Cholesterol drug manufacturer target of $40M lawsuit

LONDON, Ont. -- Local lawyers are taking on drug giant Pfizer and its billion-dollar blockbuster Lipitor, claiming the company knew or should have known its cholesterol-fighting drug would cause some Canadian women to get diabetes.

For more than 16 years, the lawyers allege, Pfizer Canada and its global parent knew Lipitor could cause blood sugars to rise. But while the Japanese were warned as early as 1999 that diabetes might result, Canadian women weren't told of that risk until 2013, alleges a class-action lawsuit seeking $40 million in punitive damages plus up to $1.2 million for each woman affected.

"Why did it take from 1999 to 2013 to tell (us)?" said Sabrina Lombardi, a lawyer at McKenzie Lake taking aim at a drug whose annual Canadian sales have been as high as $1.1 billion, and for some years, the top- selling medication in the country.

Pfizer Canada hasn't filed a defence yet in court but was quick Wednesday to defend Lipitor when asked about the lawsuit, whose allegations have not been tested in court.

"There is an overwhelming consensus in the medical community regarding the benefits of Lipitor (in) men and women," company spokesman Christina Antoniou wrote in an e-mail to Postmedia Network.

"The safety and efficacy of Lipitor is supported by nearly two decades of research and more than 400 ongoing or completed clinical trials involving over 80,000 patients."

The clash of scientific claims isn't limited to Canada; more than 1,600 Lipitor lawsuits have been filed against Pfizer in the U.S., where legal rules require drug suits to be filed individually instead of as a class.

More than a dozen Canadian women so far have asked the London law firm for help, including Brenda Spearman, 51, of Winnipeg, who started using Lipitor in 2006 and was diagnosed with diabetes two years later.

It wasn't until 2013 that the product description for Lipitor on Health Canada's website noted a link with diabetes -- the drug could slightly increase blood sugar and patients should discuss with doctors the risk of diabetes.

"I felt kind of betrayed," Spearman said. "The more I found out, the madder I got."

Lipitor headlines a class of drugs, called statins, designed to lower a type of cholesterol believed to play a role in heart disease. Statins have become the drug of choice for people with risk factors for heart disease even without evidence of disease.

While sales of Lipitor have been robust around the world, Canada has been a cash cow. In 2010 alone, the country spent $1.1 billion on the drug, roughly 10% of global sales.

Big bucks in Canada came because guidelines here narrowed the choice of statins to two and regulators bargained for a lower price for Lipitor than what it costs in the U.S., an expert with the Ottawa Heart Institute says.

But while Lipitor has been an economic juggernaut, the lawsuit claims women have been harmed by its use and misled by its maker. The suit alleges Pfizer:

-- Conducted clinical trials that show those taking Lipitor ended up with high blood sugar three time as often as those receiving a placebo.

-- Had data that showed Lipitor was "causally related" to Type 2 diabetes and the incidence of high blood glucose was higher in women.

-- Didn't properly monitor or act upon reports of adverse reactions.

-- Knew there was a lack of evidence Lipitor helped women.

-- Misrepresented risks of the drug and engaged in "deceitful marketing."

"Pfizer offered misleading expectations with respect to the utility and safety of Lipitor," the lawsuit alleges.

In 2011, a study in the leading journal the Lancet found Lipitor increased the risk of developing diabetes, while two other studies concluded women who used the drug were more likely than those who did not of developing the disease, the lawsuit alleges.

http://www.torontosun.com/

Graham