urged the FDA to take make clear on the label that Levaquin is not appropriate for minor infections, which it has not done. Since its release, Levaquin has been prescribed over 300 million times.
One of the members of the November panel was Dr. Tobias Gerhard, a researcher at Rutgers University and pharmacoepidemiologist who looks at the effects and safety of drugs in populations. “What became clear in the advisory committee hearing is that the patients weren’t aware of these risks,” says Gerhard. “It wasn’t a conscious decision and a risk they knowingly agreed to take.” Gerhard says that if quinolones were prescribed less frequently as first-line treatments for mild conditions, as they should be, the serious side effects would occur more rarely. “
Michael Carome, the new director of Public Citizen’s Research Group, takes a less measured approach at Levaquin, calling it one of the most overused antibiotics in the country. “It’s overprescribed for uncomplicated things,” he said. “There are much safer antibiotics that people should use.”
Carome is not shy about implicating the pharmaceutical industry.
“Too often the reason the drugs are overprescribed is because of aggressive marketing by drug reps and other people who push the newest drugs to physicians,” he said. “That’s one contributing factor; the other is that physicians and other prescribers aren’t well informed.”