Newark, NJIt seems like Johnson & Johnson (J&J), the makers of Levaquin through its subsidiary, Janssen Pharmaceuticals, has more to worry about than tens of thousands of levaquin lawsuits. Now, in a move that is not unprecedented but is nonetheless rare, an investment firm with shares in J&J is trying to force the manufacturer to be held accountable for levaquin side effects and other injuries allegedly triggered by the powerful antibiotic.
As reported in the Star-Ledger (01/08/12), Harrington Investments has filed a shareholder's proposal with J&J, asking the manufacturer to describe any new initiatives intended to address the health and finances of patients adversely affected by the fluroquinolone antibiotic.
J&J is already facing many a levaquin lawsuit over the drug's risk for tendon ruptures, a debilitating injury that can severely impact an individual's life and livelihood. John Fratti, a former pharmaceutical rep whose health, he says, was severely affected by Levaquin, knows the fallout well. Today he works as a patient advocate for the US Food and Drug Administration (FDA).
The manufacturer of the levaquin medication has petitioned the US Securities and Exchange Commission (SEC) to disqualify the proposal from Harrington, according to a spokesperson, who noted that J&J continues to address the safety issues associated with levaquin tendon rupture. "We're very sensitive to the issues," said J&J spokesperson William Price.
However, an attorney specializing in corporate responsibility plans to formally submit the Harrington proposal to the SEC, with a view to letting the regulators decide whether or not the proposal belongs on the J&J proxy statement.
Harrington Investments, described as a socially responsible firm, feels that given the problems over levaquin tendon and the sheer volume of levaquin lawsuits, the manufacturer should be forced to address the issues raised in their proposal.
"When something generates this much litigation and this much negative attention," said Jack Ucciferri, director of research and advocacy for Harrington Investments, "maybe it's time to take a look at whether the product is worth the hassle??"and the expense," Ucciferri said. "We were appalled at the number of lawsuits."
And yet, according to the Star-Ledger, Levaquin continues to be one of J&J's biggest sellers. IMS Health reported that the antibiotic generated $1.5 billion in sales for the manufacturer on 2010.
The possibility of levaquin side effects tendon has always been a concern since the powerful antibiotic, intended to treat the most serious and stubborn of infections, was brought to the market in 1996. However, over that time the popularity of Levaquin has snowballed, together with increased reports of tendon ruptures as Levaquin took hold with the wider population.
Warnings have stepped up over the years, with black box warnings against the potential for levaquin torn tendons as well as for the potential to worsen symptoms of myasthenia gravis.
Public Citizen (PC), the consumer advocacy group, has been fighting with J&J and the FDA over the need of better warnings for years, employing tactics such as a legal challenge against the FDA in 2008 in an attempt to force the regulator to mandate a black box warning for levaquin and Achilles tendon problems.
Dr. Sidney Wolfe, who heads PC's Health Resource Group, indicated that in spite of the manufacturer's claims it is doing everything possible to warn the public and address issues surrounding its levaquin medication, "the company had every ability to do something sooner," Wolfe said.
"But the truth is, the more warning there is on a drug, it will arguably reduce the use of it."
Harrington Investments, based in California, wants to see J&J undertake for alleged victims of Levaquin outside of litigation. Fratti, who has had opportunities to address J&J shareholders in the past, supports the idea of establishing some kind of program to help alleged Levaquin victims.
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