All major drug manufacturers have been accused of wrongdoing at one time or another, and Johnson & Johnson is no exception.
Most recently, five users of the Johnson & Johnson drug Levaquin accused it and the company's Janssen unit of deliberately downplaying the drug's side effects to avoid a decrease in sales of the medication. Five users of the antibiotic filed a lawsuit claiming the drug was mislabeled and misbranded, which led to “significant harm and/or death to consumers…”
In addition to Johnson & Johnson and Janssen, former FDA commissioner Margaret Hamburg was also named as a defendant in the lawsuit. Plaintiffs are seeking more than $800 million, $120 million of which is in compensatory damages and $750 million in punitive damages.
Levaquin is an antibiotic medication prescribed by doctors to treat bacterial infections. It is part of a class of drugs known as fluoroquinolones, popular because they are able to treat such a wide variety of infections. Some of the most common uses include respiratory and urinary tract infections.
In November 2015, the FDA held a hearing at which more than 30 Levaquin users spoke of their experiences, which included chronic pain and fatigue following their use of the medication. Many said they “… lost years from their lives…” because of the side effects of the drug, and one of the plaintiffs in the Levaquin lawsuit, reported feeling “… tired all the time…” with “…pain every day…”
Following the hearing in November, the FDA's Antimicrobial Drugs Advisory Committee, as well as the Drug Safety and Risk Management Advisory Committee called for a black box warning to be included on all fluoroquinolones after the drugs were linked to side effects including peripheral neuropathy, heart problems, tendon damage, and various skin conditions. Though these side effects, as well as hypersensitivity and myasthenia gravis (muscle fatigue and weakness) are mentioned on Levaquin's label, users feel the manufacturer did not go into specific enough detail or do enough to warn them of the severity of their risk.
Serious Concerns Over Levaquin and Heart Health Issues
In addition to fatigue and chronic pain, fluoroquinolones might pose an even greater threat. Recent studies have linked the drugs to aortic dissection and aortic aneurysm. Two recent studies found up to a tripled increase in risk for aneurysm in patients using fluoroquinolones.
The most recent lawsuit is just one of thousands faced by Johnson & Johnson in relation to Levaquin. The first case to go to trial resulted in the company paying the plaintiff $1.8 million after it found it did not properly warn of the side effects. There are additional federal cases in multi-district litigation in Minnesota and New Jersey, with hundreds settled so far.
Despite decades of issues with fluoroquinolones, many doctors still feel the drugs are valuable and continue to prescribe them, increasing the odds there will be even more lawsuits forthcoming.