Six plaintiffs filed an $800 million lawsuit (PDF) against former Federal Drug Administration chief Margaret Hamburg and health giant Johnson & Johnson, accusing them of hiding the dangers of the antibiotic Levaquin to increase profits.
There are many unconvincing claims in the lawsuit, but that the lethal effects of the drug were not adequately communicated to physicians is not one of them.
“The pain is almost unbearable in both legs and left shoulder,” a user named Diane wroteon Consumer Affairs in October. “I am now walking with a cane.” Ruptured tendons, which Diane was diagnosed with, are a rare but serious side effect of Levaquin, as are a host of other physical and mental issues.
“I can barely walk,” another named Linda wrote one month ago. “Can’t sit or lay without discomfort.”
Filed as a federal racketeering lawsuit, the complaint is as salacious as it is tenuous, 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 whom the Southern Poverty Law Center calls a “pathologically litigious attorney.” His argument hasn’t made it far on the Internet and likely won’t in court—because, as the attorneys for Johnson & Johnson argue: “This is a product liability suit wrapped in a conspiracy theory.”
Hamburg’s attorneys called Klayman’s lawsuit “patently false,” “defective,” and lacking in factual evidence. “We are confident the court will dismiss his claims in their entirety,” they said in a statement to The Daily Beast. “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.”
The concept that the FDA chief conspired to get rich by gaming the system will be a tough one to prove and, as of now, Klayman’s complaint lacks the evidence to do so. The already weak claim is further discredited by the fact that Klayman routinely finds creative ways to attack President Obama and the Clintons, the latter of which he has sued 18 times.
But while the suit may not have merit, it revives a critical conversation about the drug in question. Hamburg’s intentions aside, the fact remains: Warnings surrounding the popular antibiotic Levaquin have been dangerously insufficient. The drug, capable of causing debilitating tendinitis, permanent nerve damage, and even psychosis, is meant to be reserved for severe life-threatening infections.
Instead, it’s a 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 (PDF). With a panel of experts urging the FDA to add further warnings, the question of how this happened seems secondary to a more urgent one: Why hasn’t it been fixed?
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, such as hospital-acquired pneumonia and anthrax inhalation. For this reason, the drug is incredibly valuable to the medical world.
But the strength with which Levaquin operates is a double-edged sword, leading to a host of side effects that patients allege have been underplayed. Most commonly, these include nausea, vomiting, diarrhea, headaches, and insomnia. Less often, but well documented, are 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. The six plaintiffs in Klayman’s case are a small sampling of a larger problem that, according to the science world, experts have known about for decades.
Levaquin began causing problems soon after hitting the market, but reports on the negative effects were scant. 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 did not agree to send a letter to doctors highlighting the risks. The black box did little to curb prescriptions and by 2010 Levaquin was the best-selling antibiotic in America.
Patient complaints began pouring in online as academia attempted to piece together the issues. 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.
Eventually, users suffering long-term consequences from Levaquin began taking legal action. 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.
Their stories resemble those in the 72-page complaint that Klayman filed (PDF), in which six plaintiffs describe being injured by Levaquin. One of them, Terry Aston, told a local ABC affiliate that taking the drug to treat a non-serious infection ruined her life. “I’m tired all the time,” Aston said. “I have to really push to get anything done. I have pain every day, all day, throughout my body… I can’t lift things like I used to.”
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 told local news.
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.
Among them was Michael Christian Kaferly, an engineer with a young son whose body began deteriorating in 2008 while he was taking Levaquin to treat a minor cold. “I quickly went from an intelligent and healthy man who worked out almost daily to being bedridden, unable to understand the world around me and in horrific pain not of this earth,” Kaferly told the panel.
Seven years later, Kaferly—who was diagnosed with mitochondrial damage—said Levaquin had “hijacked” his life. “In 2008 there was no warning about mitochondrial damage,” he said. “If the FDA protected me and allowed me to make an informed decision, I absolutely would have chosen to keep the cough.”
Also on the panel was 45-year-old Rachel Brummert, who suffered nerve damage and 10 ruptured tendons after taking Levaquin for a sinus infection. “I am living proof that the risks in using a fluorquinolone to treat a routine infection far outweighs the benefits,” Brummert told the panel. The panel agreed with her, voting 21 to 0 that Levaquin is not appropriate for minor infections.
The group urged the FDA to take make this clear on the label, which it has not done.
While the FDA said it does not comment specifically on pending legal matters, it has released a statement saying that it “takes concerns raised about drugs very seriously.” Janssen Pharmaceuticals, the branch of Johnson & Johnson that makes the drug, told The Daily Beast that its “first priority is the well-being of the people” who take Levaquin.
Jennifer Norton, a spokesperson for Janssen, confirmed that the drug is still marketed as appropriate for uncomplicated urinary tract infections, a condition which she says it has “proven to be safe and effective” in treating.
Since its release, Levaquin has been prescribed over 300 million times. Norton says that despite the recommendations of the FDA panel, that the company believes the existing label “appropriately reflects the current understanding of the safety and efficacy of the fluoroquinolone class,” adding that Janssen is continuing to work with the FDA panel as part of an “ongoing collaboration to support the safe and appropriate use of fluoroquinolone antibiotics.”
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. In an interview with The Daily Beast, Gerhard said that he left the meeting in which 30 patients shared their plight convinced that safety warnings about the drugs have not been adequately communicated to them
“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. “It’s difficult for doctors. Generally they feel that quinolones are safe—and for the vast majority of cases they are,” he says. “But if you give quinolones to enough people, you’ll see a significant number of serious adverse effects, even if they are rare.”
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.”
Despite the drug’s severe side effects, Carome isn’t advocating to get it off the market (which Public Citizen has succeeded in doing with 38 drugs). “For certain infections, such as a serious UTI where you’ve become septic, fluoroquinolones’ benefits outweigh these risks,” he says. Instead, like other activists, Carome wants the pharmaceutical industries to stop marketing the drug for minor infections—a concept that, given their billion-dollar budgets, will only happen if the FDA changes the label.
Whether Klayman’s lawsuit will go to court or not remains to be seen. If so, given the CDC’s new report calling one in three antibiotic prescriptions unnecessary, it’s likely to have company.