Statement of Claim (Text)
Johnson & Johnson, the US pharmaceutical giant which manufactures the potent antibiotic Levaquin, has been settling thousands of lawsuits filed against it out of court in the United States. That is now causing uncertainty about whether a proposed class action suit against Johnson & Johnson and Levaquin (known generically as levofloxacin ) in Nova Scotia will move forward.
Wagner & Co., a class action law firm based in Halifax, has filed a Statement of Claim in the Supreme Court of Nova Scotia on behalf of clients in Atlantic Canada who have suffered possibly compensable injuries after taking Levaquin. But the firm is also weighing the benefits of proceeding with individual cases only.
A powerful and popular drug
Levaquin was approved by the US Food and Drug Administration (FDA) in 1996 and by Health Canada in 1997. It was heralded as a wonder drug, an antibiotic that cured infections others couldn’t.
In 2002 and 2007 the FDA insisted that all pharmaceutical companies manufacturing Levaquin place warning labels on the drug to alert doctors to possible tendonitis and tendon rupture, especially in patients over 60 years of age.
By 2008, the FDA warning had been upgraded to a black box warning, the sternest warning from the FDA that a medication can carry and still be sold in the US.
Despite the order, Johnson & Johnson did not add labels to their product. Not long after 2008, lawsuits began to be filed by users of Levaquin in the US, most of whom had suffered tendon rupture.
More than 450 reports of adverse reactions have also been reported in Canada since 2008.
Side Effects
The injuries allegedly suffered as a result of taking Levaquin are clearly horrific. They include spontaneous tendon ruptures, tendonitis and retinal damage, usually within four to six weeks of taking Levaquin. Many patients require invasive, possibly life-altering surgery to repair the damage.
Dr. Judy Mader, a family physician who operates a busy practice from the Professional Building at 5991 Spring Garden Road in Halifax says Levaquin is an “excellent drug”.
Mader was surprised to learn that there was a possible class action lawsuit involving Levaquin and says she has never had a patient complain of side effects, especially involving tendons.
Where the lawsuits are headed now
Michael Dull, class action lawyer/ photo: Anne Calder
Michael Dull, a class action lawyer with Wagner & Co, says that lawyers in the US are not allowed to litigate pharmaceutical cases as class action suits. Instead they proceed as ”multi-district litigation”. All cases from one jurisdiction fall under the management of one judge.
The opposing parties then pick two or three of their most hopeful cases from the larger group. These cases – or “bell weather” cases – are heard in court and at the end of the process both sides should know the strengths and weaknesses of their respective positions, says Dull.
Johnson & Johnson is surprisingly quiet in its financial statements and on its website about lawsuits, including Levaquin.
However, Bloomberg reported recently that “in a filing in federal court, the drug maker said it had agreed to settle, for an undisclosed sum, 845 of the legal actions brought by patients who claimed the drug maker didn’t do enough to warn about the dangers of antibiotic Levaquin, which has been tied to tendon problems. It is in negotiations to settle another 190 of the cases.”
US courts also allow pharmaceutical companies to use the defence that their failure to warn physicians of the possible side effects of taking Levaquin would not have made a material difference if the physician had been warned, a defense that is not available in
This defense favours the pharmaceutical companies and for that reason, many settlements in the US have been marginal. Dull says drug companies tend to fight these cases and spend millions of dollars on legal fees, rather than chance paying individual awards, which in the US tend to be large.
In the US in 2013, the Minneapolis District Court alone had 1,879 cases filed against Johnson & Johnson with respect to Levaquin. Of these, 1182 were settled out of court by the company and 153 were still in negotiations.
There were also 1228 active cases in New Jersey, 898 due for dismissal because of settlement.
Johnson & Johnson is surprisingly quiet in its financial statements and its website about its various lawsuits, including Levaquin. Bloomberg reported that “in a filing in federal court, the drugmaker said it had agreed to settle, for an undisclosed sum, 845 of the legal actions brought by patients who claimed the drug maker didn’t do enough to warn about the dangers of antibiotic Levaquin, which has been tied to tendon problems. It [the company] said it is in negotiations to settle another 190 of the cases.”
What this means for litigation in Nova Scotia
Dull says approximately 30 people have contacted his firm and he believes that roughly half of them have a compensable injury. Nearly all involve tendon ruptures or tendonitis in clients in their fifties or sixties.
But Wagner & Co. is also weighing the benefits of proceeding on an individual basis for a small number of clients who have suffered the most serious injuries and have the strongest cases, in the hope of receiving more appropriate compensation if they are successful. The full extent of their losses are individually assessed in those cases and awards are generally much more beneficial.
Although Dull believes his firm has the makings of a strong class action suit, he says that the US settlements have tempered some of the enthusiasm in Canada and Wagner & Co. has yet to determine if the class action suit will proceed.
Dull explains that class action suits are more the norm in pharmaceutical cases in Canada because the cost of experts’ fees, and hiring one lawyer just to peruse millions of pages of documents about a drug’s development is normally just not going to happen. A lawyer or law firm will not do that much work for say, a percentage of an $80,000 settlement. But they likely will if they can get a percentage of 80,000 people who are potentially worth that much money.
Dull believes his firm has the makings of a good class action suit,but he says there is no doubt that the US settlements have tempered the enthusiasm in Canada and Wagner & Co. has yet to determine if the class action suit will go forward.